Medicines and Medical Devices Bill
Monday 2nd March 2020
(4 years, 8 months ago)
Commons ChamberRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts
The Secretary of State for Health and Social Care (Matt Hancock)
I beg to move, That the Bill be now read a Second time.
While the world grapples with the challenge of coronavirus, it is vital that we do not lose sight of the important long-term reforms that we must make. Medicines and medical devices are evolving faster than ever. Not long ago, we could only record an ECG with hospital-grade equipment; now we can do it at home with a cheap device linked to our phone. Already, artificial intelligence is being used to discover new drug compounds. Now that we have left the European Union, we need a regulatory system that is nimble enough to keep up with those developments while maintaining and enhancing patient safety. That is what this Bill will achieve.
The aims of the Bill are fourfold. First, it gives us the means to depart from EU rules and regulations in future, moving at a faster pace, if that is what we choose to do as an independent, self-governing nation. Secondly, it ensures that we can easily amend regulation through secondary legislation without having to bring a new Bill before the House every time we need to revise the rules. That means our system of regulation will be flexible and responsive, quick to adapt to innovation and quick to respond when a safety issue emerges. Thirdly, the Bill will strengthen patient safety by strengthening the Medicines and Healthcare Products Regulatory Agency, our world-class medicines and medical devices regulator. That includes giving it powers that were not available under the EU, including over registration of devices and disclosure. Fourthly, the Bill will ensure that we strike the right balance between capturing the benefits of innovation without compromising patient safety.
Sir Desmond Swayne (New Forest West) (Con)
All those objectives of the Bill require a level of investment to bring about the innovations that we seek. The Prime Minister made a commitment of £200 million in September. How much private sector money does the Secretary of State expect that to leverage? What is our ambition?
Matt Hancock
We do not have a figure for medicines and medical devices specifically. As a nation, we have a goal that we should reach 2.4% of GDP spent on research. We are increasing the medical research budget; for instance, we are doubling the budget for research into dementia. As my right hon. Friend rightly points out, the public budget for research is only one part of it. There is huge private sector and charitable sector investment —for instance, from the Wellcome Trust. The Bill will allow research money—whether it comes from the public sector, private sector or third sector—to go further and get medicines and medical devices to NHS patients faster, as well as supporting our life sciences sector.
Steve McCabe (Birmingham, Selly Oak) (Lab)
I recognise the Secretary of State’s support for innovative medical technology. I am interested in the registers to which he referred, covered in section 13 of the Bill, and in particular the need to ensure that we get the maximum benefit without their being too onerous. Will he give an assurance that there will be some kind of consolidation where there are multiple registers in the same field and that we will only collect information that is specific to the subject stated for the registers?
Matt Hancock
It is almost as though the hon. Gentleman has read my speech. That is the broad intent of that part of the Bill. I will come to it in more detail in a moment, and I am glad about the constructive tone that has been adopted across the House when discussing the Bill.
As I said, the fourth purpose of the Bill is to get innovation while not compromising patient safety—indeed, I would argue that we will enhance patient safety by being able to use modern techniques. It will do that by requiring the Secretary of State to have regard to the safety of medicines and medical devices; to the availability of medicines and devices, because sometimes getting availability as fast as possible is crucial for both innovation and patient safety; and to the attractiveness of the UK as a place to conduct clinical trials and bring medicines and medical devices to market. I will come on to clinical trials in more detail.
Let me turn to the main parts of the Bill. The first part, covering clauses 1 to 7, gives us the ability to update the law relating to human medicines—for example, to reflect changes in manufacturing methods or new types of product. We need that ability because coming down the track are cutting-edge personalised medicines that a hospital might literally have to assemble at the patient’s bedside. Those include gene therapies, medical gases and 3D-printed tablets—bespoke treatments so tailored to the individual that they will only be produced once, with a shelf life that might be measured in minutes. It is just not appropriate to regulate those kinds of treatment in the same way as a mass-produced factory drug, with mandatory batch numbers and packaging information. The Bill gives us the flexibility to respond to those developments. It also allows us to make changes to the regulation of clinical trials, ensuring that we are a globally attractive market to test new drugs and treatments.
But the Bill is not just about the latest science and innovation. It also means that we can update the rules on things such as labelling requirements—for instance, whether the leaflet in a pill packet should have a digital equivalent; rules on how online pharmacies ensure that medicines reach their intended customer; and rules on how the medicine brokerage market works.
We have said that we want to do more to boost the role of our brilliant community pharmacists, and the Bill helps us to do exactly that. It will allow us to remove the barriers to hub-and-spoke dispensing once EU rules no longer apply. Large companies such as Boots already do that, but the law as it stands prevents small, independent pharmacies from joining this kind of arrangement if the hub is not part of the same retail business as the spokes. That is an unnecessary barrier for smaller businesses in the pharmacy sector, and the Bill means that we can remove those barriers.
It also allows us to continue to add to the range of healthcare professionals who can prescribe medicines, which will relieve pressure on the frontline NHS, and it gives us the ability to make rapid changes to regulations to ensure the availability of and access to medicines in an emergency; I am sure we can all understand right now why that is important. Nothing in the Bill changes all the regulations immediately. Instead, it is about getting ahead of the game and giving us the power to make these changes as and when we need to, suitably scrutinised by Parliament.
The next part of the Bill concerns veterinary medicines. It broadly replicates the first part, giving us the ability to amend or supplement the Veterinary Medicines Regulations 2013. Changes could include, for instance, how veterinary medicines are supplied and the information that must be supplied with them. It sets out that, in making new regulations, we have an obligation to consider the safety of the medicines in relation to animals, humans and the environment. These are important matters, not least for me as the Newmarket MP. The Bill will ensure that we have a veterinary medicine system that is fit for purpose.
The third part of the Bill deals with the medical devices regulatory framework, covering everything from MRI scanners to embolisation coils and pacemakers to prophylactics. Like the first part, it allows us to fast-track a new diagnostic test in response to an emerging disease.
Ben Everitt (Milton Keynes North) (Con)
Is this not an example of how, having left the EU, we can now move at a much faster pace on a lot of regulatory things that are really important to our constituents?
Matt Hancock
Yes, that is right. This Bill empowers us to be able to move faster. Essentially, it empowers the UK to build a life sciences regulatory framework that is the best in the world—of course, working with EU partners, but also with partners from right around the world—and all with the intention of getting the most innovative products, as quickly as possible and as cost-effectively as possible, into the NHS. That is the goal of the entire Bill. It is a benefit of Brexit, but it is also worth doing in its own right.
The measures to strengthen innovation with respect to diagnostic tests again strengthen patient safety, because they strengthen the role of the Medicines and Healthcare Products Regulatory Agency. This includes, for instance, allowing us to legislate to create a comprehensive statutory register of medical devices in the UK. Such a register could be held by the MHRA, and we would make it compulsory to register a device along with information such as who manufactures and supplies it. This would mean that the MHRA could conduct post-market surveillance of devices in the UK, making it easier to trigger device recalls where a safety concern arises.
Indeed, we will enhance patient safety by giving the MHRA a new power to disclose to members of the public any safety concerns about a device. This was not possible while we were part of the EU. Previously, if an NHS trust raised a concern about a device and asked if similar reports had been received elsewhere, too often the MHRA was restricted in sharing that information; nor could it always routinely share information with the Care Quality Commission or other NHS national bodies. This Bill gives us the ability to share vital information about reporting patterns with the NHS family, and where necessary with the public, with enforcement powers that will be proportionate, transparent and suitably safeguarded.
Dr Philippa Whitford (Central Ayrshire) (SNP)
I do not recognise the Secretary of State’s description that it was not possible to inform NHS bodies of concerns about machinery or devices. In my 33 years on the frontline, we received daily information about anything that was considered a danger or a failing, so I do not recognise that.
Matt Hancock
In some cases it was possible to share that information but not in all cases, and it will be possible now. I have no doubt that the hon. Member, like others on the frontline, will have received some information, but the MHRA is currently limited in the information that it can share with other NHS bodies. We are removing the limits on that information sharing, which of course needs to be done appropriately, but should not be set in primary legislation.
Our goal is this: we want the UK to be the best place in the world to design and trial the latest medical innovations. This Bill gives us the powers we need to make that happen. It will mean that the NHS has access to the most cutting-edge medicines and medical devices, with enhanced patient safety; it will help our life sciences seize the enormous opportunities of the 2020s, supported by a world-leading regulator; and it will help us pave our way as a self-governing independent nation. I commend the Bill to the House.
Jonathan Ashworth (Leicester South) (Lab/Co-op)
We do not intend to divide the House on the Bill this evening. We understand the need for the Bill because its purpose is for the UK Government to take the powers they need as a result of Brexit. In that respect, we broadly support the principles of the Bill, and we offer to work constructively with the Government on strengthening and improving aspects of it. I have a couple of remarks to make that are related to this, but not to the exact contents of the Bill.
May I start by saying that we all know, not least because of the coronavirus outbreak, that disease knows no borders and defeating disease cannot be done in isolation? International co-operation and research and development are vital and must be accelerated, not hindered. Will the Secretary of State—or indeed the Under-Secretary of State for Health and Social Care, the hon. Member for Bury St Edmunds (Jo Churchill), in her winding-up speech—explain or comment on the press reports today suggesting that the UK is not seeking to participate in the EU pandemic preparedness measures, which may obviously help in relation to coronavirus and other future outbreaks?
I am of course talking about the early warning and response system. It was suggested in The Daily Telegraph today that No. 10 had overruled the Secretary of State. Since then, a former Minister, Baroness Blackwood, has told Sky News:
“My advice while I was in there was that I thought it was absolutely appropriate that we should stay engaged with that system… I think this is something that the EU would want to maintain and we as Britain should seek to maintain.”
I agree with her. I believe it would be foolhardy to pull out of something like this at the best of times, but to do so at the time of an outbreak such as this is surely putting narrow dogma before the public health of the country. I would be grateful if the Minister responded on that.
Secondly, we also learned at the weekend that the UK will not participate in the unified patent court, which will make developing medicines here in the UK more expensive, not cheaper and easier, and it may make doing clinical trials here less attractive. The Government have done lots of briefing on this Bill, but over the weekend they slipped it out while briefing trade magazines that the UK will not be seeking involvement in the unitary patent system. Again, that is disappointing, and I would welcome some remarks from the Minister on that front when she sums up.
However, this Bill is important, and we do not want to see anything that undermines what has been built up over many years in the United Kingdom. We do have much to be proud of in the field of medical innovation. We have long history of taking a leading role in scientific advance and novel trial design. Indeed, the recent deal to give NHS patients early access to a new cholesterol treatment demonstrates that the UK is already a world-leading destination in which to develop cutting-edge treatments. We want to build on that, not undermine it.
Members across the House will be aware that our pharmaceutical industry is the single largest private sector investor in UK R&D and provides many jobs across the country for many of our constituents. We should be proud of that sector and of the contribution that life sciences make in providing access to the most cutting-edge treatments. We should be proud that they are vital to economic growth, enhance UK productivity and ensure prosperity for the future.
Yet while the opportunities before us to develop medicines and medical devices are transformative—both saving lives and radically improving the quality of life for those with the most debilitating of conditions—we also know that things can go wrong. There must never be any compromise on patient safety. Patients put their trust in practitioners, literally trusting them with their lives, and they rightly expect medicine and medical devices to be safe, yet too often in recent years the system has failed patients.
For many years, long before I acquired the health brief in my party, I worked closely with a constituent, Emma Friedmann, who has campaigned for justice for women whose children were impacted by sodium valproate. Members from across this House have spoken with passion and eloquence on behalf of women affected by Primodos. Equally, we have heard heartbreaking stories in this House about the surgical mesh scandal. My hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson), the shadow Minister, has been one the leading campaigners on this issue, along with colleagues across the House. We eagerly anticipate the Cumberlege independent medicines and medical devices review, but there have been other scandals too—breast implants, hip replacements—that are not necessarily covered. We would welcome an update from the Minister about that review and some remarks on whether the Government expect to implement its findings.
My point is that a robust regulatory framework for medical devices to protect patients and users is paramount. We will be testing this Bill to ensure that it provides the safety standards that our constituents deserve, while at the same time ensuring it is forward looking enough to be the correct framework to capture the fast pace of innovation in this field, which the Secretary of State mentioned. However, I believe that the existing regulatory framework has become complex and, arguably, unwieldy.
The House will be aware that much of the regulatory landscape derives from EU directives that have been implemented in domestic legislation. At the end of the transition period, these frameworks will be preserved as retained EU law, but as I understand the Bill, the Secretary of State is proposing to take delegated powers to allow these existing regulatory frameworks to be updated without the need for primary legislation. The Bill requires the Secretary of State, as he said, to have regard to the safety and availability of medicines and medical devices, as well as to the attractiveness of the relevant part of the UK with respect to the life sciences sector. We argue that that attractiveness clause could benefit from some definition, and it would allay concerns if the Government accepted an amendment in Committee to indicate that the Secretary of State, or some other appropriate authority, would always prioritise safety.
The overall effect of the provisions is to confer on the Secretary of State an extensive range of delegated powers to make regulations that span the manufacture of medicines, marketing and supply, falsified medicines, clinical trials, fees, information and offences, and emergencies. That extensive range of powers risks inadequate scrutiny of what will become major policy decisions, and in Committee Labour will press Ministers to support time-limiting those delegated powers.
Matt Hancock
I am sure that this debate will continue in Committee, but for clarity, those delegated powers existed under the European Communities Act 1972. The Bill proposes to replace existing delegated powers from the 1972 Act with new powers to make such regulations under the new Act. This is not a new set of delegated powers; it replaces one set with another—indeed, the Bill replaces those powers with clearer safeguards on those matters to which the Secretary of State must have regard.
Jonathan Ashworth
That is a welcome clarification, but I am sure the Secretary of State will agree that it is important that decisions made in this field are properly scrutinised through the usual procedures. We are keen to ensure that by tabling an appropriate amendment in Committee.
We are leaving the EU, but Labour Members consider it essential that we stay closely aligned with it on medicine regulation. With that in mind, the Government should clarify their attitude to new EU regulations such as the in vitro diagnostic medical devices regulation, which is due to be implemented in 2022. As I understand it, that regulation will not automatically apply to the UK. Is it the Government’s intention to align with it? The EU tissue and cells directive is being reviewed. Do the Government intend us to align with it? To ensure that the UK remains a world leader in scientific research and discovery, it is vital that we align with guidelines on clinical trials. Otherwise, patients could miss out on participating in trials and the UK could find it harder to access funding.
Effective joint working with our European partners has been vital for the NHS over recent years on everything from infectious disease control to the licensing, sale and regulation of medicines. Patients in the UK can access EU-wide trials for new treatments and the UK has the highest number of phase 1 clinical trials across the EU, as well as the highest number of trials for rare and childhood diseases. It is vital for improving health outcomes in the UK and EU that the UK continues to access those networks. Otherwise, we run the high risk of patients with rare diseases being adversely impacted.
The Bill contains provisions to extend the range of professions that can prescribe medicines, thereby allowing additional health care practitioners such as paramedics and midwives to be given restricted prescribing rights. We welcome those provisions and, assuming that their competencies have been assessed in the same way as those of other prescribers and that equal safeguards are in place, we support that sensible and timely reform. Will there also be plans for a consultation on the future prescribing rights of physician associates and surgical care practitioners?
I will not say too much about part 2 of the Bill, other than to confirm that any measures that help in the battle against anti-microbial resistance have Labour’s support. Part 3 is about medical devices. I have already commented on the use of delegated powers, and as I said at the outset, patient safety must be the priority and we will look to strengthen regulation in that area. Unlike medicines and drugs, many surgical innovations can be introduced without clinical trial data or centrally held evidence. That is a clear risk to patient safety, and it undermines public confidence. Manufacturers are often in charge of testing their own products after faults have developed and they can shop around for approval to market their products without declaring any refusals.
Two years ago, freedom of information requests to the Medicines and Healthcare Products Regulatory Agency revealed 62,000 adverse incident reports that were linked to medical devices between 2015 and 2018, and more than 1,000 had resulted in death. Most devices are cleared through a pathway that allows new products to inherit the approval status of “substantially equivalent” products already on the market. In some cases, after lengthy chains of equivalence-based approvals, the new devices scarcely resemble the original version. Indeed, a study in The BMJ in 2017 found that the family tree of 61 surgical mesh products related to two original devices that were approved in 1985 and 1996. Unless we fix that and put patient safety at the heart of the regulatory framework, patients will suffer and lack confidence.
We know the Secretary of State is a great champion of and has promoted many health-based apps. We need a robust and sophisticated mechanism to evaluate app-based healthcare for use in the NHS, and in Committee we will look to strengthen the regulation of that. We welcome what appear to be plans for a devices register, and I took note of what the Secretary of State said in his interaction with my hon. Friend the Member for Birmingham, Selly Oak (Steve McCabe). We believe, however, that such a register must provide comprehensive data on who, where, how and why devices were implanted, and by whom, so that any recall could be quickly enacted.
To achieve that, we encourage Ministers to strengthen the Bill by reflecting provisions in existing EU regulation and to ensure there are unique device identifiers, such as serial numbers on medical devices that are labelled with tracking information, as well as the power to track the use of those devices, so that the NHS can find and notify affected patients if and when problems arise. By the same token, the Government must reassure us that with such a register it is practically possible to cover all devices, including everything from implants to bone screws, software, apps, mesh, medical cannulas, pacemakers and so on. That is an extensive list of different devices, and I would be keen to hear how such a register could be implemented practically.
Dr Luke Evans (Bosworth) (Con)
The hon. Gentleman’s point about “why?” is important. As a doctor, I know that things move on, and when someone leaves medical school 50% of what they have learned is out of date. With devices that are likely to exist for 10, 20, 30 or 40 years, looking back it can be difficult to work out exactly why something was implanted. I would like the Bill to request an explanation from the clinician at the time to say what the thinking was. In the future, that would inform people who needed to deal with someone who had something implanted in their heart 20 years ago, for example, by which time the history might be exactly that—history.
Jonathan Ashworth
It has taken me some time, but let me welcome the hon. Gentleman to his place, particularly as a fellow Leicestershire MP. His contribution is well made, and I look forward to working constructively with him on health matters, as well as on various Leicestershire matters. I hope the Minister will reflect on his contribution and answer it when responding to the debate.
The Opposition will not seek to divide the House. We want the Bill to proceed to Committee, and we will work constructively with the Government to improve and strengthen it. It is up to Ministers to allay concerns about patient safety and about the UK’s ability to develop medicines rapidly for NHS patients in the future, and we look forward to a constructive debate on the Bill.
Chris Green (Bolton West) (Con)
It is a pleasure to follow the hon. Member for Leicester South (Jonathan Ashworth) and to speak in this important debate. This is an immensely important subject of great national interest. In the context of leaving the European Union, the Bill will allow existing European Union regulations on medicines and medical devices to be transposed into UK law. The Bill is closely linked to the timings of the transition period as we leave the EU—and perhaps to any extension, which we hope to avoid.
I welcome the Bill’s principal thrust, which is to remove unnecessary bureaucracy for the lowest risk clinical trials, to encourage the rapid introduction of new medicines, to ensure patient safety by combating counterfeit medicines, and to extend the UK’s global lead in personalised medicines and artificial intelligence in health. Ultimately, all those concerns link up to what ought to be our principal focus in this debate: better patient outcomes and creating a healthier society.
Many people would be surprised to hear just what a contribution the life sciences sector makes to the UK economy. It encompasses pharmaceuticals, medical devices and medical technology, and it is worth over £74 billion per annum. The sector also employs close to 250,000 people in the UK. Many of those jobs are often secure, and are highly skilled and highly qualified. We will shortly introduce an immigration Bill. It is right that we focus on the skills and the contribution people can make to the UK. Bringing more people to the UK with PhDs and STEM—science, technology, engineering and maths—qualifications ought to complement and enhance the support of our life sciences sector. The more we hear about technicians, engineers and scientists who want to come to the UK, the more it will be a really positive thing not only for the sector but for immigration to the UK as a whole, and how people perceive it.
Dr Whitford
Does the hon. Gentleman recognise that young graduates with a degree or a PhD, technologists and researchers often do not earn more than the threshold the Government have set for a visa?
Chris Green
That is a significant concern. The Government have reduced the starting point in the immigration Bill from £30,000 to about £25,000 and I believe the points-based system will have the flexibility we require, but those areas should be judged and reviewed as time goes on. Certainly in these sectors we want highly qualified, highly skilled and highly experienced people to come to the UK.
One big concern in medicine is data. A lot of what we do in medicine falls into the category of big data: the acquisition, transmission, storage and application of that data. This is a really interesting time for technology. The devices themselves are able to generate good quality data. As has been highlighted, it is now so much easier for personal devices to be worn not just for a few hours or a couple of days, but for a long period of time. People are now able to go about their daily lives in a normal way, whether they are exercising or doing something as basic as having a shower. Some devices could not previously cope with people taking exercise or having a shower, but increasingly, devices are able to cope. They can amass a vast amount of data. It is pretty much impossible for a clinician or a GP to judge such a huge wealth of data, so we are increasingly looking at how GPs and hospital consultants can use artificial intelligence and other methods to give them a helping hand in carrying out the assessments. They might end up with tens of thousands of pages of data and a consultant just will not have time to consider it all. Using artificial intelligence could help them to do the assessments and come to conclusions.
Munira Wilson (Twickenham) (LD)
Does the hon. Gentleman agree that all Members, on both sides of the House, still have a big job of work to do with the public to inspire confidence in how their data is used in an appropriate and anonymised way? What he is saying is really important. Data saves lives and can improve outcomes, but there is, understandably given previous experiences, a great deal of suspicion among the public about how their medical data might be used.
Chris Green
That is an incredibly important point. We need confidence that when data is taken, it is secure, protected and anonymised in the appropriate way, and that only the right organisations have access to it. I believe that data is a key area for the NHS and what it ought to be able to deliver. The NHS should be a huge repository of data, and universities, charities and businesses, with the appropriate controls, ought to be able to use it. As we move on—perhaps a particular aspect relates to rare conditions—the size of population needed in order to gather and analyse that data will increase. I hope my hon. Friend Minister will take note of this point and perhaps elaborate on it at the end of the debate. We need to ensure that our relationship with the EU will enable us to continue to collaborate on clinical trials and that data transmission across the European Union, and across Europe more widely, is efficient and effective.
Dr Luke Evans
My hon. Friend talks wisely about big data. Big data can be used to empower patients as individuals. Providing them with more data to understand and interpret, if it is provided in the right way, can empower them to make better choices. After all, the biggest under-utilised resource we have in healthcare is our patients. Healthcare is very doctor-heavy and nurse-heavy. Empowering patients helps them to make better choices. For example, patients with diabetes can monitor their own blood sugar. That has revolutionised the way in which people care for themselves. I would like my hon. Friend’s thoughts on whether he thinks we should explore this area further.
Chris Green
That is a vital and well-made point. Data can empower the individual. They can have more detailed access to their own records and their own data. The data generated by someone wearing a device day in, day out, week in, week out can be transmitted to a consultant, who can call a patient more promptly if there is anything a little worrying. If there is a heart murmur or someone feels a bit dizzy, the person can register that concern at that moment. That is useful information for the clinician, who will be able to recognise when someone’s lifestyle has aggravated a condition. There are many ways that the data can be used. I think we are in relatively early days. I am not sure I would include Fitbits and that kind of technology—there is far more interesting and advanced technology—but it is important that people are increasingly engaged.
There is a concern about the embrace of technology, devices and data, and the streamlining of processes in hospitals. The contribution of individuals, GPs and consultants provides an opportunity to consider a more engaged approach to hospital and GP services in a way that could reduce the number of appointments that are necessary. Some hospital trusts have a chief innovation officer on their board. I think there are about 20 across the country, which is a relatively small proportion. It may be worth considering what the Minister can do to promote that. Ideally, we need the early adoption of approved medicines in the system. This is where the register ought to help. If we can have people in hospital trusts leading and championing the adoption of new technologies, providing information and insight, perhaps we can give more confidence to chairmen and boards as a whole. We could then have more trusts adopting technologies. We could therefore support the industry and patients, and get them the medical treatment they need earlier.
Dr Whitford
That might well be the case with gadgets, devices or new digital apps, but with new drugs, it is usually the clinicians who are desperate to get their hands on them. Most new drugs, particularly for challenging conditions such as cancer, are expensive and it will be several years before they are passed by NICE in England or the Scottish Medicine Consortium. The delay is not the clinicians not wanting access; it is the cost of introducing them.
Chris Green
I agree—the hon. Lady makes a good point. What I was saying relates more to devices than drugs. Devices and drugs each have their own challenges and we will hopefully make some progress in resolving those concerns.
One of the concerns about the current system relates to the legal framework, which has been criticised for being complex and lacking in consistency and transparency, and it is somewhat difficult for it to respond quickly to problems, especially when patient safety is at risk. The Bill provides us with the perfect opportunity to streamline our approach to giving access to new and innovative treatments to patients, particularly those with rare diseases and conditions, while ensuring that we are fully committed to a system of regulation for medicines and medical devices that can respond to changes in technology and patient safety concerns as soon as possible. This is more relevant now than ever, given the dramatic expansion of digital health and artificial intelligence, and other rapid advances.
I have some questions about the Bill. Will the Minister provide clarification about the exact role that the Medicines and Healthcare Products Regulatory Agency will play in constructing and maintaining a register of devices that have been approved for industry use? Industry has generally welcomed the idea of registries and their usage, but how will registry data be used in the future? Should the Bill not consider changing the way in which NICE prioritises data? NICE currently prioritises level one data—data gained through randomised clinical trials—ahead of real-world registry data. For medical devices, it is often impossible to conduct a blind, randomised clinical trial, so this level of data is unavailable, making it more difficult to get positive NICE guidance. Can we perhaps consider placing a higher weighting on registry data in decision-making processes and use it to inform outcome measures to assess the success of treatments? Registries could support the collection of data on longer-term outcomes—perhaps five to 10 years, for example, rather than the standard 12 months. There is a very significant concern relating to the contrast between drugs and devices. A drug will perhaps be more likely to have in-year savings or result in an in-year delivery, whereas it might take two, three, four, five or even 10 years to see the improvements, delivery or financial return from a device, or medical technology that has been purchased. It is not certain that the current financial landscape lends itself to longer-term planning.
Will the Minister clarify whether the Bill will include provisions on how countries and notified bodies might be considered competent to make an assessment on behalf of the United Kingdom? This would help to avoid duplication and having to seek approval for new devices and treatments from bodies in different countries that share very similar standards.
Much of industry has expressed the need for further clarification on how closely we will remain aligned with European Union regulations after the end of the transition period. That is particularly relevant to how we conduct clinical trials, particularly for rare diseases, where there are not a significant number of patients to test new ideas on. Maintaining easy access to patients and co-operation around data sharing has been cited as a top priority, so will the Minister clarify whether she intends for us to remain closely aligned with the EU regulations where there is a mutual interest in doing so? The transition from the clinical trials directive to the clinical trials regulation is of particular interest. It has not yet been adopted across the EU and there has been a succession of delays. I understand that it should have been adopted in 2016, but it has been delayed and delayed, and there are plans for it to be adopted later this year if conditions work in its favour.
In conclusion, I welcome the Bill and the framework that it seeks to create by ensuring that the UK remains a global player in the world of R&D. The powers in the Bill provide us with the perfect opportunity to significantly build on and improve aspects of medicine development processes in the UK—notably, by speeding up the approval process. The Bill has been generally welcomed by industry, but I would be grateful if the Minister, time permitting, took note of the questions I have asked and offered as much clarification as possible.
Dr Philippa Whitford (Central Ayrshire) (SNP)
The Bill is necessary because of Brexit, as the UK is losing the European Medicines Agency—one of the great advantages was working together to have a single licensing system that licensed new drugs right across Europe. As the hon. Member for Bolton West (Chris Green) described, it is about working with other countries to avoid duplication and to speed up getting new drugs from the laboratory to patients who need them.
The problem is that manufacturers will have to apply separately to the UK, which means extra processes and additional costs. It is important, therefore, that whatever system is adopted is as similar to the EU as possible and does not ask for a whole different set of work-up, investigation and paperwork, or that will put manufacturers off launching their drugs in the UK. The same issues apply to veterinary medicines, hence they are in the Bill.
The simple fact is that the EU is a market of 500 million people—a quarter of the world pharmaceutical market. The UK on its own is only 3%, which is why drugs tend to be launched in the US and Europe at the same time. In all my 33 years on the frontline, I saw an acceleration of drugs getting from the bench top to the patient, because of the EU and the European Medicines Agency. This means that there are likely to be delays for patients. Canada and Australia wait another six to 12 months before drugs are launched there, so how will the Government avoid a delay in patient access, particularly for new drugs from outside the UK and for conditions such as cancer, where patients are literally waiting for the drug?
Chris Green
I realise that this is a distinct area, but does the hon. Lady share my concern that sometimes the EU as a whole is quite slow at reform—for example, with the clinical trials directive and the clinical trials regulation? The CTD was first devised in 2001. We are now in 2020 and we have not yet updated it. Industry and wider sectors would like the update to happen, but it is taking a very long time.
Dr Whitford
I thank the hon. Gentleman for that point. When we are trying to collaborate and get a group of 28 countries—indeed, 31 countries, because the European economic area is involved—to all agree to such enormous changes, with legal ramifications for their drug and device producers, and so on, it takes time, but in the end, I think it will be worth it. Of course, I would have liked it earlier. Having been involved in breast cancer trials, I know that the clinical trials directive was clunky and bureaucratic, but it is being changed.
Dr Lisa Cameron (East Kilbride, Strathaven and Lesmahagow) (SNP)
I thank my hon. Friend for answering the extremely important points that have been raised. Does she agree that it is also extremely important that those with rare diseases still have access to the clinical trials that can perhaps only take place in the EU, because they need to have so many participants? The UK on its own might struggle to have those clinical trials for rare diseases.
Dr Whitford
That is an excellent point, which I will come on to shortly, and I absolutely agree with my hon. Friend.
The Bill puts attractiveness as a place to do trials and supply medicines almost on a par with safety and drug availability. What exactly does that mean? The shadow Health Secretary was right to seek a definition of that phrase. Is it about cutting red tape? If so, I would point out that one man’s red tape is another man’s life and limb. The Association of the British Pharmaceutical Industry says that the industry does not want divergence or lower standards, or standards that change all the time. Alignment with the EMA and the FDA in America keeps costs down, reduces delays and keeps bureaucracy down. The industry here will have to match EU standards for the bulk of its production and will not be keen on doing small-batch production for the UK only if that has a totally different set of standards.
It is important that the new measures on falsified and counterfeit medicines be taken. The unique identifier number, including barcode scanning, is important, as are tamper-proof containers. There is a whole market out there in counterfeit drugs and it endangers patient safety, which is vital in all of this. As part of that, we will have to negotiate data sharing with the EU and the EMA to enable pharmacovigilance on a bigger scale and make it possible to recognise much earlier patterns of side effects and complications.
How will the Government provide the extra funding and support to the MHRA, which is to take on an extensive area of extra work? How will it combine that with delivering quicker assessments and licensing so as to encourage companies to launch their devices or other drugs in the UK? As has been referred to, there is a need to replace the clinical trials directive, which in the original version was indeed very bureaucratic. As a clinical trialist within breast cancer, I found it to be often quite off-putting. The new clinical trials regulations create an EU-wide portal—a single point of digital registration of trials and collaboration on design, recruitment, data, entry and analysis. Unfortunately, UK-only regulations will not replace that when it finally goes live in 2022.
International collaboration is critical to research, and the European research network is the biggest in the world—bigger than China and bigger than the US. As mentioned by my hon. Friend the Member for East Kilbride, Strathaven and Lesmahagow (Dr Cameron) and the hon. Member for Bolton West, that collaboration is vital for rare diseases, where the number of patients in any one country is low. That is why we have made so much progress in rare diseases, childhood diseases and childhood cancers in the past decade or so—because of funding from the EMA and collaboration on an extensive Europe-wide basis. As regards cancer, my own specialty, half of all UK cancer trials are international, and 28% of Cancer Research UK trials involve at least one other EU state. The BEACON trial for recurrent neuroblastoma involves 10 countries. It was designed in the UK, but the principal investigator is in Spain. Some of the original funding came from the UK, but the drug comes from Switzerland. Ten countries are contributing to trying to find hope for children and families suffering from this horrible disease, for which we are struggling to find a cure. There were 4,800 UK-EU trials between 2014 and 2016. How will the Government maintain that sort of collaboration and involvement?
Part 3 of the Bill relates to medical devices, and I totally agree it is not before time. The EU has also moved to bring in regulations regarding medical devices. It is important to apply similar rules to devices as are applied to drugs. Until now, it has been far too lax. As was mentioned, manufacturers pay for assessments, and I would suggest the same apply to digital health apps. At the moment, the companies that design them assess them themselves. We need instead a neutral and independent system of ensuring that they are safe. Just because something is AI or digital does not mean it will give patients good advice.
Registered clinical trials of devices should report all findings. It is far too common, where there are negative findings or findings of no advantage, that they are not published and that therefore in essence the information is hidden. As we have heard, there should be no tabletop licensing of devices whereby a device is simply migrated from one form to another without being retrialled. This was exactly the problem with vaginal mesh, where in essence the end operation, compared to the original operation in the trials, was unrecognisable. The Cumberlege review should give us food for thought and help us focus on safety and not market expediency. It is also important that there is a system to report complications to the MHRA, like the yellow card system with drugs, so that problems are spotted sooner. Again, across a bigger population that is likely to be quicker.
Implants should also have a unique identifier number that can be scanned as a barcode to the patient’s electronic records, to the hospital episode system and to any registers. A register will be data that is just sitting there and which can be interrogated if someone needs to recall patients with certain implants because of a problem. Following the scandal around PIP implants, which did not have medical grade silicon in them, I remember having to wade through the case sheets of patients who had had breast reconstruction. It was not an implant we had ever used in our hospital, but we had to be 100% certain that no patient treated in the plastics unit in Glasgow had had the implants either. It is critical that we avoid such chaos in the future, and if a register has an expert steering committee, it can become a registry, a dynamic beast that can monitor practice and bring knowledge back to medical practitioners, researchers and so on. One of the earliest and biggest examples is the national joint registry.
The Bill includes provisions to extend low-risk drug prescribing to other healthcare professionals. We all recognise the changes in the workforce that have already happened and which are coming in the future. There are processes for assessing competency and certifying that someone—an advanced nurse practitioner, for example—can prescribe in their own right. The Royal College of Surgeons and the Royal College of Physicians have raised the issue of physician associates and surgical care practitioners. They feel that if prescription powers are to be given to such individuals it is critical that they are registered and regulated, but while these new professions are developing they are not registered or regulated. If this is the future of the NHS workforce across the UK, it has to be dealt with—they need to be registered practitioners.
Jim Shannon (Strangford) (DUP)
The hon. Member refers to physicians and others and to the shortage of doctors, but is there not also a role for pharmacies to play in diagnosing people early on? Is that not something that should be done as well?
Dr Whitford
In Scotland, we have had the community pharmacy system since 2005, which includes that, and the range of protocols for a pharmacist to prescribe against has been increased, but I agree it has further potential. One advantage is that pharmacies are usually open all day Saturday and often have longer hours. For people who are working who have a relatively minor condition, being able to get both advice and treatment from a pharmacist makes a big difference.
Jim Shannon
I forgot to mention that I also believe pharmacies could play a role in diagnosing sight loss, glaucoma and other things—small things that can be done in pharmacy. Is that something else that could be addressed?
Dr Whitford
In Scotland, we put a lot of effort into sweating the assets, if you like, within the community, so optometrists can carry out that job. They no longer refer through a GP. If they diagnose cataracts, for example, they refer directly, and they provide a lot of out-of-hours care for people with acute eye problems, foreign body inflammation, infection and so on, to the point that very few patients now go to A&E with an acute eye problem. We have all sorts of expertise in our communities, and we should use it, so I agree with the hon. Gentleman.
I welcome the Bill’s reference to internet pharmacy provision, but I think that there should be a step up—a whole step change—in the form of stronger action to control internet pharmacy providers, especially in the context of what are described as prescription-only medicines. The son of a constituent who came to see me was able to obtain large quantities of dihydrocodeine, a fairly addictive painkiller, over the internet simply by filling in an online form, having not seen a GP and without producing a prescription. I asked the constituent to find out what the website was so that I could report the organisation, but the website had gone. That is the problem with the internet: it is ephemeral. Unfortunately, that young man has now become addicted to dihydrocodeine, and is trying to be weaned off it. As in the case of other versions of online harm, we need to deal with people who are hiding in the internet: we cannot allow the supply of counterfeit or addictive medicines to patients without any form of control.
I have some concerns about the Bill. For instance, I agree with the hon. Member for Leicester South (Jonathan Ashworth) about the extensive delegated powers. The Secretary of State said that the same powers had been in place when the United Kingdom was in the European Union, but their purpose in the past was to enact EU directives which had been debated and consulted on in the European Council and the European Parliament. They had been worked out before agreement was reached, and were therefore purely about enacting something that had been hammered out and agreed within Europe. That is not the case here. Almost every clause in the Bill simply hands over a delegated power, but I think some of the major changes that are being introduced in the Bill are significant and should be in primary legislation. Of course regulations will flow from that and will be covered by delegated powers, but for radical changes to made purely in relation to such powers represents a missed opportunity, and they should be limited.
Part 3 provides for the maximum sentences for offences against the Bill to be set at six months. In Scotland, the maximum sentence in a summary case is 12 months. Removing that sentencing power in Scotland with no consultation does not seem right, and a presumption against sentences below 12 months there would make custodial sentences less likely. What kind of prevention and what kind of warning will there be if it is clear to people that imprisonment is never going to happen? The civil penalties presided over by the Secretary of State prevent criminal prosecution if either the maximum or a lower sum is paid in advance. That fetters the operation of the Scottish criminal justice system, because those involved in it would lose the right to prosecute if they felt that the issue was serious enough. The Lord Advocate in Scotland should have been consulted on both issues, and I suggest that that should be corrected as the Bill proceeds.
Part 4 does indeed call for consultation prior to any new regulations, but there is no formal mention of Ministers in the devolved Government, despite their responsibility for healthcare. In other Bills with which I have been involved, it has been normal for the Ministers of the devolved nations to be listed specifically. When legislation is to impinge on such a major devolved competency, it is important for them to take part in discussions. I also think it important to have a structure enabling medical bodies, experts and industry to contribute to the consultations, to ensure that all aspects have been considered.
There is no choice but for the Bill to go ahead because of the legislative gap that will result from our leaving Europe and the European Medicines Agency, particularly at the end of the transition period. We will therefore not force a vote, although I hope that we will be able to strengthen some aspects in Committee. Having to leave the EMA is just one example of what we are losing because of Brexit. Far from cutting red tape, Brexit will increase bureaucracy and costs for the pharmaceutical industry, the NHS and patients—and that is even before the possible impact of a United States trade deal on drug costs.
I am concerned by the threat to walk away from negotiations in June and move towards a no-deal outcome yet again. That would increase the risk to patients. Simply calling it an Australian deal does not cut it, because the Australians do not have a trade deal with the EU. I should like to know whether the Prime Minister or the Secretary of State has somehow solved the problem of supplies of insulin and medical radioisotopes, not just for a couple of months around the transition point but in the long term. The UK does not produce insulin or medical radioisotopes, and any friction at the border—which at present looks inevitable—will increase costs and delay access.
I also find it concerning that despite covid-19, which initiated a Cobra meeting this morning, the UK apparently does not even want to remain in the PANDA—Protocol for the Assessment of Nonviolent Direct Action—early warning and response system of the EU post-transition. Such isolationist policies are dangerous for everyone: for our constituents, and for our patients. We cannot get away from it: Brexit is a loss to healthcare and research, and the Bill cannot stop that. The principle of collaboration is central to the EMA, the European research network and, indeed, the EU itself, and it will be hard to replace that if we are throwing up barriers.
Dr Luke Evans (Bosworth) (Con)
I congratulate the hon. Member for Central Ayrshire (Dr Whitford), who has made me feel rather nostalgic. Listening to her speech gave me a flashback to when I used to go to Grand Ronde and hear someone speak so eminently plausibly in many a debate of which I had very little understanding.
Let me make this declaration now: I am a simple GP. When I entered the House, I always said that I would speak about the coalface and what really affected me at that point, and that is why I felt that I needed to speak about the Bill today. I welcome it because I approve of the emphasis on the creation of a world-leading research-driven, standards-based clinical care framework that can drive the UK forward, but two aspects have struck me in particular. The first is prescribing, and the second is trials and tests.
Members on both sides of the House have broadly welcomed the provision for new prescribers, and the flexibility for that within the framework. As the workforce and the demand grow and as the roles change, that new prescription will be necessary. I agree about the importance of ensuring that those prescribers have the necessary due diligence, training and registration, which, after all, will provide the safeguards and the accountability that are needed when it comes to writing a prescription. However, I think that the Bill has missed the issue of prescription waste, or waste medication. On numerous home visits doctors see piles of unused medication, and that does not apply only to their patients: there is a crossover in hospitals and, of course, in care homes. Some of it is purely coincidental as people are taken into hospital or from hospital into a care home, but there is a huge amount of it, and, anecdotally, doctors see it all the time. I have seen patients hand in up to 100 boxes of, say, warfarin, and that cannot be right.
When I consulted the House of Commons Library, it came up with a figure of £300 million a year in losses from 2011 on the basis of only one study. That suggests to me that, over a decade, it is hard to find sufficient information. Last week I spoke in the debate on the Environment Bill, one of whose first principles is that any other legislation should consider environmental impacts. I think that this Bill would do well to take account of prescription waste, which it could do that in a couple of ways.
Pharmacies and, indeed, any dispensers could be asked to legally collect the statistics on returns. That would allow us to see how big the problem actually is, and allow us to create solutions. It might sound strange for someone who has worked in the workforce and had lots of paperwork to be suggesting more paperwork, but at least if we open up the statistics, I am confident that my medical colleagues would look at them and see a way to resolve this.
I would also argue that we should review the charitable donation of medications. I freely admit that there are issues over their storage and over how to check the safety of this practice. However, the problem is not insurmountable if the medications are returned in their original state. If the Government do not address the matter in this Bill, I suggest that they might want to consider it going forward. We could, however, consider a more severe statutory obligation on pharmacies, care homes and dispensers to be far more vigorous in the way in which they dispense their medications and follow up, particularly for repeat prescriptions. Things such as emollients, moisturisers and day-to-day painkillers often pile up and end up on repeat prescriptions, and it is quite hard to monitor them. As someone who has written hundreds of prescriptions in a day, I know that it is very easy to sign them off rather than check them, and if there is no obligation for me to check whether the patient actually needs the medication, who does that responsibility fall to? It is arguably the patient, but if that is not happening, and if there is as much waste as we think there is, I suggest that the Government might want to consider that issue.
Jim Shannon
I recognise the fact that the hon. Gentleman is a GP. I declare an interest, in that I am a type 2 diabetic. At my surgery, my doctors and those who are in charge check my prescription every time to make sure that I am not over-ordering or getting more than I should be getting. Some GPs are doing that already and thereby controlling what medications people get.
Dr Evans
Absolutely, and I agree with the hon. Gentleman that that is exactly what a GP should be doing. However, when a GP is dealing with hundreds of requests for repeat prescriptions, it is unlikely that they will have time to phone every single one of those patients to say, “Is this what you need? Have you already got it?” That has been the role of clinical pharmacists, particularly in relation to people who have multiple prescriptions for four, five or six medications, at the time of their medication review, which I entirely agree with. A GP will indeed look at a medication review, but when someone asks for a repeat prescription, they usually do it either electronically or by making a simple mark or cross on a piece of paper that they take to the GP surgery. It is unlikely, if the prescription has already been set for six or 12 months, that there would be a review of the prescription each month. That is the whole idea of having an annual review. In the old days, people could be on medications for months, if not years, without ever being checked. The reason for doing that was convenience. If a patient had to come in to see their GP every month to justify why they wanted their medication when their condition, say diabetes, was stable, that system would not be sustainable, given the current pressures on the NHS.
My second point relates to trials and tests. For me, another element that is missing from the Bill is a duty of care. I would like to give an example of a patient who came to see me who had had her genome sequenced. She came in with a report, and she said, “Dr Evans, I have been told I have a 50% chance of having cardiovascular issues and an 80% chance of having Parkinson’s disease. Please can you help me out?” That was very difficult to deal with. First, there is as yet very little we can do to influence Parkinson’s. Secondly, at that point I had had no training on counselling someone who had had genomic testing. The cardiovascular side was easier: we know some remits, and we can make a difference with cholesterol, exercise and lifestyle advice. But this is just the tip of the iceberg, and as the tests become more advanced and more people have them, I would like to see emphasis being put on ensuring that those doing the tests have a duty of care to ensure that there is follow-up and comeback for the person who has the test.
Dr Whitford
Does the hon. Gentleman therefore agree that it was completely wrong last year when the NHS in England tried to offer genomic testing for £500 or £600, provided that people were willing to allow the data from their genomic testing to be used in research, without any thought of the outcome that that would generate for general practices right across the country?
Dr Whitford
If the hon. Gentleman thinks that genomic testing for completely asymptomatic people without any family history is a benefit, does he then support the idea that it would only be the better-off people who could afford £500 or £600 who would have the test? Would that not widen health inequalities, which we will be debating on Wednesday?
Dr Evans
I am grateful for the hon. Lady’s point, but I would simply say that the NHS is going that way and will be providing those tests. My simple point is that whoever goes through such a test must have counselling afterwards to tell them what to do with the information. We could put that in law. It does not matter if the testing is done by the NHS or by a private testing facility. If an individual makes the choice to have the test, it must be incumbent on the person doing the test to inform them completely and counsel them throughout the test and of course afterwards when they are given the result. That duty should fall on the NHS, if the NHS has done the test, and on the private provider if the private provider has done it.
Ben Everitt
This is a brave new world for medical science and for the NHS, and we should not let ideology get in the way of getting the data that we need or of trialling things and accepting good ideas when they come our way, while of course taking on board what my hon. Friend is saying about getting it right at the GP end and ensuring that we look after the people who are involved in this pioneering work.
Dr Evans
Absolutely, and I am grateful to my hon. Friend for pointing that out. As I said at the start of my speech, this is about creating a framework that can be built on, and that framework should have standards and safety, but I would argue that a third strand that is needed is communication. That is the angle that is missing at this point.
That leads me on to my final point. When it comes to some medical devices, I use the term “device” in a slightly quizzical manner. For example, is lip filler a medical device? I would argue that it is probably not, but in the context of this Bill it might well fall into that category, and it probably should. Many people have cosmetic surgery. They have lip fillers, and all too often, I as a GP have had to pick up the pieces when something has gone wrong. My hon. Friend the Member for Sevenoaks (Laura Trott) is not here today, but she is bringing forward a private Member’s Bill to try to address some of these issues. This illustrates the point that now is the time to enshrine in legislation a duty of care to talk to people and to inform them, categorically, before, during and after any test or medical intervention. After all, that is the duty of a good health professional.
I support the Bill. I believe that it is about responsible research, medical provision and future-proofing medicines and medical devices, and I hope that in considering my points on prescribing, tests and trials, the Government will provide a framework that helps to strengthen our world-leading position on health.
Ms Marie Rimmer (St Helens South and Whiston) (Lab)
It is a pleasure and a privilege to follow the hon. Members for Central Ayrshire (Dr Whitford) and for Bosworth (Dr Evans). I agree with everything they said.
I welcome this Bill and the steps that will be taken to improve patient safety and the availability of medicines and medical devices. I will keep my comments short today, as I hope to be further involved in the Bill’s later stages. There are some key points to make on Second Reading, however, as the Bill has the potential to affect so many people’s lives, both domestically and abroad.
As we all know, patient safety is vital and should not be compromised. Sadly, we have seen patient safety standards disregarded in the cases of valproate, Primodos and surgical mesh, which shows a clear need for the legislation in this area to be tightened. The experience of those patients shows the life-changing effect that medicines and medical devices can have on people if they are not thoroughly tested—a medical intervention designed to drastically improve a patient’s quality of life can, instead, leave them in a more dire situation.
We not only need to be aware of, and have concern for, patients in our own nation when we look at the medicines entering our national health service; we must also ensure that due care is given to the patients involved in the development of those medicines. We cannot sacrifice the health, rights and dignity of other human beings just to gain medicines for people in our country.
When we look to China, for example, we see that the evidence supplied by the independent China tribunal, which was released in full yesterday, overwhelmingly shows that organs have been harvested from unwilling political prisoners and prisoners of conscience such as members of Falun Gong and the Uyghur Muslims.
Jim Shannon
It is important that is put on the record. There was a question in the other place today on this very issue of organ harvesting. The hon. Lady and I, like others in this House, recognise that commercial organ harvesting is happening in China. Is it not important for our Government, and for all responsible Ministers, to contact the Chinese authorities directly to ensure that organ harvesting does not take place? It is not just the Uyghur Muslims but Christians and those of other ethnic minorities, too. They are all being discriminated against for being alive.
Ms Rimmer
The China tribunal report was issued yesterday, and it clearly states that organ harvesting is being done in a commercial, business-like manner. It is absolutely horrendous. People are being taken into prison for nothing, and their DNA is taken. A doctor who now drives an Uber taxi in London was forced to remove the liver and kidneys of a Uyghur Muslim while he was still living, which is horrendous. I and a number of others intend to get this resolved. We must ensure that medicines entering the United Kingdom have not been tested on or developed using those organs or any other human rights abuses, and I am sure the Government are aligned with me on this issue.
If appointed to the Public Bill Committee, I hope to move an amendment on this issue, on which there is cross-party support in both Houses. In the light of this week’s stories in The Guardian and The Daily Telegraph about major companies profiting from Uyghur slave labour, it seems there is no indignity, no suffering, that those poor people are not forced to endure. The trade in their organs must surely be one of the most wicked crimes against humanity of the 21st century. This Bill will provide the House with one small opportunity to strike a blow on their behalf.
Domestically, we must ensure that regulators are properly equipped with the resources and financial support to take on the new responsibilities outlined in this Bill so that we do not place more stress on an already overstretched NHS system. We must also better understand how the Government intend to monitor the effectiveness of those regulations and regulatory bodies, as well as the nature of their role in doing so.
The NHS is one of our nation’s greatest achievements, and any attempt to make it stronger is always to be welcomed. We must make sure that the United Kingdom’s health industry and the NHS help to make the lives of our citizens and those abroad safer, healthier and more dignified.
Anne Marie Morris (Newton Abbot) (Con)
I welcome this Bill. It is crucial that we have an effective regulatory system in this country, so we should enable the Government to amend existing regulations post Brexit. We could be a little more ambitious, however. Government time is precious, and I doubt we will have many occasions to discuss medicines and medical devices, which I suspect is why many of my colleagues have raised things that are not covered in the current legislation.
In a world in which medicines and medical devices are changing fast, the Government need to take greater powers to meet those changes and take advantage of them post Brexit. They need to be able not just to amend but to create regulations. My real concern is that the parameters of these new powers are drafted in such a way that they give power to the Government only to amend existing regulations—four sets of them. The Bill does not give the Government the power to do more, which is a missed opportunity.
Although I am conscious of the need to consider this at a European level, medicines and medical devices are, for most of us, a global issue. This Bill should not just be about ensuring we can cope after leaving Europe; it should be about the opportunity that can be created in the new global world we are entering.
A lot has been said, and rightly so, about the challenge of medical devices, which is a fast-growing area in which Britain is a leader, but it involves a huge variety of small and medium-sized enterprises, and innovation within devices is happening at a faster rate than within medicines. That is what we need to address, and I do not feel we achieve it with this Bill.
This legislation will not help with the challenges of breast implants, vaginal mesh and spinal implants that crumble, because the registry that is to be created is within the constraints and confines of existing registries that, by and large, collect information about devices. They do not collect information about the journey of those devices through the patient experience, from implant through to removal and replacement, including where the device may be defective. That information, properly recorded, would enable us not only to recall devices that we knew were faulty, but to go to patients in whom we knew a device had been implanted to expedite dealing with a medical emergency.
More importantly, medicine is about innovation and creativity. Unless we have a mechanism to evaluate the progress of medical devices implanted in individuals, how can we know which ones work and which ones do not? If a patient does not re-present, and if there is nothing added to the record, we will never know. Such a registry is mission critical.
The Government should be brave and consider a new clause to create such a registry, and they need to consider how we can consolidate the existing registries. There are many national, European and international registries for particular disease areas, and a lot of thought has been given to what best practice and the ideal registry look like. The International Medical Device Regulators Forum set out in 2016 exactly what it thought that should look like, and it seems to me that the Government would be well advised to consider that. It suggests collecting information not just about the device but about the journey through and in the patient. It seems to me that only through a change to the Bill will we achieve what we want to achieve.
Things probably go beyond that. Indeed, some of my hon. Friends have explained the complexity of understanding what a “device” is—does it include lip fillers, artificial intelligence and so on? The list of new innovations grows and will, to be honest, grow beyond current human imagination and we need a regulatory system that enables us to take advantage of that and regulate appropriately and quickly. We therefore need the capacity to change the definition of a device, and right now we do not have that because we are effectively adopting the definitions in the rules we adopted from Europe. We are giving ourselves the ability to fiddle, but not to change them fundamentally, and that is actually quite important.
We need to create an international search database so that we can deliver on some of the challenges of urgent harm, which we can prevent and deal with once a defective device is identified, and so that we can create something that gives us the opportunity to be world leaders in not only medical devices but medicines. It seems to me that that is the opportunity. Why do we constrain ourselves to being a follower? Why do we always talk about keeping up with Europe? Why not be the leaders? The National Institute for Health and Care Excellence was always set out as the global standard that everybody looked to—as absolutely what we wanted in every country. Why not have exactly the right system, whatever the NICE or the Medicines and Healthcare Products Regulatory Agency of the future looks like? Why not set the standard that others then follow?
In the earlier part of the Bill, where it covers the regulation of medicine as opposed to medical devices, there are some changes that look to the future—that is certainly the case for the changes regarding medical trials. However, it seems to me that that is a missed opportunity not only to consider the sort of regulatory system we might want in the future, but—even though we have NICE, the MHRA and notified bodies for the lower levels of medical devices, which provide CE marks— to look at this all over again. As has been said, some things that seem to be harmless and very simple, and seem simply to merit a CE mark, can become very dangerous in how they are ultimately used by a practitioner. We might need to look at all this again, but the power to do that simply is not in the Bill.
There is also nothing in the medicines section, as far as I can see, about increasing the speed of access to new developments and new medicines. That has always been a mantra of this Government, but I cannot see any provision for it. If we had control to look at the MHRA and NICE, we could do that, but as the Minister well knows the reality is that she has no power. The power to deal with the regulatory system and the regulations set by the MHRA and NICE is in the gift of NHS England. Following the Lansley reforms, that power is not now in the gift of the Government and it seems to me that the Government, who have this proactive agenda, should be taking the initiative so that they can be more direct in ensuring that we have the regulatory system we need. At the moment, all we have is the ability to limit the money that is available.
For example, the Government have talked about an innovative medicines fund, but I see nothing in the Bill to provide for that. I understand that the idea is that it can be just an extension of the cancer drugs fund, but, I ask the Minister, is that actually right? There should be different criteria—there will be different tests and different needs. Simply extending the cancer drugs fund will muddy the water and not deliver what we are really looking for, which is something that looks specifically at innovative medicines, which need clearly defining and properly clarifying. If we are to cover both groups, we need to increase the pot, but there is no suggestion of doing so.
There is a lot still to be done. Earlier, one of my colleagues made the good point that if we are to be a global leader rather than just a follower, we ought perhaps to look at how our marketing authorisations could be adopted and accepted in other countries, effectively saving costs and getting medicines to market faster. The UK would therefore be seen as the place to come for one’s marketing authorisation, rather than Europe, despite the size differential, because we would be the market leader in the mechanism to develop that.
For me, the Government have made a good start, but there is much to do. I look forward very much to the Minister’s closing remarks and, more importantly, to her confirmation that the Government have an ambitious vision and will be working hard during the following stages of the Bill’s consideration, of which I would very much like to be part, to consider changes that will deliver opportunities that the as drafted Bill does not offer. That said, it is a good start and something we can build on.
Liz Twist (Blaydon) (Lab)
The Bill is, of course, necessary to ensure that, in the absence of the European regulations under which we operate until the end of the implementation period, there are effective ways to regulate medicines and medical devices. Even under the current regulatory arrangements we have seen some patients face real difficulties, so it is vital that we get this right, as others have said.
The Minister will be aware that I and many hon. Members across the House have been working with the National Society for Phenylketonuria, or PKU, through the all-party group, to ensure that people with PKU have access to Kuvan, a drug widely available in many other countries. It feels like that has been a pretty hard slog at times, and we have not got there yet. I pay tribute to the NSPKU and, in particular, to Kate Learoyd and Caroline Graham, who have done such a lot of work to get the all-party group established and keep it very lively.
How much more difficult must it be for those people living with PKU—children and adults—to know that there is a drug that would help many of them, but to find that it is not available, than it is for us to see that situation for our constituents? In introducing the debate, the Secretary of State made a great deal of our new powers to act under these arrangements, and I hope very much that that means that Kuvan will become available very quickly. More broadly, I ask the Minister what this Bill will mean for patients with PKU who are hoping to have that drug made available, and how it will affect new therapies and drugs that are in development to treat PKU. How will they be licensed and made available?
Many rare diseases require a large pool of patients to have effective clinical trials of new treatments, and again I ask the Minister if she can say how she will ensure that UK patients can take part in those trials and benefit from innovative treatments. This will be important to the community of patients with rare diseases, not only those with PKU, and I know that there will be great anxiety about the issue of translating EU regulation into UK law and making sure that issues of access, safety and clinical trials are fully covered and regulated. UK patients with rare diseases must not be disadvantaged by separate licensing and trial arrangements, and I ask the Minister to comment on that.
Secondly, this legislation clearly impacts on the role of the MHRA. At this point, I want to mention the great work of Emma Murphy and Janet Williams, who have worked so hard on the issue of fetal valproate spectrum disorder, to which my hon. Friend the Member for Leicester South (Jonathan Ashworth) referred. They have found that, despite the devastating impact arising from women with epilepsy being prescribed the drug valproate during pregnancy and despite these problems being known about among the medical profession for many years, that drug is still being prescribed, sometimes in unmarked boxes, and is still causing damage to babies whose mothers have taken the drug. I hope that this new system will ensure that the regulations are strengthened to ensure that that cannot happen in any case in the future—the will is there to do it. This is happening even after advice to doctors and pharmacists had already been given as a result of the fetal valproate syndrome campaign, so we need action to resolve that straightaway.
Dr Whitford
I totally agree with the hon. Lady about the concerns and, we hope, the opportunity to ensure that any pack of sodium valproate that is dispensed carries the information. Does she share my concerns at the talk of having digital information, as many people are digitally excluded? Having actively to seek information about a drug is perhaps an additional barrier. We should be making this easier, simplifying the leaflets that are in with drugs, perhaps by having more infographics, to allow people with poor English or limited understanding to recognise what they should be doing around their medication.
Liz Twist
I thank the hon. Lady for her intervention, and I agree that there is a concern about that. All forms of communication are great, and digital, as an extra, is good, but it must not exclude people who do not have access to computers or the internet. It certainly must not replace those paper warnings on boxes of tablets—we need to strengthen that bit as well.
I would like to see a strengthening of this legislation to make sure that what I have described could never happen again. I would also like to see effective data sharing, so that issues such as this were identified and acted upon quickly. Data sharing with the EU will continue to be important, so I ask the Minister, how will such data be shared with EU countries to ensure that we share those experiences and warnings?
Finally, I am concerned at the use of Henry VIII powers to create pharmacy hubs. There is already a concern that some community pharmacies face challenges from prescription-by-post services, at the same time as we are encouraging people to seek advice from their local pharmacist first. It is really important that local pharmacies are not pushed out of communities as a result of these measures, because they are really valued by the people who use them. Will the Minister tell me how she will ensure that that does not happen as a result of the powers to create pharmacy hubs?
Munira Wilson (Twickenham) (LD)
I must start by declaring an interest: before arriving in this place, I spent some nine years working in the pharmaceutical industry for two European companies, and I continue to hold a small number of shares granted to me by Novartis Pharmaceuticals Ltd.
Although I and my party support this legislation, clearly it is important that the UK should have the ability to regulate human medicines, veterinary medicines and medical devices following the end of the transition period. It will not surprise Members to hear me say that we believe it is extremely regrettable that we are even in this position in the first place. Clearly, in terms of ensuring that British patients have safe and swift access to medicines and medical devices, and ensuring our life sciences industry continues to remain competitive, our interests would have been best served by staying in the EU. That is why we will continue to fight tooth and nail against a hard Tory Brexit, despite the reckless and threatening approach to negotiations being taken by this Government. A hard, no-deal Brexit at the end of this year could spell catastrophe for British patients and the life sciences industry.
My main concern is that the provisions of this Bill could allow for significant regulatory divergence for medicines and medical devices from the rest of the EU. The medical research community and manufacturers are united in their call for the UK to remain as close as possible to the EU, preferably through negotiating associate membership of the European Medicines Agency. Any divergence from European regulation should take account of three principles: patient safety; early access for British patients to the latest innovations; and the competitiveness of the UK life sciences sector. In using the powers of this Bill to seek any divergence from the European regulatory framework, the No. 1 consideration should always be protecting patient safety. Any bid to make a UK stand-alone regulatory system more competitive than Europe must not seek to undercut the EU in safety standards, be that in terms of clinical trial regulation or the hurdles a new medicine, vaccine or device must clear to secure marketing authorisation or accreditation in the UK.
I would also take this opportunity to urge Ministers to consider, as they enter into negotiations with the EU, the critical and indeed life-saving importance of remaining part of the EMA’s pharmacovigilance network. By collecting and sharing real-time data on approved medicines, the EMA is able to identify trends and quickly take actions to inform patients and health professionals about safety concerns. By remaining part of a network across 28 countries rather than just the UK on its own, our network would have far wider coverage, with a far greater number of patients using a drug, thus increasing the likelihood of the data collected being more accurate, and concerns being picked up at an earlier stage. Related to that point, I wish to highlight the shocking and wanton disregard for public health and safety that we have heard from the Government about wanting to withdraw from the EU’s early warning system on pandemics, given the serious global challenge we face on coronavirus. Even the Government’s former Minister Baroness Blackwood has been saying in the media today that that is not the way forward to ensure that we protect patient safety. We all know that disease knows no borders, so it is ridiculous and isolationist, as the hon. Member for Central Ayrshire (Dr Whitford) has said, to withdraw from that system.
The second principle to consider when using the powers within this Bill to diverge from European regulation is ensuring that British patients continue to have swift and early access to the latest innovations. I welcome the Government’s intention to use these provisions to ensure that NHS hospitals are able to manufacture and trial the most innovative new personalised and short-life medicines. The UK should be at the cutting edge of supporting those pioneering new treatments to be made available to British patients. However, we must not forget that the vast majority of medicines, and indeed devices, coming through the pipeline are not in that category. Any significant divergence from the EU regulatory framework will inevitably lead to delays in new technologies being made available to British patients.
As has been mentioned, the maths is obvious: the EMA covers 25% of global medicines sales, whereas the UK on its own makes up only 3%. Companies are likely to submit applications for new drugs to the EMA before the MHRA, meaning that UK patients risk having slower access to the latest medicines—we see this with Switzerland, Canada and Australia already. How will the Government ensure that the MHRA’s processes remain among the fastest in the world, while maintaining patient safety? The hon. Member for Newton Abbot (Anne Marie Morris) implores us to be a leader in that regard, not a follower, but it makes no commercial sense for us to be outside the European regulatory framework. I know that from my personal experience of working on the dreaded Brexit taskforce when I was in industry. My European regulatory colleagues were not in the slightest bit interested in helping me and British colleagues define, and then represent to Government, what a competitive new divergent system might look like. Understandably, commercially their priority was and remains the 445 million inhabitants of the other EU27, as opposed to the 66 million or so in the lone ranger that is the UK. That point is not lost on Cancer Research UK, which has specifically called for clause 2(1) in part 1 of the Bill to be used to facilitate UK recognition of and participation in the EMA’s medicines licensing processes.
One of the earliest ways that patients gain access to the latest innovations is through clinical trials. The Bill could be used to amend the regulations that govern clinical trials in the UK. It is worth noting that the number of trials conducted in the UK has fallen since 2016, with the UK falling behind the USA, Germany, Canada and Spain for phase 3 commercial clinical trials. Although there is an opportunity to make the UK more attractive for clinical trials, any such opportunity must not come at the cost of patient safety, and high standards should be maintained. Any stimulation of the clinical trial environment must include continued UK-EU collaboration on trials, which is critical for trials involving medicines for rare diseases or children, in respect of which the population in any one country is not sufficiently large for a trial. Furthermore, the EU’s clinical trials regulation, which is due to be implemented in 2022, should accelerate trial setup times, improve safety reporting and facilitate collaborative research, because of the digital infrastructure that underpins it. The UK played a pivotal role in developing the CTR and our patients would benefit greatly from it being implemented here.
My third point is closely connected to my previous point: any divergence from European regulation should take account of the competitiveness of the life sciences sector, which successive Governments have often described as a “jewel in the crown” of UK plc. Our remaining an early launch market by keeping in step with EMA is key to our continuing to attract high levels of foreign direct investment into the UK from pharmaceutical companies. Any additional burden on applying for marketing authorisation for medicines, or a separate system for the accreditation of medical devices in the UK, away from the CE marking scheme, will make the industries less competitive. Also key to competitiveness is the securing of frictionless and tariff-free trade as part of the negotiations with the EU. That is critical given the integrated and complex cross-border supply chains in the manufacture of medicines and medical devices.
To summarise, the Bill is necessary in view of the UK’s unfortunate decision to leave the EU. However, I urge caution on Ministers in respect of how the powers in the Bill are used. British patients must be kept safe, they must be able to access the latest medicines and technologies at the earliest opportunity, and we must not undermine the thriving life sciences industry in the UK. The Government’s quest to make the UK a Singapore-style regulation-light country must not see us undercutting safety standards in a bid to improve our competitiveness. As the Government seek to negotiate a trade deal with the EU, the way to safely ensure that British patients can access the medicines and technologies that they need, and the way to keep attracting industry investment into the UK, is by remaining as close as possible to the European regulatory regime.
Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
This has been an excellent debate—and we seem to have plenty of time left for winding up. I thank all Members from all parties who have taken part, and particularly my hon. Friends for their excellent speeches: my hon. Friend the Member for Blaydon (Liz Twist) made the case for Kuvan for sufferers of PKU, which I shall mention again in a moment, and my hon. Friend the Member for St Helens South and Whiston (Ms Rimmer) made a powerful speech about organ harvesting that I am sure we will discuss in more detail in Committee.
The hon. Member for Bosworth (Dr Evans) raised an issue that is not currently on the face of the Bill but perhaps should be. It is something that I have discussed with Health Secretaries for well over a decade now—probably around 12 years—starting with the then Member for Kingston upon Hull West and Hessle when Labour was in government, and I raised it with the Minister only last week. The issue is the waste of prescription medication. The hon. Gentleman mentioned a possible figure of £300 million a year from the House of Commons Library, and that did not surprise me. I can well believe that that could be the figure and agree that there has to be a way to reduce that waste. As the hon. Gentleman said, we should start by measuring it, and perhaps consider the active, safe charitable donation of such medicines, because £300 million-worth of perfectly good medicines being put into an incinerator every year cannot be the best outcome. There has to be a better way. I am grateful to the hon. Gentleman for raising that issue, which the Minister will remember we discussed just last week.
I thank the Minister and her officials, who have taken the time last week and since to brief me and my team on the Bill. As my hon. Friend the Member for Leicester South (Jonathan Ashworth) said in his opening remarks, the Opposition support the principle of the Bill, but we have some concerns that I shall briefly outline and to which I hope the Minister will respond, if not now then perhaps at a later stage in the Bill’s progress through the House. The Bill deals with both human and animal health, and I shall start with human health.
Patient safety is of the utmost importance and I recognise that with the Bill the Government are taking steps to improve both patient safety and the availability of medicines and medical devices to patients in the UK after the transition period is over on 31 December this year. However, as the Minister knows, in the cases of valproate, Primodos and surgical mesh, which we have heard about already in the debate, patient safety and patients’ experiences in the past—sometimes even now, in respect of mesh—have sometimes been disregarded when they have reported issues to their GP. The independent medicines and medical devices safety review has been looking into that, and I very much look forward to seeing Baroness Cumberlege’s recommendations later this month.
I should also mention that there are questions of patient safety in respect of other devices, such as breast implants and metal-on-metal hip implants. There are a host of examples of patient safety having been compromised. We must ensure that that does not happen again.
Medical devices are not subject to the same strict regulations as medicines. Faulty washing machines are treated with far more caution than a medical device that goes wrong. A case in point is that we will all have been written to recently by Whirlpool. Regulations must be tightened for both medicines and medical devices. I am sure that the Government will consider seriously the forthcoming recommendations from Baroness Cumberlege in the review.
One mechanism in the Bill to increase patient safety is the provision to establish a database for medical devices and provide the Secretary of State with new powers to share information about medical devices in limited circumstances. However, there are approximately 80,000 different medical devices on the UK market. Will every device be entered into the database? What steps have been taken to establish such a database? Will the Minister please provide some more information about the point at which the Secretary of State will be mandated to share the information held on a medical device with the public? I wholeheartedly agree that there should be a database of this nature, but it must be fit for purpose and healthcare professionals must be able to access an updated database to make sure that they can provide the best treatment and care for their patients that is safe. I hope that the database would go further and become a register or even a registry, as the hon. Member for Central Ayrshire (Dr Whitford) suggested. A barcode could be included on each device that is scanned into a patient’s records so that a register or registry is created.
As I have mentioned, the Bill makes provisions for access to medicines and medical devices after 31 December. However, it is causing concern for some patients who are currently participating in EU-wide clinical trials and for patients who fear that they may miss out on future trials. Can the Minister provide any assurances today about access to EU-wide clinical trials, especially for those patients who are already on them? Access to such clinical trials would especially benefit patients with rare diseases, who have a small patient group here in the UK. Will the Minister please set out what provisions will be made for patients with rare diseases who could benefit from participating in a clinical trial?
As this Bill comes into force on 1 January 2021, will the Minister reassure the House that the supply of medicines and medical devices will be maintained in the run-up to the end of the transition period? This Bill could enhance access to medicines, but what does that mean for patients with rare diseases? For example, as we heard from my hon. Friend the Member for Blaydon, who spoke so passionately about PKU, patients have been waiting for more than 10 years for the drug, Kuvan, to be made available on the NHS. We know that Kuvan works for patients with PKU, because some have raised funds for it and been paying for it privately. Although it is expensive, the cost is not outwith the reach of some patients, but patients in the UK should not have to go without effective drugs. I am sure that we have all had constituents who have brought these cases to us. I therefore hope that provisions will be made to improve access to medicines, particularly for those people with rare diseases.
I welcome the Government’s announcement today about faster access to cannabis-based medicines, and I would be very grateful if the Minister could please expand on that announcement and how that relates to this Bill in particular. I also welcome the provisions in the Bill that allow for prescription powers to be granted to some bodies within the healthcare system—for example, to physiotherapists. Will the Minister set out what she envisages this system will look like, who will be able to prescribe, and what they will be able to prescribe and under what circumstances? Will these new prescribers be trained sufficiently to fulfil this role? Where will they get their information from about medicines and medical devices that they are prescribing, especially if there are new warnings on them, as we have seen, for instance, with Valproate.
The Bill also allows for pharmacy hubs to be established under a Henry VIII power, so will the Minister give the House a timescale for this power to be used? I would also be grateful if she outlined how these pharmacy hubs will work in practice, as I am concerned that this could open up an Amazon-style prescription service.
Let me move on to animal health and veterinary medicine. Although this subject is more likely to come under a DEFRA brief, I know that there is a link between human health and animal health, not least when it comes to antimicrobial resistance. Keeping our animals fit and healthy and ensuring that vets have the medicines that they need to provide treatment and care for animals is, of course, crucially important to many of us. Will the Minister please assure the House that the supply of veterinary medicines in the UK will be maintained in the run-up to the end of the transition period and that standards for veterinary medicines will be upheld to ensure that animals are given the best possible treatment after the transition period.
The Bill gives powers to relevant bodies to amend regulations as necessary, so will the Minister assure the House that the regulators are equipped with the right finance and resources to take on these new responsibilities? I am pleased that, in non-urgent cases, there will be consultations held before any regulations are changed, but can the Minister outline how long these consultations will run for and how soon after the consultation closes the new regulation will be implemented? What formal processes will be put in place to ensure that industry is involved in these consultations and, finally, how will the Government monitor the effectiveness of the regulations? What bodies will be able to scrutinise the performance and delivery of the regulators?
As I mentioned at the beginning of my speech, we do not want to find ourselves in several years’ time with news that a medical device or medicine is causing serious harm to patients—more than we have already, given what Baroness Cumberlege is looking into. Regulators must be held to account on this as much as the manufacturing industry and healthcare system.
In closing, human and animal safety is of the utmost importance, which is why we on the Labour Benches welcome this Bill, but I would be grateful if the Minister could answer these questions. If that is not possible in the time available tonight, especially given the rate at which I have put these questions to her, then perhaps in writing or indeed, during the passage of the Bill in Committee.
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
First, let me thank all hon. Members for their support in discussing this enabling legislation. It is a pleasure to close this debate on the Medicines and Medical Devices Bill. The Bill is both a piece of legislation to future-proof our regulatory regime going forward and an opportunity to clarify and improve the one that we have now.
I am gratified that hon. Members have approached this debate with thoughtful consideration. Obviously, there is a lot more to discuss in Committee, because several themes came up during the course of this afternoon’s debate on which I can only touch now. I will take up the request of my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson) and write to her. I have not had the chance thus far to have a specific briefing with the hon. Member for Central Ayrshire (Dr Whitford), so perhaps we could do so to enable us all to understand our direction of travel.
Patient safety is not a partisan issue; it is paramount. It is what drives us to do what we do. It does not matter which side of the House we sit on, the patient is at the centre of our concern. We hope that, in going forward, we can enhance and strengthen that view and show ourselves as an exemplar to the world in the way that we conduct trials and in the way that the life science and pharmaceutical industries work. We hope to assist the whole industry in making sure that we never compromise on patient safety.
This will be the first opportunity in 40 years for the UK to make choices regarding how we regulate medicines, veterinary medicines and medical devices in the best interests of the UK now that we have left the EU. This is all part of our making sure that we transition smoothly on 1 January next year. Members from all parts of the House feel passionately about the outcome of negotiations on the future relationship. I would like to assure hon. Members that the Bill allows us, in the future, to set rules that are best for the UK, whatever the outcome of those negotiations. The Bill is important, as it makes clear the Government’s commitment to the life science sector, which is worth over £75 billion to our economy and which contributes almost 250,000 jobs to the UK. We are rightly proud of that sector, but innovations and advancement must be matched by rigorous standards to protect patients. I very much take on board the comments of the hon. Member for Twickenham (Munira Wilson), which were particularly pertinent to the experience that she brings to this House. I hope to enjoy more of that debate when we are in Committee.
The Bill sets out clear principles: ensuring patient safety; ensuring their continued access to medicines and devices; and maintaining the attractiveness of the UK as a market and a place for clinical trials. There is a delicate balance there that we must continue to strike, and the debate today demonstrates the paramount importance of all those principles. On that point, I will move on to the comments of hon. Members.
Mr Alistair Carmichael (Orkney and Shetland) (LD)
The provisions on veterinary medicines are essentially a straight lift from the human medicines part of the Bill. There is one significant difference, of course: animals that have been prescribed and administered medicines are put into the food chain. With regard to withdrawal periods, that, in turn, can have a significant impact on the access to markets of exported meats. Will the Minister consider later an amendment to clause 8(2), to provide at least some regard to the commercial position of the end meat products?
Jo Churchill
As the right hon. Gentleman knows, I am always happy to have a discussion to see whether any accommodation can be made. As far as veterinary medicines go, I should say that, unlike with human medicines, we pay attention to the environmental impact as they go through.
Dr Neil Hudson (Penrith and The Border) (Con)
I should declare an interest as a veterinary surgeon. I want to bang the drum for part 2 of the Bill and the importance of the way in which it addresses veterinary medicines. The Bill will go some way towards providing assurances to the UK veterinary profession that there will be continuity in its ability to prescribe for and treat a group of patients that have not been discussed much tonight: animal patients in our country.
Jo Churchill
I am happy to give my hon. Friend the assurance that there will be that continuity. That is precisely the aim of the Bill.
The shadow Secretary of State asked me to comment on reports that he had read in the papers today about health security. The UK is open to exploring co-operation between the EU and other specific narrowly defined areas when it is in the interests of both sides—and on matters of health security, it would be foolish not to.
Several Members discussed clinical trials, with a particular eye to the rare diseases cohort, which is obviously, by its nature, small. It is only sensible to ensure that we have the ability to collaborate across Europe to determine that we have the best environment for the development of drugs. I would caution people to breathe before we go forward. We are committed to ensuring that we remain the best place for those on rare disease trials.
The Medicines and Healthcare Products Regulatory Agency has taken steps to ensure that there is absolutely no disruption to clinical trials and that they can continue seamlessly. It is important that we are tempered in tone to ensure that people’s clinical trials carry on. We want a world-leading regulatory system for clinical trials that allows us to collaborate effectively—not only across Europe, but globally. We have one of the best life sciences industries in the world, for which effective collaboration is important.
Now that we have left the European Union, it is important to make it clear that UK sponsors will still be able to run multi-state trials across the world. We want a regulatory system that maintains and enhances the attractiveness of the UK as a site for global co-operation in research.
I move on. We will extend prescribing rights to physician associates through other means. We are discussing the extension of physician associates’ rights for prescribing in the context of the increase in clinical professionals who will be working in the health service. The broader ability of the Bill to ensure prescribing rights will be carried through only in collaboration with the appropriate regulatory oversight, whether from the General Medical Council or the Health & Care Professions Council, depending on whether allied health professionals or physician associates are involved.
The hon. Member for St Helens South and Whiston (Ms Rimmer) asked whether clinical trials data would include those forced to participate. I assure her that clinical data used to support regulatory activity in the UK needs to comply with international good clinical practice standards, including ethical considerations such as the critical principle of informed consent. That means that the appalling cases to which she alluded could not be involved in clinical trials.
Ms Rimmer
There are signs up in Chinese airports saying “Organ transplants this way” in English; there is a clear path through. I am not saying that it is the English who are going, but the system is international. People are going out. France is already taking steps to stop organ tourism.
Jo Churchill
I thank the hon. Member for that intervention.
Let me point out to the shadow Secretary of State that it is possible that the use of artificial intelligence—to determine what treatment to give a patient, for example—would fall within the scope of the regulation-making powers in the future. It is right that we have the tools to respond to this kind of technology in the years ahead. I was most interested by the comments of my hon. Friend the Member for Bolton West (Chris Green) about better patient outcomes. I could not agree with him more about the importance of the life sciences sector, and about using data to inform as we go forward. The MHRA will be able to conduct inspections for manufacturing, distributions, clinical trials, laboratories and pharmacovigilance, and it is important that that continues to ensure that we uphold standards.
There were numerous other comments, particularly about the medicines and medical devices lists and register. I look forward to ensuring that we have a robust debate in Committee about what is best for the patient and the clinician. My hon. Friend the Member for Bosworth (Dr Evans) made an important point about clinicians perhaps annotating patients’ notes with information about why they used a particular medicine or device.
We have spoken about medical devices perhaps being manufactured at a patient’s bedside. The shadow Minister mentioned having a barcode on each device. It would be quite hard to barcode a device when it was manufactured in order to put it on to a register. I hope that having this discussion in later stages will inform us all how best to do this.
I hope that the spirit of this debate—one in which we are all in support of a common purpose—carries through to the examination of the Bill. This legislation offers an opportunity for the UK to protect patients, support the development of an exciting and important sector, and do what is best in the UK for the UK’s interests. I commend this Bill to the House.
Question put and agreed to.
Bill accordingly read a Second time.
Medicines and Medical Devices Bill (Programme)
Motion made, and Question put forthwith (Standing Order No. 83A(7)),
That the following provisions shall apply to the Medicines and Medical Devices Bill:
Committal
(1) The Bill shall be committed to a Public Bill Committee.
Proceedings in Public Bill Committee
(2) Proceedings in the Public Bill Committee shall (so far as not previously concluded) be brought to a conclusion on Thursday 23 April 2020.
(3) The Public Bill Committee shall have leave to sit twice on the first day on which it meets.
Proceedings on Consideration and up to and including Third Reading
(4) Proceedings on Consideration and any proceedings in legislative grand committee shall (so far as not previously concluded) be brought to a conclusion one hour before the moment of interruption on the day on which proceedings on Consideration are commenced.
(5) Proceedings on Third Reading shall (so far as not previously concluded) be brought to a conclusion at the moment of interruption on that day.
(6) Standing Order No. 83B (Programming committees) shall not apply to proceedings on Consideration and up to and including Third Reading.
Other proceedings
(7) Any other proceedings on the Bill may be programmed.—(James Morris.)
Question agreed to.
Medicines and Medical Devices Bill (Money)
Queen’s recommendation signified.
Motion made, and Question put forthwith (Standing Order No. 52(1)(a)),
That, for the purposes of any Act resulting from the Medicines and Medical Devices Bill, it is expedient to authorise the payment out of money provided by Parliament of:
(1) any expenditure incurred by a Minister of the Crown, a government department, a person holding office under Her Majesty or any other public authority by virtue of the Act; and
(2) any increase attributable to the Act in the sums payable by virtue of any other Act out of money so provided.—(James Morris.)
Question agreed to.
Medicines and Medical Devices Bill (Ways and Means)
Motion made, and Question put forthwith (Standing Order No. 52(1)(a)),
That, for the purposes of any Act resulting from the Medicines and Medical Devices Bill, it is expedient to authorise the charging of fees, or other charges, arising by virtue of the Act.—(James Morris.)
Medicines and Medical Devices Bill (First sitting)
Monday 8th June 2020
(4 years, 5 months ago)
Public Bill CommitteesRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Public Bill Committee Amendments as at 8 June 2020 - (8 Jun 2020)
The Committee divided: - Ayes: 5 / Noes: 9 - Question accordingly negatived.
The Chair
Before we begin, I have a few preliminary points to make. Members will understand the need to respect social distancing guidance, and I will intervene if necessary to remind everyone. I also remind Members to switch electronic devices to silent, and that tea and coffee are not allowed during sittings. Proceedings Time for conclusion of proceedings Clauses 1 to 4 1 pm on Monday 8 June Clauses 5 to 11 6 pm on Monday 8 June Clauses 12 to 26; Schedule 1; Clauses 27 to 33 11.25 am on Wednesday 10 June Clauses 34 to 36; Schedule 2; Clauses 37 to 45; new Clauses; new Schedules; remaining proceedings on the Bill 5 pm on Wednesday 10 June
Today, we will first consider the programme motion on the amendment paper. We will then consider a motion to enable the reporting of written evidence for publication, and I hope we can take these matters without too much debate. The Hansard reporters would be most grateful if Members emailed any electronic copies of their speaking notes to hansardnotes@parliament.uk. I call the Minister to move the programme motion, which was agreed by the Programming Sub-Committee last week.
Ordered,
That—
(1) the Committee shall (in addition to its first meeting at 11.30 am on Monday 8 June) meet—
(a) at 3.30 pm on Monday 8 June;
(b) at 9.25 am and 2.00 pm on Wednesday 10 June;
(2) the proceedings shall be taken in the order shown in the first column of the following Table;
(3) the proceedings shall (so far as not previously concluded) be brought to a conclusion at the times specified in the second column of the Table.
—(Jo Churchill.)
Resolved,
That, subject to the discretion of the Chair, any written evidence received by the Committee shall be reported to the House for publication.—(Jo Churchill.)
The Chair
Copies of written evidence that the Committee receives will be made available in the Committee Room.
We now begin line-by-line consideration of the Bill. The selection list for today’s sitting, which shows how the selected amendments have been grouped together for debate, is available in the room. Amendments grouped together are generally on the same, or a similar, issue. Please note that decisions on amendments do not take place in the order they are debated, but in the order they appear on the amendment paper. The selection and grouping list shows the order of debates; decisions on each amendment are taken when we come to the clause that the amendment affects. We will begin with amendment 9 to clause 1.
Clause 1
Power to make regulations about human medicines
Alex Norris (Nottingham North) (Lab/Co-op)
I beg to move amendment 9, in clause 1, page 1, line 5, at end insert
“for a period of two years following Royal Assent.”
This amendment provides a sunset provision for the Bill requiring the Government to return with primary legislation.
It is a pleasure to serve under your chairship, Mr Davies. As the shadow Secretary of State for Health and Social Care said on Second Reading, we understand the need for, and urgency of, the Bill. We will therefore be supportive during its passage, but we will seek to improve it. These improvements will take three forms: a focus on patient safety, a focus on promoting greater transparency about the development and use of medicines and medical devices, and seeking to contain the massive and extraordinary powers the Secretary of State is securing for himself.
I am conscious, certainly in this first sitting, that we have an awful lot on. I hope that colleagues will be understanding if it feels like I am moving at pace, because there is quite a lot of ground to cover. However, I wanted to say how grateful I am to the Clerks for having helped me put these amendments together, and to the Minister and her officials for their constructive support so far. The tone of discussions about the Bill has been really good, and I am sure we will continue in this way.
Finally, a lot has happened since the First Reading of the Bill, not least the fact that I have taken over from my hon. Friend, the unstoppable Member for Washington and Sunderland West (Mrs Hodgson), as the Opposition public health lead. As I have been telling stakeholders, they will probably find me similar in approach—committed, but in good humour—but perhaps lacking the same colourful jackets.
This is an enabling Bill. It is a necessary Bill, but we cannot give the Government a blank cheque. We are talking about the power to decide critical, life-and-death matters involving medicines, devices, humans and animals, and we should not just wave that off to secondary legislation without understanding what that might mean and whether there might be a better way to do it. As such, amendment 9 seeks to put a limit on that power.
The proposed arrangements allow the Secretary of State and his successors to make hundreds or more individual decisions to change our current regulatory regime into a markedly different one, one statutory instrument at a time, which I do not think is desirable. Instead, this amendment offers the Secretary of State two years of that considerable power, but asks him to return in two years’ time with a comprehensive set of regulations across medicines for both humans and animals; for medical devices; and, critically, for the proposed new regime surrounding the Medicines and Healthcare Products Regulatory Agency.
That would provide a chance for proper consultation across the sector, including with patient groups, industry bodies and interested companies, as well as more parliamentary scrutiny to set up the regime that we all want—a safe one, an effective one and a world-class one. It would also give us two years of life outside the European Union and would really help us to land in that place and find out how different we intend to be, certainly in this sector. It would provide time for piecemeal change, but it would at least then reset things, and then I would be at the point where I would be much more relaxed about the use of secondary legislation to diverge from that as circumstances require, because we would have reset things in the full knowledge of Britain’s new place in the world.
There is a case to be made that the arrangements being proposed in the Bill reflect current arrangements; after all, we do not have parliamentary scrutiny over the regulations that have come traditionally in previous decades from the EU. However, that is a political argument—a very effective one—and we know that, outside the white-hot light of public debate around the EU, the EU works differently from that. That was a theme developed by the Member for Central Ayrshire on Second Reading.
Page 4 of the Government’s impact assessment of the Bill describes how a higher-risk medical device enters circulation in the UK for use, saying that for a high-risk medical device to enter the market “a Notified Body”—for us, that is the Medicines and Healthcare Products Regulatory Agency—has to “certify” it. So far, so similar—that is essentially what the Bill would allow, as well. However, at the moment the device would be checked by two further notified bodies from within EU structures and the European Commission, as it says on page 5. That is quite a protection; that is a triple lock. It is not just our own MHRA saying whether or not a device is safe; there are two other equivalent bodies saying that, too.
That system will go and instead we will have a Secretary of State, we will have a Department, and I am sure that NHS England will have a view, too, but fundamentally we will just have a Committee of the House—a statutory instrument Committee. That is quite a diminution. Surely we at least need to know that there will be adequate safeguards in place. If the Government do not accept the amendment, I would be very keen to know what can be done to protect that triple lock.
I will move on to tell a story about two page 10s. Paragraph 42 on page 10 of the impact assessment refers to the potential to move to “hub and spoke dispensing” for pharmacy. That is a very live debate in the field of pharmacy at the moment, I have to say. I have probably not checked this with the shadow Secretary of State, but I see some positive arguments for it, although I can also see significant risks. It is the sort of thing that I think parliamentarians from all parties will be very interested in. I think that we would form different views on it, and not on party lines, because we are basically saying that pharmacy changes—that it is less about dispensing and more clinical, and that bigger nationally based pharmacies, as it were, will instead provide an outsourced dispensing arm. I can see efficiencies in that system; we are doing an awful lot of that at the moment in the context of coronavirus. However, that would be a radical change for pharmacy. At the moment, paragraph 42 on page 10 of the impact assessment says it is a potential direction for where things will go for pharmacy.
If we look at the Bill, we do not see the words “hub and spoke” anywhere, which is very significant. I gently say to Back-Bench Members of the governing party: “You could be in a situation in a year’s time where you are in a statutory instrument Committee being asked, basically, to make the most significant change to pharmacy in decades, and one that you will get a lot of emails about from your local pharmacists, certainly in community pharmacy, and I really do not think that is the sort of power that the Bill is intended to give.”
I said that this was a story of two page 10s. Page 10 of the delegated powers memorandum refers to clause 1 of the Bill and justifies the use of delegated powers:
“The human medicines regulatory regime is ever-changing and requires technical changes in order to keep up to date. These are changes we cannot predict in advance and therefore would not be practical or appropriate for these amendments to be made through primary legislation each time an update is required.”
That is saying, “Something changes a little bit and we would not want a whole new law to keep pace.” Of course, I understand that. However, we are talking about something really significant here; I would argue that it is an entire model change for pharmacy. We know that this is of interest to the Government, because it is in their own impact assessment. They say that it is a possibility. We really need to square that.
I accept that the Secretary of State will need powers and will have to do things through secondary legislation to keep us up to pace with, or to diverge from, European regulations. However, I am not confident that this is a mandate to make really significant changes to something that is very important to us all. That is why I have moved amendment 9. It would say to the Secretary of State, “Go and have a look at this for a year-plus, and then develop legislation to reset that.” Let us have proper consultation with the sector and with citizens. Let us have proper parliamentary scrutiny. Then, if we come to the view that this is the best way to do it, by all means that is what we should do.
I hope that the Government are minded to accept the amendment, but I am sceptical of that chance, so I would be keen for the Minister to return to these two points. First, will this provision mean a diminution of protection, certainly when it comes to the triple lock on medical devices? Secondly, there needs to be at least an acceptance from Government that the liberty to make quite big and bold changes is not licence to make any changes that they want, bolstered by a Committee majority, because I do not think that that is in the spirit of the legislation or of this exercise, which is about getting us to a safe position following the end of the transition period.
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
It is a pleasure to serve under you, Mr Davies. I agree with the hon. Member for Nottingham North that we have worked on the Bill in a spirit of co-operation, and I would very much like that to continue, because sitting at its heart is the patient, and patient safety is what we are after here. I will come on to the two specific points, but I shall address now the sunset element and why, in our opinion, that is not the way to proceed, because of its time-limited nature.
As the hon. Gentleman said, the Bill is necessary because at the end of the transition period, we will lose the ability to update. I am grateful for his words saying that both he and the shadow Secretary of State for Health and Social Care understand what we are trying to do. We need to be able to amend the legislation that governs human medicines and medical devices and veterinary meds. This measure will enable us to update the regulations in the light of patient needs and in the light of changes and innovation. I am sure that the hon. Member for Nottingham North would agree that one challenge is the dynamic nature of how medical devices in particular, but also medicines, are changing—at the bedside, but also right across healthcare. Patients and their best interests are at the heart of the Bill, and that is where I want to start.
On amendment 9, what the hon. Gentleman says is important, but the explanatory statement, while giving clarity, still leaves us with the challenge of an overarching sunset clause for the Bill, such that two years after Royal Assent, the primary legislative framework would fall away and Parliament would have to re-legislate for the provisions in the Bill once again. I understand that the hon. Gentleman’s intention is to ensure that Parliament reconsiders, and those checks and balances are important —it is important that we think about the legislation that we are passing. One would hope that at that time, Parliament will be sitting under normal circumstances, but, to be frank, we are not sure. That said, I would like to set out specifically why this proposal would be unhelpful and cause a potential risk to patient safety.
The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices. It provides a framework of powers to ensure that regulatory change can be made as and when necessary. It does, as I hope all hon. Members will recognise when we reach the relevant clauses, increase the level of parliamentary scrutiny, and it is that that enables us to look before something goes forward. There is going to be more scrutiny, under the affirmative procedure, for us to look and understand what it is we are legislating for than we have had thus far. Use of the affirmative resolution is made near universal, other than in the event of an emergency and for very minor changes.
Alex Norris
I take the point about not wanting to rely on primary legislation all the time. I would be much more comfortable—in this Bill in its entirety, but certainly in any future legislation—with provisions for technical updates. Nobody would think that we would need to return to primary legislation, especially not in an emergency, but I do not think that anything in the clause says that would have to be the case. I would probably accept that two years is too short a period, given the amount of work that has to be done prior to something coming into law. However, that might be an argument for a greater sunset clause rather than none at all.
I did not quite agree that nearly everything would be covered under the affirmative procedure. I am very happy to be wrong on this, but the delegated powers memorandum states, on clause 1 alone, that the scrutiny will be by the affirmative procedure
“with the exception of…the labelling and packaging of human medicines…advertising human medicines…prohibitions in the supply provisions for human medicines…the charging of fees in relation to human medicines”
and emergency powers.
If we discount the emergency powers because of the need to move quickly, we are still talking about the labelling, advertising, prohibiting and charging of fees for human medicines. Those are quite significant areas that will not be covered under the affirmative procedure. That may be a distinction without a difference, given that fundamentally there are devices that the Opposition could use if we wanted those to get an airing. However, it is important that hon. Members know that not everything will be covered by the affirmative procedure except for some very small elements.
Finally, I really appreciate the clarity on the hub and spoke model, for which the Minister made a very strong case. The argument is going on sector-wide. I do not think that there has been much of a political conversation on it. I cannot remember it in the Conservative manifesto, but I might be wrong. It feels a little bit as though we have reached the conclusion without having done all the work behind it—the Minister may well have done; I mean more generally.
Jo Churchill
This will be done in consultation with pharmacists, in a discursive way. As the hon. Gentleman has articulated, we have found ourselves in unusual times. Ensuring that we seize the advantage, in a way that is clear, transparent and consultative, is the aim of what we are trying to set out.
Alex Norris
I am grateful for that clarity, which gives me much reassurance. All I will add is a request that the Government include Opposition parties in that. For something this sensitive, forming a political consensus would be good for everybody. I do not intend to press the amendment to a Division, although we are likely to return to it at future stages. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Alex Norris
I beg to move amendment 22, in clause 1, page 1, leave out lines 10 to 16.
This amendment removes the requirement to consider the attractiveness of the relevant part of the UK when making regulations under subsection (1).
The Chair
With this it will be convenient to discuss the following:
Amendment 23, in clause 1, page 2, line 3, at end insert—
“(5) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of human medicines.”
This amendment requires the appropriate authority to consider patient safety first when making regulations under subsection (1).
Clause stand part.
Amendment 24, in clause 8, page 5, leave out lines 18 to 24.
This amendment removes the requirement to consider the attractiveness of the relevant part of the UK when making regulations under subsection (1).
Amendment 25, in clause 8, page 5, line 32, at end insert—
“(5) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of veterinary medicines in relation to animals, humans and the environment.”
This amendment requires the appropriate authority to consider animal, human and environmental safety first when making regulations under subsection (1).
Amendment 26, in clause 12, page 7, leave out lines 26 and 27.
This amendment removes the requirement to consider the attractiveness of the relevant part of the UK when making regulations under subsection (1).
Amendment 27, in clause 12, page 7, line 27, at end insert—
“(3) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of medical devices.”
This amendment requires the appropriate authority to consider safety first when making regulations under subsection (1).
New clause 3—Report on availability of medicines—
“The Secretary of State must report to Parliament when a medicine which is clinically beneficial has not been made available on the NHS.”
This new clause requires the Secretary of State to report to Parliament when a medicine which is effective has not been made available on the NHS.
Alex Norris
Turning to clause 1, page 1, subsection 2, as we might have said at school—I think this is verbal reasoning, if my memory is good enough—one of these is not like the other. As the Minister said, and as I think every person in the room and indeed across the House would say, the most important thing is patient safety. The human medicines regime must be safe. There is no doubt about that, and I know that is a personal priority for the Minister and something that she works very hard on.
Similarly, availability is crucial. We all want everybody in this country to have access to the vital medicines and medical devices that can enable them to live full, happy lives. We know that is challenging. Since I am here, I might cover new clause 3, which is essentially the Orkambi clause. Hon. Members who were here in the previous Parliament will know what a difficult and perhaps even unedifying process it was to get a much-needed medicine on to the market to give relief to thousands of people in the UK, and how frustrating and ineffective it was— for whatever reasons people would think that was frustrating—over a number of years to get from the place of this thing existing and being available to some people in other parts of the world but not in the UK. What could be more frustrating?
Rushanara Ali (Bethnal Green and Bow) (Lab)
It is absolutely right that there should be some way of setting out a hierarchy, with public safety at the top. Like my hon. Friend, I have a major project in my constituency to promote the life sciences, through The Royal London Hospital, Queen Mary University of London and others. It would be great for investment and we want to see that happen. However, in the light of what has recently happened and the public loss of confidence in the focus on public safety, particularly with reference to chlorinated chicken and the rest of it, the public feel great concern about safety. It is important that the Minister is able at least to provide the reassurance that public safety would be at the top of the agenda, with some sort of hierarchy.
Alex Norris
I completely agree. I think that if we stood in the street for a bit and just straw-polled people, everybody would say that safety is uppermost and they would see the value in its being set on a higher tier, which is what I am suggesting. We are at this possibly significant moment—I believe it is 8 July—when the noble Baroness Cumberlege will come back with her review into what has happened. Obviously, it is a sign of the times and where we are, but at Second Reading people talked about it coming out in March. The world has passed us by, but I understand that publication of the review is imminent and I am keen for that date of 8 July to be confirmed.
If the review says that there are issues around patient safety, we would expect there to be recommendations and changes, which I think is reasonable. I will return to this theme later in the day. What might this say about the MHRA? Is it possible that the regime that we seek to put in place through the Bill might be overrun by events? If recommendations come out of that, is there a possibility of revisiting that in future stages to be clear about it? That is an argument against the sort of piecemeal regime that the Bill proposes, instead of coming back in, if not two years, then three or four, to set a full codified bringing together of the different Acts into one Bill.
I will finish on amendment 23 by referring to one of my favourite contributions from Second Reading:
“Patient safety is not a partisan issue; it is paramount.”—[Official Report, 2 March 2020; Vol. 672, c.689.]
The Minister may recognise her words. I completely agree with her.
Amendments 24 to 27 essentially make the same provisions across veterinary medicines and medical devices, and I do not intend to rehearse the arguments. On medical devices, surgical matters was a good example. There is the potential for life-changing and wonderful things, but also the real potential to do harm. We want to know that with every hip, breast, knee—whatever it is that is done—safety is paramount. Amendments 22 and 23 seek to create a special place for patient safety. I hope that the Minister will accept them.
Jo Churchill
First, patient safety is paramount. That is where I began my journey into Parliament. In my case, it was access to cancer drugs—something close to my heart. With regard to Orkambi, I understand and share the frustration felt by everyone. My heart goes out to those affected, who are very often parents. The cystic fibrosis campaign has, I think, a 98% sign up of all parents who have had children with cystic fibrosis. On their fight for Orkambi, I am sure everybody feels sympathy for them, because it took so long to provide access.
Drug companies have a responsibility here. This refers slightly to the comments the hon. Member for Nottingham North made about life science sectors or pharmaceutical companies all being large. The drug companies have a responsibility to price their drugs responsibly in a way that reflects the benefits that they bring to patients. I feel that the arrangements that we have in place in the National Institute for Health and Care Excellence and the cancer drugs fund have helped people to get access to medicines rapidly. There is still work to do, but they need to be marketised at a fair price. We made a commitment in our manifesto to establish an innovative medicines fund to address slightly some of the points that he made.
Amendments 22 to 27 relate to the three considerations the appropriate authority must have regard to when making regulations in relation to medicines for human and veterinary use and medical devices. The effect of the amendment would be to remove the requirement to have due regard to the attractiveness of the UK as a place to market and develop these products, and to assert the primacy of patient safety above all other considerations.
The safety of patients and the environment, people and animals—when moving into the area of veterinary medicine—absolutely underpins the regulatory decisions that are made. It is absolutely the case that we would never seek to make a regulatory change that puts somebody’s health at risk; that would be counter-intuitive. However, I do not think that patient safety or safety in general is in conflict with the other considerations that these amendments are intended to affect.
The purpose of the regulation is to ensure that we do what is in the best interests of UK patients, or the veterinary sector when it comes to animals, so that they receive the best possible treatment without undue impact on the environment. It is likely that having a dynamic and innovative market, where treatments or technologies are developed in the UK, contributes to the overall benefit of the patient, as those treatments will become available to them. These are not binary principles where regulation works only in the interests of one or the other.
The hon. Member for Nottingham North mentioned Nottingham—I also shout out to Cambridge, which is just down the road, and London, which the hon. Member for Bethnal Green and Bow mentioned. This country’s life sciences sector is envied. The Government have committed to supporting it through the life science industrial strategy, in which we have sought to address the challenges faced by the industry and provide an environment that encourages companies to start and grow. All large companies start somewhere, and the hon. Member for Nottingham North knows that in the incubators around Nottingham, Cambridge and even my constituency of Bury St Edmunds, lots of small firms are working on the most incredible things to help patients.
Rushanara Ali
Nobody doubts that innovation will thrive if there are proper frameworks and safeguards in place, but it is clear that, in a post-Brexit world, our Government will want to see more innovation in research and development and investment, and sometimes the choices will come into conflict. There will be a trade-off, and we must ask what is a greater priority. Frankly, in recent years, some of the narrative that we have heard from the Government has not inspired confidence. I am looking for a very clear message that public safety will be set in stone. It is not good enough for Ministers to give reassurance; it has to be set in stone. We have to have confidence that public safety will not be compromised in the interest of getting investment. That is necessary, but it should not come at the cost of public safety.
Jo Churchill
I thank the hon. Lady for her intervention. The reason why the safety of human medicines is listed first is because safety is the paramount objective in everything.
In the life sciences industrial strategy, we have sought to address the challenges faced by the industry, provide an environment that helps companies to grow, and support collaboration between the NHS and industry better to adopt innovative treatments and technologies. Life science is one of the most productive and strategically important parts of the UK economy—it is worth more than £74 billion per annum—and we wish to cement our position as a world leader in that field to allow patients to benefit from cutting-edge treatments as soon as possible. The Bill is a key part of that, and it also keeps safety right at the top of the agenda. It is therefore right that, when we make regulations, the appropriate authority considers their impact and looks at whether they would constrain companies from seeking to bring new and innovative medicines or medical devices to market.
The concern of the hon. Member for Nottingham North is that the consideration of the UK’s attractiveness, if applied, would mean a reduction in regulation on the sector, such that safety concerns would arise. That is simply not the case. I appreciate that he would like clarity on how the attractiveness consideration would work in practice, and the hon. Member for Central Ayrshire quizzed me about that too. The consideration would not mean reduced regulatory barriers to manufacturing, for example, as that would be to the detriment of patient safety. No! We have not sought to define attractiveness in the Bill, because the definition is as it is in ordinary language. There is no hidden or nefarious intent here. We want the UK to remain at the cutting edge of medical advancement, and that is done by recognising that the pharmaceutical industry benefits patients by making innovative therapies available through clinical trials and bringing them to market, or, indeed, collaborating in the event that expedited access to treatments is necessary.
Alex Norris
It feels to a certain extent as if we are having this conversation the wrong way round. I have not been in Parliament very long, but I have been on quite a few Bill Committees—I am sad like that. Normally the Opposition try to put words in a Bill and the Government say, “We agree with the principle; it just does not need to be on the face of the Bill.” It feels as if on the attractiveness point we are doing that the other way round. I completely accept that there is no nefarious aim, but I personally think that it is superfluous. We can perhaps pursue that at a later stage.
I agree, too, that those things are not necessarily in conflict but, as my hon. Friend the Member for Bethnal Green and Bow said, I can see circumstances in which they might be, in the sense of pressure to drop our standards in order to get certain investments. For the Opposition, that has been a fear throughout, and we can certainly see it in this place, which is why we would like to enshrine a provision in the Bill.
Finally, I accept the point that patient safety must come first, but I do not think that the Bill—although it was written with lots of lists in it—creates hierarchies in those lists. It does not specify what falls down, that A is better than B which is better than C which is better than D, so that does not quite cover the point. I will not press the amendments to a vote, but with permission, we might come back to them later. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 1 ordered to stand part of the Bill.
Clause 2
Manufacture, marketing and supply
Ms Marie Rimmer (St Helens South and Whiston) (Lab)
I beg to move amendment 1, in clause 2, page 2, line 23, at end, insert—
“(o) the origin and treatment of human organs used in the process of developing or manufacturing medicines”.
This amendment empowers the appropriate authority to make provisions on the process of developing or manufacturing medicines in relation to the origin and treatment of human organs.
It is a pleasure to serve in Committee under your chairmanship, Mr Davies.
The purpose of the amendment is to empower the Government to make regulations providing for the treatment of human organs in the development of the manufacturing of medicines. This is necessary due to the actions of the Chinese Government in Beijing.
The China tribunal launched the first independent legal analysis of all evidence related to organ harvesting in China. The tribunal is headed by Sir Geoffrey Nice, QC, who served as the lead prosecutor of Slobodan Milošević. It stated:
“Forced organ harvesting has been committed for years throughout China on a significant scale”.
I have forwarded copies of this document to all members of the Committee. I am trying to be as transparent as possible—this is not about trying to kid or trick on our commitment. I am sure that people in the country would agree. All members have copies, which I sent out over the weekend. I have given a short version of what the independent public tribunal said. Clearly, on the second page, it stated:
“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one—and probably the main—source of organ supply. The concerted persecution and medical testing of the Uyghurs is more recent, and it may be that evidence of forced organ harvesting of this group may emerge in due course.
The Tribunal has had no evidence that the significant infrastructure associated with China’s transplantation industry has been dismantled and absent a satisfactory explanation as to the source of readily available organs concludes that forced organ harvesting continues till today.”
There is therefore clear evidence that China is conducting medical testing on organs forcibly harvested from Uighurs, the Falun Gong, conscientious objectors and political prisoners. Indeed, a study by medical journal The BMJ raised ethical issues about more than 400 Chinese medical studies. The harvesting of organs from those people not only is an abhorrent act in and of itself, but often involves forced brain damage and vegetation of the person involved, of course leading to their eventual death.
Those papers that I sent to all Committee members refer to a debate in the House of Lords on 2 March, which raised the issue of the tribunal on forced organ harvesting in China. On that harvesting, Lord Alton commented that the
“organised butchery of living people compares to ‘the worst atrocities committed in conflicts of the 20th century’, including the gassing of Jews by the Nazis and the Khmer Rouge massacres in Cambodia”.
The UK Foreign and Commonwealth Office informed the UK House of Lords that the World Health Organisation, which previously advised that China’s transplant system is ethical, responded:
“The evidence that it uses is based on the self-assessment made by the country that is a signatory, and in this case that is China.”
That comes from the UK Foreign and Commonwealth Office. The British Medical Association calls on the Government to reconsider their position on this issue in the light of the findings of the tribunal, and to use their influence with the international community to ensure that a full, proper investigation takes place.
We therefore need to take the necessary steps to protect the United Kingdom’s healthcare system from being morally compromised through an injection of Chinese medicines developed in a way that breaches some of the most basic human rights. This amendment does not aim to shut down trade in medicines between the United Kingdom and China. Leaps in progress made for preserving human rights should be readily shared and traded across the globe. However, these leaps in progress should not come at the expense of innocent human lives, and we must do all that we can to ensure that this practice cannot be profited from.
By passing this amendment, the Government will be empowered to make regulations ensuring that medicines supplied in the United Kingdom meet basic human rights standards with regard to how organs have been obtained in their development and manufacture. Any medicines that meet these standards and any other standards set by the Government will, of course, be welcomed into the United Kingdom.
This amendment does not force the Government to implement these regulations now; it merely empowers the Government and the relevant authorities to take the necessary steps to regulate around this issue when they are prepared to do so. I can therefore see no moral or practical reason why members of the Committee would not wish to see this amendment added to this Bill, and urge the Committee to consider it.
Alex Norris
My hon. Friend has made a persuasive and powerful case, as she did on Second Reading. From the debate on Second Reading, I took away the phrase that this gives us a chance to “strike a blow” against this heinous industry. I certainly support her in that regard.
Jo Churchill
I thank the hon. Member for St Helens South and Whiston for raising this issue and the pack that she so diligently sent to us all over the weekend, which I read with great interest. I know she holds this issue dear to her heart and she is passionate about it. I fully understand the intention behind the amendment. It is absolutely right that medicines that enter the UK supply must not have been manufactured or developed to using organs or human tissues that do not come from authorised sources.
I can assure the hon. Lady that safeguards are in place to provide surety on these issues. The requirements around the donation, procurement, testing, processing, storage and distribution of organs, tissues and cells intended for human application are set out in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004, which are separate from measures on medicines manufacture.
Medicines legislation already ensures that human tissues and cells used in the manufacture of medicinal products must meet those requirements. Safeguards are in place in those Acts to ensure that the appropriate quality, safety and origin of human tissue is known—for example, consent and traceability requirements apply to any human tissue or cell component imported into the United Kingdom and used as a material in the manufacture of a medicinal product. Importantly, a researcher is not able to conduct research on human tissue in the UK if they cannot provide evidence that it has been obtained ethically and in accordance with legal requirements. The Government will ensure that, under the new deemed consent arrangements for organ donations, donations of cells for advanced therapy and medicinal products cannot happen without expressed consent.
Ms Rimmer
I am sorry about this—really sorry—because I understood that being a Minister was about co-operation, patience and morals. I do not disbelieve what the Minister says. However, there has been a public and independent inquiry, which found beyond all reasonable doubt. Those running the inquiry were people of stature and good regard, with a history of working for human rights.
I cannot withdraw the amendment. I ask that, at the very least, the Committee considers meeting Sir Geoffrey Nice and a Chinese surgeon who was forced to carry out the removal of organs in China, and who is now a taxi driver in London. They could meet somehow—I am sure we could do it on Teams or something like that. Before we get to Report, I urge the Committee to agree to such a meeting or to listen to and read the evidence. I cannot in all conscience accept that the learned people who sat on the China tribunal would have not researched and challenged—people such as Lord Alton, Lord Hunt and others in the House of Lords. Indeed, many hon. Members spoke about China’s treatment of Uighur Muslims in a Westminster Hall debate that was led by a Conservative Member on 11 March. I am sure some of them would have looked and questioned.
I will not and cannot withdraw the amendment, but I urge the Committee to have neutrality and meet the relevant people so that we can check. I would certainly have to check with learned people before I can begin to consider withdrawing the amendment. I cannot accept that the learned people who have engaged with this issue for so long—we have worked on it for nearly two years and, coincidentally, the Bill came along. I have tried to get a private Member’s Bill but have not succeeded. I have tried every nook and cranny to do anything I can to stop this practice. I do not want to risk our health service or our country’s reputation, which could be tarnished by being involved. I have dear friends who are Chinese, but I do not trust the Chinese Government in any way. I urge the Minister please at least to let us meet and consider this issue before Report. I have not sat on a Bill Committee before, Mr Davies, so I am not sure of procedure and, as you know, I am profoundly deaf. I urge the Minister please not to throw out amendment 1 without us doing that and rechecking every nook and cranny.
Jo Churchill
I understand the hon. Member’s passion for this area. As she said, she has tried to find every nook and cranny. I gently repeat that the Bill is not the right place for amendment 1, but I commit to writing to my Foreign and Commonwealth Office counterpart on this point and to exploring it further, if that would be of assistance to her. However, I say again that the Bill is not the vehicle for the amendment and I ask her to withdraw it.
Rushanara Ali
I welcome the Minister’s offer to write to the Foreign Office, and I commend in particular my hon. Friend the Member for St Helens South and Whiston for what she said. I have worked on human rights issues for other at-risk groups and there is a sense of concern about the position we may inadvertently find ourselves in. Will the Minister, in addition to writing to the Foreign Office, commit to ensuring that there is a review within Government to ensure that our safeguards are up to date? While I accept that the legislation is there, some gaps may need to be addressed and, if they cannot be addressed by the Bill, we need to find a way to assure ourselves that we have all the right safeguards in place. That will require a Health Department lead working with the Foreign Office and others.
Jo Churchill
As I said, I am willing to write to the Minister for Asia and the Pacific to explore this matter further, but I am afraid at this point that is all I can commit to.
Neil O'Brien (Harborough) (Con)
The hon. Member for St Helens South and Whiston made a hugely important and impassioned point, and I strongly support her. Will the Minister undertake to circulate her letter to members of the Committee?
Jo Churchill
Yes, of course, I will be happy to inform the Committee when I write to the Minister for Asia and the Pacific, if hon. Members would find that helpful. We heard from the hon. Member for St Helens South and Whiston, and I am sure we all read the pack she sent at the weekend about the trade in human organs, which is truly heinous.
The Chair
The hon. Member for St Helens South and Whiston said she was inexperienced in Bill Committees. I can happily tell her that at this moment in time she is in charge and it is entirely down to her whether she wishes to press her amendment to a Division or to withdraw it. It is for her to indicate which of those options she would prefer.
The Chair
With this it will be convenient to discuss the following:
New clause 2—Report on medicines under development—
‘On the date on which this Act is passed, and once every twelve months thereafter, the Secretary of State must lay before Parliament a report detailing what medicines the UK Government are developing.’.
This new clause requires the Secretary of State to lay before Parliament a report covering medicines that the UK Government are developing.
New clause 4—Antimicrobial Resistance—
‘(1) The Secretary of State must regard antimicrobial resistance a priority in the development of new medicines.
(2) The Secretary of State must, within 12 months of this Act receiving Royal Assent, lay an updated report before Parliament setting out a UK-wide strategy for tackling antimicrobial resistance.’.
This new clause requires the Government to prioritise tackling antimicrobial resistance and produce an updated report setting out how it shall do so.
Jo Churchill
The clause allows for changes to be made to the law relating to the manufacturing, marketing and supply of human medicines. It provides an exhaustive list of matters on which amendments can be made by regulation, giving clarity and limits on what may be done by secondary legislation. I will take each subsection in turn as these are important areas for the Committee’s consideration.
Subsection (1)(a) provides that changes may be made to update regulations in relation to manufacturing to reflect advances and innovation in the way in which medicines are prepared. That will enable us to take a revised approach to regulation, ensuring that regulations do not become barriers to patient access and to medicines manufactured in new ways while maintaining high regulatory standards to protect patient safety.
Subsection (1)(b) allows for changes to be made to the law governing the import of human medicines. It will support the continued ability to ensure that imported medicines are safe. We also want to be able to ensure that no unnecessary additional burden is placed on companies so that the UK remains an attractive place to supply medicines while protecting patients.
Subsection (1)(c) allows for changes to be made to the law governing the distribution of medicinal products by way of wholesale dealing. A wholesale dealing authorisation is required to supply or sell human medicines to anyone other than the patient using the medicine. In the light of any emerging safety concerns or innovative new techniques or technologies, changes may be required to maintain the quality of, and ensure proper distribution of, medicinal products. That could include such matters as providing and maintaining staff, premises equipment and facilities for the handling, storage and distribution of medicinal products under a wholesale dealer’s licence as are necessary.
Subsection (1)(d) provides that changes may be made to the law relating to marketing authorisations for human medicines. We want to ensure that UK patients have access to high-quality medicines and new treatments, so we need a regulatory system that maintains and enhances the UK’s attractiveness as a place to market novel and generic medicines while ensuring that medicines are safe and efficacious. We could, for example, amend the current regulations to offer additional statutory rewards or incentives for a certain type of application for a marketing authorisation, which would encourage new medicines to continue to come to the UK in a timely fashion.
Subsection (1)(e) allows for changes to be made to the law governing the manufacture, import or distribution of active substances. An active substance is an ingredient used to make a finished medicinal product and gives medicine its therapeutic effect. The ability to amend and update regulations in relation to active substances is necessary to protect public health, because if there is not adequate control of an active substance, contamination can carry over to the finished medicinal product. The ability to change the rules governing active substances means that we can update the UK regulations to react in response to emerging public health risks resulting from issues relating to active substances and ensure continued supply.
Subsection 1(f) allows for changes to be made to the law governing the brokering of human medicines. The brokering of medicinal products consists of negotiating independently and on behalf of another person in relation to the sale or purchase of medicinal products. We need to be able to amend the rules governing brokering in response to any new industry practices that arise and risk infiltration of the supply chain with falsified medicines. We could use this provision to restrict such activities, thereby securing the medicine supply chain and reducing the risk to patient safety.
Alex Norris
I am conscious that our carriage will turn into a pumpkin shortly, so I will move with some tempo.
New clause 2 is the Porton Down clause, and the world has changed greatly in the last few months. We now know, in a way we could never have grasped before, how an air-borne virus can lock us up in our homes for months on end, and even longer for many. We also know that what happens on the other side of the world can be with us quickly, and that at times, as with the current coronavirus, there is not much we can do about that.
We ought to reflect on what we are doing at home. We have reached a point where we could have a greater public understanding and scrutiny of the sorts of things being developed in our name by our Government. Porton Down is a world class facility full of incredibly talented people serving our national interest, but we do not know what they do. We get snippets. We know that in the past decade they have experimented on 52,00 animals, which is six times the rate of any other UK lab. I have absolutely no idea whether that is too high, too low, or just right, because we do not know. I am trying to probe the ways in which we can get greater transparency about what potentially life-saving or possibly life-ending products are being developed on our doorstep. If the Minister thinks there are better ways to do that, I am happy to consider those. The drafting does not refer to everything developed in the UK, but things developed by the Government. It is behind closed doors, very secretive, and potentially quite dangerous, so I am keen to know how we might get greater scrutiny.
New clause 4 on antimicrobial resistance is a passion of my predecessor, my hon. Friend the Member for Washington and Sunderland West. It is topical now as we wrestle with a horrendous virus, and I express my solidarity with the Minister and her colleagues on their efforts in doing so. Clearly, microbial organisms can adapt and have an incredible impact, as we are seeing. They can also disrupt much more conventional matters such as the antibiotics that are crucial for transplants and chemotherapy. It is laudable that the Government have a 20-year vision for this, although I hate long strategies. What is done in year one is much more important than what is done in year 20. I know there is a five-year plan sitting behind that, but even that feels too long a time. The new clause gives the opportunity instead for an annual report, which would be an improvement. If that is not the right vehicle, how might we be able to play our role in the conversation around antimicrobial resistance, and how do we get an appropriate period in which to hold the Government to account to ensure that we make progress?
Jo Churchill
I am grateful to the hon. Gentleman for raising the development of new medicines in new clause 2, which are important in new clause 3 as well. Antimicrobial resistance, as he has mentioned, is an absolutely critical issue of today. I will first set out what we are doing in that area. The development of medicines is an integral part of the UK life sciences sector, and we are committed to making sure that we can develop such medicines. The Bill gives us powers to maintain an effective system for regulating, including with respect to clinical trials. New clause 4 allows us to adapt the regulatory framework around them in a way that best suits the industry. The development of medicines is the role of the pharmaceutical industries and researchers, and we want to support them fully. The Government are committed to supporting a thriving sector, investing more than £1 billion a year in health research through the National Institute for Health Research, which is committed to openness and transparency about where the funds go. It ensures that all trials publicly register before any patient intervention, and key trial outcomes are made publicly available. However, the arrangements for Government support and funding through trials is not within the Bill.
I will address some of the work that the hon. Member for Nottingham North alluded to at Public Health England’s Porton Down campus, sometimes referred to in the context of medicine developments. The current PHE facilities at Porton Down do not develop medicines for Government, but engage in a range of scientific work for commercial and public sector customers. This includes the safety and efficacy of testing vaccines and therapeutics, and discovery work relating to novel and dangerous pathogens. Porton Down is also the site for work by Porton Biopharma Ltd, which is a public non-financial corporation and is outside central Government. Although PBL develops and manufactures biopharma products, this falls outside the Government and we are therefore not in a position to publish reports on the development of its work.
The hon. Gentleman also raised the important issue of AMR in new clause 4. I want to reassure the Committee that tackling AMR is a high priority for the Government and that its impact remains on the national risk register. The UK continues to lead the way on global action to tackle AMR, working alongside international partners, the most famous of whom is probably the most recent chief medical officer before Professor Sir Chris Whitty, Professor Dame Sally Davies, who has taken up her position as the special envoy for AMR. Her role will continue to underline the UK’s position as a world leader in developing and delivering international action in that space.
In January 2019, the UK Government published their vision to contain and control AMR by 2040. Achieving that is supported by the delivery of a five-year national action plan from 2019 to 2024. The delivery of the cross-Government commitments in the action plan is being overseen by a joint DHSC and Department for Environment, Food and Rural Affairs-chaired programme board, established in October 2019. The commitments in the national action plan cover all sectors, including human health, animal health, food and the environment.
The UK has already made good progress in reducing its use of antibiotics in humans and animals, and we now have the fifth-lowest level of antibiotic consumption in food-producing animals out of 31 European countries. We have also seen unprecedented levels of investment in collaboration in research on AMR nationally and globally. The UK invests significantly in AMR through the Fleming Fund and the global AMR innovation fund.
The hon. Member for Nottingham North is correct that the Government should prioritise the development of new medicines to address antimicrobial resistance, including antibiotics. Indeed, we already do. Having a pipeline full of antimicrobial drugs is critical to our efforts to contain, control and mitigate AMR, as outlined in the strategy towards 2040.
In July 2019, the UK formally launched a project for developing and testing the world’s first subscription-style payment model for antibiotics. If successful, it would mean that pharmaceutical companies received payment up front for access to their antibiotic products, based on the products’ value to the NHS, as opposed to the volume used. We are the first country in the world to test such a model and more information will be published on it in due course.
Although we know how important new medicines are in tackling antimicrobial resistance, a strengthened focus on prevention and the control of infection will help to contain the emergence and spread of resistance to antibiotics. By limiting and reducing the need to use antibiotics in the first place, we are taking a zero-tolerance approach to avoiding infection in human healthcare settings, as set out in the action plan. Our plan will result in at least 15,000 fewer UK patients being affected by infections each year by 2024, and 5,000 fewer drug-resistant infections.
In parallel, we are focusing on reducing animal exposures and susceptibility to pathogens that could result in the need for treatment with antimicrobials. By working closely with the veterinary profession to implement those preventive measures, we will reduce the need for new antimicrobial medicines as we reduce them in the food chain.
I hope that hon. Members will agree that the UK Government are working hard to ensure that AMR is controlled and contained through the vision for 2040 and the five-year action plan. New clause 4 is not necessary for the Bill. If the hon. Member for Nottingham North has further specific questions in relation to either medicines by the Government or AMR, I would be happy for him to write to me and I will endeavour to answer those points in a closed format. On that basis, I ask him to withdraw the new clause.
Alex Norris
I do not intend to press new clauses 2 and 4 to a Division. The Porton Down answer was helpful. In the terms of the amendment, it is not necessary, but I will have to work out how to get from accepting the principle about not developing medicines to accepting the next sentence about testing vaccines. That is a distinction without a difference, but I accept that it would not quite work in the Bill. The answer about the limited company does not hold either. As a wholly owned subsidiary of the UK Government, I think we could take an interest in that.
I was grateful for the detailed answer about AMR. I will take up the offer of engaging directly as and when. To be clear, we are keen to engage on that, because it is a significant issue and we want the Government to succeed at it. I hope that can be part of an ongoing conversation about it. On that basis, I will not press the new clause.
Question put and agreed to.
Clause 2 accordingly ordered to stand part of the Bill.
Medicines and Medical Devices Bill (Second sitting)
Monday 8th June 2020
(4 years, 5 months ago)
Public Bill CommitteesRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Public Bill Committee Amendments as at 8 June 2020 - (8 Jun 2020)
The Chair
As I mentioned this morning, I remind Members to respect social distancing guidance. I will intervene if necessary to remind people of that. I also remind Members that tea and coffee are not permitted in Committee sittings and to ensure that their mobile phones are switched off or switched to silent mode. Finally, the Hansard reporters would be very grateful if Members could email copies of their speaking notes to hansardnotes@parliament.uk.
Clause 5
Fees, offences, powers of inspectors
Alex Norris (Nottingham North) (Lab/Co-op)
I beg to move amendment 11, in clause 5, page 3, line 39, at end insert—
“(1A) The Secretary of State must publish a fees regime within three months of the date on which this Act receives Royal Assent.”
This amendment requires the Secretary of State to publish their proposed list of fees in respect of human medicines.
It is a pleasure to resume serving under your chairship, Mr Davies. We move to the rapid-fire round, which will almost inevitably lead to me at some point giving a speech to a previous or future amendment—I am sure colleagues will be gentle and generous with me when I do so. This short probing amendment relates to fees in the discharge of the human medicines sphere. The principle is that, in the exercising of clause 1(1) it is conceivable that the Secretary of State, the Department and the Government in general will incur costs, so clause 5(1)(a) allows for provision to be made to exercise a function to charge for that, which makes perfect sense.
The Medicines and Healthcare Products Regulatory Agency has previously worked on a cost recovery basis, which makes a lot of sense, but the amendment is designed to test whether it would not be better to have a comprehensive, clear and consistent fees regime. The MHRA and the Government in general have a tough job against a potential occasional big foe in the pharmaceutical industry—or big partner to work with, at least. I assume, but would like to hear from the Minister on the record, that the expectation is that there will be equal pay for an equal job, so a bigger firm that is better equipped to lobby would not end up paying smaller fees than a smaller firm, simply because that firm was better at arguing or making its case. Is cost recovery still in general the preferred option? If so, might it not strengthen the Secretary of State’s hand if that were put in the Bill?
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
It is a pleasure to be back this afternoon. I am grateful to the hon. Member for raising the important issue of fees in his amendment, and I recognise the intent of that probe. I am sure we agree that it is important that all new fees for human medicines are set in an open, fair and transparent way. I want to reassure him that what the amendment seeks to achieve is already standard practice and is happening. I will rapidly set out the steps already in place to ensure the fairness, openness and transparency that underpin the fees regime for human medicines.
The current fees have been subject to consultation and are provided for in legislation. They are published online and publicly available at gov.uk. All of that is supported by a formal and standardised process for reviewing existing fees and for the introduction of new fees for human medicines. The standard approach for setting statutory fees is full cost recovery, as the hon. Member alluded to, which means that fees must be set at a cost that reflects the activity involved in carrying out such a specific regulatory function.
The full cost recovery approach is set out by Her Majesty’s Treasury in its “Managing public money” guidance, which ensures that the Government neither profit at the expense of consumers nor make a loss for taxpayers to subsidise. Therefore, fees cannot be set arbitrarily, and the fee must reflect the cost of the regulatory work carried out. I think that goes some way to addressing the hon. Member’s probe on size.
Existing fees for human medicines are kept under active review by the Medicines and Healthcare Products Regulatory Agency. The amendment is specifically concerned with new fees that might be introduced under the powers in the Bill. It is already a requirement that new fee proposals are subject to consultation, and that duty continues for fee proposals under the Bill. We will publish impact assessments with the new proposals, which will set out the effects of any changes to fees in the UK on Government, industry or the general public. Her Majesty’s Treasury will be engaged throughout the fee proposal process, and any proposals for new fees will be subject to approval from HMT. It is also standard practice for the MHRA to engage with industry and trade bodies through regular meetings to discuss any new fee proposals that might be coming up.
I trust my explanation has reassured the hon. Member for Nottingham North that the requirements are and will continue to be in place so that fees for human medicines are fair, open and transparent. I therefore ask him to withdraw his amendment.
Alex Norris
I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.
Jo Churchill
Clause 5 provides that changes can be made to the law relating to human medicines with respect to fees, criminal offences and the powers of inspectors. Regulations made under clause 1(1) allow us to change the UK’s regulatory framework for human medicines as science, technology and clinical needs evolve. When the regulatory regime is updated, it is important that the regulator—in this case, the MHRA—can continue to regulate effectively and maintain compliance with all elements of the regime. To ensure this, it may be necessary to make provision about charging fees, creating criminal offences, and updating inspectors’ powers when making changes to the regulatory regime. Regulations made under clause 1 and relying on clause 5 will enable us to do this. We will consult before making any of those changes.
Clause 5(1)(a) allows us to make provision about the charging of fees. The regulator is self-funding for the purposes of medicines regulation. This work includes assessment for marketing authorisations and clinical trials of human medicines and inspections. It is funded by fees payable by the pharmaceutical industry in relation to the services and regulatory work provided. The current fees are set out in the Medicines (Products for Human Use) (Fees) Regulations 2016 and vary according to the specific areas of work.
It is important that existing fees can be amended, or fees can be introduced in connection with the MHRA exercising functions conferred by human medicines provisions as they evolve. Any proposal to introduce new fees is subject to consultation. The impacts on industry, Government and the general public would be evaluated through the usual process of an impact assessment. As part of its regulation of human medicines, the MHRA is able to impose criminal sanctions for certain regulatory breaches. As the regulatory regime is updated in future, it is important that we have the ability to also update the corresponding list of offences against which the MHRA can take action.
Clause 5(1)(b) allows us to create criminal offences with a maximum of two years’ imprisonment to cover updated requirements to supplement the evolution of the regulatory regime. MHRA inspectors play a critical role in ensuring compliance so that medicines are safe and effective for patients, and so that manufacture, research and surveillance processes are carried out to recognised standards. Inspectors already have all the powers to enter premises at any reasonable time to determine whether there has been a contravention of medicines regulations. For example, they may take samples or copies of documents if it is suspected that an offence has been committed. We have published two illustrative statutory instruments to demonstrate how provision can be made in regulations, relying on clause 5(1)(b) in combination with subsections of clause 2, to create a criminal offence for failing to comply with the new requirement set out in the regulations.
Clause 5(1)(c) allows us to update the relevant powers of entry and other powers of inspectors to align with new elements of the regulatory regime as it evolves. I commend the clause to the Committee.
Question put and agreed to.
Clause 5 accordingly ordered to stand part of the Bill.
Clauses 6 and 7 ordered to stand part of the Bill.
Clause 8
Power to make regulations about veterinary medicines
Alex Norris
I beg to move amendment 12, in clause 8, page 5, line 17, at end insert “services.”
This amendment broadens the range of issues that the Secretary of State must consider to include access to the relevant services to dispense veterinary medicines.
I did not want us to miss out the veterinary medicines part of the Bill, because it is important. We are a nation of animal lovers and we are keen that the laws we make are sympathetic to all living beings. The issue was also raised on Second Reading, because it has an impact on the food chain, so we must be mindful of setting an effective regime, as I know the Government are keen to do.
The amendment is simple. Again, I hope that it is redundant, but I want to test that with the Minister. There is a clear read-across between parts 1 and 2 of the Bill, which is that the powers being reserved for human medicines are largely the same as those being reserved for veterinary medicines. The word that I would like to be added in clause 8(2)(b) after
“the availability of veterinary medicines”
is “services”, because one way in which veterinary medicine differs from human medicine is that we do not have a universal service, so that access point is an important consideration for the Secretary of State.
I have not drafted the amendment elegantly enough. When we get to amendment 13, we will discuss something called the cascade, which was new to me until a couple of weeks ago. The principle of the cascade is that, whereas in human medicine we have expectations that certain medicines will be used to treat certain conditions and doctors do not have a massive amount of latitude to go outside that, in veterinary medicine, if such a thing is not available, the veterinarian can fall down the chain and use a different painkiller—perhaps a human painkiller. That is obviously important.
I wonder—and this is what I am testing with the amendment—whether that creates a possible inequity. If there is better access to veterinary medicines or supplies in certain communities, perhaps rural versus urban, that could create not a two-tier service, but a slightly different service from the one we want. It would therefore be useful for the Secretary of State to have regard to the services, as well as the physical ability to get pills, potions or whatever. That is all the amendment seeks to test and I am interested to hear what the Minister says.
Jo Churchill
I am grateful to the hon. Gentleman for raising the important issue of the availability of veterinary medicines. The intention is clear: to ensure continued access to veterinary medicine equitably for all the nations’ animals.
The Bill provides the power to amend or supplement the Veterinary Medicines Regulations 2013, which cover the full supply chain of veterinary medicines from development to supply. The requirement for the appropriate authority to have regard to the availability of veterinary medicines, as set out in clause 8, therefore ensures that when making regulations under the clause, the availability of veterinary medicines throughout the supply chain is considered.
Although the intended effect of amendment 12 is to expand on those factors, the actual effect would be to inadvertently narrow their scope to focus only on the availability of veterinary medicines services, such as the dispensing of veterinary medicines, rather than the availability of veterinary medicines more widely and more equitably. Veterinary medicines services alone are not the determining factor in the availability of veterinary medicines.
Clause 8, as drafted, ensures that the appropriate authority must have regard to the availability of veterinary medicines throughout the supply chain, so that the rural versus urban comparison the hon. Gentleman used would not be a comparator and medicines would be equally available. I therefore ask him to withdraw the amendment.
Alex Norris
I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
The Chair
With this it will be convenient to discuss new clause 5—Capacity of the veterinary industry—
“(1) The Secretary of State must, within 12 months of making regulations under section 8(1), lay a report before Parliament setting out an assessment of the capacity of the veterinary industry, relative to the requirements of those regulations.”
This new clause requires the Government to make an assessment of the capacity of the veterinary industry.
Jo Churchill
Clause 8 provides the power to amend or supplement the Veterinary Medicines Regulations 2013. Subsection (1) gives the appropriate authority a power, by regulation, to make amending or supplementing provision within the scope of the matters set out in clauses 9 and 10. The appropriate authority may use this power only to build on—in other words, amend and supplement —the current regulatory framework for veterinary medicines. Clauses 9 and 10 set out an exhaustive list of matters about which regulations could be made on veterinary medicines. An in-depth explanation of those clauses will be shared with the Committee throughout the course of these sittings.
Subsection (2) sets out three matters to which the appropriate authority must have regard when making regulations under clause 8: the safety of veterinary medicines in relation to animals, humans—including consumers of produce from treated animals—and the environment; the availability of veterinary medicines; and the attractiveness of the relevant part of the UK to industry for developing or supplying veterinary medicines. Subsection (3) explains that
“the relevant part of the UK”
depends on where the UK regulations will apply. The environmental safety aspects could include considering the potential impact of veterinary medicines on terrestrial and aquatic eco-systems and their flora and fauna—for example, the environment can also be affected by slurry application and excretion by grazing animals.
Subsection (4) sets out the appropriate authority for the purposes of regulations made under clause 8(1). The appropriate authority able to exercise this delegated power for England, Scotland and Wales is the Secretary of State. For Northern Ireland, the appropriate authority is either the Department of Agriculture, Environment and Rural Affairs in Northern Ireland acting alone, or the Secretary of State and the Northern Ireland Office acting jointly. This means that the powers can be exercised on their own, as well as jointly on a UK-wide basis.
Alex Norris
I will speak briefly to new clause 5. I was happy to withdraw amendment 12, but the principle was about trying to ensure that there is equitable access to services, because that is how veterinary medicine differs from human medicine. New clause 5 follows that principle through to its logical conclusion. This may have been done; I have been looking but have been unable to find it. I am sure the Secretary of State for Health and Social Care has seen hundreds and hundreds of health equity audits: how are things in Nottingham different from in Shipley, and how does that impact on health outcomes? For all the reasons I mentioned at the beginning, I wonder whether it is the same in the veterinary industry and whether there are regional, rural-urban and north-south disparities that mean access is different. The potential fall-outs from that are worth considering.
The new clause is intended to probe and to see whether the Government have that sort of information. If so, maybe they could let us see it—either shortly or during the rest of the proceedings on the Bill.
Jo Churchill
I am grateful to the hon. Member for raising the matter of capacity within the veterinary industry as it stands, in order to provide equity throughout. I recognise that he has given us examples of north-south disparities and so on, and I recognise the good intentions behind the new clause and his desire to ensure that the veterinary industry is working to full capacity and in unanimity across the piece. We agree that vets are an essential part of our animals’ lives and a key component of the UK system of protecting food safety, providing international assurance and upholding standards in welfare.
The Government are already working with various veterinary sector stakeholders, including the Royal College of Veterinary Surgeons and the British Veterinary Association, to understand the UK’s veterinary resourcing needs and ensure that there are adequate numbers of vets in the short and long term. We are working with a variety of initiatives to build a sustainable, diverse and modernised UK veterinary infrastructure to ensure that we maintain access to the right people, with the right skills and knowledge, supporting food safety and animal health and welfare, as well as trade. DEFRA has successfully secured a place for the veterinary profession on the Home Office shortage occupation list, and we are grateful to the Royal College of Veterinary Surgeons and British Veterinary Association for their work on the issue. It makes it easier for veterinary employers to gain visas.
To turn to specifics, as Members will know, the Bill introduces a statutory duty to consult before making changes to the Veterinary Medicines Regulations 2013. That consultation duty, in clause 40, requires that the appropriate authority must, before making regulations, consult those it considers appropriate. That is the most suitable route for ensuring that all those in the veterinary industry who need to be consulted are included. We are working across Government and with the veterinary profession to help to develop a flexible, skilled workforce that meets UK needs and irons out disparity of service. I want to assure the hon. Member for Nottingham North that it is a key priority to enable an innovative, productive and competitive veterinary medicine sector that invests in its people and skills. To help to achieve that, we shall ensure that there is access to sufficient appropriately skilled labour to drive continued industry growth and productivity, while ensuring that the environment for humans and animals is safe.
Alex Norris
I appreciate that answer, and the detail in it. I guess the only way in which I would supplement my questions is to ask that, once the fruits of the work with the relevant stakeholder bodies are available, they should be shared. That would be of great interest to Members on both sides of the House.
Question put and agreed to.
Clause 8 accordingly ordered to stand part of the Bill.
Clause 9
Manufacture, marketing, supply and field trials
Alex Norris
I beg to move amendment 13, in clause 9, page 6, line 11, at end insert—
‘(1A) The Secretary of State must by regulations make provision about the use of the Cascade.”
This amendment gives the Secretary of State the responsibility to make provisions regarding the Cascade, a process where veterinarians can dispense different medicines to animals, such as human medicines, should appropriate conventional animal medicines not be available.
I have buried the lede, obviously, by talking about the cascade already; but I am interested to hear a little more detail about the Minister’s vision for the cascade. It is obviously an entrenched principle across the European Union, and an industry standard. It has a significant impact on the lives of animals and, by proxy, humans as well. It seems to me an important principle, but it is not on the face of the Bill. The Government would, on Royal Assent, have the immediate ability to diverge away from the cascade quite quickly, but I wonder about the safety of that and whether that is in the Government’s plans. It was not in the impact assessment, so I am keen to scope out whether we expect the cascade to continue to be a principle in this country, and, if so, whether we expect our cascade to reflect closely the one used by our EU counterparts.
Jo Churchill
A clause or so back, the hon. Gentleman gave us a snapshot of what a cascade is, and I do not think I could put it better. My notes say that veterinary surgeons can prescribe gabapentin, a human medicine, to treat chronic pain in animals, particularly if it is of a neuropathic origin, as there is no equivalent in veterinary medicine. As the hon. Gentleman said, the cascade is about making sure that there is something in the veterinarian’s bag to enable appropriate care to be given to animals.
I am grateful to the hon. Member for Nottingham North and to the hon. Member for Central Ayrshire, who I think also signed the amendment, for raising the important issue of the prescribing cascade. However, not only is the amendment not necessary, but I argue that it could be unhelpful in certain instances. I recognise the desire to ensure that the use of prescribing cascades is regulated. The cascade enables veterinary surgeons to have access to a wider range of medicines to treat animals under their care and, in particular, to prevent the unacceptable suffering that might occur if they could not prescribe those alternatives.
The provisions with regard to the cascade are set out in schedule 4 to the Veterinary Medicines Regulations 2013 and the Bill already confers discretionary powers that would allow the appropriate authority to decide, following consultation, whether and how cascade requirements in the existing regulations might be amended in the future. That is provided for in clause 9(1), for the professionals to decide, arguably.
The amendment as drafted would appear to obligate the Secretary of State to update the regulations with regard to the cascade, as opposed to making those changes when it is appropriate to do so, and evaluate the cascade above other important aspects of the veterinary medicines regulatory framework. Although the cascade is important, it is our position that the regulations should be updated when it is clear and necessary to do so, rather than operating under a compulsion to do so for any one element, as putting it in the Bill might lead to. In that light, I ask the hon. Gentleman to withdraw it.
Alex Norris
I am happy to withdraw the amendment on that basis. The point of putting it in was to shoehorn the subject into the conversation, which was obviously effective. I did not hear from the Minister whether she felt that we are likely to continue to reflect the EU arrangements on that. Given that it is novel and specific to this area of medicine, and given that it is not risky, but diverges from what we consider basic medical practice in humans, it is of interest to people.
Perhaps now is not the moment to hear about the Government’s plans to reflect, or not, the judgments made by EU colleagues in future, but I hope that, over time, we can continue to have that conversation because I think there is public interest in that. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.
Jo Churchill
On amendment 13, I will write to DEFRA to seek clarification for the hon. Gentleman if that would be helpful. As we move through the Bill in the spirit of co-operation, I am more than happy to continue the conversation.
Clause 9(1) provides that amendments may be made to the Veterinary Medicines Regulations 2013 about the manufacture, marketing, supply and field trials of veterinary medicines. The Committee will note that in large part, clause 9(1) makes very similar provision to clause 2(1). I will take each subsection of clause 9(1) in turn.
Subsection (1)(a) sets out that the regulations made under the power in clause 8(1) may make provision about authorisations to manufacture veterinary medicines. The subsection means that it will be possible to update the rules around manufacturing authorisations—for example, to reflect the latest scientific advances in manufacturing and to address the manufacture of novel and innovative veterinary medicines. The subsection is therefore needed to future-proof the regulatory regime.
Subsection (1)(b) allows provision to be made about authorisations to import veterinary medicines, which is needed to continue to secure supply chains for those medicines entering the UK. By updating our existing regulatory framework, we can maximise the availability of veterinary medicines, while taking care that our approach does not place an additional burden on those who import medicines. Such a change can benefit animal owners, as it can lead to quicker access to veterinary medicines, a point that my hon. Friend the Member for Penrith and The Border brought up on Second Reading. We could use the subsection to allow additional professions, for example veterinary nurses, to import certain types of veterinary medicines with appropriate controls.
Subsection (1)(c) allows for provision to be made about authorisations to distribute veterinary medicines by way of wholesale dealing, which would ensure that we can provide further assurance on the quality and security of the full distribution chain for veterinary medicines. We could, for example, amend the application process for a wholesale dealer’s authorisation, supplement the requirements that must be met by the holder of such an authorisation, or amend the exceptions to the requirements for an authorisation.
The subsection could also be used to change the requirements for a wholesale dealer’s authorisation to cover new and novel products that may have new or additional storage and distribution requirements. That would maintain the quality and security of the distribution chain for such veterinary medicines and ensure that they are stored appropriately and safely throughout.
Subsection (1)(d) allows for provision to be made about marketing authorisations for veterinary medicines. This would help to ensure that the UK remains an attractive place for the pharmaceutical industry to bring to market both new and established medicines, and that UK animal owners do not have to wait for new, innovative or generic veterinary medicines. As an example, regulations could offer statutory rewards or incentives for certain types of applications for marketing authorisation.
Alex Norris
I beg to move amendment 14, in clause 10, page 6, line 35, at end insert—
‘(1A) The Secretary of State must publish a fees regime within three months of the date on which this Act receives Royal Assent.”
This amendment requires the Secretary of State to publish their proposed list of fees in respect of veterinary medicines.
This amendment is substantially the same as amendment 11, but it relates to veterinary medicines rather than to human medicines. So, assuming that the answer will be pretty much the same as for amendment 11, I do not really want to labour the point.
Jo Churchill
The short answer is probably yes, but I will just give the hon. Gentleman half a page of explanation.
I recognise that, as before with amendment 10, amendment 11 would ensure transparency, in essence, on fees that stakeholders may have to pay with regard to veterinary medicines, such as fees for marketing, manufacturing and distribution. The fees relating to veterinary medicines are set out in schedule 7 to the Veterinary Medicines Regulations 2013, and the power in the Bill is to amend the fees where necessary, rather than to create anything new. Indeed, it is unlikely that any new or amended fees would be introduced within three months following Royal Assent. The fees are already published online and are publicly available on the gov.uk website, as I mentioned earlier.
Therefore, the amendment would create an obligation for the Secretary of State simply to republish the existing fee regime, which is already publicly available; hence the continuity element. Any proposal to amend fees or to introduce new fees would be subject to consultation. In addition, potential impacts on businesses or organisations based in the UK would be evaluated through an impact assessment, which would also be made publicly available during the consultation process.
In light of that explanation, I cordially ask the hon. Gentleman to withdraw his amendment.
Alex Norris
I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.
Jo Churchill
Clause 10 provides that regulations made under clause 8(1) may make provision about charging fees, criminal offences and powers of inspectors. It enables the recovery of costs incurred in the administration of improvement or seizure notices under the Veterinary Medicines Regulations 2013.
We need to ensure that the regulator—the Veterinary Medicines Directorate, which I will now call VMD for ease—can continue to effectively regulate and confirm compliance with new or updated elements of the 2013 regulations. Therefore, it may be necessary to make appropriate changes to fees, offences and inspectors’ powers before making any such change; as I have constantly said, consultation will take place if that is the case.
The VMD is required to recover the costs of the regulatory services that it provides from fees and charges. It is important that existing fees can be amended or that fees can be introduced to meet the cost of functions exercised by the VMD. An essential part of protecting animal, human and environmental safety is ensuring compliance with the Veterinary Medicines Regulations 2013. The existing regime imposes criminal sanctions for breaches of the regulatory framework. This clause would allow for making the breach of requirements or prohibitions introduced under clause 8(1) a criminal offence, punishable by imprisonment of up to two years.
VMD inspectors play a critical role in ensuring compliance with the 2013 regulations, helping to ensure that medicines are safe and effective for animals by monitoring their manufacture and supply. Inspectors already have powers to enter premises at a reasonable time to ensure compliance with the 2013 regulations. Clause 10 would allow for the extension of existing powers of entry and inspection to new prohibitions and requirements introduced by regulations made under the Bill.
Subsection (2) provides that regulations made under clause 8(1) may not confer a power of entry to premises used wholly or mainly as a private dwelling, unless those premises or any part of them are approved, registered or authorised for the sale of veterinary medicines under the 2013 regulations.
I commend clause 10 to the Committee.
Question put and agreed to.
Clause 10 accordingly ordered to stand part of the Bill.
Clause 11 ordered to stand part of the Bill.
Clause 12
Power to make regulations about medical devices
Alex Norris
I beg to move amendment 15, in clause 12, page 7, line 27, at end insert—
“(d) the environmental sustainability of medical devices.”
This amendment obliges the Secretary of State to pay regard to the environmental impact of medical devices.
This is the “climate in all policies” amendment. We are in the middle of a global pandemic—an extraordinary time that we will all remember for the rest of our lives —but we are also in the middle of a climate emergency. Obviously, that was uppermost in all our thoughts a few months ago, and it must not fall down the order of priorities, because a similar existential threat exists as existed six months ago and it behoves us to act on it.
Amendment 15 is the first one relating to medical devices. To the principle that applies throughout the Bill of safety, availability and attractiveness, I think it would be suitable to add environmental sustainability, given that the types of materials used to create these devices could be finite resources. There could be opportunities for things to be reusable where they might at the moment be single use. I thought it important to probe this to see what the Government are doing, and could be doing, to ensure a medical devices market that promotes sustainability where that is responsible.
After tabling the amendment, I had a couple of emails from people making very fair points about things that could not be reusable. Of course, that applies to very many things in medicine; it is a very basic principle. I am very mindful of that. It is why the explanatory statement says “pay regard”. However, I think that the two things are compatible. There will be contexts where things that are currently single use do not have to be single use. I think that we should be seeking to promote that. There will be contexts where the market and the industry should be under pressure not to use finite resources, but to use all the considerable innovation to find other solutions. I feel that if Governments do not drive that in shaping the market, nobody else will. There should be pressure for, or at least interest in, buying British, for a variety of reasons. As well as being good for jobs and our local economies, that would be very good for reducing travel miles and therefore for sustainability. We have to decarbonise every industry we possibly can, so that applies to this industry also.
This is a basic principle that I seek in every policy—even though it might be a bit boring to hear me go on about it. We have to say, “But what about the climate? What about climate change?”. I think that this is the point in the Bill at which to do that. I would be interested to hear the Minister’s views on it, but also to hear what the vision is for shaping this market so that it is as sustainable as it can be.
Matt Western (Warwick and Leamington) (Lab)
My hon. Friend makes a very important point about sustainability, and of course linked to that is durability—the durability of the materials used in devices, particularly if a device is actually put into the human body. Of course, the durability is down to not just the effectiveness of the device or implant, but the cost to the health service of any subsequent revisions that may be needed, and so on. That is a significant cost, and therefore my hon. Friend is making an important point.
Alex Norris
I thank my hon. Friend for that intervention. It is important to seek quality and build to last, and to be sure that the products that enter the market are the best possible products in the round—not just those that have the best price on the box. There are other considerations of which we have to be mindful, whether they be patient safety, the long-term experiences that my hon. Friend has referenced or environmental sustainability.
Jo Churchill
I do not think anybody in the room is unmindful of the issues of environmental impact and durability, but the hon. Gentleman’s point is well made. He alluded to Baroness Cumberlege’s report, which will be out on 8 July. One of the challenges is that when something is implanted in the body, it is often there for a long period of time, and we would not want it to not be durable. That is always a consideration because, for example, we would not want something biodegradable sitting in a moist, wet environment—that product is not going to be doing its job in the long term.
I will address amendment 15, which relates to the requirement on the Secretary of State to have regard to certain factors when making regulations for medical devices. Clause 12(2) sets out those factors as
“(a) the safety of medical devices;
(b) the availability of medical devices;
(c) the attractiveness of the United Kingdom as a place in which to develop or supply medical devices.”
As I understand it, amendment 15 would oblige the Secretary of State to have regard to
“the environmental sustainability of medical devices”
as part of the assurances contained in clause 12(2).
I assure all hon. Members that the Government are fully cognisant of the need to ensure the ongoing sustainability of the environment, and have made major commitments not only on the broader issue of climate change, but to make sure that we are mindful of the reusability or sustainability of the things we use. All of this has to bring us back to the points that were made this morning about the need to be mindful of patient safety and so on. My understanding is that the intent of the amendment relates to the safe and environmentally friendly production of devices, which could include the transportation and sale of those devices, their import, and—where achievable—the reuse of devices after reprocessing. The hon. Member for Nottingham North has mentioned people getting in contact with him to say, “You’re not having my hip after I’ve used it,” but there are cases in which reuse would be appropriate, and we should be mindful of those.
The Bill is designed to support the safety of patients by maintaining a robust framework for the regulation of medicines and medical devices. The medical device regulations that clause 12 seeks to enable focus principally on the standards of pre-market and post-market assessment, as well as the vigilance required when placing devices on the UK market, so that UK patients feel safe about the products they can access. Amendment 15 would require consideration of facts beyond the regulator’s purview and introduce an added burden on the development of regulations, particularly when changes might be needed expediently to address issues of patient safety.
I totally understand the hon. Gentleman’s intention to put these issues at the forefront of our minds. However, I say gently that legislation to protect the environment, such as the Environmental Permitting (England and Wales) Regulations 2016, already exists and runs throughout the statute book, so checks and balances are in place. It is appropriate that manufacturers, suppliers and users of medical devices continue to have regard to the legislation specific to their circumstances, including the appropriate existing regulations that achieve the hon. Gentleman’s aim. I therefore ask him to withdraw the amendment. If the Opposition have points to press—with specific items, for example—they should write to me directly.
Alex Norris
I feel that I have made my point. I also discussed veterinary medicine and, with a Whip in the room, it might be misinterpreted that I am making a bid to be a shadow DEFRA Minister—I would not want that to be the sense that the Committee got. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.
Jo Churchill
Clause 12 provides the power to make changes to the Medical Device Regulations 2002, which regulate medical devices in the UK. Those regulations provide for the assessment of requirements and standards that must be met to place medical devices on the UK market, including in relation to packaging, labelling and user instructions, and for the requirements on manufacturers to conduct post-market surveillance of devices.
The first subsection of the clause is a delegated power allowing the Secretary of State to make amending or supplementing provisions to the Medical Devices Regulations. The exercise of that power is limited to making provisions about matters specified in clauses 13 to 15. Those clauses provide an explicit and exhaustive list of topics and give more detail on how the regulation-making power may be exercised. The Committee will, I am sure, hear in-depth explanations of those clauses during our consideration of them.
Subsection (2) explains that the Secretary of State must have regard to three factors when making provisions under subsection (1): the safety of medical devices; the availability of medical devices; and the attractiveness of the UK as a place in which to develop or supply medical devices. Those three factors must be taken into account, and they have been included to provide reassurance that future provisions are made with the best intentions for the safety of people and patients in the UK, as well as the continued development of our life sciences sector.
Matt Western
I thank the Minister for giving way; she is being very generous. I want to press her on that point. She talks about reassurance, safety and how important this sector is to our economy and our scientific status. When we talk about safety, we think about gauze and metal implants and so on, and the Minister mentioned how important it is for consumer protection and assurance. However, in the way that we have a building regs centre, or whatever it is called, at Watford—it came to light after the Grenfell disaster—where building materials are tested, is there such a body that does testing of these medical materials and products in the UK? If not, is one envisaged?
Jo Churchill
I will not bluff but, off the top of my head, I think that the MHRA would look at medical devices, as it does medicines—I was looking to where my box of officials would normally be. I am fairly sure that the MHRA pays regard to devices, as with the centre at Watford to which the hon. Gentleman alluded. That centre used to do its practices at the Cardington air hangars many years ago, I think, on fire in buildings, for example. Yes, I believe that there is sufficient regulatory oversight to ensure the safety of medical devices.
Medical devices are a reserved matter in relation to Wales, Scotland and Northern Ireland. As a result, unlike the enabling powers at clauses 1(1) and 8(1), regulations made under clause 12(1) can only be made by the Secretary of State.
Question put and agreed to.
Clause 12 accordingly ordered to stand part of the Bill.
Clause 13
Manufacture, marketing and supply
Alex Norris
I beg to move amendment 16, in clause 13, page 8, line 22, at end insert—
“(1A) In making regulations under section 12(1), the Secretary of State must evaluate the extent to which the market is meeting medical need.”
This amendment requires the Secretary of State to ensure that the market in devices is keeping pace with the UK’s medical needs.
This is the very nub of the Bill, and of the process of leaving the European Union and transitioning away from the relationship with it. That bears some important consideration, because presumably one does not leave unless one intends to do something differently; otherwise it would not be worth it. What is not clear is whether we intend to do something differently across all pieces, or whether that just happens inevitably over time because others choose to do something within this topic area and we, by default, do not and we start to diverge.
We could make this argument for medicines, but I have restricted it to medical devices because I think it only needs to be discussed once, and it is more easily conceivable and easier for me to explain my case when we talk about medical devices. I wrenched my wrist a few weeks ago, so I went to find some wrist support. I was thinking about it in this context, because I was starting my prep for the Bill, and it is striking how I started to see things on the box that perhaps I would not previously have seen or was not looking for, about all the different codes and regulations. The schedules to the Bill have a whole litany of them, and every medical device has some configuration of them on there.
In the future that will change, or at least the Secretary of State will be able to make that change. He can make it more complicated, much easier or more onerous, depending on our perspective; but it is almost inevitable, if only by the passage of time, that it will diverge from our friends on the continent. At that point, we create a market force. We know that companies developing medical devices will now have to make a choice about how they span the two markets. Of course, these issues have had hundreds of hours of parliamentary time, so I do not intend to rehash them much further, but I think there is a legitimate anxiety about the risk—and there must be a risk—that manufacturers prioritise the EU market over us and therefore we are behind in the queue and cannot get access to meet medical need.
The purpose of amendment 16 is to be clear about that, because that will give us a chance to do something about it as a Parliament, and for the Government it will act as a call to action. The amendment asks the Secretary of State to keep the matter under constant evaluation. I am perhaps willing to take the point that any responsible Secretary of State would do so anyway, but I would like to hear that it will be uppermost in the Government’s mind.
The changes we make are driven by the things we have talked about, which we see repeated for a third time under medical devices: safety, availability and attractiveness. We understand that, but because those changes could be very small, there could be a butterfly effect where we change something on a leaflet, or a badge that has to go on a box, and thus create a “Sliding Doors” moment where we start to diverge in different places. Then there will be a choice, and manufacturers will have to try to work out whether they prioritise bigger markets or smaller ones, or try to do something that pleases everybody.
I would be interested to know what conversations have happened with manufacturers and what lobbying of Government they have done about the sort of regime they want, because that is the substance of this Bill. The Bill remains a blank canvas for Ministers to paint on later; we are taking a leap of faith with Ministers here, and that is why we have sought to restrict that. It is worth understanding this, because it is one of the most profound implications of the Bill, and I am keen to know from the Minister how it has been mitigated and, importantly, how, and how actively, it is being considered.
Jo Churchill
Once again, I understand fully the intention of the amendment: to tease out the fact that small, incremental changes might lead to a divergence further down the line. However, I gently say that the purpose is to enable, so that, come January, we are in exactly the same place.
I will also say that innovation is a two-way street.An example is our ability to publish online to help people who might find it difficult to read the small print on paper in a packet of medicines, or who might be better able to understand from pictures how a device can be enabled or can help them. There is the chance, once we are in January 2021, to make those positive movements. That may lead to the Europeans looking and thinking, “Actually that would be useful.” There is no unique place for the good idea—I think that that is what I am gently trying to say. There is no place for a particular divergence, and we would not want there to be. As I said, there is consultation with stakeholders and the industry to be done on the exact points that have been alluded to.
Alex Norris
I am happy to leave this matter for now; we might come back to it on Report or Third Reading.
I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Alex Norris
I beg to move amendment 17, in clause 13, page 8, line 22, at end insert—
“(k) enabling the Secretary of State to compile a register of representatives for non-UK manufacturers.”
Manufacturers of medical devices based outside the UK must designate a UK representative. This gives the Secretary of State the power to compile a list of them.
This is a brief and probing amendment based on something I picked up on the road, as it were, while talking to people in the sector about what they wanted to see from the Bill and the areas that we ought to go at. I have not been able to quite stand it up in the way that I would have liked, but I am sure the Minister will humour me, in the spirit of an open constructive dialogue.
At the moment, a medical device manufacturer that is not based in the UK has to have a UK representative—and it makes absolute sense that there should be someone who is accountable for the manufacturer’s actions and the impact of its products. However, the suggestion is that there may be inconsistencies as to who that person is, whether they are a genuine person of corporate interest in the company who is in a position to make or shape decisions or whether they were an appointee almost like a paper candidate. I picked that up in a couple of places, but it is anecdotal rather than something I could stand up, despite having done quite a bit of digging. I would be keen to know whether the Minister recognises that characterisation, or at least that risk.
I have not pushed the point too far in the amendment. All I am asking is that the Secretary of State would be able to make a register for the purposes of transparency. One of the suggestions was that an individual might be acting as a representative for multiple manufacturers, and that a register would help tease that out and give us a bit of transparency. I appreciate that there may be commercial sensitivities or personal identity issues, but I am sure that such issues could be managed in a sympathetic way. Indeed, I have not suggested any obligation that the register be public.
I am interested in the concept. Do we think it is a risk, and as we move into this brave new world, is this a chance to try to close that loop? Perhaps there is a better way to do it. I am interested in the Minister’s views on that.
Jo Churchill
I am grateful to the hon. Member for mentioning the importance of establishing a UK device register that records UK representatives for non-UK manufacturers. We have actually spoken more broadly, but we both appreciate—as does the hon. Member for Central Ayrshire—that it is something on which we will probably need to have broader discussions in order to go forward.
First, I will look at the spirit of the amendment. I recognise that there is a desire to strengthen the Secretary of State’s ability to conduct market surveillance by including in the Bill a power to compile a register of representatives for non-UK manufacturers. I wish to reassure hon. Members that the regulation-making powers in the Bill are sufficiently robust to enable the Secretary of State to conduct effective market surveillance. In particular, clause 13(1)(h) empowers the Secretary of State to make provision for the creation of a device register. Discussing how that is to be done is the next step. As hon. Members can see, the intention is already laid out.
The register would hold information about the medical devices that become available for sale on the UK market. That could include information on non-UK manufacturers, if they have devices that are sold within the UK on the UK market. Government policy is to record the responsible person for all devices available on the UK market after the transition period. Furthermore, current registration requirements allow the Secretary of State to record manufacturer information for the lowest-risk devices, custom-made devices and all in vitro diagnostic devices in the UK. Mandatory registration with the MHRA provides a level of additional scrutiny on such products that would otherwise be absent.
The Bill provides a power to expand current registration requirements to deliver a more comprehensive record of information about a wider range of medical devices entering the UK market, in order to support the role of the MHRA and its post-market vigilance activity. The will is there but, as the hon. Member for Nottingham North knows, I am very keen that we get such a register, registry or data collection, over which there is already quite a lot of confusion out there. We need to work hard with clinicians and others to ensure we get this right. On that basis, I ask the hon. Member for Nottingham North to withdraw the amendment.
Alex Norris
I really appreciate that answer, and I appreciate the Minister’s commitments outside the Chamber—her work with me and the hon. Member for Central Ayrshire, whom we are all missing and who would have contributed considerably to our proceedings but cannot, for a very good reason. There is room in the space of registration. That is obviously one narrow aspect of it, so I am happy to withdraw the amendment in order to pursue the greater prize. There are subsequent amendments in my name that also look at this issue. As the Minister says, it is very complicated and there are myriad different aspects. It is potentially a barrier. It needs to be done well; otherwise, it would be a barrier to trade, which would be bad. The opportunity to come together and to hear from clinicians—to do this once and do it right—is a big prize, and I will certainly be keen to provide support in any way I can. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.
Jo Churchill
Clause 13(1), which is similar to clause 2(1) on human medicines, provides for amending supplementary provisions to be made to the medical devices regulatory framework. Clause 13 lists the matters relating to the manufacture, marketing and supply of medical devices that may be under clause 12(1). The list is exhaustive in order to provide clarity.
Paragraphs (a) to (d) of subsection (1) provide the changes that can be made to regulatory requirements, which must be met before a product can be placed on the UK market, and outlines who can make such an assessment. The provision includes requirements about the characteristics of devices, such as design, manufacture and packaging, and the requirements placed on people involved in the marketing and supply of devices. Those paragraphs also allow for changes to be made to the rules governing the appointment of a specified person or persons, UK-based or not, to assess and certify that medical devices meet all relevant requirements. Changes may be made to conformity assessments, which are assessments of whether requirements, which could include conforming to agreed standards, have all been met. Under subsection (1)(e) and (f) provision could be made about the information to be provided to demonstrate that a device has met regulatory requirements. That could include specifying declarations that manufacturers must make, or certificates that must be provided, to show that a device has been through the appropriate kind of conformity assessment.
Clause 13(1)(g) enables provision to be about labelling, packaging, and information requirements for devices. That might, for example, include specifying warnings or expiry dates that must be included on the label or packaging for a device, and what information to include in the instructions for the use of the device.
We have considered additional ways in which we can improve our regulatory system to improve patient safety and aid market surveillance activities undertaken by the Medicines and Healthcare Products Regulatory Agency. One is the provision made in clause 13(1)(h), which would empower the Secretary of State to make registration requirements for devices marketed in the UK about the registration of devices and their manufacturers and suppliers, including information—this is probably our starting point—to be entered in a register. That is where I do not want the landscape to get confused. It is important that the register sits as that important piece.
Regulations made under clause 12(1) and relying on clause 13(1)(h) will enable the MHRA to create a register of medical devices available on the UK market. That could be requirements to increase the scope of current registration rules. Currently the lowest risk class of device—where they have been self-assessed by the manufacturer rather than assessed by a notified body—is required to be registered with the MHRA. Specified information in such a register, which would not include commercially sensitive information or personal data, could be made publicly available under clause 13(1)(h)(iii), allowing clinicians and patients access to information on the device that they intend to use. Again, there would be transparency.
Under clause 13(1)(i) and (j) changes could be made to the rule around investigations and evaluations for safety, performance and clinical effectiveness, and monitoring of performance through market surveillance. Having the ability to update the rules is essential to maintaining patient safety standards.
The UK does not operate in isolation to the rest of the world, and we have provided at subsection (2) that, where regulations are made relating to matters in clause 13(1)(a)—requirements that must be met in relation to medical devices—those requirements can refer to international agreements or standards for marketing or supplying medical devices.
Question put and agreed to.
Clause 13 accordingly ordered to stand part of the Bill.
Clauses 14 to 16 ordered to stand part of the Bill.
Ordered, That further consideration be now adjourned.–(Maggie Throup.)
Medicines and Medical Devices Bill (Third sitting)
Wednesday 10th June 2020
(4 years, 5 months ago)
Public Bill CommitteesRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Public Bill Committee Amendments as at 10 June 2020 - (10 Jun 2020)
The Chair
Before we resume, I remind hon. Members of the preliminary points that I made on Monday. Members will understand the need to respect social distancing guidance. I remind them to switch electronic devices to silent mode and that tea and coffee are not allowed during sittings.
The selection list for today’s sitting is available in the room. That shows how the selected amendments have been grouped for debate. Grouped amendments are generally on the same or a similar issue. Please be reminded that decisions on amendments take place not in the order in which they are debated, but in the order in which they appear on the amendment paper. The selection and grouping list shows the order of debates. Decisions on each amendment are taken when we come to the clause that the amendment affects. Again, the Hansard Reporters will be most grateful if Members could email any electronic copies of their speaking notes to hansardnotes@parliament.uk.
Clause 17
Suspension notices
Alex Norris (Nottingham North) (Lab/Co-op)
I beg to move amendment 29, in clause 17, page 10, line 12, at end insert—
“(f) advertising it.”
This amendment allows the enforcement authority to prevent an individual who has been served a suspension note from advertising their product.
It is a pleasure to be back. Monday’s discussions were of a high quality and in a good spirit, which is what we need at this time, so I am glad to be here and back at it.
This is a short amendment: again, I want to talk about the issue rather than do anything else. Clause 17 sets the context and is mirrored in clause 18, to which I have tabled amendment 18. It sets out what the Secretary of State or the enforcement authority can do in relation to a faulty product, a medical device that is presumably dangerous or certainly not known to be safe. It includes a list of five things that can be prohibited under either a suspension notice or a safety notice. This prevents an individual from
“(a) supplying the medical device;
(b) offering to supply it;
(c) agreeing to supply it;
(d) exposing it for supply;
(e) possessing it for supply.”
I would add a sixth one—advertising it for supply. I flagged this up with the Minister the other day and will obviously be interested to hear her reply. I am conscious that she has the collective might of the legal brains of the whole Government. It could be that I have spotted a gap, or that I have not. That depends on whether advertising is covered by “offering to supply it” or “exposing it for supply”.
I want to talk about a particular phenomenon—the current way in which clickbait is used. For example, over the weekend, I saw an article that normally would be up my street. It said, “Jason Statham says he no longer needs to do the ‘Fast and Furious’ films”. I am a big fan of the “Fast and Furious” franchise, and that would grieve me enormously. I did not click on the article, because it was obviously nonsense, but I later saw an article about the very same thing. It mentioned Jason Statham and other people, and when you click on that type of thing, it takes you through to bitcoin. It basically said that he does not need to do films anymore, because he has made so much money on bitcoin and so can you. There is an argument to be had about cryptocurrencies, but the issue there is people being shown one thing that actually leads them to something else.
In the medical devices space, it is very easy to see equivalent things for people to click on. They will show someone with dramatic weight loss and then say, “You won’t believe how they did it.” In this case, there will be a picture of a medical device, and the idea is that someone says, “Wow! I’ve found a magical device. I can do the same. I can do it just like this celebrity.” Then they click through and it takes them to diet pills. I would argue that at no point there—there is no price; the article may not name or price the product, but just picture the product—have those responsible exposed it for supply, because it would be possible to argue that we literally cannot buy it, it is just a picture and certainly it has not been offered for supply.
Again, I am happy to take the lawyers’ guidance on this, and I hope that the Minister will help us with that. I just want to ascertain whether that gap—the thing that would legitimise a product, the demonstrating of it for another end—is one that we have to close.
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
I would also like to say what a pleasure it is to resume under your chairmanship, Mr Davies.
Amendment 29 seeks to amend clause 17 with regard to the suspension notices. I understand totally why hon. Members are looking to double-check where we are. The clause provides an enforcement authority with the power to serve a suspension notice on a person, where doing so is considered necessary to restrict the availability of a medical device in order to protect health and safety. It lists a number of prohibitions that may be imposed, and seeks to add a specific prohibition on advertising a medical device.
The Government recognise that the intention behind the amendment is to equip the enforcement agency with the ability to prohibit a recipient of a suspension notice from advertising a medical device where there is a need to protect health and safety. I assure hon. Members that the enforcement authority has the ability to do what the hon. Member for Nottingham North is asking and prohibit the advertising of a product already catered for in the clause. That is already in the Bill as it is currently drafted.
Hon. Members will note that prohibitions that may be impose include, in clause 17(2)(b), “offering to supply”, which encompasses advertising or an advertisement. Although I am grateful for the probe, I respectfully ask the hon. Gentleman to withdraw the amendment.
Alex Norris
I am content with that. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 17 ordered to stand part of the Bill.
Clause 18
Safety notices
Alex Norris
I beg to move amendment 18, in clause 18, page 10, line 34, at end insert—
“(f) advertising it.”
This amendment allows the enforcement authority to prevent an individual who has been served a safety note from advertising their product.
Alex Norris
This is exactly the point that I just made, so I will not labour it.
Jo Churchill
My explanation covered both points. Clause 18 provides an enforcement authority with the power to serve a safety notice on a person where doing so is considered necessary to restrict the availability of a medical device in order to protect health and safety. It provides the enforcement authority with discretion about the prohibitions that may be imposed. The amendment seeks to add a specific prohibition on advertising a medical device. We recognise that the purpose behind it is to equip the enforcement agency. I would like to reassure hon. Members that that sits in the Bill. On that basis, I commend the clause to the Committee.
Alex Norris
I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 18 ordered to stand part of the Bill.
Clauses 19 to 23 ordered to stand part of the Bill.
Clause 24
Defence of due diligence
Jo Churchill
I beg to move amendment 2, in clause 24, page 13, line 26, leave out ‘case’ and insert
‘proceedings for such an offence’.
This amendment, and amendments 3, 4, 5, 6 and 7, amend certain provisions to ensure they operate effectively in relation to Scotland.
The Chair
With this it will be convenient to discuss the following:
Government amendments 3 and 4.
Clause stand part.
Government amendments 5 to 7.
Jo Churchill
Amendments 2 to 7 relate to the clauses about defences available for offences under clause 23 and regulation 60A to be inserted into the Medical Devices Regulations 2002 by schedule 2.
Clause 23 will provide that it is an offence to fail to comply with a compliance, suspension, safety or information notice. Schedule 2 makes it an offence to fail to comply with certain provisions of the Medical Devices Regulations 2002. Further, the Bill provides that a defence of due diligence will be available with respect to each of those offences. That means that a person charged with an offence under either clause 23 or regulation 60A will be able to argue that they have not committed an offence because they took reasonable steps to avoid doing so.
The provisions that make those defences available are in clause 24 and schedule 2. It is those provisions that we seek to amend. Amendments 2 to 4 are to clause 24 and amendments 5 to 7 are to schedule 2.
Alex Norris
I do not have an awful lot to say. I am comfortable with the amendments, and I know that the hon. Member for Central Ayrshire is, too, as she put her name to them. I always find it reassuring when there are Government amendments during Committee, as it means they are still reading the Bill, which is a good thing. So, yes, we are content.
Jo Churchill
On that basis I commend the amendment to the Committee.
Amendment 2 agreed to.
Amendments made: 3, in clause 24, page 13, line 32, after ‘hearing’ insert ‘of the proceedings’.
See the explanatory statement for Amendment 2.
Amendment 4, in clause 24, page 14, line 2, at the end insert ‘, and
(b) the reference in subsection (3) to “the hearing of the proceedings” is to be read as a reference to “the trial diet”.’—(Jo Churchill.)
See the explanatory statement for Amendment 2.
Clause 24 , as amended, ordered to stand part of the Bill.
Clauses 25 and 26 ordered to stand part of the Bill.
Schedule 1
Medical devices: civil sanctions
Alex Norris
I beg to move amendment 20, in schedule 1, page 31, line 16, after ‘guidance’ insert
‘within three months of this Act receiving Royal Assent’.
This amendment requires the relevant guidance relating to enforcement to be published within 3 months rather than at an undetermined time.
The schedule compels the Secretary of State to provide guidance on sanctioning powers and how they are likely to be used. Those are the new civil powers—among the bigger changes in the Bill—and the guidance will cover when they are likely to be used, the likely level of fines, and the cost recovery, which we spoke about earlier. They are clearly an area of significant interest. Those civil powers are new and important, and we will cover them a bit when we debate the next amendment. At the moment, schedule 1 states that:
“The Secretary of State must prepare and publish guidance”.
That is it. The amendment seeks for that to be done within three months. Three months might not be the right period of time, but I am keen to test when we are likely to see the guidance and whether we should put a bit of structure around that.
Jo Churchill
I would like first to address the intention behind the amendment. I recognise that it is driven by the desire to ensure that the Government issue guidance on the new civil sanctions regime within three months of the Bill gaining Royal Assent. The new civil sanctions regime will complement the consolidation of the current enforcement regime, enabling the Medicines and Healthcare products Regulatory Agency to impose a monetary penalty, an enforcement cost and a recovery notice, or to accept an enforcement undertaking as an alternative to criminal prosecutions. That will enhance the MHRA’s ability to incentivise compliance with the Medical Devices Regulations 2002.
Under paragraph 13 of schedule 1, the Secretary of State has to publish guidance on the new civil sanctions regime. However, the timeframe for doing so is not specified on the face of the Bill. Before it is fully operational, the new civil sanctions regime provided for by the Bill will require further provision, to be set out in supplementary regulations made under paragraph 9 of schedule 1. The regulations will cover matters such as enforcement and monitoring of compliance with enforcement undertakings and appeals.
Clause 40 provides that any regulations made under paragraph 9 of schedule 1 must be consulted on. There needs to be enough time to do that, which is why a three-month period is perhaps too truncated. The Government wish to allow sufficient time for such a consultation on these matters before we make the regulations, in order to ensure that they best fit the situation that we are trying to enforce. As I have explained, the civil sanctions regime will not be fully effective before the regulations are made. Under paragraph 13 of schedule 1, the Secretary of State must also consult before issuing guidance on the new regime.
It is right that we consider the views of stakeholders. As we discussed at length on Monday, this is about getting it right for patients and all stakeholders before we bring the regulations into force. It is important that we allow sufficient time to engage effectively and to ensure that we act in the best interests of both patients and the healthcare sector. The effect of the amendment would be that the Government are required to consult on, and publish guidance on, the civil sanctions within a tight three-month period before the regulations have been made, and at a point when the consultation might still be ongoing, so that we arrive at the best place.
Paragraph 13 of schedule 1 already places a duty on the Secretary of State to publish the guidance in order to be transparent, and the new civil sanctions regime will require consultation and secondary legislation. It is therefore impractical to specify on the face of the Bill that we would have a timeframe for doing so. On that basis, I hope that the hon. Member understands that we wish to get this right, and that he will withdraw the amendment.
Alex Norris
I am happy with that, certainly for the purpose of greater consultation, because a theme in the written evidence is that the sector wants to continue to talk about such things and get them right. We will return to this issue when we debate the next amendment.
I hope the Government will not leave it too long. There is a very important bit of guidance that the Secretary of State is compelled to publish under the Modern Slavery Act 2015, but we have still not seen it. The regulations are likely to be less challenging than that. I do not like the open-ended space, so I hope the Government will move on precipitously. On the basis of the Minister’s answer, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Alex Norris
I beg to move amendment 21, in schedule 1, page 32, line 18, leave out “from time to time” and insert “every 12 months”.
This amendment requires the Secretary of State to report back on their use of civil sanctions every year rather than at an undetermined frequency
Again, this helps us to delve into the new sanctions regime and to talk about the Medicines and Healthcare products Regulatory Agency. As we see from the written evidence, there is a lot of interest in that. The Bill seems to do two things, certainly regarding the Medicines and Healthcare Products Regulatory Agency: consolidate disparate bits of legislation that govern its activity, and provide it with new civil powers.
Jo Churchill
Once again, I recognise that the hon. Gentleman is probing, to ensure we make good legislation. For that, I am extremely grateful.
The Government have every intention of providing greater transparency about the safety and effectiveness of medical devices on the UK market, including on how our use of civil sanctions will achieve that aim. On that basis, I confirm that the Cumberlege report will definitely be with us on 8 July, which I do not think I stated during proceedings on Monday. I take on board the hon. Gentleman’s point that we may well be looking at things in the round.
Civil sanctions will provide an alternative to criminal prosecution where the latter is not suitable. If, for example, a breach is judged to have had the potential to cause harm but it does not, the civil sanction is a second tool in the toolbox. As the hon. Gentleman said, there have been very few prosecutions in the last decade. Criminal prosecutions can be used where the breach of regulations leads to a serious incident or death, or where a manufacturer has directly contravened the conditions set out in a safety or suspension notice. As I am sure he will agree, other incidents very often need a flag raising, and that is the point of bringing civil sanctions into the legislation.
Currently, as the hon. Gentleman said, the Secretary of State is committed, under paragraph 15 of schedule 1, to publishing reports on the use of civil sanctions from time to time. The requirement to publish reports on the use of civil sanctions is in line with existing obligations on other Government agencies that already operate a civil sanctions regime for their sector. The Environment Agency is one—in respect of environmental civil sanctions—while the Secretary of State for Business, Energy and Industrial Strategy, who is responsible for enforcing the Ecodesign for Energy-Related Products Regulations 2010, is another. Those regulations explicitly state that reports on the use of civil sanctions will be published “from time to time”.
The new civil sanction regime would require supplementary legislation, as per paragraph 9 of schedule 1. A consultation on the supplementary legislation would be necessary to ensure that the new regime is operational. I assure Members that the Government intend to publish reports on their use of those measures at regular and appropriate intervals, and the hon. Gentleman will bring me up on that. The Government may indeed decide that reporting annually is appropriate. However, as the new regime will require secondary legislation, which must be consulted on before it comes into force, it is not practical to specify at this point the frequency of Government reports on the use of civil sanctions.
On the hon. Gentleman’s specific point about burden of proof and how we arrived at that, I will write to him. On that basis, I invite him to withdraw the amendment.
Alex Norris
On the principle of civil sanctions, we are content. I am really grateful to the Minister for her offer to write to me about the burden of proof, and I will definitely take her up on that. It is important to reflect on why that is different in different cases.
I meant to refer to the potential to do harm, which is something worth reflecting on that, and we can talk about it in the remaining stages. At the risk of going into pub chat—if only—let us imagine that I throw a stone at someone. Whether I hit or miss, have I committed an offence? Does it matter that I have good or poor aim? When it comes to medical devices, if we find something with the potential to do significant harm, the fact that it has not yet done so would certainly not be a good enough reason to downgrade the way in which that was treated. Again, we can reflect on that another time, and it is also tied up with the burden of proof, but on the basis of the answers so far, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Schedule 1 agreed to.
Clauses 27 to 29 ordered to stand part of the Bill.
Clause 30
Recall of medical device by enforcement authority
Alex Norris
I beg to move amendment 28, in clause 30, page 16, line 23, at end insert—
“(4) The Secretary of State must, within 24 months of this Act receiving Royal Assent, lay a report before Parliament reviewing uses of this clause.”
This amendment requires the Government to review any use of the recall powers made in the first 2 years of the Act.
Again, this is a simple amendment. The clause governs the recall of a medical device by the MHRA. That is of significant public interest—recall, obviously, is important to people. It is also really challenging, and we have all seen that, whether with washing machines, cars or whatever. Once devices are out there, it is hard to recall them, so we want to know that these powers are working effectively.
The obligation that the amendment would put on the Secretary of State is to provide, within two years, a report on when recall has been used. That would do two things: first, it would allow us to evaluate how effectively recall was being used; and, secondly, it would act as a further publicity tool, so that people understood that the device has been recalled and, if they were still in possession of it, that they could do something about it.
At the moment, subsection (2) states: “The authority”—the MHRA—
“may take such steps as it considers necessary to organise the return of the device”,
but the clause does not quite say anywhere that the MHRA will then tell people what it has done. If that is implied, I am probably willing to accept that answer, but I am keen for the Minister to note that the Government’s clear intent is not only to organise the recall of unsafe devices, but to publicise that significantly, such that it will be reasonable to expect people to see such publicity and therefore to act on it.
Jo Churchill
The Government consider the new recall power to be crucial to ensuring that unsafe devices are removed from the market. It is important to note, however, that subsection (3) requires that the power is used only as a last resort.
The Bill introduces this statutory power for the MHRA, on behalf of the Secretary of State, to conduct recalls on the rare occasions when a manufacturer is either unwilling to carry out a recall imposed under clause 18 or is unable to do so because the manufacturer no longer exists as an entity. I am sure Members will agree with this power, as it is intended to ensure the safety of devices for patients and, without it, there would be a gap. In the case of companies unwilling to take action, devices that are not recalled might well present risks to patients. It is right that the regulator can take action if and when companies fail to recall devices.
The statutory power also addresses an anomaly in the existing enforcement regime, whereby the MHRA has the statutory power to conduct a recall under the General Product Safety Regulations 2005 where the medical device in question meets the definition of a consumer good—typically, a low-risk medical device—but the MHRA does not currently have the commensurate statutory power to conduct recalls for higher-risk medical devices that are not also consumer goods under the GPSR. That would appear to be an inconsistency that does not align with risk to patients. I am sure all hon. Members would agree that, where possible, that is what good legislation should do, and the Bill seeks to correct that anomaly.
Alex Norris
I will not labour the point, but the Government must act not just transparently, but transparently, publicly and proactively. That is something we would be really keen on.
Matt Western (Warwick and Leamington) (Lab)
On a point of clarification, at what point does the MHRA intervene? At what point is the threshold—that is perhaps a better way of putting it—at which a recall is demanded? Depending on the product, at what point is that necessary and who bears the cost? I am not sure whether that should be covered by the clause, or whether it is simply within the remit of the MHRA.
Alex Norris
That is interesting, and if the Minister wants to intervene to address that point, I will take an intervention. Otherwise, my best guess is that it would be covered by the regs and, presumably, subject to consultation. However, I hope the Government have a clear trigger point, so that we are all clear and transparent about what will happen.
Jo Churchill
The MHRA has a specific compliance department. It works on a case-by-case basis, and it would issue a notice—see clause 18—and it would move forward on that basis with an individual recall against a company. I hope that clarifies the situation.
Alex Norris
I am grateful for that clarification. On the basis of the answer I have received, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 30 ordered to stand part of the Bill.
Clauses 31 to 36 ordered to stand part of the Bill.
Schedule 2
Offence of breaching provisions in the Medical Devices Regulations 2002
Amendments made: 5, in schedule 2, page 34, line 8, leave out “case” and insert
“proceedings for such an offence”.
See the explanatory statement for Amendment 2.
Amendment 6, in schedule 2, page 34, line 14, after “hearing” insert “of the proceedings”.
See the explanatory statement for Amendment 2.
Amendment 7, in schedule 2, page 34, line 28, at the end insert “and
(b) the reference in paragraph (3) to ‘the hearing of the proceedings’ is to be read as a reference to ‘the trial diet’.”—(Jo Churchill.)
See the explanatory statement for Amendment 2.
Schedule 2, as amended, agreed to.
Clauses 37 to 42 ordered to stand part of the Bill.
Clause 43
Commencement
Alex Norris
I beg to move amendment 19, in clause 43, page 24, line 17, leave out
“on such day or days as the Secretary of State may by regulations made by statutory instrument appoint”
and insert
“six months after this Act receives Royal Assent.”
This amendment brings the enforcement regime into force at a defined period after Royal Assent rather than at a date of the Government’s choosing.
Having accepted the principle of the new enforcement regime and seeing its potential, I am keen to know when it will be in place and what the Government’s intentions are for getting on with it. Clause 43(3) says:
“Chapters 2 and 3 of Part 3”—
the bit that governs the enforcement and disclosure around medical devices—
“come into force on such day or days as the Secretary of State may by regulations made by statutory instrument appoint.”
Basically, that means at some point in the future.
The amendment, which is in my name and the name of the hon. Member for Central Ayrshire, suggests the regime should come into force within six months of Royal Assent. As was said in our earlier discussion, I imagine that the Government want to return to consultation on that point, so that might not be the right period. We are keen to know that the Government intend to get on with it, however, because there may be some push-back from those with vested interests who do not want the scheme to go ahead. I talked about there being three prosecutions in 12 years; we are likely to see much greater activity than that, and there will be those with vested interests who do not want that to happen.
I am keen for the Government not to leave this forever. If we accept in primary legislation that the regime is going to happen and is a good idea, that is what matters, and it should happen at a defined point. I am keen to know what the Government see as the timeline for introducing it. As Parliament has decided that we will do this, I would like a firm commitment on the record that we are actually going to do it.
Jo Churchill
I am grateful to the hon. Gentleman for raising, through amendment 19, the issue of the commencement of chapters 2 and 3 of part 3 of the Bill, which is concerned with medical devices. Chapter 2 introduces a new enforcement regime that includes the civil sanctions set out in schedule 1, which we discussed. Chapter 3 concerns data and disclosure provisions, and contains a number of consequential amendments, which facilitate the introduction of the new enforcement regime in chapter 2.
On chapter 2, as I have said, a key element of the new enforcement regime is the addition of civil sanctions, which will act as a flexible, proportionate enforcement mechanism to enhance the MHRA’s ability to incentivise compliance. Supplementary regulations must be made under paragraph 9 of schedule 1 before the new civil sanctions can be fully operational. Those regulations, which could relate to matters such as the enforcement of a monetary penalty regime, monitoring compliance with an enforcement undertaking, and the provision of appeals, are subject to a consultation requirement, as set out in clause 40. It is right that we consider the views of stakeholders before bringing the regulations into force, and it is important to allow for time to engage effectively, so that we can ensure that we act in the best interests of patients, and thereby in the best interests of the healthcare sector that serves them.
The data and disclosure provisions in chapter 3 will provide greater transparency about the safety and effectiveness of medical devices on the UK market. I am sure we all agree that that is what we are after: knowing what is going where and helping whom, and, if there is an issue, being able to isolate and highlight it, and then provide a remedy. The Government are exploring how we can ensure that the new powers are as effective as possible and secure the needs of the healthcare community, patients and the wider public. It is therefore appropriate that due consideration be given to how the powers can most effectively be used before they are commenced. An amendment putting in place a deadline by which the powers must come into force could limit the MHRA’s ability to find the most effective route, and it could limit the time that MHRA has before commencement for the important process of engaging with stakeholders on the powers.
Finally, the consequential provisions in clause 36 are linked to the disapplication of the previous enforcement regime in part 2 of the Consumer Protection Act 1987. They too must be commenceable by regulations, so that they come into force at the same time as the new enforcement regime.
I reassure hon. Members that the Government are committed to bringing the enforcement, data and disclosure chapters of the Bill into force as soon as is appropriate, in order to enhance the safety of the medical devices regime, which I think we all see as important. I therefore ask the hon. Member for Nottingham North to withdraw the amendment.
Alex Norris
The final part of that answer answered my question. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 43 ordered to stand part of the Bill.
Clauses 44 to 45 ordered to stand part of the Bill.
New Clause 6
Registration of Medical Devices
‘(1) The Secretary of State shall by regulations establish a UK Registry of all devices implanted into patients on a long-term basis.
(2) The identifier details of any devices implanted into patients, on a long-term or permanent basis, must be registered.
(3) The information registered must include—
(a) The unique identifier of the patient into whom the device is implanted;
(b) The Clinician responsible for the procedure;
(c) The hospital or clinic in which the procedure is performed;
(d) A standardised description of the device;
(e) The unique identifier code of the device implanted.
(4) Efforts must be made for this unique identifier data to be gathered by barcode reader as in the trial of ‘Scan for Safety’.
(5) This Registry shall require linkage from all currently established speciality device registries, in current operation, to avoid duplication of registration.
(6) Devices without any form of specialist registry currently available shall be registered in this UK Registry.
(7) Governance structures regarding the management and access to registry data shall be established after consultation with stakeholders including but not limited to—
(a) the appropriate authorities as defined in Section 1 (4);
(b) all UK based Royal Colleges of Surgery or Radiology and any others representing clinicians involved in such procedures;
(c) Managers of current speciality device registries;
(d) the Medicines and Healthcare products Regulatory Agency;
(e) the Directors of each of the four UK based National Health Services;
(f) healthcare quality improvement bodies from each of the four UK based National Health Services;
(g) representatives of the Healthcare device manufacturing sector;
(h) academics with expertise in the design and maintenance of registries;
(i) additional stakeholders as identified during the development and maintenance of such a registry.
(8) Patient information from such a registry shall be provided to clinicians if there is concern regarding the management of or complications from any implanted device to allow closer monitoring or removal if so warranted.”
The aim of such a UK register is to ensure earlier recognition of complications from implantable devices and allow the easy identification and urgent recall of affected patients should such a concern be recognised.
Brought up, and read the First time.
Alex Norris
I beg to move, That the clause be read a Second time.
I am pleased to give this clause a run-out on behalf of the hon. Member for Central Ayrshire. We have missed her during these proceedings, and I hope that conversations are ongoing through the usual channels about how we can make Public Bill Committees work and perhaps give hon. Members who cannot be here—for very good reasons—a chance to contribute.
This is the final new clause, but it is by no means the least important. In fact, it has the most potential to be a clause with which we do something quite exciting. A great deal of pain has been caused in the past. I will not get ahead of the Cumberlege review, but when things go wrong in the space of medical devices, they go wrong catastrophically and in a life-altering fashion. None of us would want to see that; all of us would want to do anything we can to avoid or mitigate that harm.
The new clause would establish an exciting regime of registration of medical devices. It would provide information on a granular level—we have seen the level of detail that the hon. Member for Central Ayrshire has put into it—so that we know exactly what medical device has gone where and for what purpose. This is a complex area. We talked on Monday about the various different registries or registrations we could have, and all are complex and require reflection. This would be a good part of marking the Government’s card. Since Monday, we have had very good informal conversations about how we can take this forward.
Jo Churchill
As the hon. Gentleman knows, I am also enthused and excited about the register, because it offers us a space to do something good. I am very grateful to him and the hon. Member for Central Ayrshire, to whom I spoke at the weekend, as I said on Monday, and I noted that she would not be with us for Committee proceedings.
A registry of long-term implantable medical devices as suggested in new clause 6 is of significant interest to many Members. On Second Reading, many Members put forward good ideas on how we could make a register work for the benefit of patients. We should consider this in the context of the forthcoming report from the independent medicines and medical devices safety review and the matters it looked into, particularly the use of pelvic mesh, and how we oversee medical devices, including post-market surveillance. It is not only the point when the device is implanted that is vital, but also the potential impacts some years later. I know we all recognise the critical importance of ensuring that patients are heard and that concerns about medical devices are identified and dealt with quickly and effectively. That must be at the forefront of our minds. As the hon. Gentleman said, the impact on an individual’s life can be significant.
New clause 6 is similar to new clause 1, which was tabled in the name of my hon. Friend the Member for Newton Abbot (Anne Marie Morris). I know that she and many other Members in the House and the other place are interested in what more we could do to improve the tracking of implantable medical devices. The issue has also been a subject of interest to the Health Quality Improvement Partnership and the Royal College of Surgeons. It is very topical.
Clause 13(1)(h) provides for the creation of a register of medical devices to capture which devices are available on the UK market and to ensure that the MHRA can identify which device has been produced by which manufacturer. There has been some confusion in some of the written evidence as to whether that is intended to constitute a registry. A registry as in new clause 6 suggests bringing together patient and clinical information with device information. We have device registries, such as the national joint registry in the UK, which is seen as a global exemplar, so it is important to make sure that we do what we need to in order to enhance what is already in the system.
I understand the intent behind the new clause and, as ever, I am keen to understand what more we can do to protect patients in a fast-moving and constantly innovating environment, but I am not sure that new clause 6 is practical. The hon. Member for Central Ayrshire and I discussed the fact that it was heading in the right direction, but we need to work on it.
Patient safety absolutely underpins everything in our approach to regulation of medical devices in the Bill. It is the key consideration for all of us, as set out in clause 12(2)—the Government have put it there as the key priority. That is why we have introduced the ability for the Secretary of State to disclose information in the event of a safety concern, as we discussed.
I am not sure that the new clause achieves what the hon. Members for Central Ayrshire and for Nottingham North want it to. The intent is to establish a UK registry linking together all existing device registries, so that duplication of the entry of information is reduced, and to require the information entered to include the specifics of a device, such as the clinician who implanted it—information that, in the event of something going wrong, would give a clear picture of what happened. Although that is a commendable aim, the existing registries have been established over time and have expanded into different regions, evolving as they go. We have not had conversations on linkages to the registers in various parts of the country and in devolved Administrations. It is right and proper that we pull back and ensure that we have taken in the views of all stakeholders, and done the proper engagement to ensure that we collect the information from registers appropriately. That needs some work, partly due to the differing operating approaches in each registry. I gently suggest that the proposal in subsection (6) that all implanted devices without a specialist registry be logged on a national registry is a little broad at this stage. We perhaps need to talk about that with stakeholders and others.
The new clause also seeks to establish a governance structure, after consultation with a range of stakeholders, on the management of and access to the proposed registry. I suggest that the consultation requirement is out of step with the consultation duty in clause 40, which provides that consultation with those considered appropriate must take place before we make the regulations. It is a little cart before the horse but, that notwithstanding, this is very much the direction of travel. I remain of the view—no doubt we will come to this point—that we must ensure that we do not inadvertently rule out consulting those who ought to be consulted.
The hon. Member for Nottingham North and I have had discussions in this space, and we are united in wanting this idea to get to the right place. I appreciate the careful consideration that was given to the new clause, and I am grateful for it. I would welcome further discussions in the near future.
Matt Western
I am keen to clarify, not having been party to previous debate, what happens with non-medical cosmetic devices implanted by a medical procedure. Should registry for them be part of this consideration? There is a subsequent impact on our NHS when things go wrong.
Jo Churchill
I thank the hon. Member for his intervention. We are not talking about cosmetic devices here, but I very much take his point. If it involves implantation, it is worth talking about, in the round, during consultation; however, many of the cosmetic issues he refers to may be temporary—if, for example, a device is inserted and then taken away. The legislation is about implanted devices. Again, it is something that we would talk about and ensure that we had consulted on, but for the purposes of the Bill, we are specifically looking at medical devices, and the definition of them.
As I said, I welcome discussion with those interested in these matters, particularly as we look forward to Baroness Cumberlege’s review, which is coming very shortly. On that basis, I ask the hon. Members for Central Ayrshire and for Nottingham North to withdraw the motion, but I will commit to following up with arrangements to have those discussions in a timely fashion.
Alex Norris
We are in vicious agreement on this point. The new clause provides a possible destination, but through conversations and the expertise of colleagues, we may end up going in a similar but different direction. It is right that we start with the goal in mind and then work to where we get to. I think there is real potential in this area. As the Minister said, my hon. Friend the Member for Warwick and Leamington made a very important point, because the principles are very similar. There may be scope to include the areas that he mentioned also.
I thank the Clerks and you, Chair, for your support in this process. We have had some very good discussions, and laid the groundwork to do even more. I beg to ask leave to withdraw the motion.
Clause, by leave, withdrawn.
Question proposed, That the Chair do report the Bill, as amended, to the House.
The Chair
Before I put the final question, I thank all Members, particularly the Minister and the shadow Minister, for the way they have conducted themselves throughout the proceedings, which have been a pleasure to chair. I also thank the two Clerks and the Hansard reporters for their hard work.
Question put and agreed to.
Bill, as amended, accordingly to be reported.
Medicines and Medical Devices Bill
Tuesday 23rd June 2020
(4 years, 5 months ago)
Commons ChamberRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Consideration of Bill Amendments as at 23 June 2020 - (23 Jun 2020)
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
I beg to move, That the clause be read a Second time.
Mr Deputy Speaker (Mr Nigel Evans)
With this it will be convenient to discuss the following:
Amendment 21, in clause 1, page 2, line 6, at end insert—
“(5) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of human medicines.”
This amendment requires the appropriate authority to consider patient safety first when making regulations under subsection (1).
Amendment 20, page 1, line 5, at end insert
“for a period of three years following the day on which this Act is passed.”
This amendment provides a sunset provision for the Bill requiring the Government to return with primary legislation.
Amendment 19, in clause 2, page 2, line 26, at end, insert—
“(o) the origin and treatment of human organs used in the process of developing or manufacturing medicines”.
This amendment empowers the appropriate authority to make provisions on the process of developing or manufacturing medicines in relation to the origin and treatment of human organs.
Amendment 22, in clause 8, page 5, line 34, at end insert—
“(5) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of veterinary medicines in relation to animals, humans and the environment.”
This amendment requires the appropriate authority to consider animal, human and environmental safety first when making regulations under subsection (1).
Amendment 23, in clause 12, page 7, line 27, at end insert—
“(3) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of medical devices.”
This amendment requires the appropriate authority to consider safety first when making regulations under subsection (1).
Government amendments 1 to 18.
Jo Churchill
This Bill is an opportunity. It is necessary to ensure that we have the ability to continue to update our regulatory frameworks after the end of the transition period. We must ensure that we continue to be able to respond swiftly to pressing need. This is not a standstill Bill, however. It is designed to underpin the way in which the UK approaches the life sciences sector and innovation in health from 2020 onwards—an approach where we promote, to the best of our ability, patients’ access to cutting-edge treatments and encourage the cultivation of new, safe and patient-focused technology, balanced with the need to take swift and effective regulatory and system action, to ensure that patients do not experience adverse outcomes.
I put on record my gratitude to Members from all parts of the House. On Second Reading and in Committee, they have approached the Bill with a consensus that I hope will continue in the other place. We have all understood the principles behind the Bill, and any differences of opinion and scrutiny have been firmly in the best interests of patients and in the interest of ensuring that the Bill goes to the other place in good shape.
Our experience of the health system is a personal one. We have relationships with our GPs and clinicians, and some of us have long-term health conditions or short-term immediate needs that require surgical intervention. We all want to know that the health system is taking all possible steps to prevent harm to patients and that the regulator and the health system work in partnership to identify when something is going wrong and to take swift corrective action. We would hope that in the event that we experienced an adverse outcome or reported concerns to our doctor, GP or surgeon when something was not working properly, the patient, system and statistical significance of that outcome would be understood and properly addressed; and the clinician, the system and the regulator would engage with the patient on required action.
We also want to ensure that, where required, the regulator will continue proactively to engage with the manufacturer of a medical device and ensure that information is supplied alongside that device or improvements are made so that we learn from the patient experience. Finally, we want to ensure that data is available to drive regulatory or system action, to limit the use of that device or remove it from the system so that our experience as patients results in changes to prevent future harm and suffering, even if that risk cannot be removed completely.
I will first speak to the amendments tabled in the name of the Secretary of State for Health and Social care, before I move on to those tabled by hon Members present. I thank all those who have shown an interest in this area, particularly my hon. Friend the Member for Newton Abbot (Anne Marie Morris) and the hon. Member for Central Ayrshire (Dr Whitford), who put forward their own amendments. Both were extremely well intended and thoughtfully drafted and there have been further thoughtful contributions from all parties and both Houses in thinking about what an amendment to that effect might need to deliver.
Alex Norris (Nottingham North) (Lab/Co-op)
It is a thrill for a Government Minister to move my amendments, although that might be giving me false hope. But I just wanted to put on record for colleagues that the purpose of amendment 21 is to make patient safety the uppermost priority.
Jo Churchill
I thank the hon. Gentleman for his intervention. We are in completely unusual times: I get to respond to his amendments before he has actually spoken to them himself, but we will crack on.
I recognise that the hon. Gentleman said at the time that he wished to return to these issues during the proceedings and I was expecting him to do so. We agree that patient outcomes and patient safety are matters that we would expect the House to consider very seriously.
Amendments 21, 22 and 23 all seek to establish a hierarchy of considerations applied by the Secretary of State or the appropriate authority when making regulations under the Bill, making safety the primary consideration. It is important to say at the outset that there is a consensus on both sides of the House on patient safety. It matters to us as individuals and as MPs representing our constituents, who rightly wish to know that their safety and their animals’ safety is of uppermost importance when we look to make regulatory change.
Alex Norris
It is a pleasure to resume proceedings on the Bill. The exchanges in Committee were of a high quality in both content and tone, and I look forward to more of the same afternoon. I was proud to take the lead for the Opposition in Committee, as I am during the remaining stages of the Bill, and I thank my predecessor in the early rounds, my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson).
Let me turn to new clause 1. I am so pleased to see the Government introduce what we spoke of in Committee as a device registry, which is now called the information centre. Bad medicines and devices cause exceptional harm. The noble Baroness Cumberlege is looking at the impact of three of these: Primados, sodium valproate and surgical mesh. I pay tribute to the campaigners and their allies in this place for all their work to ensure that those who are suffering, or who have suffered, are not forgotten. Clearly there have been devices that, knowing what we know now, we would not have used. There is a risk of similar things happening in the future, and it is a risk that we cannot fully mitigate, so an information centre will at least put us in the strongest possible position to react quickly and clearly.
I am personally grateful to the Minister for the level of engagement from her and the Government in general. I and my colleagues in the other place are committed to continuing to develop the idea. I know that the hon. Member for Central Ayrshire (Dr Whitford)—who will be watching proceedings, and whose expertise and creativity are missed—is ready to do the same. I can tell from my inbox that there is considerable interest in the sector in making this work, and I hope the Minister will commit to full consultation with it.
Ms Marie Rimmer (St Helens South and Whiston) (Lab)
I thank the Minister for providing us with sight of her letter to the Minister for Asia. As she committed herself to doing in Committee, she communicated it to all Committee members. I sincerely thank her for that.
Amendment 19 would empower the appropriate authority to make provisions for the process of developing or manufacturing medicines in relation to the origin and treatment of human organs. This is necessary because of the actions by the Chinese Government in Beijing. The China tribunal, headed up by Sir Geoffrey Nice QC, launched the first independent legal analysis of all evidence relating to organ harvesting in China and found beyond reasonable doubt that forcible organ harvesting was taking place. China was invited to provide evidence to this tribunal but failed to do so.
Further, a study by the medical journal BMJ Open has raised ethical issues on over 400 Chinese medical studies, and there is clear evidence that China is abusing the human rights, including the right to life, of Uyghurs, practitioners of Falun Gong, conscientious objectors and political prisoners. There is no reason to believe that China is not also experimenting on such prisoners without consent and then harvesting organs to examine the results of such experiments, and we must protect the UK health system from being morally compromised by this.
The Minister stated in Committee that my amendment was not required as regulations are already in place under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004. There are codes of practice in respect of the 2007 regulations, but section 1(4) of the 2004 Act explains that subsection (1) does not apply for a body to which subsections (5) or (6) apply:
“Subsections (1) to (3) do not apply to an activity of a kind mentioned there if it is done in relation to…a body to which subsection (5) applies”—
which includes a human body that has been imported—
“or…relevant material to which subsection (6) applies”,
and that applies to “relevant material” if has been imported. “Relevant material” means material consisting of human cells, so imported human tissue does not require appropriate consent.
The importing of human body tissue for medical research does not require any consent or traceability—it is only advised, not required—meaning that human tissue from countries like China can legally be imported to the UK for the purpose of medical research without traceability, documentation or consent. Imported human body tissue for use in medicines requires traceability from donor to recipient. Although technically consent documentation does not legally require consent, in reality it would be difficult to demonstrate donor selection requirements without it.
Without my amendment, we have no assurance that harvested organs cannot find their way into our national health service. Although the legislation and regulations provide guidance, it is just that: guidance. Why should we not want to make it clear that harvested organs will not find their way into this country? International checks on the system are failing, with the World Health Organisation’s assessment of the Chinese organ transplant system actually being one of self-assessment, as stated by the WHO to the Foreign and Commonwealth Office. Thus, the regime breaking the ethical standards is also assessing whether it meets them.
The British Medical Association has called on the Government
“to reconsider its position on this issue in light of the findings of the Tribunal”.
My amendment would empower the Government to do just that and close the hole in the existing legislation. It aims not to shut down the trade in medicines between the United Kingdom and China, but to ensure that it is ethical. It would not force the Government to implement the regulations now; it would merely empower them and the relevant authorities to take the steps necessary to regulate on this issue, when and if they are prepared to do so.
I do not intend to push my amendment to a Division today, although frankly, I should not have to: the moral and practical case is as clear as day, and the Government should accept it. It seems that they will not do so at this stage, but they should when the Bill is debated in the other place. I want to make it abundantly clear that I will not let this matter lie. A growing group of cross-party parliamentarians, both here and in the other place, are determined to stop this from happening. We now need the Government to do their bit. I will leave it there.
Jim Shannon (Strangford) (DUP)
It is a pleasure to be able to speak on this issue. The Minister knows how pleased I am to see her in her position. I have always followed her progress, and she has done very well. I am pleased to note how capably she responds to the issues that are raised in the debate. What a pleasure it is, too, to see the shadow Minister, the hon. Member for Nottingham North (Alex Norris), in his place.
Madam Deputy Speaker (Dame Rosie Winterton)
I call Tim Farron. [Interruption.]
Tim Farron (Westmorland and Lonsdale) (LD)
Jim, you could have carried on a bit longer, couldn’t you? It is an honour to follow the hon. Member for Strangford (Jim Shannon).
When it comes to the regulation of the introduction of new, innovative medicines, treatments and technologies, I am bound to say that cancer will be at the forefront of many of our minds. It is an area that deeply concerns every single one of us, and it could be severely impacted if we do not get the negotiations right. The NHS long-term plan, which is full of very good and wise things, recognised the significant problem that we have in the United Kingdom with our cancer survival rates. Our survival rates, and it has been the case under many Governments of different colours, are among the worst in Europe. We have the second lowest survival rate for lung cancers and below average survival rates for nine of the 10 major cancers. The terrifying statistic for us personally is that one in every two of us is likely to get cancer at some point in our lives. That means we will, all of us, almost certainly be touched by cancer in some way in our families at some point during our lives, if we have not been already.
The need to step up our efforts to fight this horrific disease is amplified by the current context. We have seen a 60% drop in cancer referrals and a 20% fall in the numbers of those starting treatment during the covid crisis—for obvious reasons, and some of them justifiable reasons. Clearly, there are people who are at risk of their immunity being suppressed during the virus or who could gain the infection via surgery during the pandemic, so we understand why clinicians make such decisions.
Jim Shannon
The week past was Men’s Health Week, and I know the hon. Gentleman is of the same opinion as me about the importance of highlighting prostate cancer. Bowel cancer is another example. Those are two of the cancers that take people out of this world very quickly. I know the Minister will respond very positively, but is it his understanding that those are two of the cancers that, critically, we need to address early on?
Tim Farron
The hon. Gentleman makes a very good point. The two statistics I rattled out—and not for the first time, even today—are the 60% drop in referrals and 20% drop in treatments beginning. The referrals one is broadly down to people not coming forward because they do not want to trouble the NHS. It is massively important to amplify what I know Ministers and clinicians are saying around the country, which is that if people are even the remotest bit concerned, they must come forward and seek advice, because the NHS undoubtedly is open. Some of the cancellations of treatment have been for other reasons, such as not having had full access to kit and, in the early days, NICE advising against it taking place when perhaps it could have done. However, I am pleased that the Government have managed to make significant progress in recent weeks.
The statistics on the reduction of people coming forward for treatment and for referral, and on the reduction in treatments beginning, are, of course, all true, yet the numbers of people with cancer at this point is the same as it would be in any other year, give or take. That tells us that we are in danger of seeing a serious peak in late diagnoses, and, therefore, sadly, in people tragically not living as long as they would have done otherwise.
In the context of the Bill, removal from the European Medicines Agency would do our people harm. Choosing to go from being part of an organisation that represents 25% of medicine sales on the planet to one making up only 3% will inevitably see us fall down the list for those applying for new drugs and treatments. In that case, the wisest course of action would be to negotiate associate membership of the European Medicines Agency. We must be at the cutting edge of cancer treatment, yet we will hobble ourselves if we reduce access to new treatment and scale back research and development.
Of course, Britain’s membership of the EMA is no guarantee of progress. I am thinking particularly of radiotherapy technology. NHS England has just agreed to roll out the commissioning of stereotactic ablative radiotherapy—SABR technology—and to bring it forward by a year. This comes after an arduous 10-year battle for this precise and powerful treatment to be rolled out to every cancer centre in the country. To be clear, 100% of radiotherapy centres are equipped to give this treatment, but only half of them are currently commissioned to do so. I am very grateful to Ministers and in particular to the one in her place, who intervened to ensure that all centres will now be commissioned. We are very grateful.
The reason given time and again by NHS England for wasting this resource was that it did not have enough data. This is relevant, because this was a treatment being used effectively across Europe with significantly improved outcomes. If this is the case when the data is there, I dread to think what the impact will be of having reduced access to data on medicines and medical devices when we are outside the EMA.
If effective and co-ordinated implementation does not follow regulation, regulation becomes utterly meaningless. Many colleagues have rightly raised concerns about maintaining access to the best possible treatment for those in the UK, but we also need to recognise that countless people are not able to access the treatment that they need and that has been approved even now. The idea that this could be further curtailed and cost further lives is deeply troubling. Indeed, it would be an outrageous injustice. The process between the approval of a medicine or medical device and its use to treat illness and save lives is hugely important, as the experience of the development of radiotherapy in this country proves.
Jo Churchill
I am most grateful to hon. Friends and hon. Members for their contributions. This is not a stop-gap Bill to get us through the transition; it is a proportionate approach to regulating an industry that moves quickly, with regulators that want to take effective action but are renowned for working with the industry in the best interests of patients. It is about setting a new direction and making clear what the UK wants after the end of the transition period.
Let me turn to the points that hon. Members made. I reiterate to the hon. Member for Nottingham North the commitment to consult when the Cumberlege report is published. We are keen to take account of its recommendations and ensure we are taking the necessary steps to protect patients, as patient safety is paramount to the future of medicines and medical devices regulation. We have of course had routine engagement with the review team, as would be expected, to ensure it is adequately supported and resourced to conduct its review.
I believe that the situation for pharmacies is quite the contrary to what the shadow Minister outlined. For hub-and-spoke dispensing, we intend to give smaller community pharmacies the same opportunity that large pharmacy businesses already enjoy. We will support them, and remove the legal barrier that allows such an arrangement only when the spoke pharmacy and the central dispensing hub are part of the same retail pharmacy business. That would level the playing field for smaller community pharmacies, rather than put them under threat. As I outlined in Committee, particularly during covid, all 11,600 of our community pharmacies have gone above and beyond. They have kept their doors open and have been there every single day for our constituents. I thank them once again. We have committed to consulting before making regulations, and that applies to any changes to rules on pharmacy registration. It means that no changes can be made without first undertaking proper consultation.
I understand the passion of the hon. Member for St Helens South and Whiston (Ms Rimmer) on the subject she raised. As the hon. Member for Strangford (Jim Shannon) alluded to, we are talking about a thoroughly abhorrent process. As I indicated, the Foreign and Commonwealth Office regularly raises concerns with China, including on the extensive use of the death penalty, and on the treatment of religious and ethnic minorities, which sit at the heart of this. I look forward to having a conversation with her after she has had that meeting, in order to understand what was discussed and to continue the conversation further.
I thank the hon. Member for Strangford for his kind words and for highlighting that we have a unique ecosystem here; we have brilliant academics, such as those he mentioned from Queen’s and others from right across the UK. We have a world-leading life science industry, employing some 240,000 people, and they are working to bring the best products to patients. We want to ensure that in and around clinical trials we have a regulatory system that maintains and enhances the UK as a site for global co-operation in research and allows us flexibility to achieve what is best for patients.
On clinical trials, the Government value the strong, collaborative partnerships we have across Europe in the areas of science, research and innovation, and we want to continue to support those opportunities. We are committed to ensuring that the UK maintains its position as a global science superpower and continues to collaborate with Europe on scientific research. The Prime Minister has made it clear that the UK sits ready to consider a relationship in line with non-EU member states’ participation in Horizon Europe, provided that that represents value for money and is in the UK’s interest.
The Bill, as drafted, does not breach the Northern Ireland protocol and the powers in the Bill are capable of being exercised compatibly with the protocol. We will ensure that that is the case. We are clear that the protocol provides that where a GB authority currently approves goods for sale, it will continue to be able to do so, in order to have that free-flowing movement.
To the hon. Member for Westmorland and Lonsdale (Tim Farron), who never misses an opportunity to remind me that he would like more services close to his constituents, I say: I hear you, again. Following Health oral questions this morning, I can say that I know we both share that commitment to drive patient access to radiotherapy and treatments together. Many hon. Members know that that is dear to my heart, having had cancer on more than one occasion. I came here to try to get more cancer nurse specialists and to make sure that on their journey those who have metastatic cancer, which is rarely spoken about in this place, are treated as people who still have full lives to live. Living with and beyond cancer is something we should embrace. The next round of negotiations with the EU will start shortly and we will continue to explore with the EU what future relationship arrangements can look like.
In conclusion, I would like to thank everyone for their efforts in getting us to this place.
Patrick Grady (Glasgow North) (SNP)
I was not in the Chamber earlier, but just before the Minister comes to a conclusion, I wish to thank her for her comments about the engagement she has had with my hon. Friend the Member for Central Ayrshire (Dr Whitford), who has not been able to participate in person in the process of this Bill. I know, however, that my hon. Friend has been grateful for the engagement on a cross-party basis, for the comments the Minister made about the amendments tabled by the Scottish National party in Committee, for the commitments the Government made in response to them and for their engagement with the Scottish Government. I just want to place on the record our thanks for all that and my sympathy with the amendment tabled by the hon. Member for St Helens South and Whiston (Ms Rimmer). A number of my constituents, like those of several other Members, have raised concerns about these issues of forced organ harvesting, and I hope some of that can be considered as well.
Jo Churchill
I thank the hon. Gentleman for his contribution. These are unusual times, so it was my pleasure to work with the hon. Member for Central Ayrshire (Dr Whitford) to do what we could to ensure that the Bill proceeded with a degree of consensus, as it was to work with her on access to off-licence drugs some years ago.
Our consideration of the Bill has been led by good sense and common ground, and by general understanding and consensus about its purpose. I am grateful to everyone who contributed along the way. I think the themes we heard today and in Committee—the paramount importance of patients; the need to ensure that we carefully consider and scrutinise legislation and that it is made after consultation; and the use of data to underpin better regulation and improve safety—were the right ones for us to consider. Although it is not necessarily part of regulatory scrutiny, I am grateful to the hon. Member for St Helens South and Whiston for raising the important issue of the UK’s continued promotion of human rights and ethics.
I am grateful to the Clerks for their help; these are unusual circumstances, but I have felt no less supported and, working towards ensuring that we can make progress in the other place, we will continue to use imagination. The Bill is a framework for where we want to go. It will allow us to ensure that the regulation that governs critical areas that matter for us all and are likely to affect us all indirectly is up to date and supports the thriving life sciences sector and patients. To that end, I commend the Bill to the House.
Question put and agreed to.
New clause 1 accordingly read a Second time, and added to the Bill.
Clause 14
Fees, information, offences
Amendment made: 1, page 8, line 35, leave out “efficacy” and insert
“performance, including the clinical effectiveness,”.—(Jo Churchill.)
This amendment clarifies the matters relating to medical devices the recording of information about which may be the subject of provision in regulations under Clause 12(1).
Clause 35
Offence relating to information
Amendments made: 2, page 18, line 36, at end insert—
“(2) A person to whom information is disclosed under regulations under section (Information systems) commits an offence if the person uses or discloses that information in contravention of those regulations.”
This amendment and Amendment 3 provide that a person who discloses information in breach of regulations made under the new clause inserted by NC1 commits a criminal offence.
Amendment 3, page 18, line 37, after “subsection (1)” insert “or (2)”.—(Jo Churchill.)
See the explanatory statement for Amendment 2.
Clause 38
Power to make consequential etc provision
Amendment made: 4, page 21, line 41, leave out “and 12(1)” and insert
“, 12(1) and (Information systems)(1)”.—(Jo Churchill.)
This amendment enables regulations made under the new clause inserted by NC1 to make consequential and other provision.
Clause 40
Consultation
Amendments made: 5, page 22, line 11, leave out
“sections 1(1), 8(1) or 12(1), or paragraph 9 of Schedule 1”
and insert
“a provision of Part 1, 2 or 3”.
This amendment and Amendment 6 have the effect that the Secretary of State is required to consult before making regulations under the new clause inserted by NC1.
Amendment 6, page 22, line 29, after “section 12(1)” insert
“or (Information systems)(1),”.—(Jo Churchill.)
See the explanatory statement for Amendment 5.
Clause 41
Procedure
Amendments made: 7, page 22, line 32, leave out
“section 1(1), 8(1) or 12(1), or paragraph 9 of Schedule 1,”
and insert
“a provision of Part 1, 2 or 3”.
This amendment has the effect that regulations made under the new clause inserted by NC1 are to be made by statutory instrument.
Amendment 8, page 22, line 42, leave out
“section 1(1), 8(1) or 12(1)”
and insert
“a provision of Part 1, 2 or 3”.
This amendment and Amendments 9 to 17 enable regulations under powers in the Bill which are subject to negative procedure to be combined in a single statutory instrument with regulations under powers which are subject to affirmative procedure, or with regulations under powers in other legislation which are subject to negative procedure.
Amendment 9, page 23, line 12, leave out
“to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 10, page 23, line 13, at end insert
“if the only regulations under a provision of Part 1, 2 or 3 that it contains are regulations to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 11, page 23, line 14, leave out
“to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 12, page 23, line 16, at end insert
“if the only regulations under section 1(1) or 8(1) that they contain are regulations to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 13, page 23, line 18, leave out
“to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 14, page 23, line 23, at end insert—
“, if the only regulations under a provision of Part 1, 2 or 3 that it contains are regulations to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 15, page 23, line 24, after “to” insert
“—
(a) ”.
See the explanatory statement for Amendment 8.
Amendment 16, page 23, line 36, at end insert
“, and
(b) regulations under paragraph 9 of Schedule 1”.
See the explanatory statement for Amendment 8.
Amendment 17, page 23, line 37, leave out subsection (10).—(Jo Churchill.)
See the explanatory statement for Amendment 8.
Clause 43
Commencement
Amendment made: 18, page 24, line 15, at end insert
“, and
(d) section (Information systems)”.—(Jo Churchill.)
This amendment provides for the new clause inserted by NC1 to come into force two months after the Bill is passed.
Bill read the Third time and passed.
Madam Deputy Speaker (Dame Rosie Winterton)
I will now suspend the House for three minutes.
Medicines and Medical Devices Bill
Wednesday 24th June 2020
(4 years, 5 months ago)
Lords ChamberRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Amendment Paper: Consideration of Bill Amendments as at 23 June 2020 - (23 Jun 2020)
Medicines and Medical Devices Bill
Wednesday 2nd September 2020
(4 years, 2 months ago)
Lords ChamberRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Consideration of Bill Amendments as at 23 June 2020 - (23 Jun 2020)
Lord Bethell
Relevant documents: 19th Report from the Delegated Powers Committee. 10th Report from the Constitution Committee.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, the Medicines and Medical Devices Bill is crucial to the development of a modern, safe, medical regulation regime. Its focus is the development of important innovations that will improve and save lives for the next generation, and the protection of patients in an area which has, historically, been slow to move and which, in a few months, passes from European to domestic legal oversight. When we look at our plans for the health of the nation, having the agility to revise our key regulatory regimes is not a “nice to have”; it is absolutely essential to protect the lives of patients and empower the innovations that will extend their length and quality.
I begin with safety. The first and most critical consideration of any Bill on medicines and medical devices must be the safety of patients. We also consider the safety of providers, the environment and, in Part 2 of the Bill, animals, but the safety of patients is paramount. We have all reflected on the detailed and thorough report of my noble friend Lady Cumberlege. I have listened to the testimony of some of the patients and families who have campaigned on patient safety, and shared, in a small way, their pain and suffering. They brought to life how critical this Bill is. We owe them a huge debt of thanks, as we would not be here today without their determination.
There is no disagreement among us on the importance of the safety of patients. The Bill puts safety at the heart of regulatory decision-making, facilitating the sharing of information to support public health concerns and creating mechanisms to track the use of medical devices or medicines against a patient record. The thoughtful, thorough, modern use of data is how we know that something is going wrong and how to put it right. That is the view of the Government, which my noble friend Lady Cumberlege and her team brought vividly to life in the Bill’s passage in another place. That is why I am delighted with Clause 16, introduced as an amendment, which ensures that data provisions in the Bill are central to its effectiveness. By introducing a medical devices information system—or database—we have radically improved that effectiveness.
We once faced a situation where patients could not be traced, and a conversation could not be had between a patient and their clinician because we did not know which specific device had been implanted into a person or by whom. When I found this out, I was dumbstruck. This must not happen in the future. The Bill will support the tracking and tracing of medical devices and will enable a future system of clinical registries, such as the National Joint Registry, to ensure that UK patients are better supported.
When there is a problem, it is important not only that we know that something has happened, but that we take forceful action. Part 3 of the Bill therefore sets out a consolidated suite of powers available to the regulator, including the ability to step in and recall a device if the manufacturer fails to do so where necessary. Chapter 4 of Part 3 of the Bill clarifies the powers of disclosure around devices, allowing the Secretary of State to warn members of the public about safety concerns. We must ensure that avoidable harm is avoided by acting expeditiously to protect patients. Let me be clear: the regulator can and does work in close partnership with industry to deliver on behalf of patients, but it has, and will continue to have, teeth when industry fails to protect patients.
We live in a world where big data, artificial intelligence and genetics have become enormously powerful engines of innovation, and where engineering and computer science have combined with medicine to create an unexpected synthesis. These drivers of development are generating exciting new medical innovations that are aiding patients who were previously beyond help, bringing down the costs of treatment and driving growth in Britain’s thriving life sciences industry. I have seen the power of innovation at first hand in the last few months, during the Covid-19 crisis. Our National Health Service is the first around the world to have determined the importance of an effective therapeutic drug, dexamethasone, through the recovery clinical trials programme. Our medical manufacturing industry worked closely with the regulator to move swiftly and safely and put 14,000 ventilators into the health system. In the area of diagnostics—my specialist subject—innovation is driving the accuracy, cost, speed and scale of devices beyond our initial hopes.
We need this pace of innovation in day-to-day, back-to-business delivery too. That is why we are investing in the partnership between the NHS, with its unique pool of patients, and the life sciences sector, which can make treatments happen. I pay tribute to the noble Lord, Lord Darzi, who is chair of the excellent Accelerated Access Collaborative, which gets the best new treatments and technologies into the hands of patients and clinicians faster than ever before. We face a new horizon of tailored treatments and diagnostics that we never could have envisaged five or even three years ago: biotechnology, artificial intelligence, robotics. We are at an inflection point where innovation can make a huge difference. I am pleased and proud to be a Minister championing the role of innovation in the healthcare system at this incredible time. Supporting innovation through this Bill ensures that UK patients benefit from the thriving life sciences sector by bringing investment, jobs and prioritisation to Britain’s medical needs, balanced by the need to manage risk.
Availability and attractiveness are the twin pillars of the Government’s strategy on medicines and medical devices, and the key themes of this Bill. Availability means the reliability of medicines and medical devices and their availability to UK patients. Attractiveness means doing everything reasonable to be the first place where new treatments are rolled out and adopted, where investment in life science takes place and where the enrolment of patients in clinical trials is supported.
Recent months have proved how the availability of medicine relies on fast, accurate, responsive regulation. It is the work of the regulator, hand in hand with the industry, that has ensured that therapeutics, including those used in intensive care, have been in safe supply and that devices, including the important vaccines, get into the right hands to bring this crisis to an end. Clauses 2, 6, 8, 12 and 15 all deal with how we ensure the essential and safe flow of medicines and medical devices. Clauses 2, 8 and 12 allow for regulations to be made that could, for example, affect how medicines or devices are distributed. Clauses 6 and 15 allow us to make pre-emptive regulations to reflect the realities of an emergency, such as a pandemic, and to prepare early.
It is right that we do more to get regulated medicines into patients’ hands and do not keep people waiting long for innovative treatments. I pay tribute to a number of noble Lords who I know tirelessly make the case for certain therapeutics or treatments to be accelerated through the health system. The attractiveness of the UK is fundamental to getting new breakthroughs to patients here quickly.
Let me say a word about regulating for the future, and the work of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee. I pay tribute to learned colleagues on these committees: I know they approach their work diligently and seriously, with significant legal expertise, and I anticipate discussion of their conclusions. I know a number of noble and noble and learned Lords will wish to speak to those reports today, and I will pay serious attention to the points raised.
This is, as it must be, a framework Bill. I recognise that concerns have been expressed about the breadth of the powers and a number of suggestions have been made as to how the Bill might be improved. I am listening, but it is important to note the challenges of taking a different approach to that outlined here.
These delegated powers are necessarily broad, given the hundreds of pages of the Human Medicines Regulations alone. These regulations can span many different matters and it is vital that the ability to make a change for the benefit of patients, where even a really minor point can be important, is not lost. We live in a world where it was only 12 years ago that the iPhone was released, yet today we are trying to figure out how to regulate an AI-supported cancer-screening gadget from KardiaMobile that plugs in to your smartphone and delivers a medical-quality ECG in about 30 seconds. We live in a world where 3D bionic arms, such as the Hero Arm from Open Bionics, have multigrip functionality, and where the national lung matrix trial at the University of Birmingham is exploring how patients with non-small cell cancers respond to tailored treatments.
Primary legislation cannot be relied on to be passed quickly when there are matters of concern for the safety of medicines and medical devices. For example, when concerns were raised across the EU about the scrutiny of notified bodies, and safety concerns arose from certain implants, it took years to update legislation. My noble friend Lady Cumberlege has made clear what happens when change is slow: it has an impact on patients. I know this from another area and I will give an example. When the Communications Act 2003 was passed, the internet was hardly mentioned. Some will say we could not have predicted the immense role that video sharing and social media platforms would now play in our lives, but I remember at the time that legislators were urged to take internet innovations seriously and put in place frameworks to anticipate technical change. Now we have widespread fake news, cyberbullying, the intimidation of public figures and a pornography boom, but without the legislative powers that perhaps we would like to stop or regulate them, because there was no framework to make new regulations to cover these innovations. I am here to listen, so I would like to listen to the advice of the Chamber on how to handle this complex challenge.
In conclusion, I remind noble Lords that because of its importance for patients, we need to get the Bill done and to secure the ability to protect patients quickly if the need arises. We need powers to deliver and to trace and track medical devices as soon as possible. I know it is important that we discuss these issues properly, but the Bill is not just exciting, ambitious and direction-setting; it is essential that it makes it to the statute book by the end of the year. I look forward to listening to the contributions ahead; we are receptive to how we might make the Bill better, as we did in the other place. My door is open, and in that spirit of co-operation and consensus building, I beg to move.
Lord Hunt of Kings Heath (Lab)
My Lords, I thank the Minister and declare my interests as a member of the GMC board and as president of GS1, the barcoding organisation responsible for the Scan4Safety programme. The Bill is of great importance for patient safety, but also for the health of the life sciences sector, yet it is striking for its brevity and, as the Minister acknowledged, for the extensive powers given to Ministers without the exceptional justification required for the skeleton approach taken. The Minister said he was listening, but he will know that both the Delegated Powers Committee and the Constitution Committee were highly critical, and I believe there is a strong argument for the Bill’s powers in relation to medicine and medical devices regulation to be subject to sunset clauses.
Leaving the EU’s regulatory regime brings significant risks that companies will choose somewhere other than the UK to trial and launch medicines. At the moment we are nowhere near knowing whether our new regulatory system is to be aligned with the rest of Europe—the policy statement published yesterday by MHRA on devices and clinical trials regulation from 1 January 2021 is silent on this. I have to say to the Minister that I am not impressed that his department thinks it is acceptable for such a publication to be produced hours before our Second Reading debate. There is certainly no room for complacency. The European Medicines Agency covers 25% of global pharmaceutical sales; the UK on its own makes up just 3%. The odds are that companies will want to submit applications for new drugs to the EMA before the MHRA, meaning that the UK will lose its advantage and UK patients will risk getting slower access to the latest medicines.
As Sarepta pointed out to me, for many companies the attractiveness referred to in the Bill equates to speed of decision-making at every stage. That means being able to approve clinical trials faster than in the EU, maintaining swift decision-making on medicines approvals and getting approved medicines to patients faster. Yet the Minister will know that the NHS record in uptake of new medicines is very poor indeed, and I would like to hear from him what is going to be done to improve access for NHS patients to these new medicines.
On patient safety, Ministers are silent on whether they will accept many of the recommendations of the Cumberlege review. In particular, will the Minister support the appointment of a commissioner for patient safety, which the noble Baroness, Lady Cumberlege, argued for very persuasively in her report?
Finally, I turn to the abhorrent practice of forced organ harvesting taking place in China today, and to the importance of ensuring that the UK is not in any way complicit in these crimes. In a letter to me last night, the Minister referred to the World Health Organization’s view that China is implementing an ethical voluntary organ transplant system. That is simply not credible, and in fact it is based on a self-assessment by China itself. A much more objective assessment comes from the China Tribunal, which concluded:
“Forced organ harvesting has been committed for years throughout China on a significant scale.”
At the moment, human tissue and organs can be imported into the UK from countries such as China without traceability, documentation or consent. Marie Rimmer MP tabled an amendment in the Commons to deal with this. A similar amendment will be tabled here and I very much hope that the Government will agree to it.
Baroness Barker (LD)
My Lords, Brexit poses many threats to the economy and well-being of UK citizens. Perhaps the greatest is the threat to our life sciences and pharmaceutical industries which, based on our scientific resources in universities and companies that have easy access to international talent and resources, have been truly world-leading. The impact of moving away from the existing collaborative approach between the UK and the EU will be substantial. The European market accounts for 25% of all world sales of medicines and has timely access to new medicines and devices. The UK, in comparison, accounts for only 3% of the total world market. It is against that backdrop that we have to consider this legislation, which is intended to mitigate threats to our industry.
We all agree that we need legislation, but not this thoroughly unsatisfactory Bill. It is a Bill that should not be accepted unless it is thoroughly revised, for three main reasons. The first is that alluded to by the Minister: it is built on the flawed assumption that the Secretary of State or an “appropriate authority” must take equal account of the safety of human medicines and medical devices, the availability of human medicines and medical devices, and the “attractiveness” of the relevant part of the UK as a place in which to conduct clinical trials, supply human medicines or develop medical devices.
The last two considerations depend on the paramountcy of the first. If we do not accept that in legislation, none of the rest will apply; we will simply be signalling to the world a willingness to move away from international standards. One of the most interesting and detailed points made in the briefings that we were given came from the Association of the British Pharmaceutical Industry, which pointed out that it wanted to encourage the UK to apply for full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization. They are global organisations that produce harmonised regulatory guidance across nations. It was pointed out that previously the UK had represented the EU at meetings of those bodies and contributed to committees and regulatory thinking. Since 1 February 2020, we have had no direct recognised status as either a member or an observer. If we are willing to move away so swiftly from the international standard-setting bodies, we cannot do so on the basis of this unsatisfactory legislation.
The second reason for rejecting this Bill is that it is a Toom Tabard Bill, as we would say in Scotland; it is an empty cloak. The Minister put the best gloss possible on the reports from the Delegated Powers Committee and the Constitution Committee, whose comments were detailed, comprehensive and scathing—I have rarely seen reports of that nature.
On the delegated powers, Clauses 1, 8 and 12 allow Ministers by regulations to amend or supplement the whole regulatory regime for human medicines and clinical trials under important legislation such as the Human Medicines Regulations 2012. Those regulations alone contain 350 criminal offences which a Secretary of State could unilaterally or without any scrutiny change completely. It is something when the Constitution Committee says, as it has done:
“The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”
That is a very powerful reason.
Both the Delegated Powers Committee and the Constitution Committee were deeply critical of the way in which the Government have used this legislation, coming as it does at the time of the current pandemic, to confer emergency powers on Ministers to disapply existing health medicines regulations. They point out that there are no formal requirements to set out the form, publication or dissemination of protocols; Ministers can do that simply by publishing a document on a website. That is not taking back control; it is taking the mickey. It is time for us as a Parliament to stand up and say that this is not an acceptable way forward.
The third reason for rejecting this Bill is its potential to do harm. Many professionals in the pharmaceutical and medical devices industries have expressed the fear that by slightly and incrementally moving away from existing regulation from the EU we could very quickly put ourselves into sudden isolation. We should be fearful of that, not just because it could harm our ability to market into the European Union but because many other countries—African countries, for example— use EU approval as a short-cut mechanism for approving medicines which they do not have the capacity to trial themselves.
The report of the noble Baroness, Lady Cumberlege, is sobering. If we were to take just one thing from it, it would be the need for us to set up as soon as possible and as a matter of urgency not just databases but registries of medical devices. Those of your Lordships who have read the report will understand the difference that makes to traceability.
The Government are in trouble with the timescale that they have set for Brexit. This Bill demands detailed and lengthy scrutiny. For the health not just of our fellow citizens but of future generations, some forensic surgery needs to be done on it. It should not pass without receiving detailed attention from your Lordships’ House.
Lord Patel (CB) [V]
My time limit curtails me from commenting on the Minister’s or other speeches, so I shall get on.
I know that the Government feel that this is a simple Bill that is needed to implement EU laws in UK legislation in relation to medicines and medical devices, but the implications of it go far beyond that. The Cumberlege report has added the need to strengthen the Bill in relation to patient safety.
In Part 1, the Government set out their ambition to have a world-class regulatory authority for medicines and medical devices that puts patient safety at the forefront and promotes innovation by making the UK “attractive” to investors. I cannot complain about that.
The Government have stated their ambition to make the UK a science superpower in which life sciences and the development of new medicines will play a crucial part. This Bill offers the Government an opportunity to say how they plan to do this but fails to do so. As the Science and Technology Committee report on life sciences indicated, the UK leads in life sciences research, but it is not very successful at taking research to innovation and commercialisation. The stated aim in the Bill to make the UK attractive is presumably to address this deficit, but it gives no definition of “attractiveness”, although the Minister referred to it in his speech. I hope that he will clarify it in more detail in Committee and even define “attractiveness”.
The Bill falls short of identifying how it will achieve its objectives, except that the Secretary of State will take wide powers to do it. Let me highlight the areas of my concern which I wish to explore in Committee. The Bill gives broad delegated powers to the Secretary of State to amend or supplement regulations. As the Delegated Powers Committee and the Constitution Committee—already referred to several times—recognise, some delegated powers may be necessary, but the Bill grants powers far wider.
Furthermore, the Bill adds to the complex regulatory regime rather than simplifies it. Clarification is needed as to how it intends to prioritise patient safety, even when there might be conflicting interests, such as “attractiveness” for investors. The findings of the Cumberlege review, that patients’ concerns were ignored, need to be addressed in the Bill. While the creation of a registry of devices is welcome, their safety and efficacy need to be addressed. I hope that my noble friend Lord Kakkar takes up this cause. If he does, I shall certainly support him.
Why will the MHRA be the regulator that licenses devices and maintains the register, but any new information systems are to be held by NHS Digital, referred to in the Bill as the information centre? What pre-market processing will there be for devices prior to approval for usage?
Clarification is needed from the Minister on the powers that the Secretary of State will have in emergency situations and on the removal of the duty of confidentiality and privacy afforded to patients. I want to explore how the Government plan to make the United Kingdom a prime destination to conduct clinical trials, an area of considerable concern for a wide sector of pharma. The Minister may well remember the debate at the time of the withdrawal Bill on clinical trials and making the UK a prime destination to conduct trials. The key point in being able to do this was the ability for the MHRA to have a close relationship with the EMA. What discussions are going on currently to enable this to happen? Regulations for medicines is a devolved issue for Northern Ireland, a potential area of divergence in the future from the rest of the UK. The implications of this need to be clarified in the Bill.
In conclusion, I am able to support much of the Government’s ambitions through this Bill to make UK regulations in medicine world-leading. Having said that, I will support amendments that allow for greater scrutiny of the powers of the Secretary of State, place greater emphasis on patient safety and give a clear commitment to allow the MHRA to make strong partnerships with other regulators. I look forward to Committee.
Lord Lansley (Con)
My Lords, I welcome the Bill. As my noble friend rightly said in a very positive opening speech, it is not only a necessary Bill but one which presents us with opportunities. I hope that, during the passage of the Bill, we will look to realise those opportunities, and I want to refer to one or two.
My noble friend talked about the Delegated Powers Committee’s remarks, which made the very compelling point that, in reproducing the regulation-making powers, we are moving from the power to make regulations to meet EU legal requirements to the ability of Ministers to set down their own legal requirements; these are very different things. What we need to do in the latter case is not to move from where we are now, as my noble friend might have suggested, to something that sets out in primary legislation the detail of these regulations—nobody is intending that—but to something that moves us from a skeleton Bill to a framework Bill. What is the difference? The difference, in my mind, is a very straightforward one. The framework Bill is purposive. It sets out why regulations are being made and gives an ability to look at the primary legislation and ask, “Do these secondary instruments fulfil the purposes of the primary legislation?” During the passage of the Bill, we must look very carefully to meet that test.
I want to make three quick points. First, I think we are already among the best places in the world for medicines innovation. We may be 3% of the pharmaceuticals market but we are 10% of medicines innovation. I want to continue that. One thing the industry has told us, including me, over past years is that it wants to see our NHS take up new medicines and make them available to patients—a point that my noble friend reiterated. There is a commitment in our manifesto that says:
“We will extend the successful Cancer Drugs Fund into an Innovative Medicines Fund”.
I think the time has come for that and I hope that the Bill will make provision for that to happen.
Secondly, the MHRA is a world leader—for example, in the assessment of medical devices—but we have a problem, as the noble Lord, Lord Hunt of Kings Heath, said. We will be accepting CE markings through to 2023. I am pretty sure, unless somebody tells me otherwise, that the EU is not going to accept UK conformity assessments any time soon. So we are in an asymmetric relationship, and we have to think very hard about how we can sustain the MHRA. In the course of that, what the noble Baroness, Lady Barker, said is absolutely right: we must not be pulled between American FDA standards and EMA standards. We should be trying to move everybody to international standards, and that is something we will have to look at hard.
As we put more registries in place, I hope that they will include patient-reported outcomes: that is important. For medical devices, I hope that we will show how we are going to take them up in the NHS as well. On the consultation that ended last year on the medtech funding mandate, the time has come to do it. Ministers have not said that it will be brought into place this year or next. I think that the Bill should bring forward the medtech funding mandate, as the medicines mandate is in place. Finally, on clinical trials, the EU has not implemented its clinical trials information system and is not at present expected to do so until the end of 2021. We need to be in it. The legislation says “corresponding or similar to” but I do not know what “or similar to” means. We are either in it or not in it, and I hope we will be in it.
Lord O'Shaughnessy (Con)
My Lords, I declare my interests as set out in the register, in particular as an adviser to Intuitive Surgical, to Healthy.io and, until the end of August, to the Department of Health and Social Care.
I congratulate my noble friend on bringing this Bill to the House; I know how hard he has worked to do that. For those of us concerned to make sure that British patients get access to the best drugs and devices—and, frankly, after the past six months, who is not concerned with that?—this is the most important piece of legislation we have in front of us.
My belief is that the Bill gives the UK the chance to create the most rigorous, innovative and safety-conscious regulatory scheme in the world. While there are many downsides to leaving our current system in the EU, as noble Lords have pointed out, there are many benefits, too. Just look at the way that the US FDA has embraced digital and algorithmic therapeutics, while the EMA has lagged behind. To make the most of these new freedoms, we need a regulatory system that can evolve in response to new discoveries and advances in medicine.
Considerable concern has already been expressed in the House today, and no doubt will continue to be throughout the afternoon, about the use of delegated powers in the Bill to provide this kind of flexibility. Having been in my noble friend’s shoes, and having been not so gently admonished by the DPRRC in the past, I can only say that this is not a hill that I wish to die on again. But it seems to me that we are exchanging one system of delegated powers for another, with the added benefit that the authority that will be using these powers has the virtue of being elected by the people it seeks to regulate. At the very least, this is surely an improvement on the status quo ante.
There are two substantive issues that I would particularly like to focus on, already raised by my noble friend: innovation and patient safety. On innovation, we currently benefit from being in one of the top two markets in the world for medicines and devices, and our regulator is rightfully regarded as one of the best in the world. As other noble Lords have said, leaving the European system could bring challenges when it comes to patients accessing innovative therapies, but these can be more than mitigated by a new joined-up approach to research, regulation and uptake. This would require the creation of a world-beating, digitally powered clinical trials infrastructure to test ground-breaking medicines and devices; a rapid but rigorous regulatory process for the most promising technologies; as my noble friend Lord Lansley has pointed out, the creation of an innovative medicines fund to bring those to market; and harnessing the collective might of the NHS to adopt and scale those therapies.
My noble friend the Minister pointed out that during the Covid crisis this is precisely what we have done for therapeutics, vaccines and other technologies that can help. The pandemic has shown British science and medicine at its best. Does he agree that we now need this kind of regulatory regime for all medicines and devices in the future? If so, will he tell the House when comprehensive plans for creating such a regime will be published?
Even as we go about producing the most pro-innovation regulatory regime in the world, we must never forget, as my noble friend Lady Cumberlege put it in her excellent report, that our obligation is first to do no harm. Too many people—often, it seems, women—have borne the brunt of an approach to post-licensing surveillance that, historically, has been too analogue and too unresponsive to patients’ needs. The sad consequences of this are movingly documented in my noble friend’s report. I wholeheartedly endorse her recommendations, and I am delighted that the government amendments in the other place will improve the use of data for patient safety.
But let us be clear: there is much more to do, so I ask my noble friend the Minister, when will the Government respond to the Cumberlege report’s thoughtful and sensible proposals? Does my noble friend agree that we should use the next few weeks to make progress on implementing its recommendations? Otherwise, as I am sure he is aware, he might find that the House does that work for him.
I have every confidence that my noble friend will work with noble Lords to produce a pro-innovation, safety-conscious regulatory system for the UK. He has my support for those efforts, and I am happy to welcome and support his Bill.
Lord Collins of Highbury (Lab)
My Lords, my noble friend Lord Hunt of Kings Heath mentioned the China Tribunal’s final report and its conclusions about forced organ harvesting in China. Despite the overwhelming evidence, China denies the claims, relying on the fact that the WHO cleared it of wrongdoing.
In June this year, I reminded the Minister the noble Lord, Lord Ahmad, that 12 months earlier he had shared my concern that the evidence on which the WHO had cleared China was based on self-assessment by the Chinese authorities. At that time, I asked about the Government’s response to the China Tribunal and what the result had been of representations to the WHO and the Chinese authorities. The Minister replied that the Government’s position remained that the practice of systematic state-sponsored organ harvesting would constitute a serious violation of human rights. He assured this House that the UK regularly raised these concerns with China. He also confirmed that the UK had consulted the WHO, which had restated its view that China’s system was ethical. The WHO does not have an independent expert compliance assessment mechanism; it merely has a reporting requirement. So why has the UK not argued for change within the WHO? We should all, including the UK, be ensuring that there is independent verification.
UK legislation requires prior consent and traceability for human tissue for medical research and use in medicines when sourced from the UK, but if human tissue has been imported then the consent requirements do not apply. We have seen exhibitions in New York and Birmingham, in 2008 and 2018 respectively, both of which used plastinated bodies from Dalian Hoffen Bio-Technique in Dalian in China. They were classified as unclaimed bodies with no relatives to identify them. In 2008, the New York state attorney-general required a disclaimer that included the words that the organisers
“cannot independently verify that the human remains you are viewing are not those of persons who were incarcerated in Chinese prisons.”
The UK has arguably some of the most ethical and comprehensive consent requirements for human tissue in the world, yet imported human tissue slips through the net. It has also been reported that two UK companies supply organ-preserving devices to mainland China, which could explain how they are being transported around China.
I hope the Minister will heed the words of my noble friend Lord Hunt of Kings Heath and other noble Lords and ensure that the Government have the means to ensure that the UK is no longer complicit in the harvesting of human organs from living victims.
Baroness Northover (LD) [V]
My Lords, I want to address two areas. The first is the future of life sciences research and the pharmaceutical industry and the other, as mentioned by the noble Lords, Lord Collins and Lord Hunt, is the use of human tissue.
As we have seen so clearly during the pandemic, life sciences in our universities, working closely with the pharmaceutical industry—for example, the Jenner Institute with AstraZeneca—have been a key UK strength. However, our life sciences are already threatened by the Government’s decision to leave the single market and end the free movement of people, as well as by their losing access to EU funding. The pharmaceutical industry is affected by our pulling out of EU regulation, damaging its ability to access that market. Our standards must therefore be at least as high as those in the EU, and I ask for the Minister’s reassurance on that.
As my noble friend Lady Barker noted, the ABPI cogently argues that the UK should apply for full membership of the ICH and the ISO. Previously, as she said, the UK represented the EU at meetings, but since Brexit the EU has had no status here at all. We must urgently rectify that. We were global leaders because of the NHS and our history in the development of clinical trials and comprehensive data registries, such as that which demonstrated the link between smoking and cancer. As the noble Lord, Lord Patel, has flagged, we are risking that. We must not damage our life sciences sector further.
Consistent with the need to maintain standards, I come to my second area, where I fully endorse what the noble Lords, Lord Hunt and Lord Collins, have said about imported human tissue and biological medicines. We simply cannot allow human tissue from victims of forced organ harvesting to enter the UK. We have become more aware in recent times of the treatment in China of the Falun Gong and the Uighurs. The China Tribunal, chaired by Sir Geoffrey Nice, released its full report in March. Has the Minister read the report? Forwarding the letter from the WHO to the noble Lord, Lord Hunt, when he must know the current constraints on the WHO, is, frankly, astonishing. If the Minister has read the report, he will know the tribunal concludes that crimes against humanity have been committed against these groups beyond reasonable doubt.
As the noble Lord, Lord Hunt, noted:
“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one – and probably the main – source of organ supply.”
With regard to the Uighurs, the tribunal says it has
“evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”
We now hear that they are being used for unapproved Covid vaccines.
The Human Tissue Act 2004 has strict requirements for tissue sourced within the UK, but it does not restrict imported tissue in this way. That gap must now be filled if we are to maintain that the UK has the highest standards in this area. The Minister will be hearing the signs of cross-party support, and I trust that the forthcoming amendment will be immediately accepted by the Government. That is clearly right, but it is also vital if the UK is to remain a leader in the life sciences field. There are many challenges that this field now faces.
Lord Alton of Liverpool (CB)
My Lords, I declare an interest as vice-chair of the All-Party Parliamentary Group on Hormone Pregnancy Tests. I want to raise two issues: Primodos, which is part of the investigation conducted by the noble Baroness, Lady Cumberlege; and the violation of human rights in the trading and misuse of organs and human tissue, referred to earlier by the noble Lords, Lord Hunt of Kings Heath and Lord Collins, and the noble Baroness, Lady Northover.
The Minister knows how much I admire the noble Baroness, Lady Cumberlege, but I reiterate my whole hearted support for her report and recommendations, and I place again on record my admiration for the sensitive way in which she collected evidence, dealt with the many people who were affected by these scandals and brought forward these admirable recommendations. Parliament must now ensure that the report does not gather dust. The Royal College of Surgeons rightly draws attention to the review’s recommendation of a patient safety commissioner, as referred to earlier, and I look forward to hearing from the Minister what we are going to do about that.
It is over 10 years since I first questioned Ministers about Primodos after a man called Karl Murphy came to my university office and showed me the disabilities with which he has had to live all his life. Following the recent Sky TV documentary, he emailed me last week saying:
“the lies and deceit I have seen regarding this drug is an utter disgrace … I really do hope that the Government and Bayer have some respect and understanding of what these families are going through.”
The redoubtable Marie Lyon has refused over all these years to let this scandal be swept under the carpet, and I am glad that the Minister heard from her first-hand only yesterday. She made a telling point to me that in appointing Stephen Lightfoot, an ex-director of Bayer, as the new chair of the MHRA, they have clearly learned absolutely nothing about conflicts of interest and public perception and confidence. In the light of such appointments and reports of five scientists walking out of a task force for back pain after finding out that a briefing paper was funded by the drug company Grünenthal, perhaps the Minister will say what the Government will be doing to police conflicts of interest and the suppression or manipulation of data.
If Primodos teaches us anything, it is the importance of the independent assessment and scrutiny of all clinical trials. But, like others, I would like to see the Bill tackle the misuse of human tissue and organs. In the letter sent yesterday by the Minister, he says the
“government takes these allegations seriously and we continue to monitor all available evidence”,
but monitoring is simply not enough.
Two years ago, in August 2018, along with Professor Jo Martin, the president of the Royal College of Pathologists, I wrote to the Times after the NEC in Birmingham hosted the exhibition referred to by the noble Lord, Lord Collins. It was called “Real Bodies” and from the company Imagine Exhibitions. The exhibition consisted of human corpses and body parts. It advertised those exhibits as
“real human specimens that have been respectfully preserved”.
They were categorised as “unclaimed bodies”, with no relatives to identify them. As we heard, in advance of the American equivalent of that exhibition it was stated in a disclaimer —after a settlement with the New York State Attorney-General—that these human remains could be those of persons who were incarcerated in Chinese prisons. Imagine Exhibitions admitted that there was no documentation to prove the identities of the cadavers, yet they were permitted to enter the UK to be put on public display for commercial gain. Human tissue from abroad has no consent or traceability requirements to enter the UK, nor do we prohibit commercial gain. However, we should do and this Bill gives us the opportunity to do it.
Baroness Cumberlege (Con)
My Lords, I stand before you as a person who was shaken by the experience of personally listening to over 700 women and their families, who have been damaged by the healthcare system. Their testimonies actually haunt me. Their bravery impels me to right their wrongs.
In our report, First Do No Harm, we examined and researched two medications. First, Primodos, already very well explained by the noble Lord, Lord Alton, was a hormone pregnancy test taken between the 1950s and 1970s and associated with terrible damage to some newborn babies. Those newborn babies now need care and support as adults while their surviving mothers, now elderly, have lived a life wracked by guilt. Secondly, there is sodium valproate, an effective medication to control epilepsy. When taken in pregnancy, there is a 50% chance of a severely damaged child being born. Even today, that medication is still being given to women who are unaware of the consequences. Then there is pelvic mesh: a plastic net which can migrate, disintegrate and wrap itself around vital organs, severing some and causing appalling suffering and pain.
The root cause was the failure of the healthcare system as a whole, and by some in the medical profession who ignored the concerns of women and their families. These women knew what was wrong but they were dismissed. They were told it was all in their heads—just a woman’s problem, not to be taken seriously. This made me furious. As Sir Cyril Chantler, the review’s vice-chairman, reminded us, for whom is the healthcare system run? We pay for it; it is ours. It is run for us, the people and patients. Your Lordships all know, as I do, that when we are ill or in pain most doctors will listen. But if they sense that a mistake has been made, they clam up, become defensive and act irrationally.
Now for the good news. The report has raised a clarion call for action and I thank all parliamentarians who have been so supportive—particularly your Lordships, but you are not alone. There are the 15 patient groups, the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the British Society of Urogynaecology—all with their medical membership—along with the BMJ, in its stunning editorial last week. All these and so many more want to see our recommendations implemented and we can start right now, with the safety Bill.
I intend to put down an amendment to appoint a patient safety commissioner—a voice for, and listener to, patients. If a product raises concern, that commissioner must say “Stop—this is a worry. We need to investigate and research to ensure safety”. It is better to have a few false alarms than the tragedies we have witnessed, which have cost lives, caused suffering and family break-ups, and damaged children. These are personal costs beyond price, with millions of pounds to be paid from the public purse.
We parliamentarians are establishing a parliamentary group called “First Do No Harm”. Its purpose is to ensure that all our recommendations are implemented. The only cloud on the horizon is the Department of Health and Social Care, which simply does not get it. Asking everyone, as it does now, to work together better in the future simply will not work, any more than it has in the past. We need someone and something new: a patient safety commissioner. Yesterday, we heard that the First Minister of Scotland, Nicola Sturgeon, has announced that Scotland is to have a patient safety commissioner on our lines. But in England, rumours are absolutely rife of a ritual burial and answers to the PQs are evasive. I say to my noble friend the Minister: this is his opportunity to give an assurance that this report will be implemented with a taskforce and timetable, as set out in our Recommendation 9. Please can the families who have been hit so tragically hard have that assurance?
Baroness Andrews (Lab)
My Lords, it is a privilege to follow the noble Baroness and to pledge our support—I feel sure of that in this House—for what she is trying to achieve, in the light of what she has achieved so far. We all look forward to what the Minister will say in response to her plea.
This is a Bill that we can and should welcome, in many respects. For example, I share many of the ambitions mentioned by the noble Lord, Lord O’Shaughnessy, when he spoke. It sets out a necessary regulatory framework; my concern is that it comes with unnecessary risks as well. It spans the range of human and veterinary medicine. It includes clinical trials and the ability to prescribe. It addresses some of the abuses raised by the noble Baroness in her report, and it raises fundamental questions about capacity and professional standards. That means it is important, not least for the reasons which the noble Baroness has just explained in her example, that the balance between powers and accountability—between patient safety and risk—is got absolutely right. We will obviously probe this in detail as the Bill goes through the House.
I have two concerns. One is how patient safety can be protected within the context of creating an attractive environment, whatever that means. The other is the speed, direction and potential impact of the cumulative divergence from the stability and standards of inherited EU law. The Bill is designed to achieve just that and to accelerate it. Our task in this House is how to anticipate impacts and correct for perverse consequences. That is why I feel that the better purposes of the Bill are undermined by the fact that it is a skeleton Bill. We are not surprised, of course; this is what we have come to expect. Skeleton Bills have become not the exceptional position, as urged by the Constitution Committee, but the default position of this Government, who are so committed to accelerating deregulation and for whom, frankly, Brexit provides the obvious opportunity.
The first 15 clauses of the Bill consist entirely of powers to make provisions by regulations about human and veterinary medicine and medical devices. I hope that the House will challenge in particular the provocative powers of delegation in Clauses 1, 8 and 12, not least given the chaotic conditions that we seem to be approaching with no deal at the end of this year. However, it is the fundamental disregard for Parliament which explains the exasperation expressed by the Constitution Committee and the DPRRC in its report on the Bill, the latter in particular towards the flimsy and, frankly, disingenuous justifications that were offered for the use of powers.
Noble Lords will also find if they read the whole report that there is more than a disregard for the job of Parliament. In some cases, the suggestion is that the new powers offer the same restraints as the existing ones. They do not. This is why the Bill presents such a risk. The anticipated divergence is away from a stable regulatory framework into an unknown environment in ways that cannot be tested in this House because the design, as well as the delivery, is in secondary legislation. The Bill is divergence by delegation.
The Secretary of State has made no bones about this. At Second Reading in the other place he spoke of the Bill giving
“the means to depart from EU rules and regulations in future, moving at a faster pace … it ensures that we can easily amend regulation through secondary legislation without having to bring a new Bill”.—[Official Report, Commons, 2/3/20; col. 659.]
The DPRRC has replied that the Secretary of State has taken upon himself
“very wide powers to almost completely re-write the existing regulatory regimes for human and veterinary medicines and medical devices.”
In the strongest language that I can remember, it describes the powers taken to allow regulations for making the disapplication of legislation subject to conditions set out in a protocol—whatever that might mean—as
“yet another example of ‘camouflaging legislation’.”
This is Parliament; this is our job: to expose legislation, not camouflage it. Will the Minister assure us that he will listen and respond positively to the call for restraints and the removal of those powers in the Bill that have been so insufficiently explained by the Government so far? He will save himself a lot of grief if he does.
Baroness Walmsley (LD) [V]
My Lords, I very much agree with the noble Baroness, Lady Andrews. The Bill covers a multitude of issues, but apart from giving massive powers to Ministers it provides very little detail. It is an empty bucket. Henry VIII would have been proud of it.
Like others, I have read the Delegated Powers Committee’s report on the Bill. I have rarely read a report from this respected committee that is so trenchant in its criticism of a Bill and of the government memorandum, which failed miserably to justify those elements that the DPRRC finds to be “inappropriate”. The powers given to Ministers are not just for transferring EU regulations into UK law; they are extensive—almost unfettered—powers to amend, extend or disapply regulations, breaking many of which would be a criminal offence carrying a two-year prison sentence.
Many of these regulations would be laid by the negative procedure, with the excuse that they might be urgent. Even those that carry the affirmative procedure do not allow Parliament to scrutinise them or amend them in the same way as we would if they were done by primary legislation. Ministers claim that there is no alternative other than putting all the detail of all the regulatory changes into primary legislation. This is nonsense and the Government know it.
I have to agree that it is not always possible or even desirable to use primary legislation for technical changes, but there is no detail at all in the Bill about what changes the Government intend about human and veterinary medicine and very little about medical devices regulations. The Government even plan to disapply some regulations simply by introducing a protocol, thereby completely bypassing any parliamentary scrutiny at all. It is rightly described by the DPRRC as “camouflaging legislation”. Its overall conclusion is that the Bill transfers powers from the European Union directly to Ministers, completely bypassing Parliament.
If this is what the Government mean by taking back control, it is exactly what remainers feared when the EU referendum was put to the people. Control is going to Ministers, not Parliament. In a parliamentary democracy, that is unacceptable. Under the Bill, Ministers could completely rewrite the regulatory frameworks for medicines and medical devices, so it is not surprising that noble Lords have received so many very concerned briefings from the field.
Having in mind the fact that patient safety must be at the heart of the legislation, what constraints do we find on Ministers in the Bill? In making regulations, Ministers must have in mind three issues: patient safety; the availability of medicines and medical devices; and the attractiveness of the UK for clinical trials and the supply of medicines and medical devices. I was surprised when I first read the Bill to find the word “attractiveness”. I have never seen it in a health Bill before—a trade Bill, yes, but not a health Bill. My primary question to the Minister is: is this a hierarchy of issues and is patient safety paramount? I would not want rigorous regulation of the safety of medicines to be subservient in any way to the ability to attract producers or researchers to come to the UK to take advantage of a more lenient regulatory regime.
Frankly, if the Government want to attract people here to do research and clinical trials, I can think of no better way than to remain as closely aligned as possible to the EMA and set up the safest, fairest, most rigorous and transparent regulatory regime in the world. This Bill does not do that. I ask for detail, transparency, appropriate parliamentary oversight and the whole package of recommendations from the report by the noble Baroness, Lady Cumberlege.
Lord Ramsbotham (CB) [V]
My Lords, I declare an interest as co-chair of the All-Party Group on Speech and Language Difficulties.
On 6 May, the chief executives of the British Dietetic Association, the Royal College of Occupational Therapists, the Society of Radiographers, and the Royal College of Speech and Language Therapists, and the chair of the British and Irish Orthoptic Society collectively wrote a letter to Jo Churchill, the Minister responsible for taking the Bill through the other place, in which they appealed for extended prescribing rights, in view of the range of benefits that they would provide to patient care and the potential savings to the NHS that would result. In particular, they pointed out that such rights would result in better support and more timely care for the patients they worked with, and improved patient safety, because allied health professionals, with appropriate expertise, were often best placed to make safe medical decisions. This is particularly apposite during the problems posed by Covid-19, because patients in the community may have to wait for weeks or months for assessment or continuance of treatment.
On 10 June, I and my co-chair of the APG, Geraint Davies MP, also wrote to the Minster, welcoming her response during the processing of the Bill in the Commons, in which she said that it would give the Government powers to extend prescribing responsibilities to professional groups where it was safe and appropriate to do so. In this connection, I note the comments on delegated powers in the damning report of the Delegated Powers and Regulatory Reform Committee, published on 22 July, to which other noble Lords have already referred.
The Minister responded to our letter on 12 August, saying that the Bill will allow the Government to continue to update the professions that can prescribe medicines where it is safe and appropriate to do so, without, however, specifying which professions. To date, the professional organisations that wrote to the Minister in May have not received a reply.
All requests by professional organisations for the grant of prescribing rights will need to be subject to intense consultation before they are granted and any resulting recommendations subject to parliamentary scrutiny, as the Delegated Powers Committee points out. Will the Minister say whether that is HMG’s intention and to which professions they plan to give prescribing rights?
Lord Ribeiro (Con) [V]
My Lords, I will focus my contribution on the safety of medical devices, post-marketing surveillance and organ donation. The noble Baroness, Lady Cumberlege, did us all a service with her review, highlighting the trauma and damage suffered by women who have had implantable devices, such as surgical mesh, inserted in the pelvis to treat urinary incontinence.
This Bill could become an important vehicle for implementing the Cumberlege review. It recommends that, in the event of an issue with a device, the Medicines and Healthcare products Regulatory Agency—the MHRA—must have the power to remove a device from the register. This can occur only if all devices, not just some, are included. The report, in recommendation 7, calls for a central patient-identifiable database for all implantable medical devices.
Post-marketing surveillance often relies on professional organisations such as the royal colleges and the specialist associations to undertake outcome studies to assess complications after surgery. The Royal College of Surgeons believes that provisions included in Clauses 13 and 16 should be strengthened to ensure expert oversight of medical devices registers. The National Joint Registry is an excellent example of a long-established registry overseen by a steering committee of experts. Recommendation 7 is key, stating that the database can be
“linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.”
The poly implant prosthesis, or PIP, breast implant is another example of a product that causes harm and misery to many women. The utilisation of systems for tracking devices, such as the Scan4Safety programme, which involves patients wearing barcoded wristbands that can be scanned and tracked against patients’ records, is to be recommended. Although new Clause 16 is welcome, we need to be clear whether the intention is to mandate the tracking of all medical devices or just a select few.
The Healthcare Safety Investigation Branch, or HSIB, has published several reports on safety problems arising from the design, usability, regulation, procurement and marketing of medical devices. For example, it has carried out an investigation into flaws in the design and usage of smart infusion pumps and several investigations into problems with poorly designed devices and equipment which might be manageable by those familiar with them but become a problem when used by those such as staff redeployed in the Covid crisis. The HSIB can highlight these issues but needs legislation to be able to enforce the withdrawal of defective equipment.
Finally, on organ donation—we have heard much of this from the noble Lord, Lord Hunt, the noble Baroness, Lady Northover, and others—in a study published in BMJ Open, ethical issues were raised over the estimated 85,477 organ transplants in China. Ninety-nine per cent of the 445 studies failed to report whether the organ donors had given consent to transplantation. The paper concluded:
“The transplant community has failed to implement ethical standards banning publication of research using material from executed prisoners. As a result, a large body of unethical published research … exists, raising questions of complicity to the extent that the transplant community uses and benefits from the results of this research.”
The noble Lords, Lord Alton and Lord Hunt, and the noble Baroness, Lady Finlay, will be bringing forward an amendment on this issue which I plan to support.
Lord Turnberg (Lab) [V]
My Lords, I, like most other noble Lords, have been inundated with briefings from a range of interested parties. Of course, everyone sees the Bill as important and absolutely essential as we leave the EU, but there is a widespread fear that, as it stands, it leaves far too many uncertainties.
The main issue at stake is that the Bill has too little detail and leaves too many actions to the regulations that the Secretary of State may or may not wish to put in place at some unspecified date. It gives the impression that the Bill has been written in haste. The fact that the Explanatory Notes are longer than the Bill speaks volumes. Here are a few of the areas where we should seek greater clarity in the Bill and not in some uncertain future secondary legislation.
The first is the clinical trials directive. It is absolutely essential that we get this, or the successor to the EU regulations, right when those regulations are no longer available to us. Heaven knows we in the UK spent enough time trying to get the directive fit for purpose. I remember spending much frustrating time in Brussels arguing the case for the workable scheme that eventually emerged, and now it seems that we will have to start again with a UK version. The research community and the pharmaceutical industry are deeply concerned that, in undertaking the clinical trials essential both for patient safety and for the timely availability of new drugs, we do not place new barriers in their way.
Can the Minister reassure us that, whatever regulations we put in place, we can interrogate them and that they are entirely compatible with the EU schemes so that we can avoid all that time-wasting frustration of submitting applications to more than one body? There is a fear that anyone conducting trials in Europe will have to employ expensive lawyers in Brussels to sort out the problems. Can he also ensure that the MHRA is given a clear remit for what is likely to be its enhanced role and that it is given the resources necessary to take on the extra work?
While I am on about clinical trials, it is clear that for many rare diseases there are just too few cases in the UK alone and that trials of new treatments have to be done with the much larger populations available across Europe. We can do this now, but can the Minister tell us whether and how it will be possible to do so in the future? For the very many rare diseases—there is a large number of them—will we be able to continue trials across Europe without all sorts of hurdles getting in the way, and will we get the full alignment so essential if we are to encourage industry investment and if our patients are to receive new treatments as rapidly as those in the rest of the world? There are opportunities to sort out some of the issues surrounding data protection and confidentiality in relation to clinical trials.
Then there is the whole question of the safety of medical devices, on which we have the important and very impressive report of the noble Baroness, Lady Cumberlege. How could anyone listening to her impassioned speech today resist her pleas? Her recommendations are clear and necessary. Will the Government take them up? Will they ensure that Britain remains at the forefront in developing safe and effective devices by making all new devices before and after development registrable and trackable so that all outcomes can be monitored? Does the Minister agree that the appointment of a patient safety commissioner, as the noble Baroness, Lady Cumberlege, proposes, would be a very positive move? Patients certainly need some sort of shepherd to take them through the myriad regulatory bodies. They, and we, need that.
There are many other concerns with the Bill where matters are skimmed over and left to be dealt with by regulations that bypass parliamentary scrutiny. I hope that the Minister will tell us when he expects those regulations to be available and that he will help us to fill in those huge gaps.
Lord Clement-Jones (LD)
My Lords, as we have heard loud and clear today, this Bill is fraught with many critical flaws that the Government must address. However, I will focus on the concerns that have been expressed by pharmacists about the wording of Clause 3, relating to the development of a successor UK system to prevent the supply of falsified medicines, which is symptomatic of the Government’s high-handed approach.
The clause refers to
“the use, retention and disclosure, for any purpose to do with human medicines”
of information collected by such a system, which considerably broadens the original data-collection provisions of the Falsified Medicines Directive. Yet the Explanatory Notes make no mention of this legislative creep and, indeed, the Health Minister, Jo Churchill, said in Committee in the Commons:
“The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices.”—[Official Report, Commons, 8/6/20; col. 7.]
In this context, data is sensitive, commercial currency. All parts of the medicines supply chain need access to broad patterns of medicines usage but, in the current scheme, access to pack information, which could highlight purchasing decisions and margins being made, is restricted to details such as the name, batch, expiry, serial number and active/inactive status, with some exceptions for investigating incidents and the national competent authority, MHRA, used for various purposes.
Because of the issue of the commercial sensitivity of data, Article 54a, regarding the protection of personal information or information of a commercially confidential nature generated by the use of the safety features, was inserted into the preamble of the Falsified Medicines Directive and the principle of “whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016, which followed the Falsified Medicines Directive.
The Department of Health and Social Care already has access to a very wide range of data on medicines sales and use in the UK under the Health Services Products (Provision and Disclosure of Information) Regulations. Ministers can request more detailed information if required. Given both this access and the known sensitivities around falsified medicines data, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme. Pharmacists have concerns not just that the department might accidentally release commercially sensitive data but that it might use such data to gain an unfair advantage, given its monopoly position as the main purchaser of medicines in the UK.
Of course, the details of a new scheme will need to be set out in regulation, but the regulation-making powers under Clause 1 are, as the Delegated Powers and Regulatory Reform Committee pointed out in very clear terms in its damning report—which many noble Lords have referred to—considerable, and they provide no guarantee at all that the use of falsified medicine data will follow the previously agreed pattern.
It is clearly important to ensure that primary legislation provides the necessary protection. I hope the Minister, on mature consideration, will agree to ensure that the Bill is amended to enshrine a duty of full consultation and agreement in the Bill over this data use as we go forward.
Baroness Butler-Sloss (CB) [V]
My Lords, I will raise two issues, the first being organ harvesting. I propose to support the amendment of the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff. Like other noble Lords, I am very concerned by the activities in China. There are other countries where organs, particularly kidneys, are also sold, and we should not be allowing them to be used in this country.
Secondly, I support the constitutional concerns of the Delegated Powers and Regulatory Reform Committee, especially with regard to the proposed use of negative rather than affirmative procedures. I am also very concerned about the creating and adjusting of criminal offences by regulation and I would strongly support sunset clauses.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, many noble Lords, including the noble Baronesses, Lady Andrews and Lady Walmsley, have made reference to the extremely strong—you might almost say scathing—report of the Delegated Powers and Regulatory Reform Committee. It is worth going back to its conclusions, in which it states that Ministers are
“given very wide powers to almost completely rewrite the existing regulatory regimes for human and veterinary medicines and medical devices”.
This Bill sees the Government seize control, rejecting the oversight and scrutiny of the elected Members in the other place and the technical experts here. In the best Trumpian style, it declares that the rules will be whatever they want them to be. Forget checks and balances, forget consultation and careful consideration; let Ministers rip. Indeed, that is what the Minister suggested he wanted in his opening remarks, focusing on speed of action, which would happen with scant parliamentary scrutiny. What he is suggesting is something new and radical.
Yet, as the Delegated Powers and Regulatory Reform Committee points out, the Government claim elsewhere that this is like-for-like replacement of existing powers. The Government cannot have this both ways: it is either new and radical or just more of the same. However, the Minister is clearly right: this is new and radical, because what exists now is
“a mechanism for transposing into UK law EU rules on medicines and medical devices ... The new powers are subject to no such constraint”.
The answer here is not to concentrate power in the hands of the Government. The current system is clearly not good enough, but the answer is not to take away controls and oversight but rather to strengthen them through democracy, openness, a focus on the patient experience and independent expertise. As the Cumberlege report suggests, a commissioner for patient safety is crucial, and I am pleased to offer the Green group’s support for the noble Baroness’s proposed amendment, which she just outlined. We need a more democratic, listening approach, as the noble Baroness, Lady Cumberlege, demonstrated so effectively, not a centralised, unchecked one, in which few have input.
Let us consider what the UK regulation might look like if the Bill goes through. We will have a Minister who will be bombarded by well-funded industry lobbyists on what the new rules should look like. A pharmaceutical company or a device manufacturer has not taken the Hippocratic oath. Their job—their legal obligation, in fact—is to maximise profits, and their profits are very large. As the former editor of the New England Journal of Medicine suggested, an appropriate metaphor for the pharmaceutical industry is an 800-pound gorilla. “What does that do?” he asked rhetorically. Whatever it likes. Your Lordships’ House might like to contemplate the image of Matt Hancock up against that gorilla.
We have already seen drug companies flexing their muscle in the notable case of Selexipag—also known as Uptravi—using a patient representative group as cover for a massive lobbying effort. We know that pharmaceutical companies are lining up for a post-Brexit bonanza, increasing the price that the NHS pays for drugs. As the noble Lord, Lord Alton of Liverpool, made clear in his excellent speech, there is a huge problem in our system with conflict of interest, which is only likely to grow.
I am most often talking about the disastrous model of US healthcare in the context of the rush to privatise our NHS, but a significant contributor to its disastrous and highly expensive outcomes is the political power of the pharmaceutical companies. This Bill is not “take back control”. This is “abandon control” and, when you are talking about medicines and medical devices from the industry that gave us thalidomide, the US opioid epidemic, Primodos and pelvic mesh, that is a frightening development.
Lord Balfe (Con)
My Lords, I too extend my congratulations to the Minister on introducing the Bill. I suspect it will be a somewhat different Bill by the time we have finished with it.
This exposes the whole nonsense of “taking back control”. We are 3% of the world drugs market; the European Medicines Agency is 25%. The way for us to gain control is to work with our colleagues in large organisations where we can have considerable impact, not to start setting up our own organisations. The impact of moving away from the European Medicines Agency is going to be a considerable extension of a centralised process of regulation and it is also going to add to the unaccountable powers of Ministers, because the EMA does have a certain amount of accountability attached to it, which I do not think will happen. Indeed, it will not be the Ministers who will be making these decisions; it will be civil servants some way down the pecking order—and many of them will in the end have to take account of what the medicines agency has to say.
One danger we face is what the British Medical Association has called the butterfly effect: we have a slight derogation from a slight position of an EMA rule, then it multiplies, because one leads to another and then to another. You have to ask yourself whether this divergence can be kept under constant evaluation, because it needs to be. I put it to the Minister—he may not like it—that in the end we are going to have to negotiate a formal agreement for continued participation in EMA assessments, because we need a common assessment. We face otherwise the danger of delay—that manufacturers will say, “Let’s be logical: 22% of the market is in Europe, 3% is in Britain, so let’s get the European agreement first, because that’s where things are based.”
As a side-effect, we will then need an agreement with Euratom for isotopes, which has not yet been mentioned but is crucial to the health service, and that will have to be a separate agreement. We will also need to maintain access to EU funding programmes; we need these joint programmes to develop to do the best job for the citizens of this country—and, of course, we need alignment with the clinical trials regulations. We cannot have a different clinical trial regulation in Britain from what is in practice in the rest of Europe. We need all those things, and we need a professional structure in Britain for advising the Minister and drawing on the advice available.
I support the idea of a commissioner for patient safety. I hope that the Minister will go away and work out how it is to be done before he gets defeated on the Floor of the House. I also believe that the proposal on the harvesting of organs will not get through this House, and there will be an amendment on that. I say to the Minister: please do your homework and bring us something that we can agree with. Otherwise, the Government are going to get defeated.
Lord Bradley (Lab) [V]
My Lords, I shall raise just one issue—that of prescribing rights, already highlighted by the noble Lord, Lord Ramsbotham. Clause 2(1)(n) deals with amendments made to provisions that govern who can supply or prescribe human medicines. As the Minister, Jo Churchill, recognised in Committee in the other place on 8 June, the provisions referred to are set out in Clause 2(2). The power gives the Government the ability to amend the rules around who can supply, administer and prescribe medicine in line with healthcare needs when it is safe and appropriate to do so. The most recent changes to prescribing responsibilities were in 2018, when legislation was amended to allow trained paramedics to act as independent prescribers.
The Minister informed the Committee that the Government had published an illustrative SI, showing how the provision could be made to permit dental hygienists to supply and administer certain medical products in the course of their professional duties. That is important, because the Government could use the opportunity presented in this Bill to extend supplementary prescribing rights training for occupational therapists and extend independent prescribing rights training to other allied health professionals, including dieticians, orthoptists, diagnostic radiographers and speech and language therapists. As the noble Lord, Lord Ramsbotham, has made clear, this could help to deliver better support and more timely care for patients; reduce pressure on other health professionals; increase system efficiency; and maximise the ability to respond to the Covid-19 pandemic now and in the predicted post-pandemic surge on services. The extension would also build on the groundwork already undertaken by NHS England’s scoping exercise over the last few years on extending prescribing rights. However, having had full consultation with professional bodies, any SIs laid must be subject to affirmative resolution in this House—and, of course, such SIs must be underpinned by efficient, robust and coherent regulation.
I support the views of the allied health professionals that there could be considerable benefits to extending these prescribing rights, including better support and more timely care for the patients they work with, enabling them to have more equitable access to treatment and reduced pressure on other stretched professionals, especially GPs. As an example of those benefits, I highlight the work of speech and language therapists. Without independent prescribing rights, speech and language therapists have to hand over a prescription to a different prescriber, such as the GP. If the prescriber is on another site, that can sometimes result in considerable delays. In addition, for those patients with eating and drinking difficulties, the current situation could increase the risk to their safety, including adverse effects such as aspirational pneumonia or reflux, with the possible increased likelihood of hospital admissions.
As noble Lords will be aware, speech and language therapists provide life-changing treatment, supporting care for children and adults who may have difficulties with communication or with eating, drinking and swallowing. They are also involved in key clinical and health pathways, including cancer, particularly head and neck cancers, learning disabilities, brain injuries, stroke and progressive neurological conditions such as dementia. Expending prescribing rights to them and allied health professionals could enable safer and more efficient patient care, and I hope that the Minister will confirm that he will support this issue as this legislation progresses though this House.
Baroness Burt of Solihull (LD)
A lady local to me wrote to me about the excellent Cumberlege report. She said: “Mesh has ruined my life. I have lost my colon, appendix, cervix, uterus and parts of my vagina to mesh. I have been violated with at least two unconsented mesh procedures in my rectum and bladder—the scans don’t lie—and if I want removal, I may lose those parts of me as well. I have lost my sex life, my continence and my well-being. I have lost four jobs and I will shortly be losing my home since I cannot work.”
I shall call this lady Jane, which is my middle name, but it could be any woman in this Chamber or this country. Indeed, the online support group for women victims of mesh alone has over 8,000 members. Jane, like many others, has been brushed off, patronised and accused of imagining symptoms or being hysterical, while the perpetrators closed ranks, covered up their mistakes and made her suffer.
Vaginal mesh implants have caused women extreme pain, “like having razor blades inside them.” The noble Baroness, Lady Cumberlege, found in her report inadequately tested and poorly regulated meshes to be the cause of so much pain and misery. But the treatment of women over mesh, and the two drugs in her report, seem symptomatic of a culture of exasperation, impatience and disbelief on the part of many medical professionals when women tell them what they are going through. Barbara Ellen of the Guardian speculates about what would happen if the boot were on the other foot, and men had penis implants that felt like slashing razors. Would they be written off as “hysterics” and “whingers”?
Although I normally steer well clear of all matters medical, I cannot allow this Bill to pass without doing my utmost to ensure that women such as Jane, and all the Janes to come, will be properly protected from the inadequate testing of products, the failure to react and recognise when things are going wrong, and the cover-ups of life-ruining mistakes which have gone on without being called to account.
I am entirely in accord with the recommendations of the noble Baroness’s report and those of the Royal College of Surgeons. What we need in this Bill is proper traceability for all medical devices; a redress agency and revision of the MHRA; registries to monitor patient outcomes and spot early on if things are going wrong; and the setting up of a patient safety commissioner. Above all, we need to recognise the importance of giving primary regard to the safety of medicines and medical devices. This medical misogyny has to end.
Baroness O’Loan (CB) [V]
My Lords, I would like to thank the noble Baroness, Lady Cumberlege, for her excellent work on the report that she has presented to the House. I would like to support her recommendations, and most particularly her recommendation for a patient safety commissioner.
This is an important Bill, and there is an opportunity presented by it to improve the regulation of human organ harvesting across the world. Organ transplantation is one field of medicine that offers great hope to the recipient. Organs are taken from deceased donors in particular circumstances and for years living donations have been possible. A person can donate a kidney, part of a liver and so on, and live perfectly well afterwards. I have seen it. It can make the difference between life and death. It is a rapidly growing field of medicine in which demand exceeds supply.
Here in the UK, we have stringent regulation of the process of organ donation to ensure that those who donate are protected and that donation is only allowed from those who are fit and are willing to donate without any payment but to help someone else. That is how it should be and at its best this is a wonderful development. Similarly, organ transplantation after death can, in the right circumstances, bring untold blessing to those who receive an organ.
However, the very fact that demand for organs for transplant exceeds supply means that there is a market in organ harvesting, both from the living and the dead. For decades, people have been forced through poverty to sell their own organs. This is unethical and wrong. There should be no support for such practices, and we must ensure control over any contribution made by British companies that enable such activity.
We know, too, that there is transplant tourism, where people travel to countries where they may be able to get a transplant, in some cases with few questions asked about where the organ donated to be transplanted came from. We know, too, that organs can be shipped and transplanted into recipients across the world without proper procedures. There continues to be a major problem in the lack of global control over organ harvesting. There has been a reference to the work of the China Tribunal and to reports of a state-run programme of forced organ harvesting in China, the organised butchery of living people to sell body parts, which the China Tribunal compared to the
“worst atrocities committed in conflicts of the 20th century.”
We know that Uighurs, Falun Gong practitioners and others are being killed and subjected to forced organ harvesting.
When an organ is taken, whether from a living or a dead body, it needs to be preserved and transported to its destination. Just as we now require that imported products, whether they be clothes or anything else, should be manufactured in ethical conditions, we need to ask ourselves whether British manufacturers are selling to China the devices, medicines and technology which will enable China to sell organs which have been harvested from people in China’s detention camps or otherwise wrongly obtained. There could be many spin-offs from such activity, including the use of such organs—that can be imported here without any evidence of consent or traceability—for medical research, a market in immunosuppressant drugs for the recipient, and a market in harvested organs which might even be imported and used here in the absence of full regulation.
China is not self-sufficient; it is highly reliant on the West for the equipment and medicines which it needs to help its organ transplant and harvesting industry. The extent of British engagement is not immediately accessible in the context of the Chinese organ transplantation process. The report The Economics of Organ Harvesting in China indicates that there are British companies with interests in this area—in research and in producing and selling organ-preservation solutions to China.
It is right to support and develop ethical, regulated organ transplantation. It is profoundly important that this Bill provides for proper regulation. We can provide regulation to prevent companies being empowered and enriched by the mass crimes that may be facilitated elsewhere. This will show the People’s Republic of China and the Chinese Communist Party that the balance between human rights and commerce will change.
We need to think very carefully about how this Bill will proceed, so that it does that which it seeks to do and protects the health and safety of those who may be forced organ donors.
Lord Brennan (Non-Afl)
My Lords, this Bill, the scope of your Lordships’ debate and the report from the noble Baroness, Lady Cumberlege, emphasise the importance of government supervision of the supply, distribution and safety of medicines and medical devices.
The noble Baroness’s report is entitled a “Safety Review”. In the Commons debates, the junior Minister for the Government, Jo Churchill, described patient safety as paramount. The conduct of the affected families, described in the report, is exemplary: the way they try to cope with their suffering; their attempts to change things, to be listened to and to make reasoned submissions; and they deserve the assistance of this House and the Government.
The report refers to three conditions arising from two drug-related circumstances and one involving a medical device. The report identifies six other separate conditions that have not been investigated. History reveals to us thalidomide, the haemophiliacs given infected plasma that caused them to have AIDS, CJD or mad-cow disease, and one or two more. There has been over a dozen major, medical events affecting the safety of our people over two generations. This is a problem that is always to be dealt with—preferably before the problem happens.
The noble Baroness’s report therefore recommends that the Government should act. First, it should create a redress agency. Doctors and staff are taught “First, do no harm”. The necessary consequence of that is, if harm is done then there should be a remedy for it. That can best be done through a no-fault fairly based redress agency, which does not take away social care, special educational provision or additional provision but gives help in addition. Some of these children will never be able to manage their own affairs.
Who should pay for it? It should include manufacturers of drugs and medical devices. The industry’s capitalised market value in this country is several hundred billion pounds. The French company Sanofi, which makes sodium valproate, have a capitalised value of over €100 billion. Such companies can afford to contribute to the downside that comes from their place in the market.
Secondly, a patient safety commissioner should be created. Legislation has three principal tests: purpose, structure and effectiveness. Let us not become hypnotised by structure. What is the purpose? How can we make it effective and safe? Those questions guide us to the structure. He or she could co-operate with the MHRA and any other relevant authorities.
Lastly, as to what is to be done, the Government should set up a task force now that is government-based, with independents involved, to find out how, at what time, in what manner and at what cost this report’s recommendations can be implemented. Let us not be told that it is too complicated. Within days of becoming Prime Minister, after years of litigation in which I was involved on behalf of the haemophiliac AIDS victims, John Major’s Government publicly accepted all the terms. I thank noble Lords for their patience.
Baroness Whitaker (Lab) [V]
My Lords, this potentially useful Bill raises many questions. I declare my interests as patron of the British Stammering Association—I am a stammerer myself—and vice-chair of the All-Party Group on Speech and Language Difficulties. In particular, it will be important to use the Bill to establish the post of patient safety commissioner, which was so powerfully advocated by the noble Baroness, Lady Cumberlege, and supported by many speakers today.
Like the noble Lord, Lord Ramsbotham, I echo the concerns of the Royal College of Speech and Language Therapists, which wants to work with the commissioner to safeguard people with communication needs, especially those with additional health inequalities, to ensure that their needs are identified and tackled, and their voices heard. There is a deficit here.
In addition, I add my voice to the call to extend powers to undertake supplementary training and to prescribe to occupational therapists, radiographers, dietitians and members of the British and Irish Orthoptic Society. This would greatly improve the efficacy of these services while reducing pressure on other professionals. I look forward to the Minister’s answer.
Lord Sharkey (LD)
My Lords, I declare my interests as chair of the Association of Medical Research Charities, whose members contributed £1.9 billion to medical research last year, and of the Specialised Healthcare Alliance, which campaigns for those with rare conditions and those needing specialised care.
I will make three broad points. The first is to do with the Bill’s structure. I welcome the Bill, in that it could create opportunities for improved regulatory regimes. We cannot, however, tell whether it will. It is a skeleton Bill with a whole array of delegated powers and no detail of how the powers will actually be used. This makes effective, proper scrutiny very difficult, if not entirely impossible. The DPRRC report is especially damning on this point, as many noble Lords have noted. It is worth quoting its conclusion:
“We are deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes for medicines and medical devices—but also by their failure to acknowledge the breadth of the powers that the Bill would confer.”
The Minister wrote to me on 2 August, saying:
“You expressed some concern that this way of regulating the sector meant that Parliament would not be able to scrutinise the powers in the Bill if we did not provide further clarity about the policy changes we intended to make through the delegated powers. I have asked my officials to think further about the extent to which we can provide Parliament greater information to aid its scrutiny.”
That was a month ago. Can the Minister say what progress has been made in his thinking and whether we will see the fruits of it before Committee? For our part, in Committee we will want to explore means to improve scrutiny mechanisms, including the use of the made affirmative procedure mentioned by the DPRRC, and the use of a sunset provision, as discussed in the Commons.
My second point is to do with clinical trials, which are an absolutely critical part of UK life sciences and of what makes the UK a global leader in medical research. Anything that reduces the number of clinical trials will weaken that leadership and could delay access to new drugs and treatments. The Government understand this, which is why I was surprised by the weakness of their approach. The Bill simply requires the Minister, in making regulation, to “have regard to” the attractiveness of the UK as a place to carry out these trials or to supply human medicines. “Attractiveness” is not defined, and in any case this is a very weak and perhaps meaningless obligation that also entirely omits to mention manufacturing. We will want to return to all that in Committee.
We will also want to ask again which aspects of the CTR the Government believe to be in the best interests of UK patients, industry and non-commercial researchers, and which they will regulate for. We will also ask how the Government will assess these best interests and what they may be.
My final point is about consultation. We welcome the commitment to consultation and to a possible early start for it. Such consultation is necessary, but is not, as the DPRRC points out, a substitute for parliamentary scrutiny. The Bill and the Explanatory Memorandum contain no detail about the form of consultation, who is to be consulted and when, or when the consultation results will be available to Parliament. Will the Minister provide answers to these questions ahead of Committee, and could he confirm that patient groups, medical research charities and academic researchers will be among the consultees?
Lord Woolf (CB) [V]
My Lords, I begin by referring to the entries in the register regarding my legal career.
When I first read the Bill, I appreciated immediately that its powers of delegation to legislate by regulation were extraordinarily broad. I do not think anyone has disputed that. The Government have done no more than say how its breadth will assist them. They have not yet dealt with the concerns that are naturally being expressed by committees of this House, and by others, about the lack of anything more than a skeletal framework for the Bill.
In that connection, I noted with interest that the noble Lord, Lord Lansley, made the point that what was needed was to make the Bill a framework Bill, which it currently is not. If his plea were accepted by Ministers, as I believe it should be, there would be a power to make sure that the regulatory power, though undesirable—especially on criminal matters—is at least capable of being controlled. What the Government actually then do in exercising the delegated powers can be tested against the framework—indeed, it can be tested by the courts. This would enable the proper disciplining of any misuse of the regulatory powers provided by the delegated legislation.
If the Minister is in listening mode, as he said, I ask him to bear the wise remarks of the noble Lord, Lord Lansley, very much in mind. It may be thought that giving powers like this is harmless. It is not. We do not know who will exercise the powers, why, and with what result, because that cannot be supervised in the way that a Bill could be. However, at least it helps.
I suggest that another thing that would help would be a sensible sunset clause. It has been suggested that the difficulty with a sunset clause is the timespan that would inevitably be involved before it would come into operation. I suggest that that matters not. The advantage of a sunset clause in this case is that those who are exercising the delegated powers will know that what they have done will come under scrutiny again within a set limit. It would be really helpful to the effectiveness of the Bill if a sunset clause of that sort were there.
Having said that, there are many things that have been said in the course of the debate today that I agree with. The first, of course, is what the noble Baroness, Lady Cumberlege, had to say in her report. I strongly endorse the support that she has already received. There are particular difficulties with harvesting paths, referred to by my noble and learned friend Lady Butler-Sloss and others. Again, I exercise my support. We must make this Bill better than it is now.
Lord Sheikh (Con) [V]
My Lords, I support this Bill as it will enable us to put together and implement the various regulations governing human medicines, veterinary medicines and medical devices. We live in a world that is changing and the medical and veterinary sciences are constantly evolving. The Bill will enable us to innovate and ensure that all medicines and medical devices will be safe to be used by the public when needed. The Bill will enable us to amend the regulations periodically and we will be able to act and react swiftly through secondary legislation and be a world leader in the pharmaceutical industry.
In formulating the regulations, we must ensure complete patient safety. In the regulations, we need to ensure that all the important issues are full covered. I note that Parts 1, 2 and 3 of the Bill stipulate that the appropriate authorities must have regard to the safety, availability and conducting of clinical trials of medicines and medical devices. I fully agree with and support Part 4 of the Bill, as it states that the regulations under Parts 1, 2 and 3 will be subject to the draft affirmative process. The proposed legislation would be required to be fully scrutinised and approved by both Houses.
Furthermore, I note that under Clause 41, the relevant authority would be asked to approach such persons as the authority considered appropriate. This consultation will be essential. I note that under Chapter 3, the enforcement authority will issue notices in respect of compliance, suspension, safety and information. The right to issue these notices will be essential to consolidate the enforcement regime.
I noted the remedies under Clause 24, which include criminal convictions. Will the Minister say whether it is in order to do so under this Act? I welcome the proposals in Clause 27 and Schedule 1 to apply civil sanctions rather than impose criminal proceedings in relation to offences connected with medical devices.
I will talk briefly about Clause 5, which refers to fees, offences and powers of inspection. Under Clause 5(1)(b), it is stated that the regulations may create a criminal offence
“for failure to comply with a provision made in the regulations”,
which may be punishable by a prison sentence of no more than two years. Will the Minister tell us whether the creation of the criminal offence is in order under the regulations?
I will now discuss the provisions of Clause 35, which relates to the disclosure and sharing of information. My slight concern is the protection of data, particularly relating to the patient. We must ensure that there is complete protection in regard to this. Will the Minister comment on the issue of protection? Will the recommendations in the Cumberlege report be fully implemented, including the appointment of a patient safety commissioner?
Finally, I have three more questions for my noble friend to address. First, under Part 1 of the Bill, will there be provisions to regulate alternative medicines, as some of these can cause serious problems? Secondly, what measures are being taken to prevent the importation of medicines from countries where human organs have been removed for medical testing? Falun Gong and Muslim Uighurs are subjected to these horrible practices in China. I am also concerned about tackling antimicrobial resistance. Can the Minister assure us that this issue will be looked into as a matter of priority?
Lord Brooke of Alverthorpe (Lab)
My Lords, I came in earlier today to listen to the Minister respond to the Question asked by my noble friend Lord Dubs on child obesity. I was pleased with what the Government announced in July—I thought it was a step forward—but then I was disappointed when I heard that Public Health England was to be dismembered. I had hoped that when the Minister responded earlier today he would have given a more positive response than he did. I was disappointed to hear that he was simply going out on consultation again to see what would follow and who would supervise the implementation of the policy. It is this kind of change of direction when we are making progress that disturbs people. That is why there have been so many criticisms made of what is happening in this area.
The Bill is needed; we are out of Europe, we need regulation and we are dealing with a technological, fast-changing world. The Minister, in presenting his case, talked about the difficulties we face in handling AI and with biotechnology, how we stay abreast of it and keep pace with it. He went on to give the example of mobile phones: how life has changed so dramatically in such a short space of time and how we have also run into difficulties. He spoke of how, having run into difficulties, the Government have learned that we need to have proper regulation of what is happening with online matters, particularly those relating to children and harm. They are now moving on that, but it has taken some years to get to that point. The Minister said that he was in a listening mood and asked how we should deal with these complex changes. Well, we try to learn from history. The history there is that we should have had a regulator in place earlier. We would then have avoided many of the problems that we currently have.
The noble Baroness, Lady Cumberlege, has come up with a range of recommendations in her warmly welcomed report that are so deserved by people who have suffered as a consequence of medical devices and treatment in the past in a way that they should never have suffered. So I suggest to the Minister that he answer the question himself. We need confidence in dealing with this; I am not going to deal with the technicalities relating to the report, particularly the regulatory report that many others here are well able to dissect and determine what is needed in terms of the law. In general political terms, the Government need to add something that will give people confidence in this piece of legislation. If the Minister is in a listening mood, he will have heard from almost every speaker that the Cumberlege report must be addressed. I ask him to answer one simple question, as there is a limit to the number of recommendations that the Government would be prepared to embrace. Is he prepared to think again about the possibility of having a patient safety commissioner to go along with this piece of legislation? If he were willing to take that step, it would be a big move in the direction that so many people in this Chamber want.
Lord Rennard (LD) [V]
My Lords, the Bill is necessitated by Brexit but, as many noble Lords have said, it does not provide the detail required to address the concerns about protecting patient safety, promoting innovation and helping British businesses at such a difficult time.
Soon after the Brexit vote, I attended a meeting convened by the MHRA involving many of the trade associations representing businesses in the healthcare sector. There was a strong feeling that the best way of addressing some of these issues would be for transitional arrangements to continue for quite some time, if not indefinitely. This case has been strengthened by the Covid crisis.
The UK has been a powerful player within the licensing framework for European medicines and medical devices for many years. The crucial role played by our scientists has been greatly appreciated across the EU and has benefited everyone, so the principle of dividing scientific expertise into two camps, one covering the UK and one covering 27 EU member states, is not a good one.
The case for the UK becoming an independent regulator of medicines and medical devices has never really been made convincingly and we have yet to see any real evidence that the risks and difficulties are likely to be outweighed by any benefits. Patients in the UK may find themselves accessing the latest innovations significantly later than patients in the EU. Businesses are told that they may benefit from different licensing arrangements in future, but if they are different, approval may well still be needed for export to the EU or to other countries which have learned to rely on EU standards. Likewise, patients who might benefit from new products licensed by the EU may not be able to get them until the UK has also approved them.
Two sets of licensing processes will mean two sets of applications, two sets of costs and two potential sets of delays, with the consequence that businesses may be less inclined to invest in innovation than they are under present arrangements. In future, we really need closer alignment in regulation between the UK, the EU and other international standards bodies.
The government case is that the UK will now be able to give more of a lead and to deal with approval processes more expeditiously, but the Bill lacks any detail showing how this could be the case. We might hope that in future greater emphasis will be placed on regulating areas of emerging and cutting-edge science where the UK has significant expertise, such as cell and gene therapies. We may aim for the UK to be seen more widely as a destination for the regulation and trialling of innovative and advanced medicines.
We should want the UK to be an attractive place for companies to undertake research and launch new products and therapies, but we have no real evidence yet that the UK will be able to achieve any of these things alone, and everything appears to be left to government Ministers to decide how things will be done at a time when confidence in some Ministers is very low. Greater detail and greater provision for parliamentary scrutiny may provide greater hope of progress on some of the worthy aspirations that have been outlined.
Lord Kakkar (CB)
My Lords, I thank the Minister for introducing this Bill. In so doing, I remind noble Lords of my registered interests, particularly as professor of surgery at University College London and chairman of UCLPartners.
The Bill is important, as has been emphasised on so many occasions during this debate, because at its heart its purpose is to secure patient safety. Beyond that, it has the objective of ensuring a regulatory environment in which our life sciences industry can thrive. That is important because, beyond financial services, the life sciences are the second-largest contributor to our economy. However, patient safety comes first.
A number of issues in the Bill should have enjoyed detailed debate at Second Reading, but the way we are forced to conduct Second Readings at this time and the limited time we have to explore these issues make that impossible. However, I will identify and bring to your Lordships’ attention two specific issues that will need to be explored in Committee.
The first is the question of clinical trials. Twice in your Lordships’ House, Her Majesty’s Government have given very clear assurances that the clinical trials regulation that will at some point be adopted and implemented in the European Union would have its provisions reflected in UK legislation. It is regrettable that the new clinical trials regulation will not be in place by the time we leave the European Union and therefore not automatically become part of EU retained law.
The important issue here is that the trials regulation replaces the current clinical trials directive, which is defective. It seems unfortunate and unacceptable that, having lobbied so strongly in Europe to replace the current directive with the new regulation, our country, our patients and our researchers will be left with the defective current directive on the statute book. Why do Her Majesty’s Government not wish to use the current opportunity of this Bill to undertake implementation of the key improving provisions of the clinical trials regulation so that our research community and patients can benefit from an enhanced and much more effective clinical trials regulatory environment as we move forward?
The second issue is regulation of medical devices. We have heard much discussion about this problem during this debate. It is quite right that Clause 16 of the amended Bill, having completed its passage in the other place, provides for the opportunity to create registries to look at marketed device products to ensure that they can be traced and patients identified, but it does not deal with the important question of what level of evidence for the safety and efficacy of a device should be necessary before marketing authorisation is provided in the United Kingdom. This is vital.
There are trial methodologies beyond clinical, randomised trials which could be instituted that provide the opportunity for limited authorisation of new devices with patients included in prospective registries with very careful follow-up. The comparison of data from those patients with broader patients with similar diseases and conditions would allow for a proper safety evaluation of newly marketed devices and, ultimately, broader marketing once those initial data were made available. That would be the appropriate approach to patient safety. I hope Her Majesty’s Government will consider using the Bill to provide that kind of certainty.
Baroness Redfern (Con) [V]
I congratulate the Minister on introducing this important Bill and the review team, led by my noble friend Lady Cumberlege, on its commitment to patient safety.
This Bill delivers an extensive programme for the regulation of medicines, veterinary medicines and medical devices in the UK, and provides for a high standard of safety. To capture the fast pace of innovation in these areas within a regulatory legal framework, it is important to share vital information and be responsive and flexible, while being less complex and unwieldy, with data central to effectiveness. Can the Minister say how the duty to consult on regulations about human medicines will be carried out and which stakeholders will be involved?
I am pleased to see the Bill upholding and enhancing of the attractiveness of UK life sciences, as mentioned by previous noble Lords, while not hindering its ability to continue to provide for these important innovations for patients. It demonstrates a wish to make clear the importance of commitment to the life sciences sector, which is worth over £75 billion to our economy. We all know and acknowledge that enhancing continued collaboration of technical and scientific expertise is of significant importance to the UK going forward, but it should not be put before patient and user safety.
There is also a government commitment to a world- leading regulatory system, enhancing us as an attractive destination for clinical trials; to allowing strong collaboration, not just across the EU but maintaining alignment with global standards on the different routes to accessing innovation; to supporting patients’ access to innovation, creating more opportunities as we leave the EU; to maintaining and strengthening our position as a global player in the world of R&D; to allowing the removal of barriers to hub and spoke dispensing, giving smaller community pharmacies the same opportunities as large pharmacies; and to extending low-risk drug prescribing to other healthcare professionals.
An area of concern in the dispensing of medicines is oversupply, particularly in repeat prescriptions. Unused medicines have an environmental impact, so I would like to know how that can be responded to. How, too, can regulations be made to provide for a database of information on medical devices, to be established and managed by the Health and Social Care Information Centre?
As with human medicines regulations, the framework in the Veterinary Medicines Regulations 2013 upholds the safety of veterinary medicines by having a robust system for their availability, development and supply. Changes making prescribing professionals for veterinary medicines as accessible as possible, without compromising animal safety and while ensuring that the person administering the medicine is protected, are to be welcomed.
The Bill is an important piece of legislation for the regulatory system for medicines and medical devices, and for enabling new developments, but it must always display safety front and centre. The Government have stipulated that they do not intend to make any bold policy changes without full consultation, and that is to be welcomed.
The Deputy Speaker (Baroness Garden of Frognal) (LD)
The noble Lord, Lord Gadhia, has withdrawn from the debate, so I now call the noble Baroness, Lady Sheehan.
Baroness Sheehan (LD)
My Lords, I will raise an issue that was not raised in the other place; I cannot hope to do it justice in four minutes. However, it is topical and urgent and, as confirmed by the Public Bill Office, within scope.
A safe and effective vaccine for Covid-19 is critical if we are to return to life as we knew it just a few short months ago. One does not yet exist. There are promising candidates out there, but we know from our experience in setting up an efficient testing regime that it is not easy to get from concept to delivery, however much of a world-beater a candidate may be. Bearing that in mind, thought and planning are necessary to help us beat this disease. Moreover—this point lies at the crux of my contribution today—we must act in unison with all countries of the world to ensure equitable access for all to any successful vaccines and treatments, because until everyone is safe, no one is safe.
Our experience here also shows that a small number of local cases can very soon become an outbreak and stringent restrictions have to be reimposed, Glasgow being the most recent example. It does not need a great leap of imagination to extrapolate this to the global stage. We really do all have to work together and co-ordinate action. Pharmaceutical companies have to play their part too.
Let us suppose that a safe and effective vaccine is found. The volumes of production required to inoculate the entire global population will be staggering and vastly outstrip the manufacturing capacity of individual companies. Holding exclusive licences over Covid-19 health technologies will not only affect pricing and hinder further research but prevent countries producing the volumes needed. Given that the UK, US, Japan and the EU countries have already secured over 1.8 billion of CEPI’s estimated 2 billion to 4 billion dose volume available until the end of 2021, the sharing of IP and know-how will be key to scaling up manufacturing capacity to meet global demand, in particular to ensure that low and middle-income countries can access a Covid-19 vaccine. To control the spread of Covid-19, it is crucial for all countries to be able to vaccinate the minimum 20% of their population necessary to protect key workers and vital health systems that, once lost, will take much time and money to reinstate.
Together with partners such as Gavi and CEPI, the WHO has been working to co-ordinate global action, resulting in myriad acronyms—the ACT accelerator, the AMC COVAX facility and CTAP, among many others. It is good that the Government have supported these initiatives, but—this is the huge part—they lack safeguards to ensure that vaccines and treatments, often resulting from huge investment from public purses, will be made available for all at a fair price.
I will give just a couple of examples of why these safeguards are so necessary. Gilead’s Remdesivir has been proven to reduce the need for mechanical ventilation for Covid-19 patients in hospital. However, with monopoly protection, Gilead was able to charge the US $2,340 per five-day treatment course of the drug, despite the substantial amount of public funding to develop the drug and researchers at the University of Liverpool calculating that the drug can be made for $9 at a reasonable profit. AstraZeneca has said it will supply the vaccine at cost to the UK Government during the pandemic phase, but what price will the NHS have to pay post pandemic? What happens to the money paid in advance if the vaccine is not approved? The contract between the UK Government and AstraZeneca has still not been published.
The Bill represents a timely opportunity to ensure that intellectual property rights support public health imperatives, as per the 2001 Doha declaration on trade-related aspects of intellectual property rights, TRIPS. The Government also have another tool in the issuance of Crown-use licences, similar to steps taken by countries such as Australia, Canada and Germany. In conclusion, will the Government take up the International Trade Select Committee’s recommendation to evaluate the case for measures to allow compulsory licensing, so that Covid-19 technologies are available as quickly, cheaply and widely as possible?
Lord McColl of Dulwich (Con) [V]
My Lords, I congratulate my noble friend Lady Cumberlege and her committee on producing such a thorough and important report.
I draw attention to a practice that many of us clinicians used for years. It detected clinical problems in treatment, equipment and management early on. We had weekly meetings for an hour or so to discuss any complications that had occurred in the previous week. It was attended by consultants, junior staff, medical students, nurses and a manager or two. It was always an interesting and very instructive meeting, and it brought problems to light early on. People were very honest about their mistakes; it became rather like the general confession. Of course, it was essential to have as a chairman of these meetings somebody who was friendly and encouraged people to adopt the attitude of “There but for the grace of God go I”. It was a very inexpensive and successful kind of quality assurance.
I have a few questions to put to the Minister. First, do the Government plan to mandate the tracking of all medical devices used in the UK and not just those selected at random? Secondly, will the use of medical device registries be extended to patient outcomes? Thirdly, will the Government go ahead and establish the post of a patient safety commissioner, as strongly recommended by my noble friend Lady Cumberlege and many of your Lordships? Some years ago, I used to carry out transplant operations and became very familiar with the problems involved.
I emphasise that in Committee I shall fully support the amendments in the names of the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, dealing with forced organ harvesting. As mentioned before, Sir Geoffrey Nice QC stated in his report that forced organ harvesting has been committed for years throughout China. [Inaudible.]
Baroness Penn (Con)
I am afraid that we can no longer hear my noble friend. If he would make his concluding point, that would be wonderful.
Lord McColl of Dulwich (Con) [V]
Perhaps those who spend so much time attacking the Government about this and that might like to turn their attacks on the Chinese Government, whose morally corrupt behaviour demonstrates to the world what is going on in China.
Finally, I again congratulate my noble friend on her outstanding report.
Baroness Uddin (Non-Afl)
My Lords, I express at the outset my gratitude to many organisations, including the BHF, PSA, Birmingham University and of course our own House of Lords Library for their insightful briefings. The Bill seeks to keep high standards and safeguard patient safety as paramount considerations and to propel the UK as a standard bearer of new innovations. Like other noble Lords, I am uncomfortable about the extensive range of delegated powers afforded to the Government over medicines and medical devices and I would have liked, given time, to have elaborated further on the implications of Clauses 2, 4, 15 and 16 on the regulatory requirements during public health emergencies. I can only hope and pray that the other place and this House will ensure continuous scrutiny, with an agreed timeframe for a review of this legislation.
While I appreciate the legislative context of the Bill and the need for it, I wish to make some general points and do so as a grass-roots advocate who has campaigned for more than four decades for accountability and equity within healthcare and social services. I spent years working in this field and recall supporting many women who had experienced untold misery as result of medical intervention; I therefore welcome the sensitive way in which the Minister in the other place, Nadine Dorries, acknowledged that women’s voices and informed choices continue to be discarded and not believed, as has gone on for decades. This recognition is critical, as the noble Baroness, Lady Cumberlege, so powerfully and lovingly spoke of: women cried out for help to alleviate the massive damage caused to them by the medicines and medical devices deemed safe for years by health institutions and professionals. Women have endured countless years of unnecessary pain and injury, leaving many with insurmountable psychological, physical and financial scars. Even the most outspoken champions for their needs found it difficult to be heard, while women awaited justice.
The report from the noble Baroness, Lady Cumberlege, First Do No Harm, must be at the forefront of the Government’s mind as we look to safeguard and embed patient safety with this Bill. We have an opportunity to ensure that this legislative framework is watertight against any such injustice and costly negligence occurring again.
I support the creation of patient safety commissioners to improve patient safety and represent patient interests. In this Bill, glaring fragmentation remains; no clear pathways are indicated in the regulatory system to where patient safety is located. The Paterson inquiry referred to these anomalies as a “jigsaw of organisations” to keep patients safe without sufficient clarity. In this context, I would have wished for clarity on further safeguarding of informed consent.
Can the Minister say how the Government intend to complete this obligation for consultation with patients and the wider healthcare sector, as called for in the most recent proposals, including the Cumberlege Report, in order to rebuild trust and confidence that another set of disasters is not in the making as we proceed rapidly to create a new vaccine in the face of this horrendous pandemic?
Of equal significance, but which appears to be absent, is reference to safeguarding informed consent. I therefore welcome the Minister’s willingness to listen. Would the Minister consider that the proposed commissioner be supported by a diverse group of experts to ensure that women, as well as minority groups, have full confidence that their voices and needs are not overridden by the Government’s rush for central decision-making? Prioritising patient safety must not be compromised. The noble Baroness, Lady Cumberlege, has reminded us of the thin wedge where the medical profession and women patients, in particular, interact. There is urgent need for a robust regulatory framework for medicine and medical devices with the principal aims of serving and protecting patients and users of our service.
Baroness Masham of Ilton (CB) [V]
My Lords, I have a personal interest in this most important Bill, as medicines have saved my life on several occasions, and I use several medical devices. But most important to me is the safety of our country in this difficult time of coronavirus and leaving the EU.
The Secretary of State has an immense responsibility in providing safe functions relating to medicines for humans and animals and to medical devices. Leaving the EU means that we will not have the advantage of voting at the European Medicines Agency, where we were among the leaders, and it puts extra stresses and strains on our MHRA. The MHRA works so well with the European Medicines Agency, which has now moved from London to Amsterdam. I ask the Minister: will the MHRA be given more support and funds to carry out its extra and vital work? What will happen with clinical trials in the UK, which are based on the EU clinical trials directive and operate through the MHRA? It is not expected to apply in the EU until after the end of the transition period. This means it will not be part of the EU law, so what will the UK do about this important matter? My noble friend Lord Kakkar also stressed this.
Thousands of clinical trials seeking new treatments for diseases, including cancer, heart disease and many rare conditions, have been suspended or abandoned in the wake of the Covid-19 pandemic. Charities that raise money to provide funds have lost millions of pounds in revenue that would go a long way to helping to research new medicines and therapies that are desperately needed. Coronavirus has cast a shadow across the world. We should work together to fight this disease. But the emphasis on the attractiveness of the UK to conduct clinical trials or develop medical devices must not be put before patient and user safety.
The Bill covers so many aspects of safety. I have been involved with the disaster of sodium valproate, the drug given to pregnant women with epilepsy; their children were born with autism. I hope that the recommendations of the Cumberlege report will be accepted, especially the creation of the post of patient commissioner. I am pleased that the Bill addresses the dangers of falsified medicines. However, the Company Chemists’ Association would like to avoid the unintended consequences of data being used for purposes other than to ensure that medicines are safe. It is asking for “any purpose” to be amended to “in agreed framework”.
Everyone to whom I have spoken agrees that we should maintain the highest possible standards of patient and animal safety. I hope that we can work globally and not become isolated.
Lord Willis of Knaresborough (LD) [V]
My Lords, I suspect that much of my contribution will echo that of other noble Lords as this vital piece of legislation makes its way through our House. I say “vital” not simply because the overall market in pharma-medical devices and medical products is worth some £74 billion a year, but because without this legislation the chaos that derived from a no-deal Brexit would be catastrophic for patients and their families.
Let us be clear: this Bill is short on detail and accountability and places far too much power in the hands of the Secretary of State. The one overriding consequence is to deliver a system of regulation that is inferior to and more expensive than the one that currently exists. That is quite a triumph.
That said, there are elements of the Bill I welcome, particularly the registry of medical devices, and the greater enforcement powers over rogue operators, which are so clearly needed, following the excellent report by the noble Baroness, Lady Cumberlege—a report, incidentally, whose recommendations are embarrassingly absent from the Bill.
I welcome a more realistic approach to prescribing and extending the ability to prescribe to more healthcare professionals. What is not clear is how this is to be achieved. Will the Human Medicines Regulations 2012 be amended by a new clause in the Bill? Will a common framework for competency, based on the Royal Pharmaceutical Society’s competency framework, be included as a requirement for any new professional prescribing group? If not, where will its standards come from? Do the Government intend to address the issue of competency for those who do not prescribe but who administer drugs to patients? A safe administering practice is crucial, particularly in community settings, where often prescribing colleagues are in short supply.
Like many Peers, I am deeply concerned about aligning future regulatory systems. I welcome assurances given by Ministers, but we have to anticipate a situation where divergence of regulation may lead to the non-compliance of either our products or those of the EU and the US, our two major suppliers. Currently, the UK is a key player in the global regulation of medicines. Despite having only 3% of the global market, compared to the rest of Europe with 25%, we are able, through the MHRA, to punch well above our weight, as the noble Baroness, Lady Masham, so clearly stated. Three years ago, the UK was a rapporteur, assistant rapporteur or scientific advice co-ordinator for one in five EMA regulatory decisions—decisions that were accepted across the globe. The UK is a global player because of our excellent science but also because it has access, through the EMA, to the EU. Should we not retain the closest possible alignment with the EU, when the regulatory cost and impact burden might see huge problems for the UK medicines industry, with a rapid decline of market authorisations?
Finally, given the surge in personalised medicine which will drive so many novel treatments, I hope that the Bill can be amended to make it a requirement that, should a health professional offer a patient treatment using a fast-track drug, therapy or device with which they have had or will have a pecuniary interest, it must be declared. That is not the case today and it certainly should be. The report by the noble Baroness, Lady Cumberlege, looked particularly at areas such as fertilisation treatment, where there are some very important differences to be made. I look forward to further examination of the Bill in Committee but regret the fact that we have to have this at all.
Lord Mancroft (Con)
My Lords, the purpose of the Bill before us today is set out very clearly in the Long Title and few could disagree with the Government’s objectives. Indeed, the Bill had a relatively untroubled passage through the other place. However, I am slightly confused. At least part of the motivation for improving the law and regulation in this area was the subject of the review of the safety of medicines and medical devices by my noble friend Lady Cumberlege—a first-class if somewhat harrowing report. I am therefore unclear how the Government can be entirely confident that the Bill achieves what it purports to, as it was drafted before my noble friend’s report was published.
I would like to take this opportunity to make a few comments about my noble friend’s review, because I became concerned and, frankly, pretty horrified by its findings, particularly in relation to the use and misuse of surgical mesh. We have become accustomed over the last few months to applauding outside our homes the sterling work of front-line NHS staff during the pandemic at a time when large numbers of people became very ill and required significant interventions and care in a particularly challenging environment. We were right as a nation to acknowledge the work that they selflessly undertook on our behalf.
However, my noble friend’s review sets out a description of another side of our National Health Service that we need to be equally willing to acknowledge, although it is less palatable and some people may not be willing to admit it. Everybody makes mistakes, and large, nationally delivered services are no exception. So it is important to keep things in perspective, which is not easy when we are talking about the lives of people we know, or our loved ones.
One thing that sticks out to me in the review is the extraordinary lack of data, which has been mentioned before in this debate. I can tell your Lordships that 336,000 people have been infected with coronavirus in the UK this year and that 41,000 have died—precise and tragic statistics. But I cannot tell your Lordships how many women have had their lives ruined by the insertion of medical mesh, because the National Health Service does not have those figures. It does not know how many people had those operations or how many have suffered adverse effects, although the number is probably in the tens of thousands, and certainly more than those who have died of Covid.
Doesn’t know, or doesn’t care? It is very hard to tell from the review or from talking to those who have suffered. But the language of the review bears repeating and should go on the record. I am obviously not going to quote all 267 harrowing pages, but perhaps I can take a few quotes from page 4, which cites
“lack of awareness of who to complain to and how … the struggle to be heard … not being believed … dismissive and unhelpful attitudes on the part of some clinicians … a sense of abandonment … life-changing consequences … breakdown of family life … loss of jobs … loss of identity and self-worth”.
Lastly, “inaccurate or altered patient records” is a particularly shocking remark to me. I will not go on, noble Lords have heard enough. This is not a service that we should be applauding on our doorsteps. This is a service that in this area should be hanging its head in shame.
I have two questions for my noble friend. Can he assure the House that the Bill will go a long way—a very long way—to ensuring that something like this can never happen again? Can he explain exactly how the Bill will contribute to that, because it is far from clear to me from his remarks on opening this debate. It is far from clear to me because, as many noble Lords have pointed out, it is only a skeleton Bill or a framework Bill—I am not sure what the difference between the two is.
Secondly, can he explain what steps the Government are taking now, today, to make redress to those women who have been harmed and how exactly they are doing that? I have read what my noble friend’s review recommends but have not yet heard the Government’s response, and this Bill does not cover that most important point.
Lastly, if my noble friend Lady Cumberlege moves an amendment to set up a patient safety commissioner, I shall be delighted to support her in the Lobbies.
Lord Bhatia (Non-Afl) [V]
My Lords, this Bill is being debated against the background of the UK exiting the EU by the end of this year and the Covid-19 pandemic, which has paralysed this country and virtually the whole world. It covers a multitude of subjects, from medical devices and medicines, to research and consultation with the medical community and the general public. I will comment on Part 1, entitled “Human Medicines.”
This vast Bill ultimately will affect every citizen in this country. Many of us have illnesses and depend on our NHS. Our GPs are our first contact; they assess our health conditions and decide on the next step of treatment. The enormous responsibility that GPs carry is truly awesome. Their work decides our fate, whether medication is needed and whether to send us to a consultant or to an NHS hospital. Few of us realise that our GP practices have budgetary problems.
Next in line are the pharmacists, who deliver the medications prescribed by GPs. In the lockdown era, they must deliver those medications to our homes. We are rightly recognising and applauding the work of our NHS hospitals, doctors, surgeons, nurses and other staff, but few of us recognise the work of the pharmacies. They work long hours. In most cities and towns a pharmacy is open 24 hours a day. They too have budgetary problems. Before the pandemic they could run profitably, since customers collected their medications and, while doing so, could buy other, non-medical items, ranging from toothbrushes to perfumes and soaps. Because of the lockdown, that extra trade has disappeared and none of us realises that pharmacies may now be running at a loss. Supermarkets have their own pharmacies and competing products. There should be better recognition of the work of pharmacies and some level of subsidy provided following the lockdown.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I declare my registered medical and university interests, and that my son is developing cardiac medical devices.
The Bill could either cripple UK medical devices development or enable the UK to become a major player in advancing new devices and medicines for the world market. There must be safety—the report First Do No Harm is aptly titled. Its recommendations must be fast tracked. I will address the proposed information centre, the need for a provisional licensing system for medical devices development, and our duty to uphold international standards.
The information centre that will be formed to collect data on medical devices must establish a level playing field, as a four-nation institution, with representatives from each nation on the board to ensure governance oversight and strategic direction, equal access to data analysis and data sharing, and reporting to all four Health Ministers. The model exists in the joint biosecurity centre, yet the lop-sided power base currently proposed will bleed the devolved Administrations of funds and information. Parity of funding and powers is essential. Clause 41 needs strengthening to require consultation with UK devolved Governments and health bodies impacted by the medical device information system.
Others have stated how EU-UK clinical trials for medicine must continue, with regulation that is compatible worldwide and rapid reciprocity in licensing. The UK must be attractive to medicine and device development by ensuring efficient streamlined systems that provide economic benefit to international investors.
We must catalyse medical device development pathways in the UK, as happened in Galway in Ireland. The UK—a small part of the world market—must grasp the opportunity to become a medical devices development and production hub by being worldwide-compatible and attractive to start-ups. Currently start-ups have the initial brilliant idea and do the safety studies required by the MHRA, but often cannot fund the utility studies in the second phase of licensing. The start-up is then bought out by overseas manufacturers, which market the device back to the NHS at great profit. A provisional MHRA licence would allow the start-up to sell to the NHS when safety studies have been completed as the utility data is gathered. A provisional licence would allow marketing to the NHS with post-marketing surveillance. I think that that reflects the proposals made by my noble friend Lord Kakkar. Patients would benefit more rapidly, with high monitoring standards in place, and it would stimulate the manufacturing infrastructure if the second stage of development happened in the UK.
Regarding China’s organ harvesting and experimentation on detained citizens, the Minister wrote to me last night, citing the WHO’s view as reassuring. It is not, as many noble Lords have already pointed out. Consent documentation for tissues from outside the UK is required only on an advisory basis. It must be statutory. There are now reports of Covid vaccine experiments in China being carried out on prisoners without consent. The UK cannot ignore increasing evidence of abuses, so I will co-sign an amendment to close the glaring gap. The Government can then prove that they really take this extremely seriously.
Lord Blencathra (Con) [V]
My Lords, I wholeheartedly agree with the noble Baroness, Lady Finlay of Llandaff, that Britain can and must become a world leader in medical innovation. I strongly supported the Saatchi Bill on medical innovation. I am currently trying out a couple of MS drugs and will volunteer for everything. Personally, I am not too worried about safety, but that is a unique viewpoint.
I begin by paying a warm tribute to my noble friend the Minister. He is one of the finest Ministers I have encountered in this House: intelligent, knowledgeable, on top of his brief, courteous and very hard-working. I am delighted that he is going to listen to the criticisms on delegated powers today. Thus it grieves me to say that the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy. Of course, it is not unique; it is just one more Bill stuffed full of Henry VIII clauses but devoid of substantive content. It is the barest skeleton, all to be filled in with negative secondary legislation.
I am speaking in my capacity as chair of the Delegated Powers Committee. We considered the key clauses—Clauses 1, 8 and 12—and concluded that they contain inappropriate delegations of power. We say that
“the Government have failed to provide sufficient justification for … the Bill adopting a ‘skeleton bill’ approach, with Ministers given very wide powers to almost completely re-write the existing regulatory regimes”.
But of even greater concern are the powers in these clauses allowing Ministers to create completely new criminal offences by statutory instrument: see paragraphs 29, 30 and 31 of our report.
Then we come to the negative/affirmative procedure ploy. We say:
“We are wholly dissatisfied by departments repeatedly arguing for powers … to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure. Departments are very well aware of that procedure and we can only conclude that their failure to mention it is a device to try to minimise Parliamentary scrutiny. In future … we will expect them to explain why the made affirmative procedure should not apply.”
That is pretty hard-hitting, and I am sorry that my noble friend the Minister is bearing the brunt of this criticism when it applies equally to dozens of Bills across all government departments. It is simply that my committee is fed up with Bill after Bill drafted with the negative procedure, on the excuse that the only alternative is the affirmative procedure. This is simply not true. The Office of the Parliamentary Counsel and the Cabinet Office are perpetuating a falsehood in their official guidance on drafting legislation, which completely, and I say deliberately, ignores the “made affirmative” procedure.
Then we come to the wonderful new term “protocols”, another ploy invented by draftsmen to avoid parliamentary scrutiny. We say:
“Allowing regulations to make … legislation subject to conditions set out in a ‘protocol’ is yet another example of ‘camouflaging legislation’ … those powers … should be set out in the regulations themselves and not in a ‘protocol’ which is not subject to Parliamentary scrutiny”.
The memorandum states on Clause 2 that the negative regulations will be made
“following extensive consideration and scrutiny by the relevant professional bodies”.
Jolly good for them—everyone is to be consulted except this Parliament.
Finally, we say in our conclusion:
“We are deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes … but also by their failure to acknowledge the breadth of the powers that the Bill would confer. In future, we will expect a more transparent approach in which a department acknowledges the breadth of the powers and seeks to fully justify it.”
Of course, Ministers must take responsibility for their legislation, but the root cause of this abuse of Parliament can be found in the Cabinet Office guidelines to departments on preparing legislation. The Office of the Parliamentary Counsel boasts on its website:
“We are committed to promoting good law—law that is: necessary, clear, coherent, effective, accessible.”
If the lawyers drafting our laws think this Bill is good law, God help us. Do they think good law includes skeleton bills, Henry VIII clauses, negative procedure everywhere, regulations masquerading as guidance and protocols, and criminal offences created with no parliamentary scrutiny at all? Parliament is effectively bypassed; that is a sick joke of good law.
I will return to this theme at a later date. I apologise again to my noble friend the Minister that he is on the receiving end of criticism that applies across the board.
Baroness Watkins of Tavistock (CB)
My Lords, I feel that I have drawn the short straw, speaking at this point.
Like other noble Lords, I broadly welcome and support this relatively short, important and necessary Bill. To promote patient safety, the meaning of
“the attractiveness of the … United Kingdom”
environment for medical research in future, particularly in relation to clinical trials, requires clarification. We see the global race to produce safe vaccines for Covid-19 that must, despite their urgency to protect populations, be tested for safety as well as efficacy. The UK currently adheres to the EU protocols that apply to ensure the safety of such products before licences are given for mass use. Can the Minister explain if there are any plans to relax our adherence to current EU legislation on clinical trials?
The Bill refers to regulations relating to medical devices and the fact that Ministers will be given delegated powers in relation to their approval. Do the Government intend to adopt the EU regulation on medical devices 2017/745, which is not due to come into force until after the end of the transition period? Will the Government ensure that, as well as approving new devices in future, any maintenance of devices necessary to keep them safe in operating terms will also be included in the provision of granting such licences? We know that patients have occasionally been put at risk due to inadequate and/or irregular maintenance of devices—for example, with smart infusion pumps used to deliver medication. What onus will the Government put on purchasers of approved devices not only for safe maintenance but for adequate training for people to use the new devices to protect patients? This does not seem to be mentioned at all in the legislation as drafted.
I too fully support the excellent report and recommendations produced by the noble Baroness, Lady Cumberlege, and the way it uses plain English to describe the horror that some patients and their families have suffered. I am reminded of trying to find out, when I was training as a nurse, what “iatrogenic complications” meant. I think it is stark that the noble Baroness uses modern language that we can all understand. That is so important.
Will the Bill be used to incorporate some of the principles of the Health Service Safety Investigations Bill, which reached a Second Reading in this House, or is it the intention that that Bill will not be timetabled for completion and therefore the medical devices Bill will need to take up many of those issues at the same time?
Without doubt, I fully support the concept of a patient safety commissioner being appointed.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, like many noble Lords who have spoken today, I agree that the provision of high-quality healthcare in which its citizens can all have confidence defines any nation. That is why this Bill, with all its warts, is so important.
We must always ensure that our ethical practices are of the highest standard. Any medical product available in the UK, or indeed anywhere, must be rigorously tested, safe and effective. That is also particularly true of any future vaccine for Covid-19.
However, I want to focus today on one aspect of this Bill, that relating to medical devices. I have long campaigned on the issue of winning justice for pelvic mesh sufferers, who have been left with internal damage and intense, chronic pain. They were failed by an appalling culture of mismanagement, ignorance and apathy within the health system. These victims deserve justice, and we must ensure that this sort of systemic failure never happens again.
The recent report by the noble Baroness, Lady Cumberlege, entitled First Do No Harm, on surgical mesh and other medical interventions was scathing in its assessment of the failures of a disjointed and defensive health system to listen to and address patient concerns. Much of the suffering, it concluded, was entirely avoidable. As someone who met victims of this appalling mismanagement when I was a Member in the other place and learned at first hand of the pain they had been forced to endure and its effect on their quality of life, I am pleased that this review was commissioned and am happy to support the noble Baroness in her proposals. I am pleased, too, that it was able to be so honest in its findings.
I am further pleased that the Minister, the noble Lord, Lord Bethell, provided an apology in your Lordships’ House on the 9 July to all the people who have suffered as a result not only of pelvic mesh issues but of certain medications. I am now going to ask the Minister a direct question. Will the recommendations of the noble Baroness, Lady Cumberlege, be reflected in this Bill through government amendments in Committee? I refer in particular to the implementation task force, which must be set up without delay to oversee progress. Like other noble Lords, I believe that that recommendation should be given statutory effect if the Government and Parliament are to take this report seriously. That goes also for the recommendation that a commissioner for patient safety be created.
In relation to Northern Ireland, there is also the issue of potential regulatory divergence. As medicines are a devolved power but medical devices are not, the Bill in its current form raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK. That matter requires clarification in relation to the report of the noble Baroness, Lady Cumberlege, and this Bill. Can the Minister provide that? There is no doubt that such assurances are very necessary, but they should not and will not close the door on the past.
Baroness Hollins (CB) [V]
My Lords, I refer to my interests in the register and congratulate the noble Baroness, Lady Cumberlege, on her review, which, as we have heard, was asked to look at three interventions in particular detail: hormone pregnancy tests, the use of sodium valproate in pregnancy, and pelvic mesh implants. The connection between these was not lost on the review, which noted that each of them are
“taken or used by women and, in the cases of valproate and hormone pregnancy tests, usage is during pregnancy.”
The review found a litany of failures in the system to monitor harmful effects and heard about: patients not being provided enough information to make informed choices; a lack of awareness as to how to raise complaints; struggles to be heard; not being believed; dismissive attitudes by clinicians; and life-changing consequences due to the harms that ensued.
For women, there seemed to be a confounding factor, which the report described as
“the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.”
In my field, we call this diagnostic overshadowing. The review described the stories of adversity and harm it heard as being “harrowing”. This is what happens when a group is not believed and when systematic prejudices diminishes a speaker’s credibility. This stark example of epistemic injustice should serve as a reminder to all of us of the harms of ignoring the voices of the disfranchised. Of course, there are many groups whose voices are not heard and have, for too long, proved to be too easy to ignore. These include, for example, the voices of some patients detained under mental health legislation.
As we have heard, the Bill we are debating today grants wide-ranging powers to the Government—and, indeed, the Minister—in relation to medicines and medical devices, with a large number of putative regulations subject only to the negative procedure. Will Her Majesty’s Government commit to using this timely opportunity to implement the recommendations of the noble Baroness, Lady Cumberlege, in the framework of the present Bill?
There were nine recommendations, which included appointing a “patient safety commissioner” and the formation of an independent “redress agency”. Another was, quite simply, for the Government to apologise to all the women who have suffered lasting harm. I hope the Minister will inform the House of Her Majesty’s Government’s specific intentions with respect to patient safety.
The report suggests that the MHRA’s yellow card safety-monitoring scheme is poorly sensitive to adverse treatment outcomes and that the MHRA needs “substantial revision”. Will the Government commit, in this Bill, to a far greater emphasis on post-market surveillance of medicines and medical devices? In Clause 1(2), the Bill places market considerations on an equal footing with patient safety and distributive justice—namely, the availability of human medicines.
While the economic implications of the pharmaceutical and medical devices market are, of course, important, there is no implicit or explicit hierarchy in the current drafting of the Bill that would enable defence of the appropriate authority’s decision-making being based primarily on safety, or safety and availability. Will Her Majesty’s Government amend the Bill to ensure that the hierarchy of these principles is recognised in statute? I am considering such an amendment myself.
The Bill gives the Government power to extend prescribing responsibilities to new professional groups where it is safe and appropriate to do so. Can Her Majesty’s Government comment as to which professional groups they propose to extend prescribing responsibilities to and, if they do not intend to do so at the present time, when they would consider addressing this issue? What safeguards would they consider to be necessary?
Baroness Blackwood of North Oxford (Con)
My Lords, I refer to my interests as declared in the register.
I pay tribute to all those who have worked tirelessly to deliver lightning-fast and globally important Covid trials, including RECOVERY, REACT and the Genomics England genomic host sequencing study. These have been a clear demonstration of the strength of the MHRA and UK life sciences. However, surely none of us can read my noble friend Lady Cumberlege’s heartrending report or watch the race to a Covid vaccine without knowing that we have more to do. Therefore, although this Bill has been triggered by Brexit, it is in fact timely regardless of Brexit.
A great deal has been said regarding the delegated powers—I note my noble friend Lord Lansley’s comment regarding framework Bills—and we will have time in Committee to cover all this, but I add that while current frameworks governing MMD will be retained, the loss of the ECA Section 2(2) power causes specific challenges for operating a safe and responsive regulatory regime. By its nature, MMD regulation requires frequent, prompt updating. The Human Medicines Regulations 2012 have been updated 11 times using Section 2(2). Over and above this, as has been mentioned, we have significant decisions to come on MDR, CTR, in vitro diagnostics and much that is as yet unknown.
Passing this Bill will mean that we will be able to shape our MMD regulatory environment in a far more tailored way. We may well choose to mirror upcoming EU regulations. The MHRA has been clear that we want a seamless process for multisite clinical trials not just across Europe but globally. However, there are other areas, such as genomics and cell and gene therapies, where innovative regulation may be highly desirable for novel trial design or surrogate end points, for example.
From Genomics England to Wellcome Sanger and Biobank, we have a unique concentration of institutions, skills and industry that puts us at the forefront of this field. This is a position that we must maintain. Furthermore, genomics drives two of our most highly skilled and high-growth sectors: life sciences and data science. These are critical to our economic recovery. However, primarily, these technologies should be assured and accelerated due to their promise for patients: more accurate diagnostics, personalised medicines, and screening tools that may even help prevent certain diseases altogether. The value of knowing that you carry a faulty BRCA1 gene and therefore have an increased risk of ovarian or breast cancer is well known. However, combining this genotyping with emerging tech such as polygenic risk scoring can sharpen that risk profile and prevent inappropriate interventions. The same is true of familial hypercholesterolaemia, promising to improve care of the highest-risk CVD patients.
We know that gene editing tools are producing entirely new casts of medicine, including cell and gene therapies such as the blood cancer drug Kymriah. It was the UK that struck the first full-access deal in Europe for this breakthrough CAR-T therapy, and there is promise of much more, with 12% of global ATMP trials happening here. The benefit of cell and gene therapies is patient-specific treatment with curative potential. The challenges include cost, complex manufacturing and short shelf lives. This Bill would help, enabling approved therapies to be processed at the bedside, and much more.
Genomics and other such tech generate vast swathes of data, and none of us needs to be reminded of the challenge and urgency of regulating the intersection of novel medicines, medical devices and health data. This Bill would help us develop a future-proof health data regulatory framework that could unlock the potential of ML in healthcare while maintaining the highest ethical and data standards. But align or innovate, it will be our decision. Clause 41 makes it clear that these decisions will be fully consulted on and largely subject to the affirmative procedure, but it would be helpful for the Minister to clarify the points raised by the noble Lord, Lord Sharkey.
The balance to be struck is articulated in all three sections, which call for Ministers to consider safety, access and attractiveness of UK life sciences. Of course, patient safety is paramount, but a sick patient is not safe if they cannot access the treatment they need, and they will not be able to do that if the UK becomes an unattractive environment to trial and launch the best treatments. This requires rigour and prompt intervention to ensure the highest standards of patient safety, yes, and I fully support the patient safety commissioner and an effective devices register, but it also requires addressing barriers to access and uptake and creating certainty and right-touch regulation that limits bureaucracy and takes a proportional approach to fostering innovation in life sciences. That way, not only will UK patients get the best and safest care but we will ensure our life sciences sector remains one of the most productive in the country and one of the most innovative in the world.
Baroness Morgan of Drefelin (CB) [V]
My Lords, I declare an interest as chief executive of the research and care charity Breast Cancer Now and as chair of the National Cancer Research Institute.
I would like to start by congratulating the noble Baroness, Lady Cumberlege, and her colleagues on her committee, for her report and her compelling contribution today; it was incredibly moving. I, too, will be supporting steps to see this Bill serve as a vehicle for the implementation of her recommendations, most notably, as so many Peers have commented today, the establishment of a patient safety commissioner.
This Bill covers two areas of particular concern to cancer patients that I wish to emphasise today, which others have touched on, too. These are access to clinical trials and speed of access to newly licensed medicines. For the estimated 35,000 women living with incurable secondary breast cancer in the UK, clinical trials can provide early access to potential new treatments which might extend the time before their disease progresses, which might extend their lives and which can improve quality of life. These women often have few treatment options available to them, and clinical trials really do offer people with incurable secondary breast cancer and other cancers hope for the future. I do not want us to underestimate the value of that in these debates.
Research is, as we have heard, underpinned by pan-European and international collaboration. As an example, over 4,800 EU clinical trials involved the UK between 2004 and 2016. That is a significant number of important trials. The new EU clinical trials regulation, which we have already heard about today, will improve patient safety and streamline the process for setting up new trials, and this is vital. The Government made an extremely welcome commitment in 2018 to align as closely as possible with the new regulation, and it is essential that this commitment is restated and honoured. Today is an opportunity for that. However, without access to the infrastructure that clinical trials require, such as the portal and the database to support the regulation system, it will become much more difficult to run clinical trials across borders; that has already been talked about today.
Where trials show that medicines are safe and effective, it is vital that they are licensed and made available to patients as quickly as possible. We have heard today that the EMEA area represents 25% of global pharmaceutical sales and the UK just 3%. These are important numbers to bear in mind. If the pharmaceutical companies have to make a separate application to the MHRA, and incur additional costs, to license their medicines, delays are likely in those medicines becoming available in the UK. This is a threat to timely access for patients to new medicines, and its importance should not be underestimated.
We are also particularly concerned about access to medicines developed by small pharmaceutical companies. Can the Minister give some reassurance to patients with secondary breast cancer and other incurable cancers that access to clinical trials and newly licensed medicines will not be adversely impacted by the effects of this Bill? I look forward to hearing from the Minister.
The Deputy Speaker (Baroness Garden of Frognal) (LD)
The noble Lord, Lord Darzi, has withdrawn, so I now call the noble Lord, Lord Freyberg.
Lord Freyberg (CB)
My Lords, I have spoken at length about the value of harnessing healthcare data in the UK, and the Bill reads across to that topic. The Bill is needed to regulate medicines and the estimated 500,000 medical devices licensed for manufacture world- wide as we transition from membership of the European Union. However, it is heavily reliant on definitions set out in the Medical Devices Regulations 2002, and the use of technology has advanced significantly since then.
Simply stated, the Bill would benefit from up-to-date definitions of medical devices, or what are commonly referred to as decision support tools, that more readily reflect recently developed and near-future technologies. Many are deployed by professionals in clinical settings, while others are designed for use by members of the public. The Bill should guarantee patient safety and the efficacy of tools, including, for example, algorithm-based smartphone apps that help people assess the extent to which they may be at risk of skin cancer. A recent study found that the regulatory process for awarding the CE kitemarking to algorithm-based apps does not currently provide the public with adequate protection.
The onus is currently on the professional or individual to make appropriate use of such devices, rather than on the developers and regulators to take clearly defined steps to guarantee patient safety. Ideally, the Bill should offer at least the same level of protection afforded to patients in the EU and the US, where legal provisions make use of contemporary definitions associated with data-driven devices.
Medical devices are being developed in novel ways, and the regulation of software that makes use of algorithms to process vast quantities of data raises different issues to the regulation of software that has traditionally controlled, for example, pacemakers. These newer products are also developed, realised and updated in a very different way. By their very nature, many change, or learn over time, as they are informed by, or amass, new data. Without the means to monitor such updates, it is impossible to assess how many patients might be adversely affected by them at any point in time.
The Government have made plain their ambition to invest in science and innovation while boosting digital trade post Brexit, and the Bill is in part designed with that in mind. However, Ministers must negotiate new trade agreements with countries that subscribe to an increasingly protectionist approach to intellectual property. I am concerned that the effect of some provisions in agreements could be to reduce access to and understanding of the algorithms which underpin data-driven medical devices, in particular where developed countries seek restrictions on forced disclosure of digital technology, treating source code and algorithms as trade secrets.
I will therefore ask the Minister three questions about the Bill. First, do the Government intend to make provision for decision-support tools and the use of algorithms in medical devices now or in the future, and, if so, when? Secondly, does the Minister perceive merit in building on pertinent provisions introduced to safeguard systems of the European Union or under development in the US, and, if not, why? Finally, if there is an opportunity to learn from other countries, can the Minister highlight which nations the UK is looking towards and outline what he thinks he can usefully learn from them?
Lord Mackay of Clashfern (Con) [V]
My Lords, first, I thank the Minister for the excellent way in which he introduced this Bill. Secondly, I want to say a word or two about the distinction made by the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, between a skeleton Bill and a framework Bill. I understand that a framework Bill would be one in which the powers given under the Bill would have to be used for purposes specified in the Bill. Accordingly, if we are to make this a framework Bill, we will have to produce realistic purposes for which the powers must be used.
My second point is in relation to tissue. I strongly support all that has been said about that already.
My third point is that I am very concerned about the question of trials. It is very important that clinical trials are ready to be used over quite a large area of population, particularly, as has been mentioned, in specialist diseases.
My last point is about my noble friend Lady Cumberlege’s report. I fully support it in every aspect. I worked with my noble friend Lady Cumberlege long ago and I know how valuable her work is. The thing that worries me somewhat is how long this might take to implement. There is certainly the possibility of a task force, which was recommended in the report and mentioned today by the noble Lord, Lord Brennan. That strikes me as a signal that nothing much will happen for some time. I regard the present situation with regard to the people mentioned who have suffered so greatly as a very pressing situation, to be dealt with immediately. I would like this to be stopped as soon as possible.
The Bill requires Royal Assent by the end of the year and therefore there is a limited amount of time available. I suggest that a possible way to deal with this would be to set up a patient safety commissioner whose job is to hear from the public and treat that information as important and give it to the people who are responsible for the authorisation and use of various medicines and devices.
I think it would be possible to frame very quickly an amendment that could be used now to set up such a commissioner, with the responsibility to hear from the public and then bring the information that he gets from the public appropriately before the authorities responsible for carrying out the safety assessments in authorisation and use. That could be done now; then a task force would be able to look with slightly more leisure at what else could be added. That could be a Bill separate from, but associated with, what I am proposing.
The Earl of Devon (CB) [V]
My Lords, I am not a medicines or medical devices expert, but I have enjoyed this debate and have benefited hugely from the breadth and depth of your Lordships’ expertise. I am an IP litigator qualified in the UK and the US and I have experience of representing pharma and medical device companies in both jurisdictions.
Many thanks to the Minister for his hard work on this Bill and throughout the current pandemic response. Never in our lifetime have our medical expertise and ability to foster cross-border innovation research and reliable clinical trials been more important. This is why the Government’s approach to this issue is such a disappointment. During the four years before I joined your Lordships’ House, I worked in the London office of a large US law firm, advising companies on the management of IP portfolios in Europe. Of particular interest to US pharma and medical devices companies was the unitary patent and the Unified Patent Court. As currently stated on the GOV.UK website, the UPC would give such companies,
“the choice of protecting your invention in up to 25 EU countries with a single unitary patent. This will streamline the system … You will be able to challenge and defend unitary patents in a single court action through the Unified Patent Court.”
The ability to use the UK’s academic and research expertise as a stepping stone for EU-wide IP protection was key to international investment in the industry and the professional services that support it in this country. In recognition of the UK’s pre-eminence in the field of medicines and medical devices, the UK was able to secure London as the seat of the UPC’s specialist central division to hear appellate cases relating to chemistry, including pharmaceuticals and the life sciences. In other words, London was to be Europe’s specialist centre for pharma and life-science intellectual property development and litigation.
Post Brexit, the previous Conservative Government agreed to proceed with ratification of the UPC, showing that it would be possible to leave Europe but retain the UK’s leadership in this field. But the current Government abandoned that sensible middle ground; in February, they withdrew our ratification of the UPC without consultation or debate. With that simple decision, London lost the UPC central division and the UK lost the opportunity to be at the forefront of the development of medicines and medical devices for a generation.
I raised this important issue with the Minister before the Summer Recess, noting how withdrawal from the UPC was simply not consistent with the Government’s aim, as stated by Matt Hancock, that they wanted the UK to be
“the best place in the world to design and trial the latest medical innovations.”—[Official Report, Commons, 2/3/2020; col. 662.]
Lord Bethell responded to me by saying that the Government did not believe that withdrawal from the UPC would make the development of medical devices, medicines and clinical trials harder and more expensive. However, in support, the Minister cited only the fact that this Bill provides for a consideration of the attractiveness of the UK as a place to develop medicines as part of the process of making regulations. This is Alice in Wonderland stuff. The Government cannot in February choose to withdraw the UK from the UPC and terminate its leadership position, and then hope to replace that leadership position with some warm words in a framework Bill. That is simply not enough.
The UK is currently negotiating free-trade agreements with Europe, the US and a host of other countries. Will the Minister enlighten us as to what the Government’s goals are in those negotiations with respect to intellectual property? How will the Government use those opportunities to make the UK once more
“the best place in the world to design and trial the latest medical innovations”?
Baroness Jolly (LD)
My Lords, I am sorry that my noble friend Lady Brinton is unwell and not able to lead today. I hope that she is better and back in her place soon.
The Bill creates extensive delegated powers in the fields of human medicines, veterinary medicines and medical devices—but, I note, not veterinary devices. They enable the existing regulatory frameworks in those fields to be updated following the UK’s departure from the EU. The Bill creates a delegated power to establish one or more information systems in relation to medical devices, consolidates enforcement provisions for medical devices, introduces sanctions and provides an information gateway to enable the sharing of information held by the Secretary of State about medical devices. Your Lordships’ Delegated Powers and Regulatory Reform Committee published a report on the Bill in July. I was going to have a go at the Government about how poor the Bill was, but the noble Lord, Lord Blencathra, did it so much better.
Medical devices legislation currently relates only to medical devices for the field of human healthcare. Thanks to the health and cost benefits, these devices have also found their way into veterinary medicine. Somewhat surprisingly, however, the regulation of these products is missing altogether, unlike in some other European countries. Veterinary practice makes use of all kinds of medical devices, including products designed for use on humans, regardless of their regulatory status and control. With rapid growth in the animal health monitoring field, there should be opportunities to regulate such devices with regard to their safety and efficacy. Given the complexity and potential hazards of certain veterinary devices, the current unregulated state of affairs may lead to health and safety risks, both for animals and the clinical personnel involved. Perhaps the Minister would like to comment and think again.
Claims of medical relevance of new diagnostic tools should be considered because of the potential impact on animal welfare. Although ultimate responsibility for diagnosis should always rest with vets, reliance on these devices will increase, as will the need for regulation of performance standards. Although I recognise that Part 3 of the Bill, entitled “Medical Devices”, currently relates only to medical devices for the field of human healthcare, remote animal health and welfare services and remote health monitoring is a field of rapid growth. Opportunities to regulate such devices with regard to safety and efficacy, and to set standards for production, should be considered.
I move on to people. The timing of this debate, only two months after the publication of the Cumberlege report, is opportune. Many aspects of the report have not been debated, and I am sure that other noble Lords will have areas from the report that suggest amendments to the Bill. It will give us an opportunity in Committee to debate some of the recommendations.
For as long as I have been actively involved in either health governance or policy—some 20 years—the NHS has said that it wants to put the patient at the centre; there are various ways of framing it, but that is what it has said. The recommendations in the Cumberlege report do just that, absolutely and without any equivocation. We should legislate for a patient safety commissioner, tasked with focus on the patient, and for a redress agency, based on looking at systemic failure, not individual blame; I think there has been quite a lot of agreement in the House this afternoon on that.
The MHRA needs to highlight its public protection roles and ensure that it actively engages with the patient body. This is another theme running through the Cumberlege report. There will be a searchable register of who has had an implant and when; details about its type; the clinician carrying out the procedure; and, I would hope, any financial or other interests of that clinician.
While I recognise the need for the UK to remain competitive, patient and user safety must be paramount. There is a real need for strong regulatory oversight. Recent scandals, such as those concerning DePuy metal-on-metal hips, as well as those already discussed today relating to Primodos, sodium valproate and pelvic mesh, highlight the importance of safety.
The final recommendation of the Cumberlege report is that the Government should set up a task force to implement its recommendations. Public confidence needs to be restored, and with a matter of urgency, so will the Minister tell the House when he expects the task force to start its work and how its members will be selected?
The Bill confers on the Secretary of State an extensive range of powers to make regulations pertaining to medicines, clinical trials and medical devices. This is necessary in the short term to facilitate alignment with those parts of EU law which are to be implemented post transition—notably, the EU clinical trials regulation and the medical devices and in vitro devices regulations. However, the ongoing use of delegated powers in this area should be time-limited. Will the Minister tell the House whether this was debated in the department when the Bill was being drafted and why time-limiting was rejected?
On trade, the UK has a strong industry base in both medicines and devices, but we will not be able to be self-reliant. How does the Minister expect that we will be able to trade with the rest of the world in the future? What conversations has the department had with the EU, and what strategy is in place to work with non-EU countries? Time is against us. Negotiations with the EU are ongoing but if we have to set up treaties with various countries, it will be some time before all this is pulled together.
Our pharmacies not only dispense medicines, and some devices, but act as a local high-street source of information and advice; that is welcome to those who think that they do not need a doctor but want an expert’s opinion. The Bill enables community pharmacy contractors to use innovative new systems to support dispensing and is welcomed by members of the profession.
There is much that I have not had time to outline and I suspect that we all have a long list of points that we were not able to shoehorn into our speeches, but I look forward to the detailed work in Committee. I hope that the Minister will acknowledge that this Bill is important but needs detailed examination.
Baroness Thornton (Lab)
My Lords, I thank the Minister for introducing the Bill, all noble Lords for their contributions and all the organisations, including the Library, that have sent us briefings. I particularly thank the Delegated Powers and Regulatory Reform Committee and the Select Committee on the Constitution for their reports, produced in a timely fashion at the beginning of the recess, thus giving us all time to digest and reflect upon the issues concerning powers contained in the Bill.
We on these Benches recognise that this is an important Bill; indeed, the issues that it addresses are vital. I will concentrate on two or three, or maybe four, issues, most of which have been mentioned in the debate.
As the noble Lord, Lord Blencathra, said in his stirring contribution earlier, it seems that most of the Brexit Bills between now and Christmas will contain the same or similar constitutional challenges, so I think that we can anticipate some serious learned and constitutional debates throughout the autumn.
I am not sure whether I want to describe the Bill as a Trojan horse—something that has a seemingly innocent and benign exterior hiding huge and serious dangers within. Perhaps it is yet another example of the Prime Minister’s cavalier disregard for both timeliness and accountability, combined with our own Health Minister’s self-confessed aptitude for hustling, or perhaps it is all those things combined. However, it is worth recalling the words of one of our most distinguished Cross-Bench colleagues, the noble Lord, Lord Wilson, during the passage of the international healthcare arrangements Bill in February and March last year. On 19 February, he recounted his time as a junior civil servant when he went to discuss a Bill with our very much respected parliamentary counsel. He said:
“My assistant secretary was asked why we needed a particular power, and he rather flippantly replied, ‘Because I thought it might be useful’. Parliamentary counsel gave him a withering look and said, ‘I am not going to draft a clause for you simply because it might be useful. You have to know what you want it for’. He did not know, and we did not get that power.”—[Official Report, 19/2/19; col. 2185.]
It feels as if it is the same with this Bill. Powers have been thrown in just in case they might be useful. The Minister called it “agility”. We agree that agility can be useful, but if it is not linked to policy and what you want to do with it, it is a power that can be abused.
Do the Government know what they want, or are they are putting these powers in simply because they might be useful later? I suggest that they do know what they want: they want the power to do exactly as they decide, whenever they decide it, without scrutiny, accountability or due consideration. For our NHS and care services the important matters are whether medicines are available and how much they cost, the future of scientific research, fake medicines, proper safeguards for medical devices and putting patients at the heart of this. They deserve our full scrutiny and the best constructed Bill possible.
As my noble friend Lord Hunt said—this risk was amply illustrated in the stark narrative of the noble Earl, Lord Devon—leaving the EU’s medicines regulatory regime poses a significant risk to the UK. The Bill is crucial for maintaining the attractiveness of the UK’s life sciences sector and ensuring that patients continue to benefit from the excellent clinical research that takes place in the UK. Therefore, it is vital that we fully understand what constitutes “attractiveness” on the global stage.
Will the Minister reflect on the rumour that leaving the EU is likely to see the UK drop down the list of markets that companies will choose to trial and launch medicines in if mitigating steps are not taken? It is crucial that this legislation carefully defines what the Government mean when they talk about the UK’s attractiveness as a place to conduct clinical trials or supply human medicines. Does “attractiveness” equate to the speed of decision-making at every stage of the medicine pathway? How will patient safety be assured? Will the Minister set out what the Government mean when they talk about attractiveness, how they will apply this to medicines access and what he is doing to ensure that patients in the UK can access new therapies on the NHS as soon as countries such as France can?
The British Medical Association asked about the potential divergence in standards and suggested that this must be kept under constant evaluation to ensure that such changes do not negatively impact the timely supply of safe medicines to UK patients, as my noble friend Lord Turnberg said. The new EU regulation on medical devices is an example of a change coming through from the EU that the UK should seek to capture in the future regulatory framework around medical devices, as facilitated by the Bill. Expected to come into force in 2021, the revised rules were drafted in the aftermath of the metal-on-metal hip and PIP implant scandals. They will introduce stricter requirements on the bodies authorising medical devices and ensure greater post-market surveillance. Will UK patients benefit from changes such as these, which were orchestrated at EU level, when we are no longer part of the EU’s processes? How will that happen?
The impact of moving away from the existing collaborative approach between the UK and the EU could be substantial. The centralised processes that we are currently part of reduce the burden on the regulatory authority in each member state, create a larger European market for the pharmaceutical industry and medical device manufacturers, and thereby facilitate timely access to new therapies and technologies to patients across the EU and EEA. As many noble Lords have said, the EMA accounts for 25% of world sales of medicines, second only to the United States. By comparison, the UK accounts for only 3%.
On medical research, negotiating a formal agreement to maintain access to EU funding programmes, ensure alignment with clinical trials regulations and secure the participation of the MHRA in clinical trials that cross the EU and the UK to maximise collaboration between researchers in both is particularly important if UK researchers are to benefit from the EU’s new clinical trials regulation, which is due to be introduced in 2022 and is expected to significantly improve the current research climate via the introduction of a single clinical trial database and a centralised clinical trial portal. I have been talking to your Lordships’ House about this portal ever since the Brexit vote. It looks like we will not be part of it. I would like the Minister’s comments on that and an explanation of the disadvantage that this will bring to UK patients.
As many noble Lords have said, the Bill presents an opportunity to address the issues raised in the excellent report First Do No Harm, launched and led by the noble Baroness, Lady Cumberlege, whose remarks were very moving indeed in addressing the terrible sufferings of women at the hands of the NHS and the regulatory regimes that failed them so comprehensively. Surely we need to take this opportunity to provide for its recommendations. As other noble Lords have said, we need to consider amendments that will fall within the scope of the Bill and cater for the nine recommendations in the report. At the heart of the Bill lies the issue of patient safety in terms of medicine and medical devices, so it must be an appropriate vehicle with which to implement the report’s recommendations. Will the Minister bring forward amendments to remedy these omissions?
It is rumoured that there are mutterings, possibly among officials, about burying the proposed patient safety commissioner. I would really appreciate it if the Minister could take this opportunity to refute such rumours and commit to working with colleagues across the House—I include these Benches—to make sure that the necessary amendments happen.
I briefly turn to other issues. We are very supportive of extending the prescribing rights to additional healthcare professionals, as the noble Lord, Lord Ramsbotham, and my noble friend Lord Bradley outlined. It is time that this issue was resolved. We intend to support or table amendments in Committee requiring proposals and a timetable for additional prescribing rights.
We will seek clarification about Northern Ireland and regulatory divergence. We will probe the changes to the hub-and-spoke proposals. We will look closely at the work of the proposed patient safety commissioner, the medical devices register and, of course, the impacts of the Bill on animal medicine and veterinary regulation.
Although only 46 clauses, the Bill is a veritable cornucopia of medical and other proposals. We hope to work with the Minister, the Bill team and other noble Lords to improve it and make it worthy of the importance attached to it.
Lord Bethell (Con)
My Lords, what a debate. This is without doubt the House of Lords at its best, with thoughtful and powerful points covering medical regulation, legal propriety, patient safety, the European transition, animal welfare, foreign relations and much more. We have listened to powerful points made by 50 speakers. There was a great deal to take in. Our time together in Committee and on Report promises to be rich with important material. I fear I will therefore be unable to address every single point from every noble Lord who has spoken today, but I will give it my best shot.
Noble Lords addressed five broad themes in their contributions: my noble friend Lady Cumberlege’s review, improving regulation for medicines and medical devices, the Delegated Powers and Regulatory Reform Committee report, organs and tissues, and the UK’s future relations with the EU. I will take them in turn.
I am exceptionally grateful to my noble friend Lady Cumberlege for her report and her contribution today. Noble Lords have sent a clear message to the Government and the public that patient safety must be paramount in how we regulate medicines and medical devices. My noble friend is right that patients should be believed. She is also right that it is counterproductive to create an environment in which health professionals clam up or go into hiding. I note her intention to table an amendment on a patient safety commissioner and the large number of noble Lords who expressed their support.
The noble Lord, Lord Alton, gave poignant testimony from his own long-standing campaign on these important causes, including on Primodos. The noble Baroness, Lady Hollins, spoke of the epistemic injustices towards the disfranchised, and the noble Baroness, Lady Burt, spoke movingly about mesh, giving testimony of what she called “medical misogyny” that was hugely uncomfortable. There is a limit to how much I, as a man, can really understand all these cases, but as a husband and a father of two daughters I understand the claim that our healthcare system has not treated women fairly. This Government and this Minister are committed to doing what we can to address this.
I have heard the clear commitment from many Peers, including the noble Lords, Lord Brooke and Lord Patel, the noble Baronesses, Lady Ritchie, Lady Uddin and Lady Watkins, and my noble friend Lord Sheikh to see the report of my noble friend Lady Cumberlege implemented. I said that I would listen, and I have heard very clearly the support for a patient safety commissioner. The nine strategic recommendations in the review need to be considered carefully and we will respond in due course.
I reassure the noble Baroness, Lady Barker, who asked that registries of devices as well as databases should be our expressed direction of travel: we have set this out in the government guidance published alongside the amendment. I would be happy to write to set this out clearly. Many have spoken of the importance of Clause 16 and the underpinning of data. I assure Members that we are able to capture all devices where it is considered necessary to track their use. My noble friend Lord Mancroft is quite right that it is unacceptable in the 21st century, and makes no sense, that our National Health Service cannot keep track of who puts what in whom, and we are determined to change that.
The noble Baronesses, Lady Barker, Lady Walmsley and Lady Andrews, and the noble Lords, Lord Patel and Lord Brennan, raised patient safety. That must be a first consideration. I concur completely with the Minister in the other place that patient safety is paramount—under no circumstances will we seek to make changes that increase risk to patients in the UK. It is absolutely right that we ensure the delicate balance between supporting innovation and maintaining the UK’s position as an attractive place to develop new medicines and devices, but patient safety remains paramount. Innovation and patient safety are not mutually exclusive, and we want to continue to ensure that our regulatory framework facilitates the furtherance of both.
Several noble Lords mentioned the importance of consultation with patient safety groups on regulation that directly affects patients. I reassure all noble Lords that the consultation clause is worded such that where matters affect a particular group or groups, it will be entirely appropriate for them to be consulted.
I turn to the improved regulation of medicines and medical devices. The noble Lord, Lord Patel, expertly described the need to ensure the safety of medical devices. This is something I have indicated that we are wholeheartedly committed to, as indicated by the inclusion of Clause 16. The Government are determined to deliver regulatory change to the current UK system for medical devices to increase patient safety and drive pre-market scrutiny, and we will continue to assess opportunities to improve the wider regulatory system at the end of the transition period. The Bill is vital as it provides the necessary powers that will allow us to make regulatory changes in the interests of patient safety and confidence. The Government are committed to ensuring that patients continue to have rapid access to new medicines, and we have increased access through the early access to medicines scheme. We recognise the importance of innovation and clinical trials for patients and are absolutely committed to building on the UK as a centre of excellence for trials after the end of the transition period. We will ensure that no patients are disadvantaged.
I reassure my noble friend Lord Balfe that the UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The Bill ensures that the legal frameworks around medical devices, human medicines, veterinary medicines and clinical trials can be updated to protect patient safety and reflect innovative practices. This is vital as negotiations on the UK’s future global relations continue, as several noble Lords alluded to.
I agree with the noble Baronesses, Lady Redfern and Lady Whitaker, and the noble Lords, Lord Ramsbotham, Lord Bhatia, Lord Willis and Lord Bradley, that it is right that patients are treated by the healthcare professional best qualified to care for them, including prescribing for them where that is safe and appropriate. However, putting individual professions on the face of primary legislation is not the right platform for any potential amendments to medicine supply or prescribing responsibilities. Over time the roles of staff within the health service will evolve and, using this proposed power, professional groups can be given new or additional powers to supply or prescribe medicine, subject to consultation, by amending human medicines regulations. NHS England and NHS Improvement are considering across all non-medical groups, influenced by learning from the Covid-19 pandemic, where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities for several professional groups.
The noble Lord, Lord Hunt, spoke of his frustration that the NHS is slow to adopt new technologies. He is right. Uptake of new medicines is still too slow, and we are working to address that. We recognise the importance of aligning regulatory and health technology assessment processes to ensure timely access to effective medicines.
My noble friend Lord Lansley is right that 10% of global medical innovations in the UK is good—but it is not good enough. I welcome his persuasive points on a new innovation fund and confirm that the Government have made a commitment to support innovative medicines by extending the successful Cancer Drugs Fund into an innovative medicines fund. The Cancer Drugs Fund shows the impact that this approach can have for patients, with 81 drugs treating 167 cancer indications funded by the CDF since July 2016.
I reassure the noble Baroness, Lady Bennett, that there is no contradiction between an intention to change very little in the immediate future and a commitment to evolving our domestic regime to protect patients, to meet the opportunities of technical revolution and to make Britain a destination for life sciences investment, clinical trials and better health services for patients.
My noble friend Lord O’Shaughnessy spoke wisely about the regulatory arms race, the impact of the FDA’s competitiveness and the opportunity of leaving the EMA. I welcome my noble friend Lady Blackwood’s point about the fact that the Bill is incredibly timely, irrespective of EU exit. I am proud of the energy and flexibility that the MHRA has shown during the response to Covid. I agree wholeheartedly with my noble friend Lord O’Shaughnessy that this is an opportunity that must be taken.
The noble Lord, Lord Clement-Jones, speaks knowledgeably about falsified medicines and the importance of commercial data. I reassure him that our objective is to fully consult with industry, patient groups, pharmacists and all interested parties on any regulatory changes before they are implemented.
To the noble Baroness, Lady Sheehan, I say respectfully that I reject the idea that we need to move away from the intellectual property rights regime that has provided incentives to create new inventions and accelerate the development of health technologies, such as Covid vaccines, over more than a generation.
By way of conclusion of this point, I echo my noble friend Lady Blackwood, who set out the opportunity well: there are key areas of regulation where we must choose to develop new regulatory regimes, including gene therapies, genetics, AI and big data. The Bill will help us to produce future-proof, proportionate regulations and standards in full consultation and largely with affirmative regulations that will have full parliamentary scrutiny.
On the question of parliamentary scrutiny, I turn to the DPRRC report. I reassure noble Lords that the majority of the delegated powers in the Bill are not new. They are absolutely necessary if we are to have the appropriate powers to make changes to the critical regulatory frameworks after the end of the transition period. We can currently make changes to those frameworks under Section 2(2) of the European Communities Act 1972, but that power will not be available once we have left the EU and we cannot allow those regulations to stagnate. While oversight of the delegated powers in the Bill will be different from that which currently occurs, we have taken deliberate steps to ensure that the oversight will involve greater parliamentary scrutiny and secure greater involvement by patients, industry and other experts. We will carefully consider the specific and detailed recommendations of the DPRRC as to how we might go further.
As reiterated by my noble friend Lady Blackwood, the majority of regulations are subject to the draft affirmative procedure—a high level of scrutiny that has usually been applied when we have used Section 2(2) of the European Communities Act 1972. As noble Lords know, by its nature this procedure requires parliamentary approval before those regulations may be made and come into force.
I am grateful to my noble friend Lord Blencathra for early sight of his speech, which was a model of courtesy and delicacy. I have heard his message loud and clear. I would welcome his counsel on the central challenge of how to legislate for a fast-moving industry in which there is so much opportunity and so much danger, but also so much uncertainty.
The noble Lord, Lord Hunt, and the noble and learned Lord, Lord Woolf, called for sunset clauses. Here I must express some scepticism. Sunset clauses would emasculate a Bill that is meant to give regulators the powers to be effective and to future-proof medical regulations in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.
I firmly agree with my noble friend Lord O’Shaughnessy that the Bill gives us the ability to respond flexibly in future to regulate, for example to support the transformation of community pharmacy, to respond to innovations in the market and to improve standards of scrutiny of medical devices. Without the powers in the Bill to update the existing comprehensive regimes, we will be in danger of having static rules that could jeopardise patient safety. We must not allow ourselves to end up in this position.
The noble Baroness, Lady Barker, suggested that there is no scrutiny of the regulations generated under this Bill, but in fact the regulations come back to Parliament and cannot be enacted without scrutiny. I assure the noble Baronesses, Lady Andrews and Lady Walmsley, that we are certainly listening carefully. We are open to ideas for improving the Bill.
I welcome the constructive remarks by my noble friend Lord Lansley, my noble and learned friend Lord Mackay and the noble and learned Lord, Lord Woolf, on the building of a clear framework for the Bill. I have sought to outline such a framework in my remarks on patient safety, availability and attractiveness. I anticipate that these thoughts will be developed ahead of Committee and I look forward to further discussions on these points.
On China and organs, I have heard clearly the points of the noble Lords, Lord Hunt, Lord Collins, Lord Sheikh and Lord Alton, the noble and learned Baroness, Lady Butler-Sloss, the noble Baronesses, Lady O’Loan and Lady Northover, and my noble friends Lord McColl and Lord Ribeiro on imported human tissue, the suggested role of British firms in enabling this trade, the plight of the Falun Gong and the Uighurs, and potential forced organ donors. As the noble Lord, Lord Alton, put very clearly, the idea that British companies are profiting from these trades is abhorrent.
The noble Lord, Lord Collins, is right that we have one of the most ethical regimes for human tissue use in the world, and I share his concerns that we should in no way enable a horrible trade. I recognise that noble Lords are concerned about reliance on overseas reassurances, as outlined in the Human Tissue Act, and I hear these arguments clearly. I note that the noble Lord, Lord Alton, and the noble Baroness, Lady Finlay, will bring an amendment with the support of other noble Lords, including the noble Lord, Lord Balfe, and my noble friend Lord McColl. I reiterate my offer to the noble Lords, Lord Alton and Lord Hunt, and the noble Baroness, Lady Finlay: I would be happy to meet them to discuss this in further detail and will take this up with my noble friend Lord Ahmad, Minister for South Asia and the Commonwealth.
On EU exit, I am committed to ensuring that the UK has one of the best regulatory regimes that ensures patient safety and that patients benefit from innovative products. My noble friend Lord Lansley and the noble Lords, Lord Turnberg, Lord Kakkar and Lord Sharkey, raised the EU clinical trial regulations, which are currently expected to take effect during 2022. I am committed to ensuring that the UK’s regulatory framework for clinical trials is geared towards providing the best possible environment that takes into account the needs of patients, industry, non-commercial researchers and hospitals. That is why this Bill is so critical. The powers will ensure that we have the flexibility to adapt our regulatory framework and that the UK retains a thriving clinical trials environment, so that those engaged in clinical trials can continue to develop innovative and cost-effective treatments that both benefit patients and boost growth.
To the noble Baroness, Lady Morgan, I say that I am totally committed to improving the clinical trials regime. I assure the noble Baroness, Lady Masham, who touched us all with her account of the life-saving efficacy of modern medicines, that we are looking to give the MHRA the resources it needs to provide the best regulations and to give horizon-scanning intelligence and industry insight to help innovation.
The noble Lords, Lord Clement-Jones and Lord Freyberg, highlighted the importance of data. We are considering how to improve the regulation of software-driven devices, including AI and algorithms, and will consult on this. The Bill provides a power to make regulations about the use of data collected for the purpose of preventing the supply of falsified medicines.
Currently, the EU scheme information held on the system can also be used for the purpose of reimbursement, pharmacovigilance and pharmacoepidemiology. Determining the best model for the UK will be subject to consultation and parliamentary scrutiny of the proposed regulations. I will be happy to follow up with further detail in writing.
To my noble friend Lord Balfe, whose knowledge of European democratic structures is extensive, I say that we should embrace the opportunity we have now to discuss our own future and regulatory system here in this place. However, we should continue to work with our international partners.
A number of noble Lords referred to the importance of co-operation with the EU and EMA. As outlined in our approach to negotiations with the EU, we want to agree with the EU an annexe on medicinal products to facilitate trade and support high levels of patient safety.
The noble Lords, Lord Hunt and Lord Rennard, referred to the guidance published yesterday on standstill arrangements. We recognise the importance of continued access to medicine and medical devices. Therefore, to ensure continuity of supply of medicines and medical devices from 1 January 2021, the UK will unilaterally recognise certain EU regulatory processes for a time-limited period. By communicating this well in advance of the end of the transition period, we are providing industry with clarity on the preparations that need to be taken for the 1 January and beyond to ensure the supply of vital goods to UK patients. I would be happy to meet the noble Earl, Lord Devon, to discuss his concerns.
The noble Baroness, Lady Ritchie, referred to arrangements in Northern Ireland and I want to underscore that the implementation of the Northern Ireland Protocol is a top priority for the Government.
There is much more that could be said about the debate tonight. It is a testament to the interest in these issues and the importance of getting this right. I welcome the scrutiny of noble Lords in seeking to make the Bill better, as we so diligently try to do when it reaches us.
Medicines and Medical Devices Bill
Monday 19th October 2020
(4 years, 1 month ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-I Corrected Marshalled list for Grand Committee - (15 Oct 2020)
Baroness Thornton
Member’s explanatory statement
This amendment provides a sunset provision for Part 1 of the Bill requiring the Government to return with primary legislation.
Baroness Thornton (Lab)
My Lords, at last we begin the scrutiny of this important Bill.
Although we have been keen to make progress with the MMD Bill, if I might call it that, it is not at the expense of proper debate, and I am afraid we feel that some of the amendments before us today will not benefit from the contributions they deserve because of the clash with the Second Reading of the Internal Market Bill and the rules of the hybrid House, which seem to mean we lose the contributions of at least four, five or possibly six noble Lords who have either put their names to amendments or are keen to take part in our discussions today.
The procedure, if the House were sitting normally, is that noble Lords would “Box and Cox” between the Chamber and the Grand Committee. As it is, they are not allowed to do so and I put on record that either scheduling or rules need to ensure this does not happen again. I would be very grateful if the Minister and his colleagues ensured that the usual channels are aware of this. This clash will not deter those who are absent, I am sure, from making their contribution either later in Committee or on Report.
The group of amendments right at the beginning of this Bill concerns sunset provision, a time limit on delegated powers and draft consolidated legislation. As my honourable friend Alex Norris MP said at the beginning of the Committee session in the Commons,
“we should not just wave … off to secondary legislation without understanding what that might mean and whether there might be a better way to do it … The proposed arrangements allow the Secretary of State and his successors to make hundreds or more individual decisions to change our current regulatory regime into a markedly different one, one statutory instrument at a time, which I do not think is desirable.”—[Official Report, Commons, Medicines and Medical Devices Bill Committee, 8/6/20; col. 4.]
I agree with my honourable friend.
This is a skeleton Bill. Its aim is to provide the Government with powers to regulate on critical, life-and-death matters involving medicines, devices, humans and animals. It is at risk of inadequate scrutiny; it has an overreliance on delegated powers; it gives rise to potential regulatory divergence in Northern Ireland; it has a need for streamlined primary legislation, not statutory instruments; and it gives rise to concerns regarding patient and user safety.
It has to be said that the Delegated Powers and Regulatory Reform Committee and the Constitution Committee agreed with my honourable friend and us at Second Reading, and were particularly unimpressed by the delegated powers memorandum the department produced. It said:
“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made using the powers. The Government has not provided the exceptional justification required for this skeleton approach. We accept that regulatory regimes in policy areas such as these require frequent adjustment, and so need to be flexible, but the Government has not made a persuasive case for conferring largely unrestricted delegated powers that can be used to rewrite the existing regulatory framework. We recognise that the existing powers to amend these complex regulatory regimes will cease to have effect on 31 December 2020 and that alternative arrangements are required. If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses. This would allow Parliament to scrutinise a new bill which provides sufficient detail on the policy it is being asked to approve.”
This Bill gives Ministers very broad powers indeed. We acknowledge this and are seeking full justification for them. Those are just the opening remarks from both those committees, which agreed that Clauses 1, 8 and 12 contain inappropriate delegations of power and that the Government have failed to provide sufficient justification for this part of the Bill, adopting a skeleton Bill approach, with Ministers given very wide powers indeed.
Instead of seeking to justify such powers, the Government have downplayed them by suggesting that they are like-for-like replacements for the existing powers in Section 2(2) of the 1972 Act. The delegated legislation committee found this not to be the case. The Section 2(2) power is subject to a very significant built-in constraint; it is a mechanism for transposing into UK law EU rules on medicines and medical devices that the UK is required to follow. The new powers are subject to no such constraint; they would give Ministers free rein to legislate in those areas. The Government claim that the new powers are constrained in significant ways, but the reasons found for those constraints were described as “more apparent than real”.
I suggest that over the next few weeks we need to make those constraints real, democratic and accountable, and at the same time support medicine and devices safety and supply, and promote and protect innovation and research. Given the threatening no-deal scenario which seems to be looming, it becomes even more urgent that the issues dealt with in this legislation are clear and that the routes to ensuring medicine supply, safety, research and innovation are also clear and protected, in the interests of the NHS and patients, through parliamentary accountability.
This suite of amendments aims to open that discussion. Amendment 1 in my name and that of my noble friend Lord Hunt provides a sunset clause for Part 1 of the Bill, requiring the Government to return with primary legislation. We need this to happen because it is not satisfactory or democratic to run such an important part of public policy through regulation alone. We feel that three years is a generous, sensible and reasonable amount of time. It allows for a settling in of the new regime following Brexit and time for new legislation to be framed.
Our Amendment 140 follows the advice of the two committees and ensures that there is a time limit on delegated powers.
My Amendment 116 inserts a new clause which requires the Secretary of State to publish draft consolidated legislation within two years to streamline the existing regulatory framework. It offers the Secretary of State two years of that considerable power, but asks him—it might be “her” at some point—to return in two years’ time with a comprehensive set of regulations across medicines for humans and animals, medical devices and, critically, the proposed new regime surrounding the Medicines and Healthcare products Regulatory Agency.
This would provide a chance for proper consultation across the sector, including with patient groups, industry bodies and interested companies, as well as more parliamentary scrutiny to set up the regime that we all want—a safe one, an effective one and a world-class one. It would also give us two years of life outside the European Union and would really help us to land in that place and find out how different we intend to be, certainly in this sector. I beg to move.
Lord Patel (CB) [V]
My Lords, as I had four minutes to speak on Second Reading, it is inevitable that it will take me longer to speak to my amendments in Committee. I refer to Amendments 50, 67 and 115 in my name, and am grateful to the noble Lord, Lord Kakkar, for his support.
Amendment 50 requires consolidated legislation for medicines, veterinary medicines and medical devices. Together with Amendments 67 and 115, it creates the same obligation in respect of veterinary medicine and medical devices and intends to complement a later amendment calling for the powers of this Bill to be time-limited to three years. The Bill confers an extensive range of delegated powers in relation to medicines, veterinary medicines and medical devices. The Government state that they intend the Bill to be the primary legislation in this area while providing no substantive content to the law.
The powers granted in this Bill go far beyond what is necessary or prudent. The existing regulatory regime for medicines is complex and unwieldy, running to more than four pieces of primary and secondary legislation implementing several EU directives in preparing for Brexit. This complexity is mirrored in respect of medical devices as the Bill merely grants powers to create future regulation through such statutory instruments. It does not provide a clear picture of the future shape of regulations that can be scrutinised. This adds to the existing regulatory complexity.
The lack of detail in the Bill in its current form could lead to uncertainty among stakeholders as to their obligations. There is a need for clarity, for regulatory bodies, manufacturers, patients and other end-users, which makes the case for more streamlined primary legislation. The lack of detail in the current Bill, the broad delegation of powers with no indication of the substantive content of future regulation created by them provides no clear or certain path ahead for medicines and medical devices that can be scrutinised or relied on by stakeholders. For this reason, this amendment, together with similar amendments for veterinary medicines and medical devices, requires that the Government return with consolidated legislation in due course.
I refer briefly to Amendment 115, which relates to medical devices. As with medicines, the regulation relating to medical devices is complex and unwieldy. Currently, it consists of the Medical Devices Regulations 2002, which implement three different EU directives and the Medical Devices (Amendment etc) (EU Exit) Regulations) 2019, which came into force at the end of the EU exit implementation period and runs to over 200 pages of detailed amendments. The 2019 regulations were intended to ensure that the existing medical devices regulations continue to operate correctly, once we had left the EU, but they also mirror and implement key aspects of EU regulation on medical devices, Regulation (EU) 2017/745 MDR.
The regulations were due to be implemented this year, but following the European Union withdrawal agreement, they will come into effect at the end of the transition period. The MDR was also due to be implemented during the transition period. Had it done so, it would have automatically become part of UK law. However, due to the disruptions of Covid-19, the implementation date of MDR was postponed by a year. The situation is complicated further by the ambiguous operation of the 2019 regulations in light of the postponement until the end of the transition period, much like the MDR. The 2019 regulations contain clauses which set specific dates and periods of transition between the implementation of different provisions and considerations.
I hope I have made the point that there is a need to have consolidated legislation. The current Bill will simply add to the existing body of regulations without consolidating or clarifying any of these issues. This demonstrates the need to time-limit these delegated powers and ensure that consolidation primary legislation is introduced to Parliament after three years, in order to subject any policy changes to adequate scrutiny.
Baroness Jolly (LD) [V]
My Lords, given that we are in Committee, I will not be making lengthy speeches, but I will raise what I think are the key issues in each of the groups. The amendments to the Bill relate to some of the constitutional issues. As a general rule, noble Lords do not much care for delegated powers because it is not considered good practice or procedure to give a Secretary of State carte blanche in any area. There are some areas in this Bill where the Secretary of State is being given powers that we would rather that he or she did not have.
As the Bill is skeletal and consists mostly of delegated powers, it is important and a good idea to ensure that appropriate steps are taken to set an end date on these, so sunset powers are being proposed. The noble Lords, Lord Lansley and Lord Kakkar, and the noble Baroness, Lady Thornton, have requested the Secretary of State to publish draft legislation to consolidate the legislation relating to human and veterinary medicine within three years of the Bill being enacted.
My noble friend Lord Sharkey and I have put our names to several amendments in this group. My noble friend calls for the super-affirmative procedure so that all powers given in the Bill will elapse after three years. I confess that this is the first time that I have seen that being used. The super-affirmative procedure involves an additional stage of scrutiny where Parliament considers a proposal for a statutory instrument before it is formally laid. This procedure is used for those instruments that are considered to need a particularly high level of scrutiny, which I think is certainly the case with this Bill.
Some of the amendments call for consolidation within three years, but in general what we are saying to the Minister is that there are not enough checks and balances. Please use the time between now and Report stage to look again, speak to Members of the Committee and bring forward government amendments—otherwise, I suspect that we may be voting on Report.
Lord Hunt of Kings Heath (Lab)
My Lords, I have added my name to Amendments 1 and 140 tabled in the name of my noble friend Lady Thornton. As we are at the start of the Committee stage, perhaps I may remind the House of my membership of the board of the General Medical Council and my role as president of GS1 and the Health Care Supply Association.
I agree with my noble friend Lady Thornton about the clash between the first day of the Committee stage of this Bill and the Second Reading of the United Kingdom Internal Market Bill in the main Chamber. Today we are dealing with some of the most important debates in the whole Bill and when we come back on Report there will be a need to give more time to allow those people who could not be present today to make a full contribution to these debates. I hope that the usual channels will take that away. I am not quite sure about the procedure in these unusual circumstances, but in normal times I would have asked that the Committee stage procedure be used for these introductory debates on Report in order to allow for interventions. However, since interventions are now limited, that may not run well, although I think that noble Lords will understand what I am getting at.
This is an important Bill on patient safety and the health of our life sciences sector. It is striking in its brevity and in the extensive powers to be given to Ministers. The noble Lord, Lord Patel, has spelled out the wide range of delegated powers contained in the Bill, while a pungent analysis by my local university, the University of Birmingham, points out that, while delegated powers may be needed to ensure responsiveness in the EU exit transition period and to meet the challenges of technological change, they should not be used indefinitely or relied on to implement matters of policy. I am not going to repeat what the Delegated Powers Committee or the House of Lords Select Committee on the Constitution have said, but it is rare for two Select Committees to comment at the same time and in such a critical way about the skeletal nature of a Bill. It is to be hoped that the Government will listen carefully to what is being said.
At Second Reading, the Minister suggested that the sunset clause as proposed by my noble friend would emasculate legislation
“meant to give regulators the powers to be effective and to future-proof medical regulation in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.”—[Official Report, 2/9/20; col. 433.]
I have to say to the Minister that most of the regulatory uncertainty has been caused by the Government’s failure to be clear about what regulatory regime they want for medicines and medical devices. They have now had four years to think about this and we are still nowhere near knowing what regulatory system they want to put in place. Are they going to go for alignment with the European Medicines Agency or do they want to strike out on their own? Do they want to ally with the US FDA? What on earth are the Government’s aims? The industry is at risk because of this huge uncertainty. The idea that we should allow the Government willy-nilly to get this Bill through and make whatever changes they want without the House treating it as primary legislation simply will not wash. I am absolutely convinced that the long-term regulatory system must be subject to detailed primary legislation. As far as I can see, the amendment to bring in a sunset clause is probably the most appropriate vehicle to ensure that that happens.
Lord Kakkar (CB) [V]
My Lords, in contributing to the first day in Committee on this Bill, I draw the attention of noble Lords to my registered interests, in particular to those as a professor of surgery at University College London and as the chairman of UCLPartners.
I support Amendments 50, 67 and 115 tabled in the name of my noble friend Lord Patel, to which I have added my name. The point has been well made by my noble friend that the ecosystem for the delivery of healthcare in our country and therefore the use of medicinal products, medical devices and veterinary medicines is a complex one that is attended by substantial legislation, much of which has been brought into force as a result of the European Communities Act 1972. It is therefore absolutely right, to echo a point made previously by the Minister, that there is a need for this Bill to ensure that such regulation can continue, so that we can continue to have a safe and effective healthcare system and take advantage of the essential requirement to avail ourselves of medicinal products and medical devices.
There is surely also an absolute obligation to ensure that regulation should avoid adding to the complexity that already exists. For those who have to labour under these regulations and ensure that they can present innovation and advances to benefit our fellow citizens within the context of the regulations, we should always be working to simplify them.
In this regard, we are all conscious of the fact that many different types of regulations touch on the healthcare system. There are those that pertain to ethics, and those that deal with the function and delivery of ethics committees and the evaluation of intervention at a local and national level. We have regulations that deal with the adoption and evaluation of innovation within the context of the MHRA, and with the evaluation of intervention and innovation pertaining to NICE. We have heard from the noble Lord, Lord Patel, about the medical device regulations enacted in 2002, which codify and implement various EU directives in this matter, and the substantial amendment attending medical device regulations in terms of the legislation passed as part of EU exit regulations in 2019.
Lord Lansley (Con)
My Lords, I am grateful for the opportunity to speak on this group of amendments. May I, however, begin by seeking clarity about the grouping of the amendments? Amendment 116 is also to be found in the eighth group and is more appropriately to be found there. It is my amendment; I know where it should sit properly. It does not belong in this group and is not relevant to this subject. However, I think the Marshalled List should list Amendment 116 in the name of the noble Baroness, Lady Thornton, who raises what is effectively the sunset issue in that amendment. The noble Lord, Lord Patel, who I always think of as a friend, referred to his Amendment 141, which is not listed in the grouping but should be here; Amendment 142 is listed in group five and also should be here. With those two changes, I think that we are talking about the right group.
I could stop now, but I will be quick and refer to just two things. First, as a former Leader of the House of Commons, responsible for the legislative programme, I view with deep unhappiness the idea of attaching three-year sunset clauses to all the legislation we put through the House. If we start down that path, we will never introduce new legislation but will constantly be revisiting old legislation and trying to renew it. There is an argument about the nature of this Bill but it is an argument I am proposing to have when we debate the next group of amendments. It is skeletal, and there are things we can do to make the power not only clearer in its purposes but much more accountable if used. So, I am against the sunset clause.
My other point relates to Amendments 50, 67 and 115 in the names of the noble Lords, Lord Patel and Lord Kakkar. I have great sympathy with these. I think it was the noble Lord, Lord Patel, who referred to the consolidation of human medicines regulations in 2011 or 2012. There is a great deal to be said for the regular consolidation of legislation to make it more accessible. I do not regard consolidation as a purely technical legal exercise; it should always be used as an opportunity to simplify and clarify. It is not, in my view, sufficient to say, as I think Ministers might well reasonably do, “We consolidated human medicines legislation and we will continue to keep the regulations in as clear a form as we can”. From time to time, there is a purpose in coming back to primary legislation and looking for clarity and consolidation. That is often what we use the Law Commission to do, because it has particular expertise in this area. It may be inappropriate to do so at this stage for human medicines because of the necessity of making the regulations and of transposing former EU regulations and directives into UK law. It is perfectly reasonable for that to happen over some period of time, but I hope that Ministers will consider that.
Where medical devices are concerned, there may be a better argument. The noble Lord, Lord Patel, was quite right—navigating medical devices legislation is, if anything, harder than navigating human or veterinary medicines legislation. There is a lot to be said for finding the consolidation instrument for medical devices regulation, once we know what it looks like and we have brought it into force. My friends the noble Lords, Lord Patel and Kakkar, are on to something; I just do not think that new primary legislation within three years is the route. However, for Ministers to recognise the value of consolidating instruments including, from time to time, consolidating primary legislation is certainly desirable.
Baroness Walmsley (LD) [V]
My Lords, I support the attempts in this group to put a sunset clause into the Bill. I have a great deal of sympathy with the demands of the noble Lord, Lord Patel, for consolidation. It is vital that through these amendments and others to later clauses, we are able to review the use of the Bill’s powers by this failed Government, who have made so many mistakes. A Government who cannot even secure the free trade agreement that was supposed to be the easiest thing ever, who disastrously and expensively have not produced the promised world-beating test and trace system and who have presided over one of the worst rate of Covid-19 deaths in Europe due to their dithering and failure to put health first, must have their powers fettered. But, as has been said, this is a skeleton Bill and gives the Government extensive powers with little ability for Parliament to intervene.
A lot is changing. The Brexit transition phase is coming to an end in a couple of months. We have learned many lessons from Covid-19, which should be implemented. The NICE review is coming up, and every month new medicines and therapies are coming on to the market. It would be folly not to have a sunset clause in the Bill. I therefore support what was said by my noble friends Lady Jolly and Lady Thornton, and urge the Government to consider, in all humility, that in two or three years’ time they may not be in power, and the whole landscape will have changed. It is therefore essential that we have an opportunity to review how the powers in the Bill have been used to change things, especially if all has not gone well.
Lord O'Shaughnessy (Con)
My Lords, I point out to noble Lords my interests as set out in the register. On Second Reading, when taking a somewhat unfashionable stance in defence of the delegated powers, I said that I was not going to die on that hill again—but, to mix my metaphors, I have been drawn, like a moth to a flame, back into this argument.
I want to make two brief points. The first has been perfectly well made already by my noble friend Lord Lansley, and is about the sheer impracticality of sunsetting legislation. Committing to an arbitrary deadline of that kind is not something that any Government could responsibly do, particularly at this time, and given the uncertainty that has already been discussed.
The second point is that many of the criticisms raised by the Delegated Powers and Regulatory Reform Committee and by the Constitution Committee have been dealt with, to some extent, by changes that the Minister, my noble friend Lord Bethell, has proposed to the affirmative procedure, which we are not discussing today. It is therefore worth recognising the progress that the Government have already made to try to meet those concerns, which were set out so well by the noble Baroness, Lady Thornton, and others, about the powers being given to the Government.
Again echoing my noble friend Lord Lansley, I would say that if we were to go down that route, the amendments tabled by the noble Lord, Lord Patel, represent the right approach, which is to commit not to a sunset clause, with all the cliff edges that that would involve, but to providing draft consolidated legislation. There is a good case in its own right for doing that, particularly in the circumstances. Like my noble friend Lord Lansley, I encourage my noble friend the Minister to look seriously at that idea.
Lord Sharkey (LD) [V]
My Lords, we have Amendment 139 in this group. It would require all the delegated powers in the Bill to expire on the third anniversary of its passing. We chose the three-year time limit because that had been discussed in the Commons. But, having heard what other noble Lords have said on the issue of expiry, I am persuaded that two years may be more appropriate, as the noble Baroness, Lady Thornton, has argued, given the wide-ranging and carte-blanche nature of the delegated powers. I am also persuaded that a sunset provision is absolutely necessary.
As many noble Lords noted on Second Reading, this is a skeleton Bill. It contains no, or very little, policy, and allows policy to be made by secondary legislation. This clearly avoids meaningful parliamentary scrutiny, and is a direct and flagrant abuse of the delegated powers system.
In its 16th report of the 2017-19 Session, The Legislative Process: The Delegation of Powers, our Constitution Committee noted that the Government had designated
“functions for which delegated powers may be appropriate”.
These included
“providing for the technical implementation of a policy; filling in detail that may need to be updated frequently or is otherwise subject to change; and accommodating cases where the detailed policy has to work differently in different circumstances. Such purposes constitute reasonable uses of delegated powers.”
The Constitution Committee’s view of all this was clear. It considered the use of delegated legislation to formulate policy, or to create new criminal offences or public bodies, to be “constitutionally unacceptable.”
The Delegated Powers and Regulatory Reform Committee, in its recent report on the Bill, points out that the Government say nothing about why it would not be appropriate to have aspects of the regulatory regimes which are not detailed or technical on the face of the Bill, combined with more focused delegated powers to fill in the detail. This is still the case.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, I thank all those involved in this first group; indeed, they are the team who, I feel, are likely to be walking with us through a great many groups of amendments. I enormously regret the fact that some noble Lords are unable to make this session, but I thank the usual channels for their efforts in the challenging process of trying to programme the hybrid House, and for finding time for this session, and for the Bill, in a packed programme.
We are starting with one of the most important groups of amendments, which address the principles behind the Bill. I believe that is the purpose of Amendment 1, in the name of the noble Baroness, Lady Thornton, and also her Amendment 140, Amendment 139, in the names of the noble Lord, Lord Sharkey, and the noble Baroness, Lady Jolly, and Amendments 50, 67, 115 and 141, in the name of the noble Lord, Lord Patel.
Although there is some variation in the specific effects of the amendments—such as which clauses they amend and which clauses come under their scope—they all look ahead towards drawing a line under the Bill, whether that be through a sunset clause or by asking the Government to return with consolidated legislation.
I emphatically believe in the Bill. I have listened to the criticisms of the Delegated Powers and Regulatory Reform Committee, and noted the comments of the noble Baroness, Lady Thornton, and the noble Lord, Lord Patel. Those points have been powerfully made in the report, on Second Reading and here today.
I know that the report may have inspired some of these amendments, because the committee considered sunsetting the Bill to be an appropriate response—but only if the Bill had remained as previously drafted. However, as your Lordships know, I have engaged extensively with noble Lords on these matters, and have tabled many amendments to address the specific concerns that we are debating today.
A sunset clause, reviewing these matters again in two or three years’ time, will not change the very good reasons why delegated powers are necessary. It would be an unhelpful precedent, which could lead to a rolling review of all legislation. My noble friend Lord Lansley, a former Leader of the House of Commons, and my predecessor, my noble friend Lord O’Shaughnessy, both made that point very powerfully.
The noble Lord, Lord Patel, is right to say that clarity is important, but that will come through consultation. As I respond to this point, and to my noble friend Lord O’Shaughnessy and to the noble Lord, Lord Sharkey, it is worth remembering that we have published six illustrative SIs—so it is not true that we have provided no examples of how the powers could be used. I want to ponder on this well-made thought, and give further thought to how we might go further. It is hard to see how sunsetting the whole Bill would bring additional clarity to the situation.
Returning to first principles, particularly patient safety, we need to react quickly and effectively to harm. Taking swift action, such as making changes to how medicines can be administered in the community—as we are doing in relation to the Covid vaccine—is absolutely necessary when the situation requires it. So sunsetting Clauses 1 and 12 would mean also sunsetting Clauses 6 and 15. We would have no emergency provision at all until that could be replaced—a regulatory cliff edge that I would find difficult to explain to patients who needed that flexibility to get the necessary treatment.
Harm can be also significant and require more fundamental regulatory change. The report of the noble Baroness, Lady Cumberlege, suggests that the system has been slow to move and respond, and that patients have not been heard. We cannot predict or pre-empt every risk of patient harm that will emerge. Patient safety cannot wait for primary legislation. When new measures have been introduced—such as databases of medical devices under Clause 16—I cannot think why we would want to go backwards. Saying that we should no longer be able to track and trace patients, nor be able to update the data types that should be recorded to protect patients, does not make sense. Using measures in the Bill such as the information system in Clause 16, we will do better for UK patients. This is not only what the Government want but what patients want. I hope that such a system will mean that the Government will know which patients have been affected by which specific device so that they can avert problems in future.
Secondly, the changes range on a scale from significant to relatively minor, for which primary legislation would be inappropriate. For instance, changing labelling to include pictograms is not a matter that needs to wait for a future Bill.
Thirdly, this is a modern and fast-changing industry, as the noble Lords, Lord Hunt and Lord Kakkar, put it so well. In two or three years’ time, we may still need to preserve our ability to amend and update regulations. We will need to provide confidence to businesses, patients and other parties that the statute book will keep pace with change. While much will be said on the attractiveness of the UK, this is a very real issue.
In response to the comments of the noble Baroness, Lady Thornton, on the benefits of a new round of consultation, perhaps even more serious is the fact that two or three years is simply not enough time for all the regulatory changes to take place—especially when we are obligated to consult all the people that noble Lords will identify when we come to that debate. Bills take time. This Bill was announced last year and was introduced in February. We are not there yet. We simply did not have enough time to judge its efficacy before we had to write it again.
On noble Lords’ amendments seeking to consolidate the legislation made in under three years, I say this: the Human Medicines Regulations were the consequence of a consolidation exercise. The Medicines Act 1968 was originally the method for regulating the way in which medicines were licensed for use in the UK. However, a number of changes were made over the years through regulations, which Parliament approved, to regulate medicines under that Act better. As such, the Human Medicines Regulations were meant to provide exactly what the noble Lord, Lord Patel, asked for: streamlined legislation that places regulatory matters in a single set of regulations.
Nor was there a lack of consultation on this approach. At the time, the MHRA took action to draw on stakeholder views and a formal consultation was run in late 2010. Parliament considered it appropriate to redirect into secondary legislation regulatory matters that required frequent changes to respond to potential safety concerns or changes in how medicines might be produced. The MHRA indicated that, should further consolidation be needed, this could be revisited. The noble Lord asked me whether there are ways of considering consolidation in the future. I must listen to him but, again, I say that three years is not a very long time at all for regulatory changes.
We recently published guidance for businesses that sets out the expected arrangements for the end of the transition period, in order to provide enough time to bring forward a standalone regulatory system and give businesses time to comply. That period of standstill will run for two and a half years; in that context, it is unlikely that, in the space of two years, there will be regulatory change that is so significant that it requires consolidation.
If your Lordships seek assurance on the visibility of how the Government will make regulations, or if your Lordships are asking me to specify our plans for how quickly we might move to the current regulations inherited from the EU, let me say this: we do not intend to make changes for the sake of it. We will do what is in the UK’s best interests. Whether our choices mean that our regulatory framework is similar to or different from regulations made by the EU does not change that approach. Regulations, rather than primary legislation, are the appropriate vehicle to protect patients best. Changes will be made subject to public consultation, and the amendment that I have tabled—on reporting obligations—will enable Parliament to consider and reflect on the Government’s use of powers in plans.
I am listening. I have proposed changes to improve the Bill—we will come to those later, having reflected on the debate—but I will face a real challenge in the new year as a result of the gap that will open up at the beginning of January if this Bill is not finished by then. I would not want to put in my place another Minister for Innovation who might also need swift regulatory change for UK patients, whether that is getting medicines approved quickly or changing who can administer them.
I hope that the noble Baroness has heard enough to reassure her and that she feels able to withdraw Amendment 1. I hope that other noble Lords with amendments in this group do not feel the need to move them.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I have received a request to speak after the Minister from the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, I am grateful to the Minister for his response and, to a degree, his assurance that he is at least prepared to look at ways to consolidate the legislation. I do not accept his point about time. We are not asking that this Bill be held up; we are asking that the Government consider over the next three years bringing in legislation to consolidate the current legislation.
I am also grateful to the noble Lords, Lord Lansley and Lord O’Shaughnessy—both of whom are experienced in dealing with matters related to medicine in their own right—for their comments and support. I hope that, in the debate on the next group of amendments, the Minister will confirm in a more tangible way how he will address this issue because when we discuss those amendments, we will have an opportunity to come back to what he has said about the government amendments.
Lord Bethell (Con)
My Lords, I hear the noble Lord, Lord Patel, very clearly. The arguments that he made during our conversations and engagement earlier were powerful. The comments made by my noble friends Lord Lansley and Lord O’Shaughnessy, one of whom is my predecessor and one of whom is a former Health Secretary, were also extremely persuasive.
The Government do not think that putting consolidation in the Bill is wise, but we hear the points made by the noble Lord, Lord Patel, loud and clear. We would definitely consider this matter at a future date if the arguments made were persuasive and agreeable.
Baroness Thornton (Lab)
My Lords, I thank all noble Lords who took part in this preliminary and important debate on the Bill.
The noble Lord, Lord Patel, made an important point concerning primary legislation after three years. The Minister seemed to suggest that three years is not long enough. That cannot be right; three years is certainly long enough. Without the principles and policy that my noble friend Lord Hunt spoke about, rule by regulation is not only inadequate but probably quite dangerous. That lies at the heart of this group of amendments.
The noble Lord, Lord Kakkar, made the important point that we have a well-designed regulatory framework in the UK; this amendment is not about disrupting that. He also said that the Bill should be about improving the framework; that is exactly right.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, a short adjournment has been requested by the Government. The Committee will adjourn for 15 minutes.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, we now come to the group beginning with Amendment 2. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during debate.
Amendment 2
Lord Bethell
“(1A) The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
Member’s explanatory statement
This amendment provides that the appropriate authority may only make regulations under subsection (1) of Clause 1 if satisfied that they would promote the health and safety of the public.
Lord Bethell (Con)
My Lords, Amendments 2, 7, 51, 54, 56, 68 and 72 are a package intended to respond to the comments made at Second Reading and the consideration of the Bill by your Lordships’ Delegated Powers and Regulatory Reform Committee and the Constitution Committee.
I have said at both the Dispatch Box on Second Reading and in meetings with a number of noble Lords that I am listening and ready to make improvements to the Bill where they are necessary. I am ready to provide reassurance about how the powers are intended to be exercised. Amendments 2 and 68 would require that regulations may be made only if the appropriate authority is satisfied that the regulations promote the health and safety of the public. A number of noble Lords spoke in favour of clarity regarding how the considerations applied in making regulations and whether the first consideration—that of safety—had primacy. This was a point made by the noble Baronesses, Lady Barker, Lady Andrews and Lady Walmsley, and by the noble and learned Lord, Lord Woolf. Their remarks on how the Government could improve the nature of the framework Bill were ones that I paid particularly close attention to. In making legislation, there is a delicate balance between making it absolutely clear that regulatory change will not be made that is contrary to promoting the health of the public and not binding the Government so completely that necessary regulatory change that is not explicitly for the purpose of promoting the health of the public is not possible. This amendment seeks to provide that comfort: that the Government’s making of regulations must satisfy that obligation.
Amendment 51, on veterinary medicines, is drafted differently to reflect the specific circumstances of how veterinary medicines are made. For example, a medicine that might be suited to the health of an animal might unhelpfully contribute to antimicrobial resistance in humans. An overarching requirement to be satisfied that regulatory change promotes the safety of animals, without reflecting that we must also consider the safety of animals as food products in the food chain, would have inadvertent consequences. Amendments 7, 54, 56 and 72 are consequential to these.
I have considered carefully the alternative constructions tabled by your Lordships. I wanted to demonstrate our absolute commitment to patients’ health and safety that is at the heart of this Bill. My noble friend Lady Cumberlege’s report has highlighted the importance of this.
My amendments do not fetter our ability to make good regulations that will enable the development of new medicines and devices in the UK and ensure the availability of those medicines. But, in doing so, the requirement to be satisfied will protect against the inadvertent impact on the health of the public. This will answer the requirement to make it clear how the Bill is a framework Bill, as opposed to a skeleton Bill, providing that test against which regulations can be measured.
I hope that these amendments provide assurance not only to those in this House who sit on the Delegated Powers and Regulatory Reform Committee and the Constitution Committee but to others who are keen to see the Government reflect my noble friend’s recommendation that patient safety be put first. I beg to move.
Lord Lansley (Con)
My Lords, I am glad to have this opportunity to speak to my Amendment 5 and to Amendments 70 and 76 in this group. I am particularly grateful to the noble and learned Lord, Lord Woolf, and the noble Baroness, Lady Jolly, for putting their names to Amendment 5. As the Minister rightly said, he set out to respond in government Amendment 2 to the remarks of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee. We discussed this a lot at Second Reading. The essence of the argument that I among other noble Lords made was that the Bill was a skeleton, the skeleton approach was criticised by the Delegated Powers Committee and we needed to move it from a skeleton to a framework by making it clear that the power to make regulations is for a purpose. The noble and learned Lord, Lord Woolf, and I set out to do that in our amendment: to express a purpose rather than have a power that essentially had no test other than whether the Secretary of State had had regard to certain factors—there was no objective test that could be examined, because it is very easy for Ministers to say that they have had regard to something.
Why did we have the objective of safeguarding public health? The relevant EU regulation, which is the EU human medicines directive 2001/83/EC, as amended, says at what is essentially its first article:
“The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.”
Therefore, rather than invent our own purpose, we thought that the starting point for the legislation should be to reflect the same objective as incorporated into the regulation-making power up to now. The Minister may well say, “But the EU regulation is not only based on the public health treaty objective but on the internal market objective”. However, Article 3 of the EU regulation, which follows that, is quite clear:
“However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.”
Therefore, the other legal bases, if anything, tend to act alongside and be balanced with the original treaty objective, which is to safeguard public health. It seems that there is therefore nothing inherently wrong in our own power to set out the objective, which is to safeguard public health, and then to set alongside it in the subsequent subsection the other considerations to which the Secretary of State must have regard. We will go on to discuss those, but they include the safety of human medicines, the attractiveness of the UK as a place to conduct clinical trials, and so on.
This is the test: why are we moving from the current legislative basis to a new one? What is inherently better in saying that Ministers must be satisfied that they will promote the health and safety of the people and in what sense is that different from safeguarding public health? Noble Lords might well say, “You have won—you put your amendment down and the Minister has put government Amendment 2 down, and they say more or less the same thing”. We submit that they do not quite say the same thing, since the government amendment’s construction is that the Secretary of State “must be satisfied that”. Our construction is that it
“must have the objective of”.
I am not qualified to say any more about this matter; I will leave that to my noble friend in this regard, the noble and learned Lord, Lord Woolf. An objective test should be expressed in the legislation in objective terms, not in subjective terms of whether the Secretary of State is satisfied.
Amendment 70 does a similar thing in relation to medical devices. Amendment 76 begs the question: is the safety of a medical device to be assessed in the absence of knowing its therapeutic use? It may well be that the answer is that assessing the safety of a medical device must necessarily consist not only of the approval process but of understanding its use in therapeutic settings. If the answer is that that will necessarily be the case and if Clause 12 of the Bill means that anyway, I am perfectly happy to accept that. However, I am looking for an assurance from the Minister that that is what Clause 7 means: safety of a medical device is not simply through its approval processes but through understanding in the approval process how it will be used in therapeutic practice.
In conclusion, from what I have said we do not think that government Amendment 2 is better than our Amendment 5. However, government Amendment 2 is clearly better than what is in the Bill at the moment, because it gives us a purpose for which the regulation-making power is to be used. I make a plea to noble Lords. At this stage, in Committee, I would far rather change the Bill by accepting the government amendment and its sequelae, as we would say, and therefore send the Bill to Report in at least a form that one Front Bench agrees with than not change the Bill and have to have this same debate all over again on Report. We might have the same debate, but it would clarify for the benefit of noble Lords on Report if at least the Bill has moved from where it has been to show how the Government are seeking to meet the objectives set out at Second Reading and by the Delegated Powers Committee so that we can look at it again properly on Report. I of course reserve my position and that of my noble friends whose names are attached to this amendment, as we might well want to come back to the issue on Report and say that our formulation with an objective test is better than the subjective test that government Amendment 2 implies.
Lord Woolf (CB) [V]
I am most grateful to the noble Lord, Lord Lansley, for setting out the position we are in with such clarity. I will add just a few words to explain my involvement. It has already been pointed out that not many of my legal friends who I would expect to be concerned about this are present in Committee today. I am sure that the ones who one thinks of are busily engaged in the Chamber over a different piece of legislation which is causing them greater concern than the proposal here, although I believe that they would not disagree with my comments.
In this House, we naturally think as parliamentarians and are concerned about our process of scrutinising legislation, but bad legislation all too frequently ends up not being disputed in this House. That is not the end of the matter, however: the difficulties it creates then have subsequently to be sorted out, which is frequently done by judicial review in the courts. What the noble Lord, Lord Lansley, has said so well is very relevant to judicial review, and that is an area where I feel that, just as the doctors can comment about this Bill with a certain background of knowledge, I should refer to my entries in the register, which, at least with regard to judicial review, are quite important.
If the courts are to provide scrutiny at a later stage, they must know the purpose of the legislation. That is why what the noble Lord, Lord Lansley, has already said is so important. With blank cheques, the danger is that they can be used for all sorts of purposes. I have been trying, under the leadership of the noble Lord, to ensure that the blank cheques given by this legislation are as restricted as they can practically be, bearing in mind the situation in which we find ourselves.
I agree with what the noble Lord said about the amendments with regard to the present proposals. On the one hand, there is the proposal put forward by the Government; on the other is the proposal that the noble Lord, Lord Lansley, and I have suggested might be appropriate. My view, for the reason he indicated, is that our proposal is better, but, above all, I am attracted by the fact that what the Government are proposing is much better than what was there before. On that basis, with a degree of reluctance, I would be capable of being persuaded that we should accept what the Government offer, whereas I am quite satisfied that we should not have accepted what was there before.
Leaving the matter in that way, I hope that the further discussion which will no doubt take place will enable agreement to be reached on an amendment which achieves what is needed for the purposes I have indicated.
Lord Hunt of Kings Heath (Lab)
My Lords, I am glad that the Minister said that he was listening, and his amendments are important, particularly the one that makes the principle of the health and safety of the public the key consideration when making regulations under the parts of the Bill relating to human medicines and medical devices. He will be aware that concern was expressed by patient groups, in particular, about the Bill as originally drafted and the implication of the attractiveness provision. That concern takes us back to our first debate on “whither regulation in future”.
If we are not going to be aligned to the European Medicines Agency and are to plough it alone, the UK pharma industry will be at a huge disadvantage unless the Government offer an incentive. It may be a bung—the debate about state aid is very relevant to that—or much faster regulation. Otherwise, it is very difficult to see why the industry would continue to invest in R&D in this country. Its position could be as vulnerable as is the motor car industry as a result of the bumbling ineptitude of the Government in their Brexit so-called negotiation.
It is not far-fetched, it is a legitimate question to ask what on earth the Government really want from medicines and medical devices regulation. They may have issued all sorts of draft regulations, but we are clueless about what they are actually seeking to do. The MHRA is clearly not allowed to talk to anybody about this. I remember when the MHRA would talk to politicians and debate these things. It has clearly been given an instruction not to talk to anyone. We are absolutely clueless about the future direction of regulation. None the less, the amendments are clearly helpful, and no doubt we will consider them between Committee and Report.
I would, however, like to ask the Minister about Amendment 2 and its relevance to Northern Ireland. I understand that, exceptionally, it will be moved in Grand Committee because legislative consent takes three months to get through, which impacts on the Bill’s process. I understand that, but, as Parts 1 and 2 of the Bill affect Northern Ireland, does that similarly affect any amendment to Part 1 or 2 passed on Report? What is then the impact on Northern Ireland legislation?
Overall, however, most of the amendments are a constructive improvement, but we will obviously consider them further between now and Report.
Baroness Barker (LD)
My Lords, we must consider the whole Bill as building the foundations for the future of the medicines and pharmaceutical industry in this country. We do so in the knowledge that we have had a perhaps pre-eminent role in the world in pharmaceutical development because of the coming together of a number of factors—the European medicines regulations and all the conventions to which we are party, plus the existence of the NHS and the potential it offers for clinical research and our long tradition of working in the life sciences and biosciences sector.
The Minister definitely listened at Second Reading to the many voices of concern that perceived the Bill as it came to us as a weakening of the many factors that underpin our success in this area. He understood entirely, I think, that if we were to take away the pre-eminence of the health and safety of the industry, we would fatally undermine the whole basis of the construction of this very important sector for our economy.
The Minister has listened but not quite hard enough. I agree with the noble Lord, Lord Lansley, that Amendment 2 is an improvement, but it still leaves the decision-making on whether something promotes health and safety to the Secretary of State. I much prefer the construction in Amendment 5, to which my noble friend Lady Jolly has added her name.
My main concern in this group is with Amendment 51 on regulation for veterinary medicines. In his introduction, the Minister pointed to the fact that medicines for animals can work back into the food chain and to humans. I understand the interplay between taking into account things that are done to improve human well-being, animal well-being and the environment, but he will understand that, when people see the amendments, it will not be immediately apparent to them that human welfare is pre-eminent in the list. It says that the regulations must promote “one or more” of the three. I agree that the Minister has moved on the first set of amendments, but he has not gone anywhere near far enough on the regulations on veterinary medicines, so we may well need to come back to that at a later stage.
Lord Patel (CB) [V]
My Lords, before I start, I should point out that someone is typing with their microphone on, which interferes with the sound, so would they mind turning it off?
The noble and learned Lord, Lord Woolf, said that other legal Members of your Lordships’ House were not able to be present today. That is a pity, because I thought that I had amassed a good legal team in the noble Lord, Lord Pannick, and the noble and learned Lords, Lord Mackay of Clashfern and Lord Judge, to support some of my amendments. I wonder what comments they might have made on what the noble and learned Lord, Lord Woolf, said.
I find myself in support of what the noble Lord, Lord Lansley, said. I would be interested to hear the Minister’s response to the question whether market approval of a device also means that it has therapeutic approval. I know that the noble Lord, Lord Kakkar, has an amendment on the therapeutic values of devices.
I do not find myself in total agreement with what the Government have produced and I do not think that Amendment 2 is satisfactory. Let me try to explain and we will see what the comments are. The amendments are about promoting public safety and insert into Clauses 1, 8 and 12 a new subsection (1A), so that the Secretary of State may only make regulations under those clauses where
“satisfied that they would promote the health and safety of the public.”
However, this is coupled with the insertion of the words “considering whether they would” to replace the start of subsection (2) in each clause. That means that, in the decision on whether the regulations would promote the health and safety of the public, the appropriate authority must have regard to the safety of medicines—or veterinary medicines or medical devices—their availability and the
“attractiveness of the relevant part of the UK as a place”
to conduct clinical trials or supply medicines, or develop or supply veterinary medicines or medical devices. That would be the effect of the amendments. That construction is open to the interpretation that the “attractiveness” of the UK is to be treated as part of what promotes public safety; the Minister might want to comment on that. If so, the amendment would not address the concern—indeed, it would appear to prevent the argument being made—that attractiveness and the safety of medicines and medical devices can sometimes be in conflict and that considerations of attractiveness undermine considerations of safety. This is in line with the Government’s repeated assertion that attractiveness cannot be in conflict with safety. In essence, the amendment appears to make little substantive change.
Lord O'Shaughnessy (Con)
My Lords, my only intention in speaking on this group is to ask a question. Given the flag raised by my noble friend Lord Lansley in his Amendment 76, I am glad that I am not the only one with the question, which is whether the concept of medical devices inherently includes their therapeutic usage. My understanding is that they are regulated as medical devices, not simply devices, and therefore the way in which we regulate and risk-stratify them as we regulate them inherently includes therapeutic use. The fact that my noble friend raised the question in his amendment made me slightly worried, so I seek the Minister’s reassurance on that point.
I have also become aware during this discussion of another issue worth considering. There has been some debate about the appropriateness of government amendments being approved in Committee. I concur with the view of my noble friend Lord Lansley that a Bill on which only half the Front Benchers agree is better than one on which none agree. I have been in my noble friend’s shoes and have been frustrated, as I know noble Lords opposite have been, by the need to stick to concession strategies, holding back concessions and amendments until Report. I do not agree with that approach. My noble friend has done absolutely the right thing in bringing forward amendments at the earliest possible opportunity, however imperfect they are. The problem with leaving everything to Report is that it is an all-or-nothing approach, as we do not tend to amend at Third Reading, whereas this potentially leaves open the iterative approach that I would like to see more of. Maybe my noble friend has even set a precedent, heaven forbid, in doing this. We would all welcome it as giving more than one opportunity to improve legislation, on Report. I hope that we can agree the government amendments because, as everyone has said, they are an improvement on where we were and we would have another opportunity, if the House felt it necessary, to improve them further on Report.
Baroness Walmsley (LD) [V]
My Lords, I support Amendment 5, which would insert the words
“objective of safeguarding public health by promoting the availability and supply of human medicines”.
While the purpose of the Bill is to bring some sort of order out of the chaos of Brexit, it is vital that we put those words up front. In the first words on page 1, before Clause 1, the purpose of the Bill is described as
“the protection of health and safety, in relation to medical devices”.
Why does it not say, “in relation to medicines and medical devices”? That is why we need Amendment 5.
Government Amendments 2 and 7 are weak, in my view. For example, the words “promote health and safety” in Amendment 2 and “considering whether they would” in Amendments 7 and 72 are well meaning and better than the original but, I dare to say, legally useless.
The word “promote” also appears in government Amendment 68. In contrast, the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, use the much stronger word “safeguard” in their Amendment 70, which I support. I also support their probing amendment for clarification in Amendment 76 that therapeutic practice is also included. I will be interested to hear whether the Minister can explain whether this is needed or, perhaps, not.
Lord Kakkar (CB) [V]
My Lords, I support Amendments 5 and 70 in the names of the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf. I seek further clarification on the Government’s purpose regarding the amendments proposed by the Minister.
First, what is the rationale for moving away from the current basis on which regulations in this regard exist, which states the purpose of safeguarding public health? Why do the Government not think that appropriate as the basis for legislation for medicines and medical devices? It has been the basis on which regulations have previously existed in domestic legislation and it seems counterintuitive to move away from that purpose, as so clearly explained by the noble Lord, Lord Lansley.
Secondly, there is this question of whether there should be an objective or a subjective test attending the purpose of legislation, all parties having agreed that it is of benefit to move away from simply having a power to clearly defining a purpose. There has been considerable debate and discussion about what is considered the frequent use of judicial review now and how in some way it undermines the position of Parliament and is less than helpful more generally in our country. It seems therefore intuitive for a Government who have concerns about what is sometimes considered excessive use of judicial review to try to provide legislation that would make it less necessary and less frequently turned to.
The noble and learned Lord, Lord Woolf, made the point that clarity is essential. Surely an element of clarity would be to have in place an objective test—to safeguard public health—rather than, as currently, merely being “satisfied”. The need that the Secretary of State can make regulations if he is satisfied, as we have heard in this debate, is much more subjective and therefore must be open to much more frequent challenge.
Lord Sharkey (LD) [V]
My Lords, I have only just learned that if we do not pass the government amendments in this group, we put at risk the required legislative consent order for Northern Ireland. I had intended to oppose Amendments 2, 7 and 14; I did not understand why Amendment 2 was necessary or had any real force or meaning—in any case, I much preferred Amendment 5 —and Amendment 7 seemed downright confusing, since its net effect is to impose an obligation on the Minister to have regard to certain things when considering making regulations but no obligation to consider the specified things when actually making these regulations.
I have spoken to the Minister and will now not oppose the government amendments. However, I feel that we have been bounced. I first realised the Government’s intention to move when I read today’s Chair’s guidance and I understood that there was a Northern Ireland problem when I was given, about 40 minutes ago, a copy of the note from the noble Lord, Lord Bethell, to the noble Lord, Lord Lansley, from yesterday. We were not copied in on that note. I strongly feel that this is all very unsatisfactory.
The Minister has not really answered the question that I asked him in our impromptu interval of why we need to rush. Could he explain why delaying the start of the legislative consent order process until Report would be a problem? It is still not clear to me. I trust the Minister’s assessment but I do not understand how he arrived at it. In his note to the noble Lord, Lord Lansley, he says, for example, that the delay would mean that we could not meet some unspecified timing objective but he prays in aid the notion that the minimum interval between Committee and Report is a contributing factor. We can change that interval; we could choose. Could the Minister explain again why it is necessary to do this today?
Baroness Jolly (LD) [V]
My Lords, this has been a useful debate on health and safety when making regs. The Government have tried to strengthen this with their amendments in this group. My noble friend Lord Sharkey just spoke about that; I too will look at them in the light of Committee and determine what to come back with on Report.
On government Amendments 2, 7 and 68, we should have these regulations only if we are absolutely satisfied that they would promote health and safety. Government amendments 51, 54 and 56 are all about the promotion of one or more of health and welfare of animals, health and safety of the public, and the environment. There is a clear connection with animals and the environment; has the Minister spoken to Defra and BEIS about these amendments?
I also wonder that we are not discussing those medical devices that are joint veterinary and medical devices. As I said at Second Reading, veterinary medicine is becoming much more sophisticated and slightly less agricultural—that is not the right way to describe it, but it is now very high-tech in certain areas. Could the Minister outline the legal situation here, as, when we are discussing medical devices, veterinary devices are not included? Clearly this should fall within the scope of the Bill but, as I see it, there are no amendments covering that.
Moving to the amendments from the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, I supported Amendment 5. We have left the EU, but I see no reason why we cannot use its regulation if we think it cannot be improved on. I was happy to put my name to this amendment and agree that subjective measures are nowhere near as effective as objective ones. This is an area where objectivity is much more important than subjectivity.
The amendment elegantly reflects the objective of safeguarding the public health element in EU regulations. A Secretary of State has a duty to maximise the public health of our English population. I am sure it is not written down anywhere, but that is absolutely what he or she is responsible for doing. As such, I firmly believe that this amendment belongs in the Bill. My noble friend Lady Walmsley spoke powerfully about Amendment 5; we should really consider her arguments when we determine what we will do on Report.
My final point is on the objective of Amendment 70 to
“safeguard public health through the supply of medical devices.”
This amendment elegantly reflects the objective of safeguarding public health in EU regulations. There is much to look at in this group. I am sure that we will determine what comes back on Report later in the day.
Baroness Thornton (Lab)
Like the noble Lord, Lord Sharkey, I shall have a minor moan. It is normal practice to give fellow Peers sight of government amendments at least on the day are put down, so even though the Bill team had not managed to discuss their intention with Opposition parties and other noble Lords involved in Committee, we received the letter from the Minister explaining the amendments on Thursday. I hope the Minister and the Bill team will not continue to leave things so late. I remind the Minister that he has a whole Bill team and a department at his disposal. Other noble Lords write their own speeches, do their own research and need more time to give amendments due consideration. I am fortunate to have some excellent support and we work very hard on our side to get our amendments down as early as possible to give other noble Lords the opportunity to consider them and discuss them with us. The Government should always bear in mind the unequal nature of resourcing in this place.
We need to see these amendments for what they are. Of course, they are mostly worthy and we welcome the improvement, but essentially, to echo the words of the noble Lord, Lord Patel, they are there to placate and circumvent. We are late in the day in beginning to understand the nature of these amendments and we now understand the urgency of them as a result of our earlier discussions, for which I thank the Minister and his team. We are waiting for reassurance from the Minister about what happens at the next stage.
The noble Lord, Lord Lansley, made some very important and pertinent points, particularly about the difference between the objective test and the subjective test. It is clever and very important. He is on the side of objectivity and the Government’s amendments are definitely on the side of subjectivity. I agree with him that Amendment 2 is not as good as his Amendment 5. The noble and learned Lord, Lord Woolf, also said something very pertinent and quite correct about not giving blank cheques. He accepts what the Government are offering, but made the point that further discussions are needed and an amendment might be needed as we move forward.
I say to the noble Lord, Lord O’Shaughnessy, that I do not have a principled objection to government amendments coming forward; it is just that we need to know the context for them. The noble Lords, Lord Lansley and Lord Kakkar, and others, including the noble Baroness, Lady Jolly, made a very important point about safeguarding public health, and I hope the Minister will be able to address it. I can probably feel an amendment coming on on that one.
Lord Bethell (Con)
My Lords, I am enormously grateful to my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, for Amendments 5 and 70. I greatly appreciate their scrutiny and contribution on the way in which regulations under the Bill might be made. I am grateful to my noble friend for his constructive dialogue with my officials. His experience and expertise in making legislation on health matters is a real benefit to all of us.
My noble friend and the noble and learned Lord, Lord Woolf, have drawn on the framework of legislation in the EU context. I am grateful for their explanatory statement on the basis of the amendment. My noble friend knows that I pressed very hard to see whether this is something we could accept. The challenge your Lordships have set me is why, if this framework exists in EU legislation, is it too constricting for the Bill? The answer is that examples of significant recent EU legislation in relation to human medicines, clinical trials and medical devices include: directive 2001/83/EC, regulation 726/2004, regulation 536/2014, and regulation 2017/745. In other words, while citing the aim of safeguarding public health in Article 168, on public health, of the Treaty on the Functioning of the European Union, these pieces of legislation were also made in reliance upon Article 114 of the treaty, being measures for the approximation of laws which have as their objective the establishment and functioning of the internal market. To make that point again, safeguarding public health is not the only objective of the EU legislation in relation to medicinal products and medical devices. That is why we have a challenge in this area and why we have posited our amendment.
I shall say something about the other government amendments, specifically replying to the noble Lords, Lord Hunt and Lord Sharkey, and other noble Lords who commented on them. The overall timing of the Bill means that currently, it cannot reach Report any earlier than mid-November. If we start the consent process with Northern Ireland then, it will add a minimum of two months past the end of the Bill’s timeline. To explain to the noble Lord, Lord Sharkey, we need to start the consent process now in order to make further changes. The Government need to demonstrate that this is a policy they wish to make in order for Northern Ireland to get that process properly under way. We have written to Northern Ireland seeking consent to make changes. Parts 1 and 2 of the Bill are transferred to Northern Ireland. I sought consent from Northern Ireland on the Bill as a whole when the Bill was introduced, and again after the change made on Report to Clause 16.
We sought to make government amendments at the earliest opportunity to respond to the DPRRC, partly to demonstrate how significantly we take that report and partly to start this process. That process has now started, but it has not concluded. It does not preclude noble Lords from further consideration and, as my noble friend Lord Lansley, indicated, the Bill has moved. The process of consent is unavoidably three months long in order for the Northern Ireland Assembly to conduct its work. That is why we have had to start now. In reply to the noble Lord, Lord Hunt, I can supplement the legislative consent Motion at a later date.
I will listen. I understand and acknowledge that the noble Baroness sees this as the beginning, not the end, and I acknowledge that she will return to the issue on Report. Accepting these amendments today does not prevent her doing so, and I will continue to listen.
I completely hear what the noble Lord, Lord Hunt, says about engagement with the MHRA. I would be glad to arrange a suitable engagement with June Raine from the MHRA and parliamentarians to discuss these points.
To the noble Lord, Lord Patel, I confirm that the efficacy of a medical device is assessed as part of the process of obtaining a CE certificate. The therapeutic value of a device is not part of the CE certificate assessment; that is a function carried out by NICE. On the point made by the noble Baroness, Lady Barker, on the food chain, I would be glad to arrange a follow-up discussion on the veterinary medicines directorate with the relevant Defra Minister. To the noble Baroness, Lady Jolly, Defra and BEIS are content with this amendment. To the noble Baroness, Lady Walmsley, the medical devices section of the overarching bit at the beginning of the Bill is a carry-on from the sentencing enforcement, and in Part 3 enforcement is in relation to medical devices only. I do not think these are reasons to rewrite the purpose.
I obviously hope to win the argument on some of this, but that will come from extensive engagement and thorough communication going forward, for which I thank noble Lords. I therefore hope that the noble Baroness feels able to accept these reassurances, and I am grateful that my noble friend considers this sufficient reassurance not to move his amendments.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I have received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.
Lord O’Shaughnessy (Con)
I thank my noble friend for addressing the point about therapeutic use, but I think I am slightly more confused now than I was before. He talked about NICE, but of course, NICE does not assess every medical device and assesses from a health economics perspective, as opposed to a purely regulatory, safety and efficacy perspective. It is not something that need detain us, but perhaps he could follow up afterwards with a bit more detail.
Baroness Thornton
“( ) In making regulations under subsection (1), the appropriate authority must have regard to the desirability of—
(a) regulatory alignment with the European Medicines Agency’s medicines regulation;
(b) regulatory alignment with EU clinical trials regulations;
(c) recognition of and participation in the European Medicines Agency’s medicines licensing processes.”
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the desirability of regulatory alignment with EU regulations.
Baroness Thornton (Lab)
My Lords, in many ways this group of amendments is at the heart of the Bill. The Minister will know that there is real anxiety among stakeholders, be they large or small pharma, researchers or patient groups, particularly now that we might face a no-deal exit at the end of this year. Life sciences companies have concerns about the administrative and cost implications of having to file for marketing authorisation with a separate national licensing authority after Brexit. It will be important to consult closely with the industry—industry groups, but also individual companies that have specific expertise in high tech areas—to ensure that the regulatory regime is robust, internationally competitive and fit for future scientific breakthroughs.
The amendments in my name and that of my noble friend Lord Hunt require the appropriate authority to have regard to the desirability and necessity of regulatory alignment with EU regulations. The amendments in the name of the noble Lord, Lord Patel, the noble and learned Lord, Lord Mackay of Clashfern, the noble Baroness, Lady Finlay, the noble Lord, Lord Lansley, the noble Baroness, Lady Jolly and the noble Lord, Lord Kakkar, in this group have similar objectives.
The UK via the MHRA plays a leading role in developing the clinical trials regulation, which came into force in 2014. Due to the length of the implementation period of the regulation, the UK is not currently committed to implementing it in full following the end of the transition period. Failing to implement this longstanding legislative proposal would create significant uncertainty for life science companies.
I am grateful for all the briefing we have received over the last few months from organisations and companies which have a great deal of interest at stake in the Bill. For example, Silence Therapeutics wants to make ground-breaking treatments available to patients in the UK as quickly as possible and to conduct clinical trials in the UK. In order to ensure that the UK remains a competitive and attractive destination for clinical trials, it thinks the Medicines and Medical Devices Bill should provide for continuing alignment with EU clinical trials regulations—the UK was involved in the development of that—and, in the immediate term, ensure harmonisation of clinical trial and medicines regulatory processes, while enabling international collaboration for the benefit of patients, at the end of the transition period. It also thinks the Bill should adopt an approach to clinical trials that will allow the UK to lead the world in innovation while assuring patient safety standards. These seem to me to be reasonable tests of this legislation and indicate the challenge it faces.
The danger is that the European Medicines Agency covers 25% of global pharmaceutical sales and the UK on its own makes up only 3%. The odds are that companies will want to submit applications for new drugs to the EMA before the MHRA, meaning that the UK will lose its advantage and UK patients will risk getting slower access to the latest medicines. While the Bill could help maintain patient access to new medicines and UK access to pan-European clinical trials, its capacity to achieve this will be subject to the shape of the future relationship between the UK and the EU.
On medicine access, will the Bill allow the Government to establish new regulations on marketing authorisations for new medicines? If so, how and when? Does a no-deal outcome mean an independent UK marketing authorisation process, along the lines set out in the Medicine and Healthcare products Regulatory Agency’s plans for a no-deal outcome which came out in 2018 and 2019 and which some of us lived through. Is this what might be used? Alternatively, could the UK choose unilaterally to continue to recognise a new European marketing authorisation as valid? Has that been considered? Depending on the outcome of UK-EU negotiations, what will happen if the MHRA is unable to participate and contribute its expertise in the European Medicines Agency’s marketing authorisation process?
On clinical trials, will the Government replicate the EU’s clinical trial application system, thereby reducing the administrative burden on UK-EU collaboration? This would be necessary if the MHRA had to develop a separate clinical trial application system that would operate in parallel to the EU’s. Is this the case?
Given the influence that the UK-EU future relationship will have on how the Bill’s powers can be used, will the Minister guarantee to encourage, update and consult the medical research sector as negotiations progress? Are the Government doing so already? Perhaps the Minister can give some positive reassurance by describing some of the recent discussions and negotiations. I am aware that this is in line with the ethos of Clause 40, which requires the Government to consult relevant people and organisations when proposing regulatory changes.
Treatments that utilise innovative techniques such as gene silencing are often used to treat rare diseases. These affect limited numbers of people and are often used in areas of unmet need, where no effective treatment options are available. The number of patients with a rare disease in an individual country, such as the UK, is likely to be low by definition, but for clinical trials to work—the House has discussed this many times—they require a large number of patients to take part. As a result, these trials are conducted across multiple countries.
Unified and streamlined international processes are essential to ensure that the application and authorisation processes for these clinical trials can continue to work effectively and at pace. By implementing the clinical trials regulation, the UK can remain eligible for access to the central EU portals and processes for clinical trials, which ensure that they can recruit enough patients from different countries to be successful. These processes include clinical trial submissions, reporting and authorisation requirements and, particularly importantly, inclusion in patient registries.
Lord Hunt of Kings Heath (Lab)
My Lords, I support the two amendments in the name of my noble friend Lady Thornton. I have also put my name to Amendment 22 from the noble Baroness, Lady Finlay—she is currently in the internal markets Bill Second Reading debate—which links this to a definition of attractiveness, and to Amendment 39 in the name of the noble Lord, Lord Patel, which focuses on clinical trials for rare diseases and the importance of alignment with the European Medicines Agency.
At the end of this debate, I hope we will have a better idea of the Government’s approach to the regulation of medicines and medical devices. I do not want to repeat myself, but, as my noble friend said, the big question seems to be that at the moment the EMA covers 25% of global pharmaceutical sales and the UK on its own makes up 3%. We know that the NHS is a very poor customer in terms of adopting new medicines. The UK market is pretty hopeless for pharma. If we are not going to be aligned to the EMA, what will this mean for UK pharma in terms of future investment? My guess is that it will snap off that investment.
This is the big issue, which we do not yet understand. What is the Government’s aim? Is it the idea that a no-deal Brexit is a good thing and UK pharma will survive with a hopeless home market and all the problems of dealing with Europe? Countries will clearly not come to the UK first when they have the EMA next door, unless we offer fast-track licensing, which brings us back to patient safety, which is why the two link so much together.
I hope that this time the Minister will give us some idea of what the Government are aiming for. The same applies to medical devices, although there are some specific opportunities, because at the moment the MHRA has no involvement in the pre-market phase of medical device development. Is the intention that the UK develops a proactive regulatory role for devices that is more akin to the licensing of medicines? If so, what will be the implications for industry and patient safety? Clearly, there have been many issues about medical devices in the past which have not gone through such a robust regulatory regime. Is it the intention that the UK goes through a more extensive regime in the future under its own steam? What will the general implications be?
Again, we know that Covid-19 is having an impact on clinical trials, a significant number of which have been paused. It is my understanding that only 45% of studies are currently open to recruitment and only 36% of them have successfully recruited patients since 1 June. The ABHI has highlighted the need for a sustainable plan and aims to return clinical research to pre-pandemic levels by spring next year.
This is important because, despite the size and growth of the global market for clinical research, the UK’s share of clinical trial applications and patient recruits has fallen since 2016. The UK is now falling behind the US, Germany and Spain for phase 3 commercial clinical trials. What is to be done about that? What is the Government’s approach? Again, how does this relate to the future regulation of clinical trials?
I hope that the Government’s intention is to stimulate the UK’s clinical research environment, but part of that must be enabling multi-state UK-EU trials to continue. The idea that we can have multi-state trials that do not involve some agreement with the EU seems fanciful in the extreme. Again, at this stage, we are entitled to know from the Government exactly what they intend.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I call the noble Lord, Lord Sharkey.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
Could the noble Lord please unmute his microphone?
Lord Sharkey (LD) [V]
Can you hear me now? Yes? Good. Noble Lords will be relieved to hear that I will not start again. I will speak to Amendments 34, 36 and 37.
Clause 4 deals with clinical trials, which delivered £1.5 billion in GVA and £335 million to the NHS in 2018-19. They are an absolutely critical part of UK life sciences and part of what makes the UK a global leader in medical research. Anything that reduces the number or share of clinical trials in the UK weakens that leadership and could delay access to new drugs or treatments.
In its briefing, the APBI points out that our share of clinical trial applications and patient recruits has fallen since 2016. As the noble Lord, Lord Hunt, said, we now rank behind the US, Germany and Spain for phase 3 trials—and Covid has had a dramatic effect. The University of Southampton has published research showing that 1,500 clinical trials of new drugs and treatments for cancers, heart disease and other serious illnesses have been permanently closed down in Britain, with a further 9,000 suspended.
The Government know all this and acknowledge the importance of clinical trials. Given that, Clause 4 is a surprisingly weak response. It does not require the Government to do anything at all. It simply says that they may regulate—it does not say how they may regulate—and lists the areas in which they may regulate. This is another example of the abuse of secondary legislation. It gives unspecified policy-changing powers to Ministers without saying what these policies might be, except that they should do no harm—not a very demanding qualification.
When questioned about this and asked which bits of the CTR they will carry across, the Government’s response is, “The elements that are in the UK’s best interests.” These best interests are to be identified after consultation with interested parties. This all seems unnecessarily feeble. Researchers, commercial and academic, need certainty and stability as soon as possible. Ideally, they would like the provisions of the new UK regime to incorporate all possible provisions of the CTR as they come into force. We know what these provisions are. We know all the thinking behind them. The UK played a central part in their construction in the first place. Our amendments try to give some clarity and certainty to the situation.
Amendment 34 would replace “may” with “must”. It would oblige the Government to do something and does not just give them the power to do something if they feel like it. Substituting “must” for “may” would mean that the Government must make provision corresponding or similar to provision in the CTR.
Amendment 36 would modify this requirement slightly to acknowledge that we cannot adopt certain provisions of the CTR. These are the provisions that relate to the EU clinical trials information system and the assessment model involving co-ordinated decision-making on multi-state trials. Amendment 36 would add “where possible” to the requirement to make provision corresponding to or similar to provision in the CTR to allow for this.
Amendment 37 specifies two features of the CTR that the Government must incorporate. These are specified because they are new and very important, and for the avoidance of doubt about the meaning of “corresponding to” or “similar”. The two new features are the new definition of clinical trials and the allowing of co-sponsorship. In its briefing, CRUK notes that the MHRA has had considerable input in the new definition of clinical trials. It notes in particular that the new definition expands the scope of low-risk trials and excludes altogether some studies, such as pure pharmacology studies that are focused on how medicines work rather than on the extent to which they do. The CTR also defines and allows co-sponsorship, where two or more sponsors across multiple countries may share responsibilities. CRUK regards this as a very positive move, allowing for more flexibility in trial set-up and helping to foster collaboration. We helped to design both these new features. We should ensure that they are incorporated into our new regulatory regime.
Lord Lansley (Con)
My Lords, I am glad to follow the noble Lord, Lord Sharkey, because he made some important points and it saves me having to make the same points less well.
The purpose of Amendment 35—in my name and that of the noble Lord, Lord Kakkar—is precisely to explore the issues that the noble Lords, Lord Sharkey and Lord Hunt, raised. I am concerned that, as it stands, the provision may mean that we do not align sufficiently with the clinical trials regulations as they exist in the European Union. That is a great pity because we have gone to an enormous amount of trouble to try to improve the clinical trials regulations in the European Union; indeed, we arrived at a point where they were significantly better than the previous regulations. To depart from them now seems a retrograde step.
We cannot be sure that we will stay aligned with those regulations for ever but having the objective of seeking to have our clinical trials regulations correspond to those in the European Union opens the option for us to be in the clinical trials information system. If we start to diverge from the EU clinical trials regulations, I am not sure how we can then be incorporated into that system. That automatically means significant difficulties in trying to manage multi-state clinical trials in Europe with a view to an authorisation process through the European Medicines Agency because the information system will, I think, be an essential pre-condition for marketing authorisation applications to the EMA. The purpose of Amendment 35 is precisely to explore this issue. What do the Government mean by “or similar”? Do they intend to diverge or not? If they intend not to diverge and to retain corresponding regulations, that is excellent. If they intend to do otherwise, that is not so good.
I do not intend to enter into the argument about aligning with the European Medicines Agency for the simple reason that we have been here before. We legislated in the Trade Bill in the last Session to align ourselves with the agency and to participate in its processes. Unfortunately, I do not think that that is going to be available to us, so legislating for it in the United Kingdom will be, I am afraid, without effect. I will focus on the Clinical Trials Information System because there is likely to be a willingness and interest on the part of our European partners to retain the United Kingdom in this process. I hope that is so, that we might be able to attain that, and that that will be the Government’s objective.
Lord Kakkar (CB) [V]
My Lords, I shall speak in support of the amendment in the name of the noble Lord, Lord Lansley, to which I have added my name. Important arguments have been made with regard to the need to ensure that we can move away from the clinical trials directive which is currently the basis for such legislation in our country, and to adopt the clinical trials regulation to which our regulatory authorities have made such an important contribution over recent years.
On previous occasions Her Majesty’s Government, with specific regard to the 2018 EU withdrawal agreement Bill and the 2018 Trade Bill, made clear commitments that we should implement the clinical trials regulation in full as part of a negotiated agreement incorporating its legislative and non-legislative provisions; or, in the event that no agreement can be reached, that an element of the regulation would be adopted to the greatest extent possible on a unilateral basis in domestic legislation. We have received further reassurances in terms of the withdrawal agreement Act that the Government would give priority to taking the necessary steps to bring into UK law without delay all the relevant parts of the EU clinical trials regulation that were within the control of the United Kingdom. With regard to the Trade Bill, in September 2018, the House was reassured in the strongest possible terms by Her Majesty’s Government that a commitment was being made to implementing the regulation. However, when the Bill before us was considered in the other place, no such commitment was made and therefore, this probing amendment is vital.
I know that arguments have been made that not all the elements of the regulation are within the power of Her Majesty’s Government to implement, but as we have heard from the noble Lord, Lord Lansley, there is the opportunity to deal with the clinical trials portal and information system in a different way and to design, as other amendments propose, a system that might be agreeable. Arguments have also been made that the clinical trials regulation itself, although a substantial improvement on the current directive, is not perfect, and that the GCP and ICH guidance to which the clinical trials regulation makes reference need themselves to be advanced. Work is being undertaken in that regard.
The European clinical trials regulation provides for referring to guidance on the operational delivery of clinical trials or other guidance, so that should not be seen as an impediment. The real concern here is that while, unfortunately, impediments and hurdles to the adoption of the clinical trials regulation may be identified, that would be the wrong thing to do. The regulation is important. The current clinical research legislation under which we labour in our country is not ideal, which is why we have this regulation. On many occasions, Her Majesty’s Government have committed to the adoption of the regulation, so can the Minister indicate why the opportunity provided by this Bill should not be taken to fulfil those undertakings and thus provide us with the greatest possible certainty regarding the conduct of clinical research in our country? This is vitally important to patients, to the economy and to sustaining a viable life sciences ecosystem.
Lord Patel (CB) [V]
My Lords, I support Amendment 38, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to Amendment 39. I am grateful to the noble Lord, Lord Hunt, who has already spoken, for lending his support. I have listened carefully, and I support what has been said about the issues raised, particularly about whether we remain aligned with the EU trials mechanism or whether we are to be part of that mechanism.
During the EU withdrawal debate this issue was discussed at length. In fact, there was an earlier opportunity for the amendment to be put—as noble Lords may remember, it was widely supported—but I withdrew it, because the then Minister, the noble Lord, Lord Callanan, said that at an appropriate time, when legislation was brought in, the Government would address the issue. By that I supposed he meant that they would address the issue of remaining part of the EU clinical trials regime—but this Bill does not do that.
What options are available to the United Kingdom? One of them, of course, is to remain and participate in the EU clinical trials regime, if that is possible. An alternative is silent participation, as in the EEA model. That would mean that we could not vote, we could not lead projects and we could not raise objections. The third option is to be independent and aligned. The noble Lord, Lord Lansley, referred to that, and I agree with him that the important part of the EU clinical trials regime is its portal—a portal that the UK played a major part in developing—through which companies can apply for clinical trials.
The fourth option is to be independent and divergent: the UK would create a new clinical trials system. There is no time to do that by the end of 2020, but over time the UK could create a new system and build alliances. However, the risks need to be clearly understood, and balanced. Where will the companies go? Will they go where they have a bigger market, and a bigger opportunity, with larger numbers of patients for the trials, or will they conduct their trials in the United Kingdom?
There might be novel ways to approach this, and I understand that the MRHA is discussing and trying to develop a novel way of conducting clinical trials, which might be more attractive to companies. But of course, as we do not know what those are and we are not being told what they are, we cannot comment on them.
Currently, what looks like the best option is to be part of the EU clinical trials mechanism. With clinical trials for rare diseases, it is even more important for the UK to remain aligned with, or to be part of, the EU processes for rare diseases in relation to trials, to the data that will be available, and to medicines—for example, treatments developed for muscular dystrophy and metabolic disorders.
About 3.5 million people in the UK suffer at some point from one of the 7,000 or so rare diseases. The number for which treatment is available is small; hence the great need for collaborative research, data collection and the development of medicines, because a larger population is needed for clinical trials. Companies such as Silence Therapeutics, which the noble Baroness, Lady Thornton, mentioned, use gene silencing technologies for developing novel therapies for rare diseases. Others, such as Sarepta, use gene therapy for developing medicines. Companies such as Gilead Sciences are developing CAR T therapy; it was the first to introduce CAR T therapy for cancers in the United Kingdom. All those companies have said that they would wish to remain in the United Kingdom to do their trials, if the environment was right.
The treatments that will utilise innovative techniques, such as gene silencing, are often used to treat rare diseases that affect a limited number of people, as I said. The number of patients with a rare disease in an individual country such as the UK is likely to be low by definition. However, for clinical trials to work, they require large numbers. Unified and streamlined international processes are essential to ensure that the application authorisation processes of these clinical trials can continue to work both effectively and at pace.
By implementing the clinical trials regulation, the UK can remain eligible for access to the central EU portals and processes for clinical trials, which ensure that clinical trials can recruit enough patients for rare diseases and include submissions, reporting and authorisation requirements and, particularly importantly, inclusion in patient registries. Those were developed as part of the EU-wide MHRA initiative to develop registries for rare diseases.
The UK should also seek to maintain alignment with patient safety and pharmacovigilance standards, as mentioned by the noble Baroness, Lady Thornton, to give patients and clinicians confidence in trials that are conducted in the UK and to support the UK’s ability to host trials that need to take place in multiple countries. Without this level of alignment, it is likely that clinical trials, particularly for innovative treatments such as gene silencing, will not be able to go ahead in the United Kingdom, denying UK patients access to new treatment options at an early stage.
I will end by saying a few words in support of Amendment 125 in the name of the noble Baroness, Lady Jolly. Given the global nature of the Human Medicines Regulations, the UK should be a member of the ICH—the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Having recently joined as an observer on Project Orbis and the Access Consortium, the UK can work towards providing a leadership role on global regulatory standards, and it is more likely to do that if it is part of the EU clinical trials mechanism.
Baroness Barker (LD)
My Lords, the noble Lord, Lord Hunt of Kings Heath, succinctly set out what we all know: post Brexit, the UK as a market will be significantly less attractive than it was as part of a single regulatory system for the development of medicines and clinical trials. The economics of that are inescapable. However, it is also true, as the noble Lord, Lord Lansley, said, that however much some of us may wish that we continued to be aligned with what will inevitably be a developing clinical trials basis in Europe, it may not be within our gift to do so. However, what we can do, and what all the amendments in this group attempt to do, is encourage the Government to come clean about the extent to which they will seek in future to maintain an ongoing alignment with those clinical trials regulations in Europe.
The noble Lord, Lord Patel, mentioned—as I intend to—the announcement last week of the UK participation in the Orbis trials, which are the new mechanism for fast-tracking cancer treatments, with players from the US, Canada and Australia. I still think that, given the history of this country as a leading player in the life sciences and biosciences fields, and given the amount of investment in research that we have traditionally had and which we must seek to maintain in the NHS and within our universities, if we do not signal at this stage a willingness to keep the regulations in place and ensure that we remain aligned with the European system, we stand to lose a great deal—not least involvement in the clinical trials information system. The Government would be well advised to take some, if not all, of these amendments, which all seek to do the same thing.
Lord O’Shaughnessy (Con)
The noble Baroness, Lady Thornton, got to the heart of this when she said that these discussions are central to our debate on the Bill and its purpose.
I preface my comments on the amendments by drawing on my experience as a Minister with responsibility for preparing the health and social care sector for Brexit and for medicine regulation. During that time, I spent hours and hours—days and days—of time with pharma and medical device companies, patients and others. There was a consistent message from almost all of them about the desirability of remaining part of the EU family if possible and the importance of the MHRA and our notified bodies as regulators within that regime. I, together with others, worked extremely hard to make sure that that was recognised in the withdrawal agreement that was agreed at the time. We managed to create a special category of safety products. For those who remember back two or three years, there were chemicals, pharmaceuticals and medical devices in the withdrawal agreement and, indeed, the political declaration. I worked very hard to achieve that position and supported it.
It might also be worth reminding noble Lords that Parliament passed up the opportunity to agree that withdrawal agreement. It did not succeed. That has led to a different Government with a different agenda and with a majority, which might be something for us all to reflect on.
I make those points only so that noble Lords will understand that my concerns with the amendments on aligning with the EMA and European regulation in general are not ideological but practical. Actually, this is a very heterogenous group of amendments: it ranges from alignment through to collaboration to similarity where possible. When considering the issues around this, we need to tread very carefully as to what we commit ourselves to. The fact is that, as negotiations have progressed, it has become completely clear that the European Commission will not tolerate any meaningful associate membership: you are either in or you are out, and there is no possibility of the UK participating in making the rules that bind it. Clearly, being in is not compatible with leaving the European Union, so the question that falls to us is what we do when we are out. What should we do as a sovereign regulator that is not part of the EMA?
This is where I disagree with those amendments that seek to align us with the EMA. The truth is that we cannot have the best of both worlds; we cannot—as the Prime Minister might put it—have our cake and eat it. We cannot be in and take advantage of the opportunities that being out gives us. Tying ourselves in advance and in perpetuity to EU regulation over which we have no control or, critically, judgment of quality, would be a big mistake.
It is quite right that we should seek to mitigate the negative impacts of leaving the EMA family. I have never sought to sugar-coat those—I do not take a Panglossian view of the consequences—but tying ourselves in such a way is not the way to do it. Multiple stringent regulators in the world do just as good a job, if not better, as our MHRA—in Japan, Switzerland, Canada, Singapore and bits of the EFTA. We should as a nation be seeking to accept licensing applications and modelling our regulatory structures on all and any of those that we think are the best. That is the way to take advantage of our freedoms and give us the best possible opportunity of getting innovative medicines and products as they come on to market in any market in the world.
We do not need, as the noble Lord, Lord Hunt, and others, said, to create our own bespoke, novel, difficult regulatory system that puts up more barriers to innovation; nor should we tie ourselves to one other regulatory regime. I use just one example to exemplify why I think that is true. It is a well-worn example but is worth rehearsing: the introduction of the HPV vaccine. That was something that most regulators in the EMA family did not want to proceed with. The MHRA provided a very compelling case for us to do so. European countries did so. The effect of that in England alone has been to reduce HPV infections among 16 to 21 year-old women—the figures are a couple of years out of date but are probably still accurate—by 86%. Bear in mind that HPV causes 80% of cervical cancers among women. We might be tying ourselves to things that we regret and which cause harm; I know that that is not something that anyone would want to do.
I note from the ABPI’s briefing—obviously, I have worked closely with it—that it does not call for alignment with the EMA. It calls for making sure that
“the information or data required by the EU regulator is consistent with other leading regulators around the world and benchmarked against them for speed and approval.”
It also calls for the UK to apply for full membership of the ICH, as the amendment in the name of the noble Baroness, Lady Jolly, calls for—I quite agree with that—and generally to look to provide leadership on developing global regulatory standards in human medicines.
I utterly understand the impulse. The Government have partly got themselves into this difficult situation by creating a vacuum into which people are seeking to put policy. That is completely understandable but it would be a mistake to tie ourselves to one particular regulator. It may not be quite as true of clinical trials—I defer to the expertise of others—although I note that the ABPI briefing paper does not talk about the clinical trials directive; instead, it uses a much broader palette and says that future clinical trials and regulations in the UK should both support and enable international collaboration.
I know that that is not the only position and that people take a different view, but as we move forward, we will want to tread carefully over which regulators we seek to collaborate with, emulate and draw on, rather than tying ourselves to an in-perpetuity relationship that we may come to regret on occasion.
Baroness Walmsley (LD) [V]
My Lords, Amendment 3 makes clear the desirability of alignment with the EMA and the EU clinical trials regulations. It sets out early in the Bill the store for those of us who feel that the advantages we have gained from such alignment must not be sacrificed on the altar of some mistaken ideology of this failed Government. I point out to the noble Lord, Lord O’Shaughnessy, that we managed to introduce the HPV vaccine before we left the European Union.
Amendment 22 attempts to define the rather vague expression “attractiveness”. We have other definitions in later clauses; we certainly need to choose one of them but I will leave my preference for a later debate.
I support Amendments 34 to 39 to Clause 4 on clinical trials. As my noble friend Lord Sharkey pointed out, they tighten up the wording in the Bill to emphasise the benefits and avoid the damage of diversion from EU clinical trials regulations. British patients benefit from alignment, British bioscience research and development benefits, and the whole system is worth millions of pounds to the Exchequer. I and other noble Lords have received briefings from a number of organisations working on behalf of patients, such as the British Heart Foundation, emphasising that any diversion from these regulations will affect the rapid availability of new medicines and treatments to British patients. They are also concerned to protect the large amount of EU research funding that they currently receive. Diversion could also affect, to use the Government’s favourite word, the attractiveness of the UK as a place to conduct clinical trials. The problem is that the Government have not told us what they might want to change unilaterally in future, as a number of noble Lords have pointed out. I invite the Minister to tell us now.
Amendment 39 asks the Government to establish a clinical trials portal that aligns us with the EMA regulations for medicines for rare diseases. This is particularly important if we are independent from the EU as our population of 68 million is so much smaller than the EU population of more than 400 million, which would make it harder to find a big enough cohort of people with rare diseases for a clinical trial. The noble Lord, Lord Patel, pointed that out.
The EU clinical trials portal, which will come into play with the new and improved EU clinical trials regulations in 2022, was to a great extent designed by British participants. This shows how important it is considered to be by British scientists because it makes applications for clinical trials so much easier and less time-consuming. In its previous inquiry, the Science and Technology Committee heard from a number of witnesses about the issues with the current system, which wastes a lot of their time. So, like the noble Lord, Lord Lansley, I feel sad to know that we will be out of the system by the time the improvements are put in place.
Our current alignment also encourages British scientists to go abroad to broaden their expertise and EU scientists to come here and become part of our very successful research teams. I know the Government are in favour of that because I heard Amanda Solloway, the Science Minister in BEIS, say so last week to your Lordships’ Science and Technology Select Committee. I hope, therefore, the Minister will be minded to accept the amendment.
Baroness Masham of Ilton (CB) [V]
My Lords, I support this group of amendments, especially Amendment 22, but I first congratulate the Minister on his stamina and enthusiasm at this incredibly difficult time. I hope he will be able to answer some of our questions.
I spoke at Second Reading of the need to provide an attractive life science environment for researchers coming from abroad. If we are to recruit the brightest and the best to work in research and clinical trials with the highest standards, we must improve. How will this be achieved? Should they not feel welcome and needed?
Can the Minister assure your Lordships that there will be no barriers to access to medicines for UK citizens?
How can we still have a regulatory leadership role following the UK’s exit from the European Union and the European Medicines Agency? We must not become isolated. I hope we will still collaborate with the EMA and other international regulators. We desperately need new medicines for the very rare diseases. There is nothing more frustrating than other countries having medicines which are denied to people living in England.
I hope the Government will accept the need to incorporate these points, which have been expressed today, to make the Bill clearer and more positive and will put their own amendments down on Report to further improve it.
Baroness Sheehan (LD) [V]
My Lords, I will speak to Amendment 125 in the name of my noble friend Lady Jolly. Like other amendments, it aims to probe the Government on their plans for future regulatory alignment with the European Union following Brexit. It also seeks to ensure that we seek full membership of any bodies or agencies that help safeguard regulatory alignment and standards in medicines and medical devices.
The EU and UK markets for medicines and medical devices are closely linked. According to the Association of the British Pharmaceutical Industry, at least 45 million packs of medicines are exported monthly from the UK to the EU, and 37 million packs come the other way. The UK also relies heavily on the EU for its supply of medical devices, with more than half of its 5 billion imported medical technology originating in the EU.
The European Medicines Agency provides a centralised approval procedure for licensing to allow pharmaceutical companies to submit a single marketing authorisation which, once granted, is valid across the EU and EEA. Given its role in harmonising the regulation of clinical trials, about which we have heard much during this debate, it is clear that divergence would have a major impact on people in the UK and the EU. With respect to medicines, should the UK develop a significantly different regulatory process to the EMA for medicines regulation, the increased regulatory burden on pharmaceutical companies could lead them to prioritise the much larger EEA market over the UK’s. This could cause delays in new drugs being made available for patients in the UK and vice versa. What is the Government’s analysis of potential delays? Is it in the order of 12 to 24 months, as some have said?
Baroness Jolly (LD) [V]
It was almost inevitable, looking at the amendments that were coming up and knowing the people who would be discussing them in Committee, that this was going to be one of the most interesting debates. It has been fascinating and well informed. The amendments relate to our future relationship with the EMA and other international organisations after Brexit. My Amendment 125 in this group is on future regulatory alignment; I am grateful to my noble friend Lady Sheehan for her contribution.
The Government have not been forthcoming on whether they will pursue regulatory alignment and, more importantly, what the implications of not doing so would be. I would be grateful if the Minister clarified that second point. Our clinical trials are hugely important and widely respected. The clinical trials information system is critically important; the noble Lord, Lord Lansley, made that vital point. What aspect of the role of the EMA are we trying to replace? It has four parts: to facilitate development and access to medicines; to evaluate applications for marketing authorisations; to monitor the safety of medicines across their life cycle; and to provide information to healthcare professionals and patients. We need urgent clarification on how the future information system will work, who will host it, how it will be staffed and how we will share our research.
As the noble Lord, Lord Patel, said, we do not have a large enough population for significant research without partners. Are we clear that we could work with the FDA in the US—or, indeed, with the TGA in Australia? Would that give us a sufficient body of people from which to take on our research? Perhaps. Are there any moves to seek full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use? I am sure that the Minister will have the answers but the regulations must have regard to the desirability of alignment, somehow or other, with the rest of the world. We cannot work as a small unit—perfectly formed, maybe, but we are small compared with the US, Europe and other groupings.
How is this going to be measured and monitored? The noble Lord, Lord Hunt, spoke about the fast-track licensing of medicines and devices. The point he made so clearly is that public safety has to be paramount so we cannot rush this sort of thing. We have to get it right; if people have to wait, so be it. It has been interesting to hear the reflections of the noble Lord, Lord O’Shaughnessy, because he was sitting in the hot seat of the department. I wonder whether he is glad that he is not there now.
The other interesting amendment concerns the definition of attractiveness, which included collaboration with the EMA. The noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, attempted a definition. I am sure that if we were all given a piece of paper and asked to write down our definition of attractiveness, there would probably be as many answers as there are people in the debate today. I would like a definition from the Minister: how is this to be measured and by which body?
Without a doubt, under the provisions of Amendment 34, regulations must be made, while under Amendments 35 and 36, they should correspond with the EU clinical trials regulations. Amendment 38 provides that we must continue our collaboration with the EU in whatever form we can manage between us. We also need to look hard at clinical trials portals, not only with the EU but with our other partners in future.
Lord Bethell (Con)
My Lords, as the Minister for Innovation, I am very keen on the UK’s continued leadership in this area; I have made it something of a personal cause. I am very proud of the fact that the MHRA approves around 950 medicinal trials a year, over half of which are multinational.
We know that once an early phase trial is established in this country, the industry is more likely to keep its later phase multi-country trials here. I would say to the noble Lord, Lord Hunt, and others who have questioned this point, that I can confirm that the purpose of the measures in this Bill are absolutely to build on our established strengths so that the UK has the opportunity to anchor international drug development in this country and grow that capability. I am committed to international standards, international partnerships and multi-country clinical trials. It is of course important that we work with our international partners both within the EU and globally to the benefit of patients. I assure noble Lords emphatically that we are committed to international co-operation.
However, I do not agree that our future relationships will be furthered by mandating the consideration of alignment with EU regulations and the European Medicines Agency. The UK has a long track record of jointly tackling global challenges with strong international links already in place between research and innovation communities. The UK works closely with many other regulators; those relationships are underpinned by many shared international standards. The EU bases its regulations on exactly those standards, as do we, and we will continue to do this going forward.
As a number of noble Lords have noted, we have the opportunity to create a better regulatory framework. The feedback from the industry is that an agile, proportionate UK system with familiar data submission requirements would increase the UK’s attractiveness as a place to conduct multinational studies, even if we are operating outside the EU’s network. My noble friend Lord O’Shaughnessy’s quote from the ABPI made this point. The powers in the Bill as it stands will allow us to develop exactly that kind of system.
Progress is already happening. The MHRA and the Health Research Authority are already taking steps to streamline the approvals process for UK clinical trials and are currently piloting a new process that has been shown to reduce overall approval times by more than 30%. I say to the noble Lord, Lord Sharkey, that this change does not rule out co-operation. Data generated in a UK clinical trial will continue to be admissible to support regulatory activity in the EU—and, indeed, globally. We can also look at how we can go further in making clinical trials and their results transparent and visible to the public. Co-operation does not require alignment.
Amendment 3 in the name of the noble Baroness, Lady Thornton, also suggests considering alignment with EU licensing processes. In the short term, the MHRA has already taken steps to recognise for two years future EMA decisions for medicine licences approved through the centralised authorisation procedure from January 2021. In the long term, there are opportunities to establish new UK routes to market, such as a new expedited pathway for innovative products, and to establish shorter assessment timeframes.
We have the ability to make corresponding or similar provisions to the EU CTR, but Amendment 38 would oblige us to align. Amendment 35, in the name of my noble friend Lord Lansley, does something similar. My noble friend makes the point that we have the opportunity to do better than the EU CTR, and that is very much our intention. That regulation replaces current separate regulatory authority and ethics approvals with a single national decision for a trial. The UK could adopt a similar methodology and associated data requirements for approvals, but in a much quicker timeframe. We have already introduced the combined ways for a working pilot to streamline approvals by the MHRA and ethics committees, and industry has told us that our scheme is one of the most appealing among the various pilot schemes in the EU, leading to a reported 30% reduction in timelines. The UK may wish to go further and develop our existing national system to further adapt requirements according to risk so as to reduce unnecessary burdens, such as academic trials involving a marketed product already in common usage.
In his Amendment 49, the noble Lord, Lord Sharkey, suggests that there would be benefits in adopting certain definitions in the EU CTR. These include the EU’s revised definition of a clinical trial and co-sponsorship set out in the EU clinical trials regulations. Under the EU CTR, this new definition of clinical trials is an attempt to avoid current variation in interpretations in different member states. Whether this will have the intended effect remains to be seen. EU legislation already includes a definition of a clinical trial, and the MHRA offers trial sponsors free advice on whether their study meets that definition, to ensure a consistent interpretation. If we wished to amend our definition of a clinical trial corresponding to that in the EU CTR, the Bill as drafted would enable that.
My noble friend Lord Lansley is right that the EU CTR introduces a single submission portal and co-assessment model, but I confirm that member states involved still have to individually authorise the trial, and therefore one or more member states could refuse authorisation. The portal is an IT system, the method of delivery. This does not mean centralised EU approval of a trial. Where a member state has national restrictions that require separate approvals outside the scope of the EU CTR, the sponsor would still have to seek the approval separately of the individual member state, in addition to the processes for seeking authorisation for the trial through the EU portal under the EU CTR. Industry has told us that if the UK has a rapid approval system, the lack of access to the EU portal is not a particular issue.
Amendment 52 introduced by the noble Lord, Lord Patel, suggests provision to develop a clinical trials portal that aligns with the European Medicines Agency for medicines for rare diseases. The EMA’s IT system does not address complex trial designs, such as umbrella, basket and platform trials that involve the use of master protocols. These are the very trial designs that have delivered the UK’s successes in Covid-19 research. On the EU portal, it is also extremely unlikely that the EU would agree to UK involvement, even if one were to request it, given that it is for EU member states and EEA countries. There are many other reasons why the UK is such an attractive place to run global rare disease trials: our world-class research infrastructure and centres for excellence, and so on and so forth.
The Deputy Chairman of Committees (Lord Bates) (Con)
I have received a request to speak after the Minister from the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, the Minister referred to the large number of trials that are started in the United Kingdom. Can he say how many phase 3 trials have been started here? He also referred to the platform that the MHRA has developed with regard to Covid that accelerated the delivery of drugs, which is correct. However, that is not the same as a platform for rare diseases.
I agree that the licensing that was done at speed, within six months, would normally have taken two years: for instance, the licensing of the use of Remdesivir, produced by Gilead Sciences for the treatment of Covid-19. However, that is not the same as the noble Lord’s implication that it could be used for rare diseases. Those require a larger database, which Covid had, because there is no shortage of Covid data. Furthermore, he said that the EU portal means that individual countries have to approve. That is correct, but the approval is a speedier process because it has gone through the portal, unlike before.
Lord Bethell (Con)
My Lords, I will be happy to write to the noble Lord with the precise figures for phase 3 trials. However, he is right that they are incredibly important. The Bill must defend our position on phase 3 trials, which are very much the sharp end of the clinical trials process.
The learning from RECOVERY is that it is not a direct read-across to rare diseases. The noble Lord is right that in rare disease trials, we are often trying to drill down into very small communities, whereas 113,000 signed up for RECOVERY, and tens of thousands took some of the drugs that went through the trial process. However, it is the general capability of being able to run significant platforms, manage ethics at speed, get regulatory sign-off for these trials, and have a clinical trials regime which suits many different purposes. That is our objective, that is why we are putting through these reforms, and that is why we believe that the Bill can support a modernisation of our clinical trials regime.
On the European trials process, the noble Lord is entirely right that the portal contributes to speedy processes. However, it is not the only way of having a speedy sign-off of trials through Europe; we believe there are other ways of doing that.
Baroness Thornton (Lab)
Responding to the very last thing that the Minister said, he will have to tell us what those other ways are during the course of this discussion.
This has been a well-informed debate, as I assumed it would be. I think I was right in saying that this issue is at the heart of the Bill and how we move forward. My noble friend Lord Hunt—I thank him for his support —was quite right that this is the big issue. As the noble Lord, Lord Sharkey, said, this is the start of the discussion that we are going to have about attractiveness and where that lies and how it can express itself.
The noble Lord, Lord Lansley, put his finger on various important issues to do with clinical trials. He asked the key question, which I do not think the Minister answered. It is: if we diverge, what will that mean and how will it happen? I did not hear an answer to that question. The answer will determine what some of us do next as we move forward with this Bill. The noble Lord, Lord Kakkar, was completely correct when he said that it is vital that we get this right for the future of life sciences in the UK.
I am grateful to the noble Lord, Lord Patel, for his support for our amendments. He reminded us that we had this discussion during the passage of the main Brexit legislation, when we were told that it was not the appropriate place to such a discussion so the amendment was withdrawn. Now, at the last minute, this must be the place where we have these discussions and come to some conclusion on them.
The noble Lord, Lord O’Shaughnessy, is right. As we strike out on our own as a country, we will need new relationships and we will need to take advantage of what is on offer in the rest of the world. The transition will be very important because what happens in the meantime is vital. We will also need to ensure patient safety in this laissez-faire world, as the noble Lord explained, for example, if we decide to ignore the portal and strike out without it.
I do not doubt for a moment the Minister’s emphatic commitment to making this a success, but as we move forward, this Committee will need to understand much more than what the Minister has told us so far on the risks and opportunities. My final request to the Minister is that we will need a cross-party meeting of some depth—possibly more than one—to discuss this matter with his Bill team and the MHRA. We had such a meeting. It feels as if it was aeons ago, but I think that it was in February, perhaps March. Anyway, it was before we went into lockdown. We absolutely will need meetings and discussions before we move on to the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Bates) (Con)
We now come to the group beginning with Amendment 4. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the course of the debate.
Amendment 4
Lord Hunt of Kings Heath
“( ) The power under subsection (1) may not be exercised to—
(a) create a criminal offence of failing to comply with a provision made in regulations; or
(b) modify penalties for existing criminal offences.”
Member’s explanatory statement
This probing amendment would remove provisions for criminal offences to be created by delegated legislation. The DPRRC considered this an inappropriate delegation of power.
Lord Hunt of Kings Heath (Lab)
I have added my name to Amendments 4, 52 and 69, which would remove the provision for criminal offences to be created by delegated legislation.
The Government are developing a reputation for riding roughshod over the law, personal liberties and the role of lawyers. Indeed, the Internal Market Bill, debate on which is taking place in the Chamber today, is a reflection of that.
I am afraid that this Bill continues that trend, as indicated by the Delegated Powers and Regulatory Reform Committee in its very direct criticism of the criminal offence provisions. The committee drew attention to provisions in the Bill which give Ministers powers to create and modify imprisonable offences by statutory instrument. Thus regulations under Clauses 1 and 8 may create a criminal offence of failing to comply with provision made in such regulations that is punishable by imprisonment up to two years. Regulations under Clauses 1 and 8 may also amend the dozens of offence-creating provisions in the existing regulations. Regulations under Clause 12 may create new criminal offences relating to medical devices that are punishable by imprisonment for up to one year. Schedule 2 inserts a new regulation 60A and a new schedule into the 2002 regulations which make it a criminal offence, punishable by imprisonment for up to one year, to breach any of the provisions in the 2002 regulations that are listed in the new schedule. It goes on: Clause 14(1)(d) provides that regulations under Clause 12 may amend the new Schedule 30.
The powers conferred in all these provisions give rise to two concerns. As the Select Committee reported, it has previously expressed the view that it expects a compelling justification for the ingredients of a criminal offence to be set by delegated legislation. The powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences, yet the memorandum does not appear to contain any justification at all for this. The committee also points out that it has also said that where the penalty for a criminal offence may be set by delegated legislation, it would expect the maximum penalty to be included in the Bill, save in exceptional circumstances.
While the Bill limits the maximum penalty for offences created by regulations under Clauses 1 and 8, it is unclear whether this limit also applies to the many existing medicines offences which could be modified by regulations under Clause 1 or Clause 8. Again, the memorandum does not appear to shed any light on this. The Minister in his Amendments 43, 44, 64 and 65 has attempted to soften the pill by ensuring that regulations under Clause 1 (1) and Clause 8 (1) may not provide for an offence to be punishable with a sentence of more than two years. That is obviously welcome, but I do not think it goes far enough. From my reading of the amendments—no doubt we will hear about them later—they do not deal with the other substantial concern of the committee that the powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences. Given that, I do not think we can allow these delegated powers to be retained in the Bill. I beg to move.
Lord Patel (CB) [V]
My Lords, I shall speak to Amendments 42 and 63, in the name of the noble Baroness, Lady Thornton, to which I added my name and to which the noble Lord, Lord Hunt of Kings Heath, has just alluded. I also have my name to Amendment 92 in the name of the noble Lord, Lord Pannick, and the noble and learned Lords, Lord Mackay of Clashfern and Lord Judge. Noble Lords can immediately tell that I must be the tenth reserve speaking on this important amendment, but the noble Lord, Lord Hunt of Kings Heath, has laid out very clearly the problems with the government amendments that were brought in and the powers they seek.
I shall be brief on this as the Constitution Committee report spelled it out in its last line:
“The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”
It was making a constitutional point.
As the noble Lord, Lord Pannick, who is a member of the Constitution Committee, cannot be here, I shall speak on his behalf. Paragraph 21 of the Constitution Committee’s report states:
“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”
The noble Lord, Lord Pannick, went on to say that the response of the Minister, the noble Lord, Lord Bethel, that regulations cannot be used to provide for an offence to be punishable with a sentence of imprisonment of more than two years is not satisfactory. A sentence of imprisonment of up to two years is a very serious matter. Parliament, not Ministers, should decide when such a potential sentence should be available to the courts.
Lord Sharkey (LD) [V]
My Lords, we strongly support Amendments 4, 42, 52 and 92 in this group.
The proposal in the Bill to create new criminal offences by statutory instrument is completely unacceptable. It is a matter of basic principle that the creation of new criminal offences requires proper parliamentary scrutiny. The delegated powers affirmative procedure does not provide this or anything like it. This ought not to be controversial. The Government’s own list of the areas in which it is appropriate to use delegated legislation does not include the creation of criminal offences.
Our Constitution Committee has made its position very clear. It considers the use of delegated legislation to formulate policy or create new criminal offences or public bodies constitutionally unacceptable. The Government propose to do the first two of those things in this Bill; it is dismaying that they should so directly and bluntly ignore the conclusion of the Constitution Committee.
The Government appear, however, to have felt the need to modify their initial position somewhat. Their amendments in this group preserve the power to create new criminal offences by statutory instrument, but now cap any sentence for breach at two years. That is a category error. Our objection is to the creation of criminal offences by delegated powers. The length of the sentence attached is completely irrelevant and I am amazed that the Government think that capping the sentence might make the creation of criminal offences proposal more acceptable.
There is an obvious and fundamental principle at stake here. Criminal offences, no matter what penalties are attached, should not be created without full parliamentary scrutiny. They should not be created by the use of delegated powers. I urge the Minister to think again and to remove the offending provisions from the Bill. If he is disinclined to do that, I hope that the House will insist on Report.
Lord Kakkar (CB) [V]
My Lords, I very much support what the noble Lord, Lord Sharkey, has just said. In so doing, I support Amendments 4, 42, 52, 63, 69 and 92 in this group.
It seems counterintuitive at the very least for a Government to come forward with proposals to give a Minister powers using a delegated provision to create new criminal offences and, when challenged, to justify the position by saying, “Well, we will limit the sanction to two years’ imprisonment.” This completely misses the point, as we heard from the noble Lord, Lord Sharkey. There is a clear principle at stake here, which has been well described by the Constitution Committee in its report on this legislation. Very simply, it offends liberty and the functioning of our democracy that a Government can propose to create criminal offences that would deny a citizen their liberty for one day, let alone a maximum of two years, and feel that there should not be proper parliamentary scrutiny in the accepted fashion for the creation of criminal offences. Her Majesty’s Government should think very carefully about what they propose to do here and bring their own amendments beyond the government amendments suggested in this group.
Baroness Barker (LD)
My Lords, I just want to add to what my noble friend Lord Sharkey said. This is a matter of principle; from the two reports by the two committees that have been cited and from the Second Reading debate, the Government can be in no doubt about the strength of feeling on it. In the light of those, the Government’s response in the government amendments in this group is, frankly, rather pathetic and not at all acceptable.
The Bill represents an enormous upheaval for one of the critical areas of our industry. The pharmaceutical industry is of immense importance to this country. Apart from anything else, to add criminal offences created through delegated powers by means of a Bill that is so spare and lacking in detail does a huge disservice to people who want to continue to pursue not just high-quality but ethical production of badly needed medicines in this country and within international frameworks. If the best the Government can do is to table the amendments in this group, they do the industry a great disservice.
Baroness Thornton (Lab)
I do not think that I need to say much in response to the remarks that were, I think, unanimous in their support for my amendment and the other amendments in the group. The cap on the sentence is not a good enough response by the Government. Earlier in our debates, I made a remark about amendments designed to circumvent; I am afraid that the government amendments before us are exactly that kind of amendment. They will not serve, I am afraid.
Unless the Government are prepared, as I hope they are, to table amendments that actually solve the problems and address the issues raised by the Constitution Committee and the Delegated Powers and Regulatory Reform Committee—they could not have been clearer on this issue: in this country, we do not set up criminal offences and their sentences by delegated legislation—there is nothing more for me to say, other than that I hope the Government will think again.
Baroness Penn (Con)
My Lords, it is perhaps appropriate if I begin by speaking to the government amendments—Amendments 43, 44, 64 and 65 in the name of my noble friend Lord Bethell —in this group. In doing so, I thank my noble friend Lord Blencathra for his committee’s report. As previously noted, we have listened to that report, and the changes that we propose through these amendments are intended to address the specific concern in that report regarding penalties for existing criminal offences.
As drafted, Clause 5(1)(b) already provides a restriction limiting the maximum penalty to imprisonment for two years when creating a criminal offence. The DPRRC asked us to explain whether the penalties for existing offences could be amended when there was no maximum specified in the Bill. I want to be clear that we do not intend to increase the penalties for existing offences.
Amendments 43 and 44 would work together to amend Clause 5. They make it clear that, under Clause 1, we may not make regulations that provide for a criminal offence to be punishable by more than two years’ imprisonment. This will apply to both new and existing criminal offences. For veterinary medicines, Amendments 64 and 65 seek to achieve the same by amending Clause 10.
The government amendments will, I hope, remove any concern that powers in Clauses 1 or 8 could be used to make regulations extending sentences for existing offences beyond two years’ imprisonment.
I now turn to Amendment 4 and the other amendments in this group to which noble Lords have spoken. The ability to enforce breaches of the regime governing medicines is a power originally conferred on the Secretary of State in the interest of protecting public health. This was introduced by the Medicines Act 1968 and provisions around offences are found throughout the Human Medicines Regulations 2012. They are also contained in the Veterinary Medicines Regulations 2013.
Offences deter potentially harmful activity and make it possible to take punitive measures against those whose actions put people, animals and the environment at risk. As we make necessary updates to the regulatory requirements, we must be able to remain consistent with the current enforcement regime, which already imposes criminal sanctions. It would not be right that a person may face a criminal sanction for breaching current requirements but not for breaching new regulatory requirements, for example relating to novel technologies and medicines. As with other changes to provisions, making changes to offences will be subject to the draft affirmative procedure, and we will make offences proportionate and necessary. It is imperative that we are able to balance novel regulation with enforcement of that regulation.
It cannot be ignored that crime involving medicines is increasing. Furthermore, criminal activities adapt to new environments and technology. In recent months we have seen opportunistic criminals selling online unauthorised and unapproved medicines and devices for the treatment, prevention or diagnosis of Covid-19, including antimalarials, self-testing kits, “miracle cures” and “antiviral misting sprays”, which could cause harm and unnecessary stress to patients. Enforcement capabilities must be able to keep pace with criminal exploitation. Delegated powers afford us our continued ability to enforce the regulatory requirements for medicines and devices for public protection. To be effective, they must be enforceable.
The Veterinary Medicines Regulations 2013 contain numerous criminal offences for breaches of the regulations; again, this is for the purposes of enforcement. The Veterinary Medicines Directorate’s enforcement strategy is risk-based; it focuses on proportionality, consistency, transparency and targeting. The VMD works with businesses and individuals to assist them in complying with the legislation through the provision of advice and guidance. However, where necessary the VMD will use more formal means of enforcement to secure compliance. It is critical that we have the delegated powers to enforce this.
We have always been clear that we are trying to provide greater clarity on how to enforce the regulations on medical devices. The regulator’s ability to have teeth when we are looking to raise medical device safety standards in future is essential. The report from my noble friend Lady Cumberlege tells us that.
The Bill is also clear on the maximum time limit for imprisonment, which applies to any new criminal offence introduced. This limit matches the current system for devices, where criminal offences for medical devices are already punishable for up to six months. The devices regulations are in place to protect public health; breaches of those regulations put people at risk and can cause significant harm. It is only appropriate that there is a clear consequence for any such actions, including potential criminal prosecutions. We will of course have regulations subject to the duty to consult at Clause 41, which will mean the public have the opportunity to comment on the necessity and proportionality of the approach.
I hope the necessity of enforcing the new regulations, and the safeguards the government amendments have provided, persuade the noble Lord to withdraw his Amendment 4 and others not to move theirs.
The Deputy Chairman of Committees (Lord Bates) (Con)
I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to respond to the debate on his amendment.
Lord Hunt of Kings Heath (Lab)
I first thank my noble friend Lady Thornton for her words in support of the amendment and the noble Lord, Lord Patel, who was hoping to field an impressive cast list in this debate. I thought he did very well; I have always thought he would make a first-class lawyer—he should take that as a compliment.
At the heart of it, as he and the noble Lord, Lord Sharkey, said, this is a constitutional point: the advice we have had from a House of Lords Select Committee is that what the Government are proposing is constitutionally unacceptable. While the Minister’s amendments are always welcome, the fact remains that the Bill, after the Government’s amendments, would allow Ministers to create completely new criminal offences and make changes to existing offences. The Minister kindly explained this, but here we get to the heart of this Bill and the problem that many of us have with it. She talked about novel regulation and the need to keep pace with developments. I understand that.
The Deputy Chairman of Committees (Lord Bates) (Con)
We now come to the group beginning with Amendment 6. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 6
Lord Sharkey
“( ) Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Member’s explanatory statement
This amendment, and the amendments to page 5 line 12, page 7 line 22 and page 9 line 27 in the name of Lord Sharkey, replace the existing affirmative procedure with a super-affirmative procedure in order to increase parliamentary scrutiny.
Lord Sharkey (LD) [V]
My Lords, Amendment 6 deals with human medicines. Amendments 53, 71 and 98 in the group make the same provisions as Amendment 6 but for veterinary medicines, medical devices and information systems. I will also speak to Amendments 143 and 144, which deal with the mechanisms that make Amendments 6, 53, 71 and 98 work. Our Amendments 135, 136 and 142 would replace the negative procedure in cases of urgency with the “made affirmative” procedure. I shall not speak to these because the Minister has more or less conceded the point in his new amendments.
Amendment 6 is in my name and those of the noble Lord, Lord Forsyth of Drumlean, the noble and learned Lord, Lord Judge, and the noble Baroness, Lady Andrews. I am immensely grateful for their support and regret that they cannot be present today because they are all speaking at the internal market Bill Second Reading in the Chamber. It is extremely unhelpful that the Government have scheduled two significant Bills for the same time slots. They should be decoupled to prevent future clashes.
Amendment 6 and its equivalents deal with the non-urgent scrutiny procedures currently set out in the Bill. They replace, in Parts 1, 2 and 3, the affirmative procedure for delegated powers with the super-affirmative procedure set out in Amendments 143 and 144 later in the Bill. The purpose of these amendments, taken as a whole, is to restore an element of parliamentary scrutiny to a Bill which so conspicuously lacks it.
This is a skeleton Bill. Parts 1, 2 and 3 contain no policy detail but give the Minister effective carte blanche. The Minister is given almost unfettered power to remake our human medicines, our veterinary medicines and our medical devices regimes. The reports of the DPRR Committee and the Constitution Committee were highly critical of this approach. At Second Reading, the noble Lord, Lord Blencathra, chair of the DPRRC and speaking for it, said that
“the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy.”
He went on to say that his committee was
“deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes … but also by their failure to acknowledge the breadth of the powers that the Bill would confer.”
He concluded:
“Parliament is effectively bypassed; that is a sick joke of good law.”—[Official Report, 2/9/20; cols. 415-16.]
Despite all this, it is likely that the Minister will choose to represent the proposed use of the affirmative procedure in this Bill as meaningful parliamentary scrutiny, but it is emphatically not that. Parliament cannot amend SIs and this House has voted down affirmative SIs just four times in the past 70 years. The Constitution Committee in its 2018 report The Legislative Process: the Delegation of Powers noted:
“Without a genuine risk of defeat, and no amendment possible, Parliament is doing little more than rubber-stamping the Government’s secondary legislation. This is constitutionally unacceptable.”
Affirmative SIs do not constitute meaningful parliamentary scrutiny, and the Government’s promise of wide, but unspecified, consultation on the powers in the Bill does not somehow magically restore parliamentary scrutiny. Parliament is still bypassed.
There is a delegated legislation procedure that allows for significant parliamentary scrutiny. This procedure, which comes in several flavours, is known to the Government as “exceptional procedures” and to Erskine May, in Part 4 Chapter 31.14, as the “super-affirmative procedure”. This is what our amendments propose should replace the existing affirmative procedures written into Parts 1, 2 and 3. Erskine May characterises the super-affirmative procedure as follows:
“The super affirmative procedure provides both Houses with opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form.”
It notes that
“the power to amend the proposed instrument remains with the Minister: the two Houses and their committees can only recommend changes, not make them.”
Our amendments follow this pattern and are more generally based on the variant of the procedure used in the Public Bodies Act 2011. Amendments 143 and 144 set out the details and the stages. First, the Secretary of State must lay before Parliament a draft of the proposed regulations and a document explaining them; secondly, he or she must request a committee of either House whose remit includes health, science or technology to report on the draft regulations within 30 days; and thirdly, in proposing a draft statutory instrument containing the regulations, the Secretary of State must take account of any representations, any resolution of either House and any recommendations of the committee to which the draft was referred. After the expiry of the 30-day period, the Secretary of State may lay before Parliament regulations in terms of the original or a revised draft. The Secretary of State must also state what representations, recommendations or resolutions were made in the 30-day period and give details of any such. He or she must also explain any changes made in a revised draft. After that, the normal affirmative procedure continues.
The Library records that the last insertion in a Bill of the super-affirmative procedure was by the Government themselves in October 2017 in the Financial Claims and Guidance Bill. When they are not doing it themselves, the Government traditionally put forward any of or all three routine objections to the use of super-affirmatives. The first is that it is unnecessary because the use of the affirmative procedure provides sufficient parliamentary scrutiny. Sometimes, this objection is elaborated by praying in aid extensive consultation. I remind the Minister of the DPRRC’s remarks in paragraph 45 of its report on the Bill where it says that
“we are concerned at consultation being presented as a substitute for Parliamentary scrutiny.”
It is quite obviously untrue that the affirmative procedure allows any kind of effective scrutiny.
The second routine objection is that the super-affirmative procedure is cumbersome. I take this to mean only that this procedure is more elaborate than the affirmative procedure, which is, of course, the whole point. It is necessarily more elaborate because it provides for actual scrutiny where the affirmative procedure does not. The third routine objection is that it all takes too long. This has force only if there is some imminent deadline. The Minister may argue that there is such a deadline at midnight on 31 December. At this point, the Government lose the powers conferred by Section 2(2) of the European Communities Act to modify the regimes, but does this really present a deadline? I leave aside here the issue of whether this Bill will have been passed by then, given its very slow progress and the sparse future scheduling.
The impact assessment helpfully sets out, in Annexe B, the number of times the Section 2(2) powers have been used. Between 2013 and 2019 they generated a total of 11 SIs. In each of the last four years they have generated just one SI. This is not an avalanche. Nothing in these figures shows urgency. Nothing suggests we need to rush regime changes by excluding scrutiny provisions from the Bill. Nothing suggests that using the super-affirmative procedure would cause significant delay or disadvantage.
The impact assessment notes explicitly, on page 5:
“policy development is at an early stage”.
This was in June. If policy development has made progress since then, perhaps the Minister can now tell the Committee what policy changes he intends to propose, using the delegated powers in Parts 1, 2 and 3.
If policy development has not made progress, it is vital that when it does, and sees daylight in SIs, those SIs are scrutinised as fully as possible, as the super-affirmative procedure permits. In the event that a policy or technical change is required urgently, the provisions of this Bill, with the latest Government amendment, should allow the use of the “made affirmative” procedure.
This is a skeleton Bill. It is an attempt to bypass Parliamentary scrutiny. It contains no policy details and has no special claim to urgency as a reason for limiting scrutiny. The affirmative procedure is not meaningful scrutiny, as our Constitution Committee has pointed out—but the super-affirmative procedure is. That is what these amendments propose. Parliament should not be bypassed. I beg to move.
Lord Kakkar (CB) [V]
My Lords, I support the noble Lord, Lord Sharkey, and everything he has said in moving Amendment 6. These are clear matters of principle, and although one must accept that government Amendment 133 is an attempt to provide concessions on them, the noble Lord has set out clearly why adoption of even the affirmative procedure will not provide sufficient scope for appropriate scrutiny of what may turn out to be exceedingly important regulations.
The argument for adoption of the super-affirmative procedure has been well made, and I shall not repeat all the noble Lord’s arguments, save to say that in moving his amendment he also dealt with all the potential arguments that could be put against what is proposed in the amendments. In those circumstances, bearing in mind the importance of the issues that the legislation will cover, and the deep anxieties already expressed in Committee about the nature of the Bill, both in practical terms and in terms of its constitutional implications, Her Majesty’s Government should seriously consider accepting these important amendments.
Lord Patel (CB) [V]
My Lords, Amendments 137 and 138 in this group are in my name. They have partly been answered by government Amendment 133, and I shall speak about all three. My amendments are probing amendments, which would prevent regulation exercise in respect of Clauses 6 and 15 in relation to the disapplication of certain provisions in the medicines and medical devices regulations where there is a serious risk to public health. The reasons for this are the same as those set out earlier on the amendment tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath.
The Government do not require the negative procedure to intervene swiftly in emergency scenarios, as the affirmative procedure is available, and safeguards parliamentary scrutiny. That is what the amendment is about. The Government have tried to respond to it, to some extent, through their Amendment 133, which removes subsections (3) to (9) of Clause 42 and inserts instead many new subsections, including a table detailing which specific provisions will be subject to the negative procedure, the “made affirmative” procedure and the draft affirmative procedure.
Baroness Jolly (LD) [V]
I speak in support of these amendments in the names of my noble friend Lord Sharkey and other eminent noble Lords. I confess that I had not heard of the super-affirmative procedure until my noble friend sat me down and talked me through it, and it struck me as being eminently sensible and doable, and this is exactly the right sort of Bill—or the regulations contained herein are exactly the right sort—for the super-affirmative procedure. I ask all noble Lords to support this amendment and those who support it.
Baroness Thornton (Lab)
My Lords, I thank the noble Lord, Lord Sharkey, for his comprehensive introduction to this group of amendments, particularly those that he is supporting.
We are minus at least four noble Lords from this debate because of the clash with the other Bill. I have certainly made my view known to the usual channels in the next booth that we cannot continue to discuss this Bill in those circumstances because we will be missing too many people who have a stake in the Bill and amendments down. I cannot imagine what the noble Lord, Lord Forsyth, is saying to his own Benches about this—actually, I probably can, and it will not be polite, I suspect. He put his name down to this amendment and, presumably, found out that he was not allowed to speak in both the Second Reading debate and in this Committee at the same time. I can see why that rule is there, but we are finding that this really does not work.
While the affirmative procedure offers nothing like the scrutiny given to a Bill, which typically goes through several substantive stages in each House and can be amended, we agree wholeheartedly with the DPRRC’s view that Clauses 1, 8 and 12 contain inappropriate delegations of power. We are where we are, and we therefore take the view that the affirmative procedure should apply. Amendment 134 provides for all regulations to be made subject to the draft affirmative procedure rather than the negative procedure and for urgent regulations to be subject to the made affirmative procedure rather than negative procedure.
Both the DPRR Committee and the Constitution Committee have expressed considerable concern at the inappropriate use of the negative procedure in this Bill. For example, Clause 2(1)(n) provides that regulations under Clause 1 may make provision about prohibitions relating to the supply of human medicines. Clause 42(9) provides for such regulations to be subject to the negative procedure. The explanation given for this in the memorandum, which I think I referred to in the very first debate in this Committee, is as follows:
“proposals to make changes to existing provisions, or to introduce new provisions enabling the supply, administration or prescribing of medicines are made to reflect shifts in best practice following extensive consideration and scrutiny by the relevant professional bodies.”
The DPRRC found this an unconvincing explanation. I probably do as well. It noted:
“It isn’t clear why consultation with relevant professional bodies lessens the requirement for scrutiny in Parliament. Indeed, if proposed changes are sufficiently important for there to be extensive consideration and scrutiny by professional bodies, this supports requiring the higher level of scrutiny in Parliament that the affirmative procedure affords. Furthermore, the prohibitions to which clause 2(1)(n) applies are sufficiently important that breach of them is a criminal offence (punishable, in the case of 4 of the 5 prohibitions, by imprisonment for up to two years). Even accepting the appropriateness of the delegation of powers in clause 1, we take the view that the affirmative procedure should apply. The consultation requirement imposed by clause 41 of the Bill is to be welcomed but we are concerned at consultation being presented as a substitute for Parliamentary scrutiny. On the contrary, if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”
The committee also highlighted and raised concerns about Clause 9(1)(f), which provides that regulations under Clause 8 may make provision about the categories of person who may apply for veterinary medicines. The EM states:
“any proposals to make changes to existing powers or to introduce new powers for veterinary professionals to supply, administer or prescribe medicines will be subject to extensive consideration and scrutiny by professional bodies”.
Again, the committee found this unconvincing for the same reason, and took the view that the affirmative procedure still applies. I must say, I wholeheartedly agree with its assessment. As it says,
“if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”
My amendment also addressed the egregious provisions of Clause 42 that provide that where any such regulation needs to be made urgently to protect the public from imminent risk of serious harm to health, the negative procedure applies instead. The Government’s justification for departing from the affirmative procedure was that:
“It is appropriate for regulations made in these circumstances to be subject to the negative resolution so that they can come into force immediately and provide an efficient means of addressing an imminent serious public health risk. We expect that such regulations would only need to be in place for a very short period of time, potentially shorter than it would take to schedule and hold debates”.
This is wholly inadequate.
The DPRRC stated:
“We are wholly dissatisfied by departments repeatedly arguing for powers otherwise subject to the affirmative procedure to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure … Even accepting the appropriateness of the delegation of powers in clauses 1 and 12, if the affirmative procedure provides the appropriate level of Parliamentary scrutiny for regulations made in reliance on clauses 6 or 15 in non-urgent cases then, in the absence of cogent reasons for the negative procedure to apply in urgent cases, we take the view that the made affirmative procedure should apply in urgent cases.”
The Constitution Committee concurred, recommending that
“the emergency powers in this Bill are subject to the made affirmative procedure, rather than the negative procedure, such that Parliament is required actively to approve them.”
The Minister will be well aware that regulations under the “made affirmative” procedure can be made and laid as expeditiously as can regulations subject to the negative procedure. They can also be laid during a parliamentary recess, unlike draft affirmative instruments. Quite frankly, it is insulting that the Government have the gall to argue for emergency powers to be subject to less scrutiny under the negative procedure, especially in the current climate when hundreds of emergency regulations have been introduced with considerable haste using the “made affirmative” procedure. Can the Minister say how this dereliction ever made it into the Bill, never mind through the Commons? I imagine that the Minister might be quite embarrassed to put her name to the Bill, which is perhaps why the Government have introduced Amendment 133 at the 11th hour.
I also speak in support of the super-affirmative amendments in the name of the Lord, Lord Sharkey. They are supported by Members across the House—including my noble friend Lady Andrews who is not here to give her support although she is extremely enthusiastic about this amendment.
Given that this is a skeleton Bill, the use of the super-affirmative procedure seems a sensible and proportionate mechanism. In this case, it would allow relevant parliamentary committees, in consultation with stakeholders, opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. It has been used effectively by Governments of all colours, who recognise that it allows them flexibility when they need to bring forward regulations, while consultation and scrutiny happen before any amendments come to the House by affirmative resolution.
That is particularly important given that many areas in which we expect regulations to be laid, ranging from life sciences and clinical trials to hub and spoke pharmaceutical models, could make the contents of the SIs—and, in the absence of policy details in the Bill, even examples of draft regulation that have been published in respect of other Brexit legislation—controversial. I hope that the Minister recognises the merit of this proposal.
Baroness Penn (Con)
My Lords, I will begin by speaking to government Amendment 133 on behalf of my noble friend Lord Bethell. It provides significant changes that I know many will welcome. We have listened to the concerns raised about parliamentary scrutiny on emergency powers. I assure noble Lords that we have carefully considered their views and the different amendments that have been put forward on this topic.
As a result, government Amendment 133 would change applicable parliamentary procedure for reactive emergency regulations to the “made affirmative” procedure. It also provides that regulations about prescribing, advertising, packaging and labelling in relation to human and veterinary medicines will no longer be subject to the negative resolution procedure, but instead to the draft affirmative procedure. Using the “made affirmative” procedure when making regulations reactively in emergency situations affords the Government the required speed and flexibility to react to emergencies while providing that Parliament can scrutinise what has been done and why. When we make the regulations proactively, we must demonstrate the need to protect the public from the risk of serious harm; these regulations will be subject to the draft affirmative procedure.
It is important to acknowledge that the emergency powers are not intended to be used. However, as the noble Baroness, Lady Thornton, said, we are in a situation where we are currently using emergency powers, so she is correct that the “made affirmative” procedure has been put to good effect during the current pandemic. None the less, these powers are a measure of last resort to protect the public from the risk of serious harm to health.
We want to avoid using the powers reactively where possible. It is already a condition in the regulations that the situation must be accompanied by a declaration of the urgent need to protect against the imminent risk of serious harm to health. I note the questions asked by the noble Lord, Lord Patel, about the definition of that statement. I will write to him further on that matter.
The Deputy Chairman of Committees (Lord Bates) (Con)
My Lords, I have received one request to speak after the Minister. I call the noble Lord, Lord Patel.
Lord Patel (CB) [V]
I thank the Minister most sincerely for her extensive response. I understand some of the points she made. I am also grateful that she is going to write to me and other noble Lords about the definitions that I questioned in my speech.
I accept that at times the Government will need to have powers in emergencies, but some of the examples the Minister gave were not really emergencies. I made the point that in such situations government Amendment 133 and the table do not allow for parliamentary scrutiny. The fact that there is no sunset clause means that the Government will have power to make regulations under both the negative and the affirmative procedure for evermore. That cannot be right. Yes, there will be a learning process, but there should be more ability for Parliament to scrutinise.
The Deputy Chairman of Committees (Lord Bates) (Con)
I call the Minister to respond to the point made by the noble Lord, Lord Patel.
Baroness Penn (Con)
My Lords, I believe that the noble Lord’s comments reflect the themes that we are discussing throughout our scrutiny of the Bill. I certainly take them on board with regard to this group of amendments, I believe that we have discussed them before and will discuss them again on other groups of amendments.
The Deputy Chairman of Committees (Lord Bates) (Con)
Finally, I call the noble Lord, Lord Sharkey, to respond to the debate on his amendment.
Lord Sharkey (LD) [V]
I am grateful for the support of the noble Lord, Lord Kakkar, and the noble Baronesses, Lady Jolly and Lady Thornton, but I am disappointed that the Minister still seems to regard the affirmative procedure as constituting effective scrutiny. Let me briefly quote again the Constitution Committee, which says:
“Without a genuine risk of defeat, and no amendment possible, Parliament is doing little more than rubber-stamping the Government’s secondary legislation. This is constitutionally unacceptable.”
Neither the DPRRC nor the Constitution Committee agrees with the Government’s position on this, I think largely because it is obviously wrong. I am also disappointed that the Government seem to continue to believe that extensive consultation is equivalent to or a substitute for parliamentary scrutiny—another obviously wrong position, as the DPRRC makes clear.
As to the objection that the super-affirmative procedure is too cumbersome or lengthy, neither of these objections could have any weight unless there were some urgency. As I have explained, there is not; even if there were to be, the “made affirmative” procedure would kick in and take care of it.
As I remarked in the opening group this afternoon, at the root of all this is a desire by the Government to take powers to make policy before they have decided what that policy is. This is not only perverse but evades parliamentary scrutiny and bypasses Parliament. We will return to this issue on Report. In the meantime, I beg leave to withdraw my amendment.
Lord Bethell
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 1 in considering whether regulations made under subsection (1) would promote the health and safety of the public.
The Deputy Chairman of Committees (Lord Bates) (Con)
We now come to the group beginning with Amendment 8. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. I call the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
May I ask for some clarification? Normally in Committee—under normal life, as it were—we would not start another group that would take at least three-quarters of an hour or so if we knew we were going to rise at a set time. I want some guidance as to why we will start this group now, when we know that we will not finish it within the time allowed. We might get through my speech and the next one, but that will be it. I am looking for guidance, Lord Chair.
The Deputy Chairman of Committees (Lord Bates) (Con)
Weighty matters of this nature are dealt with by the usual channels; the Government Whip will respond.
Baroness Penn (Con)
My Lords, I understand that the need to rise at a set time is part of the needs of the hybrid House. With other Grand Committees that have taken place in this circumstance, we have made progress on groups and had to adjourn mid-group. That is incredibly important in order to make progress on legislation when we are operating to time-constrained sessions.
Baroness Thornton (Lab)
I have to register my objection to that. If we want a proper debate, this is not just about people making timed speeches; it is about a debate. A debate should be a coherent whole, not one or two speeches and then continuing after maybe a week’s break. Would I be allowed to make my opening speech again when we go back on the second day of Committee?
Baroness Penn (Con)
My Lords, we would not have a second opening speech. If the noble Baroness has strong objections, we can adjourn.
Baroness Thornton (Lab)
I think we should. This is an important debate and we need it as a whole debate. I would be very grateful if that could be considered. I promise to make a small speech when we restart.
The Deputy Chairman of Committees (Lord Bates) (Con)
That concludes the work of the Committee this afternoon. The Committee stands adjourned. I remind Members to sanitise their desks and chairs before leaving the Room.
Medicines and Medical Devices Bill
Monday 26th October 2020
(4 years ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-III(Rev) Revised third marshalled list for Grand Committee - (26 Oct 2020)
Earl Howe (Con)
My Lords, it may be for the assistance of noble Lords if I make a short statement before we recommence proceedings. As noble Lords will be aware from my noble friend Lord Bethell’s letter to Peers of 13 October, the Government have tabled a number of amendments for consideration in Grand Committee. Many of these amendments are designed to address criticisms of the Bill expressed by noble Lords at Second Reading, and in particular by your Lordships’ Delegated Powers and Regulatory Reform Committee and Constitution Committee, in an endeavour to provide reassurance to this Committee at an early moment.
Unfortunately, it has since come to light that the Government’s intention to move these amendments in Grand Committee, which we had believed was implicit in my noble friend’s letter and understood from subsequent discussions, had not in fact been clearly and properly communicated. I further understand that there was a two or three-day delay in noble Lords on the Labour Front Bench, and perhaps others, receiving the letter. I apologise to the Official Opposition, Liberal Democrat Peers, noble Lords on the Government Benches and those on the Cross Benches for the shortcomings in our communications, which, I need hardly add, we shall use our utmost endeavours not to see repeated.
There is a substantive reason why the Government wished to move their amendments in Grand Committee. It is that, according to the clear advice we have received, a legislative consent Motion by the Northern Ireland Assembly cannot be put in motion until such time as the government amendments to which I have referred become part of the Bill. Were we to delay approval of the amendments until Report, our clear advice was that this would put back the Northern Ireland legislative consent process by up to three months. Such a delay would in turn have serious consequences for the completion of this Bill, whose importance in the context of the United Kingdom’s exit from the European Union cannot be overemphasised. It is very important for the health of the public that we achieve a timely completion which does not leave us without a means of passing necessary regulations at the start of 2021.
These were the reasons why, in the short adjournment that took place during last Monday’s Grand Committee proceedings, we asked noble Lords to allow two government amendments to go through on that day. We did so particularly bearing in mind that the alternative to moving the amendments was to withdraw them, which might in turn have signalled to the Northern Ireland Executive that the amendments no longer represented government policy. We are sincerely grateful to noble Lords for their understanding and for the agreement reached on that occasion. As I have indicated, we made that request to noble Lords in good faith, driven by clear legal advice relating to the process around Northern Ireland consent Motions. Since then, some doubts have been cast on whether that advice was in all respects accurate. It is still our belief that it was, but we are seeking urgent confirmation of this, which we shall convey to noble Lords at the earliest opportunity.
More importantly, however, for this Committee, we have received unequivocal legal advice from the Public Bill Office that, notwithstanding any amendments approved in Grand Committee by unanimity, it is open to the House, and indeed to individual noble Lords, to return to the issues covered by such amendments on Report and to debate and vote on any further amendments that noble Lords wish to table. That means that by allowing government amendments to go through in Grand Committee, noble Lords would not be precluded from returning to those issues, in any way they chose, on Report. On behalf of the Government, I undertake that the Government will raise no objection to this if it is the wish of noble Lords that such further debates take place. If, notwithstanding the assurances I have given, any noble Lord wishes to object to a government amendment spoken to in Grand Committee, the Government will withdraw that amendment. In the meantime, it is the Government’s wish to enable all noble Lords to engage with Ministers and officials as fully and as regularly as they may require in an effort to achieve what we all desire for this important Bill, which is understanding and, if possible, consensus across the House.
Baroness Thornton (Lab)
I thank the noble Earl for that statement, which is extremely helpful. I am alarmed, or surprised, that we are at this stage looking at a grey area about whether or not it is necessary for these amendments to be moved and accepted. It is very important that that is clarified, and I would just like to make one or two other points.
Grand Committee is for probing; it is for consensus, and then it is up to the House to take the decisions on Report about that. These amendments, which we are being asked to nod through, really are not consistent with what the Companion says Grand Committee is there for, so the clarification that we will have to return to these at a later stage is, of course, absolutely necessary.
However, that also means that on Report we will have a Bill before us that is not the same Bill as we have now. It will have been significantly amended in some very significant areas of policy. So I am writing to the Constitution Committee and the Delegated Powers Committee today to ask them to look again at the Bill. When the amendments have been accepted, it will not be the same Bill as we have now.
We will not negative the amendments today, because I accept the noble Earl’s statement and, on the balance of risks, the Opposition would not wish to delay the Bill for three months, into next year. We can see the dangers that that would represent. However, I ask the Government to examine the proposal made by my noble friend Lord Hunt to the Minister and the Bill team in a meeting to discuss the issue. That was that they should look at paragraph 8.127 of the Companion and consider removing from the Bill all the government amendments concerned with this issue. We could then take those in a group at the end, on the Floor of the House. That would give us time to do the stuff we have not yet done and discuss the substance of the amendments.
If the Minister and the Bill team had come to us a month ago and said, “We’ve got this problem with the Northern Ireland consent process, and this is what it means,” we would not be having this discussion now, because we would have worked out how to resolve that problem. I regret that that is not what happened and I hope that we will now move forward in a more positive way. Finally, we will look carefully at what is added in Grand Committee as a result of these very particular circumstances and we may seek to delete or amend some of the government amendments at the next stage of the Bill.
Baroness Jolly (LD) [V]
With the Northern Ireland component, a time constraint was imposed on the Committee, and people have been looking at ways of solving the problem since our previous meeting. Since 8.30 am I have been in various meetings with various people looking for ways forward. The one described by the noble Earl, Lord Howe, is on the table and has been agreed by all party spokespersons. It was finally agreed at a meeting with the Minister and others at 1.30 pm. Like the noble Baroness, Lady Thornton, I am grateful to the noble Earl for his help in resolving this issue.
Earl Howe (Con)
I am grateful to both noble Baronesses for their responses. I think that this provides a basis on which to proceed with our Grand Committee debate today, pending further clarification on the matters that I referred to earlier between now and Wednesday, our next Grand Committee day. I can assure noble Lords that my colleagues and I will endeavour to achieve that clarity, which we will disseminate at the earliest opportunity.
Baroness Thornton (Lab)
I thank the noble Earl. I think that we probably need to continue this discussion, to make sure that we end up in the right place, with a Bill that we can take forward to Report.
Baroness Thornton
Member’s explanatory statement
This amendment places a duty on the Secretary of State to act with a view to ensuring, rather than have regard to, safety, availability and UK attractiveness when exercising powers.
Baroness Thornton (Lab)
The amendment, in my name and that of my noble friend Lord Hunt, gives the Secretary of State a duty to act with a view to ensuring, rather than having regard to, safety, availability and UK attractiveness when exercising the powers in the Bill. The Bill states:
“the appropriate authority must have regard to … the attractiveness of the relevant part of the United Kingdom”,
and we want to change that. However, there is no definition of attractiveness in the Bill.
The Independent Medicines and Medical Devices Safety Review, led by the noble Baroness, Lady Cumberlege, published in July, focused on safety issues with just three medical interventions. Along with these, recent scandals such as those relating to metal-on-metal hips and PIP breast implants, show the need for strong regulatory oversight. Patient safety must be prioritised, including where there are competing considerations, such as the attractiveness of the UK as a place to conduct clinical trials and supply medicines and medical devices.
To address this, we believe that either the attractiveness clauses should be removed, or a statutory definition of attractiveness should be included in the Bill, along with a further provision that the appropriate authority should always prioritise safety. I beg to move.
Lord Sharkey (LD) [V]
I shall speak briefly to Amendments 9 and 13. I should start by saying that I enthusiastically support Amendment 8, moved by the noble Baroness, Lady Thornton. We all know that the phrase “have regard to” lacks any real force. Like her amendment, our Amendments 9 and 13 are intended to strengthen Clause 1(2), whose opening words read
“In making regulations under subsection (1), the appropriate authority must have regard to”,
followed by a list of the things to which it must have regard. Amendment 9 would change those opening words to read, “In making regulations under subsection (1), the appropriate authority must have regard to, and in the case of regulations not subject to section 42(6), (7) or (8), must publish with the draft regulations an assessment of their impact on,” and then the list of things to which regard must be had.
Clause 42(6), (7) and (8) are excluded because they contain urgency provisions and may now anyway make use of the “made affirmative” procedure. The purpose of the amendment is to ensure that there must be a full assessment of the impact of any regulation on the three specified areas. This applies to all three of the areas and is of particular importance in the assessment of safety and how it is to be prioritised, in subsection (2)(a).
Amendment 13 addresses the issue of assigning priority to the safety of human medicines, as do other amendments in this group. It would rewrite subsection (2)(a), so that instead of reading,
“the safety of human medicines”,
it would read “the priority of ensuring the safety of human medicines”. Other noble Lords have tabled amendments suggesting different ways of ensuring this priority and I look forward to hearing their contributions. But whatever the variations in approach, it is obvious that a strong, clear and unambiguous statement of the priority of the safety of human medicines needs to be inserted in the Bill.
Baroness Cumberlege (Con)
I shall speak to Amendments 10, 12, 74 and 75 on the second Marshalled List, and I thank the noble Lords who have supported these amendments—the noble Baronesses, Lady Burt of Solihull and Lady Hollins, and the noble Lords, Lord Patel and Lord Hunt of Kings Heath.
This Bill chimes perfectly with the review that I led into two medications and a device. The review culminated in the report First Do No Harm, which states:
“Innovation in medical care has done wonderful things and saved many lives. But innovation without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous.”
In conducting the review over two and a half years, my team and I listened to hundreds of women and their families, with their stories of anguish, acute suffering, destroyed relationships and parents whose children have been harmed, deformed and had their potential lives ruined.
I have been told that this Bill is not a safety Bill. If it is not, what is it, for goodness’ sake? How can safety not be the overriding purpose of the Bill? My modest amendments, and those of other noble Lords, seek to make it so.
In paragraphs (a) to (c) of Clause 1(2), safety is not the primary consideration but is on an equal footing with the availability of medicines and the UK as an attractive place in which to conduct clinical trials and the supply of medicines. These aspirations are of course important but in the way in which the Bill is drafted safety is simply an “also ran”. It should not be; it should be of overriding importance. As the noble Lord, Lord Patel, said in his amendment on the first day of Committee, the construction of this clause needs improvement.
My review found safety seriously wanting. We were commissioned to review two medications given to women. The first was Primodos. Between the 1950s and the 1970s, two little pills were given to women to test whether they were pregnant. From the late 1950s, concerns were raised that these tests could harm and cause abnormalities in a developing baby. Although disputed, there is a body of opinion that has linked these hormone pregnancy tests to a wide range of various malformations. We discovered opportunities where action should have been taken and was not.
These pregnancy tests were taken off the market in 1978 following concerns over their safety—more than a decade after safety concerns were first raised. No one listened. The risk to patient safety was not prioritised, one result of which has been a 40-year battle to get an independent review of the regulations that were found wanting. I accept that regulation was in its infancy in the 1960s and 1970s, but patient safety should have been the overriding consideration then, as it must be now.
In the course of our review, we met the children—now adults—who suffered so much and their families. Many dreadful impacts have been associated with these pregnancy tests, such as loss or shortening of limbs—we have seen other examples of this happening in the past—heart defects, spinal issues, seizures, dysmorphic facial features, digestive and bowel issues, and so on. We were struck by the unremitting guilt felt by the women who took the pills. They feel to blame for their children’s disabilities. They suffer enduring psychological harm, and although we told them, “It wasn’t your fault; you weren’t told; how can you be blamed?”, I fear that we did not convince them.
The second medication reviewed was sodium valproate. It is a very effective drug for controlling epilepsy but it has a history that should never be repeated. When first licensed in 1972, it was known to be teratogenic in animals. Prescribing doctors were warned that it should be used only in severe and resistant cases of epilepsy in pregnant women. In the 1980s, academic literature drew attention to the risks. In the 1990s, the risks of neural tube defects and other congenital malformations were known. Even then, women were saying that exposure to sodium valproate had caused damage to their offspring.
In early 2000, doctors were again warned of an association with delayed development in children, with delayed speech, IQ affected and reports of autism. Throughout this tragic history, clinicians have been warned and women and their families have not been listened to; they have been dismissed and had their knowledge denied. It took 40 years after sodium valproate was introduced to the market to produce a toolkit, the purpose of which was to provide information to women of childbearing age and healthcare professionals about the harm that could be caused. Two years later, in 2018, a pregnancy prevention programme was introduced; it stipulated three measures that were designed to prevent further harm.
You would suppose that this is the end of a tragic story—problem solved—but that is not so. It is truly shocking that, today, epileptic pregnant women on sodium valproate have a one in two chance of having a disabled child. They are still exposed to huge risks because they are not told what those risks are. Babies continue to be been born with lifelong disabilities due to exposure to this drug. We know that the results are catastrophic.
The third and final area that we were asked to review was surgical mesh, a device inserted to support pelvic organ prolapse and to treat stress urinary incontinence. For many women, mesh surgery is trouble-free and leads to improvements in their condition, but that is not the case for all. A BMJ article published on 10 October 2018 had the arresting headline “How mesh became a four letter word”. In the article, Jonathan Gornall charts the rapid rise and fall of vaginal mesh; it is, as he says,
“a story that offers lessons for the entire medical community, and for manufacturers and regulators”.
Unlike many other devices, polypropylene mesh is intended to remain in situ for life. We heard from countless women who sought to have it removed but were unsuccessful; sometimes attempts even caused further serious damage.
Why would they want it removed? Because mesh ruins their lives. We were told by hundreds of women that they suffer excruciating pain, recurrent infections and haemorrhages, bowel issues, recurring or new incontinence, and nerve damage that restricted their mobility. Fit young women were confined to a wheelchair for the rest of their lives. I will always remember one little boy telling us, “I just want my old mum back.”
We heard about sexual difficulties leading to the loss of a sex life and broken marriages. We heard from women how the constant pain resulted in the loss of employment—that is, their job—so they lost their income. Because of that, they could not afford the mortgage or rent so they lost their homes, and because they were homeless, they were fearful that their children would be taken into care. One woman told us:
“This is not a life. It is an existence.”
We were so shaken by what we heard that, in July 2018, we recommended that vaginal mesh should be paused. Our recommendation was immediately accepted by NHS England and the Department of Health and Social Care. The scandal is that our recommendations were not new; all had been suggested before, but no action had been taken. It should not have been for us to recommend this. If safety was of paramount importance, the healthcare system should have picked this up decades before. After all, mesh was first used in the 1960s. It gathered pace in the 1990s; by 2001, it was the most common operation used for ameliorating stress urinary incontinence—a very unpleasant condition, but not life-threatening.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege, and her enormously powerful contribution. I wholeheartedly endorse her concerns about safety and share her worry that patient safety is still not being prioritised after so many years of disaster stories. One cannot but note the gender aspects of the failure of medicine over so many decades—not listening to patients, particularly female patients. Clearly we need to make this Bill better, with a focus on safety.
The report by the noble Baroness spoke to me very personally. My late mother suffered decades ago from endometriosis. She was not listened to or taken seriously and I have been distressed and angered by hearing, just this week, reports of how difficult endometriosis patients still find it to get taken seriously and obtain the treatment they need. The noble Baroness, Lady Cumberlege, has done a brilliant piece of work in highlighting these issues, with a focus on particularly abusive cases.
I have been following the story of vaginal mesh with a sinking heart for some years. It is such a familiar account of vulnerable, suffering individuals being trampled over, ignored and even derided by commercial interests. “First do no harm” is, indeed, a principle that a company —every company, not just those in healthcare—should be forced to consider as a key part of its approach.
However, at this point I will speak chiefly to Amendment 59, which is in my name. I apologise for not coming in to support earlier excellent amendments, or indeed others in this group. With our small Green group juggling crucial issues tangled up in the Government’s legislative pile-up, I just did not manage to get there. I thank the small number of Peers who are carrying a huge weight in this Committee. Amendment 4, tabled by the noble Baroness, Lady Thornton, was particularly important, but many amendments contain constitutional and legal principles that make it a particular regret that so many potential contributors—both last week and today—are in the main Chamber. However, as I plan to speak at some length to the group starting with Amendment 18, I will be brief here.
Amendment 59 seeks to ensure that the welfare of animals is considered when making regulations about veterinary medicines. I can see that some might think that health and welfare go together, but that is not always the case, particularly in the world of factory farming and considering the context in which noble Lords are seeking, on the Agriculture Bill and Trade Bill, to defend existing veterinary and farming standards against the introduction of truly dreadful health and welfare standards from elsewhere.
There has been a tendency to use drug treatments as an alternative to decent husbandry. Animals might be protected from disease arising from miserable, crowded, inadequate conditions, but their welfare is not being protected. Any intervention should improve their welfare, not block disease caused by misery.
Animals might also be given drugs. I am thinking here particularly of the use in the United States of antibiotics, as growth promoters, and of growth hormones, which leads to animals becoming overly large—sometimes too large to move themselves around, which can be a great source of misery. We might find drugs being sought or used as sedatives to keep animals in conditions in which they would otherwise be uncontrollable or dangerous. The answer is not to drug them but to ensure proper conditions. Health and welfare must go together. That needs to be in the Bill and I hope that the Government will consider including this amendment.
Lord Hunt of Kings Heath (Lab)
My Lords, although I am a member of the GMC board, I am not speaking on behalf of the GMC on this group of amendments.
I speak on behalf of my noble friend Lady Thornton’s Amendment 8, which seeks to beef up the duty of the Secretary of State to make regulations under Clause 1(1) in relation to the safety and availability of human medicines and the attractiveness of the relevant part of the UK as a place to conduct clinical trials or supply human medicines. Amendment 73 does essentially the same for medical devices. As she said, the concept of attractiveness is rather vague and open to misunderstanding, which makes a statutory definition so important. I have also put my name to Amendments 74 and 75 tabled by the noble Baroness, Lady Cumberlege, and will speak in support of her Amendment 12.
Apart from teasing out from the Government what attractiveness means, this is essentially an opportunity to draw out from the Minister their response to the noble Baroness’s report, First Do No Harm. The report is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I have met many of the campaigners involved and their stories were heart-rending, as she has said. I am particularly grateful to the organisation known as Sling the Mesh, whose representatives I had the pleasure of meeting. Noting that the noble Lord, Lord O’Shaughnessy, is speaking later, I say that I remember, after I asked an Oral Question about mesh, that he met campaigners and talked to them for some considerable time. That was very helpful in getting across to the Government and Ministers just what damage had been done by a procedure that for many women proved to be positive and life-affirming. The awful thing is that the women who had terrible outcomes were ignored, because it was inconvenient and the operation was so successful for quite a large percentage. The system completely pooh-poohed them. Even now, under the counter, there is a lot of resistance to the noble Baroness’s recommendations.
The noble Baroness found that the healthcare system—in which she included the NHS, private providers, regulators and professional bodies, pharmaceutical and device manufacturers—was disjointed, siloed, unresponsive and defensive. That is why her core recommendation is the appointment of an independent patient safety commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. Obviously we are debating this later, but it would be helpful to get some sense of the Government’s response. No doubt the Minister might point to the work of Aidan Fowler, the NHS national director of patient safety, and the strategy produced under the auspices of NHS England and NHS Improvement last year. That is fine so far as it goes; it makes the point that patient safety is about maximising the things that go right and minimising the things that go wrong for people experiencing healthcare.
I commend Aidan Fowler for his efforts and commitment. Does the strategy go far enough? Does it represent a systems approach to safety where that becomes the No. 1 objective of the NHS? Does it mean that all equipment and buildings in future will be designed with safety as the first consideration? Will boards of NHS trusts treat safety as their No. 1 responsibility? Will that lead to a wholly different approach by the CQC, because I do not think that safety is a priority so far as it is concerned in its inspections? The big question is: will NHS England and NHS Improvement change their approach and make it clear that safety is an important priority for them? Unless they do, I do not think that any change will take place. The strategy—an NHS England strategy, of course—feels like a collection of good practices, but not something that will change the system, which clearly needs to happen.
To get some sense of this, I looked back to the report by Don Berwick, whom I regard as the guru on patient safety internationally, entitled A Promise to Learn and produced in 2013 in the wake of the Mid Staffs inquiry. Berwick was clear that the quality of patient care, especially patient safety, should be placed above all other aims. He said:
“Patient safety problems exist throughout the NHS as with every other health care system in the world. NHS staff are not to blame—in the vast majority of cases it is the systems, procedures, conditions, environment and constraints they face that lead to patient safety problems. Incorrect priorities do damage: other goals are important, but the central focus must always be on”
patient safety.
What Berwick said in 2013 holds good today. The NHS has made progress since then—I readily accept that—but on no count has safety been embedded as the No. 1 concern. That is what makes the report by the noble Baroness, Lady Cumberlege, so important and why she wants an external champion of patient safety, because it clearly ain’t going to come from inside. It is too diffuse. No one is responsible for patient safety. If Aidan Fowler were directly accountable to the Secretary of State and resided in the Department of Health and Social Care, I would begin to believe that that was a serious attempt, but because the Government have decided that all the national clinical directors should be placed under an NHS management system, direction and accountability at the top of the office have been lost. Therefore, the report by the noble Baroness, Lady Cumberlege, makes sense and will have to be listened to positively.
Baroness Burt of Solihull (LD) [V]
My Lords, I speak to Amendments 10, 12 and 74, to which I have added my name. Although I support all the amendments in this group, they pretty much do the same or a similar kind of job, but I added my name to those amendments specifically because they speak to safety being paramount for new drugs and devices. I say that because the excellent Cumberlege report tells the graphic and heart-rending story of what happens when it is not.
We have heard about the effects of the drugs Primodos and sodium valproate from the noble Baroness, and other noble Lords will cover those areas. My interest relates to mesh and what happens when insufficient care is taken in the implementation and tracking of the well-being of women who have had it inserted. When it goes wrong, it really can ruin the life of the woman affected. Noble Lords may recall the case that I mentioned on Second Reading of how Jane’s life has been ruined by mesh—not just physically but emotionally and economically. The noble Baroness described such things as well. Yet the surgeons who did this to her seem to exhibit no remorse and have closed ranks, denying the very existence of some of the pieces of mesh inside her.
It makes my blood boil to hear those harrowing stories, and the noble Baroness had to listen to such testimony from victims for two years. As she says in her report, this took its toll on her and the other members of the panel, but how much worse must it have been for the victims themselves? Yet we see phrases in the Bill such as,
“the appropriate authority must have due regard to ... the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.
Attractiveness? What does that even mean? My noble friend Lady Jolly spoke on the third group of amendments about the multiple interpretations that the term could have. Are we trialling drugs and devices on human beings so that we can subsequently flog them abroad? I am sure that the Minister will deny that and give us a proper definition of the word.
Attractiveness and availability must be a low priority compared with safety and that is why I strongly commend the amendments. If the Minister believes that safety must be the overriding consideration, I trust that he will have no difficulty in accepting them.
Lord Patel (CB) [V]
My Lords, as I was not able to get in following the comments made by the noble Earl, Lord Howe, I say that, as a Cross-Bencher, I was irritated that we were not involved in the communication, I am glad that the statement has been made and I concur with most of the comments of the noble Baroness, Lady Thornton. I hope that from now on the procedure will be better. I had threatened to negative the amendments, but I will not do so now.
I speak in strong support of Amendments 10, 12, 74 and 75 tabled by the noble Baroness, Lady Cumberlege, to which I have added my name. I concur with all that she and other speakers have said. So far as her findings were concerned, I will repeat what I said when we debated her report. The profession needs to hide its head in shame that such trauma was inflicted on women and that such harm to unborn children was caused by disregard for guidance. As an obstetrician, I have never used mesh; I am one of those old-fashioned surgeons who did not use any artificial devices, but then I was not regarded as an avant-garde or fancy surgeon in that respect. Her report is a salutary lesson about the importance of patient safety. I will confine my remarks to medicines and medical devices, and the importance of embedding patient safety.
The noble Baroness’s report is entitled First Do No Harm. I say with humility that the motto on my coat of arms is “Primum non nocere”. I am privileged that the shield that bears it will hang for ever in the chapel of St Giles’ Cathedral in Edinburgh. I took that motto not because of the medical oath, which of course is correct, but because I was at the time chairman of the National Patient Safety Agency of England, an organisation that the noble Lord, Lord Hunt of Kings Heath, had chaired before me. It no longer exists, but its aim was to establish the whole concept and methodology of patient safety in the NHS in England. The NPSA, as it was then known, had developed a confidential reporting system for incidents relating to patient safety for healthcare staff and patients. Nearly 40% of the large number of reports—we used to get as many as 200 confidential reports a day—were related to medicines, medicines delivery and devices.
The concept of the safety of medicines is not new, and the experience of over a century has framed laws, regulations and amendments to make medicines safe and effective. In 1937, more than 100 deaths were reported in relation to sulfanilamide. They were due not to the medicine itself but to the solvent, diethylene glycol, which was added to the active ingredient. This led to regulations requiring testing of medicines in non-clinical and clinical settings prior to their being licensed for therapeutic purposes. Is it not ironic, especially in the context of the report of the noble Baroness, Lady Cumberlege, on Primodos, that the drug thalidomide, used as an antiemetic in early pregnancy, was not licensed in the USA due to animal studies that had shown some deformities in animal embryos? The USA therefore avoided the harm that the medicine caused to unborn children and a condition called phocomelia. It was accepted in a large part of the world, including the United Kingdom, and resulted in tens of thousands of children being born with such deformity.
There are patient groups to whom regulators need to pay special attention when approving medications, such as pregnant women, children and older people. We will come to amendments later on alluding to this. There are many examples of medications that are withdrawn from the market because of patient harm, emphasising the importance of a secure system of post-licensing surveillance. Some 1.1 billion prescriptions are supplied every year in primary care. Furthermore, a mid-sized hospital supplies about 50,000 doses a day. A study in 2018 showed that 237 million medication errors occurred every year in England, of which 68 million caused some degree of harm. While the harm may appear in one part of the system, the solution often lies across it. Much can be learned from a well-run and monitored national reporting and learning system, particularly as to which medicines are commonly involved in errors and hence patient harm. A single change that would make a big difference is a system that recognises and establishes the greater involvement of patients in their own care.
A healthcare system that wants to achieve a significant reduction in patient harm from medications will need a national programme in which different parts of the system work together. The amendment in the name of the noble Baroness, Lady Cumberlege, may be a start to that, and I commend her for it.
Unlike with medicines and the EMA, even at EU level, there is no agency for the safety of medical devices. Regulation relating to medical devices or standards is often a voluntary process and is not governed by national or international standards unless recognised by a regulator as mandatory. The list of what constitutes a medical device is long and ranges from machines and in vitro reagents to software. As the UK leaves the EU, it has an opportunity to devise a system of regulation focused on safety. In 2017, there were more than 16,000 device-related reports of harm. Following the publication by investigative journalists of a series of reports on medical devices known as “The Implant Files”, there has been a demand from doctors and others for greater transparency from manufacturers of devices, particularly regarding safety. The same stringent regulatory process, including disclosure of data related to adverse events, should be part of a market approval process.
I know that several amendments coming up are related to safety and licensing, which currently does not exist in the UK for medical devices. The amendment in the name of the noble Baroness, Lady Cumberlege, in relation to patient safety, including medical devices, will go further than current requirements for market approval. Information and data related to safety, both short-term and long-term, may well be a requirement for market approval. Why is it necessary to have full safety data to license a cardiac drug but not for an implanted pacemaker? As an example, a device called Nanostim was withdrawn from the market three years after safety approval due to the alarming number of patients to whom it was causing harm, by which time 1,400 patients had had it implanted. The noble Baroness is right to highlight the need for more effective regulation for safety of medical devices and medication overall. I am pleased to support her amendment.
Baroness Hollins (CB) [V]
My Lords, it is a pleasure to follow my noble friend Lord Patel. I commend his work on patient safety over many years. I strongly support the amendments in this group, which are intended to improve patient safety—in particular, Amendments 10 and 12 tabled by the noble Baroness, Lady Cumberlege. I withdrew my own, very similar amendment and added my name to that of the noble Baroness.
In the present drafting, as the noble Baroness has explained, there is no explicit hierarchy of the three stated principles: safety, availability and attractiveness of parts of the UK as a place to conduct clinical trials or supply medicines, yet this Bill could be so much more effective if it was more explicitly about patient safety. These amendments put patient safety first, as so clearly called for in the noble Baroness’s shocking recent report First Do No Harm. I quote from that report’s foreword:
“The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.”
I simply stress that safety must apply across all aspects of the development and provision of human medicines with respect to both mental and physical illness. Noble Lords may be unfamiliar with the national STOMP programme, launched in 2016—STOMP stands for stopping over-medication of people with a learning disability, autism or both. Public Health England says that, every day, between 30,000 and 35,000 adults with a learning disability take psychotropic medications when they do not have the health conditions the medicines are for—they are also prescribed to children and young people—yet such medicines may have serious side effects, including adverse effects on their mental and physical health.
I do not wish to speak at length about this or other aspects of these amendments other than to stress that patient safety must be the foremost consideration in this Bill.
Lord O'Shaughnessy (Con) [V]
My Lords, I have spent far too much time with patients harmed by medicines and medical devices going wrong—valproate, mesh and Primodos—and many people affected adversely by other treatments in which they had vested so much hope to be unconcerned about the issue of patient safety. I applaud all noble Lords who have tabled amendments on this topic, and especially pay tribute to my noble friend Lady Cumberlege, whose exemplary work on this issue through her review has given the issue, and the women—because it is mainly women who have been affected—the profile that they should always have had.
I certainly agree with all noble Lords that safety should be considered of greater importance than the attractiveness of the UK. There is and should be no trade-off necessary between attractiveness and high regulatory standards. I also agree with the point made by the noble Lord, Lord Hunt—that there is so much more to patient safety than the regulatory regime for medicines and devices that we are discussing today, but that is what we are discussing.
Having said all that, I have something nagging slightly at me about the topic, which I want to explore in my comments. I wonder whether there is some tension between availability of medicines and devices on the one hand and their safety on the other. As the Bill stands, it fails to elucidate this tension properly. The question that we need to solve is whether it is always right that safety should trump availability and access to medicines.
I start by looking at the purpose of our regulatory regime. The homepage of the MHRA says that it is to
“maintain the safety, quality and effectiveness of our medicines, devices and diagnostic tools”.
Of course, its reputation stands on its ability to make judgments against those criteria, which can sometimes be in tension: a drug can be safe but not efficacious, and it can be effective but not acceptably safe. If there are shortages, which sometimes happens, quality variation might be needed to access necessary medicines and devices. Striking a balance between all those factors and getting the right balance between risk and reward is where the hard task of regulating occurs.
We have heard many examples already on Second Reading and in Committee today of the tragedies that have happened when there have been regulatory and other failures of medicines and medical devices. However, it is also true that some of the greatest success stories in medicines have come about through a more pro-risk approach. I mentioned the HPV vaccine last time, which of course has been extended to boys, even though there continues to be some concern about the level of adverse events. The early access to medicines scheme allows patients to be treated with unlicensed medicines that have not yet had regulatory approval but where there might be a transformative opportunity for patients. Of course, in considering these issues, the words of the noble Lord, Lord Saatchi, and Baroness Jowell in the debate that they so wonderfully led, inspiring us all, also ring true. Creating more access to experimental therapies for ordinary patients can often be the right thing to do for them. It is not that we want unsafe medicines—of course not. But what matters ultimately is the safety of the patient, and sometimes that might mean—or their health and best interests might mean—better access to riskier medicines for some patients that would be unacceptably risky for most patients. Indeed, it is quite possible that the move to personalised medicine will make this more and more likely.
I am strongly supportive of the patient safety agenda, and encourage my noble friend the Minister to commit the Government to taking forward the recommendations made in my noble friend Lady Cumberlege’s review. However, I am a little worried, perhaps wrongly, about the potential impact of these amendments on patients’ ability to access experimental medicines and devices, or even the availability of standard medicines that are experiencing a shortage that might improve people’s lives. In a spirit of this being Committee, though not quite as iterative as it usually is, I wondered whether a different approach would be to amend the Bill so that Clause 1(2)(a) instead reads,
“the safety, quality and effectiveness of human medicines”,
which could then unambiguously be made the overarching priority of the legislation, involving as it would recognition of the trade-offs and tensions in the standard to which regulators are currently held, then applying this approach to medical devices. Whether this is the right way forward is up to noble Lords, but I hope that my noble friend the Minister is open minded on this issue and will consider very carefully the various arguments being made.
Baroness Watkins of Tavistock (CB) [V]
My Lords, it is a pleasure to follow other noble Lords, the majority of whom I completely agree with. I put my name down to speak to this group as I wish strongly to support the amendments tabled by the noble Baroness, Lady Cumberlege, Amendments 10, 12, 74 and 75.
Last year, I was on the pre-legislative scrutiny committee for the Health Service Safety Investigations Bill, which did not proceed as a result of the election. Therefore, I believe that putting patient safety at the heart of this Bill and making it a safety Bill as other noble Lords have outlined makes complete sense. It would protect our population and make our country far more attractive for medical research, because we would be seen internationally as a leader in safety in that work and in any licences we gave to medicines and medical devices.
As well as medical devices inserted in the way that was so eloquently outlined by the noble Baroness, Lady Cumberlege, and my noble friend Lord Patel, there are other pieces of equipment used regularly in intensive care and other care settings, including the community settings, where safety is paramount, particularly for the safe delivery of very small amounts of medication. Engineers in our country are developing far safer equipment for that kind of healthcare, which is largely delivered by nurses and other community health- care workers. Therefore, if we can make these issues clear in the Bill, we will be an extremely attractive country to sell such pieces of equipment internationally. For that reason, the priority of the Bill must be for patient safety, because it will result in much-increased attractiveness for us as an exporting nation in this field.
Lord McColl of Dulwich (Con) [V]
I fully support the amendments in the name of my noble friend Lady Cumberlege, and pay tribute to her for all the hard work that she put in—and for her coping with such harrowing experiences.
I hope very much that the Bill will prevent any such disaster as the use of mesh in operations in the pelvis. If experts had been consulted, they would almost certainly have warned that putting rigid materials under tension in such a position would run a very serious risk of acting just like a cheese cutter.
I emphasise what my noble friend said about safety, which is of overriding importance. I feel certain that, as many speakers have already said, it must become an essential part of the Bill.
Baroness Masham of Ilton (CB) [V]
My Lords, I wholeheartedly support Amendment 74 and similar amendments in this group. Nothing is more important than safety in all medicines and medical devices. First Do No Harm, the excellent report by the noble Baroness, Lady Cumberlege, highlights that patients should be listened to. They are the people taking medicines and using medical devices. In the last few months, coronavirus has cast a shadow over other needs, but safety is paramount for everyone. Masks and all PPE are in demand worldwide. Has the UK got an ongoing adequate supply?
The correct dressings for patients with wounds is an important safety issue. There is a lack of tissue viability nurses to give expert advice in rural areas. If NHS trusts and CCGs had joint working in local areas, this would increase capacity and save resources. If the correct treatment is not given, there can be long-term problems.
Patient safety will be improved if patient experience is listened to. Patient groups, academic researchers and medical research charities should work together to find the best solutions. Some of the technologies for blind people and people with speech problems are amazing. It is essential for the safety of patients that all staff and patients using medical devices should be trained in their use. A medical device turned off when it should be on can cause a disaster; the wrong substance in a drip can be fatal; and not listening to patients or their families about allergic reactions to medication, with doctors ignoring this information and prescribing the wrong medicine, can be a serious safety issue.
I hope that the Minister agrees that safety in everything should be paramount and should be the overriding consideration of this Bill. I hope that the Minister will do his very best to help with this matter.
Lord Kakkar (CB) [V]
My Lords, I would like to support Amendments 10, 12, 74 and 75, in the name of the noble Baroness, Lady Cumberlege, and in so doing recognise the very powerful and thoughtful interventions by many noble Lords on this group.
It is clear that there is really no dispute in recognising that safety, availability and attractiveness are all important elements in securing, promoting and safeguarding public health. The question simply is whether safety should be given priority. The report of the noble Baroness, Lady Cumberlege, is clear in having identified, in a number of specific instances, why the system failed because safety was not at the forefront of the obligation and, in particular, the regulatory obligation.
The question is how best to ensure safety going forwards when as a country we have the opportunity to establish a new regulatory environment for medicines, medical devices and veterinary medical products. The four amendments in the name of the noble Baroness, Lady Cumberlege, and other noble Lords provide the opportunity to explore the Government’s thinking in this regard.
Why would Her Majesty’s Government not prioritise safety over the other two important objectives? The noble Lord, Lord O’Shaughnessy, in his thoughtful intervention, has suggested that there may be potential for patients to be denied experimental or targeted interventions as the result of inadvertent limitation by way of the regulatory regimen. At present, of course, we have the capacity to intervene with such medicinal products to ensure that, where it is appropriate, sensible and in the interests of the individual patient, interventions can be provided with less extensive clinical evaluation. However, as a general rule, for the entirety of the population where there is broad and relatively unfettered prescription, surely it is right that fellow citizens should expect that interventions—medicinal or medical devices—that are available to their clinicians for a prescription in their individual cases are, first and foremost, safe.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
We seem to have lost the noble Lord, Lord Kakkar.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
Lord Kakkar, please keep going. We lost you for a minute.
Lord Kakkar (CB) [V]
Is the Minister able to indicate why there might be anxiety about giving priority to safety? Is it because methodology by way of clinical trials evaluation is not sufficiently well developed to make that a statutory principle for the availability of medicinal products or medical devices? Is it that there might be some basis for legal challenge that would make this ill-advised? If not, it appears that putting safety at the forefront is in the interests of patients, our healthcare system, clinicians and the standing of our country as a place to lead in the development of the life sciences.
Lord Lansley (Con)
My Lords, I am glad to have the opportunity to contribute to this important debate, to which I have very much appreciated listening. I want to talk about Amendments 10, 12, 74 and 75, in the name of my noble friend Lady Cumberlege, on which I think I very much follow and share the views of the noble Lord, Lord Kakkar.
We are all agreed about what we are trying to achieve at this stage; the issue is how we go about putting it into effect in this Bill. My first point is on patient safety. In the excellent report of my noble friend Lady Cumberlege and her colleagues, what I read is the imperative to minimise harm and to stop avoidable harm. It is clear in the report that stopping avoidable harm is what is being sought and I am assuming that that is what is meant by the proposition that we must make patient safety a prime consideration. In my view, we are all agreed that patient safety is a consideration above those of availability of medicines and the attractiveness of the United Kingdom as a place for life sciences. I do not object to that; I think that that must be true. Indeed, as a number of noble Lords have said, the achievement of a regulatory regime that properly prioritises the safety of patients is absolutely right.
However, when we think about how we translate that into law, we have to look at all the considerations for a medicines regulator. Let me take two angles on that. First, what do my noble friend Lady Cumberlege and her colleagues expect the MHRA to do? In their report, they say that they expect the MHRA to engage with patients and understand better patient-reported outcomes and patient-reported experiences in order better to be able to assess the benefits and risks of the medicines that it regulates—I emphasise “benefits and risks”, not just risks. In that sense, I want the legislation to tell the MHRA that that is indeed what it should be doing.
Secondly, we start with the medicines regulations that we have from the European Union. To some extent, as noble Lords will have gathered from my incorporation of the phrase “safeguard public health” into Amendment 5, which we debated last week, I think that that proposition enables that consideration by the regulator to be incorporated into its operations. It should be there. Otherwise, how can safeguarding public health be demonstrated if one is not properly assessing both the benefits and risks of new medicines?
Indeed, one of the early paragraphs of EU directive 2001/83/EC on medicines for human use says:
“The concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other”.
The end of the paragraph says that applications for marketing authorisation for a medicinal product must
“demonstrate that potential risks are outweighed by the therapeutic efficacy of the product.”
For this reason I wanted to incorporate safety and therapeutic efficacy in an early draft of my Amendment 5, since both are essential. It is correct to prioritise safety over availability, attractiveness or other considerations, but to attach to patient safety the proposition that it is an overriding consideration seems wrong. It is not an overriding consideration; it is an essential one, alongside the therapeutic efficacy of the current or new intervention being examined, whether a device or medicine.
That is not reflected in the amendment’s language at this stage, entirely due to where we are in Committee: we should understand that and decide how to capture that thought. It might be that we have done it already by capturing the proposition of safeguarding public health—in my view we have. However, we should make safety not an overriding consideration but a primary consideration for the medicines regulator. That is a difference. Perhaps my noble friend Lady Cumberlege and the Minister might like to think hard about how we might reflect that.
Finally, I think Hippocrates would agree. “Do no harm” is of course not in the Hippocratic oath, but it derives from Of the Epidemics, in which he wrote,
“have two special objects in view with regard to disease, namely, to do good or to do no harm.”
The two must be together. The medicines regulatory system must ensure that we can do good through better outcomes for our medicines and devices, but also do no harm.
Lord Alton of Liverpool (CB)
My Lords, I support Amendment 12 and the other amendments in the name of the noble Baroness, Lady Cumberlege. In doing so, I also express my support for the amendments in the name of the noble Baroness, Lady Thornton.
At Second Reading I referred to the Primodos scandal. I remind the Committee of my interest as vice-chair of the All-Party Group on Hormone Pregnancy Tests. I know that the Committee will join me in wishing Yasmin Qureshi, Member of Parliament for Bolton South East, the chair of that group, a full and speedy recovery to good health following her discharge from hospital last week, having contracted Covid-19. Ms Qureshi and I have been working with Marie Lyon and the campaign group seeking justice for Primodos victims since 2011.
I am not surprised that the redoubtable and admirable noble Baroness, Lady Cumberlege, has chosen to make, in the words of Amendment 10,
“the safety of human medicines as the overriding consideration”
the standard or battle flag to raise through these amendments. The paramountcy of patient safety is a battle flag to which anyone who has read her compelling report will flock. I concur with the remarks of my noble friends Lord Kakkar, Lady Masham and Lady Watkins of Tavistock on putting the centrality of patient safety at the heart of the Bill, but I also listened carefully to what the noble Lord, Lord Lansley, just said about the use of the word “overriding” and the need to balance conflicting needs. I do not think that there needs to be any conflict between the United Kingdom being a place that upholds patient safety as an overriding concern and a leader in life sciences. However, it might be that the words need to be considered further between now and Report.
Too often after a public outcry over something such as surgical mesh or Primodos, Governments say that they will set up a committee to carry out a review and then everything will be all right. The committee goes away, evidence is gathered and hearings take place. By the time it reports, public indignation and media interest have often moved on to some other injustice. Recommendations are politely acknowledged, those who compiled the report are dutifully thanked and, after promises are made to consider appropriate action, the report is found covered in dust on a basement shelf in a padlocked room in the department, preferably marked “Confidential”, with a get-out clause to tell anyone who inquires, “We can’t say anything because there are legal proceedings pending, but don’t worry, everything will be all right.”
The noble Baroness, Lady Cumberlege, told us at Second Reading that she had learned that attempts were being made to bury her report and to rely on the passage of time, the constant shuffle of ministerial chairs, the comings and goings of elected representatives and the shifting sands of changing priorities to assist in that task. But the people making those attempts made three serious miscalculations. The first is the noble Baroness, Lady Cumberlege. They are significantly underestimating the noble Baroness—a former Minister in the Department of Health and a highly experienced and effective parliamentarian—if they believe that they can bury her report; she will bury them first. Secondly, they have the misfortune of a Bill before Parliament—this one. It provides a legislative vehicle to give effect to some of her central recommendations. Across both Houses, in all parties and none, she has allies who will not be easily bought off. Thirdly, the House knows that it has a duty to act in response. We have heard so many accounts. I listened again to the moving testimony of the noble Baroness, Lady Burt, about victims of mesh. We have an overriding responsibility to act because of the abject failure to protect the public. As legislators we have an overriding duty to ensure that the law protects the public. Manifestly, the law has failed to do that and the amendments seek to put that right.
As we just heard from the noble Lord, Lord Lansley, and from the noble Baroness, Lady Cumberlege, herself, the noble Baroness’s report takes inspiration for its title from the Hippocratic oath: First Do No Harm. I say in parenthesis that the Hippocratic oath should be restored to a central place in the training and teaching of doctors and all those involved in the medical profession. Having systematically and sensitively investigated, winning plaudits from all those with whom she dealt, she found that “avoidable harm” had been caused to women by the drug Primodos—an oral hormone pregnancy test—but also by the epilepsy drug sodium valproate, and by vaginal mesh.
I first raised Primodos a decade ago, in the House in Questions and in letters to the noble Earl, Lord Howe, who we heard from at the beginning of our proceedings, after a Primodos victim, a man called Karl Murphy, had been to see me at my university office in Liverpool. On Primodos, the report laid bare widespread and systemic failings, repeatedly ignored, again and again, for decades. The review rightly concluded that the system was
“disjointed, siloed, unresponsive, and defensive.”
Despite repeated requests—I have written to the noble Lord, Lord Bethell, and tabled Parliamentary Questions —I regret that the Government have so far declined to say how and what redress will be provided. They have also failed to set out clear guidance on how those who have suffered should receive better care and support and, most notably, have failed to set out a timeline.
The Minister could put that right and tell us that there will be no ritual burial of the report. He could tell say why, as the noble Baroness reminded us, we are lagging behind the Scottish Government, who have already started to implement some of the report’s recommendations, notably the crucial appointment of a patient safety commissioner. Perhaps he could also tell us whether the Government will assist the German Government, who have finally set up a similar review after years of refusing to engage with parliamentarians or with Primodos victims in Germany.
At the beginning of this month the leaders of the SNP, the Liberal Democrats, the DUP, the SDLP, Plaid Cymru and the Green Party all wrote to the Prime Minister, urging him to implement the findings of the noble Baroness’s review. They make the point that many mothers who took Primodos, believing it would help their pregnancy, are “now elderly” and have
“lived a life wracked by guilt.”
Yet this was through no fault on their part. They also point out that, as the noble Baroness reminded us, even today sodium valproate is given to women, who are unaware of its potential consequences, with a 50% chance of a baby in the womb being severely damaged if the drug is taken during pregnancy. In their letter, the political leaders point out that 15 patient groups, along with the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the BMA have all called for the report’s recommendations to be implemented.
Baroness Sheehan (LD) [V]
My Lords, is a pleasure to follow the noble Lord, Lord Alton. I agree with every word of his contribution, which is no surprise; I am usually in agreement with him.
I wish to speak briefly in support of Amendment 8, in the names of the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, and to add my voice to support other amendments in this group. Amendment 8 would amend the wording at the start of Clause 1(2) to read
“the appropriate authority must act with a view to ensuring”.
This offers greater purpose of intent on the part of the Government of the day than the existing
“the appropriate authority must have regard to”.
It would strengthen the Government’s responsibility to their citizens over the safety and availability of human medicines, as well as the attractiveness of parts of the UK for clinical trials, et cetera, however that attractiveness is defined. I look forward to the upcoming debate on that issue with interest. It would of course also strengthen the duty of the Government of the day to ensure fair access to medicines, as per Amendment 19, which will be debated later and is in my name and that of my noble friends Lady Jolly and Lord Sharkey, and the noble Lord, Lord Alton, who I always think of as a friend.
It goes without saying that I strongly support all amendments relating to the report of the noble Baroness, Lady Cumberlege. Finally, I lend my support to Amendment 59 in the name of the noble Baroness, Lady Bennett. Animals cannot speak for themselves yet they are sentient beings. Their welfare should be our concern.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn from the debate, so I call the noble Baroness, Lady Jolly. Is Baroness Jolly with us? I am going to call her one more time; then we will have to move on, I am afraid. Baroness Jolly? Apparently not, so I now call the Minister.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, I give profound thanks for the debate on this group and start by reassuring the Committee that safety is very much at the heart of the Bill. Doing what is right for patients is at the heart of it but I acknowledge the remarks alluded to by my noble friends Lord Lansley and Lord O’Shaughnessy: patients are also entitled to have conversations with their doctors about what is right for them. That sometimes goes beyond a conversation about safety. To have those balanced, personal conversations to offer them hope, with innovative new treatments or in a clinical trial, we need other considerations to work together; we need the full picture and I want to make a few remarks on getting that balance right.
Before I do, I acknowledge the very touching and moving human stories that a number of noble Lords remarked on in this debate. I always find this subject extremely moving, and it is entirely right for us to remember the tough anecdotes and testimony of those groups which have advocated on behalf of the victims of terrible misadventure and clinical mistakes in the past. I also acknowledge what the noble Lord, Lord Alton, referred to as misogyny and what the noble Baroness, Lady Thornton, referred to as being ignored by the clinical profession. These two aspects of the situation weigh most heavily on my mind.
Before I move on to the testimony of the noble Baroness, Lady Cumberlege, I thank her for the hard work that she and her team put into her report. I reassure her and others that there is no question of the report in any way being buried or overlooked, or not cared about. The report, which was delivered in late July, is being weighed up with seriousness and intent. I reassure all those who are part of this debate that the Minister for Patient Safety, Nadine Dorries, is working up a response to it which will be delivered thoughtfully and with impact when the time is right. I completely and utterly recognise the support from across the House and from patient groups for the report’s recommendations and import.
However, patient safety is not the only aspect of the Bill, which we think needs to get the balance right between different aspects. Perhaps I may flag to noble Lords our amendment on this, Amendment 2, which inserts on page 1 at line 6:
“The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
We think that Amendment 2, agreed last Monday, gets the proportionate and balanced approach correct and that we have practical regulation which can rise to the challenge of public health. I spoke last week to the reason for Amendment 2; it is a floor, not a ceiling. It means that the appropriate authority must be satisfied that regulatory changes promote public health, which is an important introduction to the Bill.
Whenever we reach this House, we deal with matters of nuance. We have discussed my noble friend’s amendments to change the way in which considerations apply, to one of an “objective”. With Amendments 8, 55 and 73 the noble Baroness, Lady Thornton, has proposed additional curbs. She has asked for regulations to be made that
“act with a view to ensuring”
that three considerations are met. I would expect to be asked under what circumstances regulations might be made that do not
“act with a view to ensuring”;
It would not be scrutiny by noble Lords if I did not. When we looked at this construction, it seemed likely that matters we might well wish to regulate on that were not specific to the considerations would fall out of scope. The burden of proof that those regulations met the bar the noble Baroness would set would be very high. “Ensuring” is the question here.
Government Amendment 2, which was passed last week, sets that threshold for regulation, where the authority must be satisfied that regulation would promote public health. I hoped that it would satisfy, but I am open to further conversation with the noble Baroness on this and, of course, other matters.
If the root of the issue is how the considerations will be applied by the appropriate authority, the noble Baroness will be aware that the Government have tabled amendments to Clause 41. Those amendments would change the way in which consultation is run. We would be obliged to include initial thinking on how the considerations have been applied to the development of regulatory change proposals so far.
The noble Lord, Lord Sharkey, has with Amendment 9 also suggested that an assessment of impact on these three considerations be published alongside draft regulations. He knows that an Explanatory Memorandum and an impact assessment must be produced when making a statutory instrument. While we are not there yet, I draw his attention to government Amendment 131, which would oblige the Secretary of State to report to Parliament every two years. That report must contain concerns raised during consultation, with that consultation informed by the Government’s initial assessment of the considerations. Parliament will therefore have the Government’s assessment but also the public’s assessment of the Government’s assessment. I hope that that is reassuring to the noble Lord.
I started this group by touching on the importance of patients and I am grateful to my noble friend Lady Cumberlege for her Amendment 10. She has support for it. I fully understand and support the rationale for wanting medicines and medical devices to be safe for patients. However, Amendment 10, placing the safety of medicines above all other considerations, could inadvertently put patients at risk.
The noble Lord, Lord O’Shaughnessy, alluded to availability, for example. During the pandemic, much has been done to ensure supplies of medicines—new experimental medicines, old medicines for different purposes or medicines that are at least available when others are in short supply. We have introduced a number of regulatory flexibilities, which have been widely welcomed by industry. They have helped to secure continued supply in a very challenging situation.
While patient safety underpins everything that the MHRA does, these changes were introduced for the primary purpose of ensuring continued supply. If we placed the safety of a medicine above all other considerations, we might put the safety and health of the patient and wider public at risk should they not receive the medicines that they need.
It would also potentially mean challenges in getting patients new medicines. A medicine that is novel or offers a great deal of hope might be inadvertently ruled out because of concerns regarding poor clinical practice or potential use in patients for whom it is not appropriate. We do not want to deny a potentially effective medicine to all patients in all circumstances. By placing safety as the primary consideration, clinical trials would also be almost impossible to conduct. By their very nature, they seek to test the safety of medicines.
I understand the noble Baroness’s concerns. She is deeply motivated by a desire to prevent what has happened before from happening again. I have spoken to patient groups. I am a father of daughters and a husband to a wife. I was deeply affected by the speeches made at Second Reading. However, I think that her objective—the safety of patients, not the safety specifically of medicines and medical devices—is protected by the government amendments that were passed last week. We will not be able to make regulations if we cannot be satisfied that they promote public health. That rules out deregulation for deregulation’s sake, for instance, but it allows, particularly in the case of an emergency, getting treatment to patients.
I hope that the noble Baroness will understand that we are aligned in intent, if not in delivery. We have designed that overarching test—that the appropriate authority is satisfied—to deliver on the safety of patients without preventing, for example, regulation in a pandemic. I know that she has spoken to my officials. I welcome ongoing conversations through the passage of the Bill, in Committee and beyond.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I have received one request to speak after the Minister, from the noble Lord, Lord Hunt of Kings Heath. Once we have heard from the noble Lord, I will try one more time to establish contact with the noble Baroness, Lady Jolly. However, I have to tell the Committee that so far we have not been successful.
Lord Hunt of Kings Heath (Lab)
My Lords, I thank the Minister for his response. Could he say a little more about the Government’s overall patient safety strategy? He is saying essentially that the Bill is confined to medicines and medical devices regulation, yet underlying the concerns of the noble Baroness, Lady Cumberlege, is the fact that patient safety has not been gripped. In a sense, he has given a technical response. We will come to more specific amendments relating to, say, a patient safety commissioner, but at some point it would be interesting to get an insight into government thinking about patient safety more generally.
Lord Bethell (Con)
I will be candid with the noble Lord. The Cumberlege report has put patient safety absolutely at the top of the agenda. If it was not for Covid, it would be the primary issue of today in health matters and would lead all our thinking for the year ahead. The report is incredibly important and it has made its mark in a big way. However, it was delivered at the end of July and, if you take out August, that is only six or seven weeks ago. It takes a bit of time to respond to these reports. I know that the noble Baroness is chafing at the bit and wants a response—of course she does—but it has not been very long in report terms.
I cannot avoid the obvious, which is that we are in the middle of an epidemic. The Department of Health is completely overrun. We have nearly doubled in size in the past four weeks, but even so the capacity for response, in ministerial time and official time, simply is not there. I completely understand the keenness of noble Lords in this Room to get a clear response, but the sequencing is that this is a Bill on medicines and medical devices. We seek to take on board the lessons of the Cumberlege report and, where possible, specific items, but the Bill is not designed to be a vehicle for the implementation of the report recommendations. We will acknowledge and, where possible, accommodate the report’s insight, but the report needs a formal response from the Minister for Patient Safety and I am not that Minister and there has not been time for that response to arrive yet.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I will have one more go to get the noble Baroness, Lady Jolly, to join us. Lady Jolly? It is rather sad calling into the void. I take it that she is not able to join us, so I call the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
I thank the Minister for his reply and all noble Lords who took part in what has been a worthwhile, interesting and sometimes rather impassioned debate.
The Minister is probably being slightly optimistic in thinking that we will not attempt to implement as much of the report of the noble Baroness, Lady Cumberlege, in this legislation as we can, because we are not sure when the next Bill where we could do so will come along. He might think about that. A little while ago, we had a Bill that would have been perfect for this report’s purposes but, unfortunately, we never got any further than Second Reading.
I thank the noble Lord, Lord Sharkey, for his support as we have moved through slightly difficult times in the past few days. The noble Baroness, Lady Cumberlege, knows that she has our support for the recommendations in her amazing report. We will do everything that we can from this side of the House to make progress.
The noble Baroness, Lady Bennett, is quite right to remind us of the fact that we are dependent on animals for making sure that our medicines are safe. We should never forget that.
My noble friend Lord Hunt was quite correct when he said that patient safety needs to be central. In fact, my noble friend’s remarks reminded me of the time when I was number two to the noble Lord, Lord Darzi, when he was a Minister in the House. He was absolutely passionate about patient safety and how it could be implemented. He also made a coherent argument for the fact that you could ultimately save money if you got patient safety right from the broad GP level all the way through to the implementation of new drugs and so on.
The remarks from the noble Lord, Lord Patel, were a tour de force. They illustrated again to us, if we did not already know, that his experience and knowledge are of enormous use to the Committee.
The noble Lord, Lord O’Shaughnessy, was doing a balancing act, saying “Ooh, attractiveness, ooh, patient safety, how is that going to work out?” He started off by saying that there should not be a trade-off but I think that he might have come to the conclusion that there will be one.
Between them, the noble Lord, Lord Kakkar, and the noble Baroness, Lady Watkins, brought enormous wisdom to this discussion. Both of them were balanced in the way that they expressed the need to put patient safety at the centre of the Bill.
The Minister and my team and I need to discuss the difference between “having regard to” and “with a view to ensuring”. The two things are not the same; this is not just about semantics. We probably need to have that discussion between now and the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
We now come to the group beginning with Amendment 14. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 14
Lord Bethell
“(c) the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 1(2)(c) in the Bill as brought from the House of Commons.
Lord Bethell (Con)
My Lords, in moving Amendment 14, I will also speak to Amendments 57 and 77 in my name. These all relate to clarification of the Government’s use of “attractiveness” in the Bill.
Our life sciences sector is critical to this country. It achieves great things. We have the RECOVERY trial. We have an industry that rose to the ventilator challenge issued earlier this year. It contributes to the economy and jobs; in turn, the Government have committed to ensuring that it continues to do so.
Our approach to regulation is a pivotal part of supporting that. I know that much was said at Second Reading as to how attractiveness might be defined. A number of amendments have been tabled to define it, all of which demonstrate the importance of this part of regulatory consideration. I look forward to hearing the debate on them.
To provide greater clarity on our meaning and intent of the “attractiveness” consideration in Clauses 1, 8 and 12, I have brought forward Amendments 14, 57 and 77. They set out that, as an integral part of the development of proposed regulatory changes, regard will be given to the favourability of the UK as a place to conduct critical medicine and device development, manufacturing and supply processes.
They also clarify our intent that Clauses 1(2)(c), 8(2)(c) and 12(2)(c) reflect that the Bill is a platform for us to continue to support increased investment in the UK to develop and supply medicines and devices, by ensuring that we make regulation that is sympathetic to that need. That is why the amendments strengthen the consideration regarding the likelihood of the relevant part of the UK to be seen as an attractive or favourable place in which to trial and supply human medicines or develop and supply veterinary medicines and medical devices.
I am pleased to see that this focus on favourability echoes language in amendments put forward by the noble Baroness, Lady Thornton, and the noble Lords, Lord Patel and Lord Hunt. Many of the proposed amendments on the definition of attractiveness provide an explicit list of specific elements that could underpin a consideration of favourability or attractiveness of the UK as a place to develop and supply medicines and devices, but I am confident that the current drafting already captures the multiple different stages that are inherent in seeing these goods placed on the market and supplied to patients.
The noble Baroness, Lady Thornton, and others have commented on the fact that this is a new term in legislation. Attractiveness means doing everything reasonable to be the first place where new treatments are identified, developed, rolled out and adopted, where investment in life sciences takes place and where the enrolment of patients in clinical trials is supported. It is neither necessary nor helpful to set out in the Bill all the different factors and stages of the development and supply landscape that will enhance the attractiveness and favourability of the UK. Providing a narrower definition limited to specific factors and elements of the current development and supply landscape risks excluding aspects of supply that are not yet in place. If we cannot currently predict the scale of innovation that these sectors may offer in future, can we accurately predict all the factors that will ensure that the UK is an attractive place to bring those innovations?
Government Amendments 14, 57 and 77 work together with government Amendments 2, 7, 51, 54, 56, 68 and 72. These place an obligation on the appropriate authority to be satisfied that the effect of the changes will be to promote the health and safety of the public or, in the context of veterinary medicines, that the regulations promote the health and welfare of animals, the health and safety of the public or the protection of the environment. It is part of that assessment into whether health and safety would be promoted that the appropriate authority must have regard to safety, availability and attractiveness.
In combination, I am firmly of the view that these amendments will ensure that appropriate rigour is given to how the key powers in Clauses 1, 8 and 12 are exercised. These amendments provide additional nuance. They clarify but they do not proscribe. They rule in rather than ruling out. I beg to move.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, the next speaker was to have been the noble Baroness, Lady Jolly. I am afraid we have not been able to establish a connection with her, so I call the next speaker, the noble Lord, Lord Lansley.
Lord Lansley (Con)
I want specifically to refer to Amendment 16 in this group, which is in my name and that of the noble and learned Lord, Lord Woolf. The purpose of that was prompted by looking at subsection (2)(c), and this question of attractiveness, or
“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines.”
In this particular instance, we concluded that while one might think that the United Kingdom was, or was not, an attractive place to supply human medicines and derive certain conclusions from that, the process of medical innovation is not well captured by a simple reference to clinical trials. The process of medical innovation is a wider set of factors than clinical trials alone. In particular, I think that in our minds, in looking at the United Kingdom, one of the underlying strengths of the United Kingdom as a place in which to develop medicines is because of our strengths in discovery.
For example, I remember as a resident of and former Member of Parliament for South Cambridgeshire that my constituency included the Laboratory of Molecular Biology which, among its other attributes, is the single research institute with the largest number of Nobel prizes in the world. The strength of discovery is an absolutely central aspect of the fact that AstraZeneca, Cancer Research UK and Addenbrooke’s and Papworth hospitals are close by and the biomedical campus at Cambridge is bidding to become Europe’s single strongest location for life sciences. If you delved back over the last 50 years and asked what the distinguishing characteristic of that was, you might well say Cambridge University—and people would well understand that—but you might equally say the Medical Research Council’s Laboratory of Molecular Biology and all that went with it. This is not because the LMB does clinical trials; it is because it does discovery. I think our intention was to say that, if the medicines regulator is having regard to these factors, maybe it should have regard to discovery as well.
I entirely take the point that perhaps, where the medicines regulator is concerned, discovery is something that happens before it really gets involved. However, if it is thinking about the environment for life sciences, I find it very hard for it to think about it in parts, and not as a whole. That is what Amendment 16 is intended to explore.
There is another question conveyed by a number of these amendments, which, as my noble friend the Minister has quite rightly highlighted, is this interesting use of the word “attractiveness”. I may well have regard to the attractiveness of many things, but that does not necessarily mean I do anything about it. That the Minister has brought forward his own amendment to point to
“the likelihood of the relevant part … being seen as an attractive”
place is very interesting and takes us much closer to where we want to be. However, it still begs the question of what the medicines regulations should require the regulator to do about it, having had regard to this thing. There are other amendments which, I think, perfectly properly raise the question of whether the regulator should seek to enhance the attractiveness of the United Kingdom as a relevant place, et cetera. I think it raises a very interesting question. I get the impression that the Minister is trying very hard to move to the right place; I am just raising the question of whether we are quite there yet without something like the word “enhancing”.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, before I call the next speaker, I should just inform the Committee that we now know that the noble Baroness, Lady Jolly, is unwell, and will therefore be unable to take part in the remainder of today’s proceedings. In due course, no doubt, we will know who will take her place in subsequent groups. I call the next speaker, the noble Lord, Lord Hunt of Kings Heath.
Lord Hunt of Kings Heath (Lab)
Can I just follow the noble Lord, Lord Lansley? Clearly, we are going to continue teasing out “attractiveness”. I have no doubt that I want the UK to be attractive in terms of the development of medicines and medical devices, and I think the noble Lord, Lord Lansley, was absolutely right when he paid testimony to the underlying strength of our medical innovation and discovery, and indeed the life science sector as a whole. I think one of the questions we are going to consistently talk about is that we do have a problem with the attitude of the National Health Service to those very medical innovations that take place in this country. As I will touch a bit on procurement, I should declare an interest as president of the Health Care Supply Association, because clearly it is involved in procurement decisions.
As I think was discussed in the first day of Committee, the ABPI has reported that for every 100 European patients who can access new medicines in the first year, just 15 UK patients have the same access. It is a major problem that we are so slow to take advantage of developments in new medicines and devices, both in our country and globally. We are seeing in the NHS essentially an unprecedented level of rationing, both locally and nationally. My own view is that NICE has developed into more of a rationer than it was ever intended to be. Locally, clinical commissioning groups are making almost perverse decisions, ranging from cutting out health promotion programmes to being very restrictive on some operations or, again, on access to innovative drugs.
Of course I understand that the drugs budget cannot be open-ended, and the NHS must achieve value for money. But the fact is that we are at great risk of losing our place at the top table when it comes to medicines and medical devices innovation, despite the excellence of the people we have, which the noble Lord, Lord Lansley, referred to. At the moment, I think we have developed around 14% of the top 100 global medicines, but 20 years ago it was 25%, and the risk, of course, is that we go lower and lower.
Similarly, in relation to access to devices, we have a very innovative devices sector, but again it is utterly frustrated by the NHS’s record in adopting innovation. Its suppliers are forced to battle against a fragmented marketplace—they lack a clear route to market—budget silos that impact on buyers’ ability to release savings directly, and a short-term focus on cash-releasing savings at the expense of longer-term benefits. As an example, I was approached by the Urology Trade Association, which represents the suppliers of the majority of urology projects to the NHS, which pointed out that, in normal times, urinary tract infections are the greatest single cause of unplanned hospital admissions, so it has a big impact on quality and duration of life and on use of NHS resources. If we were prepared to invest in improved devices, it could have a major benefit. But essentially, whatever the Government say about procurement and value-based procurement, they always go for the lowest price, and I am afraid that we often buy the lowest-quality products.
The ABHI has told me of one company in the dialysis sector which now sees the UK as a second or third-tier sector, due to the prices it commands here. I know that on the first day of Committee the noble Lord said he cannot talk about reimbursement; the problem is that Ministers will never talk about reimbursement. It is interesting that, in general, if we are increasing staff—the numbers of doctors and nurses—I think Ministers tend to proclaim that as a good thing. However, increased budgets in devices and medicines is a shock, because the whole philosophy of his department and the NHS is to hold down the budget.
The problem is that, essentially, we do not invest in the great things that are happening. It is naive to think otherwise. There are a lot of things we can do to encourage the kinds of things that are happening in Cambridge—through tax incentives, for example, and schemes for faster access—but they relate only to a few selected medicines and devices. Overall, we are at great risk. I am afraid that the NHS has to face up to some responsibility for that, both in terms of the industry, and in terms of patients. Why should we in this country have to wait so long for medicines that in other European countries are available much sooner? This is a major issue which we need to tackle.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I call the next speaker, the noble Lord, Lord Patel. Lord Patel? Oh dear, we are not having a great afternoon. If we cannot establish contact with the noble Lord I will move on to the next speaker. Lord Patel, are you with us?
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I am sorry. We could not hear you and we still cannot see you.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
Ah! You are with us in all your glory. Please continue.
Lord Patel (CB) [V]
Not much glory, but thank you very much.
Before I talk about the amendments I intended to speak to, I want to comment on the amendment tabled by the noble Lord, Lord Lansley, and the comments that the noble Lord, Lord Hunt of Kings Heath, just made, which I absolutely agree with.
The noble Lord, Lord Lansley, is right about innovation. It should be part of the Bill, together with clinical trials. As he rightly said, we are a nation that excels, and has done for more than 20 years, in discovery science, particularly in biology and molecular biology. He mentioned Nobel prizes: the United Kingdom has won 29 Nobel prizes in medicine and physiology, and 29 in chemistry, two subjects often linked with discoveries in biology.
However, as the noble Lord, Lord Hunt, said, we are poor at taking the biology forward into innovations and drug development. We have some fantastic universities for drug development, but for that they require a strong allegiance with the NHS. The science base needs to be integrated with our NHS and its data, including patient data, to develop drugs. That is what we lack. He is absolutely right. I hope that we will have another opportunity to address this matter. Are our policies on how drugs are procured and assessed holding us back? That is a good debate to have, and it is a pity we are not having it today.
I have already said that I support Amendment 16, in the name of the noble Lord, Lord Lansley; I also support Amendment 20, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to my own amendments—Amendments 21, 61 and 82—which are supported by the noble and learned Lord, Lord Mackay of Clashfern, who could not be with us because he is in the Chamber.
With regard to government Amendment 14, I have said before, and I repeat now, that the construction is open to the interpretation that the attractiveness of the UK is to be treated as part of what promotes public safety. If so, the amendment would not address—indeed, it would appear to prevent—the argument being made that attractiveness and the safety of medicines and medical devices can sometimes be in conflict. The consideration of attractiveness can undermine the consideration of safety. This is in line with the Government’s repeated assertion that attractiveness is never in conflict with safety.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I understand that the noble and learned Lord, Lord Woolf, who was due to speak next, is not with us this afternoon. I am saying this very slowly in case he is, but I do not think so. In that case, I call the next speaker.
Baroness Watkins of Tavistock (CB) [V]
My Lords, I support Amendment 20 in the name of the noble Baroness, Lady Thornton, to which I have added my name. Its purpose, together with Amendment 21 in the name of my noble friend Lord Patel, who has just spoken so eloquently in favour of it, are to provide a definition of attractiveness for clarity and the primacy of safety, while maintaining an environment that promotes the UK as a centre for global life science research and innovative working with academic partners in all continents across the globe. In addition, Amendment 20 should ensure that the UK population has prompt access to new medicines once they have been approved in line with Her Majesty’s Government’s philosophy for the future.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
That was commendably brief. I call the next speaker.
Baroness Masham of Ilton (CB) [V]
My Lords, in supporting Amendment 61 and the others in this group, I declare an interest as I have a farm and I often use vets, who supply veterinary products and medicines. I must say that vets have been exceedingly careful and all precautions have been taken that have been put in place for protection over Covid-19. The Veterinary Medicines Directorate protects animal and public health and the environment. This needs our support, which this amendment provides, as it ensures that safety remains a priority.
In recent years, over half the veterinary surgeons who register in the UK each year have qualified elsewhere in the EU and the EEA—38.5% from the UK, 52% from the EU and EEA, and 9.5% from other countries. Free movement of people has had an enormous impact on our veterinary workforce. Additional barriers to the movement of EEA-qualified vets to the UK will have significant consequences for animal health and welfare, public health and trade. If understaffing happens, it will become a safety issue. Some 95% of the veterinary workforce in abattoirs graduated overseas, mainly from the EU. This information comes from the British Veterinary Association. Does Regulation (EU) 2019/6 on veterinary medicinal products aim to make more medicines available in the EU to treat and prevent diseases in animals through simplifying our procedures for obtaining a marketing authorisation and reviewing incentives for breakthrough medicines? The Bill provides the means to make “corresponding or similar provision” to both regulations. Will the Minister give an assurance that that will happen? It is a safety issue and very important.
To make the UK an attractive place to do research and development, the much-needed bright people coming from abroad should feel wanted and safe. It is time that the UK realises that we cannot achieve the high standards that we want without help from others in veterinary science. We should be welcoming and kind to each other. I hope that the Minister will help to prioritise safety in this important Bill. I send my best wishes to the noble Baroness, Lady Jolly, and hope that she gets better soon.
Lord O'Shaughnessy (Con) [V]
My Lords, I echo the point made by the noble Baroness, Lady Masham, about the noble Baroness, Lady Jolly. I am sure that we all send her our very best wishes.
I speak on the amendments tabled by my noble friend the Minister. However, on a quick clarification on something that the noble Baroness, Lady Thornton, said in the last debate, which is germane to this debate, I was not making the point that I believe that there can be trade-offs between safety and attractiveness as the Bill currently defines it. Rather it was around the effectiveness and efficacy of medicines and medical devices—points that were, thankfully, made much more clearly by my noble friend Lord Lansley than they were by me—and the impact on what that means for safety and its overridingness as a priority, even if it is always our most important consideration.
On the substance of the amendments, I am sure that my noble friend was not expecting complete consensus around his amendments and he certainly has not found it yet. However, I applaud him for his clarifications on the impact of the attractiveness subsection and also applaud him for moving so quickly in response to noble Lords’ concerns. None the less, there is an issue around this, which the noble Lord, Lord Hunt, brought out. It is an unfortunate truth that the NHS has a poor history of performance in scaling up innovative medicines and devices. I know that that is something that my noble friend is very concerned about.
I have a specific question in this area. In asking it, I draw attention to my entry in the register of interests, in particular as an adviser to Healthy.io. Do my noble friend’s plans for improving the attractiveness of the UK include improving the attractiveness of the UK as a place to develop, trial and scale data-driven health technologies? I know that we will come to that topic later, when the noble Lord, Lord Freyberg, has his amendments, but can my noble friend confirm that they are included in the definition of devices and explain his intentions in this regard?
Baroness Walmsley (LD) [V]
My Lords, this group begins with the Government’s minimal attempt to define the word “attractiveness” in Clause 1(2)(c). I am afraid that I preferred the version in Amendment 20 in the name of the noble Baroness, Lady Thornton, and others. I think that it became clear to the Minister in meetings before Second Reading and in the debate itself that many of us felt that a word such as “attractiveness”, which is very unusual in a piece of health legislation, requires a clear definition in the Bill.
“Attractiveness” is one thing, if properly defined, but “ambition” is another. That is what my noble friends Lord Sharkey and Lady Jolly—to whom I send my best wishes—seek to do in Amendment 15, for human medicines, Amendment 58 for veterinary medicines and Amendment 78 for medical devices. I am sure that my noble friend Lord Sharkey will say more about these in a few moments. But if Brexit must happen, which unfortunately it must, there is really no point if it does not allow us to do better than we have done before. That is why inserting the words “maintaining or improving” is so important. As others have said, the UK has hitherto been a very attractive place to conduct clinical trials, partly because of our massive access to patients through the NHS, partly because of our expertise and high standards and partly because of our alignment with the EU and its 400 million citizens.
This is particularly important for rare diseases, where the numbers of sufferers in the UK alone are too small for a trial of statistical significance. Alignment with the EU is, therefore, particularly important for maintaining our attractiveness, and this is dealt with by other amendments that the Committee will debate later. However, we should be wary of throwing away the advantage of that alignment; to do so would give us a much bigger mountain to climb if we are to improve our attractiveness. I hope that the Minister will bear that in mind when he replies.
Lord Sharkey (LD) [V]
My Lords, I will speak to Amendment 15, but I begin by supporting Amendment 16, in the names of the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf. I strongly agree about the importance of the UK being seen as an attractive place to promote medical innovation.
Amendment 15 is in my name and those of my noble friend Lady Jolly and the noble Baroness, Lady Finlay of Llandaff, and I am very grateful for their support. The amendment addresses Clause 1(2)(c). As we have just discussed in the previous group, subsection (2) lists what an appropriate authority must have regard to when making regulations under subsection (1). Subsection (2)(c) specifies that the appropriate authority must have regard to,
“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.
But we have, in extraordinary circumstances, accepted the Minister’s Amendment 14, so that the text will now read,
“the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines”.
That is not a formulation that lends itself to easy measurement.
I listened very carefully to the Minister’s brief explanation of the merits of his amendment, but I was unable to see a clear and actionable distinction between his new version and the old one. It was all getting a little theological—“angels dancing on the head of a pin” sprang to mind. In any case, the new Government amendment shares two defects with the old version.
The first is that they are both completely unambitious. We should be looking at least to maintain, and preferably to increase, the attractiveness of the UK as a place to do clinical trials or supply human medicines. I spoke last Monday about the critical importance of clinical trials to the UK’s global leadership in the life sciences. I have already noted that the number and share of clinical trials has declined since 2016, and we now rank behind the US, Germany and Spain. Because of Covid, we have abandoned 1,500 trials and suspended 9,000 more. We need to do better than simply to have regard to the attractiveness or the likelihood of being seen to be attractive. We need explicitly to maintain or improve that attractiveness, as our amendment proposes.
The second defect in both the Minister’s first and second versions of subsection (2)(c) is that they fail to mention manufacturing. Why is the appropriate authority not required to have regard to maintaining or improving the attractiveness of the UK as a place to manufacture human medicines? The ABPI raised this issue in its briefing for Second Reading, saying that, in addition to having regard to the attractiveness of the relevant part of the UK to conduct clinical trials or supply human medicines, the ABPI would also value an assurance from the Government that secondary legislation will support the attractiveness of the UK as a destination to develop and manufacture human medicines.
The ABPI has a point. I raised this question, and the ABPI’s position, with the Minister in a meeting on 13 October. In that meeting, the Minister’s officials replied that they thought that manufacturing was covered in other regulations. Will the Minister confirm that and tell us which regulations explicitly require the appropriate authorities to have regard to the attractiveness of the UK as a place for developing or manufacturing human medicines? If, however, there is no such statutory requirement elsewhere, would the Minister consider adopting Amendment 15?
Amendments 58 and 78 would make the same provisions as Amendment 15 but for veterinary medicines and medical devices.
I should also say that there are obviously enough opposing or various views on the attractiveness issue to make it clear that we will want to return to this subject on Report, not only in the context of Amendment 14. I look forward to the Minister’s response to Amendment 15.
Baroness Thornton (Lab)
I thank all the speakers who supported our Amendment 20 and the amendments that follow on from it. I need to start by placing on the record that we do not agree with the Government’s amendments to this clause but we will not object to them. Were we not in the situation of basically having to agree to put these amendments in the Bill, this is a very good example of where we would need to have a different kind of debate. Looking specifically at the Government’s amendments, I think that adding the word “favourable” does not clarify the meaning or elucidate anything. Since we are not absolutely certain what “attractiveness” means, I am not sure we can be clear what “favourable” means either.
Our amendments, and others that noble Lords have tabled, would take the first stab at defining “attractiveness”. I am very attracted to the amendments that the noble Lord, Lord Sharkey, spoke to, because the idea of improvement is also very important. We are in the same territory and we will need to put further thought into this between now and the next stage of the Bill.
My noble friend Lord Hunt was completely correct when he spoke about the need to address how slow we are in this country in the uptake of new medicines and innovations. The noble Lord, Lord Patel, said that if we do not define “attractiveness” we might end up with the sort of undesirable trade-offs we discussed earlier today.
We have had a very interesting and useful discussion—the kind of discussion we should have in Grand Committee—where various points of view come together. We can see that we might end up with a completely new amendment at the next stage that will define “attractiveness” in the Bill and talk about the need for improvement and innovation. We will probably need to put our heads together between now and then.
Lord Bethell (Con)
My Lords, this has been an important discussion as to what attractiveness of the UK means. We have already moved on this issue with our amendments. We are still listening. I thank noble Lords for an instructive and wise discussion of this issue.
The noble Lord, Lord Sharkey, offers a definition in Amendment 15 that would include manufacturing. My noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, suggest adding “medical innovation”. In Amendment 20, the noble Baroness, Lady Thornton, and others set out a number of additional aspects, such as
“favourability to the establishment of research, design or manufacture of medicinal products or related services”
I reassure all those noble Lords that it is our instinct that the consideration of “attractiveness” as written in the Bill is sufficiently broad. It contains multitudes. While processes such as the clinical investigation of devices are not specifically listed as a consideration in Clause 12, they are covered in the current wording. Manufacturing is of course a vital element of the supply chain. Any impact on manufacturing will be relevant when considering the attractiveness of the UK as a place to supply medicines.
I acknowledge that the term “attractiveness”, as noble Lords have remarked in conversation, is not ordinarily found in legislation. However, I believe it is largely one of common sense. We all wish to protect the ways in which the UK is attractive. In 2015, the ABPI estimated the value of the life sciences sector to be £30.4 billion. Some 482,000 jobs were supported by the sector. We wish to protect that and to be a place for both innovators and generic manufacturers.
That is why this test is essential. It is a reminder, but it does not need to be comprehensive in the legislation. It needs simply to rule in, not rule out. That is why manufacturing is not explicitly mentioned, nor the other factors, although it is covered. Were we to list all the various aspects of how medicines and devices are made, we might miss something. We might interpret this list as prescriptive, rather than illustrative, and not cover an equally important but novel aspect of the future.
I hope that the government amendments provide further clarity. While noble Lords have drawn attention to specific aspects of how the UK is attractive, which are very important, their amendments are unnecessary. However, if there are particular considerations that the noble Lords, Lord Hunt and Lord Patel, and the noble Baroness, Lady Thornton, have concerns about—I note words such as “procurement”, “scale up”, “adoption”, “take-up of innovation” and “data-driven technologies”—I ask them to write to me. If further reassurances can be provided on why we consider this to be the right construction, I will be happy to respond.
In this instance, I hope the noble Lord, Lord Sharkey, is therefore willing not to move Amendment 15, and that other noble Lords do not feel compelled to move their amendments.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, we now come to the group beginning with Amendment 17. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 17
Lord Lansley
“( ) the effect of the regulations on the ability of the National Health Service to meet the needs of patients;( ) the result of any consultation under section 41.”Member’s explanatory statement
This amendment adds further aspects to which the appropriate authority must have regard in making regulations under section 1(1) , to include the impact on the NHS and the results of consultation undertaken in accordance with section 41.
Lord Lansley (Con)
The amendment is in my name and that of the noble and learned Lord, Lord Woolf. This group includes four amendments, three of which are mine. I am glad to see in it too Amendment 124, in the name of the noble Lord, Lord Hunt, because it goes to similar issues. I hope that he will find some common ground between us.
Amendments 17 and 79 would add to the considerations to which the Secretary of State should have regard when making medicines regulations and medical devices regulations respectively—Amendment 17 referring to the former and Amendment 79 to the latter. They would bring the same factors into play.
The first factor is the effect of the regulations on the ability of the National Health Service to meet the needs of patients. There could be two interpretations of how this might be seen. The first is that the medicines regulations could give rise to the authorisation of medicines that the NHS was not in a position at that point to fund. I do not think that it is about that. If the NHS has difficulty in paying for such medicines, it has a power under the National Health Service Act to vary the funding mandate that would otherwise be applicable under NICE. The NICE funding mandate for medicines is in that Act and not in the regulations for medicines. What I think this is about is the NHS being increasingly keen to secure the benefits of innovation. We have had a decade or more of reports telling the NHS that while there is a great deal of innovation there is poor diffusion of its benefits through its adoption in the National Health Service. This is about the ability of the medicines regulations to help the NHS to meet unmet medical need, to bring forward innovations and to deploy them. One might say, “Well, the medicines regulator just authorises medicines”, but let me give a couple of examples.
The first is the early access to medicines scheme, which is precisely about giving the NHS the opportunity to bring forward innovative new medicines that meet unmet medical need and to do so more quickly and in ways that often require collaboration between the NHS, MHRA and NICE. The second example is the Accelerated Access Collaborative, which also looks at other schemes such as the small business research initiative. Its purpose is to bring products through to authorisation and approval, which is quite often in relation to medical devices.
The amendments would require the Secretary of State when making the regulations to have regard to the potential for innovative medicines and medical devices respectively, so that they might be accelerated through processes of authorisation in order to realise their benefits more quickly and hence help the National Health Service to meet its objectives.
The second factor to which the amendments would require the Secretary of State to have regard is consultation. Clause 41 places a requirement on the Secretary of State to consult when making the regulations. A later amendment, Amendment 131, requires the Secretary of State to make a report on any such consultation—I think that my noble friend the Minister referred to it earlier—but there is nothing that links back the consultation to the making of regulations. The amendments say not only must the Secretary of State conduct consultation but he must have regard to the outcome of it—these are specifically “have regard to” factors; they are not factors that should be placed above any other factors in the hierarchy that we are talking about or conflict with them.
Amendment 85 is a bit different. I freely admit, before my noble friend the Minister explains it to me, that trying gently to insert it into Clause 13 is probably quite difficult in terms of the legal structure, because that is a place where requirements are to be laid on those who bring products forward for marketing and supply, whereas the amendment would place a requirement on those who are effectively buying medical devices—that is, the NHS in particular. However, I want to ask my noble friend to consider that we are trying to stimulate innovation in medical devices and bring them through into practice. We know that there are significant potential benefits to the National Health Service in such innovations, which improve outcomes for patients and can reduce costs—it can be a win-win. However, there is no funding mandate for medical devices which mirrors that for medicines, so that when NICE produces a positive evaluation the NHS after a period of delay has an obligation to bring forward the funding for those devices.
In January 2019, the NHS Long Term Plan said that the NHS wanted to accelerate proven affordable innovations into use in the NHS. In November 2019, a consultation was launched to look specifically at what is known as the medtech funding mandate—that is, to give that funding mandate to medical technology devices, not just medicines. By March this year, the Accelerated Access Collaborative was meeting and agreeing—this was one of its objectives—that, in the financial year beginning in April 2020, three such products would be brought forward. Those three products were placental growth factor-based testing, whose title more or less explains what it is; SecurAcath, which, as the title again implies, makes catheters more secure, reducing infection; and HeartFlow, which piloted at the Royal United Hospitals Bath NHS Trust and is a 3D model mechanism for imaging coronary arteries in ways that reduce intensive testing and enable clinicians to work with a highly developed form of imaging in their practice.
Those three products were to come forward in 2021. The intention, as reported to the board of the Accelerated Access Collaborative, was to do more in future years. As I understand it, NHS England intended to establish this as a medtech funding mandate—perhaps with slightly different characteristics and requirements than that of medicines but, none the less, to give medical device manufacturers the same sense of assurance that, if they bring this forward in the United Kingdom, the NHS, with a positive evaluation, will bring them into practice. However, that has stopped. I have seen nothing since April; it seems to have fallen by the wayside. I seek from my noble friend the Minister an assurance that NHS England wants to do it, that the Accelerated Access Collaborative will help to push it forward and that we will see action on this—if not this day, then this year. I beg to move.
Lord Hunt of Kings Heath (Lab)
My Lords, my Amendment 124 concerns NICE’s current review of its methods and processes as part of the agreement of the voluntary scheme for branded medicines pricing and access—commonly known as the VPAS. I will also speak to Amendment 85 in the name of the noble Lord, Lord Lansley, because he made some important points in his opening remarks.
I have a particular interest in NICE. Under Frank Dobson, I was the first Minister and worked closely with it for the first few years. It was established because of concern that effective new treatments, including medicines and devices, were not getting to NHS patients. This is a continuing problem. At the beginning, we put an additional sum into baseline budgets to cover the estimated cost of technology appraisals.
I have to say that pharmaceutical companies were obviously reluctant to embrace NICE, but so was the NHS. As early as December 2001, I was responsible for a funding direction to the NHS—the original one, referred to by the noble Lord, Lord Lansley—which required NHS bodies to implement their technology appraisals, because research showed that they were not doing so. They had been given the money, although it was not identified but put into baseline budgets, which is an interesting point.
The funding directions have been modified a few times since then and, to an extent, have reduced the impact. But the fact is that the NHS remains a reluctant partner—and you can add that to the unprecedented level of rationing taking place locally. There is a tendency, even when NICE has approved drugs or a technology appraisal, and even when the funding direction applies, for local mechanisms to be used to restrict access by patients. I have already referred to clinical commissioning groups: they are informed by regional medicines optimisation committees. Essentially, these are rationing committees designed to legitimise decisions by CCGs to ration treatments. I come back to this point: why do we tolerate NHS patients missing out on medicines and devices that are available to most patients in most European countries?
We come to the NICE review. I am a great admirer of NICE, which has done a fantastic job and has some brilliant people. It works with some fantastic universities, and we are world leaders in this field. However, I hope that the methods review will lead to tangible change and that we will get a fair and effective assessment of the true value of innovative medicines.
We are clearly at a crossroads: exiting the EU represents a significant threat to the attractiveness of the UK for pharma and devices companies. What factors do companies take into account? Clearly, the strength of our life sciences sector is one of them. Secondly, there is the regulatory system, which we are discussing in Grand Committee. Thirdly, there is the ability to launch medicines and technologies quickly into a market, getting medicines to patients who need them quickly. These are clearly part of the equation for any company, and pharmaceutical companies tend to be global, to all intents and purposes. The risk is that we will start to lose our reputation as a leader at the cutting edge of medical science. My hope is that NICE’s approach to appraising value must take into account the strategic benefits of the NHS remaining at the forefront of medical innovation.
I shall give an example of where NICE’s current rules rule against this. Gene therapy is a prime example of a medical technology that the UK should embrace, but a procedure called discount rate, used by NICE to adjust for future costs and health benefits when valuing treatments, discriminates against one-time therapies that offer potential long-term health benefits over many years, such as gene therapies. NICE almost always uses the 3.5% rate but can apply a lower 1.5% rate for therapies that offer longer-term health benefits. I understand that it chooses to do that only on exceptionally rare occasions. Post the new 2019 voluntary scheme, negotiated to deliver a triple win for patients, government and industry, we now see NHS England doing bespoke commercial agreements, which of course significantly undervalue innovation.
There is always a tension, but the tension is that the main interest of NHS England is to pare down drug costs. The impact that that has is that, for all the brave words about innovation, it simply does not play out in the field. I was very interested in what the noble Lord, Lord Lansley, had to say. There is a HealthTech Connect portal, but I am told that not a single innovation submitted via that portal was adopted by NHS Supply Chain during the first year of operation, March 2019 to April 2020. Are we to assume that none of the submissions meets the criteria in terms of evidence, efficiency or satisfying unmet needs, or are they simply being thwarted by a process that raises the bar to unrealistic levels?
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, unfortunately, a connection has not been made with the noble and learned Lord, Lord Woolf, who was due to contribute remotely.
Lord O'Shaughnessy (Con) [V]
My Lords, it is a pleasure to be able to follow the noble Lords, Lord Hunt and Lord Lansley, on these amendments. The issues that they raise could not be more important. Indeed, they have both been assiduous, particularly the noble Lord, Lord Hunt, when he was opposite me at the Dispatch Box, in raising this issue of the NHS’s attitude to medical innovation. His point about the methods review is very well made. He is also right to raise the fact that the voluntary pricing scheme for medicines is designed with a cap-to-cap growth of 2%. It is hard to explain how, with the cap in place, rationing attempts are still going on within the NHS, because the cap is precisely meant to give that protection. The problem is that, with the benefits of the cap, the rebates go to the Treasury, whereas the costs of paying for medicines bite locally. Until we get that imbalance sorted out, I fear that we will have strong imperatives on local trusts and CCGs to ration as he has talked about. I regret that, as the Minister responsible for negotiating that scheme, that was not something we were able to resolve—but I hope that my noble friend will be able to next time around.
The reason why I wanted to speak in this group was to offer my strong support for the amendment proposed by my noble friend Lord Lansley, Amendment 85 on medtech funding guidance. I declare another interest here in that this was one of mine, in its current incarnation, in the industrial strategy life sciences sector deal 2 from autumn 2018. It was hard won with the NHS, for obvious reasons, but the case for doing it was very powerful, and was brought home to me by a device—a diagnostic tool by Roche Diagnostics for pre-eclampsia. It had sailed through all the medtech evaluations and had gold star guidance next to it but had only something like 5% of the uptake that we would expect, despite the fact that it saved money and lives and did everything that we would want of it. In a way, that was a powerful emblem of why we could not go on as we were and needed some sort of medtech funding guidance.
It has been two years. My noble friend Lord Lansley is quite right in tabling his amendment to, I hope, elicit a response from my noble friends at the Dispatch Box on a commitment to when a full introduction of this will be done. As we are, I hope, in that kind of positive mood, perhaps I could entice my noble friend the Minister to commit also to exploring two things: to extending the eligibility criteria for the guidance, which were very strictly drawn and quite limiting; and, as is very germane to our Covid efforts, to consider how it could be used specifically to support the diagnostic industry.
Lord Blunkett (Lab)
My Lords, although I was the shadow Health Secretary for two years in the 1990s, I speak with some temerity because the three contributors that we have just heard have expertise on this issue that I do not. I rarely say that when I decide to speak in Committee or on the Floor of the House.
I want to make three points. One was made by my noble friend Lord Hunt but reinforces the points made by the noble Lords, Lord Lansley and Lord O’Shaughnessy. It is about innovation and the way in which the acceleration of known therapies—in this case, gene therapy—can make such a difference. My much-missed and much-loved friend, the late Baroness Jowell, pioneered the idea of rapid, speedy throughput of potential new therapies, including gene therapy, and ideas to fruition. As a Minister at the time, the noble Lord, Lord O’Shaughnessy, was extremely helpful and supportive. I will always be grateful to him for attending Tessa’s funeral and being really committed to seeing her ideas go forward. I am glad that he was able to contribute this afternoon. I hope that the Minister will bear in mind the reality of what happens to individuals in practice and not forget the continuing campaign and support of Tessa’s family, particularly her daughter and her son.
I want to touch on two tangential issues. One is the real problem we have with substituting for procedures that are withdrawn because overseas manufacturers decide that they will not sell to us, including how we can initiate alternatives within the research available to us. Eighteen months ago, I had a procedure on my hand. I was told by the consultant that this procedure avoided having to have surgery; your Lordships and those who are taking any notice of this debate will be aware that hands are rather critical to me in a whole range of ways, so it was a very attractive alternative. However, she told me that I was one of the last patients to benefit from it because it had been withdrawn by an American supplier.
The very opposite happened in my old constituency, where Swann-Morton, a mutual that has existed for more than 80 years, produces a large number of cutting-edge facilities, from old-fashioned scalpels to the most modern and up-to-date tools for doing the job. I want to know what we will be able to do post Brexit to protect the likes of Swann-Morton, which is a big employer in the locality—it is a mutual in every sense, including the decisions taken by the employees themselves —from being excluded from markets that they previously had obvious access to, which reduces their competitiveness and ability to proceed. They have also been hit by Covid, of course; the fewer the procedures undertaken through the NHS, the more this hits the budgets of those who rely on a continuing flow of orders.
I could not find another niche in this particular group of amendments to make my point, so I have used my ingenuity. I am grateful for not having been heckled.
Lord Patel (CB) [V]
My Lords, there is no need for me to speak at length because I agree with much of what has been said. It has been fascinating to listen to how people who were Secretary of State and Minister of Health change, once they are not in that position, in fighting for resources and more innovation to be brought into the NHS quicker. I commend that, but I wish it had happened when they were in charge. I say this tongue in cheek to tease them, of course.
I support the amendments in the names of the noble Lord, Lord Lansley, and Amendment 124 in the name of the noble Lord, Lord Hunt of Kings Heath. What they both said is correct: the NHS is very slow to bring in innovation. Also, when innovations are available that will benefit patients, trying to use them is very difficult as a clinician because they are sometimes quite unique and not routinely used.
I will give noble Lords an example. Standard radiotherapy is used for cancer treatment, but occasionally the cancer does not respond, so the radiotherapist and medical oncologist would on very rare occasions want to use what is known as CyberKnife—focused radiotherapy that deals with the tumour but does not damage the surrounding tissue. I am told that to do this would require a request to be sent through the NHS trust system to the CCGs to get their approval, but this treatment is usually required now—today—not in about three weeks’ time, because the patient is in the advanced stages of cancer.
This is just one example; there are lots of others. What the noble Lord, Lord Hunt, said at the end of his speech was right: while this debate is maybe not directly linked to regulatory issues in medicines and devices, a much wider debate needs to be had on whether we have evolved processes that are counterproductive to bringing in or even developing innovations, as the noble Lord, Lord Lansley, referred to on a previous group of amendments. I am slightly hesitant to say that.
The original concept of NICE was to have an opportunity to bring modern innovations rapidly into the NHS. Yes, there was another side to it: that it should be effective and not increase costs unnecessarily. I know this because I was associated with it at the time of its formulation. I took a different route; I did not continue to be involved with NICE, but I became chairman of a similar organisation that the Scots established, at the time called the Clinical Standards Board for Scotland. I deliberately separated bringing innovations into the clinical area from the area of medicines by having the Scottish Medicines Consortium be quite different. However, the concept was the same in England and Scotland. Unfortunately, we need to get back to finding how we can bring in modern innovations more quickly and how we can use our science and the NHS as the core to make more innovation. However, I commend what the noble Lords, Lord Lansley and Lord Hunt, had to say.
Baroness Barker (LD)
My Lords, I thank your Lordships for allowing me to come off the substitutes’ bench to take part in place of my noble friend Lady Jolly. I did not have the opportunity to speak on the last group, but if I had I would have strongly echoed the words of the noble Baroness, Lady Thornton. I do not believe that the Government’s amendments go anywhere near strengthening, clarifying or taking away the reservations that many of us have that the definition of “attractiveness” is one that largely depends on the watering down of regulation and standards and the increasing of commercial competitiveness. That is very much germane to this set of amendments, because it is against this backdrop that the amendments from the noble Lord, Lord Lansley, sit.
Baroness Wheeler (Lab)
My Lords, we are grateful to the noble Lord, Lord Lansley, and my noble friend Lord Hunt for amendments that would ensure that the future role and funding of NICE are placed firmly in the Bill. Amendments 17 and 79 to Clauses 1 and 13 —in the name of the noble Lord, Lord Lansley—underline for both human medicines and devices the importance for the appropriate authority making regulations under the Bill to consider the ability of the NHS to meet the needs of patients and ensure consultation in accordance with Clause 41.
Amendment 85 to Clause 13, in the name of the noble Lord, Lord Lansley, and Amendment 124 in the name of my noble friend Lord Hunt, which proposes to insert a new clause after Clause 38, deal with the funding mandate to the NHS, the availability of human medicines and medical devices, timescales, and ensuring effective monitoring and reporting arrangements by the Secretary of State to both Houses of Parliament.
Noble Lords speaking to this group, particularly those with experience as former Ministers, have made powerful arguments based on their expertise. Those speeches have been very illuminating. I hope, therefore, that the Minister will respond in a positive way that reflects these concerns and these amendments’ intentions.
My noble friend Lord Hunt’s amendment, in particular, places a duty on NICE to take account of the availability of innovative medicines and medical devices for human use on the NHS. It also requires the Secretary of State to report to Parliament on the anticipated impact of new medicines and devices on inward investment and the attractiveness of the UK life sciences sector, whose vital importance to patients and the UK economy we all recognise fully.
As we have heard, my noble friend’s Amendment 24 is very much embedded in the current review of the methods and processes of NICE, amid widespread concerns that despite its recognition as a world-class institution, there is still a major problem with the take-up of new medicines by the NHS, with many CCGs financially or structurally unable to deliver the innovation that NHS patients deserve and must have. The recent report from the cancer charities showing how UK patients are missing out on new innovative treatments that are readily available in any other comparable country shows that stark reality. The NHS’s record on implementation of technical appraisals of new drugs by NICE says it all.
We must therefore ensure that the review of NICE’s methods, which is under consultation until the end of the year, and the consultation on changes to NICE’s processes, which is due to follow early next year, deliver real and effective change, and are open and transparent. The Bill should set out clear responsibilities for both NICE and the Secretary of State on their role in funding; they will be more important than ever in getting that change and innovation.
My noble friend expressed a genuine fear, which is shared across the NHS, about the de facto rationing of innovative medicines and the role that NICE often ends up playing in this without having the clear funding mandate from the NHS that these amendments would provide. His amendment is important because it would inject some parliamentary oversight into the review of NICE’s methods and process, which many consider as having been progressing very much under wraps for a while.
I declare an interest as vice-chair of the cross-party Specialised Healthcare Alliance. We have heard worrying noises about the rarity modifier consideration on rare diseases being removed. I have heard real concerns from rare disease charities among our 100-plus members that the review could be taking a worrying turn in terms of impeding access to treatments for rare diseases. This remains to be seen but it would certainly be a retrograde step; I hope that the Minister will provide me and rare disease charities with some reassurance on it today. I hope that the Minister will at least commit to more parliamentary scrutiny of the review’s work as it reaches its conclusions over the coming months. It is crucial for NICE to be obliged to improve, rather than frustrate, access and for Parliament to be given a view on these matters.
Amendment 85 in the name of the noble Lord, Lord Lansley, would ensure that the NHS has to implement NICE’s recommendations on medical devices as swiftly as for medicines. It is squarely in line with the Government’s stated aims, in so far as the Government have promised a medtech funding mandate of the kind referred to by the noble Lord himself and the noble Lord, Lord O’Shaughnessy.
However, the reality of the Government’s limited proposals—which are now delayed until next year at the earliest—is rather different. Many of the SHCA’s charities represent patients who have already had to shield this year, and now have to do so again, and the newest medtech innovations stand to help them care for themselves at home better. Does the Minister acknowledge that the Government’s medtech funding plans need to be expanded and accelerated rather than delayed? I hope that the Minister will commit to this important issue.
Finally, the threat to the UK life sciences industry from leaving the EU, and the steps that must be taken by the Government to ensure that the NHS does not start to lose its reputation as a global leader in medical science and innovation, have been fully explored. They are a constant theme from these Benches and across the House on the Brexit legislation that we have considered so far. A statutory duty on NICE to take account of the need for improved availability of innovative medicines and medical devices for NHS patients, with a duty on it and the Secretary of State to work together to ensure that the latest medicines are able to provide the care and treatment that patients need and deserve, will be a key part of supporting a world-leading life sciences sector in future.
Baroness Penn (Con)
My Lords, if the noble Lord, Lord Blunkett, speaks with temerity given the other speakers on this group, I ask noble Lords to consider how it feels to be the Minister responding.
I assure the noble Lord, Lord Patel, that Health Ministers may not be completely transformed on leaving government, but discussions that may have taken place in private can become much more public once they are on the other side of the fence.
I turn to Amendment 17, with which it may be convenient to take Amendments 79, 85 and 124 in the names of my noble friend Lord Lansley and the noble Lord, Lord Hunt. On the first half of Amendments 17 and 79, my noble friend conceded that the Bill likely already delivers what is within its scope to deliver. The consideration of the availability of medicines and medical devices when making regulations is relevant. This is what sits behind the ability of the NHS to meet the needs of patients, where it relates to regulation. The Bill simply does not deal with matters related to the NHS supply chain. It supports it by ensuring that medicines and medical devices that are safe are available on the UK market. As my noble friend knows, and has referred to, these matters are set out in other pieces of legislation. NICE was established as a statutory body by the Act that he took through as Secretary of State. I know that his Amendment 85 also probes on issues to do with the NHS supply chain.
I was interested to hear my noble friend Lord Lansley’s fuller explanation of the intention behind the amendment: to enable access to innovative medicines in the NHS. I know that he has done a huge amount to improve such access in the NHS. Although the Government do not think that this amendment is necessary to achieve his goal, I hope that when we come to debate later groups of amendments, including on the Innovative Medicines Fund, I can provide him with further reassurance on this matter.
On the second parts of Amendments 17 and 79, which deal with the results of the consultation on subsequent regulations that flow from the Bill, my noble friend Lord Lansley may have noted government Amendment 126, which we shall reach in a later group. This would add to the consultation requirements in the Bill. On the result of any consultation, I assure him that there is already case law requiring that consultation responses are taken into account. This is reflected in the Cabinet Office consultation principles, which require the Government to explain the responses that have been received from consultees and how these have informed the policy. A public consultation must be formally responded to. Not only that, the Explanatory Memorandum that must accompany a statutory instrument must explain the consultation outcome. Between these various documents, the Government must not only take into account the consultation but set out what has changed as a consequence of that consultation. I therefore think that the amendment may render these changes unnecessary, as the requirement to respond and explain is already there.
My noble friend Lord Lansley also tabled Amendment 85. While I understand his interest in ensuring that we have the appropriate funding and frameworks in place so that NICE-approved devices are made available to patients—an issue already touched on in the previous discussion on attractiveness—he may have anticipated my saying to him, once again, that the Bill is not necessarily the appropriate vehicle.
None the less, my noble friend and other noble Lords have raised an incredibly important issue. I reassure him and others that the NHS medtech funding mandate will be launched in April 2021. It will get selected NICE-approved, cost-saving devices, diagnostics and digital products to patients more quickly and ensure that specified innovations are funded locally. In advance of the mandate’s launch and to support adoption of relevant technologies, the NHS standard contract has been updated to include reference to the medtech funding mandate. I hope that that provides my noble friend with the reassurances that he seeks from me. We are on the way. This Bill is not the means to the end, and I hope he feels sufficiently assured to refrain from pressing his amendment to a Division, when we reach it.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received no request to speak after the Minister, so I call the noble Lord, Lord Lansley, to conclude the debate on this group.
Lord Lansley (Con)
I am most grateful to all noble Lords who participated in this debate, which I thought was very good, with a lot of points well made, including points by the noble Lord, Lord Blunkett. There were good points throughout, with hardly any that I would take issue with.
Both the noble Lord, Lord Hunt, and my noble friend Lord O’Shaughnessy will have anticipated some of the arguments that we can perhaps develop a little further when we come to Amendment 28. It may enable us to cut to the chase, as it were.
I was prompted, in listening to my noble friend and the noble Lord, to wonder what the collective noun is for former Health Ministers. I had always imagined that the appropriate collective noun for those who leave the job was a “release” of Health Ministers. I was struck, after today’s further discussions, by the thought that maybe we should be called a “frustration” of ex-Health Ministers. In every case, we know that we have become enmeshed in and, generally, absolutely fascinated by and engaged with all the issues that we get involved in in the Department of Health, but we never stay long enough to see them through in the directions that we wanted them to go or the conclusions that we wanted them to reach. Perhaps when we come to Amendment 28, I shall have a chance to talk about value-based pricing, which was something that I started but which did not happen after I left. I am thinking in this particular instance of the December 2011 report on innovation in the NHS. Many of the things that we have been talking about today were there nine years ago and continue to be there today, and we need to keep pushing forward with them.
In that context, what my noble friend the Minister said by way of reply about the consideration that the medicines regulator should give to the availability of medicines will certainly cover the ground. If, for example, the NHS makes it clear that it wants earlier access or what we might think of as breakthrough designation for medicines, that will definitely get into the “availability of medicines” consideration, so I take that point entirely. I am grateful for her explanation about the requirements laid on Ministers where they engage in consultation—that satisfies that factor.
I am particularly grateful that we have a date for the medtech funding mandate. I am glad that we are making progress. I know that that will mean that it is not subject to the vagaries of the Covid-19 crisis, which has delayed so many of the objectives that we were hoping to progress during this year and next. For NHS England, it is important. It will enable it to look after patients more effectively and potentially save costs. I am grateful to my noble friend for that. With that positive response, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, we now come to the group beginning with Amendment 18. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 18
“(d) the environmental and social impact of such medicines, including their manufacturing.”Member’s explanatory statement
This amendment seeks to ensure that the environmental and social impact of medicines is considered in the making of regulations.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I shall speak also to Amendments 25, 41, 80 and 91, which are also in my name.
My intentions in participating in this Committee and engaging on this Bill were originally modest. As a feminist and someone concerned about the impact of the profit motive on healthcare, I wanted to back up the work of the brilliant, ground-breaking and terribly important report prepared by the noble Baroness, Lady Cumberlege. However, when I looked at the Bill, I saw some gaping holes, which I have done my best to fill with assistance—which I wish explicitly to credit—from the British Society for Antimicrobial Chemotherapy; Dr Felicity Thomas, co-director of the WHO Collaborating Centre for Culture and Health at the University of Exeter; and, on the medical devices side, Team Consulting, which has provided me with a great deal of pro bono assistance. I am informed also by participants in the Westminster Health Forum event on sustainability in healthcare that I chaired recently.
The context in which this Bill comes before us is an ageing demographic, the rise of chronic health conditions in our deeply unhealthy society, and the advent of “lifestyle” drugs, all of which have been key drivers in increasing use of pharmaceutical medicines and, although I do not have any statistics on it, I would also believe in medical devices. Prescriptions for just one type of statin used to reduce cholesterol rose from 12.8 million items to 18.2 million items over one year alone. One in six 18 to 64 year-olds was prescribed antidepressants at some point in 2017, rising to one in five of those aged 65 and over.
Critics of the pharmaceutical industry have highlighted how a “culture of optimism” generates new drugs, which increases the demand for such treatments while exaggerating their benefits and not counting their flow-on costs, including the environmental. Medicines and medical devices already have significant environmental impacts which, in the context that I have outlined above, are likely to grow rapidly. As we tackle many other causes of environmental damage, the proportionate impact of medicines and medical devices will grow unless we act.
The point that I am about to make is crucial. I note that the veterinary medicines section of the Bill states that
“the appropriate authority must have regard to … the safety of veterinary medicines in relation to animals, humans and the environment.”
I ask the Government why “the environment” appears only in the veterinary medicines section, when, as I will set out, human medicines and medical devices have significant environmental effects.
There are well-known concerns about veterinary medicines—I note in particular the impact of anthelmintics on insect life—but these issues are not contained to them. Why is there no parallel provision in the medicines and medical devices parts of the Bill? I ask the Government to consider parallel provisions from the veterinary part in the human medicine and medical devices part, which is what my amendments aim to achieve.
I am well aware that people will say that human health is different and has to be the top priority, and I agree with many of the issues about safety and health that we talked about in earlier groups of amendments. But this is not a case of saying that we have to weigh health benefits against environmental ones; it is not either/or. As Covid is reminding us, public health is very dependent on the state of the environment, whether that is in the rising danger of zoonoses; the spread of antimicrobial resistance; the well-documented impact of air pollution on health; or the as yet little understood but extraordinarily pervasive existence of microplastics in the air, soil and water in our lives. This is systems thinking—the sustainable development goals approach to which the Government are signed up.
If we look for an overarching way to think about this, the phrase “green pharmacy” recognises the potential for designing new drugs that are less harmful for the environment, whether in their composition, their impact when they escape into the environment or their packaging. It is clear to me that the expectation of this approach should be built into this legislation.
There are some examples of this happening. A project under the EU’s innovative medicines initiative aims to develop tools to screen environmental properties earlier in drug development. I hope to see that transferred into automatic practice in the UK through this legislation. In Sweden, Stockholm county council grades medicines on their environmental effects and doctors can choose to prescribe a less harmful drug where the option exists. If the Government want to be world-leading, that is the standard to be ahead of. The organisation Health Care Without Harm has elaborated 15 recommendations to the European Union for sustainable healthcare. I hope the Government are already well aware of those.
With the exception of Amendments 41 and 91, the amendments do not spell out in detail, in keeping with the Bill’s status as a framework Bill, what kind of provision should be made, although I suggest that they should be included in regulation. They set out the environment as a key issue in the development of medicines and medical devices, and their manufacture, distribution and use. I suggest that that is essential.
Amendments 18 and 25 both look at environmental impacts, with Amendment 25 explicitly about the disposal of unused medicines and the impact of medicines that otherwise reach the environment. That often, although not always, means talking about how medicines reach waterways and get into our drinking water. A 2014 report by UK Water Industry Research found that, in most of 160 sewage treatment works studied, several common drugs were present in the final effluent in concentrations high enough to potentially affect ecosystems. With current trends, the amount of pharmaceutical effluence leaching into waterways could increase by two-thirds before mid-century, according to a 2018 study by the Delft Institute for Water Education.
There are three ways in which drugs can enter into our waterways: by passing through the body, through being disposed of in waste, or during or after manufacturing. It is worth noting that, globally, over half of all medicines are prescribed, dispensed or sold inappropriately, and that half of all patients fail to take them as directed. Unused and waste medicines are also a problem, when they stay within the healthcare system. In the UK, the estimated cost of dealing with medicine waste in the NHS ranges from £100 million to £300 million a year. Research undertaken in Germany found that up to 16,000 tonnes of pharmaceuticals were disposed of annually from human medical care, with 60% to 80% of these drugs flushed down the toilet or placed in normal household waste.
I am aware that, in this context, there are often disproving statements of, “Patients are not disposing of the drugs properly”, but there is often very little information on drug packets or in information given to patients. I have heard anecdotal reports of people taking drugs back to their GP for appropriate disposal and being told, “Why are you doing that? Just throw it in the bin.”
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, the noble Baroness, Lady Sheehan, has withdrawn from the debate so I call the noble Baroness, Lady Barker, who will once again speak in place of the noble Baroness, Lady Jolly.
Baroness Barker (LD)
It is a great pleasure to follow the noble Baroness, Lady Bennett of Manor Castle, who introduced these amendments in her customarily thorough and diligent way; I thank her for taking the time to do that. I also thank her for bringing to the Committee information about the sources from which she brings forward these amendments. They not just represent the aspirations of politicians who wish to pursue their own green agenda; they present the thinking on the part of clinicians and people in the health services about the impact of medicines and medical devices and what they do.
It is no bad thing to remind ourselves that, in the NHS long-term plan, there is a specific commitment to the sustainability of the NHS. It is perhaps no wonder that, when the NHS Sustainable Development Unit reports that the NHS is responsible for 25% of public sector CO2 emissions, there is a recognition that large entities such as the NHS and the British Army will be crucial if the Government are to reach our carbon reduction targets within the timetables set.
As the noble Baroness, Lady Bennett of Manor Castle, said, the NHS is an organisation that British people value very highly. It is an institution that British people do their best not to demand much of—indeed, to minimise their demands on it. It is an ongoing source of frustration for many people that it is difficult for patients to assist with recycling medicines and devices. I know that I am not alone in saying this: when I came to empty the house of my mother, who not only depended on medical devices—hearing aids—but had multiple conditions for which she took medication, I could not dispose of things such as batteries or medicines in an acceptable way. I could not take them to pharmacies and get them recycled for people who needed them. I know that many people have found themselves in that position; it is a source of great frustration for people who do not want to waste precious NHS resources and for whom being in that position is offensive.
I rather suspect, as the noble Baroness, Lady Bennett of Manor Castle, suggested, that the NHS is, at a corporate level, beginning to make some progress in looking at its use of single-use plastics, its disposal mechanisms and, in particular, its use of water. I also suspect that Covid has had a huge and damaging impact on all of that. I do not expect that we will see the NHS able to prioritise this subject for the whole of next year. That is all more the reason for us to do what the noble Baroness said we should do: make sure that this remains an aspiration towards which the NHS should work and should have an obligation to work. With that in mind, I would be very pleased to support the noble Baroness’s amendments.
Baroness Wheeler (Lab)
My Lords, I am very grateful to the noble Baroness, Lady Bennett, for tabling these amendments so that we can discuss these important issues in the context of the Bill. Many of the broader issues she addressed will of course be under detailed scrutiny in the forthcoming Environment Bill, but it is valuable to consider them in the context of the supply of human medicines and devices. I very much value the detailed information she provided on a range of issues of concern, here in the UK and globally.
To touch on a few of the points the noble Baroness raised, Labour strongly opposes the production of single-use plastics and agrees with the Government’s policy of producer responsibility when it comes to new plastics being manufactured, but they have been slow to introduce it. As we have stressed, waste, including plastic waste, pollutes our land and seas, kills wildlife and contaminates our food. We are committed to making producers responsible for the waste they create and for the full cost of recycling or disposal. Sustainable design and manufacturing are crucial to this. Can the Minister reassure the Committee that producer responsibility will extend to the manufacture of medical devices? What incentives are being provided for hospitals to use reusable metal equipment, which can be sterilised after each use?
The Environment Agency has found examples of contaminated hospital waste being illegally exported to developing countries, such as Malaysia, for disposal. What steps are the Government taking to prevent the illegal export of such waste and ensure that we dispose of our own waste in the UK? As we know, there are also major issues about the use of incinerators for hospital waste and concerns about health impacts on those living nearby. What alternative means of secure disposal are the Government planning which will protect the environment and cut the impact of carbon emissions?
Are the Government doing enough to ensure that chemists and GP surgeries provide a secure depository for unused medicines, so they do not contaminate the water supply by being washed down the sink or end up in landfill? Is the Department of Health working with the water companies to prevent the water supply being permanently contaminated by drugs that are flushed into sewers and cannot be refined out of the clean water system? There are concerns that the contraceptive pill might be affecting male fertility through the water supply, but high levels of cocaine are also being identified. What research is taking place on the effects of residual medicine in the water supply on human health?
We also know the deep concerns about the huge expansion of single-use PPE during the Covid pandemic. What arrangements are being made for the safe disposal of this equipment and what consideration is being given as to whether these materials can be sterilised and reused? There is strong concern about the widespread distribution of single-use masks to the general public, which are now causing a huge litter problem, as we have heard, as well as being washed away into our oceans. What are the Government doing to encourage the use of cotton masks, which can be washed and worn again?
On decontamination standards, as we have heard, decontamination and sterilisation are key topics for many medical device companies, particularly those involved in reusable surgical instruments and dental and endoscopy businesses. Key issues include prion removal, healthcare-acquired infections and the logistics of moving medical devices along the contamination chain. What engagement has the DHSC had with manufacturers, medical device decontamination and sterilisation providers and medical device users? Can the Minister tell the Committee what plans the Government have to review the decontamination guidance that is currently in place?
Finally, the important issue of antimicrobial resistance was pursued by Labour in Committee in the Commons by an amendment stressing the need to recognise its importance in the development of new medicines, and which would have laid a duty on the Secretary of State to produce an updated report to Parliament, setting out progress on a UK-wide strategy for tackling AMR. The Government’s 2019 five-year plan—which is part of the 20-year strategy, as we know—has been welcomed and has been the subject of considerable discussion in your Lordships’ House. The noble Baroness, Lady Bennett, is right to underline the awareness of AMR for those participating in clinical trials. The focus must be on developing new medicines to tackle AMR and curb the spread of bacterial diseases requiring antibiotics, and on the prevention and control of infection to contain the emergence and spread of resistance to antibiotics.
Baroness Penn (Con)
My Lords, the noble Baroness, Lady Bennett of Manor Castle, is a tireless champion of matters environmental and I am at one with her in wanting to consider sustainability in all that we do. However, I do not think these amendments are necessary and they are not strictly within the realms of regulating medicines and medical devices, which is what the Bill seeks to deal with.
Legislation is already on the statute book regarding the impact on the environment more broadly. In fact, I suggest that the Bill is part of a wider legislative canvas that delivers what the noble Baroness seeks reassurance on. Within that wider canvas is legislation on packaging waste, which is enforced by the Environment Agency in England. That imposes obligations on packaging producers to seek to reduce the amount of packaging produced, reduce the amount of waste going to landfill and increase the amount of packaging waste that is recycled. I will pick up her point on the production of medical devices being within this principle of producers being responsible for manufacturing waste and write to her on it.
Turning to elsewhere on the canvas, I say that there is also legislation on the statute book to address the environmental impact of producing and disposing of manufactured goods such as medical devices. This includes the Waste Electrical and Electronic Equipment Regulations 2013, which require the recycling of certain types of electrical equipment, including some types of medical devices. I hope that provides the noble Baroness with reassurance that these regulations are part of a wider whole.
The noble Baroness, and the noble Baroness, Lady Wheeler, also raised the importance of the appropriate use of reusable medical devices, which is essential to the provision of health services, with many medical devices being reusable in some form. I think we all agree that it is vital to ensure that decontamination of those devices is possible and, where it is, that it is efficient, effective and safe for patients to reuse. I assure the noble Baronesses that, under Clause 13, we would have the power to make provisions specifying that reusable medical devices must be designed and manufactured in such a way as to facilitate decontamination.
Amendment 25 deals with the important issue of medicines waste and medicine disposal, also touched on by the noble Baronesses, Lady Barker and Lady Wheeler. The environmental impacts of these are taken seriously, but dealt with by other legislation. For example, the Environmental Protection Act 1990 makes provision for the safe management of waste. The Act imposes a duty of care on any person who disposes of controlled waste to take all reasonable steps to ensure that it is not disposed of in a manner likely to cause pollution of the environment or harm to human health. Community pharmacies must comply with this legislation, and the NHS community pharmacy contractual framework makes specific provision for pharmacies in England to act as collection points for the public’s unwanted medicines. These returned medicines are then stored securely by pharmacies until they are collected for safe disposal.
I understand that the noble Baroness and others may also want to know what we are doing to reduce waste medicines in the first place. Medicines optimisation is a key workstream within NHS England’s medicines value programme; it aims to ensure that the right patients get the right choice of medicine at the right time. Through focusing on patients and their experiences, the goal is to help patients to improve their outcomes, take their medicines as intended, avoid taking unnecessary medicines, reduce wastage of medicines, and improve medicines safety.
The Secretary of State for Health and Social Care has asked Dr Keith Ridge, the chief pharmaceutical officer for England, to carry out a review of overprescribing in the NHS. Following a pause due to the Covid-19 pandemic, the review is due to report later this year. This work is looking at reducing inappropriate prescribing with a particular focus on the role of digital technologies, research, culture change and social prescribing, repeat prescribing, and transfer of care. The report will provide recommendations to reduce overprescribing, which will help to reduce medicines wastage.
Amendment 41, proposed by the noble Baroness, Lady Bennett, highlights the serious and growing global problem of antimicrobial resistance, or AMR. It has been placed on the National Risk Register of Civil Emergencies as a “longer term trend” likely to change the overall risk landscape for the UK over the coming decades. Already it is estimated to cause more than 700,000 deaths each year globally. That figure is predicted to rise to 10 million, alongside a cumulative cost of $100 trillion by 2050 if no action is taken. She will be aware that in January last year the Government set out the UK’s vision to contain and control AMR by 2040. This vision is supported by a five-year national action plan that includes comprehensive One Health action across the spectrum of human and animal health, agriculture, the environment and food.
While recognising the serious threat of AMR, I respectfully suggest that this amendment, specifically in the context of a clinical trial, is not necessary. Clinical trials of medicines, including those of antimicrobials or antibiotics, have strict requirements for reporting adverse events and for continuous monitoring of the benefits of the medicine under investigation versus the risks, as set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 and associated good clinical practice guidance. Development of AMR during a clinical trial may manifest as an adverse event or as a lack of efficacy to the medicine being investigated. In either case, the investigators and trial sponsor have obligations to take action to protect the safety of the trial participant. This action might include taking an urgent safety measure, amending the trial protocol or terminating the trial early. These actions would require notification to the medicines regulator—the MHRA—and a research ethics committee. Development of AMR during a trial would also be expected to be transparent via the publication of the results of that trial.
The Health Protection (Notification) Regulations 2010 places a legal duty on the operator of a diagnostic laboratory to notify Public Health England of the identification of specified causative agents in a human sample within seven days. On 1 October, those regulations were updated to require diagnostic laboratories to report the results of any antimicrobial susceptibility test results and any resistance mechanism identified in respect of a sample. I hope that provides reassurance of the Government’s focus, not just to maintain high levels of surveillance of rates of AMR but to successfully contain and control its spread for future years. Given the existing provisions and ongoing work in the department, I hope I have reassured the noble Baroness that additional powers in this regard are unnecessary and she now feels able to withdraw her amendment.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I thank the noble Baroness, Lady Barker, for adding to the outline that I provided on the importance of the greenhouse gas emissions of the NHS and bringing in the issue of the use of water, which is becoming an increasingly rare resource in the UK. I thank her for providing her personal account of the frustrations of individuals who want not to waste NHS resources, based on her own experience.
I thank the noble Baroness, Lady Wheeler, for focusing on plastic waste. I shall restrain myself from commenting on the broader points of this issue, but thank her for highlighting the particular importance of illegal exports of medical waste and the big issues around Covid-19 and the waste unavoidably being generated at this point, as she said.
Coming to the Minister’s response, at the start there was a suggestion that this was a provision to go somewhere else—that all these issues could be in the Environment Bill or packaging regulations, et cetera. I do not accept that. If we take a systems-thinking sustainable development goals approach, then we have to make sure that all these issues are in every piece of legislation. Everything has to be considered as a whole. Rather than saying “We’ll deal with it somewhere else”, given the issues of legislation being delayed—we do not know when the legislation that we have not yet seen will arrive—it needs to be built into every element of our thinking on this fragile, much-abused planet.
Coming to some specifics, the Minister commented on current arrangements for recycling of devices. I note that there was a disturbing report out this morning through the waste industry about the number of fires occurring in waste management facilities as a result of the inappropriate disposal of batteries. I do not know how many of those involved medical devices, but I would think it highly likely that, in some cases, they would be. There is clearly a real problem with our current disposal systems. The Minister referred to Clause 13 dealing with the contamination issues. I will take that back to my technical advisers. I was pleased with her comments about the efforts on medicines optimisation. If we think about this in the context of a waste period more broadly, we know that “reduce” is always the best option.
I am also pleased with the overall tenor of this debate and the focus that we have seen on antimicrobial resistance. If we think back—gosh, it is two Prime Ministers back now—David Cameron gave a major speech on antimicrobial resistance and we have seen growing awareness of this issue. I am pleased that this debate has been an opportunity to highlight it and focus on the need for more action. For the moment, I beg leave to withdraw my amendment, but I reserve the possibility of further consultation, and potentially bringing it and my other amendments back in this or a different form.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 19. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 19
Baroness Sheehan
“(d) citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966; (e) the public health safeguards within the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) which include but are not limited to—(i) the right to grant compulsory licences and the freedom to determine the grounds upon which licences are granted;(ii) the right to determine what constitutes a national emergency and circumstances of extreme urgency;(iii) the freedom to establish the regime of exhaustion of intellectual property rights.”
Baroness Sheehan (LD) [V]
My Lords, I metaphorically rise to move Amendment 19, which is in my name and that of my noble friends Lady Jolly and Lord Sharkey and the noble Lord, Lord Alton, whose support is always very welcome. I look forward to the contributions from other noble Lords who have signalled their intention to speak. It is a matter of deep frustration that a number of noble Lords who wished to contribute to this debate are instead committed to the equally important debate on the internal markets Bill, which is pitted directly against this Bill.
Amendment 19 has been tabled simply to ensure that fair access to medicines is a core aim of the Bill. It would root the Bill in the International Covenant on Economic, Social and Cultural Rights of 1966, which is a binding international human rights treaty that we in the UK ratified in 1976. The amendment would put into the Bill the fundamental right of every citizen
“to access medicines as part of the right to the highest attainable standard of physical and mental health.”
Fair access to medicines is an issue at the forefront of concerns expressed by patients’ groups. There are regular reports in the media about price gouging by pharmaceutical companies. Furthermore, one of the key calls in the collated briefing of the Royal College of Physicians, the Faculty of Pharmaceutical Medicine and the British Association of Dermatologists is that:
“The Bill must include provisions which allow for review of processes for issuing sole manufacturing licenses and consider the use of price control mechanisms in relation to costs of production, to increase access to medicines at fair prices.”
Yet this issue was not brought up during the Bill’s passage through the other place, nor does it feature directly in any other amendment before the Committee. So I hope that your Lordships will forgive what will be a rather full presentation of the important issues raised in the amendment.
Lord Alton of Liverpool (CB)
My Lords, in her prescient, topical and important speech, the noble Baroness, Lady Sheehan, asked a number of important questions of the Minister. I look forward, as I know other Members of the Committee will, to his response later in his remarks. The noble Baroness was right to remind us of the importance of fair access to medicine and the role of pharmaceuticals. Any vaccination programme for Covid-19 should be equitable and fair. She referred in her remarks to some work done at Liverpool University, which I will return to a bit later in my remarks. In her amendment specifically, she draws our attention to the International Covenant on Economic, Social and Cultural Rights of 1966, and, as she has done in her remarks, reminds us of the public health safeguards within the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights—TRIPS.
Earlier this year, with other noble Lords who serve on the International Relations and Defence Committee, I participated in hearings which led to the publication on 10 July of our report entitled The UK and Sub-Saharan Africa: prosperity, peace and development co-operation. The inquiry was chaired by the noble Baroness, Lady Anelay of St Johns. We became acutely aware of the potentially catastrophic effect of Covid-19 on already fragile economies and societies. John Hopkins University suggests that across the continent of Africa, with its population of around 1 billion people, there have been about 37,000 deaths, compared with 230,000 in Europe. Indeed, there have been more deaths in the United Kingdom than in the whole of Africa. But we must treat the data with some caution and even scepticism. Reporting in many places is rudimentary, with Nigeria carrying out just 2.7 tests per 1,000 people, compared with 381 in the United Kingdom, so the data may have to be treated with caution.
Mercifully, the reported death rate—18,000 in South Africa, for instance—does seem to be lower than in some parts of the world, perhaps assisted by younger populations; few homes for the elderly; less common incidence of type-2 diabetes and obesity; more outdoor living and low travel; and experience of dealing with Ebola, malaria and AIDS. We should nevertheless be concerned that, as recently as last week, the World Health Organization said there had been a substantial rise in deaths and recognised that disparities in our health systems and economic power could still see an acceleration in infections and fatalities.
The smouldering pandemic in Africa has been held at bay by swift and significant lockdowns in many African countries, leading inevitably to significant loss of jobs. That cannot be sustained indefinitely. These fragile economies will see increases in destitution and chronic poverty if we are unable to ensure protection for all as and when a vaccine becomes available.
James Duddridge MP, the Africa Minister, told the inquiry that, as a consequence of Covid-19, the World Bank projected 40 million to 60 million additional individuals falling into extreme poverty, and it has been projected that the economy of sub-Saharan Africa will be between 2.1% and 5.1% smaller by the end of the year. The London School of Hygiene & Tropical Medicine told the inquiry that the region was likely to face particular contextual challenges from Covid-19, including
“economic, social and cultural inequalities, lack of personal protective equipment … and the additional health burden of communicable and non-communicable diseases”.
It cited three factors which could worsen the impact:
“overcrowding and large household sizes”,
which increases transmissibility, a
“high baseline prevalence of co-morbidities”
and
“lack of intensive care capacity”.
Lord Crisp (CB) [V]
My Lords, I support Amendment 19, which would have been important at any time, but is, of course, as we have already heard, particularly important at the moment. I will speak briefly, and I can do so thanks to the eloquent contributions by the noble Baroness, Lady Sheehan, in moving the amendment and by my noble friend Lord Alton.
There are points of principle here, and practical points. I start with the points of principle. First, the UK signed up to the International Covenant on Economic, Social and Cultural Rights in 1976, which guarantees access to medicines as part of the right to the highest attainable standard of health. This should be integral to all our medicines regulation.
Secondly, as we have heard, the World Trade Organization’s TRIPS Agreement explicitly included public health standards, giving countries the right to grant compulsory licences and to determine where there is a national emergency, and the freedom to establish a regime of exhaustion of intellectual property rights—in other words, taking control of access to medicines on behalf of their populations. Both these principles are underpinned by the basic responsibility that Governments have for maintaining, protecting and improving the health of their people, but also by the wider points that my noble friend Lord Alton just talked about on our interconnectedness and responsibilities to our fellow citizens of the world, in our own self-interest as well as from other motivations.
However, as the noble Lord and the noble Baroness said, in addition to principles there are very practical issues that should guide our thinking on this. The first is that there is good precedent. The UK and other Governments have used, and/or threatened to use, these rights on several occasions over the years with good effect for the benefit of their people. They are useful and viable measures, and should be at the front of our minds at this time, because—here the point is being made again—the response to Covid is bringing with it a frankly unprecedented number of new treatments and vaccines in a relatively short period of time. It is vital that these are made available as quickly, widely and cheaply as possible, not just in the UK.
I echo the questions from the noble Baroness, Lady Sheehan. I will be interested to hear the Minister’s response about our participation as a country in the global sharing and the global effort.
It was good to hear my noble friend Lord Alton’s description of the situation in Africa and of the imperative need for us to bear that in mind in our policy-making here in the UK, while also bearing in mind the great reputation that we have had over several years for doing so. On Friday, I got in touch with the World Health Organization in Africa. Some of the figures that the person I spoke to talked about, regarding the impact of the pandemic on wider health issues, were formidable indeed. I was told that we have lost the gains of 25 years in the past 25 weeks—an extremely depressing statement.
Just as depressing, as both noble Lords mentioned, is the fact that we are already seeing signs of the way in which some pharmaceutical companies will approach this extraordinary period of new vaccines and treatments in what is happening with remdesivir, with shortages and treatment rationing here in the UK, let alone anywhere else.
This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.
Baroness Walmsley (LD) [V]
My Lords, the Government take an enormous number of powers to make regulations in the Bill.
In the light of the paucity of parliamentary powers to check these, particularly prior to them coming into effect—as demonstrated by the recent Covid-19 regulations —the only way in which Parliament can influence these regulations before they are even drafted is by inserting into the Bill those things to which Ministers must have regard. That is why my noble friend Lady Sheehan seeks via Amendment 19 to insert two important elements into the Bill after the priorities of safety, availability and so-called attractiveness. I support her amendment and look forward to the Minister’s answers to her questions.
Proposed new paragraph (d) would ensure that the Government have regard to the International Covenant on Economic, Social and Cultural Rights of 1996, which the UK ratified 10 years later. This affirms a citizen’s basic human right to access medicines without discrimination, which means that they must be both affordable and available. We have committed ourselves to that.
Proposed new paragraph (e) reaffirms the international protections conferred by the WTO’s TRIPS Agreement. It recognises that these intellectual property rights protections have been misused and abused by big pharma; that resulted in the WTO’s Doha declaration of 2001, which reaffirmed public health safeguards for citizens of all nations. The details are in the amendment.
The amendment is absolutely crucial as the world awaits new tests, treatments and vaccines for Covid-19, as other noble Lords have mentioned. In particular, the pandemic demonstrates the importance of paragraph (e)(ii): the right to determine what constitutes a national emergency. The Government have used that.
However, the track record of big pharma does not bode well for equitable distribution of medicines, and this demonstrates the importance of the right to issue a Crown use licence. Drugs to treat cancers, HIV/AIDS, hepatitis C, cystic fibrosis and toxoplasmosis have all been withheld from citizens while Governments were held to ransom during negotiations with pharmaceutical companies. The NHS has had to ration necessary drugs because of price gouging. The threat of using a Crown use licence, and the actual issuing of one, has been helpful in such negotiations, and several countries have used the powers to great effect.
The issue of compensation, however, needs to be clarified. This section of the law has not been tested in court. Will the Minister commit the Government, therefore, to review Section 57A of the Patents Act to ensure that it does not block the use of the crown use licence provision? Countries such as Australia, Canada and Germany have revised their patents laws for this purpose, and other countries have taken action. Will the UK Government do the same? This power could be needed to ensure access to Covid vaccines and treatments, so time is of the essence. Will the Government act now and not just stick to business as usual?
Baroness Penn (Con)
My Lords, I suggest that this is an appropriate moment at which to pause our debate for today. I beg to move that the debate on this amendment be adjourned.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, that concludes the work of the Committee for today. The Committee stands adjourned. I remind Members to wipe their desks and chairs before leaving the Room.
Medicines and Medical Devices Bill
Wednesday 28th October 2020
(4 years ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-III(Rev) Revised third marshalled list for Grand Committee - (26 Oct 2020)
Lord Patel (CB) [V]
Thank you, Chairman. It is a pleasure to resume where the Committee left off last Monday. I will speak to Amendment 19, in the name of the noble Baroness, Lady Sheehan. I congratulate the noble Baroness, who spoke with eloquence and passion. On Zoom, you can see faces more clearly and you could tell by looking at her while she was giving her speech that she really feels for the cause. I will speak briefly to support the noble Baroness in her efforts to use human rights legislation to get medical therapies available to patients, particularly in developing countries.
I am no expert in human rights law, but I have seen at first hand what lack of everyday medicines, which we in developed countries have easy access to, does to patients in need in developing countries. In my own medical speciality of obstetrics, I have come across situations where mothers die, or end up with lifelong disability, for lack of availability of cheap medications that would have saved them from dying of childbirth-related haemorrhage. Medicine that costs less than £2 would have saved those mothers’ lives in a very short time.
Despite progress, over 2 billion people worldwide face obstacles in getting the medicines that they need. The current research and development model is mostly market driven and is ill equipped to deliver medicines for neglected tropical diseases and emerging infectious diseases that only affect those in developing countries. Only 1% of the total number of new medicines coming to market are licensed for treating tropical and rare diseases in poorer countries. Another big barrier is the pricing mechanism that makes what we may regard as cheap medicines unavailable in poorer countries because of cost. A human rights model, proposed by the WHO and the United Nations, for making more treatments available in poorer countries, faces serious obstacles because of world trade and patent regulations. The monopoly market power of patent rights plays against the availability of medicines for poorer countries.
All that being said, a soft-power model can sometimes be effective. The Bill & Melinda Gates Foundation has had considerable success in its efforts to create an access-to-medicine index for pharma to demonstrate its commitment to getting medicines to the developing world. One example is the generic medicine for treatment of hepatitis C, but some pharma companies prevent early recourse to generic versions of medicines through extending patent laws by using tactics such as data exclusivity. I heard an announcement today that, if the Sanofi and GSK vaccine works, they will provide 200 million doses of it free to the developing world. That is good news, but it is far away from the billions of doses that we will require.
If there is a serious desire for the world to make treatments available to patients in poorer countries, at a price that they can afford, laws will be needed to change the market-driven model to a more rigidly applied human-rights-driven one. The noble Baroness is right to highlight the problem. The Government can help by working with other Governments to create opportunities for easier access to medicines for developing countries. There has to be a way to get around the model of profit versus patients.
Lord Stunell (LD) [V]
My Lords, I endorse what the noble Lord, Lord Patel, has said about the excellent speech of my noble friend Lady Sheehan. I support her arguments and those of all the previous speakers. I could never hope to bring the level of expertise that the noble Lord, Lord Patel, does to this subject.
I want to focus, very simply, on what happens next—and what happens next is based on what has happened so far. Proposed new subsection (2)(d) in Amendment 19 is an affirmation of the International Covenant on Economic, Social and Cultural Rights, which was first passed in 1966 and the United Kingdom Government ratified 10 years later in 1976. My first question, therefore, is to ask the Minister: do the UK Government still stand by that covenant, or is it another piece of international legislation that can be broken in certain limited and specific circumstances? I think that noble Lords will want to hear the Minister say very clearly that the Government are still committed to the full meaning of that covenant. If he does, I hope he will also acknowledge that the key feature of that covenant is that it requires access to medical care and treatment to be affordable and available to all. That is exactly what the second part of Amendment 19 is talking about. It aims to give teeth and real substance to that covenant and to make sure that medicines and treatment are indeed affordable and available to all.
What is the risk that we are guarding against? Why do we need to do this? The noble Lord, Lord Patel, also focused on those questions. Although there are many risks, the leading risk which this amendment deals with is greedy pharmaceutical companies. The story of Gilead selling its drug in the United States for £2,300, when it can be manufactured with a profit for £9, was drawn to our attention by the noble Lord, Lord Alton, on Monday. That is just one of many examples of companies unscrupulously using their monopoly to reap profits at the expense of those who need the treatment. Sadly, there have been many other examples of it. In the current worldwide search for a vaccine, the pressure on companies to deliver a treatment, and the pressure from communities throughout the world to receive it, means that the risk of profiteering and gouging are very much higher.
Of course pharmaceutical companies are fully entitled to recover their costs, and that should include the costs of their research, including for the research on products which they cannot bring to market for one reason or another; and of course they should be entitled to make a profit as well. But in the case of Covid-19 vaccines, nearly all the money has been pumped into the research from the public via Governments around the world. Hundreds of millions of pounds from the United Kingdom Government have gone to these firms. The Government therefore have some really powerful levers to pull to make sure that there is fair and equitable pricing by those companies and fair and equitable sales around the world.
Of course, the truth of the matter is that we have a WTO TRIPS agreement that protects pharmaceutical companies’ monopoly purchasing. But attached to that is the Doha declaration of 2001, which gives Governments the right to step in to prevent that profiteering and price gouging. Under the declaration, the United Kingdom has in principle the right to grant compulsory licences so that other manufacturers can make the product in an alternative way at an alternative price. We need to hear from the Minister today that the UK Government will use the powers available to them in the Doha declaration to prioritise the safeguarding of access to medicines for all right round the world. “All” has to mean all, not just within the United Kingdom but worldwide, as my noble friend Lady Sheehan made so clear, especially in low and middle-income countries.
The role of the United Kingdom in ensuring that an effective worldwide response to Covid actually happens may well require compulsory licensing using the basis provided by the Doha declaration. Certainly, having that basis, and having this amendment passed, gives the Government a credible threat that they will indeed make sure that medicines are available for all. I look forward to hearing the Minister agree that, if not Amendment 19 itself, at least a loud and clear commitment from the Government to implement their powers under the Doha declaration is very much a part of their armoury in tackling the current situation.
Lord Sharkey (LD) [V]
My Lords, it is a pleasure to follow my noble friend Lord Stunell. As my noble friend Lady Sheehan so clearly and compellingly explained on Monday, this amendment deals with the key question of access to medicines and is particularly relevant as we find ourselves swept along by wave 2 of the global pandemic. It is clear that, at least initially and perhaps for much longer, supply of any Covid-19 vaccines will fall behind demand. This raises the urgent question of who should receive priority access to these vaccines. Who should get them first, here and internationally? How should equitable access be decided?
The Government appear to be adopting two contrasting approaches to this question. On the one hand, we have Gavin Williamson saying:
“It’s the right thing to be doing to be at the absolute front of the queue to make sure we’re in a position to get those vaccines first when they become available”—
and that does seem to be what we are doing. As of August, the United Kingdom was the world’s highest per caput buyer, as the noble Lord, Lord Alton, mentioned on Monday. The vaccine taskforce has placed orders for six unproven vaccines, taking its potential stockpile to 340 million doses. Of course, we do not yet know to what extent, if at all, these vaccines might work, so some duplication is obviously prudent. But on the other hand, and while securing our place at the front of the queue as Mr Williamson recommends, we are also involved in trying to work out, under the auspices of the WHO, an equitable access scheme. The rationale for that is pretty obvious. Unless we have such a scheme, rich countries will end up vaccinated well in front of poor countries. In the face of a global pandemic, that approach carries obvious risk. It also carries moral risk.
The Government have committed £60 million to the WHO COVAX facility—the Covid-19 Vaccine Global Access Facility mentioned by my noble friend Lady Sheehan on Monday. COVAX seeks to enable global collaboration and equitable access to vaccines. It views this model of pooled procurement as preferable to rich countries doing bilateral deals. We have also joined 150 countries in expressing an interest in participating in COVAX for our own vaccine purchases. But there is clearly a risk that the bilateral purchasing of vaccines by the United Kingdom and other rich nations could undermine the work of COVAX. Could I ask the Minister how we balance our Williamson approach with our COVAX approach? How are these approaches prioritised? How much should we try to secure for ourselves and how much should we share? What criteria will be used to decide what access means in practice? We know something of what people in the UK think about the issue. Some 96% of the UK public supported the idea that national Governments should work together to ensure that treatments and vaccines can be manufactured in as many countries as possible and distributed globally to everyone who needs them.
My noble friend’s amendment also raises the issue of Crown use licences. We have previously used or threatened to use these licences in our negotiations with pharma. Can the Government confirm their willingness to use these licences if price negotiations on Covid-19 vaccines fail to reach a satisfactory conclusion?
I urge the Minister to give very serious consideration to the issues raised by this amendment. I will listen to his reply with great interest.
Baroness Barker (LD)
I thank my noble friend Lady Sheehan for her introduction to this amendment and the noble Lord, Lord Alton, for the detail that he added to that.
My interest in this matter stems back to 2013, when I was part of the All-Party Parliamentary Group on HIV and AIDS, which produced a report called Access Denied. It was about barriers to access to antiretroviral drugs for HIV and AIDS in low and middle-income countries. In the course of our research work for that report, we held a number of hearings with all sorts of representatives from a number of international research groups based in the United Kingdom but which worked across Africa and Asia. We met user and patient groups and also included representatives from the pharmaceutical companies.
I vividly remember sitting in a room in Portcullis House during one of our question and answer sessions and putting a question to a representative of a pharmaceutical company that has cropped up in our discussions in the last couple of days. I asked him a simple question—whether there was a direct correlation between the R&D costs of a drug and the price. With disarming candour, he said, “No”. Once people’s jaws had ceased to drop, we had the revelation that actually there is no transparency about pricing in the pharmaceutical industry or about the extent to which public and private funding goes into the development of new medicines—and, in effect, an admission that the overstatement by pharmaceutical companies of the need to charge excessive prices in some markets to maintain their viability is not substantiated.
I am not an anti-pharma campaigner. I believe that human and animal welfare rests very much on the development of pharmaceutical knowledge and science, and I am all in favour of extension of research and development of new drugs. However, for far too long Governments of all sorts have been held over a barrel by pharmaceutical companies, and that should stop.
I say this as someone who has had a long-standing interest in HIV. To see some patient groups in some parts of the world continue to become infected and, perhaps, have threats to their lives that would not occur if they had simply been born in another country is devastating. For example, in the world of HIV, very little work is being done on development of antiretroviral drugs for paediatrics because there is very little call for that in western developed nations, whereas there is a very big need for it in sub-Saharan Africa. Our involvement in these matters has a direct bearing on the lives of people across the world and on our standing not only as one of the major governmental funders through the different international funds but as a country in which research into new and emerging transmissible diseases is second to none because of our long-standing history.
For all those reasons, I very much support my noble friend Lady Sheehan, and I await with interest the answer to the question that my noble friend Lord Stunell put, which was the one I was going to ask, about proposed new paragraph (d) in my noble friend’s amendment.
Baroness Thornton (Lab)
The Committee owes the noble Baroness, Lady Sheehan, a debt of gratitude for bringing forward this amendment. I very much enjoyed her opening speech—and, indeed, those of the noble Lords, Lord Alton and Lord Crisp, both of whom are so well qualified to speak about international health responsibilities.
What this debate does is to remind us of how privileged we are to live in a country with free access to new medicines and innovations. However, we are now entering choppier international waters. We have been sheltered, as it were, over 40-odd years or so by the European Union’s heft and regulatory framework. So we need to take notice of the need for greater co-operation, as has been outlined by the noble Lord, Lord Patel.
I was very struck by the mention of things like price gouging by the noble Baroness, Lady Sheehan, and their dangers for those less fortunate than ourselves. On the immediate responsibilities and dangers around the Covid vaccination, which we so desperately need, the World Health Organization says that it is working on a plan to ensure equitable distribution of vaccines, but how that would be enforced in practice is not clear. Professor Mariana Mazzucato, who heads the University College London’s Institute for Innovation and Public Purpose, says:
“In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available.”
That is absolutely right.
However, as the noble Lord, Lord Crisp, said, we need to pay attention to what is happening in the UK and what the effect of Brexit might be—and, goodness me, we are all on tenterhooks as to whether we get a deal or not. Rick Greville, the director with responsibility for supply chain at the Association of the British Pharmaceutical Industry said, in the run-up to a no-deal Brexit—the last time this happened—that there could be currency fluctuations, including a fall in the value of the pound. He said:
“You can imagine in that situation that exporting medicines into Europe would become even more profitable. It may be that”
drugs
“that currently aren’t being exported suddenly become attractive to export, driven entirely by profit”.
The UK is not invulnerable to what might happen next, and I would like the Minister’s observations on that.
Launched earlier this year, COVAX wants wealthy nations to pool funds that together can be used to develop and scale up vaccine production. In return, rich countries would have a guaranteed supply for about 10% and 15% of their population. I would also like the Minister’s answer to that, because several noble Lords have raised that question.
This is one of those debates in which one feels that so many people are better qualified to speak than oneself. I finish by quoting the noble Lord, Lord Crisp, and what he said on Monday. He said:
“This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.”—[Official Report, 26/10/2020; col. GC 71.]
I could not have put it better myself.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, there can be absolutely no doubt about the importance of patient access to medicines. This is very much at the heart of the NHS constitution, and it is absolutely fundamental to how we regulate human medicines.
I completely agree with the noble Baroness, Lady Thornton, that the noble Baroness, Lady Sheehan, has done us a great service with an incredibly impressive speech, which was thoughtful and powerful and a privilege to listen to on Monday. The speeches of the noble Lords, Lord Alton and Lord Crisp, who I do not think is present, drew on many years and huge experience of international affairs and comparisons. We are very grateful for the challenge that those speeches have given us on this extremely important subject. But I reassure all speakers to this amendment that this Bill will absolutely not change the importance of patient access to medicines and how we regulate that.
The Deputy Chairman of Committees (Baroness Henig) (Lab)
I have received a request to speak after the Minister from the noble Lord, Lord Alton.
Lord Alton of Liverpool (CB)
My Lords, I thank the noble Lord, Lord Bethell, for the response he has given to the debate, but I have two questions I want to put to him. Like the noble Lord, Lord Stunell, and others, I accept that pharmaceutical companies will always want to and are entitled to reclaim research and development costs. On Monday, I referred to the phenomenal difference in the cost of remdesivir when purchased in the US at over $2,000 for a five-day treatment and Liverpool University’s estimate of $9 as the basic production cost. I asked how much public money went into developing that drug. If the Minister is unable to answer that question today, I would really appreciate it if he could undertake to write to us to let us know how much public money went into the development of that drug.
My second question is about Crown use licences, a question posed to the Minister by the noble Lord, Lord Sharkey. Are the Government considering using the Crown use licence, should the circumstances require that? It was used in the 1960s, and more recently the use of it was threatened in the case of an innovative new treatment for cystic fibrosis. The Government used the power, and that had the desired effect of bringing down the cost of that drug. Are the Government giving serious consideration to how they will use Crown use licences, should that become necessary?
Lord Bethell (Con)
I thank the noble Lord, Lord Alton, for his questions. On remdesivir, I will be glad to find out whether any UK funds were used in its development and will write to him. I will also be glad to write to him about Crown use licences.
Baroness Sheehan (LD) [V]
My Lords, this has been a quite passionate debate and I am profoundly grateful to all noble Lords who have taken part in it. The debate goes to the heart of how we see ourselves. We are a kind, caring compassionate country that also abides by the rule of law, whether that is national or international law. That is why I thought it was right to include our ratification of the ICESCR—the International Covenant on Economic, Social and Cultural Rights. The noble Lords, Lord Crisp and Lord Stunell, both invoked that treaty as being an important and fundamental part of Britain’s reputation abroad. The amendment reminds us quite forcefully that a ratified international treaty is national law. That is quite a topical point as we debate this Bill in step with United Kingdom Internal Market Bill.
I am grateful to the noble Lord, Lord Alton, for his contribution, which was a real tour de force. It was informed by many years as a human rights activist and by his membership of the International Relations and Defence Committee, chaired by the noble Baroness, Lady Anelay. He reminded us that the African continent imports 94% of its pharmaceutical requirements. That figure struck me quite profoundly because the next figure that the noble Lord quoted was 96%. That was the finding of the YouGov poll of the proportion of the country that supports what we are trying to achieve here—equitable and fair access across the world for essential medicines. That is a very important reference point for the Government to bear in mind.
At all costs, we must avoid the unseemly debacle that we saw across the world in the early days of Covid-19 as countries scrabbled to get hold of scarce PPE. We must think ahead, put logistics planning in place and up front and support the global effort that seeks to do that.
The noble Lord, Lord Crisp, and my noble friend Lady Walmsley reminded us that public health safeguards were built into the TRIPS agreement because, as my noble friend Lady Barker noted, countries in the least developed parts of the world are right at the back of the queue when it comes to the development of medicines that are desperately needed.
My noble friend Lady Walmsley also highlighted that the insertion of the amendment in Clause 1(2) would mean that the Government would need to have regard to the provisions of the amendment. That is an important point. In his reply, the noble Lord, Lord Bethell, said that we have such a right already—of course we do—but the issue is that existing price control mechanisms are not used effectively enough at the moment; otherwise, we would not see the recurring incidence, which many noble Lords referred to, where the NHS is regularly held to ransom in trying to negotiate prices. While those negotiations go on, with all the delay involved, patients suffer and some patients die.
I thank the noble Lord, Lord Patel, who from his deep health expertise spoke passionately about the ways in which pharmaceutical companies bend the rules and how patients suffer as a consequence. I repeat the request made by the noble Lord, Lord Alton, and by my noble friend Lord Stunell. Why is it that Gilead can get away with charging £2,350 per dose, when the Liverpool University work shows that £9 per dose would reap sufficient profit?
I also thank the noble Baroness, Lady Thornton, for her support. I agree that we ought to listen to Professor Mazzucato on how to approach global challenges, because she understands global economics and can explain it in a way that I find very compelling. My noble friend Lord Sharkey gave a superb summary of the issues at stake. He highlighted, yet again, the moral imperative: it is so true that no one is safe until everyone is safe and, if nothing else, enlightened self-interest must compel us to act more collaboratively on the global stage.
On the issue of C-TAP, the waiver requested by South Africa and India at the TRIPS council meeting speaks to the need to have some way of overcoming the issues in respect of sharing IP rights, data, know-how and the expertise that is lacking at the moment. They would not be asking for that and would not be pushing for it unless it was necessary. Without that, we will not immediately be able to ramp up manufacture of the vaccine when we need it, which will be immediately.
In conclusion, this is a reputational issue for Britain, because it speaks to who we are as a country. I am with the 96%. If we truly want global Britain to be seen as a force for good, we must take this opportunity to join others, to lead from the front and to throw our heft—our quite considerable heft—and expertise behind the global collaborative effort to keep control of Covid-19. And when we are good, we are very, very good.
The Deputy Chairman of Committees (Baroness Henig) (Lab)
We now come to the group beginning with Amendment 23. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 2: Manufacture, marketing and supply
Amendment 23
Baroness Wheeler
Member’s explanatory statement
This is a probing amendment that would omit the Secretary of State’s power to make changes to wholesale dealing, including hub and spoke models.
Baroness Wheeler (Lab)
My Lords, I am pleased to move Amendment 23, in the name of my noble friend Lady Thornton, and to support Amendment 29, in the name of the noble Lord, Lord Clement-Jones.
Our amendment is a probing amendment, which has two aims. First, it provides us with the opportunity to hear from the Minister why the Government consider that the extensive delegated powers on the hub and spoke model for pharmacies are needed at this present time under the Bill, rather than ensuring that any such proposals are instead contained in future planned and well-thought-out primary legislation—properly consulted on and worked through—that amends existing legislation and regulations.
Secondly, we understand that there has been some discussion with key stakeholders in the pharmacy industry since the Government’s intentions were revealed in the nine short paragraphs on dispensing medicines in the impact assessment for the Bill—as we know, hub and spoke dispensing centres are not referred to on the face of the Bill. Today is an opportunity for the Minister to update us on the Government’s response to the concerns and issues raised by MPs in the Commons and by noble Lords during the Bill’s Second Reading, and in representations from leading industry organisations, including the National Pharmacy Association and the Pharmaceutical Services Negotiating Committee.
We need far greater clarity on what exactly is proposed, how the Government intend to take all this forward and how the very limited proposals that we have heard so far fit into the NHS long-term plan vision for the transformation of community pharmacy as an integral part of local primary care. How will pharmacists’ enhanced role in the future limit the number of people who will not have to see their GPs, in the way that the Government envisage?
Amendment 23 would amend Clause 2, on the “Manufacture, marketing and supply” of human medicines, and would delete the Secretary of State’s power to make provision for the distribution of human medicines by wholesale dealing, as is proposed for hub and spoke dispensing in the delegated powers proposed in the Bill. I have deep concern about the extensive range of delegated powers proposed under the Bill, and I support the decisive views of both the Delegated Powers Committee and the Constitution Committee on this matter, which have been made crystal clear by my noble friend Lady Thornton at all stages of the Bill. Major changes such as those envisaged for the community pharmacy sector through the extension of hub and spoke dispensing should be on the face of the Bill, with appropriate safeguards on their development, including a full public consultation.
The impact assessment tells us that
“dispensing needs to become more efficient to free up pharmacists’ time for other activities”
and that this will be achieved if all pharmacies have access to more efficient hub and spoke dispensing. We strongly support the aim of freeing up pharmacists’ time, better use of the skill mix in pharmacies, extending prescribing duties for pharmacists and a greater role in clinical service delivery. We also fully acknowledge the work, expertise and development of the hub and spoke models, including automated prescription assembly facilities—PAS facilities—operated by the large pharmacists, such as Lloyds Pharmacy, within their community retail pharmacy operations.
The impact assessment acknowledges the scale, substantial up-front and running costs and slow timetables of setting up and then operating hub and spokes efficiently and effectively, which are in reality way beyond local groups of pharmacies not part of nationwide businesses to fund and operate. In a moment of understated frankness, the IA admits:
“The costs and benefits remain uncertain, as do some details around the policy design, and the changes would be provided for by regulations made under the Bill.”
The Minister will know that the NPA has serious doubts about the suggested economic efficiency of the hub and spoke model, particularly in light of the impact assessment’s uncertainty. Under the five-year community pharmacy contractual framework agreement, the PSNC is tasked with the role of agreeing hub and spoke models which will allow the sector to benefit fairly. Can the Minister explain to the Committee how it is envisaged that hub and spoke models will be able to operate to ensure that the arrangements are fair to all pharmacies?
The NPA has stressed that, without a level playing field, competition and choice in the pharmaceutical wholesale market could be reduced by the pressure to set up or join hub and spoke arrangements. The resilience of the medicines supply system could be impacted, and medicine prices could rise as a result. As the NPA says, huge barriers will need to be overcome to make any model fair and appropriate for independents, including the risk of introducing new process errors, lack of clarity on the ownership of problems between the hub and spoke, longer lead-in times and impact on procurement margins—essentially, a reduction in system resilience and problems caused by restrictive distribution arrangements.
The impact assessment stresses that the proposed regulatory change is intended to be entirely permissive, with pharmacy businesses developing hub and spoke arrangements only where they deemed it would be
“beneficial for them to do so”.
Paragraph 255 sets out three types of hub and spoke arrangement that could be entered into, underlying the complexity of the range of models and reinforcing the need for greater consideration and thought to be given as to how further hub and spoke models could be introduced.
The Company Chemists’ Association, the trade body for large community pharmacy operations, which include Boots, Lloyds, Asda, Morrisons, Tesco and Superdrug, has expressed particular concern at hub and spoke models being introduced through secondary legislation and stressed the importance of extensive consultation with the industry—in fact, the consultation on the future of the industry began in 2016 but has yet to be concluded. When and how will consultation on this vital matter, which sees the most significant changes to pharmacy in decades, commence?
The Minister has rightly praised the contribution of independent pharmacies, particularly during the Covid pandemic. However, we know that, before Covid, more than half reported operating at a loss, a situation greatly exacerbated by Covid and extra costs, which led to their income decreasing while their role in the community became more important than ever, working long hours with often reduced staffing numbers, providing advice and support and supplying medicines. In rural areas, such pharmacies have always played a key role as often the only source of information and advice as well as of prescriptions and medical equipment. During Covid, in many areas they were and are the only primary healthcare professionals that patients can still see in person. What progress has been made in the discussions with the sector about additional funding on Covid costs? The £370 million provided in July was an advance payment to an already struggling industry rather than new money. Can the Minister place on record how much additional funding has been provided? My noble friend Lord Hunt will expand on this issue of funding community pharmacies and the wider pharmaceutical industry in relation to the price regulation scheme.
I want briefly to express support for Amendment 29 in the name of the noble Lord, Lord Clement-Jones, which would place a duty on the Secretary of State to consult the pharmaceutical, wholesale and pharmacy sectors and their regulators on an agreed framework for the safe transfer of patient data, prescription information and dispensed products between separate hubs and spokes. This and other provisions in the amendment would provide some vital safeguards if hub and spoke models are developed in future secondary legislation. We strongly support the noble Lord’s approach.
As I stressed earlier, the nine paragraphs of the impact assessment do not represent a strong or coherent case for moving forward at this time under the secondary legislation enabled by the Bill. Instead, they demonstrate the need for more thought, analysis and development of proposals for the future delivery and transformation of pharmacy services, with full involvement of and consultation with the industry, including on extending hub and spoke models. That would ensure a fair and level playing field and the survival of the independent local community pharmacies so valued by patients and their families and carers. I beg to move.
Lord Clement-Jones (LD)
My Lords, I want to speak to Amendment 29 in my name and those of the noble Lord, Lord Hunt, and my noble friend Lady Jolly. I thank the noble Baroness, Lady Wheeler, for her support and comprehensive exposition of the issues involved with regulation in respect of hub and spoke.
Like the noble Baroness’s amendment, mine is an attempt to flesh out concerns about the lack of detail in the regulation-making powers under Clause 2(1)(c) as regards authorising hub and spoke arrangements and the process by which new regulations will be agreed. For the record, I should say that “hub and spoke” describes how prescriptions are sent from a community pharmacy “spoke” to a central premise, or “hub”, for assembly, often using automated technology. The assembled medicines are then distributed back to the community pharmacy “spokes” for collection by patients. By removing elements of the existing workload in pharmacies, centralised automated assembly can give the pharmacist and their team more time to deliver healthcare services and advice and to support patients who have urgent and acute needs. This is not the same as an online-only pharmacy or a delivery system. It is not a means to enable home delivery of prescription items. There are significant costs of both setting up and running hub and spoke facilities, but it frees up capacity.
It is not blindingly clear on the face of it but, as a result of powers given under the Medicines and Medical Devices Bill, the Government intend to enable medicines assembly through hub and spoke models across legal entities, which is not allowed under current legislation. It is important that this technology is harnessed for the benefit of patients and the NHS within an agreed framework.
Over the past decade, many pharmacists have invested significantly in hub and spoke technology and use it to release capacity in their community pharmacy branches. It is hoped that, if wider use of the hub and spoke model can be permitted, this capacity can be used to enable community pharmacy teams to provide more clinical services to patients.
Noble Lords participating in Committee will be only too aware that community pharmacy is already helping the NHS in providing services and wants to deliver more. At a recent meeting with pharmacists I heard how, through freeing up capacity, hub and spoke arrangements support the delivery of essential and more advanced pharmacy services such as medicines use reviews, diabetes control, support during taking new medicines, minor ailments and vaccinations. NHS England, likewise, wants to open up the market to new technologies and enable greater efficiencies to be found in medicines supply, but the major pharmacy players believe that this can happen only if other barriers to automation are addressed through the community pharmacy contractual framework at the same time.
The noble Baroness, Lady Wheeler, mentioned the impact assessment and the need for much greater clarity on how the Government will deal with the barriers on the way to realising the efficiency benefits of hub and spoke. These barriers, over and above those mentioned by the noble Baroness, include, first, original pack dispensing. Very often, the quantities prescribed by doctors do not match the amount of medicines in the packs produced by the manufacturers. Pharmacy teams in England and Wales manually “snip” the plastic strips of pills to either add or take away from the manufactured quantity. Snipping is a time-consuming and expensive manual intervention that cannot be automated or delivered at scale.
A second barrier is the need for government support for infrastructure investment. Despite its potential, less than 10% of prescription items are currently dispensed using hub and spoke technology. The industry has already invested tens of millions of pounds in this technology. Government capital investment is needed for it to expand further.
A further barrier relates to fair community pharmacy funding, mentioned by the noble Baroness. The level of remuneration for pharmacy has been a challenge for some time. It needs to be addressed to help the sector to deliver the urgent care and services that the NHS badly needs, especially in the current Covid environment. This is even more important if pharmacy capacity is increased and there is a real prospect of enhancing pharmacy services to fill it.
The noble Baroness has explained the concerns over secondary legislation. I hope that the Minister will address some of these issues in her response and explain how she sees the extension of the hub and spoke dispensing model taking place and how consultation and agreement on a framework will take place.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I am glad to add my name to Amendments 23 and 29. I am a strong supporter of community pharmacies. Over the past few months, they have done magnificent work. They stayed open, took pressure off the rest of the NHS, and are a central part of community resilience. We cannot take them for granted. They face a number of extra costs at the moment: increased prescription numbers, extra staff costs from the increased demands for advice and medicines, covering for sickness and the rise in locum rates, and one-off costs such as decontaminating pharmacies when someone infected has visited. Before Covid-19, the community pharmacy network was already pretty vulnerable.
I am glad that, at the end of March, the Government agreed to inject £300 million-worth of advance payments into community pharmacy. A further £50 million was paid in May, followed by £20 million in June. That £370 million cash advance was of course very welcome, but it will not relieve the ongoing financial pressures because it is set against future income. Instead of this being treated as a loan to be repaid, there should be a recognition of the extra costs that community pharmacies have had to carry since Covid-19. Will the Minister consider that? I also ask her to consider what further financial support needs to be given to the sector over the next few potentially very difficult months.
That is the background to the debate about hub and spoke. As the noble Lord, Lord Clement-Jones, pointed out in previous debates, we have to go to the impact assessment to find any reference at all to hub and spoke. Clearly, it could offer many advantages. Mobile deliverers will be able to partner with dispensing pharmacies to deliver their prescriptions; he spelled out the key advantages. Equally, there are fears that it could undermine the whole community pharmacy network. My concern is about the impact on smaller pharmacy groups and individual companies and shops.
The Minister in the other place, on Third Reading, said that she intended
“to give smaller community pharmacies the same opportunity that large pharmacy businesses already enjoy.”—[Official Report, Commons, 23/6/20; col. 1239]
That is a good statement, but I say to our Minister that Governments often make statements about the importance of small businesses and, when it comes to the actual arrangements, those business often struggle to compete. I hope that this is not being done to try to rationalise the community pharmacy network, because it is a great strength that we have so many pharmacies on our high streets, where people can walk in and get immediate access to health advice and help.
The amendment is very reasonable. It simply asks that the Government consult the sector again on their plans. A previous consultation, started in 2016—two Parliaments ago—has never been concluded. Given the impact on the sector and on patients, surely the Government should undertake a proper consultation, to make sure that any legislation follows that rather than the anticipatory approach referred to by my noble friend Lady Wheeler. I hope that the Government will signal their support for the community pharmacy sector as a whole.
Lord Lansley (Con)
I thank the noble Baroness, Lady Wheeler, and the noble Lord, Lord Clement-Jones, for tabling their amendments, which allow us to have a useful debate; we might not otherwise reach into what some implications of the use of these powers might be. I particularly thank them for the way in which the amendments were introduced, which set out clearly and fairly the context and facts with which we need to work.
I recognise that Amendment 23 is a probing amendment. I am sure that the noble Baroness knows that, if she actually wanted to remove the capacity for legislating to introduce hub and spoke models, Clause 2(1)(g) would have to go as well as paragraph (c) to make that effective, but I do not think she wants to do that; I do not either. We all want to express our support for the pharmacy sector. In my view, the Government’s proposals in the Bill will allow that support to be given additional expression; they seem a positive step to have taken.
As someone who was shielded earlier in the year, about the only place I ever visited in April and May was the local pharmacy—not that often, but the fact that it was there and working, and the way in which it worked, was immensely impressive. Over the years, I have had a great deal to do with the pharmacy industry. In some cases, I am not sure that it was altogether happy about that. The noble Lord, Lord Hunt of Kings Heath, may remember that I worked with the National Audit Office in about 2008, when I was shadow Secretary of State, to establish the extent to which the pharmacy sector benefited through the category M reimbursement system by hundreds of millions of pounds more than it was supposed to. Those large-scale additional funds that were going into the sector had to be clawed back, as happened in the early part of the decade that we have just gone through.
That led to considerable turbulence in pharmacy incomes and values. They were overinflated and the incomes were higher between about 2015 and 2018, and the considerable clawback had a negative impact. Most recently, it is telling that the value of pharmacies—and the price increase—has gone down. It is also interesting to read the commentaries that say that pharmacy in Scotland attracts greater value because the flow of resources into it there is regarded as more stable than in England.
That is a great pity, because we have reached a point where there should be more stability and funding for pharmacies, and I want to pick up a point made by the noble Lord, Lord Hunt of Kings Heath. He suggested that the Government consider turning the advance payment into not a loan but a grant. It is a large sum of money, so it is not as easy as that. However, whereas earlier this year the global fund for pharmacies was set at about £2.6 billion and was going to be retained at that level in cash terms over five years, we have to think hard about whether that is reasonable under the circumstances. There is a good case for recognising additional costs met by pharmacies this year, and potentially into next year, and for reimbursing them perhaps through a change to the establishment fee before it disappears, with a considerable sum to recognise that.
We must also recognise that pharmacies will need real-terms increases in their resources—much as other parts of the NHS-related system are seeing real-terms increases in resources—and not to stand still in cash terms. Over the next four years, that might be something like £130 million extra.
All the way through, we have never achieved as much as we should in terms of pharmacies delivering additional services, particularly clinical services. It is partly because clinical commissioning groups have never quite recognised the flexibility they have in budget terms to use pharmacies. The noble Lord, Lord Clement-Jones, referred, quite rightly, to medicines use reviews—which are being phased out—new medicine services, nicotine-replacement services, sexual health services, minor illness services and so on. A wide range of additional services can be provided by pharmacies. If they can do it, frankly, the GPs, as those at the heart of the clinical commissioning groups, will find that it benefits them directly in reduced demand on their surgeries, which is of course one of their principal stresses at the moment. I hope that the Government will think about all that.
In this context, with these powers in the Bill, the Government do not need to know whether a large number of independent pharmacies will take advantage of the hub and spoke model. It is entirely permissive; they can choose to do so or not. The fact that they cannot at the moment is a significant potential constraint on the ability of independent pharmacies to access the benefits of automation in their sector. I am absolutely clear that we ought to give them access to this potential benefit. I do not know how many would take advantage of it or to what extent the large company chains would make their hub and spoke model available to allow independent pharmacies to get the benefits of that automation. It seems to me that they should, because there are many parts of the country that they do not reach and where they are not in competition. It is perfectly reasonable for them to allow them to access to it, particularly in some of those more remote parts of the country where dispensing is more difficult.
Many of the concerns raised about this in the debate seem to come down to the separate question that I can remember debating on legislation 15 or more years ago about whether we retain the role of the responsible pharmacist. This does not change that. The responsible pharmacist will remain as is; I do not see any plan to change that part of the pharmacy regulation. The change to hub and spoke seems potentially desirable.
While Amendment 29 does not need to be in the Bill, it makes a very good point, which is that there should be consultation and an agreed framework with the industry, and we should ensure that the framework is one that is seen to link resources and changes in the regulations, to enable it to compete more effectively. To that extent, I hope the Minister will take on board and support the intentions of Amendment 29.
Baroness Jolly (LD) [V]
My Lords, I thank noble Lords for their kind words and messages. I now have a tentative diagnosis and when I get my medication I hope to be functioning at 100% soon.
These amendments are on hub and spoke dispensing, where a hub pharmacy dispenses medicines on a large scale, often by making use of automation, preparing and assembling the medicines for regular spoke pharmacies that supply the medicines to the patient. My noble friend Lord Clement-Jones has given a detailed account of how hub and spoke works.
When the five-year funding contract for pharmacy in England was announced, the Government also pledged to change legislation so that independent pharmacies could operate this hub and spoke dispensing model. My noble friend tabled Amendment 29, which would ensure that the Government consult stakeholders on how hub and spoke is used and agree a framework with the support of the relevant sectors. This will ensure that the expected savings and efficiencies, and new healthcare services via pharmacies, can be delivered.
Baroness Penn (Con)
My Lords, as we have heard, hub and spoke is an issue on which there was debate in the Commons and we return to it now.
I first want to explain the intention of the inclusion of Clause 2(1)(c) on wholesale dealing and why it is vital that it remains. Wholesale dealers, involved in moving products from manufacturers to the person supplying the product to the patient, are an essential part of the supply chain, ensuring patient access to medicines. More than one wholesale dealer may be involved in the supply chain for a particular medicine, but anyone who intends to sell or supply medicines to someone other than the patient using the medicine must obtain a wholesale dealer’s licence.
Clause 2(1)(c) allows amendments to be made to the law governing the distribution of medicinal products by way of wholesale dealing. This could include matters around providing and maintaining the equipment and facilities needed for the handling, storage and distribution of the medicinal products under a wholesale dealer’s licence. This is vital, particularly in light of emerging safety concerns, or innovative new techniques and technologies. Omission of this power would limit our ability to maintain the integrity of the supply chain. For example, some vaccines require storage and transport at ultra-low temperatures to ensure that they remain effective. Courier companies delivering medicines are exempt from certain licensing requirements.
If we could no longer make changes under Clause 2(1)(c), we could not amend the definition of wholesale dealing to support the transport of temperature -sensitive pharmaceuticals in different ways, if needed. Recent exemptions to wholesale dealer licensing during Covid have allowed for the swift and safe transfer of flu vaccines and other medicines for treatment of pandemic disease between NHS organisations. Through this flexibility, we have been able to quickly respond to patient need. The noble Baroness, Lady Wheeler, has indicated that, in addition to the question around the need for this power in particular, there is a question around its intention for use in delivery of the hub and spoke model. That is part of the intention behind Amendment 23.
As we have heard, enabling hub and spoke dispensing arrangements where both the hub and spoke pharmacies are not part of the same pharmacy chain is one such example of how powers in Clause 2 could be used, including under Clause 2(1)(c), as we may need to amend the definition of wholesale dealing to support hub and spoke dispensing models. Under current regulatory provisions, only a subset of pharmacy businesses are realising the benefits of hub and spoke. For hub and spoke dispensing, our intention is to give all community pharmacies the same flexibility to explore efficiencies of scale and use of automation that some larger pharmacies already enjoy. Removing this barrier would level the playing field for all community pharmacies and enable them to make use of this type of dispensing model.
However, we have heard from the noble Lord, Lord Clement-Jones, in speaking to his amendment, the noble Baroness, Lady Wheeler, and all other noble Lords in this discussion the concern around how these matters were consulted on in 2016 and what the Government’s intention is for consultation on changes to this model. I reassure noble Lords that there is a difference between then and now. The proposed use of hub and spoke and changes to support it have the support of the Pharmaceutical Services Negotiating Committee, and the five-year deal under the community pharmacy contractual framework for 2019-20 to 2023-24 included a commitment to pursue legislative change so that all pharmacies may benefit from these efficiencies.
We have of course also in recent months had the changes Covid has brought. The pharmacy landscape has changed and adapted in this environment. I pay tribute to the work of community pharmacists and their teams in responding to the challenges of the pandemic. They have been on the front line supporting patients throughout this very challenging time.
The Government agree with the spirit of all noble Lords’ comments, particularly in relation to the amendment from the noble Lord, Lord Clement-Jones, on the need for proper consultation before any changes are brought in, and on the importance of the sector’s engagement to deliver hub and spoke. That is exactly what we intend to achieve. I assure noble Lords that it is absolutely the case that hub and spoke would be taken forward only on the basis of a fresh consultation, based on the current state of play in community pharmacy. Our approach to hub and spoke dispensing models is to consult and make use of productive stakeholder engagement to develop the policy, then to set out in detailed secondary legislation the new regulatory provisions. We are keen to ensure that strong engagement with stakeholders is fed into the development of this policy.
We recognise that there are some important considerations to make use of this type of dispensing model safely and to enable efficiencies. We want to consult specifically on the right approach to hub and spoke, including any patient data safeguards that may be needed, to ensure that our proposals are safe and in the public interest before legislating. To meet the requirement of the government amendment tabled later in the Bill, this would of course be a public consultation.
On the specific points in the amendment from the noble Lord, Lord Clement-Jones, it is critical that we consider how patient data will be safeguarded, as he said at Second Reading. I of course recognise that patients’ healthcare information is confidential and must be handled in accordance with data protection regulation. Handling patient information appropriately and confidentially is of course a routine part of a pharmacy’s business. As part of their professional standards, pharmacists must respect and maintain a person’s confidentiality and privacy, and owners of pharmacy businesses must make sure that they comply with all legal requirements, including data protection legislation.
The noble Lord is right that in considering changes to pharmacies’ operating models we must consider the security of patients’ data and the integrity of the supply chain carefully, drawing on the input from stakeholders. I am happy to put on record that that will be part of the forthcoming consultation on hub and spoke.
My reservation with the noble Lord’s amendment is that placing a timeframe in the Bill, as he proposes, will force the Government to consult in haste. Rather than an arbitrary deadline, which could lead to ill-considered policy development, we want to be able to consult with stakeholders fully and thoroughly on proposals. It is important that we take the time needed to get this right—noble Lords have made that very clear in the debate—first by engaging with stakeholders, as well as with formal consultation. We want to take forward this work as soon as possible, subject to the Bill’s passage.
Noble Lords raised a couple of other points relating to community pharmacy. I agree with all noble Lords on the integral role of community pharmacy in the delivery of health services. Hub and spoke is one way the Government envisage the potential for pharmacists’ skills to be better deployed in patient-facing care.
On financial support to the sector, we are consulting the PSNC on this and other matters as part of the year 3 community pharmacy contractual framework discussions. We also intend to continue discussions with the PSNC on the additional costs that Covid has placed on community pharmacies.
The Government absolutely value and support the work of community pharmacies. I hope noble Lords have heard enough by way of reassurance and that the noble Lord and the noble Baroness feel able not to press their amendments.
The Deputy Chairman of Committees (Baroness Henig) (Lab)
There are no requests to speak after the Minister, so I now call the noble Baroness, Lady Wheeler. Oh, apologies, I call the noble Lord, Lord Clement-Jones.
Lord Clement-Jones (LD)
I was very struck by the support for pharmacists and pharmacy services throughout this debate. It is not often we get a really good opportunity to talk about pharmacists’ potential. I chaired the London School of Pharmacy, which then merged into UCL. I used to see bright, bushy-tailed MPharms depart the School of Pharmacy, all expecting the bright future for pharmacy promised by plan after plan from Government after Government. To use their clinical skills in particular was the great goal.
Sadly, we are still not in the right place with community pharmacy. I was very struck by what the noble Lord, Lord Lansley, said: we have never achieved as much as we should. That is absolutely apposite in the case of pharmacy. We have all these highly skilled people, many of them very young, who are capable of taking on all kinds of clinical work in the community, with consultation and so on. We seem to ebb and flow in the services we think we can make available in pharmacy.
I am very grateful for what the Minister said about the need for proper consultation being a given and that there will be consultation to develop the policy and so on. She of course talked about the five-year plan, but many people are worried that the plan will run out and there will not be resources for hub and spoke to develop further. She talked about the fact the amendment would limit the time available but, as the noble Lord, Lord Hunt, pointed out, pharmacists have been talking about this since 2016. It is not as if we are imposing too harsh a timetable.
Underlying all this is the question: where is the plan to use that additional capacity? That is really what pharmacists are after. On the basis that automation is augmentative and will help community pharmacists free up capacity, they want to deliver more clinical services in particular. Where is the plan? That is what we all want: to use their expertise in and knowledge of the community, and the trust they have. We have talked about the access people have to the local pharmacy. I wish there was a better relationship between many general practitioners and the pharmacy profession. There is still that rather standoffish attitude to pharmacists. Be that as it may, this is a really important aspect that could deliver much greater capacity, but I do not feel that the Government have yet really picked up the ball and started running with it.
Baroness Penn (Con)
I will pick up on the noble Lord’s point about timing. The Government acknowledge that this has been committed to for a long time. However, I also pick up on the point that when this process started in 2016 it might not have been as consultative as it could have been. Therefore, there is a balance to be struck between making progress and making sure that progress happens through engagement with stakeholders and proper consultation.
On the immediate timeframe in the noble Lord’s amendment, while I would be incredibly supportive of swift progress, we need to recognise, as some noble Lords have, the pressures that Covid has placed on the sector and other parts of the healthcare system. While we are committed to making progress on this, such a firm deadline could mean that the process again did not run as well as it might, given that the Covid pressures still exist and we are not sure when that situation will change exactly. We are enthusiastic about making progress, but we need to ensure it is done properly. A deadline placed in the way it would be by the amendment might not be supportive of that.
The Deputy Chairman of Committees (Baroness Henig) (Lab)
The noble Lord, Lord Hunt, would also like to come in at this point.
Lord Hunt of Kings Heath (Lab) [V]
I just wanted to come back to the consultation. I am grateful to the Minister for her full and encouraging response, but can she say a little more about how the public and patient groups are to be involved in this consultation? In terms of the work, given what the Minister in the Commons said about the small pharmacies, will part of the consultation look at the actual economics of how those small businesses can compete and take advantage of hub and spoke?
Baroness Penn (Con)
My Lords, the commitment on the consultation is that it would be a public one, in line with the government amendment on what type of consultation we need to undertake for regulations made under the Bill. That would therefore include patient groups. On the content of the consultation, I understand that when it first took place it was very open, to hear from the sector how it would want to make use of the powers. My understanding is that we have heard the need to have a more structured conversation on the framework for how these powers could deliver the benefits which people think they could. Maybe I could undertake to write to the noble Lord with some more detail on that.
Baroness Wheeler (Lab)
Some of the points I was going to come back on have been raised pertinently by the noble Lord, Lord Clement-Jones, and my noble friend Lord Hunt. I too thank the Minister for her full and comprehensive response, and I thank all noble Lords for their contributions. Between us, we have covered a pretty comprehensive range of the issues and concerns around this. However, the Minister has not really made the case that warrants the use of the delegated powers contained in the Bill, nor met the criteria of the DPRR Committee—in particular, that the use of secondary legislation needs to be justified. The words of the DPRR were that the department should “acknowledge the breadth” and depth of the powers proposed and justify them. I do not think that has yet been done.
My noble friend Lord Hunt raised the complex issues on funding, as have other noble Lords. There is much to be achieved in putting funding on a stable footing for community pharmacists. The Minister was unable to answer the specific questions on the £370 million that my noble friend raised, but there needs to be recognition of extra costs. That point has been made forcefully in the House, in questions to the Minister, and I hope that the Government will make that response.
Overall, the Minister has not fully answered the key question of how these proposals fit into the longer-term NHS plan for transforming pharmacy as an integral part of primary care. There are a number of issues around that, which is why we particularly wanted to see a comprehensive plan going forward. Where is the overall strategy and plan for this?
The noble Lord, Lord Clement-Jones, raised a number of issues about how we want to take the development of pharmacists forward. The prescribing powers set out in the Bill are obviously the road to that, but I still do not have a comprehensive picture of how all this fits together. It comes back to the fairness of hub and spoke. Yes, of course the legislation is permissive, and community pharmacies will not have to join hub and spoke arrangements if they do not want to, but the complexity of some of the models proposed and the power of the large-scale providers really make the level playing-field so important—and important to the survival of community pharmacists—that we need to be much clearer about how it is going to work out.
I certainly welcome the commitment on consultation. That is so vital and, as everybody has said, the 2016 consultation was never really completed. As the Minister explained, there was neither the time nor the follow-through for it. I hope that this one will be comprehensive. I would have liked to have heard some kind of timescale but that is obviously yet to come. Much remains unanswered, which we may need to come back to on Report. We will look carefully at Hansard, but meanwhile, I beg leave to withdraw my amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 24. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 24
Lord Hunt of Kings Heath
“(o) the origin and treatment of human tissue used in the process of developing and manufacturing medicines.”Member’s explanatory statement
This amendment adds the origin and treatment of human tissue, including organs, to the list of matters about which regulations may be made by the appropriate authority, in the context that informed, valid, uncoerced and demonstrably documented consent may not have been given for the harvesting of such human tissue and organs.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, the world is increasingly aware of China’s forced organ harvesting from prisoners of conscience. This horrific crime of forcibly removing the organs from living victims—the process leading to inevitable murder—has recently been found by the China Tribunal to be happening extensively. The organ recipient may have had their life saved, but at the expense of another innocent life. It is now a multimillion-pound commercial business in China, with wealthy Chinese officials, Chinese nationals and organ tourists receiving treatment in high-end recovery centres.
Evidence of forced organ harvesting has grown and whistleblowers have emerged. Millions of Chinese citizens are currently detained in labour camps. UN experts estimate that at least 1 million Uighurs are being held in camps in the region of Xinjiang. Elsewhere throughout China, other ethnic and religious minorities such as Tibetan Buddhists, Falun Gong practitioners and Christians are also being held in labour camps. Companies from the West are complicit in this. Adidas, Nike, Zara and Amazon are among the western brands which, according to a coalition of civil society groups, currently benefit from the forced labour of Uighurs in Xinjiang. In July this year, a 13-ton shipment of hair products from Xinjiang, worth more than $800,000, was seized by US Customs and Border Protection. This shipment included wigs made from human hair, which is hugely concerning considering the many reports and personal testimonies of female Uighur Muslims having their heads forcibly shaved in the camps.
Last year, the China Tribunal, chaired by Sir Geoffrey Nice QC, concluded:
“forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one—and probably the main—source of organ supply.”
and that:
“In regard to the Uyghurs the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”
I point out to the Grand Committee the vast body of evidence of forced organ harvesting in China. Such evidence includes: detailed statistical analysis of transplantations and donations; numerous recorded undercover telephone conversations, including with well-known Chinese officials admitting to the practice of forced organ harvesting; legal and policy statements and practice of the CCP; advertisements and admissions of university and military personnel; incredibly short waiting times; and a large number of personal testimonies. The China Tribunal spent 12 months assessing all available evidence. Additionally, its international panel of highly respected individuals interviewed over 50 witnesses, experts and investigators, and formally invited representatives of the People’s Republic of China to respond. I do not believe it is sufficient for the UK Government to ignore this any longer.
Although Ministers have been personally sympathetic, so far the Government have relied on the World Health Organization’s view that China is implementing an ethical, voluntary organ transplant system. I am afraid this is simply not credible; the fact is that it is based on a self-assessment by China, as became clear during my noble friend Lord Collins’s PQ on 29 June 2020. The WHO has not carried out its own expert assessment of China’s organ transplant system, so I am afraid that the WHO cannot be considered reliable in this area. For me, the China Tribunal is persuasive on this point.
This Bill provides an opportunity to prevent British complicity in such crimes and to send an important signal to other countries. Currently, the Human Tissue Act does not require appropriate consent for imported human tissue. In addition, imported human tissue for use in medical research does not require traceability. The Minister has written to me to state that whether sourced from within or outside of the UK, there is comprehensive domestic legislation to ensure the ethical and appropriate use of human tissues. Yet while this is all true for human tissue sourced from within the UK, this does not address the gap in legislation for imported human tissue. On the concern about the use of human tissues in the development of medicines, which I do understand, the Minister commented that the use of imported tissue in any medicines on the UK market is very limited. However, while it may be limited, there is a gap in the legislation which could be exploited in the future.
I am grateful to the noble Lord, Lord Ahmad, for his awareness of the passion which many of us feel about the allegations of forced organ harvesting in China and for ensuring that the UK is not complicit in any way. I hope that he will acknowledge that my amendment—which has been signed by a number of very distinguished colleagues— is not prescriptive and essentially gives Ministers regulation-making powers to deal with the issue if and when they decide to do so.
Up to now, we know that many countries have pulled their punches when talking to China about these practices. Of course, as The Economist has pointed out, China’s economic power has helped it to avoid censure regarding its abuse of the Uighurs. Many companies in the West appear reluctant to use any leverage they may have to put pressure on China, and that is not helped by the reluctance of so many countries to upset that country. The UK, of course, faces dilemmas too, and we have seen them already in the issues over 5G and potential Chinese investment in new nuclear energy. I am not naive; I understand some of the pressures which are on the Government, but there must be a time when we make a stand.
I was encouraged by the reported words of Dominic Raab to the Foreign Affairs Select Committee on 6 October, when he referred to evidence of “gross human rights violations” against the Uighur Muslim minority in Xinjiang province. I pay tribute to the Government for being prepared to say that. I simply want them to go one step further, and agree to a very modest amendment. It seeks to give Ministers the powers to take action when they deem it right to do so. Accepting it would be a very important signal of this country’s attitude to gross human rights violations, and I have great pleasure in moving my amendment.
Baroness Finlay of Llandaff (CB) [V]
My Lords, it is a great privilege to follow the powerful speech of the noble Lord, Lord Hunt of Kings Heath.
While the Human Tissue Act 2004 is thorough and comprehensive with regard to human tissue sourced from within the UK, this does not hold true for imported human tissue. Human tissue can be imported into the UK without any consent or traceability. Notably, if it is for use in medicines, traceability is required through the Human Tissue (Quality and Safety for Human Application) Regulations 2007, but for use in medical research neither consent nor traceability is required. They are merely considered good practice. This means that human tissue sourced from China—where people are imprisoned and tortured, and where organs are extracted and sold for profit, a process which kills the donor—can legally enter the UK and be used in medical research.
Baroness Jolly (LD) [V]
My Lords, the amendment in the name of the noble Lord, Lord Hunt, and signed by my noble friend Lady Northover, allows the Secretary of State to make regulations about human tissue. I repeat the noble Lord’s explanation of the amendment:
“This amendment adds the origin and treatment of human tissue, including organs, to the list of matters about which regulations may be made by the appropriate authority, in the context that informed, valid, uncoerced and demonstrably documented consent may not have been given for the harvesting of such human tissue and organs.”
I find it hard to imagine when any state has power over its citizens that few other states share. I find it even harder to imagine how desperate and selfish people must be to buy these organs, knowing that their donors’ lives will certainly be blighted, or even lost, to feed such a market, which is the dark side of consumerism.
Human tissue and organs can currently be imported into the UK from countries such as China without traceability, documentation or consent, and there is widespread concern that forced organ harvesting is taking place. It is appalling that Falun Gong Christians are targeted as donors, although I hate to use the word “donor”, which suggests that the organ is freely and willingly given, whereas the evidence to the contrary is total. This amendment would urge the Government to introduce legislation to ensure that the UK is not complicit in this. I support my noble friend Lady Northover, the noble Lord, Lord Hunt of Kings Heath, the noble Baroness, Lady Finlay of Llandaff, and the noble Lord, Lord Ribeiro, who put his name to the amendment. If the Government do not support this amendment, will the Minister confirm that she will be prepared to look at bringing forward, on Report, a government amendment to stop this abhorrent practice?
Lord Ribeiro (Con) [V]
My Lords, I was delighted to add my name to the amendment, so ably introduced by the noble Lord, Lord Hunt, and the noble Baroness, Lady Finlay. The Human Tissue Authority code of practice refers to the EU tissues and cells directive, which requires importers of donated material to have a
“detailed description of the criteria used for donor identification and evaluation, information provided to the donor or donor family, how consent is obtained … and whether the donation was voluntary and unpaid or not.”
During my career as a surgeon and a urologist, I supported transplant teams to harvest organs from patients who had requested that their organs be used in the event of their death. In every case, informed consent was obtained, and relatives were in agreement and consented to the procedure. One cannot be confident that such arrangements pertain in relation to donor parts used in transplantation in China and elsewhere, particularly where the donors are likely to be prisoners.
Advice that I have received from the Royal College of Surgeons notes that, sadly, the issue of UK patients travelling overseas for transplant surgery is not confined to China and is known to occur also in Pakistan and India. A considerable number of UK patients have undergone kidney transplantation from living donors in this way. For the report mentioned by the noble Baroness, Lady Finlay, Sir Geoffrey Nice met with the Royal College of Surgeons to discuss the allegations relating to China. It found the allegations alarming and the evidence concerning. We know that, in China, patients can receive organs within a matter of weeks. Heart transplant surgery can be bought in advance and, according to data collected by the China Liver Transplant Registry, the percentage of emergency, compared to non-emergency, liver transplants is far higher than one would expect. During his investigation, the BBC journalist Matthew Hill was offered a liver for $100,000 by a Chinese hospital, at very short notice. Patients in the UK would struggle to achieve this with a waiting time of several months.
According to experts, an estimated 60,000 to 90,000 organ transplants are happening in China each year, yet China’s voluntary donation system was only established in 2013. Quite recent data, from June 2020, shows that 2,127,955 people have registered as organ donors in China. That is a significant increase on the figure in 2014, which was 22,660. Is it a coincidence that the UK signed the Council of Europe Convention against Trafficking in Human Organs in 2015 and that, in the same year, the Chinese Government introduced legislation that rendered illegal the use of executed prisoners as organ donors? Contacts in the transplant society in the UK believe that this legislation was introduced in good faith and that any such practices that continue are illegal and without official sanction. I hope that that is the case, but the perception is that these practices have not ceased completely. It is the view of some UK transplant surgeons who have visited China, as I have, for transplant-related meetings, that large, prestigious hospitals practise within the law. However, illegal practices do occur and we should use this amendment to send a clear message to the Chinese Government that they must make greater efforts to stamp out the illegal practices that tarnish the reputation of their country.
We have a moral and ethical obligation to investigate UK patients who receive transplants in China, as identified by the noble Baroness, Lady Finlay, and to clearly identify the source of the transplant organs. That is doubly important because, if complications occur, it will be the NHS that has to pick up the pieces.
Finally, it would appear that, although the UK has signed the Council of Europe convention on organ trafficking, we have yet to ratify it. Will my noble friend undertake to explain why this has not been done?
Lord Alton of Liverpool (CB)
My Lords, it is a great pleasure to be able to follow the noble Lord, Lord Ribeiro, and to support the noble Lord, Lord Hunt of Kings Heath, my noble friend Lady Finlay and other noble Lords who have spoken to the amendment. In doing so, I return to an issue that I raised at Second Reading and declare my interests as set out in the register.
On 2 August 2018, the Times published a letter signed by me, Professor Jo Martin, President of the Royal College of Pathologists, and 55 others, including Dr Adnan Sharif, a consultant nephrologist in Birmingham, who is the secretary of Doctors Against Forced Organ Harvesting. We began the letter by recalling the Liverpool Alder Hey Children’s Hospital scandal, which had involved the retention of human organs and tissue, without consent, and which led to the Human Tissue Act 2004.
With my antecedents as a Liverpool Member of Parliament and a one-time grateful parent, deeply appreciative of the skills of Alder Hey doctors, I was appalled that such an ill-judged breach of ethics had inflicted such damage on a wonderful hospital. Fourteen years later, and notwithstanding that scandal and that important Act of Parliament in 2004, I was incredulous that in 2018 an exhibition, entitled “Real Bodies”, of Chinese corpses and body parts preserved with silicon in a process called plastination, was being staged for commercial gain at the National Exhibition Centre in Birmingham—denigrating ethics, science, and human rights, and far worse than even the scandal of Alder Hey.
The Deputy Chairman of Committees (Lord Lexden) (Con)
The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn, so I call the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, it is always very difficult to follow the noble Lord, Lord Alton of Liverpool, because his speeches are always so powerful, convincing and well researched, so I do so with some hesitation. I absolutely agree with him that it is abhorrent that the plastinated bodies of human beings are used for commercial purposes in exhibitions. It is certainly not science, and I do not think it is art either. It should be banned, and I was surprised that the exhibition took place.
Tissue and organs were taken from children at the Alder Hey Hospital. I was involved in the subsequent inquiry and heard the harrowing stories of parents whose children’s organs—there were thousands of them—were taken and stored without their consent.
I was touched by and support the powerful speeches of all the preceding speakers. The noble Lord, Lord Hunt, raised an important issue and I agree that his amendment is a modest provision asking the Government to look at the issue and to amend the Human Tissue Act if necessary. In the past, I chaired for four years the Medical Research Council’s ethics committee, and for more than four years I have chaired the UK Stem Cell Bank. I am also familiar with the research ethics committee—at one time I was its chairman—of the National Patient Safety Agency, which the noble Lord, Lord Hunt of Kings Heath, chaired before me, when it introduced a nationwide regime for examining consent through that ethics committee, which is now a statutory committee. Noble Lords have rightly said that the regulation of consent in the use of tissue and organs is strict in the United Kingdom. There is strict monitoring in the use of tissues for any purpose. The noble Lord, Lord Hunt, alluded to the fact that the law on the importation of tissues is lax. If that is true, it needs to be examined. I have looked into the current law and at various websites covering human tissue importation and, in particular, the issue of consent. The noble Lord, Lord Alton of Liverpool, asked how we can be certain of the validity of the consent that was given. I agree it is an important point, and the Government should seriously consider Amendment 24.
On the issue of research, I will tell a story about HeLa cells. I do so not to immortalise HeLa cells, although they are immortal, but to immortalise the person from whom the tissue sample was taken on 8 February 1951: Henrietta Lacks—which is why they are called HeLa cells. She was a black American mother of five who developed extremely aggressive cervical cancer. She attended Johns Hopkins Hospital, in Baltimore, and a tissue for diagnostic purposes was taken from her cancer. The tissue was then passed on to a laboratory that was trying to culture cell lines. Ever since then, HeLa cells have been used all over the world to develop treatments in all kinds of therapies. For instance, Salk used them to develop the Salk polio vaccine. They were used to develop treatments for cancers, such as breast cancers. They were used for xenografts, again to develop cancer treatments. They are also being used to study aging processes. As our cells age they eventually become senescent and inflamed, which produces some of the chronic diseases that humans suffer from. That does not seem to happen with HeLa cells as regards telomerase, which controls the size of telomeres, which is part of the aging process. HeLa cells have been used for all kinds of purposes.
I have another concern about the commercialisation of tissue use. In advertisements on the internet—noble Lords can see them there if they wish—many commercial companies say: “We will supply tissues to industry for the testing of drugs”. What consent was given for the use of that tissue? Does the HTA have to give permission to import this tissue or ask where it came from? When the Government examine this issue I would only ask them to distinguish between tissues, organs and cell lines and ask why they should be treated differently. I do not say that regulation is not required; I am simply saying that, when it comes to importation, we need to have a clear understanding of why cell lines should be treated differently from tissues and organs. I support the amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
The noble Baroness, Lady Stroud, who is next on the list, has withdrawn so I call the noble Lord, Lord Sheikh.
Lord Sheikh (Con) [V]
My Lords, I fully support Amendment 24. The issue of organ harvesting was raised in the other place and at Second Reading by me and other noble Lords. The ability to use human tissue in medicines and transplants saves many lives and is a great achievement of modern science. However, we need to make sure that the way human tissue is obtained and used is completely ethical. At the moment, we do not have legislation that properly stops organs that have been obtained forcibly or without proper consent from entering the UK. That is completely unacceptable.
We should be greatly concerned about the treatment of Muslim Uighurs and Falun Gong in China. The detention and persecution of these innocent people is a crime against humanity. Millions are suffering in inhumane conditions. They are tortured and a great many have been murdered. Last year, the China Tribunal, chaired by Sir Geoffrey Nice QC, concluded that forced organ harvesting in China had been practised for a substantial time, involving a substantial number of victims. The tribunal also found that Muslim Uighurs were used as an organ bank.
The British Medical Journal found that 99% of studies that looked at organ transplants in China did not report whether the organs used were donated with consent. This is unacceptable and a disturbing violation of human rights. It is also illegal. Furthermore, The Economics of Organ Harvesting in China report found that large profits had been made from organ harvesting.
I appreciate that although the companies, including British ones, may not be directly involved with organ harvesting, they could be part of a wider system that provides devices, drugs, materials and know-how for transplantation. Sir Geoffrey Nice QC also stated that anyone interacting with the People’s Republic of China was interacting with a criminal state. If we do not have proper checks on human tissue entering the UK, we risk being complicit in this crime.
Organ harvesting is not limited to China. There are gangs and traffickers all over the world that exploit vulnerable people to obtain organs without any proper aftercare. This coercion is also illegal and must be stopped. Through this amendment we can prevent this happening and close the gaps in our existing legislation. For instance, the Human Tissue Act 2004 has strict consent and documentation requirements for tissue in the UK, but does not enforce the same standards for imported tissue. Instead, it advises only that the same standards should be applied. Although the human tissue regulations 2007 ensure that there is proper documentation and tracking from donor to recipient, they request details on how consent was obtained and look into whether the donation was voluntary or unpaid or not with consent at all. This means that there is no legislation against importing organs that have been obtained involuntarily and without consent.
We must accept this amendment so we can make better regulations that uphold human rights and values. By including the ability to make provisions about the origin and treatment of human tissue used in developing and manufacturing medicines, this amendment means that we can make regulations if there are any concerns as to whether consent has been given. This amendment would require that informed, unforced and properly documented consent must be given for all tissue entering the United Kingdom. At present we do not have appropriate safeguards against forced organ harvesting or human tissue. Innocent people are tortured and killed while businesses and some Governments have made a profit.
This amendment is an opportunity to take a proper stand against organ harvesting and to have a statutory commitment. Through this amendment we can ensure that all human tissue imports are ethical. During Second Reading, my noble friend Lord Bethell stated that the idea that any British companies profit from these trades is abhorrent. This is an abhorrent practice. We must put a stop to it and therefore we need to pass this amendment. I emphasise that it is our moral duty to do so.
Baroness Northover (LD) [V]
I am very pleased to have added my name to Amendment 24. The noble Lord, Lord Hunt of Kings Heath, is to be commended for his determination on this issue. Given his previous service as a Health Minister as well as his career-long engagement at different levels of the NHS, no one can say that he does not have a good grasp of all the implications of his amendments. As he made clear, this amendment gives the power to the Government to take action in this area. It closes a gap between what is expected in terms of the origins and uses of human tissue in the UK and that which may be brought in from overseas.
As we have heard, the Human Bodies exhibitions were able to slip through this gap. It cannot be said that no problem can be envisaged. The noble Lord, Lord Alton, laid out the potentially horrendous origins of those bodies. Like the noble Lord, Lord Hunt, the noble Lord, Lord Alton, has been determined and assiduous in pursuing such cases and he is remarkable in his ability to never pass by on the other side. He made a powerful and passionate contribution here as usual.
Lord Collins of Highbury (Lab)
My Lords, I begin by thanking all noble Lords who put their name to this amendment, because it truly reflects the cross-party concern on this issue. I also echo the comments by the noble Baroness, Lady Northover, regarding my noble friend Lord Hunt, who has been absolutely committed to continuing to raise this important issue.
As the noble Lord, Lord Patel, said, this is a modest amendment, designed to empower the Government to act and to create regulations to help protect the United Kingdom from being complicit in the abhorrent crimes evidenced by the China Tribunal chaired by Sir Geoffrey Nice QC. But, as my noble friend Lord Hunt said, it is also an opportunity for the Government to send a clear message that we will not stand by, and we will not tolerate such gross abuses of human rights.
I thank both the noble Baroness the Minister and the noble Lord the Minister for meeting me and other noble Lords interested in this issue and for arranging the FCDO Minister, the noble Lord, Lord Ahmad, to be present, so that we could all hear exactly what is being done across departments on this issue.
In its final report, the China Tribunal concluded that:
“Forced organ harvesting has been committed for years throughout China on a significant scale”,
with Falun Gong practitioners and the Uighurs being the main victims. As my noble friend Lord Hunt said, Sir Geoffrey Nice and the tribunal spent 12 months assessing all the available evidence. Additionally, the tribunal’s international panel of highly respected individuals interviewed over 50 witnesses, experts and investigators, and formally invited representatives of the People’s Republic of China to respond. Of course, Sir Geoffrey himself has an incredible reputation as the former lead prosecutor of Slobodan Milošević at the International Criminal Tribunal for the former Yugoslavia.
Some of the other evidence I want to draw attention to is a study by the medical journal BMJ Open, and reported on by the Guardian, which raised ethical issues on over 400 studies conducted in China using an estimated 85,477 organ transplants. Of those studies, 99% failed to report whether organ donors had given consent for transplantation. The paper concluded that:
“The transplant community has failed to implement ethical standards banning publication of research using material from executed prisoners. As a result, a large body of unethical published research now exists, raising questions of complicity to the extent that the transplant community uses and benefits from the results of this research.”
As we have heard in the debate, the Government of the People’s Republic of China deny all such claims, relying on the fact that the WHO cleared them of wrongdoing. In June, I reminded the Minister, the noble Lord, Lord Ahmad, that 12 months earlier he had
“shared my concern that the evidence on which the WHO cleared China was based on self-assessment”
by the Chinese authorities. At that time, the noble Lord, Lord Ahmad, stated:
“The Government’s position remains that the practice of systematic state-sponsored organ harvesting would constitute a serious violation of human rights”.—[Official Report, 29/6/20; col. 472.]
He assured the House that the UK regularly raised these concerns with China. At the recent meeting with other noble Lords with an interest in this amendment that I referred to, the noble Lord, Lord Ahmad, confirmed that the UK had sent the full report of the China Tribunal to the WHO, asking it to respond to the evidence.
The fact remains that the WHO does not have an independent expert compliance assessment mechanism; it has merely a reporting requirement. I hope that the UK, the Government and the noble Lord, Lord Ahmad, will continue to press the WHO for a clear response to the report and argue for a proper independent assessment by the WHO to guarantee compliance.
However, today is not about whether the WHO acts; it is about this country saying quite clearly that it will not be complicit in these abhorrent acts. Absolutely nothing I have heard from noble Lords much better qualified than me suggests that by passing the amendment we would hinder medical research or progress. As the noble Baroness, Lady Finlay, pointed out, the UK has arguably some of the most ethical and comprehensive consent requirements for human tissue in the world, yet imported human tissue slips through the net. This is an opportunity that I am sure we will not forget or miss. I hope the Minister will respond positively.
As we have heard in the debate, other issues have been reported. I raised this at Second Reading. Two UK companies supply organ preserving devices to mainland China, which could explain how organs are being transported around China.
We all agree that we need to ensure ethics in the origin and treatment of human tissue and organs in the process of developing and manufacturing medicines. As I said before, this amendment would give the Government the means to ensure that human body tissue and organs that are being forcibly harvested are not allowed to enter the UK for medicines or medical testing. However, as I said, just as important as that is the message we can send to the world, in particular to the People’s Republic of China, that we will not stand by. This is an opportunity that we should not miss. I hope the Minister will be able to respond positively to the noble Lords’ amendment.
Baroness Penn (Con)
Let me begin by thanking noble Lords for their time last week when they spoke to me and my noble friend about the issues raised in relation to Amendment 24. We have listened carefully to the concerns raised both in meetings and at Second Reading, and again today.
First and foremost, I want to reiterate the Government’s position that, if true, the practice of systematic, state-sponsored organ harvesting would constitute a serious violation of human rights. I know that my noble friend Lord Ahmad, Minister for South Asia and the Commonwealth, takes seriously the concerns expressed by noble Lords and he continues to monitor the issue very closely. As noble Lords may know, my noble friend Lord Ahmad wrote to the WHO encouraging it to give careful consideration to the findings of the 1 March report by the International Coalition to End Transplant Abuse in China. We hope to have a response to this shortly. As my noble friend indicated, he is happy to meet noble Lords again to discuss this further.
Noble Lords have spoken powerfully on a number of issues that go beyond the scope of this Bill, and I hope they will forgive me if I focus on the specifics of Amendment 24. As I said when we met last week, I think that we are largely agreed on the outcome that we wish to achieve, and this is about getting the mechanism right. None of us wants our UK medicines industry to be compromised by unethically sourced human tissues.
However, it is important to be clear that the vast majority of tissue-based medicinal products in the UK do not use material sourced from a donor at all; they use patients’ own tissues. As we have outlined previously, there is only one licensed medicine on the UK market that uses donor tissue. This material is procured within the EU. The product uses human adult stem cells extracted from fat tissues, and those cell donations are taken in Spain during the process of liposuction. The starting material is procured from authorised EU centres in accordance with the EU tissues and cells directive. Noble Lords will also know that there are schemes where UK sites may be licensed to manufacture tissue-based or cell-based products without a marketing authorisation, but even among those only one site uses donor tissue. That tissue is sourced within the UK.
That is not to say that I do not have sympathy with the amendment. Noble Lords have made it clear that they want to ensure that the Bill allows for changes to be made as necessary to the regulation of human medicines which could tighten requirements around the use of tissues in the development of medicines. I reassure noble Lords that the Bill already provides powers to allow us to make regulatory changes to tighten requirements, such as strengthening requirements on evidence of consent that would be provided as part of the marketing authorisation process. Nevertheless, I also understand noble Lords’ desire to make this explicit and to send a message.
However, there are some important drafting deficiencies in the amendment as it stands. It refers specifically to
“the origin and treatment of human tissue used in the process of developing and manufacturing medicines”.
My concern is that “developing … medicines” causes too much ambiguity. There is no single, established point in the pre-clinical stages of research where the development of a new medicinal product begins. How far back into research studies does the development of medicines start? Does it, for instance, capture academic research on a substance which then finds the product to be of medicinal value? Equally, medicinal products are often developed with international partners, and the early medicines development is inevitably outside of UK jurisdiction. How would new consent requirements be applied in that context?
These are important drafting questions. It is important to ensure that any enabling power is drafted with the appropriate level of precision. As noble Lords know, the drafting has a material impact on the potential subject matter of any regulations made under the power. We would not want wording in the Bill to create a risk of unintended consequences when making regulations. For instance, if regulations were made to apply significant, broad consent requirements when testing medicines, this might capture medicines tested on cell lines which date back more than 50 years, and for which seeking and evidencing consent would be impossible. As the noble Lord, Lord Patel, referred to, we would want to think carefully about the scope of any regulation and the approach that we should take.
We have heard many noble Lords talk throughout debate on the Bill about the importance of supporting future availability of innovative new medicines in the UK. They are right. The same is true for the ongoing supply of established medicines to the UK market. While I am, as I have said, sympathetic to the amendment in the name of the noble Lord, Lord Hunt, I am concerned that the current drafting would create a risk of unintended consequences when making regulations.
There is also an important point on consistency. Within the Bill, “law relating to human medicines” is defined in Clause 7 to include comprehensive legislation such as the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. With that in mind, when it comes to human medicines, the powers in this Bill are concerned with clinical trials. To add the concept of development would create confusion and inconsistency with drafting elsewhere in the Bill, in particular Clause 1(2)(c).
I thank all noble Lords for the considerable thought and engagement which they have given to this issue. I would really welcome further discussion involving officials, myself and my noble friend the Minister in coming weeks to discuss the issues that noble Lords have raised and the drafting issues that I have mentioned today. The noble Lord, Lord Ribeiro, asked a specific question about the Council of Europe and ratification of a treaty there. I will ask the FCDO to write to him on that.
I therefore hope that the noble Lord, Lord Hunt, feels able to withdraw his amendment today. I look forward to further discussions on this matter between Committee and Report.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received a request to speak after the Minister from the noble Baroness, Lady Northover, whom I now call.
Baroness Northover (LD) [V]
Can the Minister tell me whether she has read the China Tribunal report in preparation for this amendment, as I asked when I was speaking to it? If she has not, will she agree to do so before Report, especially to help inform her since she may come forward with her own amendment, as I hope she is indicating?
Baroness Penn (Con)
My apologies to the noble Baroness, Lady Northover. I have read the findings of the report and will agree to read the full report ahead of any further meetings that we have.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, this has been a very powerful debate. Each contribution has been measured and the product of expertise, human value and internationalism. I am grateful to the noble Baronesses, Lady Finlay, Lady Jolly and Lady Northover, the noble Lords, Lord Ribeiro, Lord Alton, Lord Patel and Lord Sheikh, and my noble friend Lord Collins. I am also grateful to the Minister, who I thought provided a very constructive response at the end.
When the noble Lord, Lord Alton, talked about Alder Hey, he probably did not realise that that is really where my interest in this subject stemmed from. I was the Minister responsible for the north-west at the time that scandal emerged. I appointed the chair of the inquiry and met the parents involved on a number of occasions. I listened to the harrowing tales from parents; some of them took part in three funerals for parts of their child’s body. What happened was shocking, and I learned from that how crucial it is that, when we deal with human tissues and organs, the integrity of the process is vital.
I was also fortunate to be able to take the Organ Donation (Deemed Consent) Bill through your Lordships’ House a couple of years ago; it is now law. I hope that it changes the basis of organ consent and will lead to more organ donations in this country—the noble Baroness, Lady Finlay, referred to this eloquently. Again, when you move to presumed consent, you have to have absolute trust in the integrity of all the people involved. Just as it is important in this country, so it is globally, which is why we must take action in relation to the activities of China—and other countries, as we heard during this debate.
I listened carefully to what the Minister had to say. She made the point that the use of imported human tissues is very limited. None the less, we have identified a gap in the legislation. She made two points: first, she said that the Bill already provides for the kind of authority we wish to give to Ministers; then she went into detail on the drafting challenges that she thought our amendment faced. However, she used her words in a constructive way and I am very grateful to her. I reassure her that I and my colleagues will be very willing to work with her officials to see whether we can come up with an amendment that meet our needs but does not lead to the kind of perverse incentives that she referred to.
This has been a wonderful debate. We have had a constructive response from the Government. I am convinced that we are going to make progress and, at the end of the day, in this legislation we will make a mark—important in this country but also internationally —saying that we will do everything we can to stop this appalling process. Having said that, I beg leave to withdraw my amendment.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, the Grand Committee is resuming its deliberations. We now come to the group beginning with Amendment 26. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. The noble Baroness, Lady Finlay, is no longer able to move Amendment 26, so the noble Lord, Lord Hunt, will do so on her behalf.
Amendment 26
Lord Hunt of Kings Heath
“(o) developing rapid provisional two-year licences.”
Lord Hunt of Kings Heath (Lab) [V]
I should explain that the noble Baroness, Lady Finlay, is required in the main Chamber to speak in a debate on the Bill there. I have put my name to her amendments. Amendment 26 and others in this group would ensure the development of a rapid provisional two-year licensing procedure, so that patients might more quickly access potentially life-saving medicines and medical devices, and that device trial results were consistently registered and published.
In earlier amendments, several noble Lords commented on the avoidable delays in innovation, and the tardy response of the NHS to new and improved medical devices. The current licensing procedure in the UK can be lengthy. Safety and efficacy of course are paramount, but in our debate on Monday, my noble friend Lord Blunkett referred to my late noble friend Lady Jowell and her powerful call for fast-tracking. Many patients wanting to trial novel therapies say, “It may not help me, but it may help others.”
As the Minister said at Second Reading, and all speakers on the second group of amendments last Monday, particularly the noble Lord, Lord Sharkey, we must remain an attractive place to develop new medicines and devices. Amendment 26 supports that aim through the development of a licensing procedure that would speed up making new medicines accessible to the NHS when clinical trials have shown them beneficial and safe for people with the relevant conditions.
Baroness Cumberlege (Con) [V]
My Lords, I will speak briefly in support of Amendment 84 in the name of the noble Baroness, Lady Finlay. I also wish to raise a question on Amendment 97 in the names of noble Lords, Lord Kakkar and Lord Patel, and to ask the Minister a question on equivalence, of which I have given him notice.
During my review, we heard much that greatly concerned us about the way that medical devices reach the market. Our focus was on pelvic mesh, but similar concerns apply to devices more generally. When mesh for stress incontinence and pelvic organ prolapse first came into use, the safety data available was woefully inadequate. It relied on very short-term studies, often funded by manufacturers with vested interests, with limited follow-up. Mesh is a product that is designed to remain inside the body, which presents a problem, because it is designed not to be removed. Removal can be done, on rare occasions, but it is very difficult and dangerous. Implanting a device such as this into so many patients with such a lack of safety data is, as we said in our report, foolhardy.
I recognise that some risks of new treatment options may become apparent only when they have been in use for some time. I agree with the noble Lord, Lord Hunt, that surgeons need to be able to offer new, innovative treatments. That is how medicine has made such tremendous progress in our lifetimes. We must not stifle innovation, but we must do all we can to improve patient safety and to prevent avoidable harm. We had a full discussion of this on our previous day in Committee.
In clinical trials of medicines all adverse events are reported, whatever their cause, and that is good. In the case of mesh, if selected cohorts of patients had undergone enhanced reporting, it is most likely that the adverse impacts we heard about would have been detected sooner. Thousands of ruined lives, in this country alone, could have been avoided.
In the field of medical devices, better, more thorough trials with long-term follow-up are vital, but they are not the whole answer. We also need transparency. It is one thing for trials to be conducted, but quite another to ensure that the findings they produce, and the concerns they may give rise to, are made available to the public and to potential patients. Patients have the right to know about trial outcomes and safety concerns that arise in trials. They have the right to know who is conducting the trial and who is funding it. Without that knowledge, there cannot be an informed decision about an individual’s treatment options.
Many common themes arose during our review, but one that is particularly powerful, and relevant to today’s discussions, is the phrase that so many women with terrible mesh complications used. They said to us: “If only I had known”. If only they had known the risks, perhaps they would never have had the procedure and their lives—and those of their families—would not have been ruined.
This amendment would ensure that medical device trials are entered on a publicly available database and would bring devices into line with medicines. This is much needed, which is why I support the amendment.
I turn to Amendment 97, proposed by the noble Lords, Lord Kakkar and Lord Patel. One of the issues that we encountered during our review was that the full safety implications of an implantable medical device may become obvious only once the device is inserted. Some women told us that they sensed immediately that something had gone wrong; for others it was not until years later. Trials need to be sufficiently long term to detect safety concerns some years after the device is implanted.
Lord Kakkar (CB) [V]
My Lords, I shall speak to Amendment 97 in my name and that of my noble friend Lord Patel. In so doing, I of course recognise the important points the noble Baroness, Lady Cumberlege, made. I will answer some of her questions in a moment.
The particular purpose of Amendment 97 is to extend the reach of Clause 16, which already gives powers to establish information systems for assessing
“the safety and performance … of medical devices that are placed on the market”,
to include provision for the establishment of an information system for the safety and performance of medical devices before they are placed on the market via a form of provisional licence. It would provide for the Secretary of State to require, under certain circumstances, that new devices would in the first instance be given a limited approval based on clinical evidence and clinical trials. However, it recognises that further information would be required and that a provisional licence, or formal marketing authorisation, would therefore be given only for information gathering purposes. This would ensure that the level of evidence provided prior to broad unfettered use of a device would be much greater than is currently available.
This approach is both important and practical. It is important, as we have seen in the report from the noble Baroness, Lady Cumberlege, because implanted devices can have serious, harmful effects for patients. Not all devices have the capacity to be harmful, but where there is concern, where there are limited data or where the argument is based on equivalence using the kinds of arguments that the noble Baroness has made, the introduction of a device into routine clinical practice would be limited by a provisional licence, with the need for careful, pre-specified monitoring and evaluation, both for efficacy and for safety. This will protect the patient. It will protect innovation and it will ensure that we continue to facilitate innovation but in a responsible way.
Arguments are made about the practicality of such an approach. During this debate, we have heard that there are differences between the standards required for the authorisation for marketing a medicinal product compared with a medical device. The reality is that medical devices have profound implications for the management of patients. Implantable devices, in particular, also have profound implications for patient safety. The approach is practical because successive Governments have emphasised and prioritised the ability of the National Health Service to collect data and to develop its digital capacity.
We have seen the benefit of these investments and this emphasis during the Covid-19 national research effort. The regulator working, for example, with NHS Digital could devise integrated data-acquisition platforms and clinical research methodologies, potentially applied in specialist clinical centres. Data might then be collected prospectively to a high level and a high quality on the devices selected for such a provisional licensing process. These devices would also be used under appropriate and informed clinical supervision by experts before widespread adoption across the entire health system was allowed.
Rather than stifling innovation, which is a concern, I believe such an approach would ensure that our country could secure a position of leadership in the increasingly important field of medical devices development. These are going to play an increasingly important role in the delivery of healthcare. We would provide a fully facilitated environment for the appropriate clinical evaluation of medical devices, both their efficacy and their safety. In much the same way that the establishment of NICE and the Scottish Medicines Consortium, of which my noble friend Lord Patel was a founding leader, helped establish our country at the forefront of the evaluation of medicine and the responsible adoption of innovative medicines, the proposals included in this group of amendments and the proposal for provisional licensing outlined in Amendment 97 would allow us to develop unique leadership in the development, evaluation and responsible advocacy for the use of medical devices in a way that is clearly not available currently.
The noble Baroness, Lady Cumberlege, made an important point about devices that are designed for implantation in a patient and whose removal is dangerous or practically impossible. What must be demanded here is a much higher level of evaluation in development and research—she made the clear point that equivalence is not an appropriate approach in those or any circumstances. Moreover, offering the opportunity after appropriate clinical evaluation for such devices to be introduced in a limited fashion—still in routine clinical practice but with careful, pre-specified evaluation and monitoring—ensures, as she said, that if there are early reports of adverse events, those might be identified quickly prior to any opportunity for such devices to be provided across the entire healthcare system, where reporting on their implantation and follow-up may be less rigorous. In a provisional system, data acquisition and reporting would be pre-specified, using platforms provided by the regulator and the NHS. With the remarkable capacity we now have for data acquisition and analysis in the NHS, such methodologies, applied in a routine fashion in appropriate circumstances, would provide the greatest opportunity to protect patient safety while driving forward innovation and making use of all the opportunities that the NHS provides in this regard.
Lord O'Shaughnessy (Con) [V]
My Lords, it is a pleasure to follow that excellent exposition of his and other amendments by the noble Lord, Lord Kakkar. I want particularly to speak in support of amendments aimed at putting post-marketing reporting requirements for medical devices on a par with those for medicines.
My noble friend Lady Cumberlege has again given a powerful and moving testimony of the reports that she uncovered in her review of the dangers for some patients of pelvic mesh, but severe problems have emerged in other medical devices, be that metal-on-metal hip replacements, PIP breast implants or elsewhere. They have shown how potentially dangerous medical devices, particularly, as other noble Lords have pointed out, those implanted into body tissue, are simply not regulated enough.
The regulatory regime for licensing medical devices distinguishes between different categories of risk. Higher-risk devices of course have to clear a higher bar, and the UK’s notified bodies are renowned for taking on such work—prior to Brexit, they carried out more higher-risk assessments than any other notified body in the EMA family. We therefore have potential strength in this area. However, these tragedies demonstrate that even this strong regulatory regime does not go far enough. We need a broader definition of risk which takes account of the nature of the device, the therapeutic ways in which it can be used and the places in a patient in which it can be put, as well as much better post-market surveillance and wider use of registries, including coverage of the independent sector, which is where some of the most acute problems arose.
It goes without saying that these are recommendations from my noble friend Lady Cumberlege’s report. Like other noble Lords, I strongly urge my noble friend the Minister and the Government more broadly to adopt them and reduce the unacceptable gap between the safety regimes for medicines and medical devices.
Having expressed my concerns the other day about access to experimental medicines, I applaud the intention behind the idea of provisional two-year licences, but we obviously have a job of work to do to reconcile these two sometimes competing imperatives—the noble Lord, Lord Kakkar, explained how he thinks that can be achieved. It may be stealing the thunder of a future group of amendments that we hope to deal with tonight, but I wonder whether a better answer would be the expansion promised in the Conservative manifesto of the Cancer Drugs Fund into an innovative medicines fund more broadly, as well as continuing and early access to compassionate-use schemes for medicines post Brexit.
Both the noble Lords, Lord Hunt and Lord Kakkar, raised the idea of these conditional licences being applied to devices, and my noble friend Lady Cumberlege mentioned safety concerns which might apply. I wonder whether the right approach would be to open the innovative medicines fund up to devices, digital and diagnostics. It would mean a name change, but that presumably would not be a problem. They could then qualify as well as medicines, so the kind of early access possible under these two-year conditional licences could take place in that specific, heavily monitored and controlled environment that has already demonstrated huge value when looking at transformative cancer drugs before they have achieved their full licence. Within these ideas is the right approach to balancing these two risks, and in fact merging them and getting something stronger as a result. I look forward to hearing from the Minister how the Government intend to move forward on these issues.
Lord Patel (CB) [V]
My Lords, I will speak to Amendment 97 in the name of my noble friend Lord Kakkar, to which I have added my name. Before I do so, I have a comment in response to an important question asked by the noble Baroness, Lady Cumberlege, which my noble friend Lord Kakkar answered. How do you test the effectiveness of a device which is an implant, and is likely to remain in the body permanently? This is opposed to implants such as pacemakers—as I alluded to on Monday—where, in one example, a device was unsatisfactory after having gone through testing, but was then implanted in 1,400 patients before its faults were clearly recognised. In that case, it was possible to remove the device, and put in one which functioned better. The testing of an implant which is likely to be permanent must be more rigorous, in terms of its tissue reactivity, in the training it will require, and in the possible harm it can do. This is particularly true for things like mesh that are likely to be embedded into the tissue. People claimed that that mesh was safe because it had been used by surgeons for years for hernia repairs. As I said on Monday, I have never used mesh for any of the surgery I did, so I do not know its performance. The question of the noble Baroness is quite right: it does not mean that we do not have to progress with finding new medical devices which would be effective; it means that we need to ask significant questions, depending on the device we are talking about. I may not have answered her question, but I have tried to identify ways we might do that.
My noble friend Lord Kakkar has made a very important point about the need for medical devices to be tested for their effectiveness in the functions they are supposed to provide prior to their being granted full market approval. Generally, the design of a medical device is regulated by its essential principles of safety and performance with respect to its design and construction. Less attention is paid to its clinical effectiveness throughout its expected life, whatever that might be. Medical devices play an important role in enhancing patient quality of life, but there is a need for improved methodology to obtain evidence for their safety, performance and efficacy. The UK, with its strong research base, and with the NHS at its core, is well placed to generate the high-quality evidence needed. Guidance is needed to generate, implement and produce the evidence required to foster innovation. Adopting engineering principles of continuous monitoring, reporting of accidents or near misses—similar to post-market surveillance of medical devices—is important. In developing medical devices, dialogue between clinicians, manufacturers, and end users—the patients—to identify which devices need to be developed is valuable, but not often followed.
While not as robust as a randomised control trial, observational studies are important in identifying rare, catastrophic and delayed harm. Furthermore, medical devices are less amenable to controlled trials, being part of a complex system of care, involving people in other systems. The UK has an opportunity to develop specialised medical device trial centres and clinical networks to oversee early to late-phase trials. That initiative would benefit patients and put the UK in a lead position to develop safe and effective medical devices.
The Royal Academy of Engineering and the Academy of Medical Sciences, of which I am a fellow, have much to offer in such an initiative. With his amendment, which rightly promotes the requirement that medical devices should demonstrate their clinical effectiveness prior to a full market authorisation licence, my noble friend Lord Kakkar has also provided an opportunity for the UK to develop leading-edge medical device regulation, and be a place for developing safe and effective medical devices.
Baroness Jolly (LD) [V]
My Lords, the noble Baroness, Lady Cumberlege, made some telling remarks and asked some searching questions. We support the amendments in this group relating to the granting of licences and the processes of clinical trials. They aim to improve patient safety, as the granting of provisional licences will allow more information to be available on devices and medicines.
Amendment 84 is intended to probe the various thresholds for medical device trials. At present, new devices deemed to be “substantially equivalent” to something already on the market are certified as safe via a notified body and can go on to be used quite straightforwardly. In contrast to standards for introducing new pharmaceutical products, data from robust clinical trials are not required. Delays in the introduction of innovative treatments and medical devices should be avoidable. We should, and could, become a key player in the world market.
Safety is always paramount and the amendment in the name of the noble Baroness, Lady Finlay, to develop rapid, two-year, provisional MHRA licences is a good innovation. Start-ups would welcome these moves.
The noble Lord, Lord O’Shaughnessy, spoke about hip replacements. He made some helpful remarks about registries. I was a trustee of an organisation called Orthopaedic Research UK, which was left a considerable amount of money by a wealthy orthopaedic surgeon with a view to fostering innovation in orthopaedics. Research scientists, doctors and start-ups are able to bid for funding on projects to aid orthopaedic research, with a view to taking a development to market. The amendments in this group will help researchers working on these projects, as will the granting of two-year licences on these devices.
Devices certified through this process are not tested to establish whether they deliver significant patient benefit. Rather, the system only establishes that a device is not unsafe and that it fulfils its intended function. Meanwhile, even when clinical trials are required, because a device is deemed sufficiently different from what is on the market to merit that, the rules around how that research is constructed are looser than for medicines. These are practical, useful measures.
Baroness Thornton (Lab)
This has been a wholly positive and helpful debate, and I hope that it will lead to improving the Bill and the future of this issue. I shall speak briefly to the amendment in my name and that of the noble Baroness, Lady Watkins. It would allow the Secretary of State to make regulations about notification and reporting requirements for medical device clinical investigations, as is currently the case for medicines. It is about the equality of treatment between medicines and medical devices, so it is very straightforward.
I thank my noble friend Lord Hunt, who I suspect made a double speech, his own and that of the noble Baroness, Lady Finlay, and it is all to the good that he did. I again register the protest that we are losing experts and speakers because of the clash of timetabling.
All the amendments in this group are positive amendments about how medicines and medical devices reach the market, how the UK can build and maintain a leading position, and the regulatory framework required to support that. Amendment 97, in the names of the noble Lords, Lord Kakkar and Lord Patel, does that, and I thought that the noble Lord, Lord Kakkar, made some very interesting points about how it might best be achieved. The noble Lord, Lord O’Shaughnessy, and the noble Baroness, Lady Cumberlege, were quite right about putting patient safety at the heart of this and having higher levels of evaluation—the term used by the noble Lord, Lord Kakkar. The noble Lord, Lord Patel, got straight to the heart of the issue, which is that we need to get together to work out how best to take this issue forward at the next stage of the Bill. I look forward to what I hope will be a positive response from the Minister and then to the Government taking some action.
Lord Bethell (Con)
My Lords, I start by endorsing the comments of the noble Baroness, Lady Thornton, and saying that I am extremely grateful for this debate, both the spirit in which it is being conducted and the objective of trying to improve the legislation. I think it will make a big difference to the legislation.
The issue of the safety of medical devices and medicines is, of course, critical. We have been greatly moved by the report of my noble friend Lady Cumberlege, who spoke earlier to this group of amendments. It is an extensive and important report, which highlights the impact on patients when they have not been heard, when they report problems or concerns with a medicine or a medical device. It is particularly focused on pelvic mesh but could have addressed other subjects. The Government will address its detailed recommendations when the time is right.
I understand that safety is the driving concern behind Amendments 26 and 90, tabled by the noble Baroness, Lady Finlay. She offers up an alternative way in which to regulate medicines and medical devices, with the creation of a rapid, provisional two-year licence. Medicines and medical devices are regulated very differently between the two of them. That is in part because we have anticipated regulatory change for medical devices at an EU level for some years, and it is in part down to the practical realities of how they are developed.
I shall touch on the process and distinction. However, what I would say is that, intent aside, the amendments of the noble Baroness, Lady Finlay, are not necessary. Amendment 26 would introduce a rapid two-year provisional licence for medicines. The Bill as drafted already provides the necessary powers under Clauses 1 and 2(1)(d) to make changes relating to marketing authorisations. It is similarly already possible to introduce a rapid, provisional two-year licencing process as she suggests in Amendment 90 at Clause 13(1)(b) of the Bill.
By tabling parallel amendments with the same suggestion of a two-year, rapid provisional licence for medicines and medical devices, the noble Baroness suggests, perhaps, paralleling similar requirements of a pre-market assessment. The noble Lord, Lord Kakkar, suggests using the information system in the government amendment in Clause 16 in combination with a limited marketing authorisation system as a way of assessing devices before licencing them, as in his Amendment 97. We believe that Clause 13(1)(b) is sufficiently flexible to deliver the purpose of his explanatory statement. We believe that it is not needed as an amendment to Clause 16.
However, this debate is not, I think, about what the Bill could provide for; it is about what the Government will actually do. For human medicines, we have made changes in the statutory instrument that sets out the situation on 1 January. That update provides for a national “conditional marketing authorisation”, valid for one year. It can be renewed annually. It is a procedure to expedite the assessment of medicines that fulfil an unmet medical need but, importantly, maintain the robust evaluation of supporting evidence. It is less than the five years an ordinary marketing authorisation is granted for, but none the less we believe it serves the purpose. I hope the existence of that process is what the noble Baroness is driving at.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I have received a request to speak after the Minister. I call the noble Baroness, Lady Cumberlege.
Baroness Cumberlege (Con) [V]
My Lords, it has been a really interesting debate. One of the things that I have found so wonderful in this House is all the professors. I did not go to university and, when I listen to the professors and the way they care for their students—and in this case I am something of a student—I really value it. I thank the noble Lord, Lord Patel, for pointing out the dilemmas that we face. They are very difficult. I am sure that the Minister also feels that: it is how you balance what we are trying to achieve as a successful United Kingdom in innovation, marketing and all the rest of it, and the dilemma of safety as well.
I thank the noble Lord, Lord Kakkar, very much. I need to read very carefully in Hansard what he said and then come to some conclusions. I am not sure that we have quite cracked it, but I believe we are working towards it. The noble Lord, Lord O’Shaughnessy, had some really interesting ideas about how we can take this forward, and we need more work to be done on it.
I want to say one thing. In the review, we were so horrified by the stories that we heard that we said we had to do something to prevent further surgeries taking place in women who were suffering so deeply. We called it the pause; we went to NHS England and the department and very quickly they agreed to our pause, with six safety conditions that had to be introduced if it was to be lifted—and, of course, they still have not been introduced. That was in July 2018.
The interesting thing about the pause is that, because surgeons were prevented from using what they would see as the normal solutions to stress urinary incontinence, with pelvic mesh, they started to think of different ways in which to do things and help women, ensuring that the discomfort that they had through these conditions was ameliorated. We are getting innovation in a very interesting way. I am convinced that such innovation would not have taken place if we had not introduced the pause. But it should not have been us, the review team, who introduced it. It should have been the healthcare system, which had put forward some measures and thoughts about it years before, but nothing happened. Of course, that was one of the burdens that I carried throughout the review—that promises were made and nothing happened. We called the healthcare system glacial; it just did not move. There are some hugely bright people in this country and throughout the healthcare system and beyond, in universities and everything else. Surely, if we could only utilise the wonderful brains that we have in this country, we could do much better.
I thank my noble friend for the very full summing-up today. The categories of risk relevant to devices have been so badly used in the past in terms of how pressure has been put on to change the risk when people knew that harm was being committed. We have a meeting with the MHRA, and I am sure that a lot of these issues will be discussed.
I thank the noble Lord, Lord Hunt, for introducing the amendment. It is very difficult to pick up somebody else’s work, but he did it with his usual tremendous skill.
Lord Bethell (Con)
I completely endorse the words of the noble Baroness, Lady Cumberlege, about the failings around some of the medical device regulatory regimes, which failed to pick up many of the problems with mesh. I am grateful for the interventions from the review team on that matter.
I remind noble Lords that the Bill seeks not to lay down the policy on what precise regime will suit the future of medical device regulation but to set up the framework in which those regulations are put together. The Bill meets the need on that matter. I cannot urge enough how important it is that we get the Bill on the statute book as soon as possible.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I know what the noble Baroness, Lady Cumberlege, means when we have the privilege of hearing, as we have in this debate, so much expertise on very challenging issues. Much of the debate has been about devices, but of course my noble friend Lady Finlay’s first amendment related to medicines. To reiterate, she sought to create a rapid two-year provisional licence without reducing safeguards on new medicines. She thought this would enable us to make best use of innovative new medicines without compromising safety at all.
It is understandable that much of our debate was on devices, because it was informed by the report from the noble Baroness, Lady Cumberlege. She has identified a number of issues around the regulation of devices—it is clearly a less vigilant approach than for medicines, with a lack of data and transparency, the equivalence issue and the challenges she raised. The noble Lords, Lord Kakkar and Lord Patel, went into further detail on some of the challenges around devices, particularly those that have a capacity to cause damage. The argument they put was that provisional licences would allow much more effective safety monitoring and early identification of problems and would protect innovation.
The noble Lord, Lord O’Shaughnessy, raised the interesting idea of extending the innovation fund that we are shortly to debate to devices. That deserves a great deal of consideration, although he will of course know that the innovation fund will essentially be funded by payments from the pharmaceutical industry. Seeing how money from the devices industry would come about is a much more challenging issue.
The Minister essentially said two things. The first was that what my noble friend wants to achieve in relation to medicines can be done already, that it is in the Bill and that, in any case, there is a new process to expedite medicines where it is deemed appropriate. I think my noble friend will want to look very carefully at that.
The Minister is right on devices. I think he spoke of 500,000 devices. It is a massive challenge; there is no question about that. There are reasons why devices regulation is different from medicines regulation, but when it is clear that there are defects in the current system, we must at least take advantage of the fact that we are now in a position, post-Brexit, to develop our own regulations.
The Minister went through the processes that are currently in place, including the role of notified bodies, but he said that the system can be strengthened and that regulations can be reviewed. At this stage, I urge that this be as open as possible so that we have a really good debate about medical device regulation, informed by the report from the noble Baroness, Lady Cumberlege, and by experience elsewhere. We want to do two things: to ensure that our innovative devices sector is given all encouragement, but also to ensure safety in a way that it has not been ensured before. That is a challenge, but it is one worth accepting. In begging leave to withdraw the amendment, I say that this has been a very good debate and I hope it will inform government thinking.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
We now come to the group beginning with Amendment 27. I again remind noble Lords that anyone wishing to speak after the Minister should email the Clerk during the debate.
Amendment 27
Lord Patel
“( ) Regulations under section 1(1) must make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay for the United Kingdom to get early access to new medicines.”
Lord Patel (CB) [V]
My Lords, I speak to Amendment 27, and I am immensely grateful to the noble Lord, Lord Hunt of Kings Heath, for adding his name to it. He adds not only his name, but his weight and expertise, which I look forward to hearing.
I beg the indulgence of the Committee, as I may be long, as I will also speak to the government amendments with my own, as I am allowed to speak only once. My amendment is a short and simple probing one to explore how the Government will mitigate against delays for UK patients getting early access to medicines, particularly innovative treatments such as gene therapy, gene silencing, other treatments for rare diseases, and cancer drugs. Part of the problem, as mentioned on our previous day in Committee, is that we are not able to speak to the MHRA and other regulators to know what their plans are. Yet, to my surprise, I was sent something yesterday evening, which I will refer to in a minute.
I understand that the MHRA are developing plans, but it is not clear whether that includes working with other regulators, NICE and NHS England for patient access to treatment. I understand that a new medicines designation will be created, alongside an integrated framework across healthcare agencies to enable innovative treatments to be approved more quickly. As gene therapy and other gene-based treatments, such as gene silencing, are one-time treatments, they require a different approach to the evaluation of efficacy. While the UK has a rigorous process of regulating and reimbursement, it is known to be lengthy, delaying access to treatments. When it comes to getting cancer treatments to patients quicker, clinicians are asking for complex innovative design trials to be implemented instead of the usual clinical trials. As mentioned previously, patients with rare diseases are concerned that if a UK regulator does not work with the EMA or the FDA, a lack of access to patient numbers and data will mean that UK patients miss out on treatments.
I turn now to the information that I have received. During Covid, the MHRA have been exemplary in rapidly allowing clinical trials to be conducted and therapies to be brought to patients very quickly. A process that would normally take two years was completed in six months for some medicines. Looking to the past, as was mentioned on Monday by the noble Lords, Lord Blunkett and Lord O’Shaughnessy, NHS England was very committed to ensuring that the UK was the first country in Europe to provide access to the two latest chimeric antigen receptor T-cell drugs, commonly known as CAR-T therapies, an immunotherapy for cancer. It was a very positive case study of what could be done, but this has not been the experience for all treatments. We need to ensure that the new NICE framework is fit for the future for the high number of innovative treatments coming through. There are potentially 27 cell and gene therapies that will need to be appraised by NICE within the next three years.
I understand that the MHRA has published a guidance note on new assessment routes from the end of the Brexit transition period, to which NICE needs to be more aligned. In addition to continuing to accept EMA decisions for two years, the MHRA has also announced its intention to design new approaches to market: from 1 January 2021, it will introduce an accelerated assessment procedure and then reach its opinion on approvals within 150 days of submission of a valid application. Applicants interested in seeking accelerated assessment are told to contact the MHRA in advance of the intended date of submission.
Rolling review is a new route for marketing authorisation applications which offers ongoing regulatory input and feedback. It is a good idea if the regulator wants to get involved at a very early stage in the development of clinical trials and hence get treatments to patients early. As to overlapping an integrated pathway for new medicine, the MHRA is, I gather, working with partners across the system, including NICE, to develop a streamlined route to market for new medicines. This will include a new medicines designation and an integrated pathway with multiple entry points. That is all good news, and I hope it will all come to fruition very quickly so that patients can get the medicines they need, particularly for rare diseases.
I turn to the government amendments in this group. As I said earlier, I seek the Committee’s indulgence as I will need to deal with these amendments at some length, particularly their amendment on information sharing. The Minister said in a letter that the provision was to protect public health. He said that information is currently shared between the MHRA and the Veterinary Medicines Directorate and international partners to support their work in ensuring that medicines and medical devices are safe. Information sharing currently falls within the purview of the EU, and the Minister implied that this government amendment is intended to ensure the capacity of the MHRA and the VMD to continue to collaborate internationally to ensure public safety. In principle, this amendment appeals to common sense. The MHRA and the VMD need to share information with international partners to ensure the safety of devices and medical products. However, the issue is the breadth of the amendment’s wording and the vague terms used in drafting the power.
The amendment inserts new clauses after the current Clauses 6, 10 and 35, which set out that the relevant authority may disclose information it holds in connection with human medicines, veterinary medicines and medical devices
“to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation”,
of human medicines, veterinary medicines and medical devices. That immediately raises several points. First, the provision refers to
“information which a relevant authority holds”.
That is a broad construction and could potentially cover all information in patient records relating to medicines and medical devices. The term “in connection with” is broad and vague. Does it mean any information tangentially related to medicines, veterinary medicines and medical devices? Could it include any information in medical records relating to the use of medicines for patients? No definition of
“person outside the United Kingdom”
is given, which leaves it open to broad interpretation and places no limits on the category of persons to whom information may be disclosed.
The purposes of information disclosure are also broad and could relate to the fulfilment of requirements of potentially any international agreement. That is particularly highlighted by the use of “or” in reference to arrangements “relating to the regulation” of medicines and medical devices. It means that international agreements that require disclosure of information do not need to relate strictly to the regulation. In fact, despite the arguments detailed in the letter of the noble Lord, Lord Bethell, relating to information disclosure for purposes of promoting public safety, there is no mention of public safety in the purposes of information disclosure in the amendment. The purposes are left to be determined by any international agreement, and this power is exceptionally broad.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, that was a very interesting opening speech from the noble Lord, Lord Patel, and I am very glad to have put my name to his amendment—although, of course, he went wider and commented on the government amendments. I very much agree with his desire to minimise delay for the UK to get access to new medicines. That has been a constant theme of our debates.
There are a number of elements in this, including the attractiveness of the UK to pharma companies, for our life sciences, our approach to access to early phase trials, the regulatory system for licensing medicines and the NHS’s willingness to take up those medicines, including the role of NICE. We have debated all of those.
The Minister on the first day in Committee responded to a number of those issues and said that the Government wanted to
“build on our established strengths so that the UK has the opportunity to anchor international drug development in this country and grow that capability. I am committed to international standards, international partnerships and multi-country clinical trials … The UK works closely with many other regulators; those relationships are underpinned by many shared international standards. The EU bases its regulations on exactly those standards”.—[Official Report, 19/10/2020; cols. GC 357-8.]
The issue is, that being said, will we in the end be aligned with Europe so that companies do not have to go through separate processes in which, because the market that we offer in this country is so small compared to the EU market, we will not be a country of first choice for developing new medicines and seeking a licence?
I refer the Minister to a comment that I picked up in the last few days from Britain’s pharmaceutical industry: it has appealed to the Prime Minister to strike a swift side deal with Brussels to avoid delays and shortages of medicines if we leave at the end of the year with a no-deal Brexit. We have heard continuously from the Prime Minister that he was preparing for—indeed, he would embrace—no deal on 31 December. The Government’s departure from any rationality or seeming concern for Britain’s industry and their posturing have left industry without the agreement on mutual recognition of standards that is needed to avoid hugely costly duplication of red tape to maintain the flow of trade in vital drugs. The one phrase that the Minister has not articulated in our debate so far is “mutual recognition of standards”. The fact is, if we are seriously going into a new world where we do not believe that mutual recognition between ourselves and the EU is a sensible or serious proposition, I am afraid that all the talk about this country being an attractive place for pharma will fall on rather stony ground.
The noble Lord, Lord Patel, has done a great service in bringing this matter back with a slightly different approach. I hope we can look for a positive response from the Government.
Lord O'Shaughnessy (Con) [V]
My Lords, I speak in support of the intention of Amendment 27 in the names of the noble Lords, Lord Patel and Lord Hunt of Kings Heath. As noble Lords know, I made my views on the Brexit approach of working with other regulators clear on the first day in Committee and I do not intend to rehearse them—I am sure that noble Lords will be relieved—but I was struck by how this might work in practice. While listening to the noble Lord, Lord Patel, who gave an excellent exposition, I reflected on his story about CAR-T therapies and how that provides a good example of what we need to guard against as we move out of the EMA post Brexit.
In September 2017, I went on a visit to Pennsylvania and had the opportunity to go to Penn Medicine, which is where CAR-T was developed, in a lab sponsored by Novartis. I remember sitting down afterwards and being told about the amazing progress they had made, how this was rolling out to patients and indeed how they were thinking about the next iteration of this medicine, how useful it would be and how much demand there would be for it to be given to American dogs—that is right, dogs. I was sitting there at a time when UK patients did not have access to CAR-T therapies, but American dogs were about to get access. This in a way exemplifies a problem that we have today as part of the EMA but are likely to have tomorrow: our unwillingness to accept the decisions of other stringent regulators who make good decisions and whose processes we trust.
The idea of how we could work with other regulators as expressed in this amendment is incredibly important and could be carried out in two ways. The first is, as I said, in accepting decisions from other stringent regulators, including the FDA, the EMA, of course, and others. There has been resistance—there certainly was in my time as a Minister—about so-called rubber-stamping of other decisions and the implications for legal liability if things go wrong, but I am absolutely confident that these can be overcome. Our regulator should be prepared to accept the paperwork submitted to other regulators and the decisions of other stringent regulators where we have confidence in their processes. Ideally, as the noble Lord, Lord Hunt, said, this would be in the form of mutual recognition, but it is perfectly possible for us to do that unilaterally as well. That would go a long way to assuaging the concerns of industry.
The second way, and they are not mutually exclusive, is that the UK could lead the creation of a third global market to go alongside the FDA and EMA by working with independent regulators in Switzerland, Australia, Singapore, Canada and so on. As I say, these are approaches that we could follow in tandem as part of, I hope, a global move towards a single approach.
I am confident that we can follow these routes without causing any harm to patient safety while improving patient access. I am not convinced that they require legislation. I can understand why the noble Lord has tabled the amendment and I support its intention; I do not know that we need to change the law. What I would like to hear, and I hope other noble Lords would like the same, is a commitment from my noble friend the Minister that the Government intend to take this kind of approach. We look forward to speaking to the director of the MHRA on precisely this issue, as she has kindly agreed to meet us next week.
Lord Clement-Jones (LD)
My Lords, I am very glad that I put my name down to speak on this group of amendments. I had designed my contribution to be about the government amendments. Having heard the noble Lord, Lord Patel, I am reassured that I am not tilting at windmills. I hope that when the Minister winds up on this group she will be much more explicit about the purpose behind Amendments 48 and 109 and the limitations on their use. There are very thin explanatory statements accompanying the amendments. I heard the helpful paraphrase from the noble Lord, Lord Patel, but, regrettably, I did not receive the Minister’s letter although I have spoken on health data issues in the Trade Bill at some length. I share the noble Lord’s concerns.
I have a series of questions to put to the Minister in relation to those amendments. Can the Minister confirm that they do not, as such, permit the sharing of NHS patient data, whether related to medicines or medical devices and whether anonymised or not? The new UK-Japan trade agreement permits either party, in its Article 8.73, to share source codes and algorithms for regulatory purposes. This is directly relevant to modern medical devices. Is this why the Government are seeking the provision inserted by Amendment 109? In agreeing the trade deal, did the Government realise that they did not have a clear power to do so? How widely do the Government interpret these two amendments? What is their essential purpose and subject matter? I am raising this and the noble Lord, Lord Patel, raised it. What are the constraints as the Government see them?
Of course, there is an important patient safety issue in terms of the operation of medical devices. I entirely take the point raised by the Lord, Lord Patel, that there is no specificity in the article about that but does that mean that UK medical device manufacturers will, as a matter of routine, need to reveal their source codes and algorithms? Is this to be a standard provision in trade agreements, permitted by these provisions? What safeguards will there be against IP infringement and know-how theft in these circumstances?
I am sorry to throw these questions at the Minister in this fashion, but it comes as a result of me not having any brief from the Minister in the first place. We have all commented on the fact that the government amendments, tabled as they have been, need a fair bit of explanation. I hope the Minister can answer some of these questions and I look forward to her reply, but it may be that she prefers to write after Committee.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that the noble Lord, Lord Lansley, has withdrawn so I call the next speaker on the list, the noble Baroness, Lady Jolly.
Baroness Jolly (LD) [V]
My Lords, the noble Lord, Lord Patel, set the tone for this debate. I share the concerns of the noble Lord, Lord Hunt of Kings Heath; his concerns should concern us all. We are entering new territory. We have worked across an EU framework for a long time and are now going to be on our own. We need to work out policies and procedures to deal with this new landscape, which of course is what we are doing today. However, we will still have to work with Europe, if not within it.
I understand that we are to leave on 31 December, but we really must not bury our heads in the ground. Regulation will be key; mutual recognition is important. I think the Minister has referred to mutual recognition in the past. I wonder if he or the noble Baroness, Lady Penn—I am not sure who will be summing up—could clarify that issue. We need easy and ready access to new medicines, early-phase trials and the willingness of the NHS to take them up. There is also the role of NICE. We have not looked at mutual recognition of standards, but we need to share information with international partners. My noble friend Lord Clement-Jones asked a lot of pertinent questions. If the Minister does not have these issues in her brief, perhaps we might have either a letter or a meeting, because these are really meaty issues that we are discussing.
Amendment 27 would make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay so that the UK can get early access to new medicines. Amendment 45 would require the Secretary of State to publish their proposed regime for a list of fees in respect of human medicines. What is the timescale on that? It would be interesting to see this fees regime alongside the old regime that we will be leaving.
Government Amendments 48 and 66 relate to the disclosure of information in accordance with international agreements. My noble friend Lord Clement-Jones had something to say about that. Interestingly, although I am not absolutely clear, Labour’s Amendment 118 aims to protect medicines and medical devices regulations from any form of control from outside the UK in the event of a trade deal. This goes back to legislation that we dealt with, which I think we ended up renaming the international health Bill. We need to be clear, coming up to the end of the year, about what a trade deal might actually look like and what things would look like without a trade deal. Those are my reflections on the amendments.
Baroness Thornton (Lab)
This is a slightly strange time to be making this speech, because it seems likely that we will not hear the Minister’s speech until we reconvene in a week’s time. If that is the case, I would like to register that I will probably want to ask a question after the Minister speaks, if that is where we finally end up.
I am very grateful to the noble Lord, Lord Patel, and my noble friend Lord Hunt for the way in which they spoke at the beginning of this debate. The noble Lord, Lord Patel, went into a level of detail about the effects of the government amendments that was absolutely right and accurate. It also lies at the heart of my remarks. I need to make it clear from the outset that we on these Benches regard the government amendments to this part of the Bill as dangerous, sloppy and possibly sinister. The Minister must be aware, because we have discussed it with the Bill manager, that we regard the use of “a person” in Amendment 48 as something that should set alarm bells ringing right across the House.
I am getting a feeling of déjà vu. The Bill mentioned by the noble Baroness, Lady Jolly, started its life as the international healthcare arrangements Bill and ended it as the European Union and Swiss healthcare arrangements Bill, because it cast its net so wide. One of the giveaways is what the Government say in their description of their amendments:
“This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.”
The same explanatory statement follows the other government amendments in this group and tells us what the purpose of these amendments is. This underlines why we on these Benches will ask the Delegated Powers Committee to have another look at the Bill. These amendments fundamentally change the purpose of the Bill. It is not the same Bill that it looked at when it did its first report in July.
One of the reasons why this discussion—I am afraid I do not use the word “debate” about these proceedings—is so important is the read-across to the Trade Bill, to which I moved an amendment in Grand Committee a few weeks ago. It is about scrutiny and accountability. Amendment 45 is about fees: accountability and transparency and setting the level of fees. I would like the Minister to address that issue, which is fairly straightforward.
Amendment 118 in my name concerns international agreements. In terms of its policy content, it is probably the opposite of government Amendment 48. There is a policy clash here and I need to be clear that I am very unhappy about the fact that we have to agree to amendments that are unacceptable to us because of the time problems that the Government face on the Bill. We will be looking very carefully indeed at these sections of the Bill and will be seeking to amend them at the next stage.
The read-across we need to look at is to do with the trade negotiations with the United States, the EU and elsewhere, where we have to have systems of transparency and scrutiny about trade deals. The House of Lords passed an amendment to a previous Trade Bill on parliamentary scrutiny, but the Government have not made good their promises to give Parliament a say in new trade deals. I am concerned about the threat to our NHS and public health from these amendments, and about the misuse of information. We are concerned that, at present, Parliament does not have adequate powers to guide and scrutinise either the trade negotiations or the issues that will arise out of the Bill. We will need to look at this very carefully when it moves to the next stage.
Baroness Penn (Con)
My Lords, I am responding as a Whip, rather than as a Minister. I understand that this is not the ideal moment to break, but I believe that noble Lords would wish to hear a full response to the issues raised. I therefore beg to move that the debate on this amendment be adjourned.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, that concludes the work of the Committee this afternoon. The Committee stands adjourned. I remind Members to sanitise their desks and chairs before leaving the Room.
Medicines and Medical Devices Bill
Wednesday 4th November 2020
(4 years ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-IV(a) Amendment for Grand Committee (for Fifth Marshalled List) - (3 Nov 2020)
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
A participants list for today’s proceedings has been published by the Government Whips Office, as have lists of Members who have put their name down to the amendments or expressed an interest on each group. I will call Members to speak in the order listed, but ask noble Lords to note that both the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, have had to withdraw. Members are not permitted to intervene spontaneously. The Chair calls each speaker. Interventions before speeches or “Before the noble Lord sits down” are not permitted.
During the debate on each group, I will invite Members, including Members in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will call the Minister to reply each time. Groupings are binding, and it will not be possible to degroup or amend for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate. Leave should be given to withdraw amendments. When putting the question, I will collect voices in the Grand Committee Room only.
I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an Amendment is negatived, and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group. The proceeding today will cease at 4.30 pm, earlier than originally planned. We will now resume debate on Amendment 27.
Baroness Penn (Con)
My Lords, I thank noble Lords for their patience in waiting a full week to hear the response to what was a very useful and detailed debate. By way of compensation, I hope my response today reassures them that my time has been put to good effect: I am sure they will let me know if that is not the case.
Amendment 27 was tabled by the noble Lords, Lord Patel and Lord Hunt of Kings Heath. I reassure both noble Lords that the Government and the MHRA remain committed to ongoing international collaboration for the benefit of patients and the life sciences sector in the UK. The noble Lord, Lord Patel, set out some of the work the MHRA is doing to deliver on this commitment after the end of the transition period in his opening remarks on this group. I am pleased that noble Lords had the opportunity to hear from and question the MHRA directly on this and other issues this week. The Government heard the request from noble Lords to ensure that this is part of an ongoing dialogue with the regulator and parliamentarians.
In response to the noble Lord, Lord Hunt, I am reluctant to revisit the debate on alignment with the EU, which we have already had in this Committee, as well as in many previous debates. However, I reassure him that the UK is seeking mutual recognition with the EU on a number of areas, including batch testing, good manufacturing practice and continuing co-operation on pharmacovigilance. Certain aspects of medicine regulations are also harmonised at an international level and we are committed to those international standards in all areas. Indeed, to further support the aim of continued international collaboration, we have tabled Amendment 48, which I will come to shortly.
Turning to Amendment 118, tabled by the noble Baroness, Lady Thornton, I reassure her that this amendment is unnecessary. The MHRA and the VMD are both recognised globally as leading regulators and will retain their regulatory sovereignty regardless of any trade deals agreed. This will include the MHRA’s duty to consider the safety and efficacy of human medicines placed on the UK market. We will ensure that our new FTAs provide flexibility for the Government to protect legitimate domestic priorities; we have made this clear in our published approach to trade negotiations with specific trading partners.
On the price the NHS pays for medicines, the Government have made clear that this is not on the table for negotiations. The prices of branded medicines will continue to be controlled through the 2019 voluntary scheme for branded medicines pricing and access—VPAS. To be absolutely clear, the powers in the Bill do not enable regulations to be made that relate to the pricing of medicines or medical devices. In relation to data, the UK has a strong system to protect health and care data, as set out in the Data Protection Act 2018 and covered by the common law duty of confidentiality. Our objectives for trade negotiations are explicit that we will maintain the UK’s high standards of data protection. Again, to be absolutely clear, it would not be within the scope of the powers in the Bill under Clauses 1, 8 and 12 to create exceptions to or modify the provisions of our data protection legislation.
I heard in last week’s debate that questions of safeguards and data protection were at the heart of noble Lords’ concerns about the government amendments in the name of my noble friend Lord Bethell, to which I will now turn. These amendments would allow us to share information regarding these areas with international regulators or networks where this is required to give effect to international agreements or arrangements. I reassure the noble Lord, Lord Clement-Jones, and others about the motivation behind these amendments, which have been identified as necessary as part of the work to support the future relationship with the European Union, and to protect and preserve existing work that the MHRA does. On his question about source codes and algorithms in medical devices, I make two points. The UK-Japan trade deal, as with the EU-Japan trade deal that came before it, provides for safeguards against IP infringement on the question of source code and algorithms. However, to protect patient safety, and for effective regulation, there remains provision for a regulator or conformity assessment body to request source code and algorithms as part of their regulatory responsibilities.
The MHRA and the VMD presently share and receive intelligence from their counterparts through our membership of the European Union, which will come to an end. The MHRA and the VMD will be the UK’s independent, standalone regulators and require appropriate legal powers for their own reciprocal information-sharing arrangements with other nations and forums. Without this, the UK may not be able to comply with its information-sharing obligations under international agreements; nor would it be able to participate in international arrangements facilitating the mutual exchange of intelligence regarding medicines and medical devices. These exchanges of information are of vital interest to UK patient safety. For example, intelligence sourced from international regulators through the EU has ensured access to life-saving medical devices for UK patients during Covid and has enabled the MHRA to trace suppliers of non-compliant testing kits. This is vital and will continue to be so going forward.
Future reciprocal information-sharing agreements with international regulators will help the MHRA and VMD to take swift regulatory action on medicines and medical devices that pose a risk, removing them from the marketplace if necessary. I reassure noble Lords that this data is limited to the data that the MHRA holds. The MHRA will always anonymise patient data before it is shared internationally, under the powers in the Bill. For the purpose of pharmacovigilance, for example, the MHRA might need to share information received through adverse incident reports. However, the information would always be anonymised and is usually kept at a high level—for example, description of the safety signal, or a trend report to identify whether another country has also identified an issue with a particular product or manufacturer.
I appreciate that there has been some concern over the use of the word “person” in the drafting of the amendment. We used that word, rather than specifying particular organisations, because we anticipate that international agreements will require the UK to share information not only with overseas regulators but with other bodies, such as overseas Governments, international organisations such as the World Health Organization, and international networks such as the International Medical Device Regulators Forum.
The wording is necessary because it provides the breadth, for example, to share data with international networks that might not be formalised. If we were to list all the organisations, networks and relationships that might be involved, it would simply not be possible to keep that list live on the face of legislation. Debate has been categorical that the MHRA needs to be a front-footed international regulator, and to limit it to the relationships it has now, rather than being flexible with regard to new regulatory forums or relationships, would restrict that aim.
The noble Lord, Lord Patel, asked pertinent questions about the data protection provisions in the new clauses. I have to admit to noble Lords that I had the same reaction about their potentially circular nature when I first read them, and I hope that I shall be able to unpack their effect here. The GDPR sets out seven key principles for processing personal data, the first of which involves “lawfulness, fairness and transparency”. We are providing a lawful basis for processing personal data by inserting these powers. That does not remove the other protections under the Data Protection Act that apply to the sharing of information under these clauses.
Where personal data are sensitive personal data, which are now called special category data, the GDPR requires further conditions, under Article 9, to be met for the processing to be lawful. Patient health data are a type of special category data. Relevant conditions under the GDPR, of which there are 10 that could be relied on to disclose patient data under the clause, would include “explicit consent”, reasons of “substantial public interest”, health or social care reasons, or public health reasons.
The GDPR also sets out further requirements where personal data are to be shared internationally. There must be an adequacy decision in place confirming that the third country or international organisation ensures an adequate level of data protection. In the absence of an adequacy decision, appropriate safeguards must be put in place that provide enforceable data subject rights and effective legal remedies, which can take the form of a legally binding agreement or contracts between parties. In the absence of an appropriate safeguard, data could be transferred only if it were
“necessary in order to protect the vital interests of the data subject or another natural person where the data subject is … incapable of giving consent.”
Equivalent safeguards for personal data and commercially sensitive information are already in place in Clause 35 for information relating to medical devices. This is solely to facilitate the appropriate sharing of information to give effect to international agreements and arrangements. They are critical to ensuring we can regulate effectively and uphold high standards of patient safety and access.
Amendment 45, in the name of the noble Baroness, Lady Thornton, seeks to achieve what is already standard and long-standing practice. Existing arrangements already ensure that timeliness, openness and transparency are key to the fees regime, and they are published online and available on GOV.UK. We will ensure that the industry and any other interested stakeholders know about any future fee changes in good time. We have laid statutory instruments to implement changes at the end of the transition period, as the cost of providing some regulatory services has fallen, so the fees charged will need to be reduced.
On the basis of the reassurances I have provided on Amendments 27, 45 and 118, I hope the noble Lord, Lord Patel, feels able to withdraw Amendment 27, and that the noble Baroness, Lady Thornton, is similarly assured and will not move her amendment.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock (CB)
I have received a request to speak after the Minister from the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
I gave the Minister notice last week that I might well want to speak after her, and I am doing that, for two reasons. One is to remind the Committee that, although we will allow the government amendments to go through without any objection, we do not agree with them, and will probably seek to amend them at a later stage.
The second point is to do with the word “person”. I thank the Minister for going into some detail, but frankly, that alarmed me more than reassured me, so I think we may have to engage with this, and discuss how to remove that word. It would be much too dangerous and risky to have such an amorphous expression in the Bill. Perhaps the Bill team could find some expression that, although it does not list all the different things that the person is supposed to be, provides some protection to cover the range of bodies that need to be consulted. I accept that we do not want long definitions in the Bill, but I am concerned about our having such an open definition, and we may discuss this again at a later stage.
Baroness Penn (Con)
To reassure the noble Baroness, I can tell her that the Opposition’s position on the government amendments is well noted. We will take away and reconsider the use of the term “person”, but there is a view that the safeguards that the noble Baroness is talking about are built in elsewhere, in how the clause would take effect. That does not mean, however, that we would not be happy to go away and look at those exact concerns, and see whether we can provide further reassurance. I am not a lawyer drafting the Bill, but that would be about looking at the terminology as well.
Lord Patel (CB) [V]
My Lords, I thank the Minister most sincerely for her full and comprehensive—I might even say persuasive—response. She is right to say that it has been a week since we debated this group, and even I had forgotten some things. Certainly, the venom certainly seems to have gone out of our debate.
The Minister reminded us what our anxieties were. She is right to point out that I referred to the word “person” in the government amendment, and also to the GDPR. I am pleased to hear that, on reflection, she, too, had realised why we were concerned about the use of data that might not be protected through the GDPR. Some questions remain.
The noble Baroness, Lady Thornton, has raised some important points, and I am glad that we may debate this subject again. It would be useful to have a discussion beforehand, if possible, because the word “person” is too amorphous—unless the definition could be confined as to what kind of person is meant. In her response, the Minister mostly covered organisations that might be involved in the regulation of medicines or in recommendations regarding medicines and devices, but the proposal as drafted goes much wider than that and would go beyond that. I will not say any more about that now.
The meeting that the noble Lord, Lord Bethell, arranged with the MHRA was useful, and it would have been better if we had had some of the information earlier. The information that I gave with regard to my Amendment 27 I had acquired from the industry. Of course, we got the same information from the chief executive of the MHRA. It would have been better if we had had that earlier—but that is water under the bridge. We know that there will be new ways of keeping us informed, and that will be good. At this point, I thank the Minister sincerely for her response, and I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
We now come to the group consisting of Amendment 28. I remind noble Lords that anybody wishing to speak after the Minister should email the clerk during the debate.
Amendment 28
Lord Patel
“Innovative Medicines Fund
In section 261 of the National Health Service Act 2006, after subsection (9) insert—“(9A) The Secretary of State must make a scheme to promote the availability of innovative medicines for human use within the National Health Service and must provide monies paid to him or her under subsection (9) for the benefit of that scheme to be known as the “Innovative Medicines Fund”.”Member’s explanatory statement
This amendment would require the Secretary of State to establish the Innovative Medicines Fund, as foreshadowed in the Conservative 2019 Manifesto; and provides that it is funded from rebates paid to the Government under the terms of the Pharmaceutical Price Regulation Scheme.
Lord Patel (CB) [V]
My Lords, this amendment was tabled by the noble Lord, Lord Lansley, who unfortunately is not able to attend today. My name is on the amendment and I am very pleased to move it in his name.
This is an amendment that normally one would have thought the Government would have no difficulty in accepting, because it was in the Conservative manifesto at the time of the election. So if you are going to choose an amendment, choose the one that they cannot turn down. I am in the good position of making two speeches, one in the name of the noble Lord, Lord Lansley, and one in my own name. It will be interesting to see which one the Minister accepts, because I am not going to tell her which one is which—I may as well enjoy this while I can.
Patients in the UK often face delays in accessing breakthrough innovations due to the NICE technology appraisal process. This is particularly true of treatments for smaller patient populations, such as patients with rare diseases, where there is greater uncertainty around effectiveness due to the challenges of collecting sufficient data to satisfy NICE’s requirements. To overcome similar challenges and enable access to the latest cancer treatments, in 2016 changes were made to the Cancer Drugs Fund, to increase NICE’s flexibility in decision-making. Between July 2016 and November 2019, approximately 41,000 patients were registered to access 79 drugs, used to treat 160 different cancer conditions. Despite the clear benefits to patients, similar flexibilities have not been extended to other areas such as gene therapy and gene silencing—treatments for rare diseases where there is not much treatment available.
Amendment 28, in the name of the noble Lord, Lord Lansley, would add a clause to the Bill that would require the Secretary of State to establish the innovative medicines fund. This fund was promised in the 2019 Conservative manifesto. Like the Cancer Drugs Fund, its purpose would be to bring innovative medicines into use in the NHS. It would give NHS patients in England access to the latest new medicines, as advised by clinicians, and would give the NHS and NICE valuable data on their effectiveness, often adding information about drugs being used in clinical practice which is not normally available through clinical trials alone. There is an increasing need to extend these access schemes to disease groups beyond cancer, including neurodegenerative conditions such as motor neurone disease and Parkinson’s, as well as haemophilia, cystic fibrosis and sickle cell disease. These are diseases with a high unmet need for treatment, but also with real hopes for new treatment options, including gene therapy and gene silencing, as I have already mentioned.
This amendment would amend Section 261 of the NHS Act, which provides powers for the pharmaceutical voluntary price and access schemes, often known as VPAS, as amended by the Health Service Medical Supplies (Costs) Act 2017. An essential part of VPAS is to improve access to innovative medicines. The new fund would help to deliver this, alongside the MHRA Early Access to Medicines Scheme that we have already heard about. The predecessor to VPAS was the Pharmaceutical Pricing Regulation System. However, over the years, lack of access to innovative medicines has been a source of angst in the industry about the scheme and, for many of us, is part of a system that fails patients. It was not only industry that did not like the scheme; it was denying treatments to patients. We should not have a stand-off between the NHS and drugs companies, with patients losing out in the process. We should have a scheme that adequately rewards the value that is inherent in medicines and also ensures that the NHS is able to provide the treatments that patients need.
The current VPAS sets a budget limit on the NHS drugs bill. If it is exceeded, the industry will provide a rebate. In the past, the NHS has seen rising drug costs but has not seen the rebate—so the NHS took the rebate but did not reinvest it in other innovative medicines. By way of the Innovative Medicines Fund, the NHS, the life sciences sector and patients would all see the benefit of the rebate. The proposed new clause would require the rebate to be made available to the fund, and it is that rebate which will provide the money for the fund. I hope—and I hope that the noble Lord, Lord Lansley, will agree—that it will be open to Ministers to take advantage of these powers to provide additional resources to the fund, according to its needs. The clause will provide the means by which the Government can deliver on their manifesto pledge and, in doing so, deliver to patients, some of whom are in great need.
I do not see how the Government can resist Amendment 28; they can only improve on it. I beg to move.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I am glad to support the noble Lord, Lord Patel, and I have a great deal of sympathy with this amendment. Of course, I speak as one of a long line of former Ministers who have wrestled with the tension between a cash-restrained NHS and the imperative to invest in new medicines and devices. I have come to the conclusion that we are not going to see the investment we want to see in these new medicines without a radical change of approach.
When we debated access in Grand Committee a couple of meetings ago, the Minister used words to the effect that he would not go anywhere near reimbursement. That is at one with the way the NHS regards drug costs: as a price and a cost to be pared down rather than as an investment in patient care. The unwillingness of Ministers to tackle the issue of reimbursement to the industry in a way that incentivises the use of new medicines is, I think, very disappointing. I do not think that there is any way around this, unless we top-slice some of the resource for the NHS and distribute it separately for investment in new medicines.
The noble Lord, Lord Patel, referred to current and previous agreements with the industry. I want to go back to the 2014 PPRS agreement, which does I think provide a model for us. It provided assurance on almost all of the branded medicines bill for the NHS, so the bill stayed flat for the first two years of the scheme and grew slowly after that. The industry made quarterly payments to the Department of Health when NHS spending on branded medicines exceeded the allowed growth rate. The quarterly payments that the industry made could have been used to fund new medicines—but, as the noble Lord, Lord O’Shaughnessy, mentioned last week, it is very hard to explain what exactly happened. With a cap in place and with reimbursements being made by the industry, the NHS proceeded to try to ration drug costs at local level. So, instead of having a virtuous circle where essentially the industry guaranteed the cap on drug costs in order to allow for investment in new medicines, we had a double whammy. The industry price was pared down and the NHS continued in its bad old ways of trying to prevent new medicines being accessed by patients.
Lord O'Shaughnessy (Con)
My Lords, I thank the noble Lord, Lord Patel, for moving this amendment. I also pay tribute to my noble friend Lord Lansley for laying the amendment and for creating the template for the innovative medicines fund—the Cancer Drugs Fund—in the first place. The noble Lord, Lord Patel, described the tens of thousands of patients who have benefited from that scheme. It has been a fantastic innovation and something I am sure we all want to build on.
It also seems entirely appropriate that I am following the noble Lord, Lord Hunt, who gave a powerful speech. When I was a Minister, he was unrelenting in pointing out the weaknesses in the PPRS when it came to supporting innovation. He was right then and he is right now. That is why I needed no persuading to support this idea and this amendment. It was something that I tried and failed to introduce in the VPAS when I was a Minister, but perhaps a seed was planted then. It was fantastic to see the commitment made in the Conservative party manifesto in 2019 to create an innovative medicines fund.
As the noble Lord, Lord Patel, said, there are many areas, particularly, but not exclusively, rare diseases—and I have a daughter with a rare genetic condition—where experimental drugs seem to offer great hope, whether that is cannabinoids for epilepsy in children, or gene therapies for children with spinal muscular atrophy, or the many other conditions where the promise seems huge but the data does not yet convince. It feels to me that if we accept circumstances in which it is right to give cancer patients access to those kinds of therapies, it should also be right to give all other patients access to those kinds of therapies too. That is really what the innovative medicines fund is about.
I think that we have seen the shape of the future innovative medicines fund and what it would look like. The VPAS allows for confidential, complex deals for the first time. We have seen CAR-T therapies come through that route. We have also seen a deal signed for Inclisiran—originally from the Medicines Company, now Novartis—with testing of that in a real-world situation following a very successful large-scale clinical trial that was largely focused in the UK. This provides a template for how we might go about doing business for common conditions, as well as for rare ones.
I am sure my noble friend the Minister will agree with everything she has heard today, so I want to ask her what the timetable is for introducing the scheme. Questions have been raised by the BIA and ABPI and others, and I very much agree with them that an ambitious definition of innovation is required. The noble Lord, Lord Hunt, made an excellent point when he forcefully said that we must make sure that the rebate is recycled into innovative medicines, rather than just going back to the Treasury—there does not need to be an additional expenditure control mechanism. I will be grateful for my noble friend’s guidance on that.
One other thing that has come up in our debate in Committee so far—and of course this is more difficult because it takes it outside medicines and into other areas—is the exciting potential in devices, digital and diagnostics. There is no rebate scheme or automatic source of third-party funding that could provide for that. Is the Minister prepared to entertain exploring the potential for expanding the innovative medicines fund into something broader, and beyond medicines, perhaps not in its first iteration but in the future? I look forward to hearing what she has to say.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
I call the noble Baroness, Lady Finlay of Llandaff. Lady Finlay? I think we had better move on and we can come back. I call the noble Baroness, Lady Jolly.
Baroness Jolly (LD) [V]
My Lords, this amendment would require the Secretary of State to establish the innovative medicines fund, as promised in the Conservative’s 2019 manifesto. It provides that it is funded from rebates paid to the Government under the terms of the pharmaceutical price regulation scheme.
The Cancer Drugs Fund was a Cameron initiative from the general election of 2010, and the 2019 general election saw a Johnson extension: the innovative medicines fund. He promised that
“doctors can use the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases.”
The promise was to increase the funding to £0.5 billion. Can the Minister confirm the figure and clarify how “innovative” will be defined? Importantly, how will the fund address the UK issue of combination pricing, where some new cancer treatments are not cost effective, even when the price is nothing?
There are questions about what drugs outside of cancer drugs could qualify to go into the new fund. Can the Minister help with a response here? There might be candidates from medicines selected for the early access to medicines fund, a pre-licensing indicator of promising innovation given by the MHRA. This would allow them to be funded while further evidence is generated. Given the focus on innovation and the very reason for EAMS to designate a drug as a promising innovative medicine, which is a prerequisite for any drug to get a full, positive EAMS designation, there looks to be a good fit, and we support it.
Baroness Wheeler (Lab)
My Lords, I support this amendment from the noble Lord, Lord Patel. It is very much the ambition to ensure access for UK patients to the latest and most innovative treatments. This is reflected in many of our amendments to this Bill, relating to attractiveness, clinical trials and regulatory alignment with the European Medicines Agency.
We fully support the Government’s commitment to extend the Cancer Drugs Fund into a £0.5 billion innovative medicines fund to be used for
“the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases”.
If, at last, the principle of using the rebates from the pharmaceutical rebates scheme could be achieved so that they are used for the benefit of the NHS and patients, then this will represent progress indeed, particularly ensuring that the money is used as an additional source of income and revenue for the NHS and is not part of expected and planned funding.
Like other noble Lords, we are very much looking forward to hearing from the Government the detail of their proposals, when they intend to commence the promised consultation and the proposed timetable for implementation.
We heard in previous debates important questions as to how the new fund will relate to the current NICE process for reviewing new cancer drugs, particularly those to treat rare cancers, and, more broadly, around what drugs will qualify, outside of cancer, to be covered by the new fund. For example, there may be candidates from medicines selected for the early access to medicines fund, the MHRA’s pre-licensing indicator of promising innovation, allowing them to be funded while further evidence is generated. Given the focus on innovation and the very reason for EAMS to designate a drug as a promising innovative medicine, a prerequisite for any drug to get a full, positive EAMS designation, what consideration have the Government given to this?
Detail, too, is needed, as we have heard, on the criteria that will apply to any prospective drug for the fund. I certainly endorse the comments of the noble Lord, Lord O’Shaughnessy, on needing to have an ambitious definition of innovation. Will the criteria mirror the current processes that the NICE committee considers for funding under the CDF, or will it be widened to reflect and include some of the criteria for highly specialised technologies, where NICE takes a different approach to treatments for some of the rarest conditions?
One of the key concerns in earlier discussions in Committee was the need for reassurances about NICE’s work to support innovation and to ensure that the current NICE review of its methods and processes is open and transparent and delivers real and effective change. As was made clear, it is important that we learn lessons from both the strengths and criticisms of the CDF, and that we ensure speedy access to new medicines going forward. I look forward to the Minister’s response.
Baroness Finlay of Llandaff (CB) [V]
I thank the Committee for allowing me to come in a bit late; I apologise for that.
Noble Lords have made the main points that I would have made but I simply add this. A large number of molecules are held by pharma, often with a good scientific rationale, for use in a rare condition, and we have drugs that are licensed for other uses that could be reused or repurposed. If we can speed up all these processes, and provide an incentive for medicines development, those with rare conditions—who are often absolutely desperate to try something new and very keen to be part of a monitored development—could access medicines. That would put the UK in a stronger position in the long term.
In addition, the concept of this seems so sensible that I have also put down an amendment, later in the Bill, to try to replicate it for innovative devices. We have complex situations where medical engineers may come with up a device, but we will deal with that the next time round.
In the meantime, I am most grateful to all noble Lords for the important points they have made. I await the Minister’s reply with interest.
Baroness Penn (Con)
My Lords, this debate has once again focused the Committee’s mind on the importance of innovation and the way in which it can have a transformative impact on patients’ lives.
As noble Lords have spoken of, the success of the Cancer Drugs Fund in providing interim funding means faster access to cancer drugs, saving valuable time—up to eight months in some cases—for patients accessing those drugs. Patients are now able to access cancer drugs that have received a draft NICE recommendation from the point of marketing authorisation. As noble Lords have noted, this provides the template for the innovative medicines fund.
The success over the lifetime of the Cancer Drugs Fund to date did not need legislation. It was a response to the immediate need to target access to cancer drugs. In expanding the fund to become the innovative medicines fund, I do not think legislation would advance the fund’s purpose, capacity or delivery in any material way. It will be a managed access scheme delivered by NHSEI and NICE to expand the range of medicines that could be supported by that funding.
I understand that my noble friend Lord O’Shaughnessy and other noble Lords would like this debate to cover an update on progress towards delivering that fund. I assure noble Lords that proposals for the innovative medicines fund are in development as we speak. We know that patients will be keen to understand the impact on them, as well as pharmaceutical companies and the NHS. It is our intention that NHSEI and NICE will lead an engagement exercise in the first quarter of 2021 to get the fund established.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
I have received a request to speak after the Minister from the noble Lord, Lord Hunt.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, before the noble Lord winds up, I want to thank the Minister. Clearly, the fund is welcome, but it will cover only a limited number of medicines. The debate goes wider than that.
I want to ask the Minister about the financial contribution that her department receives under the current voluntary agreement with pharma for sales of branded health service medicines. Does she not agree that it is a strange position we have reached where, if the cost to the NHS of those branded medicines goes above the agreed rate, her department receives a rebate? That is excellent, but why then does the NHS continue to treat drug costs almost as a pariah and hold down its investment in new medicines? Why cannot that rebate be used as a way to incentivise a switch by the NHS to new medicine?
I have debated this with the noble Lord, Lord O’Shaughnessy, and his predecessor. It is a real issue. The NHS itself believes drug costs to be a major problem, but the department has essentially solved the problem at a national level through the rebate scheme. Somehow, instead of a virtuous circle, we have got the very opposite.
Baroness Penn (Con)
The noble Lord speaks with great passion. He is right that the debate goes wider than the innovative medicines fund, but it might also go somewhat wider than the scope of the Bill. I am, however, happy to write to him on the points that he raises.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
I have also received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.
Lord O'Shaughnessy (Con)
I apologise for my email ineptitude.
I am grateful to my noble friend for her response. I was not planning to do so, but I have to again underline the points made by the noble Lord, Lord Hunt. We have trapped ourselves in a vicious, rather than a virtuous, circle that could well be undone. That may not be a discussion for now, but I want to underline its importance.
I want to ask my noble friend a very practical question. What did she mean by engagement? That could mean anything; it could mean pre-consultation discussion or a formal consultation. She will have garnered the strength of feeling on the topic, even in this small debate, and I am sure that will not dissipate as move forward to Report. The more detail and specificity she can give us on that process, the better.
Baroness Penn (Con)
I am reminded that my noble friend Lord Lansley referred to the collective noun for former Health Ministers as a “frustration” of former Health Ministers. I can tell my noble friend that the engagement exercise will involve the pharmaceutical industry, the NHS and associated bodies and patient groups. That is the level of detail that I can give to him today. I was very pleased with being able to say “quarter 1” next year; it felt to me like a very specific timeframe for when that engagement exercise would be undertaken.
Lord Patel (CB) [V]
Thank you, my Lords. I apologise to the Chair for jumping in. I forget that, in the new world, I do not speak unless instructed to do so.
I thank the Minister enormously for her response. She mentioned the frustrations of the former Ministers. If she thinks that former Ministers get frustrated, think about us lesser mortals who have suffered the former Ministers when they have not listened to our arguments. Maybe that should be taken into account, too.
I thank all noble Lords who have taken part. They have spoken with passion and commitment. This has been referred to by several people, but I do so again. The noble Lord, Lord Hunt of Kings Heath, has been pursuing this passionately and eloquently for a very long time. He has made an important point: if the medicines are available and people are suffering, why do we keep arguing about health and drug budgets and how to deliver it? The principle should be how we can get those drugs to the patients who might be suffering. He is right. If a rebate is available, where did the money go? The rebate was a drug fund rebate to be reinvested, you would have thought, in people getting the medicines.
No doubt the Minister is aware that there seems to be complete consensus around this amendment. I hope that it does not need to go to Report but, if it does, Ministers will be aware that there will be complete consensus. I hope that the Minister makes rapid progress with sorting this out. In the meantime, I thank all noble Lords and the Minister most sincerely for taking part. In begging leave to withdraw the amendment, I hope that the noble Lord, Lord Lansley, will feel that we gave it enough airtime and passion.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock)
We now come to the group beginning with Amendment 30. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 3: Falsified medicines
Amendment 30
Baroness Thornton
Member’s explanatory statement
This amendment tightens the provisions to avoid unintended consequences of data being used for purposes other than to ensure that medicines are safe.
Baroness Thornton (Lab)
This clause deals with falsified medicines and is a very important clause, and it is important therefore that we get this right. Amendment 30 would tighten the provisions to avoid unintended consequences of data being used for purposes other than to ensure that medicines are safe, and Amendment 33 would place a duty on the Secretary of State to act with a view to, rather than having regard to, the importance of ensuring that information is retained securely when exercising powers. The amendments in the name of the noble Lord, Lord Clement-Jones, whom I thank for supporting mine, are similarly concerned with the safety of information and accountability.
The MHRA said that the Falsified Medicines Directive will cease to apply in the case of a no-deal Brexit, because UK pharmacies will no longer have access to the database that holds false medicines data under the FMD. The noble Lord, Lord Clement-Jones, during Second Reading described the measures as “legislative creep” with regard to how any data could be used. He said that the clause
“considerably broadens the original data-collection provisions of the Falsified Medicines Directive”.—[Official Report, 2/9/20; col. 391.]
That is the whole point of these amendments. Indeed, the noble Baroness, Lady Masham, also said at Second Reading that the Company Chemists’ Association had raised concerns around the clause. Malcolm Harrison, the chief executive of the CCA, said he had grave concerns about the wording of Clause 3(1)(b), which relates to the development of a UK system to prevent the supply of falsified medicines. Jerome Bertin, general manager of SecurMed UK, said
“it is hard to determine if this would broaden the rights of access to such data, but the use of ‘for any purpose’ might suggest wider access rights, though for which stakeholders or regulators is unclear”.
Clearly, there needs not to be any ambiguity in this Bill. The wording of the clause therefore needs to be adjusted to ensure that there is no confusion and that there is a clear direction that data should not be used for any other purpose than ensuring that medicines are safe. Jerome Bertin also said that the Bill
“does not go anywhere near the detail of the EU directives (2001/83/EC superseded by 2011/62/EU) so it is hard to assess whether the FMD style protections would be diluted in a UK-only falsified medicines regulation”.
That is a legitimate question that needs to be answered.
There is no mention of this clause or this issue in the Explanatory Notes or the impact assessment for the Bill. With such a big issue regarding extremely sensitive data, there should be a more clearly outlined direction and a better thought-out way of introducing this clause for falsified medicines that also protects the extremely sensitive data that comes with it.
These amendments aim to ensure that data is protected and will not be used for any other purpose other than to ensure that medicines are safe. It is crucial that we get this right to avoid any unintended consequences, which could have grave repercussions. I beg to move.
Lord Hunt of Kings Heath (Lab) [V]
I very much support my noble friend in these amendments. As they have with her, a number of organisations have raised with me their concerns. The clause refers to the
“use, retention and disclosure, for any purpose to do with human medicines”,
which is very open-ended. In relation to information collected by such a system, it considerably broadens the original data-collection provisions of the Falsified Medicines Directive. Yet the Explanatory Notes make no mention of this. The noble Lord, Lord Clement-Jones, is not with us today but, when we debated it earlier, he referred to it as “legislative creep”—and, I must say, I agree with him.
In the Commons, the Health Minister Jo Churchill said in Committee:
“The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices.”—[Official Report, Commons, Medicines and Medical Devices Bill Committee, 8/6/20; col. 7.]
So it is very surprising to see this clause as currently drafted.
We have had briefings from the Company Chemists’ Association and ABPI, in addition to the ones that my noble friend mentioned. Because of the issue of commercially sensitive data, Article 54a, regarding the protection of personal information or information of a commercially confidential nature generated by the use of the safety features, was inserted into the preamble of the Falsified Medicines Directive. The principle of “whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016, which followed the Falsified Medicines Directive.
The Minister’s department already has access to a wide range of data on medicines’ sales and use in the UK under the Health Services Products (Provision and Disclosure of Information) Regulations, which we debated at some length a little while ago in your Lordships’ House. Of course, Ministers can request more detailed information if required. Given this access and the known sensitivities around falsified medicines data in general, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme. Why was such little reference made to it in the Explanatory Notes?
It is not unreasonable to ensure that the Bill is amended to enshrine at least a duty of full consultation with stakeholders before it goes through your Lordships’ House.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
The noble Lords, Lord O’Shaughnessy and Lord Clement-Jones, have withdrawn. I therefore call the noble Baroness, Lady Jolly.
Baroness Jolly (LD) [V]
I should apologise to noble Lords: my noble friend Lord Clement-Jones is unable to be part of today’s Committee, so I will be speaking on his behalf—at some length but without, I suspect, his bravura.
Amendment 30 seeks to tighten the provisions in Clause 3 to avoid the unintended consequences of data being used for purposes other than to ensure that medicines are safe. Amendment 31 also seeks to do this, by requiring a framework for data to be used as agreed in consultation with the pharmaceutical industry, and Amendment 33 places a duty on the Secretary of State to
“act with a view to”,
rather than
“have regard to the importance of”,
ensuring that information is retained securely when exercising powers.
There is no doubt that the noble Baroness, Lady Thornton, the noble Lord, Lord Hunt, and my noble friend Lord Clement-Jones are travelling down the same road, and I have very similar concerns. That is why we signed Amendment 30, and I am grateful to the noble Lord, Lord Hunt, for his support for the amendment tabled by my noble friend Lord Clement-Jones.
As explained at Second Reading, there are grave concerns about the wording of Clause 3(1)(b), relating to the development of a UK system to prevent the supply of falsified medicines. The clause refers to
“the use, retention and disclosure, for any purpose to do with human medicines, of information collected”
by such a system. This is an attempt to unreasonably broaden the original data-collection provisions of the Falsified Medicines Directive after the transition period.
The background to the current legislation is very clear. By the early 2000s, pharmaceutical companies were concerned about falsified, counterfeit products entering the legitimate medicines supply chain—especially high-value items such as Viagra. At that time, this was the only real way to distribute such products at scale. Schemes involving pack serialisation were proposed to reduce the risk of reputational and trading losses from counterfeit and falsified medicines entering the supply chain, and to reduce the potential risk of harm to patients.
A stakeholder model was established which is governed by the main groups in the supply chain and funded mainly by manufacturers—branded, generic and parallel trade—with smaller contributions to costs from wholesalers and pharmacies. These proposals became the EU Falsified Medicines Directive 2011/62/EU. In the meantime, the issue of falsified medicines had moved largely to the internet, where they are sold from trading platforms and/or unlicensed pharmacies.
So why is data use so important? As the Company Chemists’ Association has pointed out, data is a very sensitive commercial currency. All parts of the medicines supply chain need access to broad patterns of medicines usage for the purpose of planning or adjusting manufacturing, marketing, prescribing, buying and stock control. But access to pack information—who is handling which packs—could highlight purchasing decisions, the margins being made and those trading for import/export purposes.
So the principle of “Whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016. As a result, general access to FMD data is restricted to pack information—name, batch, expiry, serial number—and active/inactive status, with some exceptions for investigating incidents and national competent authority use for reports, reimbursement, and pharmacovigilance and pharmacoepidemiology research.
The Department of Health and Social Care already has access to a very wide range of data on the sales of medicines, and their use in the UK, under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. These require manufacturers, wholesalers and pharmacies to provide summaries of products sold and prices paid. Ministers can request more detailed information if required.
Given both this access and the known sensitivities around FMD data, it is unclear why the department has included the sweeping provision of Clause 3(1)(b) on the use, retention and disclosure for any purpose of data collected under a falsified medicines system, and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme.
The pharmacy community has concerns not just that the department might accidentally release commercially sensitive data—this is covered by Clause 3(3)—but that it might use such data to gain unfair advantage by abusing its monopoly position as the main purchaser of medicines in the UK. Pharmacies wish to see data use under any future system being part of an agreement that has been subject to discussion with stakeholders and approved by Parliament. My noble friend understands that the department has said that the details of any proposed use under a new falsified medicines system would be contained in a statutory instrument by the affirmative procedure.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, I understand that the intention of Amendment 30, in the name of the noble Baroness, Lady Thornton, is to prevent the use of data for any purpose other than preventing the supply of falsified human medicines. The noble Baroness raises an important question. Let me reassure her that we have thought very carefully about these powers. There is an important precedent already for using the data held in the current EU Falsified Medicines Directive “safety features” system for wider purposes. For instance, as well as using the data to investigate instances of falsified medicines, data on the EU system can be used for the purposes of reimbursement, pharmacovigilance and pharmacoepidemiology. The effect of this amendment would be a step backwards on what any potential falsified medicines scheme introduced under Clause 3 could deliver.
We know from implementation of the EU system that the checks involved could generate a rich source of data, and that there may be circumstances where we would want to be able to use that data to support the safe and effective use of medicines. For example, information in a future falsified medicines scheme could be useful in the event of a product recall to help quickly identify individually affected packs. I recognise that information about the supply of medicines through the supply chain can be commercially sensitive—the noble Baroness, Lady Jolly, made this point very well. That is why Clause 3 ensures that, in making regulations under this power, the appropriate authority must ensure that information is retained securely. Information will be subject to strict controls set out in regulations, including what purposes the data could be used for, who would have access to or use it, and under what conditions.
I turn to the noble Baroness’s second amendment in this group, Amendment 33. While I understand the desire of the noble Baroness, Lady Thornton, to ensure that we have robust requirements around the safeguarding of information, this amendment would cause difficulty for the appropriate authority making regulations under the provision in Clause 3. This is because it would require action to secure retention of data even where the regulations themselves may not concern data—for example, provisions related to who may set up the infrastructure.
Amendments 31 and 32, in the name of the noble Lord, Lord Clement-Jones, would operate together to place an obligation on the Secretary of State to seek to agree and lay a framework on the use of information collected for the purpose of preventing the supply of falsified medicines. This would be done within six months of the Act coming into force.
We can all agree with the noble Lord, Lord Hunt, and others that close collaboration through consultation with stakeholders, including with pharmacists, is essential to getting something like this right, not least given the importance of data security. However, Amendments 31 and 32 would not create the right mechanism for providing this. I can reassure the noble Lord that we have planned fulsome engagement and consultation with a wide range of stakeholders. This can be achieved without this additional obligation, but I would be glad to commit to an engagement session with noble Lords and officials if noble Lords would find this helpful.
The Government have committed to exploring all options in regard to a falsified medicines scheme to ensure that patients continue to be protected from the public health threat posed by falsified medicines. As part of this, we will explore with stakeholders what information needs to be collected as part of any national scheme. Only once we have established how any scheme could work can we fully consider how the information that it collects could be used to deliver the most benefits for the UK and for patients. However, this amendment would force us to consult on an agreed framework outlining the use of information within six months of Royal Assent, without necessarily having the full picture of how a national scheme could work.
We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.
I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.
I remind noble Lords that Amendment 126 in my name ensures that this will be a public consultation, while Amendment 131, also in my name, places an obligation on the Secretary of State to review regulatory changes made under Clause 1(1). The consultation will consider how the information collected as part of the scheme could be used, and any regulations providing for the use of information would be subject to parliamentary scrutiny under the affirmative procedure. In light of these reassurances, I hope that the noble Baroness, Lady Thornton, will feel able to withdraw her amendment and the noble Lord, Lord Clement-Jones, will be content not to press his.
Baroness Thornton (Lab)
I thank the Minister for his detailed response. I just have to wonder why the consultation did not take place before the Bill was drafted. You have to ask why stakeholders were not involved in the discussions prior to this happening and why they then felt the need to get in touch with those of us involved in this Committee to express their concerns. So I have to say to the Minister that I will certainly be discussing with stakeholders their reaction to what the Minister has said and whether that allays their frustrations and anxieties.
The process that the Minister described, which I shall read in detail and think carefully about, looked circular. It looked like a process that involves consultation, powers in the Bill that we have already questioned, and the affirmative procedure. All those things may not be satisfactory, so we will probably need to return to discuss this at a later stage of the Bill—or, preferably, before. I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
We now come to the group consisting of Amendment 40. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 40
Lord Patel
“(f) about requirements to consider babies, children and young people in research about new medicines, in a manner similar to the EU Paediatric Regulation.”Member’s explanatory statement
This amendment is to ensure that in the development of new medicines and clinical trials, data related to children is taken into consideration.
Lord Patel (CB) [V]
My Lords, I shall curtail my remarks, as time is limited and this is very much a probing amendment. It draws attention to the need to ensure that paediatric regulation-specific measures that preside over the licensing of medicines to better protect the health of children, are reflected in future legislation regarding clinical trials in the United Kingdom.
New medicines licensed in the EU are currently subject to an EU Parliament directive that requires research about new medicines to consider babies, children and young people. The directive means that standardised procedures are in place for sponsors to plan and conduct studies. To get new medicines intended for use by children licensed for marketing in the EU, sponsors must have in place a paediatric investigation plan that aims to ensure that the necessary data are obtained through studies in children. In short, new medicines applying to be licensed for use by children must be trialled by them. It is often the case that medicines trialled in adults are then given in lower doses to children.
New medicines trialled in the United Kingdom are currently subject to this regulation. Moving on, there are clear clinical reasons why it is important for babies, children and young people, as they may show differences from adults in their response to and tolerance of medicines. To ensure that new medicines are safe for their use, they must be involved in clinical trials. That is the important point of my modest amendment.
Furthermore, there is a commitment and a key pledge in the NHS long-term plan to raise to 50% by 2025 the involvement of children and young adults in clinical trials. If there is no regulation requiring that data be collected in clinical trials with children, we will not achieve this. So all I seek is an assurance from the Minister that the Government and the MHRA are well aware of this and that the paediatric regulation will be considered whenever the clinical trials regulations are drawn up by the MHRA. I beg to move.
The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)
My understanding is that the noble Lord, Lord Lansley, has withdrawn, so I call the noble Baroness, Lady Jolly.
Baroness Jolly (LD) [V]
My Lords, since March 2011, the European Medicines Agency made available information on clinical trials in children via a public interface, the European Union Clinical Trials Register. The register is based on the information stored in EudraCT, a European database that contains information on all clinical trials with at least a site in the EEA. Can the Minister clarify whether this information will be available to researchers and paediatricians in the UK? Can he confirm whether this point has been part of EU negotiations? Can he further clarify whether there is any difference with data from joint research projects operating across the island of Ireland? Are all data equally accessible? We support the amendment.
Baroness Thornton (Lab)
My Lords, I will not add much more, as I am very interested to hear what the Minister has to say. The noble Lord, Lord Patel, has done the Committee a great service by tabling the amendment and asking this question. I was not aware that there was an issue here, which there clearly might be, and I will be interested to hear the answer. If this is an area that is covered by European Union regulation, and we are therefore creating a new regulatory framework for children’s data in clinical trials, it is important that we know that and how it might happen. I am very interested to hear what the Minister has to say.
Lord Bethell (Con)
My Lords, in response to the point of the noble Baroness, Lady Thornton, the noble Lord, Lord Patel, is right: paediatric trials are very important, and they have sometimes been overlooked. However, that does not detract from the fact that the UK has a strong international reputation for paediatric medicine research. The MHRA authorised 177 new clinical trials that included children in 2019—more than any other country in the EU. The Bill, in Clauses 4(1)(d) and (e), already enables us to make regulations about requirements to be met before the clinical trial may be carried out and on the conduct of the clinical trial. That can provide for a number of different options, including paediatric clinical trials. I reassure the noble Lord that the Human Medicines Regulations 2012 will include provisions equivalent to those of the EU paediatric regulations when amendments come into force at the end of this year. These include requirements for the review and approval of paediatric investigation plans. These plans are aimed at ensuring that the necessary data is obtained through studies in children.
I recognise that the EU regulations played an important role in promoting the development of paediatric medicines, so that children are not forgotten when adult needs drive drug innovation. I am happy to commit to write to the noble Baroness, Lady Jolly, on her questions about EU statistics on that matter.
I understand that there is currently ongoing evaluation of the EU paediatric regulations and that this may bring about changes to the legislative landscape. This Bill will allow us to adapt the UK regulations based on patient needs and to keep pace with any changes in any other jurisdiction, including the EU. It gives us the opportunity to go even further to enhance the UK system and to encourage UK paediatric trials.
It is critical that the UK paediatric regulatory framework remains flexible, to adapt to emerging paediatric research challenges, and supports UK innovation, while also supporting global development plans. I reassure noble Lords that the MHRA has already published guidance on a new UK approach to paediatric investigation plans. This is part of the GOV.UK transition period guidance for businesses and citizens. The UK will simplify the PIP application process for applicants conducting paediatric research by offering an expedited assessment where possible and by mirroring the submission format and terminology of the EU PIP system. This approach ensures that the UK can continue to provide incentives and rewards to support innovation in paediatric drug development and to encourage manufacturers to bring medicines to the UK market.
The MHRA will aim to continue to participate in paediatric scientific discussion among the global regulators at an early stage and during the conduct of clinical trials. This will facilitate the exchanging of emerging information during the studies to minimise the exposure of children to medicines that do not work or are unsafe, and we will aim to maintain a national position of influence, so that the final paediatric development aligns with, and supports, global regulators’ requirements.
I hope that the noble Lord, Lord Patel, has had sufficient reassurance that the amendment is unnecessary and feels able to withdraw Amendment 40.
Lord Patel (CB) [V]
I thank the Minister for his response, as I thank all other noble Lords who have spoken. A small point was raised, with a good, short debate and the right response. I beg leave to withdraw my amendment.
Lord Bethell
Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name inserting new subsection (1A) into Clause 5.
“(1A) Regulations under section 1(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.”Member’s explanatory statement
This amendment, and the other amendment to Clause 5 in the Minister’s name, ensures that regulations under Clause 1(1) may not provide for any offence to be punishable with a sentence of imprisonment of more than two years.
The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)
We now come to the group beginning with Amendment 46, and I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 6: Emergencies
Amendment 46
Baroness Wheeler
Member’s explanatory statement
This amendment removes provision for the disapplication of regulatory provisions in an emergency to be made subject to conditions set out in a protocol published by ministers, which is not subject to parliamentary scrutiny.
Baroness Wheeler (Lab)
I am pleased to move Amendment 46 in the name of my noble friend Lady Thornton, which, alongside other amendments in this group, amends provisions in Clauses 6 and 15 and removes provisions for the disapplication of regulatory provisions in an emergency to be made subject to conditions set out in a protocol published by Ministers.
We understand why the Bill confers emergency powers on the Government to disapply existing health medicine regulations in circumstances which give rise to the need to protect the public from a serious risk to public health. However, we are concerned that the disapplication authorised in the regulations can be subject to conditions specified in the regulations, or conditions set out in a protocol published by the public authority. Furthermore, no formal requirements are set for the form, publication or dissemination of a protocol. It may simply be a document published on a website by the appropriate authority. This is completely inappropriate and unsatisfactory.
The Minister will be very aware that both the Delegated Powers and Regulatory Reform Committee and the Constitution Committee raised concerns about this provision. The Constitution Committee noted that:
“In other bills emergency powers are time-limited and there are often requirements for periodic reviews of their use”,
and yet
“No such constraints or safeguards exist in this Bill. These powers are subject only to the negative resolution procedure and can be adjusted by the amendment of a protocol which is not subject to parliamentary scrutiny”.
As the DPRRC commented at paragraphs 39 and 42:
“On a number of occasions, we have drawn the attention of the House to provision in Bills which enables Ministers to make what are, in effect, legally enforceable rules under the radar of the Parliamentary scrutiny that is afforded to primary and secondary legislation … Allowing regulations to make the disapplication of legislation subject to conditions set out in a ‘protocol’ is yet another example of ‘camouflaging legislation’ … we consider that, where those powers are to be used to provide for legislation to be disapplied in an emergency, any conditions to which disapplication is to be subject should be set out in the regulations themselves and not in a ‘protocol’ which is not subject to Parliamentary scrutiny.”
The Constitution Committee concurred and recommended that
“the use of these powers should be time bound, subject to periodic review and that any conditions on the disapplication of legal provisions should be set out in regulations.”
Although the Government have yet to publish their full response to those reports, as we know, the Minister has tabled, and indeed moved, a number of amendments in Grand Committee which are intended to address the concerns of the DPRRC and the Constitution Committee. This amendment provides an excellent opportunity for the Minister to explain to the Committee exactly why he has not therefore tabled an amendment ensuring that the disapplication of legal provisions is invariably set out in regulations, as recommended. I beg to move.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I am very glad to support my noble friend Lady Wheeler. I will not repeat what she said, because I thought she put across the points very powerfully. She quoted extensively from the Delegated Powers Committee, which complains that no justification whatever has been given for what the Government seek to do.
It is worth saying that the committee has drawn the attention of the House to this kind of mechanism being adopted in a number of Bills over the past few years. I was very struck by the assurance it sought from the Government that they would not continue the practice of what it called “camouflaging legislation” as guidance. In response to the committee’s report on both the Ivory Bill and the Mental Health Units (Use of Force) Bill, the Leader of the House, the noble Baroness, Lady Evans, wrote:
“As you will be aware, it is Government policy that guidance should not be used to circumvent the usual way of regulating a matter. If the policy is to create rules that must be followed, the Government accepts that this should be achieved using regulations subject to parliamentary scrutiny and not guidance”.
Lord Patel (CB) [V]
My Lords, I support these amendments. They touch on the issues and arguments returned to in respect of amendments to Clauses 15 and 42, which set out the procedures to be followed in exercising these powers, as was mentioned by the noble Lord, Lord Hunt of Kings Heath, its unjustified use of negative procedure and this case of protocols. Clauses 6 and 15 provide that the Secretary of State can disapply certain provisions of the medicines and medical devices regulations
“in circumstances which give rise to a need to protect the public from a risk of serious harm to health.”
Such provisions may be within the Human Medicines Regulations 2012, the Medicines for Human Use (Clinical Trials) Regulations 2004, and the Medical Devices Regulations 2002. However, they also may refer to those provisions that are still to be drafted at the current time and are thus unknown and not yet subject to scrutiny.
I recognise that it is necessary to be flexible in the face of an emergency situation as in the current pandemic. However, in its present form this is another example of broad-reaching powers falling outside of that which is reasonable and proportionate. While the disapplication of certain provisions using this power can be exercised to regulations under the affirmative procedure, they may also be passed in certain circumstances by the negative procedure, and, as in these amendments, by protocol. The use of a protocol, in particular, bypasses Parliament, and therefore is unnecessary. I support these amendments.
The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)
The noble Lord, Lord Blunkett, has withdrawn, so I call the noble Baroness, Lady Jolly.
Baroness Jolly (LD) [V]
My Lords, we support these amendments, which relate to the disapplication of regulatory provisions in an emergency. As the Bill stands, the Secretary of State may make regulations about these provisions. This can be subject either to
“conditions set out in the regulations”
or in
“a protocol published by the appropriate authority.”
As the protocol is not subject to parliamentary scrutiny, the amendment in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel, would remove this provision from the Bill so that, as the noble Baroness, Lady Wheeler, said, conditions would have to be set by regulations alone.
Lord Bethell (Con)
My Lords, the lockdown debate later this afternoon brings home the significance of an emergency like Covid. It requires swift, dramatic change to protect public health. Clauses 6 and 15 are essential. They would allow us to make provisions about the disapplication of a medicine or medical devices provision where there is a need to protect the public from a serious risk to health. We would need regulations to do this, because to act in breach of an otherwise applicable provision would be an offence.
Medicines is a highly regulated area. Regulations apply from development of medicines to delivery, right the way down to the pharmacy. It is a complex and overlapping system, designed to protect the end-user, the patient. But there are times when we need to switch off a circuit of the system to respond to an emergency. This is most vividly apparent when we speak of a Covid vaccine. This is end to end, from port arrival, to the logistics of its delivery, to who may administer it. We need to be able to pick this circuit out of the whole and isolate it. Otherwise, to disapply regulation without being highly specific is to disapply regulation not just from the vaccine but from other medicines as well.
This is the point of conditions that go alongside the disapplication. Where we know what the conditions will be, of course it should be in the regulations. But often we cannot know what the specific conditions are. That is where the protocol comes in that the noble Baroness, Lady Thornton, with her Amendments 46, 47, 93 and 94, would like to remove. I acknowledge that the Delegated Powers and Regulatory Reform Committee objected to the use of a protocol. I note that its condemnation was not limited to this Bill but was a broader point about other legislation as well. I hope that I can explain why such a protocol is necessary here.
Protocols are a last resort in any emergency that provides critical flexibility in highly regulated areas. They would be time limited to provide flexibility and administrative detail, tailored to the professional audience that requires it and in language which they are familiar with. A protocol will be used only where it is not be possible to determine all the necessary conditions of disapplication at the pace needed to deal with an urgent threat. The protocol allows for the finer details to be sketched in, while giving Parliament the structure of the regulations to consider. We can debate the principle of disapplying certain provisions of the regulations, without always having the specific names of medicines or vaccines in front of us.
There are existing provisions in the Human Medicines Regulations 2012 that allow for the disapplication of regulatory provisions on how prescription, pharmacy and over-the-counter medicines may lawfully be supplied. These are limited to circumstances in the event or anticipation of a pandemic disease. This formed part of the response to the swine flu pandemic in 2009. Six protocols were issued in relation to specific antivirals for the treatment of swine flu, enabling them to be supplied by authorised staff who would not normally be able to supply prescription-only medicines. This involved separate protocols for different strengths of oseltamivir, a demonstration of just how specific we would expect the protocols to be.
We have made an SI this month introducing provision for the use of protocols in relation to coronavirus and influenza vaccinations. That SI seeks to anticipate the certain flexibilities that might be needed but it is not possible to cover all eventualities. It anticipates the need for rapid supply and the potential mass administration of medicines, since the anticipated vaccine may be delivered by injection.
However, until we are presented with a vaccine, we cannot know how many injections are required, for example. That is a finer point of detail that has implications for the scale of operation required. The SI makes clear that the disapplication of existing regulatory provisions about supply and administration of medicines will be subject to conditions set out in the protocol. These conditions of disapplication will include specifics around the class of persons permitted to administer the vaccines, and the protocol would specify the process by which a person in that class is designated as a person authorised to do so. It will provide for supervision and recording requirements that must be met when the vaccine is administered. These requirements will change depending on the necessities of the specific vaccine. Parliament can debate the regulation, but until we know the detail of that vaccine, we simply cannot establish how this operation will run.
The emergency powers allow us to go broader in terms of disapplications than what is currently available, a reflection of the type of emergency we face. In the illustrative SI published on introduction we have provided some clarity on our intent. It gives an example of what might be needed to ensure the disapplication could be relied upon in response to other circumstances, including a spread of toxins, pathogenic agents, and so on, that give rise to the risk of serious harm to health. This too would operate alongside a protocol.
Amendments 93 and 97 in the name of the noble Baroness, Lady Thornton, relate to emergencies involving medical devices. Provisions already exist in the Medical Devices Regulations 2002. These provisions allow particular devices to be put into service without being subject to CE marking, following a duly justified request if the Secretary of State considers this to be in the interests of the protection of health.
The ventilator challenge allowed us to fulfil the clinical need for ventilators through a combination of CE-marked devices, and devices which were granted an exemption from the requirement. They were required to conform to bespoke technical specifications as a condition of the exemption being granted, and the technical specifications evolved as they needed to. That ensured that the only devices in service without a CE mark were those that met the highest possible standards.
Online publication will also support dissemination to the required audience, to whom it will be targeted, such as operators in the supply chain, enabling conditions to be quickly understood by those who must use them, referring to concepts, processes and so on that they are familiar with from their field.
Protocols are a last-resort power. Where we can anticipate what the conditions of disapplication will be, we will put these into regulations, but I cannot say now how many injections will be required for a Covid vaccine or how many staff will be needed to deliver it. Parliament has our intent, our plans and our proactive preparations now, but not technical specifications—nor do we. I commend the noble Baroness, Lady Thornton, and her team for all they do to hold us to account. It is right that they look at how we can write good legislation, although we need legislation that allows for practicality in a crisis. Therefore, I hope I have provided enough assurances for her to feel able to withdraw her amendment.
The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)
My Lords, I have received a request to speak after the Minister from the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, I say respectfully to my friend the Minister that he is putting up smokescreens. As he mentioned, he already has the power under the 2012 Act to do much of what he wants to do. Furthermore, the arguments used all relate to the Covid emergency. He alluded to this afternoon’s debate and the measures that are about to be taken, but he already has those powers, otherwise he would not be able to do it. We have emergency legislation related to Covid, which includes immunisation through vaccines. By the way, how many doses would be required? It is not necessary to have that in legislation: it is a clinical decision based on the effectiveness of a vaccine. I do not require legislation to tell me how many tablets I should prescribe to my patients for any disease, so I fear that these are smokescreens. He already has powers of disapplication in an emergency, and I continue to support the amendment.
Lord Bethell (Con)
I welcome the challenge from the noble Lord, but the examples we have given are also more recent, from the 2009 swine flu attack. The protocols were also used in the Salisbury Novichok attack. I know from my own experience that public health disasters can throw up extremely unexpected hurdles and barriers to action, in the form of legislative surprises. Therefore, these powers are not considered to be frequently used. In fact, they are never used—noble Lords will all breathe a sigh of relief—but public health challenges are likely to be a feature of the future, and it is prudent to put in place the protections we need in order to provide for them.
Baroness Wheeler (Lab)
I thank noble Lords for their contributions in supporting the amendment—the noble Lord, Lord Hunt, reinforced by the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly. I was particularly interested to hear the quote from the Leader of the House on this matter, and I am glad that that has now gone on record. I certainly echo the comments by the noble Lord, Lord Patel, about what he calls smokescreens, and his underlining of the powers the Government already have for dealing with such situations.
I thank the Minister for the very detailed explanation he offered on this issue, and for telling us why the Government feel that they do not need to address the DPRR Committee’s concern and table amendments. He also talked about protocols being a last resort, and I was grateful for that—and also for the fact that they would be time limited. I note those two things. This is a complex issue, not least for me. I need to look carefully at the Minister’s response, and, if necessary, come back to this issue on Report. I beg leave to withdraw the amendment.
Lord Bethell
“Disclosure of information in accordance with international agreements
(1) This section applies to information which a relevant authority holds in connection with human medicines.(2) The relevant authority may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicines. (3) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority—(a) considers that it is necessary to do so for the purpose mentioned in that subsection, and(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.(4) Except as provided by subsection (5), the disclosure of information in accordance with this section does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed).(5) Nothing in this section authorises a disclosure of information which—(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.(6) In this section—“commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;“relevant authority” means—(a) the Secretary of State, or(b) the Department of Health in Northern Ireland;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018.”Member’s explanatory statement
This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.
The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)
That concludes the work of the Committee this afternoon. I remind Members to sanitise their desks and chairs before leaving the Room.
Medicines and Medical Devices Bill
Wednesday 11th November 2020
(4 years ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-V Fifth marshalled list for Grand Committee - (6 Nov 2020)
The Deputy Chairman of Committees (Lord Bates) (Con)
A participants’ list for today’s proceedings has been published by the Government Whips’ Office, as have lists of Members who have put their names to the amendments or expressed an interest in speaking on each group. I will call Members to speak in the order that they are listed. Members are not permitted to intervene spontaneously; the Chair calls each speaker. Interventions during speeches or “before the noble Lord sits down” are not permitted.
During the debate on each group I will invite Members, including Members in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will invite the Minister to respond each time. The groupings are binding and it will not be possible to degroup an amendment for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate. Leave should be given to withdraw amendments.
When putting the Question, I will collect voices in the Grand Committee Room only. I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an amendment is negatived and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group.
Amendment 49
Baroness Thornton
“Extending prescribing rights
The Secretary of State must, within three months of this Act being passed, lay before each House of Parliament proposals and a timetable for extending prescribing rights to additional healthcare professionals under section 2(1)(n).”Member’s explanatory statement
This new Clause requires the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights.
Baroness Thornton (Lab)
My Lords, I said at Second Reading that we on these Benches are supportive of the extension of prescribing rights to additional health- care professionals, including radiographers, dietitians, orthoptists and speech and language therapists. It is time that this issue was resolved and that is our intention in tabling this amendment. The new clause would require the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights. I thank my noble friends Lord Bradley and Lord Hunt, and the noble Lord, Lord Ramsbotham, for their support and I look forward to hearing their remarks.
The background to this issue is that, in February 2020, in response to a Parliamentary Question tabled by my honourable friend Geraint Davies MP, the Government said:
“Subject to Parliamentary approval, the Medicines and Medical Devices Bill currently before Parliament will give the Government powers to extend prescribing responsibilities to new professional groups where it is safe and appropriate to do so.”
We support that extension and our proposed amendment to the Bill will expedite that, resulting in better outcomes for patients and the system as we face a surge in demand on health services both now and in the future due to the Covid-19 pandemic.
The extension will build on the groundwork already undertaken by the NHS England scoping exercise over the past few years on extending prescribing rights to members and professionals. Extending prescribing rights would help to deliver better support and more timely care for patients. It would improve patient safety, as allied health professionals with appropriate expertise would be able to make decisions rather than relying on junior clinicians signing off clinical management plans. It would decrease the number of patient group directions needed, thus reducing the time spent on development, use and training, and it would bring prescribing expertise closer to the patient. It would reduce the pressure on other stretched professionals, including GPs, and it would improve system efficiency by reducing the duplication of work among health professionals, with a potential result of significant time and resource savings. The extension of prescribing rights to these professionals and others would make a significant and positive difference to those professionals and to the ability of the wider health system to respond as swiftly and efficiently as possible to the post-Covid-19 surge in demand on health services, including the rehabilitation and recovery of post-Covid-19 patients.
It is important to recognise the impact of Covid-19 and how it has emphasised the urgency of taking action. When we discussed these issues before the Bill came before the House, representatives expressed their frustration at how long it seemed to be taking to get approvals to work their way through the system. Given that we have managed to shortcut various systems because it has been necessary to do so with Covid-19, it seems that this is one that presents itself and needs a positive response. It will benefit the NHS, patients and expert health groups. I beg to move.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I support my noble friend’s amendment and the potential for increasing prescribing responsibilities. The noble Baroness, Lady Cumberlege, was a huge champion of prescribing rights for nurses. I was able to extend that to community pharmacists and I want to see us now build on that by extending it to other professions in healthcare. Dietitians, occupational health therapists, orthoptists, radiographers and speech and language therapists all have a hugely important role to play and giving them prescribing responsibilities would help to deliver safer, better and timelier patient care.
We have seen already how dietitians have hugely expanded their role in the treatment of diabetes, gastroenterology, bariatrics, metabolic conditions and oncology. Orthoptics has seen its roles expand in stroke management and neuro-rehabilitation and neuro-ophthalmology, in particular among children with SEN and for paediatric ophthalmology. Diagnostic radiographers are increasingly performing routine interventional procedures under imaging control, while speech and language therapist roles have developed in respiratory care, ear, nose and throat services, critical care and end-of-life care. Occupational therapists have increased their advanced practitioner roles and are demonstrating a hugely beneficial impact across all areas of the NHS.
There is a problem. It has been reported that the current ability of these professions to administer medicines to support patients through patient group directions and/or patient-specific directions is apparently becoming increasingly difficult. They are either taking longer to secure or they are being more restrictive, to the detriment of patient care and safety. I ask the Minister why this is. I refer to his interesting comment on Second Reading, when he said:
“NHS England and NHS Improvement are considering across all non-medical groups, influenced by learning from the Covid-19 pandemic, where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities for several professional groups.”—[Official Report, 2/9/20; col. 432.]
This is very welcome—and, of course, implied in that statement is a recognition that during the past six months we have had to rely on professional and other staff adding to their responsibilities and going beyond the extra mile. By extending prescribing rights, we would be recognising that fact and recognising that many of our professionals can do more, if they are given the ability to do it.
Provided that this happens within safe bounds—and so far, prescribing for non-medics seems to have worked very successfully—we have a total win-win situation, in which patients will benefit and the professional development and satisfaction of many of our staff groups will increase. I believe that my noble friend’s intention is to give the Minister all support for charging on with the extension of prescribing rights, and I hope that she will embrace that support and get a move on.
Lord Ramsbotham (CB) [V]
My Lords, I must declare two interests in explaining why I have put my name to the amendment—first, as co-chair of the All-Party Parliamentary Group on Speech and Language Difficulties, and secondly, as an honorary fellow of the Royal College of Speech and Language Therapists. As always, it is a great pleasure to follow the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, both of whom know a great deal more about this subject than I do.
As I reported on Second Reading, on 12 August the Minister in the other place wrote that the Bill would allow the Government to update those professional organisations that can prescribe medicines when it was safe and appropriate to do so. This is in line with what the Minister said on Second Reading, which was quoted by the noble Lord, Lord Hunt. If the experience of dieticians, orthoptists, diagnostic radiographers and speech and language therapists is anything to go by, the role of such people has expanded considerably during the pandemic, during which there has been ever-increasing pressure on health professionals.
Prescribing responsibilities would enable allied professions to share the burden with their NHS colleagues and avoid unnecessary delay and duplication for patients. Their call for increased prescribing responsibilities is backed up by hard-pressed NHS trusts, which have identified a means of increasing their capacity. Therefore I hope that, on the basis of experience during the pandemic, the Minister will be able to announce proposals and a timetable for extending prescribing rights for certain carefully chosen health professional organisations within three months of the Bill being passed, as part of the NHS long-term improvement plan.
Lord Bradley (Lab) [V]
My Lords, I am pleased to support this timely amendment, which, as we have heard, would introduce a new clause to the Bill to extend prescribing rights to additional healthcare professionals. It is a consequence of the debate on Second Reading, which clearly laid out the benefits of extending prescribing rights to such allied health professionals as dieticians, orthoptists, diagnostic radiographers and speech and language therapists. I will not repeat all the advantages this would bring, because that argument has already been well made, both on Second Reading and in the speeches we have already heard this afternoon. In summary, I believe that it would help to deliver better support and more timely care for patients, reduce pressure on other health professionals, increase system efficiency and maximise the ability to respond to the Covid-19 pandemic, both now and in the predicted post-pandemic surge in the pressure on services.
Lord Balfe (Con)
It is a great pleasure to follow the four noble Lords who tabled this amendment, all of whom are working from exactly the same brief as I am—I can tell that from the quotes. First, I should declare an interest: I have not been present in Committee before, but am here as a former president of the British Dietetic Association, a TUC-affiliated union. The Bill was published during the dying days of my presidency and I undertook to speak in support of the proposed new clause.
I have nothing substantial to add to what has been already been so ably said by colleagues. I will just point out that dieticians are one of the groups seeking to extend this, and people often misunderstand what dieticians are for. The number of times I have been asked whether I am associated with Weight Watchers has rather driven me insane, but dieticians are actually more involved with undernutrition than overnutrition. Although people think of obesity and what are now the more popular things, the biggest challenge facing the average dietician is a person probably over 80 years old, almost certainly living alone and generally not caring for themselves. So the role of a dietician is often to get people to eat a balanced diet. They work in hospitals and in the community, and with other health professionals, particularly in developing clinical management plans. That effort would be reduced if this proposed clause were accepted.
Points about dieticians and others have been extensively made. I understand that
“within three months of this Act being passed”
is a big ask, but also that, unless we ask for something, we will probably not get anything at all. The noble Lord, Lord Bradley, has already quoted the Minister at Second Reading saying that they were
“considering across all non-medical groups … where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities”.—[Official Report, 2/9/20; col. 432.]
I realise that, at the time of Covid, there is a huge number of demands on the Minister’s department and the staff therein but, overall, if this can be made to work, it will benefit and increase the productivity of health professionals. So, in associating myself with the previous speeches, I also encourage the Minister to give as positive a response as he is able to. I am sure that, if we extend prescribing rights, we will be benefiting many patients and the medical profession. We will also be enabling many health workers to play a more effective role in the care of their patients.
Baroness Jolly (LD) [V]
My Lords, I support Amendment 49 in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath, Lord Ramsbotham and Lord Bradley. It mandates the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights. As other noble Lords have said, for well over 20 years, some appropriately trained nurses have been prescribing from a restricted list. I see no reason why, as the noble Baroness, Lady Thornton, described, appropriately trained allied health professionals and others, working from a list of approved medicines commensurate with their profession, should not do the same.
This is entirely appropriate at the moment, when it is not always easy to access a GP. We have seen how successful giving prescribing rights to both community and practice nurses has proven to be. Patients are becoming more willing to have appointments with AHPs and nurses, rather than GPs, which frees doctors to concentrate on patients requiring more experience, such as those with unusual or complex conditions. This is a win-win amendment and I heartily commend it.
Baroness Penn (Con)
My Lords, I recognise that there is keen interest in how we may use powers in Clause 2(1)(n) of the Bill, relying on Clause 1(1), to continue to update the prescribing and supply responsibilities of healthcare professionals. However, I hope to persuade noble Lords that Amendment 49, in the name of the noble Baroness, Lady Thornton, is unnecessary.
I am very pleased to say to noble Lords that NHS England and NHS Improvement are already leading work to scope the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals. On 15 October, they started consulting on a range of proposals to extend medicines administration and supply responsibilities, and to update the medicines that some existing independent prescribers may prescribe.
The consultations cover the use of patient group directions by biomedical and clinical scientists and operating department practitioners, exemptions enabling dental therapists and hygienists to supply some medicines, and changes to the controlled drugs that can be prescribed by physiotherapists, podiatrists and paramedic independent prescribers. If progressed, these proposals would allow patients to get timely and safe access to medicines from the most appropriate healthcare professionals, without the need for extra appointments from other prescribers, such as a GP. The current consultation will run until 10 December and is of course a public consultation. It will be informed by the views of key patient and professional groups, with engagement starting shortly through a series of online events.
I reassure noble Lords that we are committed to updating the prescribing and supply responsibilities of professional groups, where it is safe and appropriate to do so. In keeping with the rest of the Bill, any such changes will be made in a way that serves the best interests of patients. The powers allow us to ensure that professional responsibilities can be updated to reflect developments in professional practice, new approaches to care, changing scientific understanding and growing technical abilities. This ensures that we can continue to make full use of the skills available to us among NHS professionals, and support patients to receive the best possible care and support from NHS staff.
I know that a number of NHS professional groups are keen to see their members taking on responsibility for supplying or prescribing medicines. We have recently seen papers put forward by the British Dietetic Association, the Royal College of Occupational Therapists, the British and Irish Orthoptic Society, the Society of Radiographers and the Royal College of Speech and Language Therapists. I am very grateful to the professional groups for the careful consideration that they have given to these issues.
I reassure noble Lords that NHSE/I already has extensive joint working and engagement under way with these and other professional groups to consider whether any other changes would help keep patients safe and well. This will build on the historic work with various professional bodies and the devolved Administrations, over the last few years, which resulted in a number of changes, including allowing paramedics and therapeutic radiographers to be independent prescribers. As well as this, a wider scoping project is being led by NHS England and NHS Improvement, with the devolved Administrations and professional bodies, on the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals.
I also reassure the noble Baroness, Lady Thornton, the noble Lord, Lord Hunt, and other noble Lords who raised this that NHS England and NHS Improvement’s work on prescribing and supply will of course account for lessons learned from the Covid-19 response. For instance, NHSE/I wishes to learn from professional bodies and, in its scoping work, is asking them how the use of medicines mechanisms contributed and how they can play a role in increasing capacity to respond to future challenges. On that basis, I hope that the noble Baroness, Lady Thornton, feels able to withdraw her amendment.
The Deputy Chairman of Committees (Lord Bates) (Con)
I have received no requests to speak after—
The Deputy Chairman of Committees (Lord Bates) (Con)
Oh, right. I have received one request to speak after the Minister. I call the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
I am sorry; it was possibly delayed. It was really just to ask the noble Baroness: when is the earliest she thinks there will be change? Are we looking at three months, six months or a year?
Baroness Penn (Con)
I might need to pick this up with the noble Baroness in writing afterwards. The consultation will close in December and, obviously, work has to be done after that—but it is probably safest to write, if that is okay.
Baroness Thornton (Lab)
If these were normal times, I would have just popped up and asked that question.
I thank my colleagues—my noble friends Lord Hunt and Lord Bradley. My noble friend Lord Bradley is one of my roommates here. I have not seen him since March and I am missing him very much. So it is very nice to see him, even on the screen, and he made a very powerful case. I also thank the noble Lord, Lord Ramsbotham, who has enormous expertise in the very important areas of speech and language therapies. I also thank the noble Lord, Lord Balfe, and the noble Baroness, Lady Jolly.
Given the promise that we might actually, at some point, have a date, I beg leave to withdraw the amendment.
Lord Bethell
“(1A) The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote one or more of the following—(a) the health and welfare of animals;(b) the health and safety of the public;(c) the protection of the environment.”Member’s explanatory statement
This amendment provides that the appropriate authority may only make regulations under subsection (1) of Clause 8 if satisfied that they would promote the health or welfare of animals, the health and safety of the public or the protection of the environment.
Lord Bethell
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 8 in considering whether regulations under subsection (1) would promote the health or welfare of animals, the health and safety of the public or the protection of the environment.
Lord Bethell
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name inserting a new subsection after subsection (1) of Clause 8.
“(c) the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to develop or supply veterinary medicines.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 8(2)(c) in the Bill as brought from the House of Commons.
The Deputy Chairman of Committees (Lord Bates) (Con)
We now come to the group consisting of Amendment 62. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 9: Manufacture, marketing, supply and field trials
Amendment 62
Baroness Wheeler
“(1A) The Secretary of State must by regulations make provision about the use of the Cascade.”Member’s explanatory statement
This amendment gives the Secretary of State the responsibility to make provisions regarding the Cascade, a risk-based decision process where veterinarians can dispense different medicines to animals beyond the terms of authorisation.
Baroness Wheeler (Lab)
My Lords, I am pleased to move Amendment 62 in the name of my noble friend Lady Thornton. It amends Clause 9 of the Bill dealing with manufacture, marketing, supply and field trials. This is a probing amendment. It would give the Secretary of State the responsibility to make provisions, in respect of the cascade, risk-based decision-making process, allowing vets to prescribe unauthorised medicines when they are unable to get hold of suitable authorised medicines.
The cascade provision for the medical treatment of animals will be vitally important if there are problems with the supply of veterinary medicines in the event of no deal. The British Veterinary Association has underlined the importance of maintaining the cascade, and of the Veterinary Medicines Directorate reviewing the cascade to consider whether it would be possible to allow greater flexibility on the use of medicinal products licensed elsewhere in the EU and those of other partners within the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicine Products, known as VICH.
I am always struck by how much one learns during the course of working on legislation in the House of Lords, and how much is new that one was previously unaware of but should have been. The cascade system for prescribing unauthorised medicines is a good example for me. It is a vitally important procedure, underpinned by 2019 guidance from the Veterinary Medicines Directorate, whereby vets are permitted to use their clinical judgment where there is no suitable veterinary medicine authorised in the UK for the specific condition in the animal being treated. Cascade gives vets access to a wider range of medicines to treat animals within their care and to prevent unavoidable suffering that could happen were a vet unable to prescribe a suitable alternative.
The cascade goes through the various stages of decision-making in the treatment of animals in descending order of suitability, commencing with the desired outcome of using an available authorised UK veterinary medicine and going through other stages, including the use of clinically suitable alternatives of, for example, human medicines authorised in the UK or in another member state for use in animals. The final provision is for the use of a medicine prescribed by the vet responsible for treating the animal and prepared specially on the occasion of the treatment being required—known as “extemporaneous preparation”. This has to be prepared by a vet or a pharmacist or a person holding an appropriate manufacturer’s authorisation.
In exceptional circumstances, where no suitable veterinary medicine is available either as an authorised product or under the cascade, a vet may treat an animal with a medicine authorised in a country outside the EU via the Special Imports Scheme. Clearly, the guidelines and appropriate primary legislation will need to be amended in the light of our forthcoming exit from the EU—or if there is no deal. So can the Minister tell the Committee what preparations are being made in respect of this very important matter?
Prescribing decisions under the cascade are made on a case-by-case basis. The prescribing vet is personally responsible for the choice of product, is subject to the Royal College of Veterinary Surgeons’ code of professional conduct and must always obtain the owner’s consent for their animal to be treated under the cascade. Accurate record keeping is also required under the guidelines. Supplies of products used under the cascade and associated records can be examined during inspections of vets’ premises by the VMD and the RCVS. Under the last tier of the cascade, extemporaneous preparations —also known as veterinary specials—can legally be prescribed, supplied and used, recognising that they carry a higher risk than authorised medicines.
So this is an important scheme and the maintenance of the veterinary medicines cascade is a vital issue in the medical treatment of animals post Brexit, particularly in the event of no deal, as I said. I look forward to the Minister’s explanation of the action being taken to ensure that the cascade is maintained, continued and, if possible, simplified in line with the BVA’s recommendations. We need assurance that the Government will not use the powers in this Bill to diverge from the cascade after it is passed.
Finally, the BVA has underlined that, if it is to remain as one of the leading agencies in Europe and beyond, the Bill must be used to establish a national authorisation procedure for veterinary medicines, on the same scientific and evidence-based technical requirements as adopted by the EU, firmly rooted in the established standards set for quality, safety and effectiveness. The association has emphasised that, to have an influential voice in global veterinary regulatory affairs, it is vitally important for the UK to seek full membership of the international technical requirements registration body, the VICH, to which I referred earlier. I look forward to the Minister’s response on this vital issue.
Baroness Jolly (LD) [V]
The noble Baroness, Lady Wheeler, has given a really good description of the cascade and the way in which it works. It is a risk- based decision process whereby vets can dispense different medicines to animals beyond the term of authorisation. The BVA supports maintaining the cascade. Can the Minister confirm the arrangements if no suitable UK drugs are available? Can she also confirm that veterinary drugs will be part of trade deals with both the EU and the US?
Baroness Penn (Con)
My Lords, I am grateful to the noble Baroness, Lady Wheeler, for raising the important issue of the prescribing cascade, as put forward in Amendment 62. I recognise the desire to ensure that the use of the cascade continues to be regulated. It is an important tool for veterinary surgeons, as they can access a wider range of medicines to treat animals under their care and avoid unacceptable suffering. However, I reassure the noble Baroness that this amendment is not necessary. The Bill already confers discretionary powers that will allow the appropriate authority to decide, following public consultation, if and how the existing cascade provisions in the Veterinary Medicines Regulations 2013 should be amended.
The existing provisions for the prescribing cascade are well used and well understood by veterinary surgeons who are responsible for their prescribing decisions. The provisions were so well described by the noble Baroness that I shall not repeat them here.
The noble Baroness, Lady Wheeler, is right that the second option under the cascade is the use of human medicine authorisation in the UK or a veterinary medicine authorised in an EU member state. She and the noble Baroness, Lady Jolly, asked what will happen after the end of the transition period. On 1 January, the second option will be extended to encompass the importing of veterinary medicines from any other country, rather than only EU member states. This is being provided for through secondary legislation taken through last year, I believe.
The Veterinary Medicines Regulations 2013 also set out additional conditions that need to be met when a product is prescribed under the cascade for use in food-producing species. These conditions help protect the safety of consumers of produce from treated animals. The conditions state that the pharmacologically active substances contained in the medicines must have a maximum residue limit, an appropriate withdrawal period must be specified, and specified records must be kept. These conditions help protect the safety of consumers of produce from treated animals. We do not plan to significantly diverge from the current prescribing cascade for veterinary medicines.
The new EU regulation 2019/6 on veterinary medicinal products will apply in the EU from January 2022. This regulation introduces changes to the cascade, such as separate cascade structures for food producing and non-food producing animals. It includes provisions on the use of antimicrobial medicines under the cascade. For example, the European Commission may, by means of implementing Acts yet to be adopted by the EU, establish a list of antimicrobials which shall not be used under the cascade and a list of antimicrobials which shall be used, subject to certain conditions for cascade use. If it is in the best interests of the UK, we can make provision corresponding or similar to those in EU regulation under the powers in the Bill.
The UK Government and animal sectors have already shown their commitment to tackling antimicrobial resistance and the sectors have substantially reduced their use of antimicrobials in food-producing species—a 53% reduction in sales between 2014 and 2018. The Government will consult on proposed changes to the VMR, including changes implementing our priorities on antimicrobial resistance.
The amendment that the noble Baroness has proposed would obligate the Secretary of State to make changes to the regulations on the use of the cascade. I hope I have reassured her that the cascade remains of vital importance, and it is right that we have the option to amend the regulations when it is appropriate and necessary, subject to consultation, rather than being obliged to do so.
I will write to the noble Baroness, Lady Jolly, on her question about trade deals.
In the light of that response, I ask the noble Baroness, Lady Wheeler, to withdraw her amendment.
Baroness Wheeler (Lab)
I thank the noble Baroness, Lady Jolly, for her support and the Minister for her response. As I said, I have learned a great deal about this valuable procedure. I am grateful for the Minister’s reassurance on the Government’s continued support for and commitment to the cascade. I will certainly read her comments carefully. I did not hear any reference to the VICH, but if she would write to me on that that would be very helpful. With that, I withdraw the amendment.
Lord Bethell
Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name inserting new subsection (1A) into Clause 10.
“(1A) Regulations under section 8(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.”Member’s explanatory statement
This amendment, and the other amendment to clause 10 in the Minister’s name, ensures that regulations under Clause 8(1) may not provide for any offence to be punishable with a sentence of imprisonment of more than two years.
Lord Bethell
“Disclosure of information in accordance with international agreements
(1) This section applies to information which a relevant authority holds in connection with veterinary medicines.(2) The relevant authority may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of veterinary medicines.(3) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority— (a) considers that it is necessary to do so for the purpose mentioned in that subsection, and(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.(4) Except as provided by subsection (5), the disclosure of information in accordance with this section does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed).(5) Nothing in this section authorises a disclosure of information which—(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.(6) In this section—“commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;“relevant authority” means—(a) the Secretary of State, or(b) the Department of Agriculture, Environment and Rural Affairs in Northern Ireland;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018.”Member’s explanatory statement
This new Clause makes clear that information held by the Secretary of State or the Department of Agriculture, Environment and Rural Affairs in Northern Ireland in connection with veterinary medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.
The Deputy Chairman of Committees (Lord Bates) (Con)
We now come to the group beginning with Amendment 67A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the course of the debate.
Baroness Jolly
“Veterinary devices
(1) Within six months of the day on which this Act is passed the Secretary of State must set up a working group to conduct a review of the regulation of veterinary devices.(2) The review under subjection (1) must make reference to the impact of the current system of regulation on—(a) animal welfare;(b) human safety; and(c) the environment.(3) The working group must consult bodies or individuals who are subject to regulation concerning veterinary devices during the course of the review. (4) The review under subsection (1) must make a recommendation as to whether further regulation should be introduced in light of its findings.(5) The Secretary of State must lay a copy of the review before both Houses of Parliament.”
Baroness Jolly (LD)
My Lords, this Bill is about medicines and medical devices, and also includes veterinary medicines, which I understand the profession welcomes. I support government Amendment 131.
I confess, I wondered whether the veterinary part of the Bill was a bit of an afterthought, as although veterinary medicines are covered, I was somewhat bemused that there was no mention of veterinary devices. Modern vets make much use of veterinary and medical devices. Many pet owners expect their pets to be treated as well as they are by the NHS, and they are ready to pay. Many large animals, particularly stud animals, are of considerable value to their owners, who also expect modern treatment.
With a growing market for veterinary devices there are areas in which the absence of these devices often involves medical devices, but the profession anticipates that the veterinary device market will only increase and specialise. The Committee will appreciate that size is an issue. At present, many vets manage by using human medical devices, but I am sure the Committee will understand that vets treat animals of all sizes, from a hamster to a chihuahua, to a prize bull. I tabled these amendments in anticipation of a vibrant veterinary device market. To use devices designed for a human body weight is not always appropriate.
My amendment calls for the Secretary of State to set up a working group to conduct a review into the regulation of veterinary devices, referencing animal welfare, human safety and the environment, and make appropriate consultations before laying a copy of the review before both Houses. Amendment 67B is also in my name and calls for a review of the impact of the Bill on veterinary medicines.
We are in a transition, and by the end of 2021 or thereabouts there will be a clearer picture about veterinary medicines, a year after leaving the EU. The Secretary of State should consult relevant bodies, such as the BVA, the NFU and animal welfare groups such as the PDSA and the RSPCA, but I think noble Lords should agree that there is a case for veterinary devices in the Bill.
Lord Patel (CB) [V]
My Lords, I am pleased to speak to government Amendment 131, merely to ask a question. The amendment will require reporting, which is positive and is to be welcomed. However, it leaves the matter of who is to be consulted to the discretion of the Secretary of State, because proposed new subsection (2) refers to
“such persons as the Secretary of State considers appropriate”,
while proposed new subsection (3)(a) requires the Secretary of State to take account of
“concerns raised, or proposals for change”,
but only those made by a person in accordance with subsection (2). Those persons are left to the discretion of the Secretary of State. It is not only the people who are consulted who are chosen; the list is produced by the Secretary of State.
To have any substance to it, the proposed new clause ought not to leave it to the whims of the individual Secretary of State to decide who ought to be consulted. There should be some minimal statutory list, or principles that can guide a list in practice, to give transparency and confidence. My question is quite simple: is it likely that the Government will produce a list of who they will consult?
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I put my name down to speak on this group primarily to speak to Amendment 106 in the name of the noble Baroness, Lady Thornton, but I will comment briefly on the excellent Amendment 67A from the noble Baroness, Lady Jolly. It seems to address an obvious lacuna in the Bill and I hope that the addition of veterinary devices would be a really simple procedure that the Government could take on board. I also commend Amendment 67B in the name of the noble Baroness, Lady Jolly, and associate myself with the remarks from the noble Lord, Lord Patel, on the concerns about the apparent weakness of government Amendment 131.
I wanted to speak to Amendment 106 because many of us who have been in different roles in politics over many years are used to receiving cries for help from people who feel as if medical systems have made them more ill, treated them badly and failed to live up to the oath of “first do no harm”. It is very hard for a person in your Lordships’ House or in politics to make a judgment call on what can be done and how people can be helped—on how systematic the issue really is and where this should be going. What we really need is a place where records are kept overall; it does not feel as if that is happening at the moment. The amendment lays down a way to address that. Of course, we have not heard yet from the noble Baroness, Lady Thornton, so I am interpreting what her amendment says.
There is also a broader point here, which we need to address throughout the Bill, and which I have been thinking about in the context of Covid-19. We really have a huge problem of trust, given the concern among significant parts of the public about how systems are working and whether decisions are being made in the right interests. One thing we need to do is to make sure that the whole system is transparent and open, and that records are there and accessible. We know of so many cases—the noble Baroness, Lady Cumberlege, set out some—where there tends to be a particular issue with the way that medicine has treated women.
There is also an issue in that the people who come to us and are able to make a fuss are often those who, in one way or another, have some form of social capital in their education, knowledge and ability to reach out and seek help. If we do not have regular systems of keeping records to see problems arising, it may be the most vulnerable who suffer without really knowing how to speak out and initiate action. I commend Amendment 106 to the Committee and look forward to hearing further discussion on it.
Baroness Wheeler (Lab)
My Lords, our Amendment 106, which I am speaking to on behalf of my noble friend Lady Thornton, is in this group on reporting requirements under the Bill. Specifically, it would add a new clause providing for an annual report to Parliament on medical devices information systems established by NHS Digital under the powers conferred by Clause 16. I am grateful to the noble Baroness, Lady Bennett, for her support for this amendment.
Clause 16(1) gives the Secretary of State the power by regulations to make provision for NHS Digital to establish and operate
“one or more information systems”
for medical devices. Under the Bill, these relate to the safety, performance and
“clinical effectiveness, of medical devices … placed on the market; … the safety of individuals who receive or are treated with a medical device”,
or who have one implanted in them, and
“the improvement of medical device safety and performance through advances in technology”.
The annual report proposed in our amendment would provide for the operation of these information systems to include information on the overall data in relation to
“the number of patients who receive or are treated with a medical device, or into whom a medical device is implanted; … any safety concerns received; and … any regulatory action taken.”
Finally, the amendment would ensure that the Secretary of State provided a copy of the report from the information centre on these related areas to the devolved Administrations in Scotland, Wales and Northern Ireland.
The Government’s own Amendment 131, providing a new clause after Clause 41 on consultation provisions and requirements, limits itself to the provision of a biennial report to Parliament starting:
“As soon as reasonably practicable after”
the Bill has passed on the operation of regulations laid on human medicines, veterinary devices and medical devices. The amendment is part of the Government’s response to the Delegated Powers and Regulatory Reform Committee. It also provides for regulations to be subject to public consultation before they can be made and requires the Secretary of State to include in the biennial report, as part of a consultation process, a summary of the concerns expressed or proposals put forward and, in consulting, to set out how the key issues of safety, availability and attractiveness have been taken into account.
The Minister’s letter to Peers of 13 October, which, as my noble friend Lady Thornton has already pointed out, we did not receive until after the amendments had been laid, underlines the importance of the Government’s amendments in providing a reporting obligation on the Secretary of State which
“will inform Parliament of the outcome of consultations on regulation made under Clauses 1, 8 and 12 during the two-year period under consideration, and provide a look ahead to expected regulatory change in the future”.
While consultation before the preparation of the report and information on the consultation, concerns and proposals are welcome, we do not accept that Amendment 131 fully meets the concerns of the DPRRC. We consider that an annual report to Parliament is essential, given the vital importance of the scrutiny and accountability that Parliament must be able to exercise.
We also consider that the government amendment should make a specific commitment to consultation with the devolved Administrations in Scotland, Wales and Northern Ireland, and not just to the Secretary of State consulting such persons as he/she considers appropriate. We will take up the key issue of consultation with the devolved Administrations in our later amendment and I look forward to the Minister’s response to the question of the noble Lord, Lord Patel, on these areas.
Finally, I strongly support Amendments 67A and 67B from the noble Baroness, Lady Jolly, which call for reviews to be laid before Parliament of the regulation of veterinary devices and the Bill’s impact on veterinary medicines after the Act is passed. The noble Baroness made a pretty convincing case for these amendments. The delegated powers in Part 2 of the Bill to amend the Veterinary Medicines Regulations 2013 are wide-ranging. Close scrutiny of the impact on animal welfare, human safety and the environment, together with full consultation with key stakeholders and recommendations on the need for further regulation, will be crucial. Similarly, the review of the Act’s impact on veterinary medicines, to be published one year after it is passed; on safety in relation to animals, humans and the environment; on availability in the UK; and on the UK’s participation in the development and supply of veterinary medicines would ensure full scrutiny of how the provisions in Clauses 9 and 10 were working in respect of these key issues.
I have two further points. During the Commons Committee on the Bill, we raised the importance of the availability of veterinary medicine services, as well as medicines across the country, and of ensuring that they are available in rural and urban settings. This would ensure that we do not have a two-tier system whereby there is better access to veterinary medicines and services in certain communities. We also called for a full assessment of the capacity of the veterinary industry to meet the regulatory and other requirements set out in the Bill. These are key issues which the review process set out in the amendments of the noble Baroness, Lady Jolly, would address. Can the Minister tell the Committee what work is being undertaken with veterinary sector stake- holders, including the British Veterinary Association and the Royal College of Veterinary Surgeons, on these issues —particularly to ensure that, post Brexit, we have the sustainable, diverse and modernised UK veterinary infrastructure and skilled workforce that we need to ensure a safe environment for humans and animals?
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, Amendment 67A, put forward by the noble Baroness, Lady Jolly, relates to veterinary devices. This is a proposed new clause seeking to ensure that the Secretary of State sets up a working group to review the regulation of veterinary devices within six months of this Act passing.
There is currently no specific legislation for veterinary medical devices. The market is small and manufacturers may choose to market their products for dual use—for humans and animals. The medical devices regulations are intended only for human devices. However, we consider that the regulatory framework is also suitable for ensuring the quality and safety of equipment for veterinary use. The Bill allows us only to amend or supplement the existing veterinary regulations in the manner described in Clauses 9 and 10. Those clauses do not provide authority for regulations to introduce substantial new standalone requirements for veterinary medical devices. If a medical device is packaged with a veterinary medicine, the marketing authorisation application would need to set out relevant information on that device. The device would therefore be assessed together with the veterinary medicine before a marketing authorisation is granted. Therefore, this type of medical device falls under the regulation of veterinary medicines.
The Deputy Chairman of Committees (Lord Bates) (Con)
I have received one request to speak after the Minister. I call the noble Lord, Lord Patel.
Lord Patel (CB) [V]
I merely wish to ask the Minister about the consolidation legislation, to which he referred. Am I to understand that the Minister is saying that the Secretary of State will respond to Parliament, and that the matter will be available for debate?
Lord Bethell (Con)
I will get to back to the noble Lord with the specific answer to that question, if I may.
Baroness Jolly (LD) [V]
My Lords, I shall not detain the Committee for very long. I thank the Minister for his comments. I feel inclined at the moment not to withdraw my amendment, but I would like to read Hansard, consult and decide whether to return with these amendments, or something like them, on Report. I beg leave to withdraw the amendment.
Lord Bethell
“(1A) The Secretary of State may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.” Member’s explanatory statement
This amendment provides that the Secretary of State may only make regulations under subsection (1) of Clause 12 if satisfied that they would promote the health and safety of the public.
Lord Bethell
Member’s explanatory statement
This amendment requires the Secretary of State to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 12 in considering whether regulations under subsection (1) would promote the health and safety of the public.
Lord Bethell
“(c) the likelihood of the United Kingdom being seen as an attractive or favourable place in which to develop or supply medical devices.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 12(2)(c) in the Bill as brought from the House of Commons.
Lord Freyberg
“(3) Within 12 months of this section coming into force, the Secretary of State must initiate a comprehensive technical review of the definition of “medical device” under the Medical Devices Regulations 2002 with a view to addressing the inclusion of artificial intelligence software and algorithms including methodologies for the interpretation of data and associated technical architecture in medical devices.”Member’s explanatory statement
This amendment seeks to improve how the Bill addresses new technologies which have significant potential for harm, aligning with and improving on the EU and US equivalents.
Lord Freyberg (CB)
My Lords, I thank the Minister for the opportunity to speak today about medical devices that make use of data-processing methodologies, algorithms, artificial intelligence and other technical architecture. In moving Amendment 83, I shall speak also to Amendments 112 and 113.
I am a long-standing advocate of the use of patient data to provide better healthcare. Noble Lords can therefore rest assured that I by no means seek to introduce obstacles to the vital research and innovation that I know the Government wish to encourage and facilitate to improve the nation’s health. However, I seek to guarantee patient safety in our increasingly data-driven health service and to ensure that the UK is well placed to become a rule-maker and world leader post Brexit.
Others in this place have spoken eloquently about the need to prioritise consideration of patient safety in the Bill. In particular, I was moved by the expert and passionate speech made by the noble Baroness, Lady Cumberlege, at Second Reading. I hope and anticipate that the noble Baroness, Lady Bennett of Manor Castle, will remind us of the social and environmental consequences we should pay heed to in encouraging innovation in medicines and medical device development, which, I believe, should result in closer consideration of the implications of the growth in digital healthcare for the climate as the Government prepare to host COP 26. However, it was the noble Lord, Lord Patel, who helpfully reminded us of the importance of precision in the definitions and wording we agree in this place, and it is my intention here to do the same.
In speaking to Amendments 112 and 113, I am recommending specific protections in the form of an up-to-date definition of a medical device, because the Bill currently relies on a definition from the Medical Devices Regulations 2002, which were updated to include the term “software” in 2007 and therefore do not safeguard individuals from the potentially harmful effects of the full range of contemporary medical devices. The effect of my amendment would be to update the definition of a “medical device” and bring it in line with regulatory provisions in the EU and the US. The use of technology has advanced significantly since 2007 and I can see no good reason why the UK should be a laggard at this time.
In moving Amendment 83, I recognise that we are always, in some senses, on the cusp of new developments or breakthroughs in science and technology that have the potential to transform healthcare services as well as outcomes for individuals. I can therefore understand the Government’s desire for flexibility in presenting this Bill as they have done. However, I am certain that the Minister will agree that we find ourselves on the cusp where growth in the use of artificial intelligence in healthcare is concerned, not least because the Department of Health and Social Care has invested more than £250 million in establishing an AI lab this year and is preparing to publish the first national health and care data strategy this autumn, which is expected to state that the Government will prioritise the
“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes”.
As such, I very much hope that the Government will, at the very least, support Amendment 83, the effect of which would be to require the Secretary of State to initiate a comprehensive technical review of the definition of a “medical device” under the Medical Devices Regulations 2002 within 12 months of this Bill coming into force, with a view to addressing the inclusion of artificial intelligence, software and algorithms, including methodologies for the interpretation of data and associated technical architecture, in the legal definition of a “medical device”.
Lord Clement-Jones (LD) [V]
My Lords, I want to strongly support the amendments in the name of the noble Lord, Lord Freyberg, and myself, and to commend him on an extraordinarily well-informed speech in support of them. I absolutely support the amendments, in particular Amendment 83, which calls for the comprehensive technical review.
The noble Lord made all the points about dynamic algorithms, deep neural networks, the whole question of self-alteration by algorithm and the absolute need to avoid black-box AI, which chime strongly with everything that I know about artificial intelligence. I welcome, right at the beginning, the Minister’s agreement to meet the noble Lord, Lord Freyberg, and me to discuss these issues further. So I am taking this debate not as the end of the road but as the beginning of a dialogue on these issues.
The big question is: does the Minister really believe that we should be reviewing the definition of “medical device”? Does he believe that it is out of date but is simply reluctant to enshrine it in legislation? All Ministers hate their legislation being tampered with, but I am afraid that I am quite sure that this Bill will suffer some treatment on Report.
Even more important than the definitions is the question of how regulation takes effect on these medical devices, in particular on the new medical devices that incorporate algorithms in this way, and whether the regulation is fit for purpose. Without going into the paper at too great a length, I commend to the Minister the discussion paper from the US Food and Drug Administration, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device. I have searched but I could not find that the MHRA had done anything of an equivalent quality. I will take a few quotes from the document that illustrate that this is exactly the kind of work that our own regulator needs to do.
The document states:
“Artificial intelligence- and machine-learning-based technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day … The traditional paradigm of medical device regulation was not designed for adaptive AI/ML technologies, which have the potential to adapt and optimize device performance in real-time to continuously improve healthcare for patients.”
That is positive, but it also puts on regulators a particular duty to continuously assess and monitor, as the nature of the medical device and the algorithm within it changes.
The paper sensibly goes on to suggest a completely different way of regulating this kind of dynamic algorithm and type of artificial intelligence incorporated in medical devices. It distinguishes between locked—static—algorithms and dynamic algorithms and states:
“In contrast to a locked algorithm, an adaptive algorithm (e.g., a continuous learning algorithm) changes its behavior using a defined learning process. The algorithm adaptation or changes are implemented such that for a given set of inputs, the output may be different before and after the changes are implemented.”
Those are exactly the points that the noble Lord, Lord Freyberg, made.
The FDA, of course, is one of the great regulators globally. In a sense, it carries on regardless of whatever Administration are in place. So it has a very high reputation. I hope that we are heeding the wise words of the FDA and I very much hope that we are taking on board all the suggestions that the FDA has made for better regulation of algorithms. They are different. I hope that the Minister is not being Canute-like in holding back the thought that new technologies need new treatments in regulatory terms and I am looking forward to what he has to say.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, it is a great pleasure to follow two such wonderfully informed and informative speeches and I thank the noble Lords for tabling this amendment. So that the Committee can understand my position in this, I will say that I wrote part of a master’s thesis 20 years ago on artificial intelligence. That of course is an age in terms of these things, but I had cause to engage with the issues of medicine and artificial intelligence just last year when I was asked to take part in a debate on the subject. One of the things that I found was that a lot of the language has not changed. Twenty years ago, AI was almost there and now, while we have a great deal of big data, how much closer we are to actual artificial intelligence is another question. The noble Lord, Lord Clement-Jones, referred to what happened this year with the exam results fiasco, which was very much a cautionary tale about the use of this.
Baroness Jolly (LD) [V]
My Lords, the amendments in this group relate to technologies. Amendment 83, from the noble Lord, Lord Freyberg, to which I have added my name, seeks to improve how the Bill addresses new technologies which have significant potential for harm, and it aligns with and improves on the EU and US equivalents. The critical issue is: what is a medical device? Amendment 113, also from the noble Lord, Lord Freyberg, and my noble friend Lord Clement-Jones, updates the definition of a medical device to bring it in line with the EU and US regulation, acknowledging the progress of technology beyond the Medical Devices Regulations 2002, which, in the world of programming, is very nearly the dark ages. I wonder if noble Lords remember ALGOL, FORTRAN and BASIC.
I support Amendment 83, to which I have added my name, and received a very helpful letter about Amendments 112 and 113 from the noble Lord, Lord Freyberg. I listened very carefully to both him and, of course, my noble friend. I am happy to support their arguments and their amendments.
Baroness Thornton (Lab)
My Lords, the noble Lords, Lord Freyberg and Lord Clement-Jones, have done the Committee a great service today. I was fascinated by the speech from the noble Lord, Lord Freyberg, which set the tone for this discussion. I welcome his main points and his knowledge. He knows that I am a supporter of his work in this area, particularly on the protection of patient data.
It is a constant source of concern that either through carelessness, lack of expertise, unscrupulousness or policy fragmentation, our NHS will not benefit from AI and the use of patient data. I see this amendment as part of that discussion and that effort to decide what happens. The noble Lord, Lord Freyberg, has asked some very pertinent questions about algorithms, how they change and how they develop. Our job, surely, during the course of this Bill, is to find legislation that is ahead of the technology for once, not behind it. I was particularly struck by what the noble Lord, Lord Freyberg, has to say about GOQii and the MHRA, and the definition for medical devices and algorithms. The use of AI and algorithms is not impartial. We know that, particularly given our recent experience with A-levels, which was mentioned by the noble Lord, Lord Clement-Jones.
The Minister has to find a way of ensuring that this Bill reflects the modern situation and does not stop innovation. I really hope that she is not going to say that those of us who are asking these questions are opposed to innovation, because that is absolutely not the case. These are very important questions indeed for the future, as we find ourselves between the FDA and the European Union, and we make our way in this particular world.
Baroness Penn (Con)
My Lords, all the amendments in this group deal with the important matter of forward-thinking regulation—regulation that evolves as technology evolves. I say to the noble Baroness, Lady Thornton, that all the questions raised in this debate are very pertinent and are pro-innovation, not anti-innovation questions, concerned with ensuring that we can regulate this area properly.
As my noble friend the Minister said in previous communication to the noble Lord, Lord Freyberg, artificial intelligence is already in use in medical device technology and is already regulated—for example, Babylon’s mobile application Healthcheck is software that provides a general health assessment to users. That application is registered as class 1 medical device by the MHRA. We are also working on equipping our regulator for these products. The MHRA secured £740,000 from the Regulators’ Pioneer Fund to work with NHS Digital on developing a pilot in order to test and validate algorithms and other AI used in medical devices. There are other works in train to get the benefit of artificial intelligence in the health service. The Artificial Intelligence Award is run by the Accelerated Access Collaborative in partnership with NHSX and the National Institute for Health Research. It is making £140 million available to accelerate the testing and evaluation of the most promising AI technologies that meet the strategic aims set out in the NHS Long Term Plan.
I recognise that the intention of Amendments 83, 112 and 113 is to address the potential to cause harm to patients without appropriate regulation of these technologies. I can reassure noble Lords that software used for the application of medical devices falls within the definition of a medical device under the EU medical device directive, transposed into UK law through the Medical Devices Regulations 2002. Artificial intelligence and algorithms are encompassed within the term “software” where they have a medical purpose, and I can reassure the noble Lord, Lord Freyberg, that this covers static and dynamic algorithms.
In addition, within 12 months of this Bill gaining Royal Assent, we will start to develop new medical device regulations. The development of these regulations will include a full consultation on any changes proposed. I can commit here that the consultation will conclude within 12 months and will include the definition of a medical device, with particular reference to algorithms and methodologies used for the interpretation of data and associated technical architecture used within medical devices. This process will allow members of the public, patients and industry bodies—as well as perhaps noble Lords in this Committee—to help shape the future of regulation in the UK and the terminology that we use to describe what is captured by those regulations.
The amendments are accordingly unnecessary, as the outcome sought will be achieved under the umbrella of the wider-scale review of medical devices regulation in the UK, which will take place during a similar window as that sought by the amendment and will address the specific questions that it raises. So I hope that I have reassured the noble Lord, Lord Freyberg, that the existing definition covering both dynamic and static algorithms is sufficient and, if I have not, that he will take satisfaction from the Government’s commitment that, within 12 months, we will have concluded a consultation—to which I hope the noble Lord will contribute—that will include the definition of a medical device and specific reference to algorithms and methodologies used for interpretation of data.
This is an incredibly important debate. This is an emerging area of technology and, while we are reassured that the current regulations capture what they need to, we also need to look to the future, which is what the consultation can do. I hope that the noble Lord will feel able to withdraw his amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I have received a request to speak after the Minister from the noble Baroness, Lady Thornton. I now call the noble Baroness.
Baroness Thornton (Lab)
I thank the noble Baroness the Minister. This is such an important issue, with the potential for huge benefits and huge harms. I regard it slightly like the sort of issues we dealt with in relation to the Human Fertilisation and Embryology Authority and the Human Tissue Authority—this is very important and runs very deep into our humanity. So the question I need to ask the Minister is: when the consultation is over, will we be looking at primary legislation, because I am not sure that regulation will quite do?
Baroness Penn (Con)
My Lords, the consultation will look at the specific issue of medical device regulation that takes place through secondary legislation. However, the noble Baroness is right in that this is not the only aspect of this issue that we are looking at and working on. There is work across government on a number of areas where this technology comes up, and we have established a number of bodies to help us in our work, such as the Centre for Data Ethics and Innovation. So, although the specific issue about the definition of a medical device and medical device regulations will take place under this Bill—subject to public consultation —there is a broader landscape that we will also address across the board and across government.
Lord Freyberg (CB)
My Lords, I first thank the Minister for her attentiveness during my very long and quite tortuous speech, and for the very detailed responses I have had, back and forth, from the Minister’s officials, which have been exceptionally helpful. They have been doing that over many days and many weeks. I also thank the other noble Lords who supported my amendment: the noble Baronesses, Lady Jolly and Lady Bennett, and the noble Lord, Lord Clement-Jones. It was hugely welcome and I thank them for the contributions that they made.
I was fascinated by the fact that the Minister thought that it was both dynamic and static. That is not what I had understood from the letters, but I would like to look at that again. I will obviously follow her remarks in Hansard quite closely. Perhaps I could have further dialogue with her or the noble Lord, Lord Bethell, about that, because I am not entirely sure that that is how I have interpreted it—so I would like to come back on that, if I may.
Like the noble Baroness, Lady Thornton, I recall what the noble Baroness, Lady Cumberlege, said about the ongoing situation that faces those affected by sodium valproate and mesh. We do not want to be in a situation in years to come of not having something that adequately protects the public, and I worry that we are not getting to the root of this. So, while I am happy that the Minister has offered this review in 12 months’ time, I would like more information about that. In the meantime, I beg leave to withdraw my amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We come now to the group beginning with Amendment 86. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 86
Member’s explanatory statement
This amendment seeks to raise the issue of tracking of medical devices. Coupled with amendments by Baroness Finlay to page 8, line 17 and page 10, line 20, it would allow regulations to provide for the tracking of all devices via a Unique Device Identifier, as they are used, with the information recorded either in registries or through hospital episode statistics data.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I will speak to Amendments 86, 88 and 102, standing in my name, and in support of Amendment 103 in the name of the noble Baroness, Lady Cumberlege.
My purpose in this group is to underscore the critical importance of unique device identifiers in maintaining patient safety. Fundamentally, I ask your Lordships to reflect on the systems we have in this country more broadly, say in retail, for product recall where a safety issue arises. Let us say that a tumble dryer is found to be a fire risk, or a washing machine is liable to flood people’s homes: it is dealt with by a media campaign urging people who have the product, with the relevant model number and bought at the relevant time, to contact their retailer and the manufacturer directly. We may examine, as the Fire Safety Bill presently before the House illustrates, whether this system is adequate for domestic electrical products, but that is for another day.
This afternoon, I hope that we can agree that devices left inside human beings and used in their medical treatment should be subject to a more rigorous and effective product recall system than tumble dryers. Tracking is absolutely essential in order to ensure that, if a product is discovered to be faulty or to have adverse effects of some kind, others who have had that device used in their treatment can be contacted and, if necessary, examined.
What is more, we already have the technology in place to make this a reality. In July this year, Scan4Safety published an evaluation of six pilot sites where a system of scanning and tracking was used. At these Scan4Safety sites, all patients have a unique GS1 barcode on their wristband, which is scanned before a procedure. The system also involves scanning all equipment used for the procedure, including implantable medical devices, and the location in which the procedure takes place. At some trusts, staff have barcodes on their badges that they can scan prior to a procedure. The result is full visibility of what has been done to which patient, when and where. To quote the noble Lord, Lord Prior, who as chair of NHS England wrote a foreword to the report, this system means:
“The time taken to recall products falls to hours from days or weeks, clinical time is freed up—significant as the NHS continues to face workforce challenges—and effective stock management becomes straightforward.”
The system is good both for patient safety—providing complete traceability, speed and accurate recall, alongside reductions in drug errors and those terrible “never events”—and for cost and efficacy. It leads to cost-effective product ordering, more efficient staff with better staff well-being, the creation of accurate patient-level costings, and reductions in unwarranted variation. Across the six trusts, the pilot produced £5 million in recurrent savings and £9 million in non-recurrent ones. Perhaps more importantly, the system is said to have released 140,000 hours of clinical time back to patient care.
The purpose of my amendments is to adduce from the Minister—who I hope will be willing to help—an absolute commitment that the Government see rolling out Scan4Safety as the future of medical device use in this country, and that we will not have devices put inside people without a clear record, including of which surgeon put in the device, when, where and so on. We will come back in the group starting with Amendment 87 and Amendment 95 to talk about registries that track outcomes. They are an absolutely essential part of this picture. However, the bare minimum for registries to function is to have a full and accurate database of what devices have been used in procedures, and on which patients.
Amendment 86 addresses this issue directly by stipulating that the provision about unique device identifiers—barcodes—must be included in regulations on medical devices made under Clause 12 of the Bill and should be part of the thinking when it comes to packaging and labelling. Amendment 102 seeks to strengthen the later Clause 16 by making the regulations about unique device identifiers mandatory.
I will briefly address Amendment 103 on patient consent. The noble Baroness, Lady Cumberlege, and I are broadly aligned on this. Her report recognises the GDPR issues around recording data on patients and storing it in a database. She distinguishes between database, the subject of this group, and the registry, which is more complex and useful, and which we will discuss in a later group. There is an issue as to whether the database we are discussing here is subject to the same level of patient consent as a registry. In a registry, patient outcome data will be recorded, in addition to the simple fact of a device having been used. I will be interested to hear the Minister’s position on that, and I strongly support the idea in Amendment 103 that any distinction should be set out clearly in the regulations under this Bill.
For my own part, I would hope that the consent process and shared decision-making that are used between surgeons, radiologists and so on and their patients in deciding to go ahead with a procedure, could be used both to set out a routine action to make an entry in a database and to participate in more complex registries. We will examine the purpose of registries more thoroughly in subsequent groups. For this group, I hope that the Minister will respond by confirming a shared belief in Scan4Safety and set out a timetable for an equivalent scheme to be rolled out across the NHS. It is an approach which has the strong support of the Royal College of Surgeons and whose broad use around the country is long overdue.
I hope that the Minister will also ensure full consultation with the devolved Administrations to ensure that a system of coding is compatible with all systems across the UK. I beg to move.
Lord Ribeiro (Con) [V]
My Lords, it is a pleasure to follow the noble Baroness, Lady Finlay, who made a powerful case for knowing what happens to medical devices once they have been inserted. This was at the very centre of the Cumberlege review and to which I am sure my noble friend will draw our attention again, as well as to the key findings in this respect. Amendment 86 draws attention to the need for unique device identification information to be added to all packaging of medical devices, while Amendment 88 deals with the tracking of devices once inserted, as Clause 13(1)(h)(ii) requires information relating to the use of medical devices in individual procedures to be tracked and entered in a register or within hospital episode statistics data.
In my speech at Second Reading, I referred to Scan4Safety, which the noble Baroness, Lady Finlay, has just noted. In 2016, the Department for Health and Social Care awarded a total of £12 million to six hospital trusts in England for Scan4Safety demonstrator sites to investigate how the consistent use of point-of-care barcode scanning might improve efficiency and safety within the NHS. The noble Baroness also outlined the benefits of the GS1 barcodes. The result of the GS1 is a comprehensive, real-time view of stock, including that which is about to expire, as well as a complete audit trail. An audit trail is key to identifying problems with devices when they occur and to keep track of them in the future, as it may be many years before complications occur. Total hip replacements are one example. I have two of them, so I have a vested interest in knowing about the long-term future of those prostheses.
In June 2020, Scan4Safety published a report entitled A Scan of the Benefits. It gave two examples that are worthy of note and of repeating. In the North Tees and Hartlepool NHS Foundation Trust hospital orthopaedic department, barcodes helped to ensure that the correct patient is listed for the correct operation on the correct side. All items and implants are scanned before use. If the incorrect prosthesis is selected, for example a right knee implant for a patient who is supposed to be having an operation on the left knee, the barcode scanner buzzes and flashes, immediately notifying the potential error. At Leeds Teaching Hospitals NHS Trust, following the introduction of Scan4Safety, the average time taken to recall a product has fallen from 8.33 days to less than 35 minutes. The organisation reported £84,411-worth of staff efficiency savings on recall between January 2016 to December 2017 alone.
In Clause 16 on information systems, while I welcome the provisions, surely they are worthy of being strengthened by not using “may” so often. We need to move away from “may”, and its implied “perhaps”, to “must” and the implication that it will actually happen.
I shall end by restating my comments at Second Reading. The Government must undertake to mandate the tracking of all medical devices that are used in the UK, rather than a select few. I hope that these amendments will provide a means to do so. The Cumberlege review rightly recommended that a central patient identifiable database should be created, collecting key details of the implantation of all devices at the time of the operation. In the light of this, we strongly urge the Government to apply the powers provided for in Clause 16 as well and as widely as possible.
To give assurances in the context of this amendment, the Royal College of Surgeons believes that the Government should publish their intended regulations under Clause 16 in draft before Report, as they have for the various regulations on medicines. Early sight of the regulations would establish whether the Government intend to apply the powers covered by Clause 16 widely enough to satisfy the recommendations of the Royal College of Surgeons and those of the Cumberlege review.
In closing, perhaps the Minister would update us on the future of the medical devices information system and its application to the private sector.
Baroness Cumberlege (Con) [V]
My Lords, I very much appreciate the support that I have already received today from the noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro. I am going to go into a bit of detail on what we found during the review, but I want to say to both noble Lords that I strongly support their views on Scan4Safety. Indeed, I spent a day in Derby going through the whole process with the clinicians, support staff and policymakers, and it was very impressive.
The noble Baroness, Lady Finlay, is absolutely right to say that we should look at more than just one example. Her research, which she has told us all about today, took on the six different areas, which is excellent. However, I agree with her that we should think seriously about introducing this system across the country.
Baroness Walmsley (LD) [V]
My Lords, I add my voice to those of the noble Baroness, Lady Finlay, and the noble Lord, Lord Ribeiro, on their Amendments 86, 88 and 102, about having unique identifiers for medical devices. In these days of barcodes, this should not be too difficult nor add much, if any, cost for the manufacturers. Indeed, it has been proved to work with medical devices, as the noble Baroness explained.
It is important that products found to be faulty are speedily traced. If my digital radio can be recalled speedily because it might burst into flames, surely a medical device implanted in someone’s body must also be able to be recalled speedily. Recall could also be useful when something better comes along; it could be vital for the future treatment of the patient.
There are occasions when an individual product develops a fault, although the majority of products of that model are perfectly okay. If we are to learn lessons and improve products, as the noble Baroness, Lady Cumberlege, has just pointed out, it would be essential to know where they are and how the receiving patient has reacted to them. A unique identifier could facilitate that, and also provide some protection for the patient concerned, especially in the case of a recall.
I look forward to the Minister’s answers to the questions that the noble Baroness, Lady Cumberlege, asked about patient consent. It is vital that patients have confidence in the system. Confidence in their own privacy is part of that, and patients can have that confidence only if they know what is being shared, and by whom.
Baroness Redfern (Con) [V]
My Lords, I am pleased to speak to this group of amendments, and to thank the noble Baroness, Lady Cumberlege, who has been so diligent in her review in proposing such needed changes, and making good for the recipient and building user confidence in the devices offered. It is a pleasure to follow the noble Baronesses, Lady Finlay and Lady Walmsley, and the noble Lord, Lord Ribeiro—as well, of course, as the noble Baroness, Lady Cumberlege.
I spoke on Second Reading in support of an extensive programme for medical devices, to provide for high standards of safety and to share vital information, with data central to effectiveness. The noble Baroness, Lady Cumberlege, in her review, regarded being able to track which treatments and implants people have had as being of particular importance. A barcoded wristband, with equipment used in treatment, including implantable medical devices, being scanned and tracked to a patient’s record, would save much precious time for product recalls, and reduce drug errors.
This means knowing who has had a device used in their treatment, so that they can be swiftly notified if there is a problem. Having unique device identification is therefore very important. The noble Lord, Lord Ribeiro, said—and I agree—that we must consider tracking all medical devices used in the UK, rather than a select few.
Baroness Jolly (LD) [V]
My Lords, we support the amendments in the names of the noble Baroness, Lady Finlay of Llandaff, and the noble Lord, Lord Ribeiro, and Amendment 103 in the name of the noble Baroness, Lady Cumberlege. Registers are a tool that helps clinicians to track devices and those who have the devices fitted or implanted, and to use the data for research and to aid patients to seek redress.
The noble Baroness, Lady Finlay, explained clearly how the amendment would work to help to change a medical device that no longer functions. By citing the recall mechanism for a faulty domestic product, she illustrated what is required of a device register.
The amendments in this group relate to the tracking of medical devices, and the information stored. Amendments 86, 88 and 102 would allow regulations to provide for the tracking of all devices, as they are used, via a unique device identifier, with the information recorded either in registries or through hospital episode statistics data.
Amendment 103 is an important amendment, tabled by the noble Baroness, Lady Cumberlege, that seeks to clarify which information held by the healthcare system requires the consent of the relevant patient. Data is powerful, and should be kept appropriately. The governance of data has been a key issue in the NHS for more than 20 years.
Baroness Thornton (Lab)
My Lords, I have greatly appreciated this debate, the expertise, and the explanations we have been given as to why the amendments are important. I particularly enjoyed the remarks by the noble Lord, Lord Ribeiro, about his hips: very important they are indeed.
Perhaps we should remind ourselves that Clause 16 was inserted in the Bill during the Commons stages after a cross-party effort involving the Labour Front Bench working with the Government. It provides for a data system to be set up by regulations to assist in tracking devices once they are implanted, so that safety performance and clinical effectiveness can be better monitored. The intention is that in the long term, that would support future device registries, allowing problems to be spotted earlier and patient harm to be prevented.
The amendments would tighten up that clause. The amendments tabled by the noble Baroness, Lady Finlay, are concerned with the operation of the tracker, using the devices’ unique identification. Currently, Clause 16 provides that unique device identifiers “may” be recorded as part of the data system. Quite rightly, the amendment would change that “may” to a “must”. So much of our work revolves around changing “may” to “must”.
Amendments 86 and 88 would amend Clause 13. Amendment 86 would require that UDIs should be considered as part of the packaging information on medical devices, and Amendment 88 would require that tracking devices used in individual procedures should be part of the Government’s consideration when regulating device registries. These amendments raise questions about the detail of device tracking. How will the unique identifiers be recorded and used? Those questions were raised by both the noble Baronesses, Lady Finlay and Lady Cumberlege. Will it be mandatory to record the unique device identifier in every procedure, and feed that into the data system? How can we ensure that that data is secure, and that it is recorded in the appropriate place? The Minister has those questions to answer at the end of the debate.
The noble Baroness, Lady Cumberlege, rightly addressed the issue of patient consent. She also underlined the fact that there is an opportunity in the Bill to get the law and the framework right. Amendment 103 would add to Clause 16 a requirement that the regulations must specify what information held by a data system is subject to a patient’s consent. The intention is that data held under the system should be used and shared to identify trends and trigger regulatory and clinical action where it is needed.
In her report, the noble Baroness cites the difference between a database and a registry. She is right to do so. The amendments explore the importance of the registry and the database, and the importance of patient consent —and whether we return to the subject at a later stage will depend on what the Minister now has to say.
Lord Bethell (Con)
My Lords, I am enormously grateful for that really important discussion of these critical amendments and provisions. I will take a moment to run through them in some detail. Device safety is absolutely critical to patient safety, and that is why the Government amended the Bill to include Clause 16. I pay tribute to my noble friend Lady Cumberlege, whose team helped inspire that amendment, and to the noble Baroness, Lady Finlay, who has participated in discussions on this clause. We have the benefit of her insight now.
Amendment 86 in the name of the noble Baroness, Lady Finlay, would add the unique device identifier number to the provisions in Clause 13(1)(g). These provisions currently allow the Secretary of State to make regulations about package labelling, provision of information and instructions for medical devices. UDIs would be one of the matters included within regulations made in reliance on Clause 13(1)(g), as drafted. It is therefore our belief that the amendment is not necessary.
The noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro made important and fascinating remarks on Scan4Safety. I will limit my comments, which could be extensive, to the importance and value of that scheme. We are extremely supportive of the principle of fast and accurate traceability. Scan4Safety is not the only scheme of its kind, but it is a particularly good one. It is the hope that any UDI created by these regulations will empower these valuable services. We have a session on medical device information systems coming up in the diary, when I hope very much that we can discuss how that might work. If the concern of the noble Baroness is whether we intend to make provision to require manufacturers to provide a UDI, I reassure her that that would be a condition for being placed in the UK market.
Amendment 88 to Clause 13, as the noble Baroness, Lady Finlay, has indicated, is intended to support the tracking of devices used in medical procedures by recording the UDI in a register provided for in Clause 13 or within hospital episode statistics. I completely acknowledge the noble Baroness’s intent, but there is a difference between a register at Clause 13 and a database at Clause 16, or a registry. Clause 13 provides for a register or a number of registers. The register or registers we intend to create under Clause 13 will be a list of medical devices for sale on the UK market, held by the MHRA. It will not include the individual product identifier part of the UDIs and it will not contain data or monitoring information related to individual devices. The register forms part of wider market surveillance and vigilance activity. Regulations will be able to make provision requiring information to be entered into a register, such as the unique device identifier, which all manufacturers will be required to put on their devices. Amendment 88 is therefore unnecessary.
While the registers will enable some device identification to track individual devices, it is the information system, created under regulations made under Clause 16, which will ensure that devices and procedures are tracked in the event of a concern being identified, through which patients can be contacted and appropriate action taken in each case. The use of MDIS, which I will come on to, could prompt the MHRA to use the information in the register established under Clause 13 to identify the manufacturer and take action.
Amendment 102 would add information to be recorded in any information systems established under Clause 16. All the information set out in Amendment 102 can already be required under regulations made under Clause 16, but the regulations do not have to set out all those matters and can set out other descriptions of information.
A UDI may not always be available, such as for a custom-made device, so it may not always be possible for the providers to capture this. Amendment 102 would also require the recording of every procedure that related to a medical device. I have spoken before about the number of different medical devices on the market and that they vary greatly in risk profile. It would not be necessary or cost-effective to record every procedure related to a medical device, but they could be recorded in one of the registers provided for by regulations under Clause 12, as being on the UK market.
Amendment 103 in the name of my noble friend Lady Cumberlege deals with the important issue of patient consent. It would introduce an obligation that regulations made under Clause 16 would require the Secretary of State to set out the categories or types of information that are subject to patient consent that are held by the Health and Social Care Information Centre, otherwise known as NHS Digital, or by other persons.
My noble friend has raised this with me and with officials, and she is a tireless champion of patients. I am moved and affected by the accounts she has heard. As the testimony in her review shows, the absence of data in the healthcare system is absolutely medieval, and it is exactly the purpose of the Bill to fix that. Before any data can be collected relying on the provisions at Clause 16, regulations must be made. Those regulations are subject to consultation, as at Clause 41. It is absolutely right that the system is informed by patient views, and that the process is one where it is easy to engage, to understand what we want to do and to build consensus that it is the right thing.
My noble friend Lady Cumberlege has views on what data should be subject to opt-out versus opt-in. Privacy is a higher-order value that we should protect. The question of patient consent is really important. The noble Baroness, Lady Finlay, campaigned on the importance of opt-out organ donation and I congratulate her on her contribution to the recent change to organ donation privacy protocols, which are widely supported by the public and will save thousands of lives. She knows as well as I do that choosing to opt into measures is not as comprehensive as choosing to opt out. It is important to have enough data to draw conclusions.
Consent will not be required to input information about the surgical procedure and the UDI of the implanted device, linked to the patient, into the information system. The medical device information system is about protecting all patients who have had similar procedures, not just a particular patient. The detail of the specific device inserted, the procedure information and, if necessary, the effect that device has caused is what will be necessary for the information system to work. If there is no adverse report made by the clinician on behalf of that patient, that data acts as a control sample. It allows for other patients’ reports, where there have also been adverse reactions, to be understood as part of a wider data picture.
In her report, my noble friend raised the recommendation that detailed data should require consent in order that the data collected is necessary and proportionate. I reassure her that all data collected for the system will be necessary and proportionate. Data held by clinicians should be shared only under those circumstances, and data shared by the information system with, for example, a clinical registry for clinical assessment of whether there is an issue, should be only that which is necessary.
The intention is, that in the event there is a reported adverse reaction with a device, the medical device information system would send a report to a clinical registry. That report, suitably anonymised and stripped of patient-identifiable information but including the device UDI, would have the detail of all procedures, not just those involving adverse reactions, to further anonymise the incident. A clinical assessment would be conducted and, if it is concluded that the device is the issue, only relevant and necessary information would be sent to the MHRA to conduct its own tests.
This is a very important paragraph and one that I will emphasise. We do not need patient-identifiable information to determine whether compliance or enforcement action needs to be taken, but device information. There are routes to identifying that there are issues with adverse reactions when a clinical registry is not present, such as manufacturers’ reports or Yellow Card reports.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I have received a request to speak after the Minister from the noble Baroness, Lady Thornton, on whom I now call.
Baroness Thornton (Lab)
Can the Minister run it by me again how this will protect patients? I heard a lot being said about physicians and their reporting. I am not sure that I understand how this will avoid the problems with valproate and all the other situations with mesh unless “must” is used rather than “may”.
Lord Bethell (Con)
I can give a couple of illustrative examples if that would be helpful, but to run through the whole philosophy and system is probably beyond my ability or the time afforded by this Committee. In essence, the challenge identified by my noble friend Lady Cumberlege is that individual reports of adverse signals are not easily connected, unless those reports are somehow sent to a central registry and analysed by the kinds of experts who can spot mistakes and the connections made between those signals. This is how any problem identification system works. To do that process, you do not have to share personal details. You do not need the telephone numbers or personal identities of those concerned, but you need the clinical details and the full context in which signals have occurred. This pattern identification is often missing in the instances on which my noble friend reported. Having this information system, and analysis connected to it, will enable us to spot problems at a much earlier stage. Necessary interventions based on analysis and understanding will be much prompter and the connections made much more emphatic.
Baroness Finlay of Llandaff (CB)[V]
I am incredibly grateful to all noble Lords who have spoken in this debate. It has been very important and illuminating. We will all need to read the Minister’s words with care because there was an awful lot in them. I am most grateful to the noble Lord, Lord Ribeiro, for asking about the private sector, because if procedures are done in the private sector for patients who pay for themselves and those procedures are outsourced more and more, it will be important to make sure that this safety data is collected.
I am surprised that the word “must” is not being picked up. A supermarket will know how many tubs of mayonnaise it has ordered and which factory they came from. If there is glass in jam, a supermarket can track it back to the factory where the glass was. If we do not have complete data collection systems, we will find that all the places that are functioning above average will do really well. They will collect the data properly, and so on. But 50% of places are below the average line—that is the nature of an average. All patients need to be protected and standards need to be driven up. I was grateful to the noble Baronesses, Lady Walmsley, Lady Redfern and Lady Jolly, for elaborating on aspects of points that I have made, and particularly grateful to the noble Baroness, Lady Thornton, for giving us the history of the amendment and asking again how this would work in practice.
Consent is critical. Patients going into a hospital expect all the equipment to be safe and to be known about. They expect the fire alarms to work and that the oxygen pipes to anaesthetic machines are correctly positioned and known about, and that full servicing data is available. It is important. Here I should declare that I was a very junior doctor in a hospital, but on the periphery, when an anaesthetic accident happened many years ago. It was critical that things could be traced back urgently. Unfortunately, there are tragedies, even when it is possible to do that.
We need to be able to look right across the whole system. There is the safety aspect—the tracking and quality control—that goes along with all the routine procedures. If something faulty is used in 15 hospitals around the country, that needs to be known rapidly and safely. I, too, worry about relying on clinicians to report if there is a problem, and I rather felt that the Minister’s answer underlined the call for a distinct commissioner for safety. The noble Baroness, Lady Cumberlege, has been calling for that because we need somebody who can interrogate and analyse the data, and look at it carefully. She explained consent for patient details extremely well. The Montgomery test of consent is that you should be given the information that other reasonable people would expect. It is almost the Clapham omnibus test of what patients should be told.
This is not about what the clinicians want or do not want to tell patients. They might feel it unnecessary to tell them something, but most patients would want to know about it and therefore it should be disclosed to patients. A doctor might say, “This can happen, but it has never happened to me”, but they still have a duty to disclose. Linked to that consent, I would like us to have routine processes in clinical practice for consent data to be entered into a registry. Patients could opt out and say that they did not want it to be entered, so that box would not be ticked; their scanned-in data would then not be sent on with the additional information.
This debate has been incredibly important. It gets right to the nub of patient safety. I hope that the Minister will meet me and the noble Baroness, Lady Cumberlege. I have to say to the Committee that I am pretty convinced that we will return to this on Report because there is a lot more to do. However, we have another group of amendments to move on to, and that debate will be interesting and informative, so I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 91A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. I call the noble Baroness, Lady Finlay of Llandaff.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I beg the indulgence of the Committee for just a moment because I have a horrible feeling that I have lost my place. I had thought that we were moving to Amendment 95. Perhaps the chair would be kind enough to set me right on that.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I propose that we adjourn for five minutes.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, the Committee will now resume and I call again on the noble Baroness, Lady Finlay, to move her Amendment 91A.
Amendment 91A
“Innovative Medical Devices Fund
In section 261 of the National Health Service Act 2006, after subsection (9) insert—“(9A) The Secretary of State must make a scheme to promote the availability of innovative medical devices for human use within the National Health Service and must provide monies paid to the Secretary of State under subsection (9) for the benefit of that scheme to be known as the “Innovative Medical Devices Fund”.”
Baroness Finlay of Llandaff (CB) [V]
My Lords, I am most grateful for the kindness of all your Lordships. Lacking having all those wonderful papers in front of me really showed. It is the first time that I have missed walking into the Chamber with a large stack of papers.
Amendment 91A builds on the concept that we had in the previous debates of an innovative medicines fund, which had been carefully thought through, including how it was to be financed. It struck me then that we have fantastic potential in medical engineering in this country to develop new and innovative medical devices. I should declare an interest because my son is involved in developing devices for use in cardiology, for oblation procedures and so on.
The real issue, as the Minister pointed out in the previous debate, is about developing a piece of equipment which is a custom-made device, for one reason or another. When that happens it can turn out to be, serendipitously, something that solves a problem for clinicians in undertaking a procedure of some sort. However, when that happens, if it is a small clinical team in a district general hospital, it will not be linked into a commercial enterprise and funding its ongoing development is extremely difficult.
In previous debates, I referred to the investment that went on in Ireland—in Galway—to create an innovation hub and ensure that there is investment in innovation. This amendment would allow the Government to explore having a medical devices fund similar to an innovative medicines fund, and would allow that fund to be used to develop a device and test and trial it within the NHS, with it being available to NHS patients and clinicians much more rapidly than the current procedures require. It does not in any way suggest that the usual ethical approval processes and all the checks that go with it should be curtailed; it would simply be a way of making sure that, where a custom-made device that solves a major problem could be rolled out widely, it can be used for the benefit of UK plc, if you like to call it that. It would make sure that we have that investment, and that the clinicians do not have to give it away for the whole thing to be developed commercially elsewhere and then sold back to the NHS at huge cost. I again express my gratitude to the Committee and I beg to move.
Lord Lansley (Con)
My Lords, I am grateful to the noble Baroness, Lady Finlay of Llandaff, for tabling and moving this amendment for a number of reasons, the first of which is that it allows me to express my appreciation to the noble Lord, Lord Patel, for moving Amendment 28, in his name and mine, last week on the innovative medicines fund and to say how much I welcomed the debate on it, which I have read, and the Minister’s response.
I am also grateful to my noble friend the Minister for his subsequent letter about the innovative medicines fund. There is of course a direct parallel in that Amendment 91A would look for the innovative medical devices fund to be funded in a similar way. I just gently dispute one proposition with my noble friend: he said that the use of the rebate on the voluntary pharmaceuticals access scheme would not be appropriate for the innovative medicines fund because the amounts could vary sharply from one year to the next. This would be a problem only if there were a direct hypothecation for the amount, and that is not necessarily implied. The amount of the innovative medicines fund could be established as a fixed amount that would then be funded by the rebate or, in the absence of a rebate, by the Exchequer or though NHS England’s total budget. It would not necessarily rise or fall with the rebate. The same would of course be true for the innovative medical devices fund.
There is a central proposition that supports both an innovative medicines fund and a medical devices fund; it is not that we in the United Kingdom lack innovation, it is that we lack the adoption of innovation in the National Health Service. That was the starting point for the Cancer Drugs Fund, on which this proposition is based. The Cancer Drugs Fund arose, in policy terms, from an analysis by Professor Mike Richards, who was then the cancer tsar under the last Labour Government, that there was a significant lack of availability of the latest cancer medicines for cancer patients, compared with other, principally European, countries. At the time that was not true for some other disease groups and medicine available for other diseases. It was a problem particular to cancer.
Why does this happen? It is not simply about funding; there is a systematic issue here, separate from the amount of resource, which is that the United Kingdom has a single-payer system. A single-payer system necessarily makes decisions about the availability of medicines on the basis of the whole system moving together. I suspect the same is true for devices. Pretty much all of the other European systems are not single-payer systems, but insurance-based systems, where, essentially, clinicians advise, patients choose and insurers pay. That brings innovations into use much more rapidly. There is potentially a problem with the diffusion of innovation in the NHS, which we have seen before and we have to continually guard against.
I put this question to the Minister for when he responds to this debate: are patients in the NHS getting access to new, effective medical devices as quickly as patients in other countries? I do not know the answer to that. I am absolutely clear that there was a good case for the Cancer Drugs Fund. I am clear that there is a continuing need for the innovative medicines fund, because there is sometimes a continuing gap between the availability of the most effective new medicines here and in other countries. I do not know about devices.
To this extent I offer an apology to the noble Baroness, Lady Finlay of Llandaff, because a medical devices fund might be premature, in the sense that we do not know to what extent there is a gap in the adoption or diffusion of innovation where medical devices are concerned. We identified real potential in the previous debate on Amendment 85 about the funding mandate for medical devices. If that is rolled out, as I think is the intention, and extended to a faster and larger pipeline of medical devices going through the NICE evaluation process, then we may find there is not too much of a problem. There may well be a case for understanding to what extent medical devices are being adopted by the NHS, relative to other health economies. I hope the Minister will agree that is worth looking at.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to speak to the amendment tabled by the noble Baroness, Lady Finlay, and to follow the noble Lord, Lord Lansley. Because this is about devices, I should remind the Committee that I am president of GS1 UK, the barcoding association, and chair of the advisory board of TenX Health.
I thought the noble Lord, Lord Lansley, posed a very interesting question about whether NHS patients have less access to innovative new medical devices than those in other European countries. My gut feeling is that they do, but I agree that the more information we can obtain the better so that we can debate whether the fund that the noble Baroness, Lady Finlay, proposed is a good way forward. On the face of it, I think it is. We have a situation in this country that is rather the case for medicines, where we have a very important health technology and medical devices sector. The ABHI informed me recently that the health technology industry employs over 127,000 people, generating a turnover of £24 billion. That is very substantial.
Baroness Jolly (LD) [V]
My Lords, the amendment from the noble Baroness, Lady Finlay of Llandaff, would require the Secretary of State to introduce a scheme to promote the availability of innovative medical devices for human use within the NHS. The scheme would be known as the NHS innovative medical devices fund.
The Secretary of State is charged with providing the funding and I welcome that approach. She has explained that custom-made devices are both difficult and expensive to fund, especially for the subsequent development of innovative devices with repeated trials. It can also be frustrating. A medical devices fund could take an innovation from concept through its development to production and then be rolled out widely, with any gains being returned to the fund or to the NHS organisation hosting the work. Clearly, flesh needs to be put on to those bones, but as I explained in an earlier Committee session, there is a fund that is particular to orthopaedics which is managed by a charity. In effect, every year it calls for bids, often from start-ups. It supports a certain number of the bids and any profits come back to the charity, which can also choose to be a partner in the venture. Some of the bids come from academia and others from within the NHS, but it works.
Baroness Thornton (Lab)
This amendment is interesting and certainly worthy of consideration. The innovative medical devices fund would insert a new subsection into the National Health Service Act 2006. Section 261 provides powers for the Secretary of State in relation to voluntary schemes to control the cost of medicines. The section describes these as schemes that are joined voluntarily and limit the price that may be charged on the profits that may accrue from the manufacture and supply of health service medicines. The scheme also provides for manufacturers and suppliers to pay the Secretary of State an amount of money if the agreed limits are breached. Amendment 91A would create a voluntary scheme under Section 261 which would be specifically for medical devices to give them equal treatment as innovative medicines. The Minister will have to explain why that would not be a good idea.
In her speech at Second Reading, the noble Baroness, Lady Finlay, talked about making the UK a medical devices development and production hub. Too often the UK effort has been bought out by overseas manufacturers who then market the devices back to the NHS at great profit.
Lord Bethell (Con)
My Lords, Amendment 91A seeks to replicate the innovative medicines fund with a comparable fund for medical devices called the innovative medical devices fund. We have had a terrific debate on this. The ideas and insights shared by noble Lords have been extremely powerful, but perhaps I may address the points in turn.
The goal that is shared wholeheartedly by the Government is that we recognise the huge benefits that medical devices can deliver. My noble friend Lord Lansley and the noble Lord, Lord Hunt, put that particularly well. We recognise the astonishing pace of innovation and development that is creating new healthcare options for patients across the UK. In fact, that is one of the reasons we are considering this Bill. We are extremely ambitious and are determined to capitalise on the opportunities presented by new medical technologies to ensure that the best innovations are adopted and spread across the NHS.
Devices, like medicines, are key to ensuring patient health, but they are different and it is not necessarily helpful to use a system that was developed for medicines to be used for devices. For example, the primary purpose of the innovative medicines fund is to cover the cost of managed access agreements where NICE feels that there is insufficient evidence to give a positive opinion and asks for further evidence to be collected before the product is re-evaluated.
Devices are not assessed by NICE in the same way and we do not consider that mirroring the provisions for medicines would necessarily be beneficial. In particular, unlike medicines where, once licensed, they do not change, medical devices are constantly evolving. New iterations of medical devices are developed quickly, their impact on patients changes, often rendering earlier iterations completely obsolete within relatively short periods of time. That gives rise to the potential for funding mandates to be in place for devices that are no longer the best or most cost-effective in their category. Requiring the mandatory purchase of all but the most innovative devices by commissioners would not be a sensible use of NHS funds. We therefore need to find different systems of process to ensure that innovative and effective devices, along with other medical technologies such as digital, find their way to the NHS and to patients.
That is why we have boosted the remit of the Accelerated Access Collaborative. It will bring together leaders from across Government, the NHS, regulators and industry to address the underlying challenges that delay patient access and uptake.
As chairman of the AAC, the noble Lord, Lord Darzi, has been able to bring his world-leading expertise to bear to deliver a host of successes in recent years. Indeed, almost 750,000 patients have benefited from access to AAC-supported innovations in recent years, including more than 315,000 patients who have accessed new technologies supported through the innovative technology payment programme. The AAC is going further to deliver the commitment in the NHS Long Term Plan to accelerate the uptake of proven, affordable innovations with the introduction of a new medtech funding mandate. The mandate will ensure that all patients have faster access to selected cost-saving devices, diagnostics and digital products approved by NICE, via medical technologies guidance and, when available, NICE diagnostic guidance for innovations.
The final criteria to be used in the mandate will be announced in the consultation response to be published in December this year, and the mandate will take effect from April 2021. Additional steps are being taken to ensure that the mandate translates to front-line improvements in patient access. The NHS standard contract has already been updated to state that the relevant parties must comply with their obligations under the mandate guidance, and technologies receiving the mandate will benefit from dedicated support via the regional academic health sciences network to help drive local adoption and spread.
NICE also recognises the need to ensure its methods for assessing innovative medical technologies continue to support our ambition for the NHS to provide world-leading care that delivers value to patients and the NHS. The NICE methods review is therefore under way, with extensive input from industry and patient representative groups. The consultation on the case for change to existing NICE methodology is open until 18 December, and I encourage all those interested to submit their views.
Finally, it is also important to note that in her amendment the noble Baroness, Lady Finlay, stated that moneys should be paid to the Secretary of State under Section 261(9) of the National Health Service Act 2006 in order to support an innovative medical devices fund scheme. However, Section 261 of the National Health Service Act relates only to voluntary schemes agreed with pharmaceutical manufacturers which control the prices charged, or profits accrued, by manufacturers and suppliers of health service medicines. The vast majority of medical devices would not therefore be within the scope of such a scheme.
I trust that I have been able to reassure the noble Baroness that the funding of medical device technology in the NHS in England is of great importance to the Government and that we are actively putting in place mechanisms to support it. On this basis, I hope very much that the noble Baroness, Lady Finlay, will feel able to withdraw her amendment.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I thank noble Lords for contributing to this debate. There were a couple of comments that I would like to come back on.
The noble Lord, Lord Lansley, asked whether there was evidence of the slow adoption of innovation. I have a series of different case studies that I will happily share with him. I shall highlight one. Cytosponge had a 19-year journey from when it was thought of to when it was adopted. It is estimated that it saves 7,190 QALYs having now gone through NICE. Companies do not feel incentivised to develop low-cost devices in this country.
Another example is the CoMICs study on conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery, which compared two types of bypass machines. The difficulties there resulted in most of the study going abroad and being conducted elsewhere. Our development of robotics has been impressive, but we have huge competition from the US market, in particular in device development.
So I suggest that we need to look at a way of making sure that we can develop devices. I accept that this amendment as worded may not be right for this Bill at this time, but I hope that we will not lose sight of the need to innovate. I would like to come back on Report to the concept of provisional licensing as a way of getting new and innovative devices through the system rapidly, possibly without burdening the NHS with the financial bureaucracy that this amendment might cause. I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
We now come to the group consisting of Amendment 94A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 94A
Lord Field of Birkenhead
“Requirement to make regulations concerning medicinal cannabis and associated devices
(1) The appropriate authority must by regulations amend the law relating to medicinal cannabis and devices used to administer medicinal cannabis.(2) Regulations under subsection (1) must establish criteria for the licensing of cannabis medicines and medical devices.(3) In making regulations under subsection (1), the appropriate authority must have regard to—(a) the safety of medicinal cannabis;(b) the availability of medicinal cannabis;(c) international evidence of the efficacy of cannabis medicines.”
Lord Field of Birkenhead (CB)
My Lords, I wish, with a straight bat, to move this amendment standing in my name and in the names of my noble friends. Looking at the names of those who will be contributing to this debate, I willingly admit that I probably know least about this subject—although, in declaring an interest, I probably bring a knowledge which most of your Lordships do not have. I use cannabis. My spine is breaking up. I have tried all the traditional painkillers, but they were worse than what they were actually trying to deal with. So I am not somebody who embraced cannabis as a first option; I was driven to it because no other traditional painkillers helped.
It is important to say what I am not asking for. I am not asking for a free-for-all for people who wish to use cannabis for recreational purposes. I understand their case, although I do not share it. Others may wish to use other opportunities to move that interest. I do not. Nor am I—or the other noble Lords who have signed this amendment—asking for a random control trial. We are asking for something much subtler. This medicine helps people and relieves pain, and it is the relief of pain that I wish this debate to concentrate on.
I am no snake oil salesman. I am not here to claim—on behalf of my fellow citizens who suffer, for example, from Parkinson’s or cancer—that this is a miracle cure. I am not arguing that. I know a number of people with Parkinson’s or cancer who have been helped by this, and their lives possibly extended. But in this amendment I am concentrating merely on how to relieve pain. In proposing the new clause, I am really making a plea to the Government to renew past conversations about how we might equalise access to cannabis in this country where people are totally concerned with controlling pain. Clearly—and rather appropriately, given the previous set of amendments—the new clause concerns itself with the devices by which cannabis can be delivered to a patient. Above all, it is a plea to change the schedule within which the drug sits, so that—if they so wish—GPs can prescribe this painkilling drug.
I do not know how many times others have been able to speak in a cannabis debate with your Lordships knowing that the person speaking is actually using that drug. My plea is, very simply, that there are pains that traditional painkillers cannot reach and there is considerable evidence that in those circumstances, when all the traditional painkillers have been tried, cannabis can sometimes work.
What is so unfair is that under the present arrangements, I can pay for my cannabis. There are huge numbers of other people, probably in greater pain than I, who cannot buy cannabis, as I do, within the law as a painkiller. I am therefore moving the amendment with its proposed new clause as a plea to the Government, on behalf of all of us who suffer pain in varying degrees and have tried the traditional methods of pain relief. Where that has failed—it often makes one even more ill than when one started to take those painkillers— we have found some redress in cannabis.
As a user and beneficiary, I hope that I therefore speak on behalf of many of my fellow citizens who get relief for their pain from cannabis. I wish to equalise access to cannabis in the way that I have benefited, so that others might too. I beg to move.
Baroness Meacher (CB)
My Lords, it is a great pleasure to follow the noble Lord, Lord Field, who has knowledge that I do not have. I have never used cannabis, but he has made a powerful statement as a user.
The regulations affecting the production of prescription and medical cannabis are incredibly unhelpful. They result in about 1 million people—very sick, disabled people—accessing medical cannabis illegally, usually from the criminal market, although some go to Europe to access medicine for either themselves or their children. Although cannabis medicines have been legalised, most such people simply cannot get access to them. It just is not there for them at all.
Under the regulations in place at present, cannabis medicines are unlicensed—they are known as specials. This means that only consultants can prescribe them, on the basis that if there is a problem—it is extremely unlikely that there would be any problem with medical cannabis—the consultant has to take personal responsibility for having prescribed that medicine. The trouble is that doctors have not been trained in this complex group of medicines. The cannabis plant contains about 540 phytochemicals: 144 known as cannabinoids, 200 terpenes and 20 flavonoids have been identified so far. Maybe there will be more; I do not know.
Different mixes of these phytochemicals alleviate the symptoms for patients with a wide range of conditions. The noble Lord, Lord Field, concentrated on pain, and fibromyalgia is a particular type of pain, which apparently responds well to this. But there is also Crohn’s disease, treatment-resistant epilepsies, PTSD, Parkinson’s and an incredible number of others. I think that Germany approves medical cannabis for something like 40 conditions, which is extraordinary.
Not surprisingly, consultants have been very reluctant to prescribe medical cannabis. Only 204 prescriptions have been written in the two years since medical cannabis has been legalised, and only 10 within the NHS. It is pretty disastrous in terms of the regulations and it is essential that a way is found to license high-quality medical cannabis for the alleviation of symptoms for a specified list of conditions.
The Medicines and Healthcare products Regulatory Agency generally insists on random controlled double-blind trials, and I very much support that gold standard for the great majority of medicines. However, medical cannabis medicines are different from almost anything else I can think of, in part because in general—certainly until now—they claim only to alleviate symptoms. At this point they do not claim to be a cure, although there is some interesting current research on the curative potential of cannabis. But we will not talk about that now. Also, cannabis has been used as a medicine for thousands of years; I do not think there is any other medicine quite like it. A million patients use it today, and can provide evidence of its efficacy, minimal side effects and safety. Many patients have used it over many years, so I argue strongly that cannabis medicines are in a really different position from other medicines.
There are a considerable number of studies across the world that clearly show the efficacy and safety of medical cannabis. In 2017 the National Academies of Sciences, Engineering, and Medicine published a great volume called The Health Effects of Cannabis and Cannabinoids, a review of global research into the efficacy of cannabis medicines. It concluded:
“There is substantial evidence that cannabis is an effective treatment for chronic pain in adults.”
Why is this not taken seriously?
Until now the MHRA has been unwilling to consider that and much more international research. Bedrocan products have been widely used in Europe for more than 20 years, greatly benefiting patients. If the Government did nothing else but allow Bedrocan products to be approved in this country, that would be of enormous benefit to a huge number of patients. High-quality products are now available in the US, Latin America, Canada and many other countries across the world. Outcome data is available from Columbia Care, for example, but also from many other organisations, universities and so on.
Not only do the regulations place medical cannabis in the “specials” category, they also complicate the import and production processes, adding considerable costs to the medicines. The situation cannot, in my view, be justified. It creates criminals out of completely law-abiding incredibly sick and disabled people. It wastes police, court and prison time, and considerable sums of taxpayers’ money—and, indeed, NHS resources. Most important of all, it is ruining the lives of many of our most vulnerable citizens.
I am in touch with GW, the pharmaceutical company that has produced the only cannabis medicines licensed in this country. I hope to work with GW, and I have a meeting with its representatives—next week, I think. They understand the problem. Epidyolex, trialled by GW, is a single cannabinoid medicine. GW spent many years and hundreds of millions of pounds undertaking the double-blind trials of Epidyolex and, understandably, wants a return on its investment. I have huge sympathy with it.
Since that work started, research in other countries has shown that a single cannabinoid medicine is suboptimal for many treatment-resistant epileptic children. The evidence tells us that it helps 43% of children with two particular variants of epilepsy, and the reduction in symptoms is only 50%. I sincerely want Epidyolex to succeed. It may be the right drug for some children. However, more recent research internationally has shown that some children given whole plant products can achieve up to 100% improvement, with minimal side-effects .The evidence available justifies regulation changes to enable very sick patients to benefit from cannabis medicines, which patients say alleviate their symptoms more effectively and with substantially fewer side-effects, than prescribed medications, as the noble Lord, Lord Field, has told us from personal experience.
We genuinely wish GW well, and we are privileged to be in discussions with it to try to find a way forward that will benefit patients and work for pharmaceutical companies, while upholding the high standards of safety and efficacy for which this country is renowned. At a recent virtual meeting with our highly valued Minister and the CEO of the MHRA, I was encouraged to see that the CEO also recognised the need to discuss a possible way to increase access to cannabis medicines for patients who benefit significantly from them.
The aim of the amendment is to initiate a discussion with Ministers, alongside discussions with officials and experts, about how to remove the umpteen hurdles within the regulations which prevent patient access to cannabis medicines. We hope through these discussions to find a way forward, and I look forward to the Minister’s response.
Baroness Walmsley (LD) [V]
My Lords, I heartily support the noble Lord, Lord Field, and the noble Baroness, Lady Meacher. I thank the noble Lord for his important evidence, and congratulate the noble Baroness on her many years of energetic campaigning on this matter. Noble Lords may know that I too have campaigned long and hard for medicinal cannabis projects, that have been proved to be safe and effective, to be prescribed on the NHS for UK patients. When the Home Office changed the status of medicinal cannabis two years ago, many of us thought that, given the mass of evidence that there are many such safe and effective products in widespread use abroad, such medicines would become available free to UK patients. That has turned out not to be so. Although some expert clinicians are prescribing them for appropriate patients—including the noble Lord, Lord Field—in a private capacity at high cost, very few patients have received their medicine free on the NHS. Why is this? It seems that it is because NICE has not approved them because there have not been any random controlled double-blind trials. Therefore, several health trusts are forbidding consultants who want to prescribe these medicines to do so, on pain of losing their jobs.
There are children with intractable epilepsy in this country whose lives have been saved by the medicines, for which their parents have had to fundraise. The lives of some of those children have been put at risk because the coronavirus has prevented that fundraising, and they suffered serious preventable fits. Many of these children have been treated with approved pharmaceutical medicines that have never been approved for use with children and have serious side effects. That is why we need a proper regulatory framework based on the full cadre of available evidence, which this amendment proposes. It will not be difficult to establish the safety of these medicines, as required by subsection 3(a). If those making the regulations are allowed to take into account the health records of people who have already been taking these medicines, and also the vast amount of evidence from other developed countries which the noble Baroness, Lady Meacher, has listed, that will subsection 3(c). Subsection 3(b) requires that availability be considered when making the regulations. These medicines are readily available. Indeed, a lot of them are being made in this country and exported because they cannot be sold here. How mad is that? Nor are they expensive as medicines go, and the NHS can bulk buy at a discount anyway.
In order to satisfy those who do not trust evidence from other countries—although why is beyond me—we also need to collect data from UK patients who are managing to get cannabis medicines in order to provide the information required by NICE, but there is no system in place to do that. Will the Minister say why the NHS Commissioning through Evaluation system is not being used? It is a well-established and approved system that collects patient data and clinician observation on the use of novel medicines and treatments. It strikes me that, given that cannabis medicine’s illegal status made it impossible to collect much UK data before 2018, it would be an ideal candidate for this trusted method of evaluation. Finally, I would welcome the Minister’s response to this suggestion.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
I call the noble Lord, Lord Norton of Louth. Lord Norton? We will move to call the noble Lord, Lord Patel, and come back to the noble Lord, Lord Norton if we have time. I call the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, I will need to speak only very briefly because the noble Lord, Lord Field of Birkenhead, and the noble Baronesses, Lady Meacher and Lady Walmsley, have covered the ground extensively, fully and informatively. It is a privilege to be involved in an amendment moved by my noble friend Lord Field of Birkenhead. We have been friends, discussing such issues for very many years, although he was in a different House, so it is a pleasure to see him and support his amendment.
My noble friend Lord Field spoke from personal experience, and my noble friend Lady Meacher spoke extensively about the information available. In 1998, the Science and Technology Committee of the House of Lords recommended that there should be a programme to assess the medicinal use of cannabis and that ways should be found to use it. NICE has recommended one or two areas where it can be used, as has already been said. Very few NHS prescriptions have been given out, but more than 1 million people use cannabis preparations bought privately at huge cost. They use them because they find benefit from them. The report suggests that the people who benefit from it mostly suffer from chronic pain. Despite that, reports have been published where people with Alzheimer’s, cancer, chronic pain, Crohn’s disease and multiple sclerosis, to name but a few, found benefits from it. More than 20,000 publications on PubMed, not of clinical trials, but of people’s experience and data collected from patients, show that they have found it to be beneficial.
When recommending and assessing medicinal products using cannabis, NICE suggested that research should be carried out in six or seven areas. I do not know what research has been carried out. The problem with such a recommendation is that it does not recommend who should do the research. So I ask the question: who should be doing this research to explore the benefits that patients find in medicinal cannabis?
Private clinics prescribe more and more cannabis on a daily basis, and more and more clinics are opening in cities in England where cannabis is available. My noble friend Lady Meacher and the noble Baroness, Lady Walmsley, alluded to two important issues. One is that a way needs to be found to collect information on patients’ experiences and data to show why so many patients go to private clinics to get cannabis products and what benefits they derive from them.
I look forward to the Minister’s response, but I hope she may agree, as it would not require legislation or an amendment to the Bill, that the NIHR or the Department of Health and Social Care through the NIHR should establish a forum of specialists, including patients, to find a way forward to collect information on a more formal basis. I hope the Minister will respond positively to that. It has been a pleasure to take part in this debate.
Baroness Jolly (LD) [V]
My Lords, the amendment signed by my noble friend Lady Walmsley and others would require the Secretary of State to make regulations concerning medicinal cannabis and associated devices. The noble Lord, Lord Field of Birkenhead, made his case clearly and strongly. I have a family member who used cannabis as a painkiller towards the end of their life when pharmaceuticals failed. Given the huge relief it can bring to patients with conditions such as epilepsy, it is vital that barriers to access are removed. We have heard that since the law was changed in November 2018, only a very small number of prescriptions have been written for medical cannabis.
The noble Baroness, Lady Meacher, my noble friend Lady Walmsley and the noble Lord, Lord Patel, have for many years supported the use of medical cannabis for a small number of conditions. Very few patients have received their medicine on the NHS because NICE has yet to approve the use of cannabis in any context. Evidence is available, so why are the Government fighting shy of using cannabis or its derivatives, thus forcing individuals to become criminals by having to go abroad to countries where cannabis is legally available, but at a huge cost, and then smuggle it home? It does not make sense. We support the amendment.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
We do not seem to be able to contact the noble Lord, Lord Norton of Louth, so I call the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
I thank my noble friend Lord Field—he may not technically be my noble friend, but he is really—for bringing this issue to the Committee at this stage. He probably knows that he is not the only parliamentarian who has been driven to cannabis products for similar reasons, but my lips are sealed about who the others might be.
The noble Baroness, Lady Meacher, is absolutely correct. She and I have form. I have been supporting her from the Front Bench on this issue for quite a long time. While the debate was going on, I looked to see what Hansard had to say about this. The last time, I think, that we discussed this was in March 2019. At that time, the framework and law had been changed the previous November, so that is two years ago. At that point four people had managed to get cannabis products prescribed. When the noble Baroness put the question to the House, it was answered by the Minister’s predecessor. Will the Minister say how many more people there are now? I think it is probably not that many more, and I see this amendment as a scream of frustration about this issue. There is justifiable frustration that we have not managed to regulate this product in a way that makes it accessible to people who need it most. It also exacerbates the inequalities in our health system because, as the noble Lord, Lord Field, said, he can afford to buy it, but there are thousands of people who need it and cannot afford to buy it. I support this amendment, but I am really much more interested to see what on earth the Government are going to do to make progress with this.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
I am now able to call the noble Lord, Lord Norton of Louth.
Lord Norton of Louth (Con) [V]
My Lords, I am delighted to have the opportunity to contribute to the debate and I apologise for not being able to contribute in my allocated slot.
I was very keen to add my name to the amendment to support the noble Lord, Lord Field of Birkenhead. I do not want to repeat the points that have already been made, but I draw attention to the fact that a few years ago I initiated a debate in the House on drugs policy. My point was to argue the case not for a change in policy but that policy must be—or should be—evidence-based. At the time, the Minister who replied said that opinion on this is divided. Someone afterwards pointed out that only the Minister disagreed with me because everyone else who spoke in the debate supported the case I was making that the Government were resisting going on the basis of evidence. For whatever reason, they were sticking their heels in.
As we have heard, the evidence really supports the case for change. The APPG for Drug Policy Reform showed the case and that there is evidence for the value of medicinal cannabis in relieving pain. There is a very strong argument on the basis of evidence and a moral case as well, given the sheer number of people who are forced, at great expense and possibly some danger, to find alternative ways of getting hold of cannabis for medicinal purposes, so I very much support what has been said by preceding speakers, including the noble Lord, Lord Field. I think the amendment is a step in the right direction in what it seeks to achieve. It is targeted and proportionate. It is designed to help to expand access to safe and regulated medicinal cannabis products in the United Kingdom. There were other points I was going to make in support, but I do not want to repeat points that we have already heard. I just wanted my name to be on the record as supporting the very powerful cases that have been made for the amendment.
Baroness Penn (Con)
My Lords, Amendment 94A in the name of the noble Lord, Lord Field of Birkenhead, deals with a topic of great difficulty. As the noble Lord has personally testified, patients and families deal courageously with challenging conditions, and I know that the issue of medicinal cannabis is one that has had much debate.
As other noble Lords have pointed out, it is almost two years to the day that the Government changed the law to allow the supply of medicinal cannabis under misuse of drugs legislation. These regulations provide that medicinal products containing cannabis can be prescribed or supplied when certain conditions are met. These conditions are that the relevant cannabis product is a special medicinal product, an investigational medicinal product for use in a clinical trial or a medicinal product with a marketing authorisation.
I do not have specific figures for the noble Baroness, Lady Thornton, on the number of people who may have accessed cannabis drugs since then. I understand that the collection of data on certain private prescriptions was suspended because of Covid-19, but we can go away and look for the latest data and, when it becomes available, update the House. I believe I heard the noble Lord, Lord Field, say that there may have been 204 prescriptions. While I cannot endorse that figure, and noble Lords may feel it is low, it is considerably higher than the figure that the noble Baroness quoted for one year after the approval of medicinal cannabis. Therefore, if it is correct, progress is being made in the right direction.
Noble Lords are right that cannabis remains a controlled drug. I appreciate that the noble Baroness, Lady Meacher, already expressed views on this in our discussions with the MHRA on whether it ought to be a controlled drug at all. The noble Lord, Lord Field, also made that point. However, the changes to its restrictions are set out in the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001, for England, Scotland and Wales, and the Misuse of Drugs Regulations (Northern Ireland) 2002. Those regulations are not within the scope of the Bill.
What is within scope is when those medicinal products are regulated as a human medicine. The noble Lord is asking for regulations to provide for a specific licensing regime for medicinal cannabis. However, I stress that medicinal cannabis products already have a route to market. They fall within the scope of the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. It is entirely appropriate that they are subject to the same standards and requirements of evidence as any other medicine. The MHRA’s licensing process takes into account evidence of clinical efficacy. This includes consideration of all evidence supplied by the manufacturer. The regulators also inspect the factory where the medicine is to be made to make sure that supplies will be of a uniformly and consistently high standard. Companies can and do submit evidence of use from other countries, so there is no need to set an explicit requirement to consider efficacy internationally. If a company wishes to make a product available, it can within this regime.
Medicinal devices that administer medicinal products, including medicinal products containing cannabis, would also need to comply with the relevant provisions of the Medical Devices Regulations 2002. But a medicinal product in the UK must be safe. We have talked throughout the Committee about the critical importance of safety and the need to uphold standards. There is a paucity of evidence to support the quality, safety and efficacy of these products, meaning that very few hold marketing authorisations. To address this, the industry needs to further the evidence base and support the use of their products. Government is supporting this with a programme of two randomised control trials commissioned by the National Institute for Health Research. I hope that reassures the noble Lord, Lord Patel, as the National Institute for Health Research is engaged in assessing the evidence in this matter. These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to plan future NHS commissioning decisions for the many patients who may benefit from these innovative medicines.
Just to pick up on the question of how many drugs may already hold licensing, I can say that there are three such licensed products, including Sativex for MS and Epidyolex for rare epilepsies. These drugs are proof that cannabis-based products can meet the high standards of quality, safety and efficacy that we rightly expect in the UK. I say to the noble Baroness, Lady Jolly, that the drugs that have been licensed by the MHRA also have NICE approval for use in the NHS in certain appropriate conditions. As we heard in our meeting with the MHRA on Monday, it is able and willing to provide advice to researchers and companies that wish to conduct clinical trials and go through the licensing process for their products.
Cannabis-based products for medicinal use can also be supplied as unlicensed “special” medicines, as noble Lords have noted. A special medicinal product is a product that is manufactured or assembled according to the specifications of a specialist medical practitioner to meet the needs of a specific patient, in accordance with the stringent “specials” regime provided for in the Human Medicines Regulations 2012. Those unlicensed products have not been assessed by the National Institute for Health and Care Excellence for clinical or cost effectiveness. These are the foundations of NHS decisions about routine funding for medicines.
I appreciate that families with ill children, or patients themselves, would dearly love to have greater products available to them for more purposes, but this is not about creating new licensing routes. It is about companies coming forward and undertaking clinical trials and tests and it is about having the appropriate level of assessment and understanding of the impact. We are taking steps to improve the body of evidence available. When marketing authorisations are sought, they will be dealt with by the regulator, as they would for any other medicine. That may not be as quickly as some would like, but it is necessary to protect patients. On that basis, I hope that the noble Lord, Lord Field, is content to withdraw his amendment.
The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)
I have received requests from three noble Lords to speak: the noble Baronesses, Lady Finlay, Lady Walmsley and Lady Thornton. I call the noble Baroness, Lady Finlay.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I am most grateful to be able to come in at the end of this important short debate. I particularly commend the noble Lord, Lord Field of Birkenhead, for his outstanding and long history as a parliamentarian and, yet again, for his clarity and ethical approach to every subject that he addresses.
I am glad that the Minister has referred to the two studies from the NIHR and simply support the idea that we need to wait for those, although I draw attention to the fact that, in 2018, there was a Cochrane database review, which looked at the 16 double-blind randomised control trials that it could find. It found some support, but it was not terribly strong. One of the difficulties here is that pain is a symptom that occurs in an enormous range of disorders, but the fundamental cause of the pain will be very different in different people. To get a matched population where you can compare one with another is extremely difficult. I hope that the change that NICE is looking to in the evidence that it seeks, where it will also look at evidence in practice, will support the evidence coming through from large patient cohorts who can then be put into broader groups.
The other point about pain is that, as people get multiple pathologies, they often take several other medications as well, which can interfere with the ability to assess them. They are also often elderly. The evidence certainly needs to be accrued. I would say as a clinician that one worry was always whether there would be a leak of cannabis on to the streets. However, in practice, I think that the leakage has gone other way so that it comes from the streets into people’s homes. Clinicians have had to look at this with Nelson’s eye because they do not want to support clinical activity. In a study that I did, while we did not ask patients to tell us specifically where they were getting some things from, when we put together all the different types of alternative therapies being used by a group of people who were cancer patients, the numbers were huge. This supports many of the comments that have already been made. I am glad that the Government are looking at it and I expect that it will not be too long before we find that the ability to get the medication that is needed is made easier. I worry that it may be too late for some patients, but we are getting there.
Baroness Penn (Con)
I thank the noble Baroness for her comments about the importance of evidence. The Government and the MHRA recognise some of the difficulties around these trials. That is part of the reason that NIHR is supporting two trials and is asking people to come forward. The MHRA has also indicated that it is willing to work with those who have these products in order to support them in the process for licensing.
That has reminded me of one other point. The noble Baroness, Lady Walmsley, asked me about the NHS commissioning through evaluation programme. I undertake to write to her with a response, perhaps when I update the noble Baroness, Lady Thornton, on prescription numbers.
Baroness Walmsley (LD) [V]
My Lords, I thank the Minister for that. With regard to her earlier response, if it were as easy as that, there would have been tens of thousands of NHS prescriptions in the past two years, but clearly that has not been the case. The noble Baronesses, Lady Finlay and Lady Meacher, have both made it clear why it is very difficult to conduct randomised double-blind clinical trials for these products. That is why I have suggested that, while we wait for many more than two trials, the commissioning through evaluation system could be used. I am grateful to the Minister for promising to write to me about that.
Baroness Penn (Con)
I thank the noble Baroness for her comments. I emphasise that there has been a great deal of discussion in the debate about the use of evidence. That is what will guide the Government and the MHRA in this, and that is why we are supportive of these RCTs taking place.
Baroness Thornton (Lab)
I have two brief questions. I agree with the noble Baroness, Lady Walmsley, in what she said about 200 being two a week. That is really pathetic in terms of what the need is likely to be. I wondered if the problem was because early on, there was a certain nervousness among GPs and clinicians in terms of the legal issues as regards prescribing cannabis products. Is that still an issue? The other thing I want to ask the Minister about is whether the MHRA is drawing on international experience because some countries are much further ahead on these issues than we are.
Baroness Penn (Con)
The MHRA is very clear about its desire to be an international regulator and engage with other regulators across the world on all issues regarding the regulation of medicines and medical devices, so I am sure that it is working in this area. On the point the noble Baroness has made about the nervousness of clinicians on the legal status, this is not something that I am aware is still an issue, but I am happy to take the point away and look at it again.
Lord Patel (CB) [V]
My Lords, I wish to concur with some of the points made; I do not speak against anything said by the noble Baroness, Lady Finlay. We are in complete agreement and I do not counteract anything that she says anyway. Having said that, most people look at medicines as things that cure disease. Most medicines do not cure disease. Symptoms are what patients experience, and we have to treat those symptoms. As an obstetrician, I have spent most of my life treating the symptoms of pain, prescribing morphine and heroin as painkillers to mothers who are suffering from labour pains. I could not measure their pain in any way except by what they told me about it.
The problem with database evaluation is that it looks for the size of the randomised trials. I suggest that observational studies that look at the experience of patients are a good enough database to evaluate whether the substance used is effective in alleviating their suffering. That is the sort of evidence that I hope NIHR will seek to establish a proper database. I am pleased to hear the Minister say that NIHR is looking at ways of dealing with this.
Baroness Penn (Con)
My Lords, the only thing that I will add is that the noble Lord, Lord Field of Birkenhead, said that this was about equality. My point is that MHRA’s approach to medicinal cannabis is the approach it takes to licensing all other medicines. So whatever approach we take to evidence, or how we look at the appropriate gathering of that evidence, will be based on the approach we take to all medicines. The way in which cannabis is treated is not as a different or exceptional case, and we will want to ensure that that is the case going forwards.
Lord Field of Birkenhead (CB)
My Lords, it may be because I am a new Member that I do not quite understand the nuances of language in the House of Lords. I thank most sincerely my fellow Peers who have participated in the debate, and I agree with the Minister’s wish that at this stage I should withdraw the amendment, but in doing so, I would like to say that we will return to this issue. I would particularly like to return to the issue that my noble friend Lady Thornton raised, about equal access.
Only 10 NHS prescriptions have been offered under the new provisions that Parliament made. When I got what had to be a private prescription and took it to Boots, the pharmacist came back with it as though I had left some terrible mess, dropped the prescription back on the counter and said, “We do not dispense that drug.” So all the talk that somehow, if only we could get a prescription, we would get a supply, is also a myth.
I am disappointed with the Minister’s reply. I thought it was pretty thin gruel to offer us. Although I beg leave to withdraw the amendment, I hope that those of us who are interested in this topic will return to it at the most suitable date.
Medicines and Medical Devices Bill
Tuesday 17th November 2020
(4 years ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-VII(Rev) Revised seventh marshalled list for Grand Committee - (17 Nov 2020)
The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)
A participants’ list for today’s proceedings has been published by the Government Whips’ Office, as have lists of Members who have put their names to the amendments or expressed an interest in speaking on each group. I will call Members to speak in the order listed. Members are not permitted to intervene spontaneously; the Chair calls each speaker. Interventions during speeches or “before the noble Lord sits down” are not permitted.
During the debate on each group, I will invite Members, including those in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will call the Minister to reply each time. The groupings are binding, and it will not be possible to degroup an amendment for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate. Leave should be given to withdraw amendments.
When putting the Question, I will collect voices in the Grand Committee Room only. I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an amendment is negatived, and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group. We will now begin.
Clause 16: Information systems
Amendment 95
Member’s explanatory statement
This amendment is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill, setting up the new information system envisaged by Clause 16.
Baroness Finlay of Llandaff (CB) [V]
My Lords, this is a large group of amendments relating to expert registries. I have Amendments 95, 99, 100 and 101 and support the others in this group.
First, I welcome Clause 16, which the Government added during the Bill’s passage in the other place. The clause is a clear step in the right direction. Amendment 95, like Amendment 96, would build on this to ensure efficacy by tracking the use, and the outcomes from the use, of all medical devices rather than just a select few. We must not forget the conclusions of the Cumberlege review that registries are too
“few and far between and all too often prompted by catastrophe”.
The Bill provides a prime opportunity to move away from that position. Without tracking all devices, we will allow another scandal, involving an as-yet-unknown device, to emerge undetected until many have been affected. A proper warning system is essential.
Amendment 99 seeks to make the list of objectives for regulations listed under Clause 16(2) mandatory rather than permissive. These should be minimum standards against which to hold any regulations the Government publish, not just aspirations.
Amendments 100 and 101 then seek to add to that list of standards. In doing this in Grand Committee, I would welcome some commitments from the Minister, setting out where the Government share the objectives in those amendments. In essence, the difference between the Government’s approach and mine is that the Government foresee a future in which some medical devices continue not to be tracked, hoping that their outcomes will be audited. I strongly believe that this is a mistake.
Registries, which track patient outcomes through proper monitoring and audit, are an essential component of post-market surveillance and a prerequisite for patient safety. They should be the rule, not the exception. This is a principle that the Royal College of Surgeons of England strongly supports too. Indeed, its former president, Professor Derek Alderson, made this clear in his evidence to the review of the noble Baroness, Lady Cumberlege. As he put it
“a registry of its own right does not create patient safety; it’s just a list. The registry must contain information that can be audited”.
Essentially, as the Cumberlege review acknowledges, a registry is a registry only if it contains patient outcomes, which are then subject to expert oversight. To that end, Amendment 100, which is at the core of this group of amendments, sets out the following principles.
First, the use of all implantable devices should be recorded in a registry. That goes to the heart of the issues explored by the Cumberlege review and is surely the central lesson that must be learned from the unnecessary—and unnecessarily long—suffering of thousands of women whose experiences with mesh were horrific.
Secondly, other devices used in the course of operations should similarly be subject to outcomes tracking. I raise this in particular because it is not just devices left inside people that can later cause problems. We know, for example, that machines used in the heating and cooling of blood during open heart surgery can cause a Mycobacterium chimaera infection. The NHS now warns people of this risk, but it seems clear that the Bill should put in place measures to ensure that the use of particular machines is tracked, and that where infections develop later, a flag can be raised against that machine. To be clear, the machines involved do not actually make contact with the patient or their blood. The heater-cooler units contain two water tanks and tubing. One water tank uses warm water, which, through indirect thermal transfer, keeps the patient warm during the surgical procedure, often through the use of a warming blanket. The second water tank contains cold water, used, again indirectly, to cool the cardioplegic solution that slows or stops the patient’s heart to allow the surgical procedure to proceed. It is thought that where Mycobacterium chimaera develops in these machines, it can escape as aerosol—a fine spray—into the surgical area and thus cause infection from there. I raise the example simply to illustrate that medical devices are not only about what is left inside people, or even what comes into contact with people. The new provisions for information systems need to be flexible in recognising that.
The third provision of Amendment 100 is that information systems must be subject to expert oversight. That is to deal with the central point raised by the Royal College of Surgeons of England, which is that without this oversight a registry is just a list—not really a registry at all. A good example of a registry in action is the National Joint Registry, which is overseen by a steering committee of experts. The expert committee monitors outcomes achieved in joint replacement surgery, analysing procedures by brand of prosthesis, hospital and surgeon. Instances where performance falls below expected levels are highlighted to ensure appropriate investigation and follow-up. This is a standard we need to see replicated across surgical specialities and across the NHS.
Fourthly, and perhaps most critically, the amendment seeks assurances from the Minister that information systems set up under the Bill will provide a direct route for patients to report their own outcomes. Clinicians, of course, want to assume the best about the treatment they have commissioned and undertaken for a patient. It is a natural and not ignoble instinct to try to reassure a patient who presents with a problem following a procedure. There is human nature in a clinical transaction. When a problem emerges, patients are often reassured that they “need to give it more time” or “things will settle down”. Each GP may see only one or two patients who have been subject to a particular device or procedure. With follow-up appointments decreasing, these patients with problems can become invisible to secondary care. Yet the patients know that they feel worse, feel that they are not being properly listened to and speak to others in online communities, discovering a specific pattern of concerns.
The yellow-card notification scheme is greatly underused, and patients do not know how to self-report on it. For that reason, we need two ways for information to reach a registry. We hope that a majority will be tracked from patients, through clinicians. Where there are multiple instances of concerning outcomes, these should be flagged through expert monitoring, but there must be a failsafe for patients to approach the holders of the registry directly to have their outcome reported and considered in its monitoring. The fourth limb of Amendment 100 seeks to achieve this objective and Amendment 101 reflects the same principle. Together, the measures in Amendments 100 and 101 seek to implement this key conclusion of the Cumberlege review:
“A central patient-identifiable database should be created … This can then be linked to specifically created registers to research and audit the outcomes in terms of both the device safety and patient reported outcomes measures.”
That surely is the goal to which we must all aspire.
I want finally to address Amendment 104, to which I have added my name. The noble Lord, Lord Lansley, draws attention to the balances we have to get right in collecting all this data in the name of patient safety. As I said on a previous group of amendments, I hope and expect that dealing with consent to recording this data could and should be dealt with as part of shared decision-making between the clinician and the patient at the point of agreeing to a procedure. Of course, it should be open to a patient to have a procedure without the data being recorded, but they would have to be made aware of the increased risk to their own health if problems with a device used in the operation were later to arise.
I have sought to reflect this point in Amendment 100 by making clear that collecting data should be subject to patient consent. None the less, the noble Lord, Lord Lansley, offers another way to deal with the issue by putting in the Bill that regulations under Clause 16 should have regard to the Caldicott principles. I do not see how the Minister could argue with that and I hope he will be able to give a positive response.
This group of amendments is designed to assist the Government and to catalyse faster movement on their part. I understand that Ministers see tracking and auditing the outcomes from the use of all medical devices as the right direction of travel, but as yet we do not have a destination or an estimated time of arrival. We need to hear both from the Minister this afternoon. I beg to move.
Lord Ribeiro (Con) [V]
My Lords, I thank the noble Baroness, Lady Finlay, for introducing this group. As a surgeon, I will focus on the registries and, in particular, the National Joint Registry—the NJR—and the Breast and Cosmetic Implant Registry. The noble Lord, Lord Hunt, was Parliamentary Under-Secretary of State when the NJR was introduced in 2003, with the aim to
“improve surgery through learning from best practice, and … improve the quality of care to patients.”
The NJR is the largest of its kind in the world, with data from 3 million hip, shoulder, knee, elbow and ankle replacements. In the last year before Covid-19, nearly 200,000 hip and knee replacements were recorded. By analysing this information, surgeons are supported in choosing the best artificial joints for their patients. It helps surgeons decide whether their patients need to return to hospital by flagging up problems with a particular type of implant. I was lucky enough to have bilateral metal-on-ceramic hip implants. Had I received a metal-on-metal implant, I would be concerned, as the NJR in 2010 identified higher than expected revision rates for metal-on-metal implants, with metal debris damaging patients’ soft tissue and causing pain and loss of function. Without the NJR’s comprehensive registry, hospitals would be unable to track their patients’ progress and identify problems early. Similarly, the Breast and Cosmetic Implant Registry records implants used in patients, along with the surgeon and organisation responsible for the procedure, allowing patients to be traced in the event of a safety concern or product recall.
Lord Lansley (Con)
My Lords, I am very glad to have the opportunity to follow my noble friend Lord Ribeiro and to speak to my Amendment 104. I am grateful to the noble Baroness, Lady Finlay of Llandaff, for bringing forward her amendments as well. They highlight some useful points and—particularly Amendment 101—focus on the necessity for patients to be provided with information and for patient experience to have its place in the information systems to be created under Clause 16. My noble friend Lord Ribeiro very helpfully illustrated that the benefit of the joint registry and similar information systems is not simply to promote safety but also to improve outcomes. We can certainly look forward to seeing both happening in the future.
My Amendment 104, to which the noble Baroness, Lady Finlay, and the noble and learned Lord, Lord Woolf have added their names, requires that the regulations made under Clause 16 include specific reference to the Caldicott principles. Noble Lords will recall the establishment of those principles back in 1997. They say that an organisation should:
“Justify the purpose for using confidential information”
and that the NHS should not
“use confidential data unless absolutely necessary”.
The NHS should:
“Use the minimum necessary personal confidential data”,
while
“Access to personal confidential data should be on a strict need-to-know basis … Everyone with access to personal confidential data should be aware of their responsibilities”
and, when using data, NHS personnel should “comply with the law”. In 2003, a seventh principle was added:
“The duty to share information can be as important as the duty to protect patient confidentiality.”
In a sense, a balancing principle was added as number seven. The amendment refers to those two reports, which have given rise to those principles. I am interested generally in the proposition of how certain we are that the Caldicott principles are being applied in every case. I think in these regulations it would be to the benefit if they were restated, given the importance of this as an information system.
I will ask three questions of my noble friend. First, can he assure us that the regulations themselves will make specific reference to the Caldicott principles? This would mean that we did not need to put it in the Bill. Secondly, in establishing these information systems, can we be assured that Caldicott Guardians will be appointed specifically in relation to each of the information systems that are to be established? Thirdly, can my noble friend tell us any more about the National Data Guardian’s consultation, which opened in June and closed in September, on an eighth principle:
“Inform the expectations of patients and service users about how their confidential information is to be used”?
This ties very directly into Amendment 101 in the name of the noble Baroness, Lady Finlay of Llandaff.
If it is endorsed by the National Data Guardian, that principle would give rise to an additional principle being reflected in the regulations. I freely confess that this is a good reason not to put my amendment in the Bill, because the nature of the Caldicott principles might well change in the immediate future, so it is not very helpful to entrench it in its current form. If we get the assurance that we are looking for from my noble friend, I hope the regulations, when they are made, will be able fully to reflect the Caldicott principles.
Baroness Burt of Solihull (LD) [V]
This string of amendments all talk about recording information, and I broadly agree with all of them. I particularly mention Amendment 104, in the name of the noble Lord, Lord Lansley, because of the mention of the Caldicott principles. Many people, particularly noble Lords in the Liberal Democrat party, jealously guard our right to privacy—hence the promissory tone of Amendment 100 in the name of my noble friend Lady Jolly.
The purpose of the proposed new clause in Amendment 107, to which I have put my name, is slightly different from that of the other clauses because it seeks to ensure that a proper systematic analysis is made of the effectiveness of mesh implants through registers. The Cumberlege review notes that registries are
“few and far between and all too often prompted by catastrophe”
in relation to transvaginal mesh and PIPs. This is obviously a good phrase because the noble Baroness, Lady Finlay, has already picked it out of the report.
This clause proposes a register. It requires the Secretary of State to report on progress towards creating databases relating to other devices. I appreciate that there are many databases out there—far more than I anticipated when first became involved in this Bill. The idea of the registries is to draw all this information together. As the Cumberlege report says,
“a ‘registry’ … would act as a repository for more complex patient related information datasets enabling research and investigation into patient outcomes.”
This would be more holistic and far more useful than just a database, enabling any adverse outcomes to be spotted early and not allowed to fester, literally, for years before defaults are spotted.
Patient groups must be consulted on devising the register. Time and time again, victims reported that they had not been listened to, despite the fact that the mesh felt “like razor blades” inside them. Never again must a patient feel patronised, unheard or left to suffer in silence. Of course, those healthcare professionals at the coal face, as it were, of the issues must have their say. We know that some registries exist today, but this database would bring everything together, instead of the piecemeal system we have at the moment.
I will go back to the lady whose poignant testimony I quoted at Second Reading, whom I called Jane. Jane had an estimated five pieces of mesh inside her, although the health professionals treating her maintained that there were only two. How can this be? I leave noble Lords to speculate but, in my view, this is a sharp indictment of the state of the service our health service gives to patients in this area. Unless we have a proper register of everything that is inside a patient, when it was inserted and what its performance record is, how are we going to enable them to be given the appropriate treatment when problems arise? The Royal College of Surgeons endorses this view—it wants all medical device implants overseen by registries.
Finally, I express my gratitude to the noble Lord, Lord Bethell, for the briefing this morning. I was very heartened to learn of the hard work going on in this area and the aspiration that a register for vaginal mesh implants could be up and running in only a year. I wish the Bill well.
Baroness McIntosh of Pickering (Con) [V]
My Lords, first, I apologise for not being able to participate at earlier stages of the Bill because of the clash with speaking in the Chamber. I congratulate the noble Baroness, Lady Finlay, on introducing these amendments and, especially, my noble friend Lady Cumberlege for all her work in preparing her report in advance of this. I also thank the Minister, my noble friend Lord Bethell, for briefing us this morning. I will particularly speak in favour of Amendments 100 and 101.
I hope that my noble friend the Minister will look favourably on patients being able to report directly to the register. The testimony that my noble friend Lady Cumberlege and others heard in the context of her report was very moving. As my noble friend Lord Ribeiro said, it is absolutely essential that the voice of patients is heard. This absolutely goes to the heart of medical and surgical treatment. We must ensure that, whether they have had a good or a bad experience, patients are able to place their experiences on the record. Amendments 100 and 101 go some way to achieving that. Were my noble friend not to like those amendments, I hope that the Government would come forward with a similar provision to put our minds at rest. I thank the noble Baroness, Lady Finlay, for these amendments, and I lend my support to them.
Baroness Masham of Ilton (CB) [V]
My Lords, Amendments 100 and 101 make clear that there should be means by which patients can report into registries directly so that they can be heard even if there is divergence of opinion with their clinician. Patients need to be protected. I support all the amendments in this group and thank those who tabled them, giving extra thanks to my noble friend Lady Finlay, who works so hard.
This is exceedingly important for many patients who have rare and complicated conditions. I speak from experience, as a high-lesion paraplegic. Many GPs and general doctors or surgeons may not be familiar with several of the peculiarities and may not understand the patient’s needs. For people with spinal injuries, for example, the three Bs are very important: bowels, bladders and bedsores. If not treated by specialists, patients can get into serious problems. Severely disabled people use all sorts of complicated devices that need to be kept on a register and to be easy to track if they go wrong. Suitable mechanisms should be found for the variety of needs, which can be inside and outside the body. This is particularly difficult in this time of Covid-19.
Baroness Jolly (LD) [V]
My Lords, I particularly welcomed the remarks of my noble friend Lady Burt, as they took me back to the days in the 1990s when I taught IT. I taught A-level students the differences between databases, tables and registers. I totally support these amendments about registries and databases relating to medical devices. They form one of the key recommendations of the review of the noble Baroness, Lady Cumberlege, in light of the scandals relating to, for example, vaginal mesh.
A huge number of patients have been affected by these incidents, and introducing registries allowing the use of implantable devices to be tracked, and allowing patients to view information relating to the data stored, would make a huge difference. Amendment 95, from the noble Baroness, Lady Finlay, changing “may” to “must”, is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill setting up the new information system envisaged by Clause 16.
Amendment 96, in the name of the noble Baroness, Lady Thornton, is a probing amendment seeking clarity about whether the Government intend to track all medical devices used in the UK, rather than a selection. Amendment 99, in the name of the noble Baroness, Lady Finlay, seeks to make mandatory the list of specified issues for regulations to cover. Her Amendment 100, to which I have added my name, would allow for the creation of a system of information regarding implants, with appropriate consents and oversights. It would also allow a patient’s experiences to be reported and stored; they should be subject to oversight. The noble Baroness, Lady Finlay, has also included the point about patient experience in her Amendment 101.
Amendment 104, in the name of the noble Lord, Lord Lansley, would require regulations under this section to have regard to the Caldicott principles. It was just over 20 years ago, when I was a non-exec director in a local NHS trust, that these principles were first introduced. I can remember the way that clinicians—in particular, senior clinicians—really welcomed the new measures. They certainly changed the way that clinicians thought about information and data. We are now moving through a different step change.
Finally, my noble friend’s Amendment 107 would require the introduction of a registry for patients who have had surgical mesh implanted. Though I appreciate that this looks retrospective, there should be data held in hospital databases that could be imported into the new registry. It would then give a complete overview of surgical mesh implantations. It would require the Secretary of State to report on progress towards creating databases relating to other devices or implants and how they would lead to the creation of registries.
Like other noble Lords, we favour registries as opposed to databases because, according to the Cumberlege review, registries act as a repository for more complex patient-related information datasets, enabling research and investigation into patient outcomes. A database is really just a three-dimensional table held in store, but a registry is a richer, more useful resource than a database. However, often a database is required before a registry can be created, which is why our amendment is framed in that particular way.
Baroness Thornton (Lab)
My Lords, this group concerns the need to set up information systems—registries—which will serve the purpose of tracking medical devices. I thank the Minister and the Bill team for their very enlightening and useful presentation this morning. The noble Baroness, Lady Finlay, and other noble Lords have already explained to the Committee how these registries and databases might work. The key point, which was made by the noble Baroness, is that they should be mandatory rather than permitted. Changing “may” to “must” so that the Secretary of State has to produce the information system envisaged by Clause 16 is a small but vital change. The Minister will need to explain to the Committee why, at this stage and after the experiences expressed and covered in the report of the noble Baroness, Lady Cumberlege, there should be any discretion in this matter.
The other amendments seek to ensure that patients have a direct route to report their experience to any information system established. Again, after the dismissal of so much patient experience over so many years in the cases outlined in First Do No Harm, it would seem to be the only way to guarantee that patient experience can be heard and registered.
Amendment 96 in my name is a probing amendment which seeks clarity about whether the Government intend to track all medical devices used in the UK, or just some of them. As other noble Lords have pointed out in the course of this Committee, if supermarkets have the technology and wherewithal to track the provenance of every single food product from anywhere in the world, we would need to understand why this would not be possible for medical devices.
Amendment 107 specifically addresses the issue of surgical meshes, and requires the production of a registry for patient safety. I hope that the Committee will be seeking to discuss registries and how they are linked. On Amendment 104 on the Caldicott principles, I do not see how anybody could possibly object to that.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, we had an excellent debate last week on the subject of medical device information systems at Clause 16, which is critical for how we will go forward on these points. The noble Baroness, Lady Finlay, seeks in Amendment 95 to confirm that the Government will make regulations to establish the system, not that they might. We will introduce this system; the noble Baroness provides no timescale attached to the obligation she introduces. It is essential that the regulations are informed by consultation. The discretion that “may” provides allows for this consultation to be conducted. We want the regulations to be right, not rushed.
I spoke last week on Amendment 96, in the name of the noble Baroness, Lady Thornton. Devices have varying levels of risk profile; it is our intention in the first instance to use the power in Clause 16 to require all implanted devices to be recorded in information systems. Implanted devices pose the greatest risk to patients and it is right that these should be prioritised. Consultation will help us to determine which devices ought to be captured by the information system.
On Amendment 99 in the name of the noble Baroness, Lady Finlay, we recognise the importance of all the issues in Clause 16(2): that is why they were explicitly referred to. However, there may be occasions where the inclusion of provisions in regulations on all four of the issues listed here is not appropriate or necessary. For example, in future we might wish to update the types of information in Clause 16(2)(a) to include, perhaps, a new way of recording a procedure or a device. We might have no immediate need for further provision under 16(2)(b) to 16(2)(d). Without the flexibility afforded by the current drafting, we would be prevented from making proportionate regulation limited to what was necessary.
On Amendment 100 in the name of the noble Baroness, Lady Finlay, the drafting of Clause 16(2) is sufficiently broad as to say, “among other things”. Regulation is not limited to the four suggested areas for provision at subsection (2)(a) to (d).
The noble Baroness suggests mandating recording of information on any medical device implanted into the human body and the information related to any other medical device as considered necessary for patient safety. Clause 16(2)(a) is sufficient for both these matters. While they are clearly important, the addition is unnecessary.
The noble Baroness adds a requirement of patient consent for the information to be recorded in the information system. I hope that the assurances that I provided to my noble friend Lady Cumberlege last week gave her some comfort on this point. I am happy to write further on this, but the noble Baroness will know that the information systems are conditional on regulations, on which we must consult.
The noble Baroness adds in her amendment expert oversight of any information system established under Clause 16(1). I do not think this is necessary. The information system acts as a database. Where expert oversight is needed is in the assessment of patient outcomes, where information is reviewed by clinical registries operated by experts in their field.
I understand the intent behind Amendment 101. I pay tribute to the noble Baroness, Lady Masham, and my noble friend Lady McIntosh, who put it very well. The patient voice is very important in the assessment of the efficacy and safety of medical devices, but I do not wish to confuse the purpose of the information system. It is a hub; it is not a decision-making tool. There are existing routes to raise specific concerns and experience of devices.
The yellow card scheme allows patients to complete and submit reports themselves. This gives a single, clear route for patients to avoid confusion about who to tell and how, and to ensure that all necessary parties receive all data relating to patient concerns. However, data used for analysis needs to be consistent in format and terminology to ensure that comparisons can be drawn and to maximise the ability to spot common themes and issues.
Amendment 101A in the name of the noble Baroness, Lady Finlay, is unnecessary. Even though the overarching objective of the information system is medical device safety, and therefore a reserved matter, I have made it clear that I am committed to ensuring early and ongoing consultation and engagement with colleagues in Scotland, Wales and Northern Ireland as we look to develop a UK-wide system. I say for the record that it is of great importance to us all that we work together to improve the safe use of medical devices across the four nations. I strongly agree that there is a need for a centralised approach to address the existing gaps in the traceability of medical devices placed on the market. The Government have already introduced Amendment 126 to Clause 41. Therefore, it is neither necessary nor appropriate to set out the engagement or working arrangements between the four nations in regulations.
I understand that the aim of Amendment 104 in the name of my noble friend Lord Lansley is to ensure that organisations protect any information that could identify a patient, such as their name and their records. I reassure him and others who have spoken to the amendment that this information is used and shared only when it is appropriate to do so.
On the Caldicott principles and guardians, I am sure that these matters will be brought forward by others in consultation. That is the forum for addressing these points. Adherence to the Caldicott principles is expected of all NHS organisations, including—some would say most of all—NHS Digital. The Caldicott principles have been developed into the national data guardian principles that apply in England. GDPR also requires that personal information be treated in this way. All data collected by the information system will be subject to GDPR. The intention is that the medical device information system should hold patient-identifiable information. Information that is de-identified will be shared with the relevant organisations to ensure the protection of that patient. It is unlikely that there would be any requirement to share patient-identifiable information with other organisations. MDIS would be programmed to know, when provided with notices by MHRA or others, that action needed to be taken and which patients it applied to.
Parliament oversees data protection legislation. The standards are very high, and we have no intention of lowering them. I do not think, therefore, that having regard to the Caldicott principles is necessary or would add anything material to the legal constraints that would apply to this information. Of course, we have no intention of doing anything contrary to those principles through this legislation. Regulations under Clause 16 will be subject to public consultation. Under GDPR, they are also subject to the requirement to consult the Information Commissioner’s Office. We have already begun discussions with the Information Commissioner’s Office on this basis.
The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)
I have received a single request to speak after the Minister, so I hope that we can now go to the noble Baroness, Lady Cumberlege.
Baroness Cumberlege (Con) [V]
No, that is a mistake. Somebody else involved with the conversation that I have been having thought that I wanted to come in on this occasion. I thought that I would give noble Lords a rest—they hear enough from me, so on this occasion I did not want to come in.
The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)
I thank the noble Baroness, Lady Cumberlege—that is very gracious. On that basis, we have nobody else to come in after the Minister at this point so I come directly to the noble Baroness, Lady Finlay of Llandaff.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I thank all noble Lords who not only spoke in support of the amendments in this group but expanded on them and provided additional information.
I understand the Minister saying that it is important to get this right and not rush, and that the consultation will inform the SIs. I also understand him pointing out the rigidity of primary legislation. I accept his points and am glad for the assurances he was able to give.
I stress the importance of looking at all implantable devices, even those that look as though they are in such common use that we do not need to worry about them. An example happened just a couple of weeks ago when a guide wire for a pacemaker snapped inside a patient. Completely unknown previously, these things can happen. They need to be picked up and recorded.
We also need to update the way in which we record information and use the new artificial intelligence computer systems to analyse it. The reason I asked for expert oversight is that there is no point in putting information into any kind of database unless the right information is extracted from it, and expertise is needed to set that up. I accept, however, that this is a hub, not a decision tool in itself.
The yellow card system that the Minister spoke about needs to be publicised much more widely. I hope that, as we go forward, there will be a positive move across the whole of healthcare, in particular to make sure that patients are aware of this scheme so that they can use it appropriately and early. It is an amazing scheme; I pay tribute to Professor Phil Routledge, who instigated it many years ago—decades ago, I think—as a way of collecting adverse reactions.
I appreciate the Minister’s assurance about working with the devolved nations, particularly in the light of the unfortunate remarks made recently about devolution. It is important to have compatible information systems and oversight that allows the free movement of information. That happens in the UK Foundation Programme Office and the UK medical and dental recruitment offices, where four-nation oversight works well. I know that those types of medical practice are outside the Bill’s remit but we have examples of good working, which needs to be built on to cement the sharing of information across the different healthcare systems.
With that and with all the points made, which I hope will thoroughly inform the statutory instruments as they are developed, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)
I should alert the Committee to the fact that the House may divide during the next debate. I will adjourn our proceedings accordingly. We now come to the group beginning with Amendment 105. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 105
Baroness Wheeler
“Requirement for consultation with devolved authorities
(1) Before making regulations under section 16 that contain provision which is within the legislative competence of a devolved legislature, the Secretary of State must consult the relevant devolved authority on that provision and have regard to the views of that devolved authority.(2) In this section—“devolved authority” means the Scottish Ministers, the Welsh Ministers, Northern Ireland ministers or a Northern Ireland department; and“devolved legislature” means the Scottish Parliament, Senedd Cymru or the Northern Ireland Assembly.(3) A provision is within the legislative competence of a devolved legislature if—(a) it would be within the legislative competence of the Scottish Parliament if it were contained in an Act of the Scottish Parliament;(b) it would be within the legislative competence of Senedd Cymru if it were contained in an Act of Senedd Cymru (including any provision that could only be made with the consent of a Minister of the Crown); or(c) the provision, if it were contained in an Act of the Northern Ireland Assembly—(i) would be within the legislative competence of the Assembly, and(ii) would not require the consent of the Secretary of State.”Member’s explanatory statement
This new Clause would require the Secretary of State to consult the devolved administrations before making regulations concerning UK-wide information systems.
Baroness Wheeler (Lab)
My Lords, I am moving Amendment 105 on behalf of my noble friend Lady Thornton; it leads the group of amendments following Clause 16, which provides the legal framework for the medical devices information system. I will also speak to our other amendments in this group—Amendments 128, 130 and 132—and on the remaining amendments, including government Amendment 126.
The number of amendments in this group shows the strength of feeling on this issue. Key issues raised last week and in debate on Clause 16 earlier today are also relevant here. As we have all stressed, First Do No Harm, the landmark report by the noble Baroness, Lady Cumberlege, very much places the importance of the MDIS system centre stage. The complete lack of safety data and record-keeping on pelvic mesh implants in thousands of women—including basic details about the patient’s name, medical history and health problems, and manufacture and supply information for these devices after implantation, which would have enabled patients to be traced and treated—reinforces the need for MDIS and its future role as both an information and tracing system.
Amendment 105 would add a new clause after Clause 16 to place a statutory requirement in the Bill that the devolved Administrations in Scotland, Wales and Northern Ireland must be consulted before regulations on the MDIS are laid and that the Secretary of State must have regard to the views of the devolved authority. Government Amendment 126 and Amendments 105, 127, 128, 129 and 132 all aim to strengthen consultation provisions, including public consultation before making regulations under any provision of Parts 1, 2 or 3 of the Bill or under Clause 16(1).
This focus on the importance of consultation and ensuring that NHS Digital—with its existing remit and expertise limited to England—fully engages in meaningful and active collaboration with the devolved authorities is absolutely crucial for the UK-wide development of MDIS. If the system is to be fit for purpose, the work to deliver it must be informed by and responsive to the local requirements and realities across the devolved Administrations. The devolved nations must be fully involved in the system’s design and modelling, have equal access to MDIS data analysis and sharing, have a governance structure for MDIS that includes representatives from all the devolved authorities’ institutions, and have parity of funding across the four nations.
I am very grateful for the helpful correspondence of 9 November from the Minister to the noble Baroness, Lady Finlay, regarding MDIS and working with the devolved Administrations. It was shared with Members, together with the 4 November letter from NHS Digital setting out its intended “collaborative approach”. These letters contain a number of assurances on both the current work being undertaken and how the future four-way relationship needs to be taken forward to develop the UK-wide system.
The remaining amendments in this group, including the government amendment, refer to the general duty under Clause 41 to consult before making regulations. Our Amendment 132 would insert a new clause on the duty to consult the devolved Administrations and “have regard” to their views. I hope the Minister will agree that that is not an unreasonable requirement.
Government Amendment 126 would amend Clause 41 to ensure consultation with the devolved authorities under Clause 16, headed “Information systems”. Although the inclusion of this statutory duty to consult as far as Clause 16 goes is a step forward, other key parts of the Bill have an impact on the devolved authorities. We want to see a general duty in Clause 41 to consult the devolved Administrations, as is common practice in a number of Bills—not just limited to consultation in relation to Clause 16. I hope that the Minister will undertake to review the Bill after Committee and consider this key point in relation to Clause 41.
In his 13 October letter to noble Lords, the Minister refers to the Government’s amendments as providing “certainty” that the Government will ensure that the devolved authorities’ views are heard throughout the development of the regulations and in their implementation. The certainty given, however, is in relation only to Clause 16 and not to the rest of the Bill, as we would like to see.
Amendment 130 is a probing amendment that would remove the permissive provision in Clause 41(3) that consultation carried out before the Act was passed could satisfy the duty to consult. This clause is very open-ended. Can the Minister provide details of the purpose and intended use of this provision? There is no explanation in the Explanatory Notes. Will there be a time limit on how up to date a consultation needs to be for it to be considered done and dusted?
Lord Patel (CB) [V]
My Lords, in speaking to my Amendment 127, I also speak in support of the amendments referred to by the noble Baroness, Lady Wheeler, on consultation with the devolved Administrations. While Scotland is devolved in terms of healthcare, the regulations on medicines and medical devices, particularly market authorisation, is not. I support the comments on consulting the devolved Administrations and I have no doubt that the Minister will respond.
I am extremely grateful to my friend, the noble and learned Lord, Lord Mackay of Clashfern, for adding his name to my Amendment 127. I am pleased to see that he might speak to it later. The amendment would add to line 9, page 24 of the Bill, the words
“patients and end users directly affected by the regulations”.
It would strengthen the consultation provision by requiring that patients and end users be part of any consultation relating to potential new regulation on medicines, veterinary medicines and medical devices.
Clause 41 creates a duty to consult the relevant authorities when using the delegated powers to make provisions for medicines, veterinary medicines and medical devices. However, this duty refers only to who the authority thinks it should consult, giving a wide area of discretion and providing no guidance or guarantee on consulting patients and end users of medicines and medical devices.
The Cumberlege review found widespread failure to listen to patients’ voices. It recommended that the regulatory framework underpinning the MHRA, and medicines and medical devices in general, be reformed to better take into account patients’ perspectives in the future. In addition, the review recommended that the MHRA regulatory framework should have a requirement to demonstrate how patient views have been taken into account and influenced regulatory design. With this in mind, it is surely crucial that any duty to consult on the exercise of powers should also include reference to the need to consult patients and end users of medicines and medical devices where that is considered reasonable.
I have been deliberately brief because this proposal is so obvious that I do not, I hope, need to speak at length. I am sure that the Minister recognises this, and I look forward to his response.
Lord Sharkey (LD) [V]
My Lords, all the amendments in this group deal with the very important question of consultation. As the DPRRC has pointed out in its report on the Bill, consultations are not a substitute for proper parliamentary scrutiny, which the Bill so obviously fails to provide, but in the absence of any real parliamentary mechanisms for real scrutiny, consultations take on an added importance.
Clause 41 is slightly improved by the Government’s Amendment 126. The obligation to consult the devolved Administrations is obviously critical, although it would be helpful if the Minister could explain why in Northern Ireland it is the Department of Health that must be consulted rather than Ministers.
The Minister may also be able to reassure the Committee that the government amendment does not provide only one overriding consultation; the text seems to suggest that when it refers to carrying out “a public consultation”. Can we assume that there will be not portmanteau consultations but individual consultations on each proposed significant policy introduction, change or amendment?
The introduction of a new obligation in proposed new subsection (1B) to include a summary in the consultation document, with the relevant authority’s assessment of the matters addressed by the proposed regulations is welcome, as far as it goes. But quite what depth or rigour should these assessments have? Can the Minister assure the Committee that the assessments will have the same reach, depth and rigour as the standard impact assessments produced for SIs?
Apart from naming the devolved Administrations, it is notable that the government amendment does not specify, or even hint at, who should be consulted in any of these consultations. The Bill is entirely silent on the matter. This leaves open the possibility of narrowly drawn consultations and the omission of important interested groups, not to mention short consultations over holiday or very busy periods. I am particularly concerned that the voice of the medical research charities be clearly heard in all the appropriate consultations. I remind the Committee of my interests as chair of the Association of Medical Research Charities, whose 150 members spent £1.9 billion on research last year—the same amount as was spent by the Government. Despite this enormous contribution, the Government have form in overlooking the medical research charities sector. It took an amendment moved in your Lordships’ House to persuade the Government to agree that the board of UKRI should include a person with experience of the sector. We do not want to see the same omission here.
Our Amendment 129 is very similar to Amendment 128 in the name of the noble Baroness, Lady Thornton, which we are happy to support. Both amendments list who must be included in any consultation. The lists should not be contentious or surprising. We include
“representatives of the relevant patient groups … medical research charities”
and pharma as statutory consultees, along with academic researchers. We leave it open to the relevant authorities to add others to that list.
Our amendment also addresses the problems that could be caused by short and short-notice consultations, perhaps over holiday periods among a less than comprehensive range of consultees. It simply requires the relevant authorities to publish on their websites the terms, start dates and lengths of the consultations, along with the proposed consultees and
“date and method of the publication of … results”.
I rather hope that the Minister will tell us that this part of our amendment is not necessary. I hope that he will see our amendment as an opportunity to give firm assurances to the Committee that the groups we name will be consultees, and about the form and detail of each consultation, as we propose. I hope the Minister will feel able to oblige us.
The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)
I have been made aware that a Division may happen in the course of the next contribution. I apologise in advance to the noble Baroness, Lady Bennett of Manor Castle, should we have to suspend the Committee. I now call the noble Baroness, Lady Bennett.
Baroness Bennett of Manor Castle (GP) [V]
It is a pleasure to follow the noble Lord, Lord Sharkey. I share his concerns about the quality, depth and effectiveness of far too many consultations. As he was speaking, I was looking at an editorial article in the British Medical Journal, which says:
“The medical-political complex tends towards suppression of science to aggrandise and enrich those in power.”
That is a powerful message.
I will speak specifically to Amendments 105 and 132, in the name of the noble Baroness, Lady Thornton, to which I have attached my name and which have been ably introduced by the noble Baroness, Lady Wheeler. I do not feel the need to speak at great length—maybe I will manage to beat the bells, but we shall see. However, I want to reflect on the fact that both Amendment 105, in addressing information systems and Amendment 132, in addressing regulations, specify full consultation with the devolved Administrations. As the noble Baroness, Lady Finlay, noted in her summing up on the previous group, the Government’s attitude towards devolution is a little uncertain. It would seem that the Prime Minister’s view changes from one hour to the next, according to recent reports, but it is terribly important that we see in the Bill an absolute commitment and requirement to consult the devolved Administrations.
In his comments on the initial group, the Minister noted that data needs to be consistent. Speaking as someone who has occasionally been forced to manipulate databases and work with Excel spreadsheets, although that is certainly not my favourite thing, I think we all know the problem with inconsistent data and the kind of outcomes that it can produce. It is crucial—
The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)
I am afraid I have to interrupt the noble Baroness, Lady Bennett, because we are now about to have that Division.
The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)
My Lords, we are now reconvening the Grand Committee and I call upon the noble Baroness, Lady Bennett of Manor Castle, to perhaps recapitulate her speech and continue thereafter.
Baroness Bennett of Manor Castle (GP) [V]
Thank you. I will not go back to the beginning but I was speaking about the need for consistent data, which the Minister referred to in his earlier summing up. We have, of course, diverging systems and that is the point of devolution: it is for the devolved nations and Administrations to be able to go their own way and end up with quality, easily comparable data. It is obvious that there will need to be very tight consultation and working together. Amendments 105 and 132 would put this into the Bill, Amendment 105 being particularly important in terms of data.
I will also refer briefly to the other amendments in this group. As the noble Baroness, Lady Wheeler, said, government Amendment 126 is an improvement. Any kind of strengthening of consultation, as in the references to the public and devolved Administrations, is good but it is only partial. I can only commend Amendments 127 to 130 for pushing further on these issues. We know from the report of the noble Baroness, Lady Cumberlege, that so much needs to be done better. Transparency, openness and consultation are clearly key to all of that.
Lord Mackay of Clashfern (Con) [V]
My Lords, I join my noble friend Lady McIntosh of Pickering in apologising for having my name to amendments here while I have found myself in proceedings on another Bill which was fairly encompassing in the sense that it required a good deal of attention to understand what was going on. We were not able to achieve the result that the noble Baroness, Lady Finlay, managed of being in both places at once. However, I am glad to be here on this occasion and I am particularly interested in Amendment 117, which we may reach later.
In this group, I particularly support Amendment 127, which the noble Lord, Lord Patel, has carefully referred to already. I generally support all that has been said by others before me on this group of amendments, especially the reference of the noble Lord, Lord Sharkey, to the need to keep in mind the medical charities. I think particularly of Cancer Research, but it applies equally, as he said, to all of them.
I wondered whether the government amendment made unnecessary some of our amendments, but I really wonder about that, because a public consultation is not specifically targeted, and I think the groups that we have represented—particularly in relation to Amendment 127—require to be consulted more directly. I do not know how your Lordships feel about consultations, but I often find that I did not know that there was a consultation at all until the time allowed for it was well passed. That is no doubt due to my lack of efficiency, but I suspect that a lot of patients will not know that a public consultation is happening unless it is drawn specifically to their attention. It is important that the consultation, public as it is, has direction as well. Therefore, I think that Amendment 127 and the other specific amendments are well worth considering in relation to the new government amendment.
I am also extremely anxious that the devolved Administrations should be properly consulted. Of course, devolution and independence are different things, and we are talking about devolved institutions at present. This group of amendments is important, and I agree with most of what has been said about them. Therefore, I do not need to say any more on this occasion.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to follow the noble and learned Lord. I have added my name to that of my noble friend Lady Thornton to Amendment 128, which was introduced by my noble friend Lady Wheeler. This regards the organisations to be consulted—other noble Lords have already referred to this—and concerns the provisions of Clause 41 for consultation on Parts 1, 2 and 3 of the Bill. As noble Lords have said, at the moment, it is entirely up to the Secretary of State who is consulted, other than the clarification the Government have brought in relation to the devolved Administrations.
The context of this amendment is the extensive power given to Ministers under the Bill. We have debated this before, but it is worth reminding the Committee that the Delegated Powers Committee in its report on the Bill was highly critical of Ministers for failing to provide sufficient justification for parts of the Bill adopting a skeletal approach. As the committee said, the Bill gives Ministers wide powers to almost completely rewrite the existing regulatory regime for medicines and medical devices.
It is also worth reminding the Committee that the Constitution Committee described the Bill as
“a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made using the powers.”
It went on to say:
“The Government has not provided the exceptional justification required for this skeleton approach.”
The case for a sunset clause is readily apparent, but in its absence, the way in which consultations are done assumes more importance than normal. It is very surprising that the duty to consult is open-ended and simply leaves it to Ministers to decide who to consult. The Minister may say that he does not like lists of organisations to be consulted, but legislation is littered with lists of organisations because it is important to reflect the range of bodies that ought to be consulted. Discretion is always given to Ministers to add to those lists of organisations.
I hope that the Minister will be prepared to take this back because in the end, certainly in the absence of a sunset clause, we have to beef up the provisions on consultation.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I support in particular Amendments 105 and 127 in this group, but I shall speak briefly to Amendment 105 and thank the noble Baroness, Lady Wheeler, for introducing this short debate on it. In the context of the proposal for a requirement to consult the devolved Assemblies, I share the concern expressed by my noble and learned friend Lord Mackay of Clashfern: it is essential that we keep all the devolved Assemblies in tune with Westminster thinking as the Bill and the regulations under it progress.
Baroness Jolly (LD) [V]
My Lords, these amendments relate to consultation. My noble friend Lord Sharkey’s Amendment 129, to which I have added my name, specifies some people or classes of people who should be involved but who have in the past been omitted—patients or representatives of patient groups, medical research bodies, the pharmaceutical industry and academic researchers.
My noble friend asked a good question of the Minister about why the consultation in Northern Ireland is with the department and not the Minister. The Select Committee on which I sit has engaged with the Northern Ireland Government in various areas of policy. They often do things well, but they do it their way.
The amendment also calls for details about consultation timings, consultees and proposed publication details. The point the noble and learned Lord, Lord Mackay of Clashfern, made about contacting patients was a really good one. His remarks follow on from those of the noble Lord, Lord Hunt of Kings Heath. Many consultations involve patients, but they are often with what I might call professional patients. This is not a derogatory statement, but sometimes they are the usual suspects and the story does not change. That can lead to a loss of a total patient view.
Government Amendment 126
“requires a relevant authority to carry out a public consultation before making regulations under any provision of Part 1, 2 or 3, and to set out the authority’s assessment of any matter to which the authority must have regard in making the regulations”.
It also requires the Secretary of State
“to consult the devolved administrations in relation to regulations under clause 16 (1).”
In this morning’s useful meeting—I join others in thanking the Minister for hosting such a fascinating session—we touched briefly on Scotland, Wales and Northern Ireland. Would the Minister confirm that the devolved nations are being consulted on their involvement in their use of our registries, and maybe ours of theirs?
Amendments 125, 127 to 130 and 132 all relate to consultation when making regulations, including, but not limited to, the devolved Administrations, patient groups, various healthcare organisations and academics. Consultation is key to all this, with clinicians, who will give you one set of information, but even more so with patients, who will give you a different, richer, more detailed dataset.
Lord Bethell (Con)
My Lords, Amendment 105, tabled by the noble Baroness, Lady Thornton, would mandate consultation with the devolved Administrations before making regulations under Clause 16. This question has been raised by a very large number of those who have contributed. Amendment 132, also tabled by the noble Baroness, would insert after Clause 41 a separate obligation to consult on regulations made under the Bill that relate to matters within devolved competence.
Both amendments are unnecessary. It goes without saying that we will consult the relevant Northern Ireland departments where it may be possible to make regulations jointly under Parts 1 and 2 of the Bill for the benefit of the whole of the UK. I reassure the noble Baronesses, Lady Jolly and Lady Masham, and all others who mentioned consultation with the devolved assemblies that we are in very regular contact. There are fortnightly four-nations calls. These include NHS Digital where necessary. We intend to maintain this level of engagement. It has proved constructive and has contributed enormously to our plans for broad consultation on the mechanics of the Bill.
While medical device regulation relates to reserved matters, the provision of healthcare services, including the healthcare data collected, is devolved. As the regulations about the establishment and operation of the information systems encompass both areas of responsibility, it is right and proper that the Secretary of State is required to consult the devolved Administrations before making regulations under Clause 16(1).
The noble Baroness’s amendment appears on the list before my own, but Amendment 126 in my name, which I will come to shortly, is appropriate for this situation. It makes it very clear that the devolved Administrations will be consulted on regulations to be made under Clause 16. This reflects that provisions in those regulations may relate to devolved as well as reserved matters.
Amendment 127 in the name of the noble Lord, Lord Patel, is unnecessary. My Amendment 126, which I will come on to shortly, would apply a statutory duty to carry out a public consultation precisely because we know how important it is for patients and other stakeholders to be involved. The intent of Amendment 127 is already achieved by Clause 41 and is further clarified by the government amendment.
Amendments 128 and 129, tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Sharkey, would commit the appropriate authority to consult all those listed before making regulations under the Bill. We all wish to ensure that a range of views are adequately captured. However, we do not wish to inadvertently rule out contributions from those accidentally not listed. Those listed in the amendments would not necessarily be directly affected by each regulation. For example, regulations relating to human medicines prescribing would not affect veterinary medicines. I reassure the noble Lord and the noble Baroness that the consultations will have depth and reach, and that medical research charities will be fully involved. Requiring consultation with all those listed would be unduly burdensome and seemingly add little value to the making of regulations.
On Amendment 130 in the name of the noble Baroness, Lady Thornton, I completely understand that there are perhaps some concerns with the extent of consultation, or, indeed, its duration, or that the Government might seek to consult on proposed regulations without sufficient notice to those wishing to comment. This is simply not the case, but limiting us in this way may hinder the delivery of important regulations coming into force. If the Bill were to be significantly delayed, it would mean that we could not make an efficient start on consulting stakeholders on key policy areas, such as on a future regulatory system for medical devices.
Whether consultation is conducted prior to the Bill achieving Royal Assent or afterwards, we will make it clear to stakeholders when the consultation processes will start and end. Consultations will be targeted, form part of a process of engagement and last for a proportionate amount of time. For my part, I cannot wait for the process to begin. It is very exciting.
I know that noble Lords want to know our plans for consultation, as do I, and when precisely that will begin. I reassure my noble friend Lady McIntosh that we will publish responses to consultation. We will follow the Cabinet Office guidance, which is extremely stringent. I am incredibly enthusiastic to reach that next step and to begin to make changes to the regulatory regime to deliver a comprehensive, stand-alone and first-class medical devices system, as well as to consult and have the benefit of informed views, like those of the noble Lords, Lord Kakkar and Lord Patel, among others, when we discussed provisional rapid licensing.
I want to make changes to the clinical trials regulations and to consult on how we can make improvements and update definitions. Also, of course, I want to bring in the medical devices information system regulations so that we can establish a world-leading medical devices safety regime. I indicated the intention to consult in the first quarter of 2021 on the innovative medicines fund. We intend to start public consultation on the medical devices information system in May 2021. We also hope to take forward the medical devices regulations consultation over the summer of 2021. There is obviously sequencing to do on all the other measures that we will want to bring in. I will update the House on our consultation plans in due course. The dates are dependent on getting the Bill done, of course.
As to Amendment 126 in my name, I heard the noble Lord, Lord Blencathra, ask at Second Reading how Parliament could be consulted on regulatory changes. Others reflected on the importance of consulting patients on the regulatory changes that impacted or mattered to them. I know that there has been concern about whether the relationship to the pharmaceutical and medical device industries is such that they might be unduly weighted in consultation, but I assure noble Lords that that is not the case.
To provide reassurance, Amendment 126 changes the obligation in Clause 41 to public consultation. The effect of the amendment would not be to prevent the appropriate authority from inviting responses from certain stakeholders or groups as the authority might consider appropriate. Engagement and close working will continue, but Amendment 126 will ensure greater transparency and enable even more people to become involved in the consultation.
The duty to consult the devolved nations on Clause 16 has been the subject of ongoing conversations and correspondence between Ministers in the devolved nations and me. I spoke earlier about the nature of these regulations relating to both reserved and devolved matters. Specific considerations will need to be taken into account in relation to how the devolved healthcare systems function and we want to ensure that any information system that we create is as effective as it can be. The information system will provide an important tool for improving the safety of medical devices for patients throughout the four nations of the United Kingdom. It has always been our intention to consult fully the devolved Administrations on the development of the regulations. I am making this change to provide greater reassurance and confidence, both to the devolved nations and to Peers who have raised the significance of ensuring interoperability between any such information system and devolved healthcare systems.
The final change made to Clause 41 by Amendment 126 will mean that participants engaging with the consultation can understand how the considerations have been taken into account so far. This additional transparency will, I hope, provide noble Lords with assurances that we have taken the criticisms on board and have provided a method for Parliament, the public and stakeholders to know how our thinking progresses throughout the development of regulations made under the Bill.
The combination of these changes strengthens the consultation requirement in the Bill. I hope that, taken together with amendments that I have made elsewhere in the Bill, it goes some way to meeting your Lordships’ concerns and that the noble Baroness will feel able to withdraw her amendment. I commend my Amendment 126.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I have received a request to speak after the Minister from the noble Lord, Lord Hunt of Kings Heath. I am not clear whether the noble Lord, Lord Patel, also wishes to do so. Perhaps that could be clarified.
Lord Hunt of Kings Heath (Lab) [V]
I thank the Minister for his extensive response. Essentially, he has relied on the well-known departmental argument that, by listing certain categories of organisation, you exclude others. However, legislation that has been passed in the last few years has often contained extensive lists of organisations to be consulted. Amendment 128, which I support, would give Ministers the power to consult any other persons that the authority considered appropriate. I wonder whether the Minister will just answer this. He would surely accept that this Bill is highly unusual in giving a huge amount of powers to Ministers essentially to change primary legislation through regulation and extensively to alter the regulatory framework for medicines and medical devices. Given that, we should be careful about similarly open-ended regulations on consultation. The amendment would provide reassurance to the key sectors that they will be consulted, but it would also give discretionary power to Ministers to add to that on the occasions when greater flexibility was needed.
Lord Bethell (Con)
My Lords, I acknowledge the noble Lord’s point that the Bill puts huge emphasis on the effective and impactful nature of our consultation arrangements. That is very much our approach. He is entirely right that these consultations are key. That is why we have sought, as I have this afternoon, to give reassurances about our approach to consultation.
On the noble Lord’s point about the listing of groups, we have in mind two considerations. The first is that, by listing one group and not another, you assign a degree of legislative weight on one group and not the other. That is an unfortunate result of a listing process such as he describes. Secondly, as I have said, not all the groups that you could list in one part of the Bill would be relevant for all parts of the Bill. For that reason, we are reluctant to provide lists of groups that technically have to be consulted on every aspect of the Bill.
I take the noble Lord’s point that broad, effective and deep consultation is critical to the effective implementation of the Bill and to the drafting of thoughtful and effective regulations. All those involved in the Bill, including the department and me, very much agree with that point. That is why I tabled the amendment.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I have not received any further requests to speak, so I call the noble Baroness, Lady Wheeler.
Baroness Wheeler (Lab)
I thank the Minister for his extensive and helpful response, particularly on the comments made by my noble friend Lord Hunt about the groups that are consulted. This has been an excellent debate and I have little to add, as noble Lords put forward the issues so ably, in particular on the importance of listening to patients and patient representatives so that the consultation is meaningful and well thought through, given the enormous powers that are in the Bill and will be set out in the regulations. It is timely for my noble friend to remind us of the context of the DPRRC and Constitution Committee reports. I asked the Minister to consider whether Clause 41 should specifically include reference to consultation with the devolved authorities. If he could come back to me on that, that would be helpful. I also asked some questions about his correspondence, which I hope he will agree to follow up.
Lord Bethell (Con)
On the question why the government amendment is being made to Clause 41 rather than Clause 16, which I think is what the noble Baroness is asking about, Clause 41 is concerned with consultation. It is important that consultation requirements are provided for in one place, as that assists with clarity and understanding. The legal effect is the same, irrespective of where in the Bill the obligation to consult the devolved Administrations when making regulations under Clause 16 is found.
Baroness Wheeler (Lab)
I thank the Minister for that and I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
We now come to the group beginning with Amendment 108. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 35: Disclosure of information
Amendment 108
Lord Patel
“( ) The Secretary of State must disclose information for the purpose of warning the public about concerns relating to a medical device where there is a clear threat to public safety.”Member’s explanatory statement
This amendment places a duty on the Secretary of State to disclose the information where there is a clear threat to public safety.
Lord Patel (CB) [V]
My Lords, in moving Amendment 108, I will also speak to Amendment 114. I am immensely grateful to my friend, the noble and learned Lord, Lord Mackay of Clashfern, for his support. I beg noble Lords’ indulgence because I intend to explore these two amendments in some depth as I have some concerns about them.
Amendment 108 places a duty on the Secretary of State to disclose information
“where there is a clear threat to public safety.”
Clause 35 provides that the Secretary of State
“may disclose information for the purpose of warning members of the public about concerns that the Secretary of State has in relation to the safety of a medical device.”
This is welcome, but the power is discretionary. There is no duty to disclose information in these circumstances. It is not clear why there should not be an unambiguous duty to disclose information to the public where their safety is an issue. The Government have repeatedly committed themselves in their guidance and policy documents to patient safety as their primary concern, and have given reassurances about it in the other place. However, this clause is yet another example of where there is no explicit legal commitment to patient safety. For this reason, an amendment to this clause is suggested to create a duty to disclose information where there is a threat to medical device safety.
In addition, it must be queried what is meant by a “threat to public safety” and how any such threat is to be judged or even detected. The Cumberlege review reviewed the failure of medical professionals and the system in general to listen to patients’ own reports of pain and the seriously adverse effects of their implants. The duty to disclose a threat is only as meaningful and effective as the processes behind it that monitor and capture the information relating to patients’ adverse events. A safety issue will not be recognised if patients are not being taken seriously.
Part of the findings of the Cumberlege review related to the ineffectiveness of the current yellow card system for self-reporting adverse events. There is a lack of a clear and well-publicised route for patients to report their experiences. Clear and effective processes need to be in place to capture the information relevant to identifying potential threats to public safety. This duty to disclose should be supported by such processes.
Clause 16 gives the power to create an information system, and a later amendment introduced by the noble Baroness, Lady Cumberlege, on the setting up of a patient safety commissioner, could form part of the processes needed to ensure that the experiences of patients and the reporting of adverse events are effectively monitored, recorded and evaluated. However, effective self-reporting processes and clear routes for patients to self-report need to be established. Clarification of how such reporting is to be integrated into effective communication across the NHS and the medicines and medical device regulatory framework as a whole is needed.
As the Bill stands, so much is left unsaid and what has been laid out for Parliament to discuss was drafted and conceived before the findings of the Cumberlege review were published. Any patient safety commissioner would need to be properly resourced if they were to work in practice—equally there should be more consideration by the Government of processes for patient reporting and communication across the system. That ought to be put before Parliament.
Amendment 114 would mean that Regulation 3B on the requirement for confidentiality in the Medical Devices Regulations 2002 would remain in place. It is suggested in the Bill that this is removed. Clause 37 provides for “Consequential and supplementary provision”. Subsections (3) to (7) of Clause 37 variously amend the Medical Devices Regulations 2002. In particular, subsection (5) removes Regulation 3B from the 2002 regulations. This was only recently inserted into the law by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. Regulation 3B requires that
“all parties involved in the application of these Regulations must respect the confidentiality of information and data obtained in carrying out their tasks in order to protect … (a) personal data in accordance with the Data Protection Act 2018; (b) commercially confidential information … (c) the effective operation of … inspections, investigations or audits.”
It is not clear why the requirement for confidentiality has been removed so soon after it was created. While Clause 35 provides that commercially sensitive data cannot be disclosed except where necessary for the Secretary of State to warn of serious harm in civil proceedings or criminal proceedings, no other clauses in the Bill reflect the similar requirements that have now been removed by Clause 37. It is concerning that in removing the requirement for confidentiality, the Bill seems to emphasise protection for commercial interests more than those of patients and users.
The Government should provide clarity on why they wish to remove this condition to respect patient confidentiality in operating the Medical Device Regulations. This not notwithstanding, Clause 37(5) should be removed.
Lord Mackay of Clashfern (Con) [V]
My Lords, I warmly support the noble Lord, Lord Patel, in both these amendments. First, in relation to safety, the idea that the Secretary of State “may” disclose information in relation to concerns about patient safety strikes me as extraordinary. If I knew that something was dangerous and that somebody was just about to take it, I think I might be in very grave difficulty if I did not warn the person. The idea that the Secretary of State can have information that suggests a danger to people, and yet is allowed to keep it to himself in the exercise of his discretion, strikes me as extraordinary. It may require some explanation from the Minister as to why that should be. There is a tendency to provide for discretion rather than compulsion. We have seen a bit of that already this afternoon. In the area of safety, discretion should certainly give way to compulsion where it is a matter of risk to a person who is involved.
Amendment 114 concerns confidentiality. Patient confidentiality is one of the most important aspects of the law on medical treatment. It requires to be taken into account very carefully because people have a great concern about the confidentiality of their medical situation—some people more than others because it depends on the origin of the difficulties of the medical history. The general principle of confidentiality in relation to patients is, in my opinion, extremely important and I cannot understand why this little provision has been included that interferes, in my mind, with a very important principle, without much explanation. I support both these amendments.
Baroness Cumberlege (Con) [V]
I put my name to Amendment 108 and, when listening again to the noble Lord, Lord Patel, and my noble and learned friend Lord Mackay of Clashfern, it was so good to hear this tremendous commitment to the safety of patients. The public must be paramount and know where there are issues, conflicts and risks. It seemed to me that if there really are concerns that a medical device, for instance, may pose a threat to safety, surely the public have a right to know?
We should have the right to make informed decisions about our healthcare, our treatment options and the medicines and medical devices available to us. Too often—we have heard this and written about it in the report, First Do No Harm—the healthcare system has shown itself to be unwilling, or even unable, to be transparent. There are too many examples of cases where people have had treatments or medical devices inserted without really being aware of the known safety concerns surrounding them. That is quite unacceptable.
My hope and expectation is that, once we have an independent patient safety commissioner—of course, we are coming on to that in the next amendment—these safety concerns will be more swiftly and thoroughly identified and communicated so that patients and the public know what is going on. I fully support the amendment. It would provide another layer of transparency and assurance, which is why I am very happy to support my noble and learned friend and the noble Lord, Lord Patel, who I consider my noble friend, on this amendment.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so the next speaker will be the noble Lord, Lord O’Shaughnessy.
Lord O'Shaughnessy (Con)
My Lords, I will speak to Amendment 108. In doing so, I remind noble Lords of my interests as listed on the register and my membership of the First Do No Harm All-Party Group, set up by my noble friend Lady Cumberlege. It seems that the debate and discussion on this issue revolve around the use of “may” or “must”, as is often the case in legislation —we are all familiar with this. I fully understand why the Bill uses the word “may” in relation to concerns as set out currently in the clause because, as described, they involve ambiguity. That is implicit in the way the clause is framed. It therefore requires judgment about the balance of risks, which is difficult to prejudge.
It seems that Amendment 108 is a build, as they say, on this and an elegant solution to the existence of a higher-risk category of the kind that the noble Lord, Lord Patel, my noble and learned friend Lord Mackay and my noble friend Lady Cumberlege have talked about. It would leave “may” in place for when ambiguity exists, but would introduce “must” when, in their words,
“there is a clear threat to public safety”,
which is the highest category of risk. It seems unconscionable to think that, when there is knowledge of such risks, they should not be communicated; indeed, there should be, if there is not already, an obligation to do so. Consequently, I feel that this amendment improves on the Bill. It seems perfectly logical and rational to me, and I hope my noble friend the Minister will be sympathetic.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I next call the noble Baroness, Lady Jolly, and I dare say that there will be a little pause before she speaks.
Baroness Jolly (LD) [V]
I support Amendment 108, led by the noble Lord, Lord Patel, which would place a duty on the Secretary of State to disclose information they hold
“relating to a medical device where there is a clear threat to public safety.”
Amendment 114, also in the name of the noble Lord, Lord Patel, would retain Regulation 3B of the Medical Devices Regulations 2002, which was inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, among other things, requires the 2002 regulations to comply with the Data Protection Act 2018.
I support these amendments but wonder what might be the process to contact patients in the event of a fitted medical device fault, which might lead to a threat to public safety if it was more than just one. Would it be the same sort of process as that for recalling certain faulty domestic appliances, which, by law, also need to be recorded? Noble Lords may chuckle, but there is a system there. Where the patient has a medical device implanted, who is responsible for taking patient contact information?
More importantly, how does the patient ensure that their contact data is up to date? Will it link, using the unique patient reference number: their 10-digit NHS number? It would need the patient to ensure that their personal data is kept up to date via the website or app. Many do use the NHS app, but, given the patient demographic, I would not be that confident in relying on that mechanism. I am not sure that the general public are ready for that requirement or, in many cases, have the capacity or devices to fulfil it. Could the Minister clarify this for me?
Baroness Thornton (Lab)
I am very grateful to the noble Lord, Lord Patel, and the noble and learned Lord, Lord Mackay of Clashfern, for bringing these amendments to the Committee. They are quite different, although linked. On Amendment 108, which would place a duty on the Secretary of State to
“disclose information … about concerns relating to a medical device where there is a clear threat to public safety”,
the noble Lord, Lord O’Shaughnessy, absolutely got it when he said that this is not a “may” but really is a “must”. The thing about this that would interest me most, because it is an important duty, is how it could happen: what would trigger such a disclosure, where would it come from and how would it be handled?
The only thing I would ask about this issue is whether a Secretary of State is the right person to do that. I have in mind someone who is now a respected noble Lord of this House, who fed his daughter a burger to show us that beef was safe during the BSE outbreak, which led to the creation of the Food Standards Agency as an independent organisation that would say, “This food is actually unsafe”, to the Government. It quite rightly has the powers to bring about a closure or recall. This is exactly the right place to be on patient safety. The only question I would pose is: is that the right person to do it?
Amendment 114, on Regulation 3B, worries me enormously. I would need to have an explanation from the Minister as to why he would remove confidentiality and seemingly protect commercial interests. It is very worrying, and the Committee needs to know the justification for that because it looks to me like it probably needs to remain in place.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that there was an error, and the noble Baroness, Lady Bennett, was not called, so I call her now.
Baroness Bennett of Manor Castle (GP) [V]
Thank you, Madam Deputy Chairman; I resisted the urge to leap in. My contribution, anyway, will be brief. I want to build on my remarks in the previous group and, in particular, to address Amendment 108 in the name of the noble Lord, Lord Patel. I referred then to the article in the British Medical Journal about the medical-political complex. We have seen over the decades, again and again, in respect of medicines, pesticides and herbicides, situations where there has been growing concern about a particular chemical. Critics have come under tremendous pressure, including critics often from Governments—critics in official positions—from very large, powerful commercial interests to remain silent.
The noble and learned Lord, Lord Mackay of Clashfern, asked how anyone could not speak out in a situation where they saw that there was a danger or a serious cause for concern. We have seen again and again, however, situations where people, including Ministers in Governments, have come under tremendous pressure. Does the Minister not think that an amendment such as that proposed by the noble Lord, Lord Patel, would protect the Government, the individual and the public if she or one of her successors were in a situation where there was grave cause for concern but also very powerful multinational company forces at play?
Baroness Penn (Con)
My Lords, I thank the noble Lord, Lord Patel, for his amendment, designed to ensure that the public are always warned about concerns relating to a medical device where there is a clear threat to public safety. The Government agree that sharing information with the public—as well as the healthcare system—is important. Safety information is provided already to relevant special interest groups and through social media channels to ensure that messages are accessible and reach those affected who need to be aware or take action. This can include patients, healthcare professionals and members of the public. For example, MHRA recently urged users of Safe and Sound Infrared Ear Thermometers to check their product code and lot number due to a voluntary recall of specific lots because of a two-degree temperature overreading fault. This is a safety concern for members of the public who are monitoring their temperature, particularly in view of the pandemic. However, noble Lords are correct that it is critical that we do more to improve transparency and share more safety information to support patient safety. This has been made even more apparent in the findings of the report by my noble friend Lady Cumberlege.
Clause 35, along with Clause 13(1)(h)(iii), is designed to ensure that in future we can share information with key parts of the healthcare system, academia and the public in a considered and effective way. Under the current medical device legislation, MHRA does not have a clear legal basis to report all incidents involving medical devices occurring in the UK. By contrast, this has been common practice in the USA, via the FDA’s MAUDE database, and in Australia, via its DAEN database. Medicines legislation already enables MHRA to provide its interactive drug analysis prints, or iDAPs. It is therefore right that, via the information-sharing powers in this Bill, we are able to disclose in an appropriate manner all medical-device serious incidents. This will provide greatly improved transparency about the safety of medical devices in the UK.
Amendment 108 would place a legal requirement on the MHRA to disclose information to the public to warn them about concerns relating to a medical device where a clear threat to public safety had been determined. The amendment is unnecessary, as the MHRA would always share safety information with the public where it was necessary to do so. However, issuing warnings and safety information to the public needs careful management, a good understanding of the situation, full verification of the data and consideration of wider complexities. There is a high risk that mandating the disclosure of clear threats to public safety would commit MHRA to regular disproportionate direct communication to the public about safety issues that the public cannot act on.
The great majority of MHRA’s medical device safety alerts require healthcare workers, not members of the public, to take action to remove a public health threat. For example, MHRA’s national patient safety alert of 23 September 2020, addressing a clear threat to public health, instructed all hospital trusts and other healthcare providers on actions to be taken to avoid potential unexpected shutdown, leading to a complete loss of ventilation, when using the Philips Respironics V60 ventilator. Such messages should not be targeted and promoted to the public but should be made available passively to the public; for example, via access to a website. Otherwise, this would likely create unwarranted anxiety in the public about safety issues that they themselves could address because they required the intervention and clinical support of healthcare professionals.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I have received a request to speak after the Minister, so I call the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
My Lords, I thank the Minister for her explanation in response to Amendment 114. My desire to explore the issue slightly more is partly a result of what the noble Baroness, Lady Cumberlege, and others have said. It is also partly a result of the very helpful discussions this morning about the time that it is going to take to get the protection on devices in place. If we have another mesh situation, will that be able to emerge in this period of time? If so, who will be responsible for saying that it is not a safe device?
Baroness Penn (Con)
I believe that responsibility will continue to lie with the MHRA. We have existing systems, such as the yellow card reporting system. The report by my noble friend Lady Cumberlege will have made an important difference; as we discussed earlier and in other sittings, not just the systems but the culture will need to change. That culture change has begun already.
We must get the systems right so that they operate as intended and deliver the results that we all want, but the noble Baroness, Lady Thornton, is right: in the space that there will be while we implement these changes, we need to be extra vigilant about these potential issues.
As I have already said, adverse incidents involving medical devices are published on the MHRA website. The job is to take all that information and make sure that it is not just dispersed but that people can build the bigger picture. That is what we are working towards.
Lord Patel (CB) [V]
My Lords, before I start, let me thank my noble friend Lady Cumberlege enormously for putting her name to Amendment 108. I apologise for not alluding to that earlier.
The noble Lord, Lord O’Shaughnessy, got it: my amendment leaves it to the discretion of the Secretary of State that there might be times when disclosure is not required.
To my friend the Minister, I say: good try, but I am not convinced. I do not see why my amendment cannot be accepted—it provides discretion but just removes “may”.
As far as Amendment 114 is concerned, the point is exactly this. The Minister may recollect the journalist’s report on the regulation of devices in the EU, which raised concerns about manufacturers not agreeing to provide safety information that they may have had when they were testing the devices. Removing that requirement for manufacturers does not help patient safety—hence my amendment asking to leave Regulation 3B as it is.
I have listened. In the meantime, I beg leave to withdraw the amendment.
Lord Bethell
“(4A) The Secretary of State may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of medical devices.”Member’s explanatory statement
This amendment makes clear that information held by the Secretary of State in connection with medical devices can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.
Member’s explanatory statement
This amendment is consequential on amendment in the Minister’s name inserting a new subsection into Clause 35.
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name inserting a new subsection into Clause 35.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
We now come to the group consisting of Amendment 117. Once again, I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 117
Baroness Cumberlege
“Independent Patient Safety Commissioner
(1) An independent Patient Safety Commissioner is established.(2) The Office of Patient Safety is to be hosted and funded by the Cabinet Office.(3) The Patient Safety Commissioner must publish a business plan, reviewed annually, which sets out, in relation to the discharge of the Commissioner’s functions—(a) the Commissioner’s proposed main activities for the period covered by the plan (including the matters he or she intends to consider or investigate), and(b) the Commissioner’s proposed strategic priorities for that period.(4) The Patient Safety Commissioner must appoint an advisory board to provide the Commissioner with advice and assistance relating to the discharge of his or her functions, consisting of persons who (taken together) represent a broad range of interests which are relevant to the Patient Safety Commissioner’s functions, and must from time to time publish a report on the procedure followed and the criteria used when making appointments to the advisory board.(5) The Commissioner’s functions are to—(a) promote and improve patient safety with respect to the use of medicines and medical devices;(b) promote the views and interests of patients and other members of the public in relation to the safety of medicines and medical devices;(c) make recommendations to the Secretary of State;(d) establish and, when deemed appropriate, revise Principles of Better Patient Safety;(e) receive direct reports from patients and other members of the public, any other persons (whether natural or corporate), and the Secretary of State and, when the Commissioner deems appropriate, share those reports with relevant organisations and the Secretary of State;(f) produce and lay before Parliament for the attention of any committees of either House whose remit covers medicines and medical devices—(i) an Annual Report and Accounts, and(ii) any other reports regarding patient safety, which may include recommendations to improve patient safety with respect to the use of medicines and medical devices.(6) For the purposes of subsection (5)(d), the Principles of Better Patient Safety must—(a) describe expected patient safety outcomes relating to the safety of medicines and medical devices; and(b) be drafted in consultation with the public.(7) For the purposes of subsection (5)(f), the Commissioner may require a public body and other persons (whether natural or corporate) to provide such information as is reasonable in order to fulfil that function relating to the safety of medicines and medical devices.(8) In fulfilling his or her functions, the Commissioner may do anything which appears to be necessary or expedient for the purpose of, or in connection with, the performance of his or her functions.(9) The Commissioner has the duty to involve and inform patients and other members of the public in carrying out his or her functions.(10) The Commissioner may make recommendations to the Minister for the Cabinet Office for any additional powers which the Commissioner considers may be necessary to fulfil the duties and functions under this section.(11) The Minister for the Cabinet Office may by regulations make any other provision relating to the establishment of the Commissioner, including—(a) the appointment of a Commissioner,(b) the terms of office,(c) remuneration and financial and other assistance,(d) staff, and(e) any other matters the Minister for the Cabinet Office considers appropriate.(12) A statutory instrument containing regulations under this section may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament.”Member’s explanatory statement
This new clause would establish the Patient Safety Commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review.
Baroness Cumberlege (Con) [V]
My Lords, this proposed new clause, which would implement one of the most important recommendations in our report, First Do No Harm, is about the independent patient safety commissioner. I am conscious that you cannot change history, but you can plan for the future; that is what we seek to do through the independent commissioner.
I thank noble Lords from all sides of the House who have put their names to this amendment, particularly the noble Baroness, Lady Jolly, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel. I also thank the noble Lords who spoke in favour of the commissioner at Second Reading and have done so often since then.
Many people outside Parliament have also voiced their support. It really gladdens my heart, when we live in such troubled times, to have a rock-solid consensus. Of course, I await the response from my noble friend the Minister but I really do hope that he will choose not to stand apart but to be instrumental in improving safety and the lives of thousands of people by supporting this amendment, even if it requires a bit of redrafting.
I think that noble Lords will be grateful that I will not go through the amendment subsection by subsection, paragraph by paragraph, because that would take all night and it is all there for noble Lords to see. First, though, let me put a question. Why do we need this independent patient safety commissioner? It is quite simple: because there is no one person whose task it is to listen to the voices of patients, to stop the trends and patterns that give rise to safety concerns, and to encourage or require the healthcare system to act on those concerns when they are not being recognised and realised.
The healthcare system has failed to listen to patients’ concerns. Our review vividly and tragically illustrated that. Thousands of people have suffered. Lives have been ruined. I am absolutely convinced that, had we had a patient safety commissioner—that is, if that person had existed—much of the harm done could have been prevented.
It is not only what we found in our review that proves the need for this. Think of the recent Paterson inquiry. Its findings echoed ours, with patients voicing concern but their voices not being heard and avoidable harm going undetected. Sadly, we all know that there is a long line of similar examples; indeed, Essure, a contraceptive device that has caused many women terrible suffering, was reported on by the BBC last weekend.
We know our own bodies. We know when something is not right. We know when a treatment is causing a problem. We are the first to know, yet patient voices and experiences are all too often simply referred to as anecdotes and written off. They are not; they are serious research. We think that a patient safety commissioner would put an end to that—an end to anecdotes simply being written off.
There have been suggestions that existing organisations are already responsible for patient safety so we do not need another one. I want to tackle that fallacy head on. If it is true that organisations in the healthcare system are performing this task and doing it effectively, why has so much avoidable harm occurred?
The system simply is not working. Yes, the organisations within the healthcare system are doing their job; people are working very hard as individuals, and in the organisation, but they are disjointed and siloed, and patient safety is not their overriding purpose. They did not prevent the avoidable harm that we discovered. While some organisations have elements of safety within their remit, not one has patient safety as their total focus, and not one considers that they have the responsibility to listen, spot trends, raise concerns and get the system to act.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
Before I call the next speaker, I must tell the Committee that we normally have a break about now but it has been suggested that we delay it until there is the vote in the Chamber, expected very soon, and that we then take 15 minutes. In the meantime, I call the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, first, it was a privilege to put my name to the amendment moved by my noble friend Lady Cumberlege. It is a pleasure to follow her powerful speech, which made the case for an independent patient safety commissioner so powerfully that I am tempted to say that no more needs to be said about the amendment except for the Minister to accept it. But of course I cannot do that. I will try to make a case for why now is the time to accept what the noble Baroness is asking for. The time for her amendment has come.
I strongly support the amendment. It was one of the key recommendations of the noble Baroness’s report First Do No Harm to establish an independent commissioner for patient safety and to do this through legislation. The need to address patient safety as an important aspect of healthcare was identified in England following the publication of the report An Organisation with a Memory. This was the watershed moment in the history of patient safety development. In 2001, a report was produced, Building a Safer NHS for Patients, which led to the establishment of the National Patient Safety Agency for England; a national reporting and learning system was to be developed as part of it. In 2006, Safety First, a report for patients, clinicians and healthcare managers, was published, with the objective of recasting the functions of the National Patient Safety Agency. It was after that that I took the chair of it.
The National Patient Safety Agency did develop several good and respected methodologies and publications, and introduced some fundamental patient safety protocols, but it lacked the power and authority of an organisation established in statute. Functioning as an arm’s-length body of the Department of Health, and at its behest, was not the way to establish patient safety. In my view, it weakened its ability to deliver patient safety across the NHS.
As chair, I remember having to try to persuade management at NHS Confederation meetings that alert notices related to patient safety needed to be implemented. This lack of statutory authority meant that hospital trusts were not required to follow any guidance or alert notices. On Friday 1 June 2012, the functions of the NPSA were transferred to the special commissioning board as the NPSA fell victim to the cull of quangos. So what has happened since? Regulatory organisations have come and gone. NHS structures have changed and continue to do so. The NHS is a bit of a political football; I remember that, when I suggested that the political parties stop using it as one, the noble Lord, Lord Hunt, laughed at my comment. Change is a constant feature.
Patient safety documents and policies from 2000 to the present day all sound alarmingly familiar: progress is slow and incremental, even at present. An NAO report criticised the pace of change as regards patient safety, saying that it was too slow and that those who manage trusts focused more on financial budgets than patient safety. One result was the Mid Staffs crisis: we all remember how devastating that report was, particularly in what it had to say about the major patient safety failings.
We now have another devastating report, First Do No Harm. It is the second, and I hope the last, call for us to establish patient safety through legislation and on behalf of patients. The Government’s response to the Francis report defines the current patient safety system. Patient safety became an important aspect of government policy, with several initiatives and three global ministerial meetings, et cetera, but the processes are the same. Have things changed? In my view, not much, especially in terms of a clear demonstration of reducing patient harm. The patient safety organisations that exist are still part of and accountable to NHS departments, not to patients.
The noble Baroness focused her amendment on the safety of medicines and medical devices. Of the top five areas of patient safety errors, harm related to medicines and medical devices rank second and fourth. She is right to focus on these two areas as the first task of the commissioner for patient safety. A 2018 review of errors related to medicine estimated that 237 million errors occur every year in England. The national reporting and learning system had 204,000 incident reports related to medicine, while 712 deaths are attributed yearly to medicine-related harm, costing annually something like £70 million.
Data in relation to the harm associated with medical devices is not as readily available, except when investigated as part of a report such as First Do No Harm. However, figures from the USA can be used as a proxy, as its larger population may give some indication of the scale and types of devices implicated. A recent report in the USA showed the following as examples: 60,000 cases related to the use of surgical mesh; a similar number in relation to defibrillators; and 104,000 cases related to hip prosthesis. There were many more. These data clearly show not just the level of safety issues in relation to medicines and medical devices but the need to address them.
It is time to give patient safety the legal status it needs, as the noble Baroness, Lady Cumberlege, said. It is time for a bolder and more ambitious vision to make patient care safer. I believe that her amendment does this and I strongly support it.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that there may be a delay in the vote taking place in the House for technical reasons. I do not think that we can go on here indefinitely so I suggest that I call the noble Lords, Lord Hunt of Kings Heath, and we break then regardless.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to follow the noble Lord, Lord Patel. No doubt we will have further debates about the role of politics in the National Health Service. I would just say to him that I think the failure of NHS England is, in many ways, an example of how we end up with a quango that seems unaccountable to Parliament but Ministers wash their hands of many of the decisions that they make. The problem is that you can end up with the worst of all worlds.
That perhaps reflects some of the issues relating to patient safety because, thanks to the Minister, we all enjoyed meeting the person responsible for patient safety in NHS England. The problem is that NHS England has many other responsibilities, including financial and target responsibilities. Patient safety does not really seem to be that body’s top concern.
This seems to be the very point that the noble Baroness, Lady Cumberlege, makes. Her report’s conclusion is really rather shocking in many ways. She made a general conclusion from the three areas that she investigated. She said that the healthcare system
“is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially.”
That is a devastating critique, particularly in relation to patient safety.
I forgot to declare an interest as a member of the GMC board, but I must make it clear that I am not speaking on behalf of the GMC.
The noble Baroness’s recommendation of a patient safety commission is so powerful because she proposes that somebody sits outside the current system, accountable to Parliament and not to Ministers or the devolved NHS management system. She argues for the commissioner to have the necessary authority and standing to talk about, report on, influence and cajole where necessary without fear or favour on matters related to patient safety.
In pointing to the Children’s Commissioner, the noble Baroness, Lady Cumberlege, has really put her finger on it. This gives us an idea of the sort of person we need—someone who, like the Children’s Commissioner, challenges the positions of Governments, schools, unions and local authorities. As the noble Baroness said, I am certain that it was the Children’s Commissioner’s comments that led to the reopening of schools. I do not believe that somebody in a government department or a quango could have done that. She did it because, personally, she is a very admirable person, but structurally, because she is wholly independent.
The noble Baroness made some very telling points when she anticipated a potential criticism of her report. The core of it is that many organisations already have some responsibility for patient safety in their remit. That is true, and they all do good work, but she is right because none of them really has patient safety as a systematic approach to the NHS as their sole remit. Until we have some independent agency or person with patient safety as their sole remit, I am afraid that I do not think that we will make progress. We must accept that, if patient safety is one of many objectives of an organisation, compromises inevitably have to be made.
There is a tension between funding, throughput, targets and patient safety—not always, but sometimes. Here, I turn back to my experience as a foundation trust chair. The trust boards hold a huge amount of tension within them. Of course they are concerned with patient safety and quality, but they are also under the cosh from NHS England and the regulator, NHS Improvement, for their overall performance, whether financial or in throughput. I certainly accept the argument that many of the best organisations where everything runs well include patient safety, but to deny that there is a tension between these other objectives and patient safety is disingenuous.
That is why we look forward to the Minister making a strong statement. If he simply says that this is outside the Bill’s scope, as we have been told consistently, it will not cut the mustard, because we could easily start expanding and extending the Bill as we get other legislation and when the Government finally respond to the report of the noble Baroness, Lady Cumberlege. In my view, the Bill will not leave this House unamended unless the Government can make it clear that they are determined to implement the noble Baroness’s central recommendation.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, I suggest that the Committee adjourn for 15 minutes.
Lord Mackay of Clashfern (Con) [V]
My Lords, the Bill will confer a power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices. I respectfully submit that a power to create a system to protect the public in relation to all three, but particularly two of them, is well within the scope of the Bill.
When I first read the report of my noble friend Lady Cumberlege, I was extremely upset by what it disclosed. When the noble Lord, Lord Hunt, followed me last time, he said that doing so was a privilege. I want to say that following him is a tremendous privilege because he knows much more about the internal structures of the health service and its related services than I do.
I was privileged to represent the Medical and Dental Defence Union of Scotland for a good number of years before I joined the public service. The work was concerned primarily with mistakes of one kind or another that doctors or dentists had been involved in, but the need for safety was absolutely clear in most of the cases I was involved in. The first time I ever came to the House of Lords was on the instruction of the Medical and Dental Defence Union of Scotland, but of course, that was long ago. The case concerned the safety of a patient.
The message that cries out from the report of the committee chaired by my noble friend Lady Cumberlege is that people are suffering considerable harm as a result of treatments given in the health service, but they have no one to turn to. There is no direct public voice for patients to come to and discuss the matter. It is essential to have someone to whom patients can bring their concerns, which may not always be complaints. It may start as something much less than a complaint—a concern that becomes a complaint if not attended to in any way.
It is essential that somebody with authority and complete independence of the health service be put in place now who is able to listen to what any patient may want to say in connection with the treatment he or she has received. There is a huge deficiency, as has been exposed clearly by the examples given in the report. Therefore, there is an urgent need for Her Majesty’s Government to deal with that immediately. It is all very well to say that it is not this or that, but the truth is that this is urgent, because people are suffering and have suffered from the absence of anybody to whom they can turn in situations such as those described in the report. The Government would be heavily at fault if treatments and difficulties of this kind emerged in the future without them having done anything about it.
The setting up of a patient safety commissioner seems to require in the first instance the appointment of a completely independent person who would be a voice for patients, with a knowledge of the service but independent of it. He or she could bring a patient’s question or trouble to the attention of the part of the service that was intimately concerned with it and do something about it. The report makes it clear that the full powers that a patient safety commissioner should have is a matter for detailed work by a taskforce, but in the meantime statutory authority should be given to an independent person to listen to those suffering in some way from a difficulty in relation to the health service so that it can be brought to people who understand the nature of the subject. The independent person could bring it to the appropriate authority. It is a serious matter that should be dealt with straightaway.
I am very impressed by the example of the Children’s Commissioner, which has been referred to. In the recent discussion about whether to keep schools open, the Children’s Commissioner could not be said to be an organ of the Government, of the trade unions, or particularly of children; she stood independently in a relationship that considered all three parties. That gave her tremendous authority in a very difficult situation, which remains difficult. She was able as an independent person authoritatively to say that children should come back to school. Of course, it was necessary to take effective steps to protect them, but I believe that she was influential in bringing that about. In Scotland also, that has been an important area in delivering people from the stringency of the lockdowns.
So that is a very good illustration of what an independent person can do. I strongly hope that the Government will put forward an amendment to deal with this matter in the simplest possible terms at present, but with the possibility of enlargement as time goes on. Indeed, I suggested some time ago to the Department of Health that it would be useful for it to consider an amendment that would give effect to the report—but I gather that nothing has happened in that direction so far. So we might have to think about amendments to try to deal with some of those matters, as well as the present one. But I strongly support the essence of the present amendment, and I strongly support it happening now.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
Before I call the next speaker, could I request that the noble Lord, Lord Patel, mutes himself?
Lord O’Shaughnessy (Con)
My Lords, it is a pleasure to follow my noble and learned friend Lord Mackay of Clashfern in talking to my noble friend Lady Cumberlege’s important amendment. It is impossible to match the passion and forensic skill with which she introduced her amendment—no one can make the case better and I will not try—but I offer her my deepest support for what she is trying to achieve through it.
The review that my noble friend carried out is quite simply one of the most remarkable of its kind, detailing as it does the extraordinary harm done to patients, mostly women, because of an inadequate safety regime that was too lax on products coming into the market, not capable of fully monitoring the adverse effects of products while they were used in the health system, and unwilling to heed the voices of those crying out in agony because of the harm being done to them and their families.
The First Do No Harm report is full of arresting facts: the 11-year delay between the first statistically significant evidence of the links between hormone pregnancy tests and malformations in babies; the lack of clinical evaluation of the use of mesh—a supposedly inert and harmless device—in the treatment of pelvic organ prolapse in tens of thousands of people; and the 20,000 people exposed in utero to sodium valproate in the UK, around half of whom have been affected physically or mentally, often very severely. But its true power comes from the testimony of those women whose lives were turned upside down by the adverse effects of these tests, pelvic mesh, sodium valproate and other medical scandals.
It was a privilege to hear this testimony at first hand when I was a Minister in the department, and I pay tribute to those brave women who led delegations to bring their message of pain and sorrow, and of being patronised by those who claimed to care for them, to us. Marie Lyon, Kath Sansom, Emma Murphy, Janet Williams—women like them are the reason why Ministers, and ultimately the then Prime Minister, asked my noble friend to carry out her review. It is to tens of thousands of women like them and their families that we owe a duty to implement the findings of that review.
There are many excellent proposals in the report, and it is my sincere wish that my noble friend Lord Bethell and his colleagues at the department will implement its recommendations as soon as possible. However, one recommendation stands out: the proposal for a patient safety commissioner, which is the subject of the amendment. Having served in government, I know that there is often internal resistance when a review proposes a new arm’s-length body or something of that kind, so I will explain why I believe that this one is so important and why there is a strong precedent for a Conservative Government introducing one.
As my right honourable friend Jeremy Hunt said when he first launched the medicine and medical device safety review in February 2018, it is the responsibility of the Government to listen, hear and act with compassion, speed and proportionality when things are going wrong. As the exhaustive findings of my noble friend’s review show, this did not happen, time and again, over many decades—and it must.
Whose responsibility, then, should it be? I, like other noble Lords, have great confidence in the NHS, the MHRA, the DHSC and other bodies, but we must be honest that none of them has consistently lived up to the maxim propounded by the former Secretary of State. More importantly, too many patients have had negative experiences interacting with these organisations when they were seeking help, so confidence in their ability to act in patients’ interests is not robust.
As the review continued, it became clear to me, as it did to my noble friend Lady Cumberlege, that there was a need for an entirely independent body that could act as the patient’s friend on safety in the system, a gateway and a support mechanism where those who were not being listened to could go—if you like, a conscience for the system. This would benefit the health system too, providing aggregated access to new information on safety issues and a potential to spot emerging concerns. Nothing that currently exists could perform both these essential functions in a way that carries the support of patients.
These are precisely the roles that the patient safety commissioner is proposed to play. There are different ways it could be implemented, of course, but it must be independent of the department and the NHS, as other noble Lords have said, and it must be patient-facing in all it does. We already have examples of how this could and should work. Many noble Lords have referred to the excellent work of the Children’s Commissioner. I also point to the Victims’ Commissioner, a role fulfilled until recently with great expertise by my noble friend Lady Newlove, and the new independent office of the Domestic Abuse Commissioner. It is absolutely right that these new positions have come into being, and I am proud that it was a Conservative Government who created them.
So once again I throw my weight behind the proposals of my noble friend Lady Cumberlege. I am sure that my noble friend the Minister is highly sympathetic to this cause. For the sake of all those women—and the men and children who have also been harmed—I hope that we can work together to make it happen.
Lord Blunkett (Lab)
First, I declare a tangential interest in the sense that I am patron of the Society of Occupational Medicine and, together with the faculty, it obviously has a real interest in this area, as well as its broader remit. I apologise to the noble Baroness, Lady Cumberlege, and the Committee for not being in my place at the beginning of her incredibly powerful speech, and I endorse what people have said already about not only the speech but the incredible work and reflections in the report.
The history that the noble Lord, Lord Patel, gave us, indicates very clearly the challenges that have been faced in this area. I am the first Member to speak who, as a former Member of Parliament, had people at my surgery bewildered, frustrated and not in a position, as they were in America, to go down the litigious route to get any satisfaction. But, of course, down the road and down the line is, as the report of the noble Baroness, Lady Cumberlege, indicates, is too late. Having someone who can intervene to prevent misery, hurt and, for many, terrible trauma for life is really important.
When you have the noble and learned Lord, Lord Mackay, and a former Health Minister, the noble Lord, Lord O’Shaughnessy, on your side, you are on a winner, and I hope that the noble Lord, Lord Bethell, will be able to indicate that he is prepared to go back to what we used to call the Legislative Committee—difficult as that is, because there is enormous resistance in government, as the noble Lord, Lord O’Shaughnessy, will remember and my noble friend Lord Hunt will be painfully aware, to having substantial amendments to Bills and to conceding that measures were not thought of first within the department. But I hope that on this occasion it will be possible to do so.
Reference has been made to other commissioners, and I endorse what the noble Lord, Lord O’Shaughnessy, said about the noble Baroness, Lady Newlove, and the powerful work that she did. I respect her greatly, as I do Anne Longfield, the Children’s Commissioner. I say to my good friend and noble friend Lord Hunt that I like to think that some of us in the political arena played a bit of a part in getting the schools reopened as well as the commissioner, but she did a phenomenal independent job in that area. I hope that the commissioner recommended by the noble Baroness, Lady Cumberlege, would be able to do the same in this sometimes forgotten area.
I am not sure that she will thank me for this, but perhaps the noble Baroness will accept that there may be a connection with the Health and Safety Executive, because the research and testing facilities it has may have a relevance here, and some connection with the commissioner that she has recommended may be sensible. My noble friend Lord Hunt and I shared an interest in this when we were both at the Department for Work and Pensions and the HSE reported to us. We had a number of ideas which, because we had both moved on, did not come to fruition—but here we are, all those years later, with an opportunity to do something that would be of great benefit to many people—mainly, as the noble Lord, Lord O’Shaughnessy, said, women—who have suffered so grievously and did not need to.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
The noble Baroness, Lady McIntosh of Pickering, has scratched from this group, so we move on to the noble Baroness, Lady Ritchie of Downpatrick.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, it is a great pleasure to follow the noble Lord, Lord Blunkett, on this group. I pay tribute to the noble Baroness, Lady Cumberlege, for her report and for introducing this proposed new clause, which I feel the Minister should accept.
I apologise for not participating on previous days but I was involved in debates in the Chamber, so I ask your Lordships to accept my apologies.
I fully accept the need for this new clause. At Second Reading, I indicated that the recommendation of an independent patient safety commissioner, on a statutory basis—one of the central recommendations in the report of the noble Baroness, Lady Cumberlege, and her team—should be given legislative effect. The provision of high-quality healthcare in which all citizens can have confidence defines any nation. For me, that is why this Bill is so important and why it should be amended to include this proposed new clause, among others. Our ethical practices are of the highest standard, and any medical product available in the UK, or indeed anywhere, must be rigorously tested and be shown to be safe and effective. That also goes for the Covid vaccines which are currently under investigation and awaiting licence.
I have long campaigned to get justice for pelvic mesh sufferers who have been left with internal damage and intense, chronic pain. They were failed by an appalling culture of mismanagement, ignorance and apathy within the health system. These victims deserve better justice and we must ensure that this sort of systemic failure never happens again. I remember, as a Member of the other place, meeting many constituents —in the main, women—who had a pelvic mesh inserted and suffered immeasurable pain. They were trying their very best to have it removed.
The recent report by the noble Baroness, Lady Cumberlege, First Do No Harm, on surgical mesh and other medical interventions, was scathing in its assessment of the failure of a disjointed and defensive health system to listen to and address patient concerns. Much of the suffering, it concluded, was entirely avoidable. As I said, I met victims of this appalling mismanagement when I was a Member in the other place. I learned at first hand of the pain they had been forced to endure and the impact that it had on the quality of their lives and those of their families. Therefore, I am pleased that the report was commissioned and I am happy to support the recommendation for an independent patient safety commissioner, as per the proposed new clause. It should be placed on the face of the Bill. I believe that, if the Government are serious about that report and about the Bill, this recommendation should be given legislative effect, and I urge the Minister to accept the amendment.
It would be vital for the commissioner to lead with full patient group engagement, and be accountable to Parliament. Patient groups should also be involved in developing a set of better patient safety principles that would govern the way the commissioner fulfilled her or his remit.
As other noble Lords have referred to, we now have experience of the work of various commissioners. I can speak about those that exist in Northern Ireland. There is now a Veterans Commissioner, a Children’s Commissioner and a victims’ commissioner. They all do good work, acting as advocates for people in their specific fields, and bring forward recommendations to the devolved Administrations. In this particular instance, there is absolutely nothing to suggest that this commissioner, if established through this legislation, would not do likewise. They would be a listening ear and would seek to improve existing health service regulations and practice, particularly in the area of medical devices.
Therefore, I am very happy to support this proposed new clause, and I urge the Minister to accept it.
Lord Sheikh (Con) [V]
My Lords, I commend my noble friend Lady Cumberlege on putting forward this important amendment, which has my full support.
I referred to this issue when I spoke at Second Reading. At the outset, I congratulate my noble friend on her thorough and excellent review, including the bravery of its participants. The Cumberlege review was clear that there is an urgent need for action. I welcome this Bill, which aims to put patient safety first.
We need to listen to the review’s recommendations and create an independent patient safety commissioner through the enactment of this amendment. This commissioner would be a trusted voice for patient safety and would ensure that the Primodos, valproate and mesh scandals, or any other previous scandals, are not repeated. As the Cumberlege review shows, the harm caused should have been avoided—and could have been, if patients’ concerns had been properly listened to and acted on.
Furthermore, Sir Cyril Chantler, one of the review’s panel members, rightly said that if such a commissioner had existed before, there would have been no need for this latest inquiry as the Primodos, valproate and mesh scandals would have been dealt with at an early stage, thus preventing the high number of patient incidents that were allowed to occur. Instead, thousands of patients and their families suffered for many years. Many of them were not listened to even though they were right. If this Bill is to succeed in its goal of promoting patient safety, we must accept this amendment.
Patients should not have to fight to be heard. They should not be made to feel that they are in the wrong. Patients and their families need to be consulted, listened to and given a voice. Through this amendment, the patient safety commissioner would be that voice. As is stated in the amendment, the commissioner would
“promote the views and interests of patients”
and would be able to
“receive direct reports from patients and other members of the public”.
This way, all concerns will be listened to and properly acted on. The amendment also states that the commissioner will be able to produce
“reports regarding patient safety … with respect to the use of medicines and medical devices.”
This information will be essential in making patients aware of any potential risks or harms so that they can make fully informed decisions about their treatment. I am glad to see that the commissioner would be independent so that the public know that any information is accurate and unbiased.
Our healthcare system is one of our greatest assets. I would like to state my gratitude for all the marvellous work that the NHS has done and continues to do. As we have seen during this pandemic, NHS staff have done sterling work and work effectively as a team. Unfortunately, some key workers have paid the ultimate price and we are for ever grateful to them.
The NHS is a very large organisation that does many great things but it cannot do everything right. Sometimes it is better when activities are undertaken by outside bodies that have specific duties and expertise. This is where a patient safety commissioner will play an important role in overseeing the whole system. Furthermore, as in this amendment, an advisory board will support the commissioner in their work, using its wide range of experience.
Our current complaints system is too complex and there have been issues with reports being misplaced and poor co-ordination between the different departments and actors. As the commissioner would be constantly reviewing patient safety and be completely aware of any potential issues, they would be able to keep the Minister and the Cabinet Office informed, for the benefit of patients. The commissioner will be able to join the dots in our big healthcare system so that nobody gets lost, and will provide a more straightforward direction.
I am also supportive of this amendment because it requires the commissioner to publish an annual business plan. As a businessman, I know how important this is in creating a clear strategy to bring together different stakeholders and respond to current issues. This annual plan, alongside establishing and updating the principle of patient safety, will help guide the whole healthcare system. I am also glad to see that subsection (6) of the proposed new clause means that these principles must
“be drafted in consultation with the public.”
This will make them more accurate, and help build public trust.
Unfortunately, the Primodos, valproate and mesh scandals are not the only cases of a lack of patient safety and we must learn from previous historic mistakes. In 1958, Distaval was licensed in the UK. It was sold as a wonder drug for insomnia, coughs, colds and headaches. It also gave many women relief from morning sickness symptoms, but this drug contained thalidomide and had not been tested on pregnant women.
In November 1961, it was withdrawn from sale and, in May 1962, the Government released an official warning against its use by pregnant women. Thalidomide harmed the development of unborn babies, causing serious life-threatening birth defects, and affected 10,000 babies worldwide, and many more are thought to have died before birth. The drug led to the arms or legs of the babies being very short or incompletely formed, as well as causing deformed eyes, ears and hearts. In the UK, more than 400 adults are still living with these consequences.
In 1968, the UK producer Distillers paid 62 families of thalidomide-affected babies compensation amounting to 40% of assessed damages. A similar amount was paid to a further 367 children in 1973. However, it later became clear that these settlements were not large enough to support those affected in their day-to-day lives. Only in the last 10 or 15 years since the scandal have significant settlements been made and provided by Distillers, now part of Diageo, as well as by the UK Government.
Although there have been many improvements in drug testing since the thalidomide scandal, the delays in dealing with potential risks and proper compensation were totally unacceptable. I comment again that, if there had been a patient safety commissioner, the scale of harm would have been limited, action could have been taken more quickly and compensation may have been paid earlier.
It is imperative that we learn from these historic scandals and the more recent scandals related to Primodos, valproate and mesh. Therefore, we must have a patient safety commissioner. We have to support this amendment, and I welcome its objective to lay reports before Parliament and committees. It is important to take quick and appropriate action against any harmful medicines or medical devices before they become a scandal. It also means that the correct bodies and people can be held to account so that the right improvements can be made.
Independent commissioners have been incredibly valuable in certain areas; for example, the Children’s Commissioner, which was established in 2004. Since the start of the pandemic, 14 different reports and policy briefs have been produced by the Children’s Commissioner. They have provided key information on how children are affected, different vulnerabilities and how the Government—
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
My Lords, excuse me. The Grand Committee will adjourn for five minutes because there is a Division. We will reconvene at 6.16 pm.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
My Lords, the Grand Committee will reconvene again, and I call upon the noble Lord, Lord Sheikh, to finish his contribution.
Lord Sheikh (Con) [V]
Thank you. My Lords, I have nearly finished. I conclude by saying that a patient safety commissioner will be a champion to mobilise changes and deliver necessary improvements. This is vital for creating a healthier system that works for everyone because it can listen to everyone. We must ensure that historical or recent scandals are not repeated, and we must therefore accept this amendment.
Baroness Masham of Ilton (CB) [V]
My Lords, I would support an independent patient safety commissioner, as its aim would be to
“promote and improve patient safety with respect to the use of medicines and medical devices,”
which is vital. In the past years there have been some tragic cases: patients have been left in long-term pain after operations with medical mesh; pregnant women have taken medicines that have caused disabilities in their children; and people have died due to the wrong dose of morphine or potassium chloride by the wrong button being pressed on the infusion pump.
I hope that, if established, the patient safety commissioner would be able to help patients from the private health sector as well. There have been some unfortunate incidents in plastic surgery, for example.
I would like to ask a few questions, but I do not know whether it is the noble Baroness, Lady Cumberlege, or the Minister who can answer them. The NHS is so huge and has so many different bodies and groups. Many people get confused about who does what. Would the patient safety commissioner co-operate with the Healthcare Safety Investigation Branch and the Citizens’ Partnership, which will work with HSIB on healthcare safety investigations?
AvMA—Action against Medical Accidents—which works for patient safety and justice, would be happy to work with an independent patient safety commissioner. Would that be helpful? Many all-party groups take evidence from patients and experts on safety issues. Would the safety commissioner be interested in collecting the data and promoting what is appropriate? A great deal of time, energy and experience goes into producing these reports.
There are still cover-ups and fears about reporting safety issues. Patients and their supporters need to feel that their voices are heard and will be acted on independently, and that they will stay safe and not be victimised for reporting patient safety matters. I thank the noble Baroness, Lady Cumberlege, for her report and for bringing this subject up the agenda to where it should stay, with the lead of a patient safety commissioner.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I can only begin this contribution, as I did at Second Reading, by paying tribute to the power and importance of the report by the noble Baroness, Lady Cumberlege, as so many other noble Lords have. I also note that the length of the list of Peers speaking to this amendment reflects the fact that this is perhaps the most important element of her recommendations, or certainly the most easily and directly deliverable through legislation.
When thinking about how I could contribute within this long list of speakers in a positive way, I decided to go back to the noble Baroness’s report and to the patients who spoke to her. If I were delivering this as a public speech, I would at this point deliver a trigger warning: what I am about to say is very disturbing. That needs to be said now.
I will quote three of the patients quoted in the noble Baroness’s report. The first is identified as a mesh-affected patient who said:
“I have had a constant battle to get the help and treatment I needed with my mesh complications. ‘Gaslighting’ and a ‘fobbing off’ culture appears to be rife”.
The second quote is from a former GP and mesh-affected patient:
“I do … believe there is a huge unconscious negative bias among you all towards middle aged females in chronic pain.”
Finally, the third quote is from Teresa Hughes, from Meshies United:
“They would tell you there is nothing wrong with you and that you are just a hysterical woman”.
It is worth reflecting briefly on the history of medicine and the medical profession. The idea of a wandering womb—with strange afflictions supposedly affecting women, particularly those of reproductive age—goes back to the ancient Greeks. We have something here that has been embedded for literally millennia. If we look to more recent history, it was the book on hysteria by Edward Jorden in 1603 that really pinned down in English something that became medical doctrine for centuries. This treatment of female patients has a very long and embedded history.
If we look back at the 1960s and 1970s, up until that point in time the culture of medicine was very much one of paternalism. The doctor, who was most often a male, knew best; the patient was told what they should do and how they should be treated. The doctor knew what was best for them and the patient had very little say or control. We can credit the women’s movement as an important part of the forces driving for change in the medical profession. We have seen change, but medical habitus does not change quickly in its practices and culture. It is clear from those quotes I just read out that there is still a long way to go. There is a strong gender aspect to this, but many male and child patients were affected by it as well.
A patient safety commissioner could be someone to go to: someone who knows the system and has sufficient technical support to understand the issues, and to see where systematic breakdowns are happening and act on them. The Children’s Commissioner is a wonderful example—the noble Baroness, Lady Cumberlege, referred to it—and by chance I was referring to that commissioner approvingly in this very same Room yesterday.
We have already seen action on the recommendation for a patient safety commissioner in Scotland, and I am proud that the England and Wales sister party, the Scottish Greens, was very strong in supporting that. With this amendment, your Lordship’s House has a real chance, as we have been doing with so many Bills lately, to insert an important and key improvement.
I hope that, if not today then sometime very soon, the Government might see the sense of following the Scottish lead and the recommendations of the report of the noble Baroness, Lady Cumberlege. However, if that is not the case, I can certainly offer the Green group’s very strong support for pushing this further—as far as it needs to be pushed—to deliver this vital figure.
Baroness Jolly (LD) [V]
My Lords, Amendment 117 would establish the independent patient safety commissioner on a statutory basis, as recommended in First Do No Harm, the report of the Independent Medicines and Medical Devices Safety Review. As the noble Baroness, Lady Cumberlege, said, it is a future-facing amendment towards a proposed organisation. It has not been a surprise that all noble Lords who have spoken have been hugely supportive of her report. This recommendation from the Cumberlege review was overwhelmingly supported by the House at Second Reading and is vital to ensure that the interests of patients are represented, to try to prevent scandals such as that regarding mesh implants from recurring. We support it wholeheartedly, and I was delighted to add my name to the amendment.
At present, there is no one to listen to the voice of patients, act on concerns, gather data and put together a clear picture to report back to the department. Commissioners can bring a fresh pair of eyes to an area but also a strong voice for patients. Of course, as the noble and learned Lord, Lord Mackay of Clashfern, said, they bring independence too. In addition, they will have unique statutory powers and responsibilities, such as powers to get access to data, and investigatory powers, with power of entry if necessary. Of course, patients’ voices would need to be heard, so in all probability, there would be a helpline, as well as email access and access via a website and by letter.
The noble Baroness, Lady Cumberlege, spoke of the Children’s Commissioner, and she was not alone. It has been a great success. The commissioner knows her remit and, as the noble Lord, Lord Hunt of Kings Heath, said, she speaks with no vested interest except in children, and she stays within it. She champions children and, as has already been said, this has given her authority. As a consequence, the organisation is hugely respected.
I have heard the criticism of the cost of such a body as the patient safety commission, and I feel sure that the noble Baroness would have squared off the funding for a commissioner and their office with the Cabinet Office, which would be the funding vehicle. However, compared with similar commissions, it would amount to less than £1 per head of population per year—less than tuppence per person per week. I defy anyone to claim that that is excessive. This is indeed of value, and patients of course deserve it.
Baroness Thornton (Lab)
The last remark of the noble Baroness, Lady Jolly, was very pertinent indeed.
After this debate, I probably need to say only that, from these Benches, we support the noble Baroness, Lady Cumberlege, in her proposal to establish a patient safety commissioner on a statutory basis. We have heard powerful contributions from the noble Baroness, Lady Cumberlege, herself, the noble Lord, Lord Patel, and my noble friend Lord Hunt. I always thought, when I was a Minister and since, that you should always listen when the noble and learned Lord, Lord Mackay of Clashfern, says that, in his “respectful submission”, something is a good idea; it is always a good idea for the Minister to take note of that.
Lord Bethell (Con)
My Lords, I start by profoundly thanking my noble friend Lady Cumberlege. It has not escaped the notice of anyone in this Grand Committee that her amendment has the support of a very large number of noble Lords, including the noble Lords, Lord Patel and Lord Hunt, and the noble Baronesses, Lady Jolly and Lady Thornton. Many Members spoke in favour of her report’s recommendation at Second Reading, and I expected that we would spend time on these matters now.
Let me say at the outset that the Government take very seriously the report of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege. We are absolutely determined to learn from it. We are taking time to carefully consider the report and all its recommendations before we respond, which is reasonable. Given the important issues it raises, it is only right that the report gets due consideration. It is right that, on a report of this length and breadth, we take the time to do this properly.
At the heart of the review are harrowing stories of hundreds of people and their families. It is right that the Government have made an unqualified apology on behalf of the health system to all the individuals affected by this report.
I shall say a word about the pause in the use of vaginal mesh in the treatment of prolapse and incontinence which was introduced in mid-2018. As my noble friend Lady Cumberlege rightly observed, the pause introduced a period of high vigilance, restricted practice to ensure that NICE guidance was followed. A blanket ban on the relevant procedures was not recommended as there needed to be some exceptions within the pause. I am aware of the six conditions that must be met before the pause can be lifted. The majority of the six measures are in hand. NHSE is working closely with providers to set up specialist mesh removal centres and is working in partnership with the British Association of Urological Surgeons and the British Society of Urogynaecology to ensure that there is a consistent approach to informed consent and shared decision-making in these centres with clear and accessible information available for patients. I am aware that a data solution is yet to be fully implemented, but I reassure noble Lords that I understand that NHS Digital, working with NHSX, has put together a programme of work to establish an information system to collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures, and that this work is in the pilot stage with a view to establishing a medical device information system.
We recognise that Amendment 117 stems from the centrepiece recommendation of that bold and far-reaching report to establish an independent patient safety commissioner. He or she would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. We recognise that the role would be to help patients navigate the healthcare system architecture and to troubleshoot problems and that, as my noble friend put it in her report, the commissioner could be a golden thread tying our complex health system together in the interests of patients and the public. We recognise the significance of the intention of this amendment. We wholeheartedly accept that listening to patients is a key step to preventing the sort of issues that the report by my noble friend Lady Cumberlege has highlighted.
We accept that policymakers, the NHS, private providers, regulators, professional bodies, pharmaceutical and device manufacturers need to do more to engage patients and families, and to recognise and use their insights as a vital source of learning. It is only by listening to patients, their families and staff that we can learn from mistakes and continually improve. On this point, it has been imperative that we listen, and I am listening very carefully today to the points made by colleagues about the arguments for a commissioner and how this might sit within the wider system. I will continue to listen.
However, before I turn to Amendment 117, allow me to explain why patient safety is an unwavering commitment for the Government and the measures we are taking to embed patient safety throughout the NHS. These include putting a positive learning culture at the heart of the NHS and ensuring that providers are listening to those who raise concerns at the time they are raised, whether by patients, their families or staff, and that they show empathy and sensitivity when they respond. This is a culture where patients are listened to in the first place and not one where they feel they must resort to a third party in order to be heard.
Following the tragedy of Mid-Staffs, which the noble Baroness, Lady Thornton, referred to, and some other very concerning cases, we have overhauled the infrastructure underpinning safety and quality in the past decade. That includes taking steps to help staff speak up when they see things going wrong. A culture that listens and responds to concerns in the first place is crucial if the right lessons are to be learned and errors are to be minimised. Our measures include establishing: the Healthcare Safety Investigation Branch to examine the most serious patient safety incidents and promote system-wide learning; medical examiners to provide much-needed support for bereaved families and to improve patient safety; a duty of candour so that hospitals tell patients if their safety has been compromised and apologise; and protections for whistleblowers and freedom to speak up guardians across all trusts, supported by a national guardian.
In addition, the NHS people plan for 2020-21 sets out our vision for a health service that is compassionate and inclusive, that is not hierarchical and where people are listened to. We know that implementing change can be a slow and complex process for many organisations and individuals. Healthcare will always involve risks, but they can be reduced by analysing and tackling the root causes of patient safety incidents.
However robust our regulatory and oversight system is, ultimately, improving patient safety requires those at the executive level of our health service to act just as much as individuals involved in patient care. It is why in 2019 we commissioned the NHS national director of patient safety, Dr Aidan Fowler, to publish a new NHS patient safety strategy. Substantial programmes are planned which include: a framework to support patients to contribute to their own safety by having patients or their advocates on all safety-related clinical governance committees in NHS organisations; a requirement for all NHS organisations to identify a specialist to lead on patient safety; the first ever system-wide patient safety syllabus and training for all staff so that they have the knowledge to make care safer themselves; a new patient safety incident response framework to improve the handling of patient safety investigations in the NHS; a successor to the national reporting and learning system to support safety improvement and help the NHS when things go wrong; and a national patient safety improvement programme to prioritise the most important safety issues in the NHS, including medicines safety.
Implementation of the 10-year NHS patient safety strategy is being led by a team that is more than 50 strong. At its core, the strategy seeks to significantly improve the way the NHS learns, treats its staff and involves patients. The strategy seeks to ensure that all healthcare organisations in England adopt a different focus for patient safety that is based on culture and systems. NHS England and NHS Improvement have assessed that getting patient safety right could save 1,000 lives and £100 million in care costs each year from 2023, with the potential to reduce claims provision by around £750 million a year by 2025. The NHS patient safety strategy will be refreshed each year to support our ambition of cementing patient safety into the everyday fabric of the NHS and encouraging a safety and learning culture. NHS safety bodies are doing more to involve patients to better understand issues that give rise to patient safety concerns. Let me give a couple of examples.
The Healthcare Safety Investigation Branch has established a citizen partnership panel to bring in patient insights and ideas for referrals or improvements in HSIB’s investigations. The experiences of patients and their families are central to the regulatory approach of the CQC and its future direction. The MHRA has begun a substantial programme of work to drive forward change in its culture, where a key priority is listening and responding to patients.
Lest we forget, the healthcare system architecture is complex. This means that patient safety regulation is prone to overlaps of remit and gaps between oversight bodies. It is why our consideration of the recommendations by my noble friend Lady Cumberlege includes how a patient safety commissioner would interact with other bodies across the healthcare landscape, ensuring that they could make a difference without creating duplication or confusion.
With this in mind, although Amendment 117 from my noble friend Lady Cumberlege, the noble Lords, Lord Patel and Lord Hunt, and the noble Baroness, Lady Jolly, would give the patient safety commissioner considerable latitude about how he or she would operate, it is without detail about how the commissioner would interact with other bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among many others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants whatever the cause of the complaint may be. These bodies also have their own routes for reporting. For example, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme. Proposed new subsection (5)(e) does not address how a new route for patients to report safety concerns would mitigate the risk of drawing patients away from reporting these incidents to the MHRA or of causing a delay in the MHRA receiving this vital information or receiving it at all.
Proposed new subsection (7) enables the commissioner to require information from public bodies and others for the purposes of producing and laying before Parliament reports regarding patient safety. Although this power does not, as we might expect, extend to requiring information for the purposes of fulfilling the commissioner’s other functions, it is otherwise broad, because it would apply to both public and private bodies, and individuals, and could involve requests for sensitive personal data and confidential commercial information that these bodies may not agree are reasonable for the purposes of the commissioner’s public reports.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
I have received one request to speak after the Minister. Baroness Thornton.
Baroness Thornton (Lab)
I am grateful to the Minister for that detailed answer, but as far as I can see, it underlined the point about the fragmentation of patient safety. He is undoubtedly right about the need to change culture. Will the Minister look at this again, because I mentioned the three inquiries in the past 20 years that I knew about very well, and every one of them said very similar things to what the Minister has said? None of them has produced the kind of support that one would want for patients or been the catalyst required here from the patient safety commissioner. Will the Minister go back and think about this again?
Lord Bethell (Con)
I take the encouragement of the noble Baroness to heart. I would be very happy to think further on it. She makes a very good point: we know about the terrible incidents of the past and the very substantial responses that they had. I share with her the frustration that these problems continue to arise. For that reason, as I said, we are looking for a really thoughtful, considered response to the review overall. As I said in my earlier remarks, the case for a patient safety commissioner is one that we are looking at. I listened to absolutely everyone who has spoken in its advocacy, but we do not regard it as a silver bullet or a single point of catalysis, which I do not think the noble Baroness was alluding to. We are looking for a broad response to the review that would ultimately take on all the different points that the noble Baroness and her review team have made.
Baroness Cumberlege (Con) [V]
My Lords, I will come to the Minister’s summing up at the end, but I thank all noble Lords who have taken part in this debate. I have not heard anything really contrary or disturbing against a patient safety commissioner. It has been supported, and I am very grateful for that.
I first thank the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Jolly. I know that the noble Lord, Lord Patel, has been a champion of safety both in Scotland and in this country. I share his impatience. He considered some of the interesting reports that have been produced and we hope that they all have made a little difference—but not enough. He is so right to say that we are searching for independence, as other noble Lords have mentioned. The person who we appoint to this position is so important. We do not want a patsy or someone who is just going to do what the department and Ministers want. We want an independent voice. I thank all those who also talked about a patient safety commissioner and the Children’s Commissioner, who, as we all said, has been outstanding. I also thank the noble Lord, Lord Patel, for his revealing statistics, which were interesting.
I understand the cynicism of the noble Lord, Lord Hunt of Kings Heath, about NHS England. I say just one thing about it, but I should have declared my interest at the start of the debate because I am employed by NHS England in the context of maternity services. The chief executive took our report, Better Births, and said, “I am giving you five years to implement it”. He gave us the people, resources and everything else. We were making real progress until March. The virus has really knocked us back—we did not expect it. However, in the four years that we have completed, we have changed much of the culture within maternity services and improved the lot of many women. We have not had that response from the Government on this report. They have not said, “We will give you five years and some resources. See what you can do”. No, they have been silent. Today, the Minister told us a bit about what he has been doing. However, none of that was news to us. We know all that already.
Moving on, I refer to what the noble Lord, Lord Hunt of Kings Heath, said about the tension within boards. I chaired the Brighton health authority board when the Grand Hotel was bombed. It was a tragedy—lives were lost—but when one looked at the whole system, it worked. Why was that? It was because we had a good leader in A&E who conducted a rehearsal three weeks before the bombing. That rehearsal paid off. Preparation is extremely important. The noble Lord was of course right about the financial problems that must be weighed up within trusts.
We are so lucky to have in our House my noble and learned friend Lord Mackay of Clashfern, a previous Lord Advocate and Lord Chancellor. I remember working with him on debates about the family and all sorts of matters. If you want somebody with true wisdom, understanding and foresight, you go to him. He has done it all, knows about it and always has such integrity. I thank him very much for his support and his impatience, which I share. We know today that babies are being born deformed. One in two have a chance of having a disabled child if they are on sodium valproate, and they do not know about it. We are impatient. We do not want to see more of that. We want to see safety become a reality.
My noble friend Lord O’Shaughnessy has, of course, been a Minister in the House and he knows the tensions and difficulties. One of the things that I know about him is that he listens to patients: he takes time out to do that. He appreciates, almost more than all of us, how people have waited for decades in terrible conditions, suffering terribly. I know that he has done a lot with sodium valproate and the patient groups there, and I thank him for that. What he was telling us about Jeremy Hunt and the way that this review was first commissioned was really helpful, because Jeremy Hunt set the parameters. He was invited to take on three different areas by the Prime Minister, Theresa May. It was really her initiative first, and then Jeremy worked extremely well. I am of course delighted that he appointed me to chair the team.
I want to say a word about the noble Lord, Lord Blunkett. I am very pleased that he is taking part in this Committee; he apologised for not being at Second Reading. Whenever he comes in on a debate, we welcome him. Again, with him having been a really strong leader in his own area and then in the Commons, it is really good to have had him join us today. He talked about the Health and Safety Executive and how we have to work with it. He is of course right.
The Minister, in his summing up, asked who this patient safety commissioner is going to work with. We do not know exactly—of course not. He can read the amendment, which sets out quite a lot. He can read the report and see there what we were thinking about, but of course this needs more work. In fact, one of the members of our team said to us, “Do not lose out on the coroners’ courts; you learn a lot from them”. Her husband is a judge, so she knows a bit about it. We are saying that you have to map the whole horizon and see where things are not quite right. Why is something going wrong? That is something we ought to look at more carefully.
It is about listening to patients but, much more than that, it is about working with all the different healthcare systems. My noble friend Lord Sheikh and others talked about the NHS. We are thinking much more broadly than the NHS. We are thinking about it, of course, and we know it has done a fantastic job with the coronavirus, but we are also thinking about private providers. I was very interested that the noble Baroness, Lady Masham, brought in private providers. We need to think about other public bodies and certainly about the royal colleges, the pharmaceutical and devices industries, the manufacturers and of course the policymakers—the politicians. I appreciate that it is a broad area but that is the problem with it at the moment: it is disjointed and siloed, it is unresponsive and defensive. We need some person who is going to get into all of that and call all the organisations to account—encourage them but call them to account when things are not working right.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
We now come to the group beginning with Amendment 119. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 119
Baroness Wheeler
“Northern Ireland and regulatory divergence
(1) The Secretary of State must work together with the appropriate authority in Northern Ireland to minimise the potential for and mitigate against regulatory divergence in relation to human medicines, veterinary medicines and medical devices. (2) Where the Secretary of State has identified areas of regulatory divergence in relation to human medicines, veterinary medicines and medical devices between Northern Ireland and the rest of the UK, the Secretary of State must lay a report before both Houses of Parliament setting out how the divergence will impact—(a) the UK; and(b) Northern Ireland.(3) The report must set out the steps the appropriate authorities have taken to mitigate against such divergence.”Member’s explanatory statement
This Clause would require the Secretary of State to work with the appropriate authority in Northern Ireland to minimise the potential for regulatory divergence relating to medicines and devices, and report any areas of regulatory divergence to Parliament, including the impact they will have, and report on actions to mitigate against adverse consequences arising from divergence.
Baroness Wheeler (Lab)
My Lords, on behalf of my noble friend Lady Thornton, I am moving Amendment 119 on the important issue of regulatory divergence with Northern Ireland and reporting to Parliament. I am grateful for the support of the noble Baroness, Lady Ritchie, who raised this key issue at Second Reading, as did the noble Lord, Lord Patel, whose Amendment 120 is grouped with this amendment. I look forward to their contributions and to those of other noble Lords.
Amendment 119 would add a new clause to the Bill on the interpretation of Part 3, “Medical Devices”. It would require the Government to work with the appropriate authority in Northern Ireland to
“minimise the potential for and mitigate against regulatory divergence in relation to human medicines, veterinary medicines and medical devices.”
Where an area of divergence is identified, the Secretary of State would be required to lay a report before Parliament on the impact it will have and the steps being taken to mitigate it.
Human and veterinary medicines are transferred matters in Northern Ireland. For this reason, Clauses 1 and 8 lay out in black and white the possibility of regulatory divergence, as they give separate powers to Northern Ireland departments to make regulations relating to Northern Ireland. However, despite this being in the Bill, the rest of the legislation as drafted is completely silent on the implications this may have, or on any mechanism for dealing with them. This means Northern Ireland could end up passing different legislation.
As well as those powers in the Bill, there is the wider context of the Northern Ireland protocol, under which Northern Ireland will continue to apply certain European Union standards that will no longer automatically be part of the law governing Great Britain. For example, in the Government’s own guidance on regulating medical devices from 1 January 2021, it is stated that, unlike in Great Britain, the EU medical device regulations and the EU in vitro diagnostic medical device regulations will apply in Northern Ireland from May 2021 and May 2022 respectively.
The risks of divergence have been raised by Members in both Houses, including the risk that what may on the face of it seem to be only minor or technical differences could create a butterfly effect, leading to much larger legal and operational problems. The Bill does not itself create divergence and nor for that matter does the Northern Ireland protocol, but both permit it or create a situation in which it may arise. It is therefore vital that the implications of this are part of discussions on the Bill.
Lord Patel (CB) [V]
My Lords, I will speak to Amendment 120 and, again, I am very grateful to my friend the noble and learned Lord, Lord Mackay of Clashfern, for joining me on this amendment. I beg noble Lords’ indulgence because, when I read the legislation and the Bill related to this and then looked at the advice or guidance issued by MHRA, I got more and more confused about what the divergence is going to be, how much of it there will be and how clear the Bill is. I am sorry, but I will be labouring the point at length to get some answers.
My proposed new clause would require the Secretary of State to report on
“regulatory divergence between Northern Ireland and the rest of the United Kingdom”.
This amendment would address the issues of potential regulatory divergence between Northern Ireland and the rest of the United Kingdom. In relation to medicines and veterinary medicines, Northern Ireland is referred to separately from the rest of the UK. This means that, as set out in Clause 1(4)(b) and Clause 8(4)(b), the power to make regulations in respect of Northern Ireland lies with the Department of Health in Northern Ireland or both the department and the Secretary of State, when acting together.
Clause 40 limits the capacity of the Department of Health in Northern Ireland to act alone, only allowing it to do so when it would be
“within the legislative competence of the Assembly, and … would not require the consent of the Secretary of State.”
It is not clear in the Bill which areas would be in the sole competence of the Northern Ireland Assembly. Will the Minister clarify that?
Furthermore, while powers on medical devices are not reserved, the guidance most recently published by the MHRA paints a picture of two different systems—market authorisation and registration, among other issues—and distinguishes between the “Northern Ireland market” and the “Great Britain market”. This implies that regulation different from that in the rest of the UK may be intended for Northern Ireland in respect of medical devices.
The MHRA published guidance on medicines and medical devices based upon the potential situation at the end of the transition period, days before this House was due to sit for the Second Reading of the Bill. This advice implies that a dual system would be operating in respect of Northern Ireland for both medicines and medical devices due to the operation of the Northern Ireland protocol, to which the noble Baroness, Lady Wheeler, referred. This assumes that the Government will actually honour that agreement. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland.
The MHRA guidance makes a distinction between the EU market, the market of Great Britain and the market of Northern Ireland. It sets out that CE marks will cease to be recognised in the market of Great Britain from July 2023, unless the products in question are from manufacturers based in Northern Ireland. There are essentially two different baskets envisaged in the guidance for manufacturers that are based in Northern Ireland to bring a medicinal or medical product to the markets of Great Britain and Northern Ireland.
The first is to go through UK-based approved bodies for their assessments and market authorisations, which would be approval for the Great Britain or Great Britain and Northern Ireland markets, but it would not be recognised in the EU. The second is to submit their application to approval or notified bodies in the EEA, gaining a CE mark and thus access to the markets of Great Britain, Northern Ireland and the EU without further needing to apply to a UK body for approvals for the Great Britain market. Noble Lords will see how confusing the whole system sounds.
In contrast, manufacturers based in Great Britain would need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland but would need to undertake the separate task of getting an EU-based responsible person and applying separately for a CE mark in the EU if they were to bring their product to the EU market.
Further, from 30 June 2023, CE-marked devices originating from the EU market but not manufactured in Northern Ireland will no longer be able to flow to Great Britain. This regulatory set-up in Northern Ireland could therefore be an incentive for EU manufacturers to base their European operations in Northern Ireland to have unfettered access to both markets. Discussions about whether this constitutes state aid and would distort the EU single market are still ongoing.
On the face of the MHRA guidance, it appears that the recognition of the CE mark on medicines and devices coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. It certainly suggests a dual system applying between Northern Ireland and the UK, but the extent to which those systems will diverge in substance in future is not clear. It is not clear how systems of pharmacovigilance or the monitoring of medical devices will be co-ordinated for products available in the Great Britain market that are manufactured in Northern Ireland and subject to EU regulations and monitoring. If monitoring systems and databases are to be fit for purpose in the EU, surely it is essential that the UK has access to EU databases. In the absence of this access, how can the Government guarantee, or claim to be prioritising, the safety of patients?
What is clear, because the guidance states it, is that draft regulations with reference to medicines and medical devices exist but have not yet been introduced to Parliament. These draft regulations are what the guidance claims to be based on. If these regulations exist to the extent that the MHRA is publishing guidance based on them on issues of significant policy in these areas, why has this House not had sight of them? Why have they not been included as part of the substance of the Bill where they would receive proper scrutiny and provide much-needed clarity to all stakeholders for medicines and medical devices?
The situation regarding regulatory alignment or divergence between Northern Ireland and the rest of the UK is politically charged and should be dealt with explicitly. Given the potential for some aspects of medicine and veterinary medicine to be subject to the distinct competence of the Northern Ireland Assembly, there is potential for the requirement to have regard to “attractiveness” to have different interpretations in Northern Ireland and the rest of the UK. Further, the ambiguity surrounding the Northern Ireland protocol and its implications raises the potential for divergence, even where the United Kingdom Government have competence to regulate in respect of medical devices. For these reasons—I hope that I have made this point at length—the Government should clarify the position. This amendment would provide greater transparency about the potential regulatory divergence with a commitment to mitigate where possible.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, I am delighted to follow the noble Baroness, Lady Wheeler, and the noble Lord, Lord Patel, on these amendments dealing with regulatory divergence and Northern Ireland. I am a signatory to Amendment 119 in the name of the noble Baroness, Lady Thornton.
During Second Reading, I stated that there is the issue of potential regulatory divergence in relation to Northern Ireland, as medicines are a devolved power but medical devices are not. The Bill raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK, and that matter requires clarification, hence my support for Amendment 119. Both amendments seek to ensure greater accountability and transparency, to which the noble Lord, Lord Patel, referred, in that Parliament should receive reports on regulatory divergence as a means of oversight and accountability—with which I totally agree.
In some areas, this also relates back to the Northern Ireland protocol. There is no doubt that we must ensure the highest level of standards in relation to veterinary medicines, human medicines and medical devices. In his response at Second Reading, the Minister indicated to me that the Government intended to implement the Northern Ireland protocol, but I ask how that squares with the UK internal market Bill, this Bill and the need to ensure that we have the highest standards for medicines, medical devices and veterinary medicines—how does this all square?
I note that the NHS Confederation will continue to follow developments, analyse the implications for the health sector in the UK and push for as much clarity as possible on the implementation of the Northern Ireland protocol from 1 January 2021. It has also been stated that Northern Ireland will remain part of the UK customs arrangements constitutionally, so HMRC—not EU officials—and the UK’s Medicines and Healthcare products Regulatory Agency should administer the necessary controls. The MHRA remains responsible for placing the goods on the market and monitoring products once sold, but they will have to be approved through the European procedures because Northern Ireland will be treated as a member state in terms of regulatory decisions.
There is also concern that there will be delays in the import and export of medicines and medical devices, which need to continue to reach patients as quickly as possible, and we must ensure that any such delays are minimised, particularly during a pandemic. Avoiding delays caused by tariffs and regulatory barriers requires the UK and the EU to reach agreement on shared standards, such as manufacturing and inspections, so that goods can be licensed for rapid release into the UK market, or vice versa. With potential new checks and the lack of clarity on how the regulatory framework will apply, this could create unnecessary delays and impact on individual patients but also on medical practitioners.
There is also a need, as the Northern Ireland Affairs Committee said, for the Government to commit to covering all costs to businesses for complying with the protocol, which includes the whole area of medicines. I ask the Minister, the noble Baroness, Lady Penn, what discussions she and the noble Lord, Lord Bethell, have had with Minister Swann in the Northern Ireland Executive, as the Minister responsible for the Department of Health, about these issues, particularly in relation to the measures to minimise and mitigate the impact of divergence and how that will be achieved. We want to ensure the least impact from regulatory divergence on the availability and accessibility of medical devices and any other forms of medicine, whether for humans or for animals.
Baroness Penn (Con)
My Lords, we have unfortunately come to the end of our allotted time for this Grand Committee. I am afraid that I will need to adjourn our debate for today.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
That concludes the work of the Committee this afternoon. I remind Members to sanitise their desks and chairs before leaving the Room.
Medicines and Medical Devices Bill
Thursday 19th November 2020
(4 years ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-VII(Rev) Revised seventh marshalled list for Grand Committee - (17 Nov 2020)
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
A participants’ list for today’s proceedings has been published by the Government Whips’ Office, as have lists of Members who have put their names to the amendments, or expressed an interest in speaking, on each group. I will call Members to speak in the order listed. Members are not permitted to intervene spontaneously; the Chair calls each speaker. Interventions during speeches or “before the noble Lord sits down” are not permitted.
During the debate on each group I will invite Members, including Members in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will call the Minister to reply each time. The groupings are binding and it will not be possible to de-group an amendment for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate.
Leave should be given to withdraw amendments. When putting the question, I will collect voices in the Grand Committee Room only. I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an amendment is negatived and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group.
We will now begin.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I call the noble and learned Lord, Lord Mackay of Clashfern. He is not there. The noble Baroness, Lady Jolly, is not with us either so I call the noble Baroness, Lady Penn.
Baroness Penn (Con)
My Lords, before I speak to the helpful debate we had on this group of amendments, I should like to make a correction to my response to an earlier grouping. At the time, I said that all adverse incidents with medical devices are available online on the MHRA’s website. I would like to correct this: adverse incidents with medical devices will be published online on the MHRA’s website as part of the plans to deliver increased transparency and in line with developing future legislation enabled by the powers in the Bill. However, it is not presently the case.
Turning to our present debate, I thought it might be helpful first to address the current arrangements for the regulation of medicines, veterinary medicines and medical devices in Northern Ireland. Responsibility for medical device regulation is reserved in respect of the whole of the UK. However, Part 1 of the Bill, relating to human medicines, and Part 2, on veterinary medicines, deal with transferred matters in relation to Northern Ireland. Clauses 1 and 8 set out that regulations in relation to Northern Ireland can be made either by the Secretary of State acting jointly with the Northern Ireland department or by the Northern Ireland department. This has always been the case; however, the MHRA and the VMD regulate these areas UK-wide on a day-to-day basis. After the end of the transition period, with regard to both human and veterinary medicines, as well as medical devices, under the terms of the Northern Ireland protocol, Northern Ireland will continue to follow the acquis.
Amendment 119 in the name of the noble Baronesses, Lady Thornton and Lady Ritchie of Downpatrick, seeks to ensure that, in making regulations under the Bill, the Government must minimise and mitigate the potential for regulatory divergence between Great Britain and Northern Ireland. Along with Amendment 120 in the names of the noble Lord, Lord Patel, and my noble and learned friend Lord Mackay of Clashfern, Amendment 119 seeks to establish a requirement for the Secretary of State to report to Parliament on areas of divergence between Great Britain and Northern Ireland.
I completely understand that these probing amendments seek to ensure that Parliament has proper sight of how medicines and medical device regulation develops in the future, particularly in relation to any differences between Great Britain and Northern Ireland. That is right and proper. Noble Lords will be aware, however, that the amendment in the name of my noble friend the Minister, on reporting obligations, means that the Government must already provide Parliament with a report every two years. This sits alongside the separate amendment to Clause 41 in my noble friend’s name, which requires a public consultation on any regulatory change to be made under the Bill.
That new reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 8(1) and 12(1) is both forward and backward-looking. It must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. That may include advance notice of further regulatory change that the Secretary of State is proposing to make.
These reports, along with the public consultation on regulations under the Bill, would be the right place to deal with any issues of possible regulatory divergence raised. It would therefore be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for medicines and medical devices.
Noble Lords also asked a number of practical questions on how regulation will operate in Great Britain and Northern Ireland after the end of the transition period, which I will also address. The noble Baroness, Lady Wheeler, asked who would be responsible for any possible divergence between the Great Britain and Northern Ireland regulatory systems. I can reassure her that the MHRA and the VMD, reporting to their respective Secretaries of State, will continue to regulate human and veterinary medicines and medical devices for the whole of the UK, and will continue to ensure that patients and animals in Northern Ireland, just as in Great Britain, receive the safe and effective medicines and devices they need.
The noble Baroness, Lady Ritchie, asked specifically about the interaction between the UK Government and the Northern Ireland Executive on issues relating to future regulation of medicines and medical devices. I can reassure the noble Baroness that officials in the Department of Health and Social Care meet officials in the Northern Ireland Executive every two weeks to discuss the Bill and regulation of medicines and devices, and that a strong working relationship exists.
Robin Swann MLA has also given consent for the medicines day one-readiness statutory instrument, laid on 20 October, to be made by the Secretary of State for Northern Ireland as well as for Great Britain. We will continue to engage with the Northern Ireland Executive as plans for the future regulatory environment for devices and medicines develop.
The noble Lord, Lord Patel, also raised the approach to the day one readiness after the end of the transition period on which the MHRA has based its guidance to industry. I can reassure the noble Lord that, as I have just said, those regulations have been laid before Parliament, and we expect to debate them in early December.
Those regulations also require that from 1 January 2021, marketing authorisation holders must transmit all global serious reports of adverse drug reactions directly to the MHRA, to ensure that the agency has access to the totality of the information, to assess safety issues. This links to the noble Lord’s point on pharmacovigilance. I can reassure him that, following the end of the transition period, the MHRA will continue to be responsible for pharmacovigilance across the whole of the UK, and will use common processes for the assessment of safety issues in Northern Ireland and Great Britain.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I think that the noble and learned Lord, Lord Mackay of Clashfern, is now with us. Are you there, Lord Mackay?
Lord Mackay of Clashfern (Con) [V]
Yes, I am here. My internet was turned off on the basis that I was on an aeroplane—which I have not been since March. That shows that some things are not absolutely reliable. Anyway, the noble Lord, Lord Patel, has dealt with the subject, and I do not need to trouble noble Lords any further.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I now call the noble Baroness, Lady Wheeler. No? I gather that the noble Lord, Lord Patel, wants to speak. I call Lord Patel.
Lord Patel (CB) [V]
My Lords, I sent in a request to speak after the Minister. I am grateful to her for her lengthy response, but in a way it just shows that there will be considerable areas of divergence once we exit Europe, even after we exit Europe and the agreement with the EU has expired. What the Minister said is correct—that maybe the emergency power regulations will allow us to ask questions—but those are only emergency powers, and this is longer-term.
My amendment asks for an indication, on at least a yearly basis, of where divergences are occurring. It is interesting that the Minister said that the statutory instrument is now available and will be debated in due course. Of course it is available now—although I do not know when it was made available—and we will have an opportunity to debate it. However, the MHRA was already giving guidance on the basis of that instrument before we had seen it or debated it. The Minister’s reply did not therefore satisfy the intention behind my amendment—although I will, of course, not move it today—in terms of the necessity for the Government to produce a report of where divergences are occurring and why.
Baroness Penn (Con)
To address the noble Lord’s question about when the statutory instrument was laid, I believe it was on 20 October. I think the statutory instrument laid on 20 October, which we shall debate, is not the Government’s approach to an answer on how we deal with the future issues of regulating medicines, medical devices and vet meds in Northern Ireland and Great Britain. What I was trying to express to the noble Lord is that we have a mechanism that means the Minister will report to Parliament every two years, both looking forward to prospective changes and back at any changes that may have been made. Of course, where new regulations are proposed there will be public consultation on those, but there will also be reports to Parliament ahead of that about the intentions, and those reports will provide a mechanism, which I think the noble Lord wants, to ensure that these issues are discussed properly in Parliament in future.
Baroness Wheeler (Lab)
I thank the Minister for her response. Due to the break in the group since Tuesday, we have all had the advantage of being able to have a closer look in Hansard at the speeches made by the noble Lord, Lord Patel, and the noble Baroness, Lady Ritchie. If we had managed to squeeze in the Minister’s response, that would have been perfect; I could then have responded having read it all very closely.
Anyway, I thank the noble Lord, Lord Patel, both for his support of our amendment and his very detailed considerations and questions on the MHRA guidance on Northern Ireland-Great Britain regulatory diversion on medicines and medical devices. His speech was very much a tour de force on the whole situation, understating how confusing the situation is in relation to the distinction the MHRA guidance makes between the EU market, the GB market and the market for Northern Ireland. We will need to read Hansard carefully but, despite the Minister’s best endeavours, I cannot see that she has managed to clear up for us exactly how the whole confused system will work in the future.
Moreover, as the Minister and the noble Lord, Lord Patel, mentioned, we do have the draft regulations. My attention has been drawn to them only this week. I thought they were published on 13 November, not in October, but that may be just me not reading them properly. Both regulations deal with Northern Ireland and Great Britain regulatory diversion issues, so this debate will be paused until we have considered those regulations and come back to the main Bill, and while we see what outcome there will be on the adoption of the Northern Ireland protocol.
The noble Baroness, Lady Ritchie, underlined the need for monitoring, oversight and accountability on this issue, and the importance of reporting to Parliament, and we obviously strongly agree with that. I did not specifically hear a response to her question on what internal discussions there have been between the noble Lord, Lord Bethell, and the Minister in the Northern Ireland Executive with responsibility for the NI Department of Health. If the Minister could write to her and put a copy in the Library, so that we can see what progress the discussions have made so far, that would be really helpful.
On the issue of reporting to Parliament annually—as in the amendment in the name of the noble Lord, Lord Patel—and not every two years, as the amended legislation provides for, I think the annual report called for by the noble Lord will be very much needed as all the problems and issues underlined by him and others in this debate are being worked through.
The issue is vital, and many issues are still to be identified, considered, worked through and resolved, which will mitigate and minimise the potential for regulatory divergence in human medicines and medical devices between Northern Ireland and Great Britain. In that expectation, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
We now come to the group consisting of Amendment 121. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 121
Baroness Cumberlege
“Independent medicines and medical devices safety review: task force for implementation
(1) Within three months of this Act being passed, the Secretary of State must appoint an independent task force.(2) The task force must—(a) have an independent Chair;(b) be accountable to an oversight governance board; and(c) include representatives of the Independent Medicines and Medical Devices Safety Review, published on 8 July 2020.(3) The task force’s functions are—(a) to deliver a timeline for the implementation in full of the recommendations of the Review in subsection (2)(c); and(b) to implement the recommendations of the Review in subsection (2)(c).(4) Once the task force has fulfilled the functions in subsection (3), it will cease to exist.”Member’s explanatory statement
This new clause would establish the task force whose role it would be to implement recommendations set out in the report of the Independent Medicines and Medical Devices Safety Review.
Baroness Cumberlege (Con) [V]
My Lords, as noble Lords are well aware, First Do No Harm, the report of my review, was published in July of this year. Our ninth and final recommendation was that the Government should set up a task force to implement the other recommendations and the many actions for improvement contained in the report. That task force has not been set up, and the Government remain silent on whether they will agree to do so and, indeed, on the report as a whole.
This proposed new clause would require the Secretary of State to set up a task force within three months of the Bill becoming law. I would much rather not find myself tabling it; I would much rather the Government saw the urgency and had already set up the task force, because it is designed to help the department and the wider healthcare system to do the thinking, to make sure we get the details right and to set out a pathway and a timeline for implementing the report’s recommendations.
I believe it must be a collaborative venture; it should involve not just the department and its arm’s-length buddies but also patients. It would be a missed opportunity were it not to include the representatives of my review, because we have the knowledge and the expertise, acquired over two and a half years of work. To inspire confidence among people who have suffered, it needs to be independently chaired and overseen by a government board.
We feel that the task force is the right way to approach the job of implementing the review’s recommendations. My noble friend the Minister may well tell us that the Bill is not the right place for this measure—that is as may be—in which case, if he were able to reassure me that the task force would be set up separately by the Government, as we envisage in this proposed new clause, and on a similar or shorter timescale, I would be more than satisfied.
These matters are pressing. Our recommendations need to be implemented if we are to help people who have suffered so much already, many of them for decades. We must try to prevent further avoidable harm to more patients and families in the future. The task force is the key to making this happen, and those of us who have run organisations know that they need some discipline and something like a task force—a body that will ensure that the task set out is actually implemented and that it happens. I beg to move this amendment, and I look forward to the Minister’s reply.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege, and to support what she is saying. At the heart of her argument is the concern that, although the Minister said earlier in Grand Committee that the Government are weighing it up with all “seriousness and intent”, the Government are not going to run with the core of the noble Baroness’s recommendations. Because the Government have been so reluctant—very unusually—to respond immediately to the thrust of her report, there remains a lot of uncertainty about how far the Government are prepared to implement it.
Of course, the opportunity given to us with the medicines Bill enables us really to press the Government to be more detailed about what they are going to do. On Tuesday, we had a very good debate on the recommendation for the appointment of a patient safety commissioner. The Minister made a very extensive response, which essentially set out the measures that the Government are taking to embed patient safety throughout the NHS. I shall just mention a few: promoting a positive learning culture at the heart of the NHS; taking steps to help staff to speak up when things go wrong; establishing the Healthcare Safety Investigation Branch to examine the more serious patient safety incidents and promote system-wide learning; appointing medical examiners to provide much-needed support to bereaved families and improve patient safety; introducing a duty of candour, so that hospitals tell patients if their safety has been compromised, and apologise; and commissioning the NHS national director of patient safety, Dr Aidan Fowler, to publish a strategy, which, of course, has been done.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, I am delighted to follow the noble Lord, Lord Hunt of Kings Heath, and support the noble Baroness, Lady Cumberlege, in her amendment, to which I have added my name.
The report that the Government commissioned and appointed the noble Baroness, Lady Cumberlege, to do on these issues of medicines and medical devices made nine very clear recommendations in July. One central recommendation in that report, First Do No Harm, was the need for a task force to oversee the implementation of the recommendations from the report —hence this amendment today.
If the Government, the Minister and his colleagues, are serious about the recommendations and recognise that there is an issue and a problem in relation to certain medicines and medical devices, they should see fit to implement all nine recommendations. I think back to when I was doing some research on this. An eminent QC, Lauren Sutherland, said that the Government should not ignore these recommendations—they should implement them.
I made the request, along with many other noble Lords, for the implementation of the task force during Second Reading in early September. I said that it should be set up without delay to oversee progress, and I believe that, if the Government are to take this report seriously and ensure that such failures do not happen again, that needs to happen. What better way to have an implementation group than by the task force that is already in existence, because it was independent of government, has worked on these issues for two years and is fully acquainted with all the matters, problems and challenges met by many people, who have suffered indignity and immeasurable pain as a result of the imprecision in relation to medical devices? To ensure proper implementation and oversight of the recommendations, a task force is a necessary prerequisite and needs to be placed in the Bill. The first remit or task of such a task force should be to set a timeline for its work and delivery of the review’s recommendations. The only way for that to work is if the implementation task force is put in the Bill.
As the report states, the task force should be made up of representatives of the various arms of the healthcare system that have a recognisable role to play in delivering patient safety—in other words, people acquainted with the issues and who have knowledge and expertise. Those responsible for implementation need to know that their work and progress will be monitored and they will be accountable. Supporting the implementation process should be a reference group made up of a range of patient interests going far wider than the groups the report members dealt with. Yet again, such a reference group would consist of people with direct experience, and ongoing daily experience, of the impact of such medicines that have been specified, as well as other types of medicines, where there have been side effects, and the medical devices that have caused so many problems to so many women and men.
We need a system and task force that listens, hears and acts with speed, compassion and with proportionality to prevent further avoidable harm—hence my support for the amendment in the name of the noble Baroness, Lady Cumberlege, to establish such an implementation task force without delay in the Bill.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I congratulate my noble friend Lady Cumberlege on the work that she and her able team have done on the report, First Do No Harm. I entirely support the amendment, and I am delighted to follow in this the noble Baroness, Lady Ritchie, who has pointed out that by definition it will have only a limited life. Its main work will be to ensure that the functions of the report and all the recommendations are followed through. However, I take this opportunity to ask both Ministers if they are minded to support this. Possibly, when my noble friend comes to respond, we might hear what the nature might be of the budget allocated to the task force, as well as to whom, if at all, the oversight governance board in subsection (2)(b) of the proposed new clause might report, and whether it is intended that Parliament might have an overview of the work of the task force.
In establishing the task force, it is absolutely vital that there is a body that has the role, as is intended in this amendment, of implementing the recommendations set out in the report of the Independent Medicines and Medical Devices Safety Review. I would personally favour the mechanism in this amendment that a task force should be set up for this purpose, limited in time with a specific view. I would be interested to know what budget might be allocated, and from which budget this would come, and also if there was a mechanism to keep Parliament informed of the work of the task force for its limited life.
Lord O’Shaughnessy (Con)
My Lords, when I was preparing for today’s debate and I saw where I was in the speaking list, I anticipated that there would not be much left to say by the time we got to me. I was wondering what I might be able to add to support my noble friend Lady Cumberlege in the very powerful argument she made about the need to set up the task force in recommendation 9 from her review.
I went to look at the latest data on the use of valproate in girls and women in the UK, and I declare my interest as a vice-chair of the APPG that looks at these issues. The MHRA publishes a regular report and its version 4, which tracks the data from 2010 to 2019, was published earlier this year. From that I draw two lessons that are very germane to this debate. The first—which the noble Lord, Lord Hunt, alluded to—is that there is this fear of independence, but there is also something else that perhaps goes on, which is almost a sense of helplessness: well, harm is going to happen in practice, there are things you can do, but it is something we are always going to have to accept. The positive message that comes from the work of the noble Baroness, Lady Cumberlege, and her review, is that we can make a difference. If you look at the prescribing of valproate in pregnancy, you see that it fell by 78% from 2010 to 2019 on the back of concerted action from many people—clinicians, officials, Ministers, patients of course, patient campaigning groups particularly, and many others. It halved, year on year, from 2018 to 2019. So we can make a difference through concerted action.
The other data point I take out of it is that even now there are still 200 babies exposed each year to valproate and, as we know, half of them will experience physical or mental harm. That is 100 babies whose lives, and whose families’ lives, are going to be irreparably changed because of that exposure, when everybody accepts that exposure to valproate in pregnancy should be zero, or as close to that as humanly possible.
It is the point about urgency that I want to get across to my noble friend the Minister. I do believe that he is deeply sympathetic to the findings of the review and the need to move forward, but we cannot wait any longer, because these harms are going on. They are going on every day and we can do something about them—and the recommendations in my noble friend’s review are precisely the way we can do something about them. As my noble friend Lady Cumberlege said in her opening remarks, this is not the kind of thing on which you really want an amendment. It is not the kind of thing that should require legislation, but the reason there is such support for it is the sense that nothing is happening when there are harms going on that could be prevented if we took the concerted action that is necessary. That is why I am speaking in support of the amendment today.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I will speak briefly in favour of this amendment in the name of the noble Baroness, Lady Cumberlege. Like the preceding speaker, I am aiming to add extra angles and approaches rather than to repeat what has already been said—but I associate myself, essentially, with everything that has already been said.
As I was thinking about this amendment, I was reflecting on a session in the House—I believe it was this week, although it all blurs slightly if one looks at a screen for long enough—when the Minister, the noble Lord, Lord Bethell, was being questioned by one of his noble friends about why a whole series of Written Questions about Covid had not been answered. The fact is, of course, that all aspects of our health system are currently under enormous pressure. The proposition that I put—as I was arguing in another amendment to the Bill earlier this week—is that this is actually an amendment that makes the Government’s job easier. It carves off a recognisable, obvious piece of work that does not have to be done by already horribly overworked, stretched systems. It means that something can be done: something can be ticked off and said to be under control, managed and done, in a way that does not draw too heavily on that existing overstretched system. That is the first point I wanted to make.
The second point I want to make—and I feel that I need to apologise to the noble Baroness, Lady Cumberlege, for bringing this up—is that, as a former newspaper editor, when I was thinking about reports and what happens to reports, I had to go back to the Leveson inquiry, conducted by Lord Justice Leveson. I remember, when I first read that report, I thought about how it had been carefully structured to put aside some of the more difficult areas, particularly the issue of media ownership concentration. In the report Lord Justice Leveson had tried very hard to create something that was implementable and manageable, and that had some chance of being delivered. I think we all know that that is not what happened, so I can understand that anyone asked to take on a huge job of work, as the noble Baroness, Lady Cumberlege, did with this, must ask themselves the question, “If I devote so much time, energy and effort to this work, will it actually be delivered?”
I said before that the patient safety commissioner amendment was possibly the most important one. In some ways, this certainly vies with it. This is about delivery. We know that there are three reasons to call an inquiry. One might be to find information, one might be to reassure the public, and another might be to create a plan of action. Those are the three often-stated reasons, but sometimes there is a fourth reason—perhaps “sometimes” is not the right word; perhaps “often” might be a better word—to kick something into the long grass. It is crucial that the issues uncovered by the noble Baroness are not kicked into the long grass, and that the very clear, obvious and important recommendations are not lost. So I support this amendment and, should it need to go further, I will continue to support it.
Lord Sharkey (LD) [V]
My Lords, Amendment 121 is another recommendation, as we have heard, from the Cumberlege review. We would, within three months of the Bill being passed, set up a task force to implement the recommendations of the Independent Medicines and Medical Devices Safety Review. This particular recommendation, like the others in the review, received very widespread support at Second Reading, and a key element of the recommendation contained in this amendment is the appointment of an independent chair of the task force. It is absolutely critical that this independence is real, and perceived as being real. It should be clear to all that the chair is not an establishment place-person, and is an obviously safe pair of hands. It is vital that public confidence in the safety of medical devices be restored, and we very strongly support this amendment. This amendment is the means—and perhaps the only means currently available to us—of making the Cumberlege recommendations a reality. If the Minister is not inclined to accept this amendment, I hope that the noble Baroness, Lady Cumberlege, will bring it back on Report, so that we can test the opinion of the House.
Baroness Thornton (Lab)
My Lords, I will be very brief, as it must be clear to the Minister that there is unanimity across the Committee in support of setting up this safer care task force. My noble friend Lord Hunt was quite right that this is about whether the Government take this report seriously, and for me this is also an issue of accountability. Recommendation 9 of nine states:
“The Government should immediately set up a task force to implement this Review’s recommendations.”
I hope that the Minister will just say, “Yes, we’ve done it”, so that we can now be told what the timeline for the task force will be and who will be involved. That is my hope from the Minister’s remarks, but if that is not to be the case, I hope that it might be the case in two or three weeks’ time when we move to the next stage of the Bill.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, again, I thank my noble friend and her team for their work to produce the report and to ensure that patients and their families have been heard. Above all, I pay tribute to all the patients and their families who have so bravely shared their experiences to inform this important report. The report has been impactful and has already served to firmly put patient safety at the top of the agenda for all the healthcare system, and we in the Government are committed to learning from it.
On the amendment, if I may put this delicately, we must please remember that this is not a Bill to respond to the review. The Bill provides the powers needed to be able to update the current regulatory regime for medicines, devices and clinical trials in response to the end of the transition period, although the Bill does have the best interests of patients at its heart.
If it was not for the ongoing impact of Covid-19 on the health and care system, I believe that we would be discussing little else but patient safety. But, as my noble friend Lady Cumberlege has acknowledged in this Grand Committee, Covid has had a challenging impact on all our priorities, including on her own work on the NHS maternity transformation programme —and, of course, on the publication of her report, which was scheduled for the beginning of this year but, because of Covid, happened only 16 weeks ago.
I can assure noble Lords that much activity is already under way. Officials from across the healthcare system have been working together intensely since the report’s publication. They have been meeting weekly since August to ensure that we fully understand the report’s recommendations and the best way forward.
My noble friend has rightly mentioned the importance of listening to and involving patients in the implementation process. We absolutely recognise the need for effective patient engagement to ensure that we get implementation right. The Minister of State, Nadine Dorries, will provide an update on this and other matters related to the report in December, and I shall be very happy to report likewise to this House.
These debates have been clear, and I can assure noble Lords that, as part of our consideration of the report, we will of course want to be informed by the debates on this Bill before responding in detail to this very important report. I am very sympathetic to the desire of my noble friend and others to see the Government move quickly in responding to her report, but I do not agree that this Bill is a sensible method of delivery for that response. It is a weighty report, and our response will be rightly scrutinised when the Government responds to Parliament, but an amendment in this Bill is not the right mechanism. We should not be making policy through legislation, for that rarely makes for good government policy-making.
Therefore, I hope that this is a probing amendment, seeking some reassurance, rather than a firm request. In that spirit, I welcome the opportunity to update the Grand Committee on some of the progress that we are making to date.
Recommendation 1 has been implemented. The Government have, on behalf of the health and care sector, apologised to those women, their children and their families for the time that the system took to listen and respond.
We debated my noble friend Lady Cumberlege’s amendment for a patient safety commissioner just a few days ago, so I shall not repeat all the points raised. It was an insightful discussion, and I will think on it further, as I said during the debate.
We shall shortly be debating Amendments 122 and 123, on establishing a redress agency and redress schemes, so I will not pre-empt those discussions.
On recommendation 5, I know that my noble friend is already aware of work to establish specialist centres for mesh removal, but I would like to say a little more in recognition of its importance. NHS England is working closely with providers to set up the specialist mesh removal centres and is currently working to prepare for launch next April. The service specification for mesh centres describes how all centres must come together in a clinical summit to agree how we can develop the service moving forward, to agree standards that all centres will work to and to share data and outcomes. The first summit will take place tomorrow, 20 November. I am pleased to note that clinicians from the devolved nations are invited to that session too.
On recommendation 6, the MHRA has already begun a substantial programme of work to change the culture of the agency. Key priority areas are: first, listening and responding to patients; secondly, better utilising scientific evidence to strengthen and speed up decision-making on safety; and, thirdly, becoming more open and transparent in everything that the agency does. The MHRA is strengthening its yellow card scheme to make it easier for both patients and healthcare professionals.
On recommendation 7, as my noble friend will also be aware, we have debated Clause 16 of the Bill. Significantly, its provisions will mean that, in future, we can collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures and from that agreed next steps.
On recommendation 8, the General Medical Council already has guidance covering financial and commercial arrangements and conflicts of interest, which came into effect on 22 April 2013. In addition, the GMC’s updated consent guidance came into effect on 9 November. This reaffirms that any conflicts of interest that a doctor or their organisation may have should be shared with patients where relevant. We are considering whether these arrangements should be strengthened further.
My noble friend Lord O’Shaughnessy spoke of a worrying attitude of fatalism in the system, but I should also flag the work being done by GPs, universities and the royal colleges on long Covid and the excellent work being done to protect patients. We are listening to patients, who are presenting highly complex symptoms, including mental health, renal, cardiac, respiratory and other issues. I host a weekly round table that has full engagement with representative groups. We have mobilised a whole-system response. We are linking research with guideline writing for primary care in real time. We are using data thoughtfully, and we are mobilising networks of concerned groups around the country and around the world. This reflects the priority that we have already put on the recommendations of the patient safety report.
My noble friend Lady Cumberlege and her team took two and a half years to complete their review and present their findings, and I am intensely grateful for that. It is imperative, for the sake of patients and especially those who have suffered greatly, that we give this independent report the full consideration it deserves. I look forward to updating the House following the Minister’s Statement in the other place before recess. I therefore hope that my noble friend Lady Cumberlege feels able to withdraw her amendment.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I do not believe that anyone wishes to come in after the Minister, so I call the noble Baroness, Lady Cumberlege.
Baroness Cumberlege (Con) [V]
I thank all those noble Lords who have spoken in this debate. I am extremely grateful to them. I have listened to what the Minister had to say, and I do not deny that meetings are taking place—I understand that they are—but I have no idea what is coming out of those meetings. But we will come to that in a minute.
The noble Lord, Lord Hunt, is quite right that actually implementing policy is the most critical thing and is extremely difficult. The Paterson report was a very interesting report on things that had gone terribly wrong with an individual surgeon who acted inappropriately, and, as I said when we debated the patient safety commissioner amendment on Tuesday, I understand that the Paterson report’s recommendations echo what our report said. What has happened to the Paterson recommendations? I do not believe that anything has happened. If things have happened, I would like to know what they are. I can show shelf upon shelf of wonderful reports that have been drawn together by people who have put their heart and soul into them, but, actually, nothing has happened. I am not going to let that happen with my report—I really am not—because there are too many people who have been so badly hurt and who deserve redress, which we will come on to in the next amendment. The noble Lord, Lord Hunt, is right that there is a missing piece in the jigsaw—the most important piece—because safety has to be a system.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
We now come to the group beginning with Amendment 122, and we will not be interrupted by any Divisions. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 122
Lord Hunt of Kings Heath
“Medicines and Medical Devices Redress Agency
The Secretary of State must, by the end of the period of 12 months beginning with the day on which this Act is passed, bring proposals before Parliament to establish a Redress Agency for those harmed by medicines and medical devices.”
Lord Hunt of Kings Heath (Lab) [V]
My Lords, this is a probing amendment. Although I am a member of the GMC board, I make it clear that I am not speaking on behalf of the GMC.
It is very difficult to move on to the nitty-gritty of a redress agency after the hugely eloquent and moving speech made just now by the noble Baroness, Lady Cumberlege. The Minister said in his response to the noble Baroness that this is not the Bill to respond to the report. What I say to him is that this is the only Bill in town. Medicines and medical devices are at the core of patient safety. He promised that the Minister responsible for patient safety would make a Statement on the report in December. My assumption is that that will be made after the Bill has passed through the House of Lords, and therein lies the problem: we will not be told the Government’s response before we come to the critical Report stage. We just have to work on the assumption that, as the noble Baroness, Lady Cumberlege, said, the Government are not going to embrace her core recommendations. We will therefore have to take action on Report on that basis. I do not see what other course of action the House of Lords can take, unless the Government are prepared to bring forward their Statement so that we can see it before we reach Report.
I have just one other point. I listened to the Minister, and he has been very helpful in setting out some of the initiatives that the Government are taking. However, as with the patient safety strategy—we have been here before—the department seems to have collected all the examples of good practice it can find, bunged them into a report and called it a strategy. That is the problem, because it ain’t a strategy. It does not address the fundamental crunch that the NHS has been run far too hot and is unsafe. When you really tackle that, you have to tackle the issues of resources, work force and targets. That is a huge challenge to the Government, which is why they are so reluctant to go down that course.
What does that have to do with the redress agency? I will try to come to that in a moment. However, I want to ask the Minister whether he can say anything about this recommendation. The noble Baroness, Lady Cumberlege, argued powerfully for a redress agency to be set up on an avoidable-harm basis that looks to systematic failings, rather than blaming individuals, encourages reporting and should provide faster resolution for claimants. She argues that it should be a consensual process rather than a judicial one. Redress would be offered, not awarded, and proceedings under the scheme would be voluntary. She also said that the redress agency would have an important role to play in harm prevention as claims for adverse events would be centralised, enabling data to be provided that would help regulators detect signals earlier.
This is not the first time that a redress scheme has been proposed. Indeed, 17 years ago, an NHS redress scheme was unveiled by the then Chief Medical Officer, Sir Liam Donaldson. It included no-fault compensation for babies born with severe brain damage, and payments of up to £30,000 without litigation for patients whose treatment went wrong. Under the scheme, parents would get a managed medical care package for their child, monthly payments for other care of up to £100,000 a year, lump sums for home adaptations and equipment of up to £50,000, and compensation for pain and suffering capped at £50,000. The other arm of the redress scheme, for smaller negligence claims, would have provided a package including an explanation and apology, remedial treatment, rehabilitation and care where needed and financial compensation up to £30,000 where authorised. Legislation followed in 2006, but 14 years later it has, as I understand it, yet to be implemented. The aim of the Act was to provide a genuine alternative to litigation, but it has languished on the statute book. I would be grateful if the Minister would tell me whether that is it and whether the Government do not think it the appropriate way forward.
I also ask the Minister to say something about the increase in negligence costs to the NHS. The latest annual report from NHS Resolution shows that the total cost of payments made in respect of clinical negligence in 2019-20 was £2.32 billion. Of that figure, a substantial amount was paid in legal costs: nearly £500 million to claimant legal costs and £143 million for NHS legal costs. We know that it often takes years for cases to be resolved.
Is the Minister confident that we are getting this right? Does the noble Baroness’s recommendation not deserve examination, at least? I beg to move.
Baroness Cumberlege (Con) [V]
My Lords, it is hard to follow the very well-researched contribution to this whole issue from the noble Lord, Lord Hunt. It was interesting to hear about Sir Liam Donaldson’s report, which got on to the statute book but was not implemented. Is that not a disgrace? It is really dreadful.
Very near to where I live is the centre for Chailey Heritage, now the Chailey Heritage Foundation, for children who suffered through their mothers having taken the drug thalidomide. I chaired its governing body for years. It is interesting that that redress system still continues; it is supported by a trust, which inherited the disaster of the medication, and it has honoured that and receives government support. So we have examples where this is working.
The redress agency that we recommend is really about the future. My amendment is about the present. We know that so many patients and their families have suffered such harm, and we need a system that is more compassionate and a much more certain route for obtaining redress to compensate them. We are talking not about compensation as such, but about redress. You have to go to the courts to achieve compensation, and it is a very miserable experience—we have heard that from patients. It also takes a very long time and, as the noble Lord, Lord Hunt, said, very often the people who benefit most are the lawyers.
We are talking about Primodos, sodium valproate and pelvic mesh—the three interventions through which people have suffered avoidable harm. The suffering they endure now is terrible. All three have caused and are causing avoidable psychological and, of course, physical and neurological harm. These families really need a little help with the conditions they are living with. Indeed, some are looking after some very disabled children. We do not believe that their needs are adequately met by the healthcare, social care or benefits systems. Some of these people are actually very elderly—the parents of the children who took Primodos. It would be a scandal if those people were to live their lives unable to access the redress they need and the outcome they deserve. After all, the harm was caused not by them, but by the state.
In the case of these three interventions, there is a moral and ethical responsibility to provide ex gratia payments in respect of the avoidable damage that occurred. That responsibility falls on the state and the manufacturers of the products in question. The schemes that would be established through this proposed new clause would provide discretionary payments, and each of the three schemes would have tailored eligibility criteria.
The payments the schemes make would not be intended to cover the cost of services that are already available free of charge, such as healthcare and social security payments. They would be for other needs—for example, the cost of travel to medical appointments. We have met and talked to many of those people, and they have said that it is a significant cost burden. The payments might be for respite breaks or emergency payments where a parent has had to stop work to cover care. These redress schemes would not be in place of litigation, nor will they be to deliver compensation. People should retain the right to take legal action if they wish to obtain compensation—of course they should; that is in our law. The schemes I am talking about should be set up in such a way that they can be incorporated into the wider redress agency that the noble Lord, Lord Hunt, spoke about, once it is established.
These people have suffered for decades. They have tried to obtain compensation through the courts. That action has failed in the case of valproate and Primodos, although I am aware that a new Primodos action is under way. I have been told by solicitors that, in fact, the report does not in any way affect that action. There have been some awards and settlements in the case of mesh, but legal action takes time, as the noble Lord, Lord Hunt, said. It creates added stress and much more personal cost can be involved.
I believe that a measure of a decent society is how well it looks after those who have suffered harm, especially when that harm was avoidable. From having met many hundreds of people who have suffered and heard from many more, I am clear that help is needed and deserved. People should not be made to wait any longer. I hope my noble friend the Minister will agree with that.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I shall speak to Amendments 122 and 123, to which I attached my name. The first is in the name of the noble Lord, Lord Hunt of Kings Heath, and the second in the name of the noble Baroness, Lady Cumberlege. They have both introduced these very clearly, so I will make only three points to add some extra, different perspectives.
The first point I wish to make is that there is what I can describe only as a heart-rending report in the Guardian today about Windrush compensation two years on. The headline talks about
“long waits and ‘abysmal’ payouts”.
The story mentions an agency that talks about five people waiting more than 18 months for compensation. If this—as high-profile a scandal as we can possibly imagine, which attracted far more attention than the issues covered by the report from the noble Baroness, Lady Cumberlege—is going so badly, surely we have to address this issue, which in many ways is smaller, more limited and perhaps much less complicated, to create a situation via Amendment 123 to deal with these three issues. Amendment 122 would create a situation to deal with all cases, so that we would have a system and framework that, I hope, would do better than the Home Office is doing. I hope that such an agency in the health framework would not suffer from the same hostile environment in the Home Office that the Windrush compensation scheme has to act within.
Lord O’Shaughnessy (Con)
I shall speak to the amendments in reverse order, starting with Amendment 123 in the name of my noble friend Lady Cumberlege. As she said, these amendments deal with the here and now and with the future, and it is important that we start with the here and now. The perspective I bring to this is again informed by my work with valproate charities through the all-party group and by reflecting on the evidence compiled by charities such as INFACT and others and presented in my noble friend’s report. Historically, some 20,000 babies were exposed to valproate in the UK and half suffered harm. The disorder recognising those harms, foetal valproate spectrum disorder, was fully recognised only in 2019, although the drug was known for decades to have effects of that kind.
It must now be the case that for those families and others we put in place a proper redress scheme. They have had to battle to be recognised. They have had to battle to change clinical behaviour. They have had to battle red tape and a lack of understanding in personal impact payment schemes and in the education and health assessments carried out for young children. This is not only a historical problem; it is true today. We need a solution in the here and now. We do not need to spend huge amounts of time creating a new agency or anything else—I will come to that in a moment—but we need to address that and their harms today. I hope my noble friend will be sympathetic to that spirit.
Amendment 122 is in the name of the noble Lord, Lord Hunt. He is quite right to want to look at this structurally, given all the scandals over the years, including thalidomide, contaminated blood, which I dealt with briefly when I was a Minister, breast implants and many others. It was quite right that my noble friend Lady Cumberlege talked in her report about creating an agency and a proper redress scheme for clinical negligence. Indeed, she has been promoting such an idea since her work on maternity safety, where, as we know, are the largest financial claims and some of the most heart-breaking. I do not think any of us can deny that the system is currently broken. The noble Lord, Lord Hunt, talked about some of the data points from NHS Resolution’s annual report. The annual cost is now nearly £2.5 billion and there are total liabilities of £84 billion because of clinical negligence. A lot of that is the cost of care for people who have been harmed, but a lot of it is the frictional cost—the legal and other costs of going through the process—let alone the uncounted cost to families, especially as the average number of days to settle claims has been increasing over the past decade. There is a very strong case for acting in a big structural way to do something about this.
Having said all that, and having been responsible for this policy area as a Minister, it is a very complex situation. There is undoubtedly a case for moving to a less confrontational and swifter approach. This is not a new idea, as the noble Lord, Lord Hunt, pointed out. We have been thinking about this and legislating for this purpose for at least the past 15 years. There are good examples of no-fault compensation schemes that work in New Zealand and across Scandinavia, which generally satisfy all the participants and, importantly, change clinical behaviour, which is so important in reducing the cost. However, the truth is that this is tied up in broader tort reform, which I am definitely not expert enough to discuss, and in considerations attached to other legislation. A good example is Section 2(4) of Law Reform (Personal Injuries) Act 1948, which has been discussed in this House before and concerns the entitlements of people who have suffered from clinical negligence, but inevitably affects other people who have been harmed.
It is also true that these kinds of schemes do not necessarily save money. Indeed, the modelling I saw when I was a Minister suggested that they could end up being more expensive. That is the challenge and we have to be realistic. It might be deserved, but it is a challenge in moving from one scheme to another.
I am definitely a supporter of action on this front, and I would very much like to hear from my noble friend that work is going on. I worked closely with my noble and learned friend Lord Keen, when he was at the Ministry of Justice, on this programme, and I hope it has continued. I am not sure that this can be dealt with in the way suggested, with a clause dropped into the Bill, because of all the consequential changes and the very difficult issues that it raises, but it is unbelievably important. The cost—that liability of £80 billion—is two-thirds of annual spending on the NHS and we simply cannot go on taking on these liabilities to future tax- payers, let alone to those people who have been harmed. We need to see a more robust policy response from the Government in general on this.
The Deputy Chairman of Committees (Lord Lexden) (Con)
The next speaker on the list, the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so I call the noble Lord, Lord Lansley.
Lord Lansley (Con)
My Lords, I am in the position that my noble friend Lord O’Shaughnessy was in earlier, as much of what needs to be said has been said, but I want to add a few remarks on the two amendments.
I echo what my noble friend Lord O’Shaughnessy said. In the light of the First Do No Harm report, we have to be careful to address ourselves to the issues before us and put in place schemes of redress on the three causes. I am not an expert on those, but when I was Secretary of State for Health I was only too aware, when dealing with the Thalidomide Trust or infected blood payments, for example, that when we reviewed and made payments that were more generous, we were working in what was, in effect, an administrative structure that did not necessarily have coherence or consistency. We were making what we thought were the right decisions at the time, but those who had been harmed all suffered, from their point of view, from two problems. The first was the relative lack of generosity of the payments, which were made to reflect specific needs but were not representative of the overall harm that had been done. Secondly, there was no admission of liability, which is always an issue. Liability matters. Those who are harmed want to see liability determined and accepted.
I am sympathetic to the view that not only should redress schemes be considered for the three causes in the report, but the Government should take the opportunity to think about what a redress scheme might look like more generally. My noble friend Lady Cumberlege and her colleagues looked carefully at a number or international examples. They might well have thought, with some justification, that the French scheme—I will not attempt its title in French, but it is a national office for indemnity in relation to medical accidents—is an interesting basis on which to examine the issue. We might include not only the redress schemes from previous years but the present schemes that need to be established. This is something that Ministers might want to say in relation to the continuing review into infected blood accidents.
Again, like my noble friend Lord O’Shaughnessy, I do not want to confuse what are related but distinct issues. The schemes relate to what are, in effect, systemic failures. Recommendation 3 of my noble friend Lady Cumberlege’s report appropriately says that the schemes are to provide redress in relation to avoidable harm resulting from systemic failures. There is a question, which is not entirely resolved in the report, about which test should be applied. The Government should look carefully at where liability genuinely lies. Where there is harm as a result of systemic failings, the Government have a responsibility. That is fairly straight- forward. However, that is not the same as assuming that such a scheme should encompass all the many other cases that give rise to most of the clinical negligence claims against the NHS, which result not from systemic failings but from the failings of medical practice in particular circumstances. Those are different and separate. This debate is not the right place to go on about that at length.
I was interested to hear the noble Lord, Lord Hunt of Kings Heath, talk about the NHS Redress Act 2006. The noble Baroness, Lady Thornton, will recall that in 2009 she was not able to bring that Act into force. I was the shadow Secretary of State during the passage of that Act and Secretary of State after 2010. One reason for not bringing it into force, to which my noble friend referred, was the Government’s intention to undertake tort law reform in general and this was a tort-based liability scheme.
Lord Sharkey (LD) [V]
My Lords, I can be very brief. Amendment 122, in the names of the noble Lord, Lord Hunt of Kings Heath, and the noble Baronesses, Lady Cumberlege and Lady Bennett of Manor Castle, would require the Secretary of State to bring proposals before Parliament to establish a redress agency for those harmed by medicines and medical devices.
The arguments advanced for this by the noble Lord, Lord Hunt, the noble Baroness, Lady Cumberlege, and others, seem completely and obviously convincing, and we strongly support this amendment. We have not spoken to its proposers about this, but we wonder whether this redress agency might be hosted by the patient safety commissioner. We also wonder whether the amendment perhaps ought to be reworked into a revised task force amendment for Report, as we discussed in the previous set of amendments.
I know that the Government are in resistance mode about the patient safety commissioner but, when he responds, could the Minister tell the Committee what coherent arrangements there currently are for NHS patient redress, and whether he believes these arrangements are satisfactory?
Baroness Thornton (Lab)
I think this has been one of those really rather good and unexpectedly deep House of Lords discussions, going back into the mists of time. Until the noble Baroness, Lady Cumberlege, mentioned the redress Act, I had completely forgotten about it—it all came flooding back.
We have two quite different amendments in this group, and my noble friend Lord Hunt said at the outset that his Amendment 122 was a probing amendment. This is about opening up the discussion, which it certainly did—a discussion that has long needed resolving. The noble Lords, Lord Lansley and Lord O’Shaughnessy, were quite right in that it is an issue of the future; this group has one probing amendment about the future—what it should look like and how you create an agency that can address the issue of those harmed by medicines and medical devices. It is a very legitimate discussion, which needs to be had.
The second amendment, in the name of the noble Baroness, Lady Cumberlege, is about the future, what happens now and what happens about the harms that were done—the avoidable harms, in the case of hormone pregnancy tests, sodium valproate and pelvic mesh. That is very important indeed, and the noble Baroness is right to say that those harms must be specifically addressed by the Government and to push that. I think that is what we would be looking for—how the Government would implement those recommendations. I see the noble Baroness, and the noble Baroness, Lady Bennett, whose comments we very much welcomed and valued, but I do not think that was the last word. I hope she will involve herself in the next stage of the Bill. In fact, I am depending on it.
The Government have to address Amendment 123 in particular, because that is urgent and needs to be done now. I look forward to hearing what the Minister has to say about that in particular.
Lord Bethell (Con)
My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Bennett of Manor Castle—who indicated her interest in this along with my noble friend Lady Cumberlege—for raising the important issue of redress for those harmed by medicines and medical devices.
I share the review’s concern that patient voices were not heard, and I reiterate that we are committed to ensuring that the healthcare system does better at listening, learning and acting on patient concerns. Furthermore, we recognise that patients need to be at the centre of decision-making to ensure that their perspectives are built in.
Our focus is on improving the safety of medicines and medical devices so that in future there should be less need for redress. We are determined to increase patient safety and drive additional pre-market scrutiny and post-market surveillance of medical devices. For example, the yellow card scheme plays a vital role in providing an early warning that the safety of a product may require further investigation, and the MHRA is transforming and strengthening the system to make it easier for patients and healthcare professionals in the UK to directly report adverse incidents involving all medicines and medical devices. The UK has one of the safest medicines systems in the world and we will continue to make sure that patients and the public have access to the best and most innovative medicines.
Amendment 122, in the name of the noble Lord, Lord Hunt, would require the Secretary of State to bring forward proposals to establish a redress agency within 12 months of the Royal Assent of this Bill. Committing now to such an agency would short-cut the in-depth policy consideration that the review’s recommendation of a redress agency deserves, as a number of noble Lords have reasonably recognised. I understand that my noble friend Lady Cumberlege herself undertook substantial engagement with the affected patients and other parties as part of her review. Listening and consultation is a vital part of how we take forward any policy change, and it is even more important given the significance of this issue.
A redress agency would represent a significant addition to the current landscape for all stakeholders, and we need to give them time to contribute their perspectives and think through the implications for them. In particular, there is a need to work through what the determinations and parameters of such arrangements would be and how they would interface with current legal remedies—already complex—before we could agree to take forward this proposal. This would help us explore how that would affect the patient journey through different potential approaches, the costs and their value for money. We also need to be mindful of the potential impact on industry.
With regard to Amendment 123, tabled by my noble friend Lady Cumberlege, given that legal action is pending over hormone pregnancy tests, and as is usual when matters are sub judice, I am restricted in what I can say on this aspect of the amendment.
I know that the establishment of a specific redress scheme was my noble friend’s fourth recommendation in the report of the Independent Medicines and Medical Devices Safety Review. While I am very sympathetic to the desire of my noble friend and others to see the Government respond to her report and take forward her recommendations, I do not agree that policy should be made and deadlines set through primary legislation. Indeed, her report itself was sadly delayed during the current situation we find ourselves in.
I reassure the noble Lord, Lord Hunt, that we will respond to the issues raised in the amendment as part of our formal response to the Independent Medicines and Medical Devices Safety Review. The Government are considering all recommendations made in that review and will provide an update before the Christmas Recess. I hope that the noble Lord, Lord Hunt, has heard enough that is reassuring and feels able to withdraw Amendment 122, and that my noble friend Lady Cumberlege is similarly reassured not to move hers.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to conclude the debate on his amendment.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I think this has been an excellent debate. I fully accept, as my noble friend Lady Thornton said, that my Amendment 122 covers a much wider area than Amendment 123, which focuses on the specific issues relating to the report of the noble Baroness, Lady Cumberlege.
My Amendment 122 was definitely a probing amendment, because the current situation in relation to clinical negligence is wholly unsatisfactory. It combines the bureaucracy and slowness which the noble Baroness, Lady Bennett, referred to in relation to Windrush and she is absolutely right to draw parallels. It combines a hugely frustrating process for patients and their relatives with a system that increasingly becomes ever more expensive for the NHS. The noble Lord, Lord Bethell, was not going to be drawn on these wider considerations, but the noble Lords, Lord Lansley and Lord O’Shaughnessy, have both dealt with these—we know that it is a very complex issue, but surely, at the end of the day, we have to recognise that the current system simply is not working.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 126. I should inform the Committee that if this amendment is agreed to, I cannot call Amendments 127, 128 or 129.
Clause 41: Consultation
Amendment 126
Lord Bethell
(1A) In relation to proposed regulations under section 16(1), the Secretary of State must specifically consult—(a) the Welsh Ministers,(b) the Scottish Ministers, and(c) the Department of Health in Northern Ireland.(1B) In relation to proposed regulations under section 1(1), 8(1) or 12(1), the consultation document must include a summary of the relevant authority’s assessment of the matters mentioned in section 1(1A) and (2), 8(1A) and (2) or 12(1A) and (2)(as the case may be).”Member’s explanatory statement
This amendment requires a relevant authority to carry out a public consultation before making regulations under any provision of Part 1, 2 or 3, and to set out the authority’s assessment of any matter to which the authority must have regard in making the regulations, as well as requiring the Secretary of State to consult the devolved administrations in relation to regulations under clause 16(1).
Lord Bethell
“Reporting requirements
(1) As soon as reasonably practicable after the end of each reporting period, the Secretary of State must lay before Parliament a report on the operation of any regulations made by the Secretary of State under sections 1(1), 8(1) and 12(1) that were in force at any time during the reporting period.(2) In preparing a report, the Secretary of State must consult such persons as the Secretary of State considers appropriate.(3) A report must include a summary of—(a) any concerns raised, or proposals for change made, by a person consulted in accordance with subsection (2), and(b) the Secretary of State’s response to those concerns or proposals, including any plan the Secretary of State may have to make further regulations under section 1(1), 8(1) or 12(1).(4) The reporting periods are—(a) the period of 24 months beginning with the day on which the first set of regulations under section 1(1), 8(1) or 12(1) comes into force, and(b) each successive period of 24 months.”Member’s explanatory statement
This new Clause imposes reporting requirements on the Secretary of State in relation to the operation of regulations made under Clauses 1(1), 8(1) and 12(1).
Lord Bethell
“(3) The procedure for making regulations under Part 1, 2 or 3 is to be determined in accordance with this table and subsection (4)—
If the regulations contain provision made in reliance on | the regulations are subject to |
section 5(1)(a) | the negative procedure |
section 10(1)(a) | the negative procedure |
section 14(1)(a) | the negative procedure |
paragraph 9 of Schedule 1 | the negative procedure |
section 6 | (a) the made affirmative procedure, where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health |
(b) the draft affirmative procedure in any other case | |
section 15 | (a) the made affirmative procedure, where the regulations contain a declaration that the Secretary of State considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health |
(b) the draft affirmative procedure in any other case | |
any other provision in Part 1, 2 or 3 | the draft affirmative procedure |
(5) Where regulations are subject to “the negative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations is subject to annulment in pursuance of a resolution of either House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they are subject to negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations is subject to—
(i) annulment in pursuance of a resolution of either House of Parliament, and
(ii) negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954.
(6) Where regulations are subject to the “draft affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they may not be made unless a draft of the regulations has been laid before and approved by a resolution of the Northern Ireland Assembly, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of—
(i) each House of Parliament, and
(ii) the Northern Ireland Assembly.
(7) Where regulations are subject to the “made affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations—
(i) must be laid before Parliament after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament,
(b) in the case of regulations made by the Department of Health in Northern Ireland acting alone, they—
(i) must be laid before the Northern Ireland Assembly after being made, and
(ii) cease to have effect at the end of the period of 40 days beginning with the day on which they are made unless, during that period, the regulations are approved by a resolution of the Assembly, and
(c) in the case of regulations made by the Secretary of State and the Department of Health in Northern Ireland acting jointly, the statutory instrument containing the regulations—
(i) must be laid before Parliament and the Northern Ireland Assembly after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament and by a resolution of the Assembly.
(8) In calculating the period of 40 days for the purposes of subsection (7)(a)(ii) or (c)(ii) in relation to Parliament, no account is to be taken of any time during which—
(a) Parliament is dissolved or prorogued, or
(b) either House of Parliament is adjourned for more than 4 days.
(9) In calculating the period of 40 days for the purposes of subsection (7)(b)(ii) or (c)(ii) in relation to the Northern Ireland Assembly, no account is to be taken of any time during which the Assembly is—
(a) dissolved,
(b) in recess for more than 4 days, or
(c) adjourned for more than 6 days.
(10) If regulations cease to have effect as a result of subsection (7) that—
(a) does not affect the validity of anything previously done under the regulations, and
(b) does not prevent the making of new regulations.”
Member’s explanatory statement
This amendment provides for urgent regulations made in reliance on clauses 6 and 15 (emergencies) to be subject to the made affirmative procedure rather than the negative procedure and for regulations under clauses 2(1)(j), (k) or (n) and 9(1)(f), (k) or (l) to be subject to the draft affirmative procedure rather than the negative procedure.
The Deputy Chairman of Committees (Lord Lexden) (Con)
Amendments 134 to 138 have been pre-empted.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 145. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 44: Commencement
Amendment 145
Lord Sharkey
“Commencement
This Act comes into force on the day on which it is passed.”
Lord Sharkey (LD) [V]
My Lords, this is a probing amendment; its purpose is to allow the Minister to explain why Clause 44 contains four different commencement provisions for different parts of the Bill. The Explanatory Memorandum is silent about the reasons for that. I would be grateful if the Minister could explain on what basis the paragraphs in subsection (1) were chosen, why the coming into force of the items in subsection (2) is delayed by two months, and, in subsection (3), why Chapters 3 and 4 of Part 3 come into force at the absolute discretion of the Secretary of State. I think that I may understand subsection (4), but it would be helpful if the Minister could explain that to us too for the record. I beg to move.
Baroness Thornton (Lab)
The only question I want to ask is the question the noble Lord, Lord Sharkey, has just asked. Can the Minister give a rational explanation about why certain parts of the Bill come into force at different times? The key question on commencement is whether the commencement schedule as drafted risks holding up any of the work that needs to be done or allows the Government to move too slowly on anything.
My colleagues in the Commons drew attention to this provision as essentially a means of saying, “at some point in the future”. Can the Minister give an indication of the timeframe in which the Government expect to get these regimes consulted on, regulated for and up and running? As the Bill is drafted, the timing is left rather open-ended.
Lord Bethell (Con)
My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which would require the Secretary of State to act in accordance with the guidance on the use of civil sanctions—I am sorry, I am on the wrong amendment.
Amendment 145, in the name of the noble Lord, Lord Sharkey, seeks to amend the commencement clause, Clause 44, so that all provisions would come into force on the day the Bill receives Royal Assent. I am confident that the amendment is not necessary. Clause 44(1) provides that the clauses needed to make emergency amending regulations will come into force the day the Bill receives Royal Assent.
Under Clause 44(2), a significant number of clauses come into force after the customary two-month commencement period. Chapters 3 and 4 of Part 3 come into force on a day the Secretary of State appoints which is specified in regulations. This combination of commencement provisions is for a good reason. Patients, stakeholders and Parliament must know what the law is before the law is made. The two-month commencement period allows the Government to continue to engage with industry and the relevant stakeholders properly before provisions come into force.
Importantly, Clause 44 provides for the necessary powers and provisions to come into force on Royal Assent should it be necessary, within that two-month period, to make regulations urgently in order to protect the public from an imminent risk of serious harm to health.
I understand that there may be concern about Clause 44(3), which allows the Secretary of State to determine when Chapters 3 and 4 of Part 3 come into force, but I assure the noble Lord that, again, this is for a good reason. Chapter 3 of Part 3 is concerned with enforcement and included in that is the introduction of a civil sanctions regime. Civil sanctions will act as a flexible, proportionate enforcement mechanism, enhancing the MHRA’s ability to incentivise compliance. The new civil sanctions regime requires supplementary regulations to be made under paragraph 9 of Schedule 1 before it can be fully operational. It is important that the MHRA engages with industry and stakeholders on these regulations and the accompanying guidance. Indeed, the Bill requires a consultation to be carried out before they are made. If these provisions came into force on the day the Bill achieved Royal Assent, we would have no time to make the necessary regulations. Our time to consult in advance on those regulations and the guidance would be severely condensed.
It is absolutely right that we consider the views of stakeholders and the public before making the supplementary regulations and bringing the new civil sanctions regime into force. I assure noble Lords that the Government are committed to bringing the enforcement and data and disclosure chapters into force as soon as is appropriate in order to enhance the safety of the medical devices regime. I hope the noble Lord, Lord Sharkey, understands the reasoning behind the clause and feels able to withdraw his amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received no request to speak after the Minister, so I call Lord Sharkey—
The Deputy Chairman of Committees (Lord Lexden) (Con)
With apologies to the noble Lord, Lord Lansley, who does wish to speak after the Minister, I now ask him to do so.
Lord Lansley (Con)
I thank the Deputy Chairman. I sent the email only about 30 seconds ago so I suppose, strictly speaking, that apologies on his part are not required. I should have anticipated the need to ask a question, but I am afraid I was prompted by listening to the noble Lord, Lord Sharkey, and the Minister’s reply. I want to ask one question: how can what will become Section 1 be brought into force without Section 2? I do not understand. If a power is to be used under Section 1, it must surely make provision about some of the long list of relevant areas in what will be Section 2. In the absence of Section 2 being in force, I cannot see how Section 1 works.
Lord Bethell (Con)
My Lords, I will seek to provide an answer to my noble friend. Should it not be quite the right answer I will endeavour to write to him. It is my understanding that no substantive provision of an Act should be brought into operation earlier than two months after Royal Assent. However, some sections of the Act can be brought into force on Royal Assent, typically those setting out how the Act is to be cited and what the procedure is for making regulations or commencing them. It is under those arrangements that the sequencing which he describes can be undertaken.
Lord Sharkey (LD) [V]
I thank the noble Lord, Lord Lansley, for his intervention. I will read Hansard carefully tomorrow to make sure that I understand not only his question but the Minister’s reply. I thank the Minister for his explanations—they were useful—and for the brief preview of his next speech.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 146. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Schedule 1: Medical devices: civil sanctions
Amendment 146
Baroness Thornton
Member’s explanatory statement
This amendment places a duty on the Secretary of State to follow, rather than have regard to, guidance.
Baroness Thornton (Lab)
My Lords, we have reached the final amendment so I will be as brief as I can. The first thing I need to clarify, and I do not know if other noble Lords have spotted this, is that my amendment is actually to page 32 not page 34, otherwise it makes no sense at all. It is to amend line 10 on page 32—of the Bill that I have in front of me, anyway. But maybe I have an old copy of the Bill. Paragraph 13(7) of Schedule 1 says:
“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph in exercising functions under this Schedule.”
That is the point of this tightening-up amendment, which would require the Secretary of State to “act in accordance with” the guidance.
Amendment 146 is about the planned civil sanctions regime for medical devices. Part 5 of Schedule 1 provides that the Secretary of State must “prepare and publish guidance” on
“the sanctions that may be imposed on”
someone who commits an offence,
“the action that the Secretary of State may take”,
and the circumstances in which they may take such action. This could be, for example, when a penalty may or may not be imposed, the amount of such a penalty, what the Secretary of State will take into account in determining that amount and so on. Before publishing the guidance the Secretary of State will, of course, consult devolved Administrations and anyone else they consider appropriate. Where necessary, should changes be needed, the Secretary of State must revise the guidance and publish the revised version.
Once published, this guidance is the information that will be in the public domain on the operation of this regime. Yet after all that preparation, as currently drafted, the Bill says the Secretary of State must only “have regard to the guidance” when “exercising functions under this Schedule”. The amendment would simply tighten this up, so that the Secretary of State must “act in accordance with” the guidance. I look forward to the Minister’s response, and I hope we can locate it in the right place—I obviously have an old version of the Bill in front of me.
The Deputy Chairman of Committees (Lord Lexden) (Con)
The amendment proposed is to page 34, possibly corrected by the noble Baroness, Lady Thornton, to page 32.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I hesitate to disagree with my noble friend, but I think it is on page 34—but then, of course, I might have an old edition of the Bill as well, just to confuse things.
The reason for supporting this is the unease about provisions in Clause 27 and Schedule 1. The Delegated Powers Committee concluded that
“in the absence of a full justification … allowing the ingredients of criminal offences … and … the penalties for existing offences to be set by delegated legislation”
amounts to “inappropriate delegations of power”. The Constitution Committee said:
“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”
The Minister has made certain modifications, but I think the general principle still holds good.
The guidance to be issued under paragraph 13 of the schedule is likely to be extensive, including: the imposition of a monetary penalty; the notices to the person it is proposed to fine and the grounds for so doing; the representations that have been made; the appeals process; and the consequences of non-payment. As my noble friend said, lines 9 and 10 on page 34 provides that
“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph”.
Given that the Secretary of State is the person publishing the guidance, it is puzzling that he or she is required only to “have regard to” the very guidance that he or she has published—hence my noble friend’s amendment to require the Secretary of State to “act in accordance with” the guidance. I look forward to hearing from the Minister as to why the Bill is drafted to give the Secretary of State wider discretion on that.
Lord Patel (CB) [V]
My Lords, I speak very briefly to support this amendment. The noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath, have covered the argument extremely well. As the noble Lord said just now, the guidance is produced by the Secretary of State but, when you look at it in practice, it says that the Secretary of State “must have regard to” the guidance—that is, can take note of it but does not have to follow it.
I am a doctor and am used to following guidelines. If I do not follow the guidelines, I am liable to be reported; if I do not follow them for any reason in the management of a patient, I am expected to write down as to why I did not follow them. I am not expected to take note of it or have regard to it—I am expected to follow it. The amendment proposed by the noble Baroness, Lady Thornton, addresses exactly that point: why is the Secretary of State not asked to follow the guidelines which he or she drafted?
Lord Sharkey (LD) [V]
We all know that the words “have regard to” create no real obligations, whereas the words “act in accordance with” do create real obligations. Clause 13 seems to contain important restrictions on the actions of the Secretary of State, but it does so via guidance. As the Bill stands, with its “have regard to” wording, that guidance has no statutory force. If the restrictions are to have any reality—and I assume that the Government would like them to, or they would not have written them into the Bill—we must replace “have regard to” with “act in accordance with” as the amendment proposes. We support the amendment.
Lord Bethell (Con)
My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which is designed to require that the Secretary of State must “act in accordance with” the guidance on the use of civil sanctions that he is required to publish under paragraph 13 of Schedule 1, as opposed to having regard to the guidance. Paragraph 13 requires the Secretary of State to prepare and publish guidance about the use of civil sanctions. More specifically, this guidance must cover the sanctions that may be imposed if a person commits an offence, the action the Secretary of State may take, and the circumstances in which action is likely to be taken.
I understand the intention behind Amendment 146 and recognise that it is crucial that civil sanctions are imposed in a transparent and consistent manner to ensure that the regime operates effectively. However, the current drafting of Schedule 1, including the obligation on the Secretary of State to publish and have regard to guidance on the civil sanctions regime, will ensure this transparency and consistency.
The guidance will be prepared after consultation with the devolved Administrations and others. The purpose of any guidance is to provide clarity to the civil sanctions regime and detail the circumstances in which different civil sanctions may be pursued. However, instances of non-compliance or criminal activity, where the medical device regulations are concerned, need to be dealt with on a case-by-case basis. The scale, complexity and severity of non-compliance can vary significantly. As such, any resultant enforcement activity needs to be proportionate, effective and commensurate with the non-compliance or criminal activity.
The amendment in the name of the noble Baroness, Lady Thornton, would bind the Secretary of State, acting through the MRHA, to act in accordance with guidance in every instance. This would limit the regulator’s ability to arrive at and undertake the most appropriate course of enforcement action commensurate to the multifaceted nature of the case at hand. The MHRA cannot set out every circumstance where it may be appropriate to impose civil sanctions. However, by preparing, consulting and publishing a clear set of guidance we can be clear on the framework and illustrate circumstances on how and why a civil sanction might be imposed without being exhaustive.
The regulator needs civil sanction guidance that is flexible enough to appropriately address all forms of non-compliance. To mandate following the guidance to the letter could potentially mean that no action can be taken if the MHRA encounters a new example of non-compliance that has not been explicitly catered for in the guidance but clearly warrants a civil sanction. Under such circumstances, the Secretary of State will, of course, comply with obligation to publish revised guidance as required in paragraph 13 of Schedule 1.
I remind noble Lords that recipients of civil sanctions can contest the imposition of a civil sanction before it takes effect by appealing to the First-tier Tribunal. It is also worth highlighting that, as currently provided, the guidance will be statutory guidance and the regulator must have regard to it when carrying out enforcement activity.
Furthermore, this type of provision is standard across the statute book. For instance, provisions requiring regulators and statutory bodies to “have regard” to statutory guidance can be found in a wide range of legislation, from Section 2 of the Higher Education and Research Act 2017 to Section 5 of the Business and Planning Act 2020. In a civil sanctions context, Section 63 of the Regulatory Enforcement and Sanctions Act 2008 provides that provisions conferring a power on a regulator to impose a civil sanction must also make provision relating to guidance—in particular, that the regulator “must publish guidance” about its use of a sanction and
“have regard to the guidance … in exercising its functions.”
The Ecodesign for Energy-Related Products Regulations 2010 has a similar civil sanctions regime. These regulations are concerned with the establishment of a framework for the setting of ecodesign requirements for energy-related products. In paragraph 28 of Schedule 5 to those regulations the market surveillance authority
“must have regard to guidance”
while exercising his or her functions with regard to the imposition of civil sanctions. I hope that the reassurance we seek is not unusual but in line with how civil sanction and, indeed, other regimes operate domestically. For that reason, I therefore ask the noble Baroness to withdraw Amendment 146.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I think that I have received no requests to speak after the Minister so, hoping that I have not overlooked the noble Lord, Lord Lansley, once again, I call the noble Baroness, Lady Thornton, to conclude this debate.
Baroness Thornton (Lab)
First, I need to say that I do have an old version of the Bill which I picked up from my desk on my way here, so I apologise to the Committee for that. I will read the Minister’s comments, but if the schedule already has, as I understand it, the ability to be flexible written into it—I think the Minister said that it was there in Clause 13—it seems to mean that one does not need to have regard to it. One would need to act in accordance with it, because the Bill already has built into it the flexibility needed under the circumstances that he was describing. However, I will read his comments and reflect on them. I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, that concludes the Committee’s proceedings on the Bill. I remind Members to wipe their desks and chairs before leaving the Room.
Medicines and Medical Devices Bill
Tuesday 12th January 2021
(3 years, 10 months ago)
Lords ChamberRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 154-II(Rev) Revised second marshalled list for Report - (12 Jan 2021)
16:18 - Division conducted remotely on Amendment 2 - Ayes: 324 / Noes: 241 - Amendment 2 agreed.
17:08 - Division conducted remotely on Amendment 3 - Ayes: 320 / Noes: 236 - Amendment 3 agreed.
18:32 - Division conducted remotely on Amendment 7 - Ayes: 42 / Noes: 278 - Amendment 7 disagreed.
Lord Bethell
“PART A1THE COMMISSIONER FOR PATIENT SAFETYEstablishment and core duties etc
(1) The Secretary of State must appoint a Commissioner for Patient Safety (referred to in this Part as “the Commissioner”) to exercise the functions set out in this Part in relation to England.(2) The Commissioner’s core duties are to—(a) promote the safety of patients with regard to the use of medicines and medical devices, and(b) promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.(3) The Commissioner is not to be regarded as the servant or agent of the Crown or as enjoying any status, immunity or privilege of the Crown.(4) Schedule (Further provision about the Commissioner for Patient Safety) makes further provision about the Commissioner.”Member’s explanatory statement
This amendment inserts a new Clause which provides for the creation and core duties of a Commissioner for Patient Safety in relation to medicines and medical devices in England. The new Clause and the Schedule which it introduces would form a new Part, to appear before Part 1.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell)
My Lords, patient safety is very much at the heart of the Bill, and while we have an enormous amount to get through this afternoon, I beg the Chamber’s forbearance if I talk in some detail about this extremely important amendment. Patient safety is the golden thread that runs through this entire Bill. Safety has been our guiding force in amendments that have made it to the Bill, from the changes to decision-making on regulatory change and the new safety lock amendment—which we will debate later—to the enforcement powers for medical devices to make clearer what the MHRA can do to take action, through to the medical devices information system.
The Government have heard the calls, including the strong cross-party support, to establish an independent patient safety commissioner for the health service in England. Of course, this was the centrepiece recommendation of the Independent Medicines and Medical Devices Safety Review helmed by my noble friend Lady Cumberlege, to whom I pay profound tribute for her tireless championing on behalf of patients. I am delighted that Amendment 1 in my name—with which it is convenient to debate Amendments 54, 65, 70 to 72, 74, 86, 87, 91, 95 and 97—delivered upon that recommendation. These amendments provide for an independent advocate to champion the safety of patients. The patient safety commissioner will promote their interests and those of other members of the public in relation to the safety of medicines and medical devices.
We acknowledge that the patient’s voice can advance safe care and system improvements but that it needs to be strengthened, as explained in my noble friend’s review published six months ago. Listening to patients is central to preventing the kinds of issues which that review brought so clearly into focus. If we do not strive to listen to patients, their families and to staff, we limit our ability to learn from mistakes, be innovative and continually improve. I pay testament to the extensive listening and the passionate advocating by my noble friend, her supporters and all patient groups.
Patient safety is a system-wide concern. It cannot be tackled by a single individual but needs to be rooted in all the branches of our health system. Good progress has been made: for example, we are improving system-wide learning through measures such as the Healthcare Safety Investigation Branch and the implementation of the 2019 NHS Patient Safety Strategy with our National Director of Patient Safety, Dr Aidan Fowler, in charge. That strategy has been listening to patients.
Staff are also encouraged and protected to speak up if they have concerns about anything they believe is harming the services their organisations deliver or commission. They are supported by the NHS People Plan, which envisages a health service that is compassionate and inclusive, not hierarchical, and where staff are listened to. The Government’s emphasis on patient safety will also be reinforced by the establishment of a new patient safety programme board. The board will take an overview—with pace and rigour—of measures and actions across the health system to improve patient safety.
The Government fully support sharpening our focus on the safety of NHS-funded services to patients and the public. We accept that the patient safety system needs to get better at identifying issues and listening to patients’ experiences of avoidable harm. Better co-ordination across and between regulators and other oversight bodies is also needed.
A patient safety commissioner will help us to champion the views of people who have been harmed by treatments provided by the health service. He or she would reinforce a culture of humility, openness and learning. The role is essentially about prioritising the insights of patients as a vital source of learning.
The Government’s amendment puts this new part of the Bill first. Amendment 1 provides for the appointment by the Secretary of State of a patient safety commissioner who is an independent statutory officeholder funded by the Department of Health and Social Care. It sets out the commissioner’s core duties, which are to promote both the safety of patients and the importance of ensuring that they are heard.
Patient engagement will be integral to the role of the commissioner. Proposed new Schedule A1 outlines the ways in which the commissioner must inform, consult and involve patients. This will ensure that patients’ concerns are being heard and that the work of the commissioner has focus and relevance for the people he or she is being set up to serve.
We have reflected carefully on the patient safety commissioner model set out by my noble friend’s comprehensive report. We agree on the importance of the commissioner’s role; it is a critical new part of the map of patient safety. But there are other areas of significant importance to the Government. The commissioner is one part of the whole system—the fundamental change that it required to tackle unsafe care and empower patients. A step change is required in how the health service transforms itself in a joined-up way to put patient safety at its core. Significantly, the introduction of the commissioner should not create overlap or confusion within that health service architecture, thereby reducing the potential to deliver patient safety improvements for patients. Indeed, my noble friend’s report rightly made it clear that the duplication of the roles of other regulatory bodies should be avoided.
In view of this, the patient safety commissioner will not act as an ombudsman. He or she will not carry out functions in pursuit of specific cases. But they can consider individual cases in their role as an overarching advocate for all patients and of making thematic and systemic recommendations. These areas are where we believe the commissioner can have greatest impact.
We have also given the patient safety commissioner deliberately intrusive powers, as called for by my noble friend Lady Cumberlege. He or she will be empowered to request and share information from relevant public authorities or a “relevant person”, meaning anyone providing health care, in relation to medicines and medical devices in England. The commissioner’s ambit will cover both the public and the independent sector.
Where my noble friend and I differ is on the process of the appointment and sponsorship of the commissioner. The patient safety commissioner will be appointed by the Secretary of State for Health and Social Care and funded by the Department of Health and Social Care. It is absolutely right that this should be the case. For example, the Secretary of State is able to initiate action on reports and understands, and has strategic oversight of, the system the commissioner is looking at.
Some noble Lords have expressed concerns about how such a commissioner might maintain their independence, but I believe that such concerns are unfounded. I am encouraged by the precedent of the Office of the Children’s Commissioner, which drew praise from several noble Lords in Grand Committee for its independence. As noble Lords know, the Children’s Commissioner is sponsored by the Department for Education and guards its independence very well. The Victims’ Commissioner does exactly the same and is sponsored by the Ministry of Justice.
It is critical—that is agreed—that the patient safety commissioner is able to speak out without fear or favour. He or she must have the powers and functions to act independently to maximise their impact and confidence. That is absolutely the case here. It is also critical that the right calibre individual with a strong voice for patients is appointed to the role. I do not think any such person would accept such a role if they felt they would in any way be constrained in that role. Nor do I think they would remain silent. Furthermore, we would expect the Secretary of State to work with the commissioner to establish how they will safe- guard and secure the commissioner’s independence. Independence is not static but an active objective, which we would expect the patient safety commissioner to be prepared to approach continuously.
The commissioner will have the power to make reports to both the public sector and independent sector, and to the Department of Health and Social Care if they so wish. Those reports are entirely independent. There is no intention—and indeed no restriction—that would allow for the Secretary of State to edit those reports. As an independent public appointee, the commissioner will also be subject to the scrutiny of Parliament, including through the Health and Social Care Select Committee.
The powers in the Bill are accompanied by a regulation-making power about the terms of office of the patient safety commissioner, the appointment of staff, and other operational matters. But while this power is exercised by the Secretary of State, we are not proposing that the Secretary of State would have any power over the commissioner regarding the fulfilment of his or her functions. However, it is right that the detail is left to regulations so that we can publicly consult on this, as we are obliged to do so under Clause 45. It is important that we get the details right. That is also why the regulations will be subject to the draft affirmative procedure.
Other amendments make minor changes to ensure that the patient safety commissioner clauses work well with the rest of the Bill.
From the First Do No Harm report by my noble friend Lady Cumberlege, to earlier, well-known inquiries and investigations, we have heard numerous harrowing stories with terrible examples of how patients have been let down badly by our most loved institutions. As noble Lords have said, now is the time to act. The Government have listened to the impassioned and compelling arguments from all sides, and I thank my esteemed colleagues for their help in shaping this amendment.
We have no doubt that restoring patient trust will be at the heart of the patient safety commissioner’s role and that he or she will advance patient safety. Our commitment to amplifying and acting on the voices of patients in our health service is paramount. To that end, I beg to move.
Baroness Cumberlege (Con) [V]
My Lords, I thank the Minister for his huge support throughout this whole process—all the times we have had to meet and I have met with his officials. I also thank him for the way in which he has so comprehensively introduced his amendment today. To be honest—“O ye of little faith!”—there were times when I thought the patient safety commissioner would not see the light of day. However, I underestimated my noble friend and thank him for agreeing to the concept and for bringing it to fruition with his officials.
Lord Patel (CB) [V]
My Lords, I shall be extremely brief. It was a pleasure to support the noble Baroness, Lady Cumberlege, and I congratulate her on achieving a remarkable feat of getting patient safety in statute for the first time in the United Kingdom. Her tenacity was such that she was never going to give up. I also congratulate the Minister. He obviously listened and understood all the arguments that were made. He has produced the establishment of an independent patient safety commissioner. Having been concerned with patient safety for many years, it is good to know that for the first time it is in statute. The noble Baroness made a few important points that were well argued as to why words may be misinterpreted. I hope that the Minister has listened and will respond positively. Again, I congratulate her—it was a pleasure to support her.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I, too, welcome the Government’s amendment establishing the patient safety commissioner. This is highly significant and a great tribute to the noble Baroness, Lady Cumberlege, and her team. I should also declare an interest I must declare an interest as a member of the GMC board.
The noble Baroness’s report, First Do No Harm, is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I go back to her report because she found that the healthcare system, in which she included the NHS, private providers, regulators, professional bodies, and pharmaceutical and device manufacturers, was disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’être. Those are telling points, which led the noble Baroness to recommend the appointment of a patient safety commissioner, an independent and proactive public leader with a statutory responsibility to champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety. That is welcome and it will be essential that the person who is appointed is robust, fearless and commands wide respect. Their independence needs to be assured. I hope also that the appointment will be subject to Select Committee scrutiny and I should be glad if the Minister can comment on that.
Picking up on a point that the noble Baroness made, I should also be grateful if I could have a little more explanation about what is meant by relevant bodies, as defined in the schedule. It is clearly important that bodies with responsibilities in relation to patient safety are expected to respond to a report or recommendation made by the commissioner. Can the Minister give a broad indication of the relevant bodies? Also, in relation to the private health sector, my reading is that this is covered by the Bill and that the schedule provides for that. Can the Minister respond?
Overall, however, I commend the Minister on the Government’s response to this significant recommendation by the noble Baroness, Lady Cumberlege.
Baroness Finlay of Llandaff (CB) [V]
My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in driving up better outcomes.
I hope that in the response to these proposals it will be helpful to have reassurance that the new post will be adequately resourced, the timeframe for fulfilling the appointment is rapid, and, subsequently, regulatory requirements can be defined and relevant statutory instruments drawn up. The independence of the post-holder is crucial. The person must be able to work across all the different and varied organisations and structures that have responsibility for patients, directly or indirectly. That will require promotion to all organisations that they have a duty to co-operate and collaborate with the commissioner to ensure that early warning signals are picked up and heeded through processes that are light on bureaucracy yet rapidly responsive in order to pick up signals. We cannot have years of accumulation of distressed patients. When things start not to be right, those amber warning lights must start flashing.
I urge the Minister to ensure that the remit of the commissioner is as wide as possible. For example, the coroners’ reports that the noble Baroness, Lady Cumberlege, referred to have not had adequate enforcement by others sometimes. The reports made powerful recommendations but it was found that those responsible for enforcing them have been so slow to act that the proposals have effectively gathered dust.
In previous debates, I raised the need for the yellow card scheme to be updated—opened for easy use by patients themselves, who may wish to report adverse outcomes. The wording of the Bill that I found most helpful and welcome is the part stating that the role
“does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue”.
Can the Minister make sure that the reporting mechanisms are open to patients and do not hit a hurdle when they try to report to a clinician who does not recognise the full import of they are saying?
To conclude, I reiterate my congratulations to all, particularly the noble Baroness, Lady Cumberlege, and her team, and look forward to the next phase of working with her and others as this important development moves forwards.
Lord O'Shaughnessy (Con)
My Lords, I join other noble Lords in expressing my sincere thanks to my noble friend the Minister for the progress that we have made. In all fairness to him, he said that since Second Reading he was listening, but we all know that it is sometimes possible to listen and not hear, let alone act. On this occasion, he heard and acted. I join other noble Lords in expressing my sincere gratitude for that.
I also pay tribute to my noble friend Lady Cumberlege. No one doubted her tenacity but it has been on display in bucketloads, and she has made the progress that her superb report deserves. More than anyone, I pay thanks to the army of campaigners; many of us have met them, and they could not help but move us with their stories. This legislation is ultimately for them and a tribute to them.
I had a close look at my noble friend the Minister’s amendment and compared it to that of my noble friend Lady Cumberlege. Clearly, there is a specific issue about where the organisation, the commissioner, should sit, but there is a precedent for doing that in the way in which the Minister suggested. I take confidence from his determination to give proper independence to the role. A lot will depend on the kind of person recruited, how they are recruited and to whom they are accountable. I should like him to say a little more about how he envisages that happening.
We also need to hear more detail on the timetable. The Minister will know that when one makes big commitments of this kind, they are staging posts—never the destination. There is still some way to go in making sure that we get there quickly. That is important, as my noble friend pointed out. However, the powers in the amendment are important to recognise. On the ability to demand information from relevant persons, as other noble Lords have said, we need to hear a little more about who they are and the consequences of non-compliance. However, they are powerful ways in which the commissioner can act and create change in the system. I have no doubt that they will be effective.
In conclusion, I make a couple of comments provided by the ABPI’s briefing. They relate to further questions around the nature of the relationship between the commissioner and the MHRA and other bodies, how the four nations of the UK will act together on patient safety, given that we are a single market, and ensuring diversity of patient voice.
I would also add one more thing to that. Patient safety is not just about finding out when medicines and devices go wrong; it is also about access to them. Will the patient commissioner have a remit to investigate these kinds of issues?
However, these questions are for tomorrow. Today, we want to recognise the progress that has been made and the amendments put down in the name of my noble friend. I thank him sincerely for them and I thank my noble friend Lady Cumberlege for her dedication to this particular cause.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I, too, add my congratulations to my noble friend the Minister and pay particular tribute to the tireless work of my noble friend Lady Cumberlege in bringing us this far. I welcome government Amendments 1 and 54.
I want to take this opportunity to mention two specific issues that we focused on in Committee and seek confirmation on where we are in this regard. I want in particular to look at the right of patients to report directly on their own experience, rather than waiting for the patient safety commissioner to investigate. I would welcome hearing that my noble friend the Minister imagines that the commissioner should have this power. If not, would he consider introducing such a measure at the first available opportunity? It is so important that the voice of patients is heard. I remember the accounts that my noble friend Lady Cumberlege gave in Committee of her work and that of her team in producing the report, First Do No Harm; that will be a lasting legacy. Allowing patients the right to report directly, without necessarily waiting to be asked, would cut through many of the difficulties with medicines and medical devices, and would enable the patient safety commissioner to report directly to the Government in this regard.
The only other point that I wish to make at this stage is that of the regulations that my noble friend envisages in the government amendments in this group. Can he confirm that these will be discussed and agreed with the devolved Administrations at the earliest possible stage? Can my noble friend assure us that if the devolved Administrations raise any significant issues or highlight any problems that they have with the draft regulations, these will be acted on before the regulations are adopted and sent to each House of Parliament?
We are in a very good place. I congratulate my noble friend Lady Cumberlege and her team on bringing us here, and I pay special tribute to my noble friend the Minister for listening to the concerns of so many people, over so many years, to bring us to where we are today. I wish the amendments godspeed.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I join the universal commendations for the Government for accepting the recommendation to introduce a patient safety commissioner. It demonstrates that campaigning can work for everybody, from school pupils to Premiership footballers to Members of the House of Lords—in this case supported by patients, many of them suffering from continuing illness and disability.
I want briefly to pick up three points made by the noble Baroness, Lady Cumberlege. The first is the importance of the commissioner being a person of standing. As the noble Baroness’s report clearly explains, there is a strong gender aspect to the fact that far too many patients have not been listened to, have been ignored and have been mistreated by the system. It is really important that the patient safety commissioner is well equipped to understand that and make themself accessible to all patients. As the noble Baroness said, it is clear that the patient safety commissioner should be a person of standing and the kind of person who should shape the role that they will ultimately fulfil.
That brings me to my second point, which the noble Baroness and many others have stressed: the urgency of this appointment. As has already been pointed out, the Domestic Abuse Commissioner has been appointed before we have even passed the Domestic Abuse Bill. That is very much a model. I have a direct question for the Minister. It should not be beyond the capacity of the department to advertise this role within, say, one month. If he does not think that this timetable is reasonable, can he suggest what he thinks a reasonable timetable is? The noble Lord, Lord O’Shaughnessy, also asked this. I also echo the point made by the noble Lord, Lord Hunt of Kings Heath, that it is crucial that this appointment has Select Committee scrutiny.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, I am delighted to follow the noble Baroness, Lady Bennett of Manor Castle.
At this stage, let me congratulate the noble Baroness, Lady Cumberlege, on her thought-provoking report, First Do No Harm, which really led to the position we are in today. I also thank the Minister—the noble Lord, Lord Bethell—for bringing forward on Report this amendment regarding the patient safety commissioner and putting it on a statutory basis. Led by the noble Baronesses, Lady Cumberlege and Lady Thornton, we have had several meetings with the Minister on this particular issue. He gave commitments in this respect, for which I, for one, am particularly grateful.
Naturally, as with everything, I have some questions, to which I and others would like some answers. On the nature of the patient safety commissioner’s appointment, how independent will they be? They will be accountable to the Secretary of State for Health and the department, but what does that level of accountability mean? What will the nature of the regulations circumscribing the appointment be? When will the appointment actually take place? What is the timeframe? Will there be adequate resources on an ongoing annual basis to fund this position, to ensure that the patient safety commissioner can act as an advocate on behalf of patients?
We have heard what the Minister had to say: that patient safety is the golden thread holding this Bill together. That is particularly important, but the patient safety commissioner will be the person who will have to provide direction and leadership. This was one of the principal aims and outcomes of the report by the noble Baroness, Lady Cumberlege, First Do No Harm. Patients who have been unwell and feel that they have been slighted or undermined in their dealings with medical practitioners want to feel safe and have confidence that they are being listened to. I hope that, whenever the regulations are published and enacted, this appointment can take place at very short notice. And, of course, the commissioner must be someone who commands respect and is a person of standing.
It is vital that the commissioner leads, with full patient group engagement and involvement, on the development of a set of principles for better patient safety that governs the way the commissioner fulfils his or her remit. I am delighted to support the government amendment. It goes without saying that I also support Amendment 65 in the name of the noble Baroness, Lady Cumberlege. There are issues with who the person is accountable to—the Department of Health, in this instance. I know that the noble Baroness was looking for the Cabinet Office, but that is just a detail. We have arrived at an important stage today, and I welcome that.
Finally, I have been talking to the Minister at the meetings organised by the department with the noble Baroness, Lady Cumberlege, to give an update on Northern Ireland, where there are several ongoing inquiries. The Minister and his officials were very helpful and are having discussions with the Minister for Health in Northern Ireland. Maybe today the Minister could provide me and your Lordships’ House with an update on the position within the Northern Ireland Executive and Department of Health.
Lord Lansley (Con) [V]
My Lords, I am pleased to follow the noble Baroness, Lady Ritchie of Downpatrick, who asked some good questions. Indeed, many noble Lords have asked good questions about the functioning of a patient safety commissioner. All are agreed that we have come very far, very quickly, and the Minister and my noble friend Lady Cumberlege are to be congratulated on having brought this proposal from her excellent report to primary legislation so rapidly. Knowing how difficult it is, I commend the Minister and his team for securing collective agreement to such a significant policy innovation so rapidly, to the point that we can put it into the Bill on Report.
I want to make two points. First, as I know from the past, independence can be instrumental to the functioning of an organisation, but the NHS can, if one is not careful, see independence as something outside the system. It is somewhat discounted because of that. We must always think of the patient safety commissioner in two important respects. First, it should be not only independent but influential. A number of noble Lords have spoken about how that might best be achieved. That influence is terrifically important.
Secondly, patient safety is central across the NHS and is regarded as such. As the Minister and the noble Lord, Lord Patel, evidenced, we have come a long way with safety in the NHS—for example, in the reduction in healthcare-acquired infections. I was responsible for introducing never events and a range of other factors. Mainstreaming safety to become a central concern of commissioners and providers across the NHS has been a recurring feature of the work of this Government and their predecessors, and of my successors, Jeremy Hunt in particular.
I stress that that work on safety inside the NHS is clinically led and data-driven. The patient safety commissioner has a remit focused on hearing from, understanding and working with patients. That distinction is tremendously important and must be made clear to all those working across the health and care systems, from the outset. There is something new and distinctive about the patient safety commissioner, and it is not simply another accretion to the many organisations that those who work in the health system feel impede their lives. On the contrary, this is a representative of patients who, by virtue of that, attracts special attention from their point of view and brings a distinctive and unique voice into the NHS systems. I am pleased to have had this opportunity to say those few things and to support the government amendment in the name of the Minister.
Baroness Masham of Ilton (CB) [V]
My Lords, I agree with the noble Lord, Lord Lansley. It is very good news that there is to be a patient safety commissioner. I congratulate everyone who has worked so hard to create this amendment, especially the noble Baroness, Lady Cumberlege. It is so good that the Government have listened. Patient safety is vital, especially now when the NHS is under so much stress and demand. Over the years, some tragic incidents could have been avoided if patients had been listened to and there had not been cover-ups.
The noble Baroness feels that the words
“so far as reasonably practicable”
should be removed. She may feel that they would weaken the amendment; is this the case? This is important, because patients need clear information about how they are to communicate with the patient commissioner, so that they trust the system.
Baroness Watkins of Tavistock (CB) [V]
My Lords, I am delighted to follow my noble friend Lady Masham of Ilton. I reiterate my support given in Grand Committee for the appointment of a patient safety commissioner, and I thank both the Minister and the noble Baroness, Lady Cumberlege, for the work they have done together to get to this point.
To reflect on the speed since the report of the noble Baroness, Lady Cumberlege, I remind noble Lords of the report, in the early 1970s, called Sans Everything, about the terrible atrocities and lack of safety in some in-patient mental health services. It took nearly a decade for that to be taken seriously, so we warmly welcome the speed with which we are dealing with this situation now.
I am delighted that Amendment 54, which will be moved by the noble Lord, Lord Bethell, on behalf of the Government, will identify the principles relating to core duties, involvement of patients and amendment to primary legislation, together with regulations for appointment and operation of the office for the commissioner. I too have concerns about paragraph 3(3) of the proposed new Schedule A1, concerning the statement:
“A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner”.
This means that a reluctant organisation—we need to remember that some very small organisations deliver healthcare on behalf of the NHS—or individual is potentially provided with an excuse not to co-operate with the commissioner on a reasonable request. I ask the Minister: could the words
“so far as reasonably practicable”
be removed?
Clarity over roles and responsibilities will be key to maximising patient safety, as will the independence of such a commissioner. It may well be that, as we work forward, we can be clear about the level of independence to ensure that, as they revise the principles of better patient safety, they consider not only patients in hospitals and mainstream community care but patients further afield, particularly in areas provided by the independent and charitable sector.
Lord Mackay of Clashfern (Con) [V]
My Lords, I would like to join in the praise that has been very well entitled from the many people who have spoken today, and at other times, in thanking the noble Baroness, Lady Cumberlege, and her team for the excellent report, which lies at the beginning of this development. I thank my noble friend Lord Bethell and his team for the way they have taken this forward, because I am conscious—I have tried to think about it quite a bit —of how difficult this has been. I feel that, apart from some questions that have been raised—which I do not seek to mention again as it would be useless repetition—the scheme that is involved in these amendments is very good indeed. I shall say one thing about it in a few minutes.
It is quite clear to me that safety in the NHS and in other services is an extremely important matter. When you see the amount of money that the Health Foundation pays out in respect of claims against the health service, it is fairly plain that it is a very serious problem, in fact, and one which has been found to be extremely difficult to reduce substantially. The money that goes out for these claims is a very substantial proportion of the total amount spent on the health service, so this is certainly a very important area, and it is important that it should be attended to in this way as soon as possible.
When I read the report originally, I felt that it revealed a very urgent and important problem in the health service, and that it was vital that patients should have a voice when damage emerged from a particular source, particularly where that source was in some general use. There can be no question but that this is a difficult problem and that it will take all the skill and command of the Government to produce a satisfactory and workable answer.
The report emphasises the need for principles to guide the commissioner and the wisdom of seeking the help of the public to enunciate them. I am very pleased that the Government have taken this on and that the Scottish Government have also indicated their hand to tackle this problem. Although health is devolved, it is important that, if it is at all possible, the answer to this question is agreed across the whole of the United Kingdom.
The title of the report is First Do No Harm. However, the report indicates harm having been done in a number of cases. Many treatments start with an incision and, sadly, some patients pass away on the operating table. In none of these cases do any of the practitioners involved intend to do harm. Surely this shows the calibre of the person required to take on this essential role. To enunciate the principles involved in patient care I consider to be an extremely important labour and a task demanding a person of tremendous responsibility.
I strongly support these amendments, subject to the questions that have been raised, and I am happy that they have been put forward so fully at this stage by the Government.
Baroness Jolly (LD) [V]
My Lords, the amendments in this group relate to the introduction of a commissioner for patient safety. We have supported this proposal right from the publication of the review, First Do No Harm.
At Second Reading and in Committee we supported the amendments tabled by the noble Baroness, Lady Cumberlege, to put the patient safety commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review. I was pleased to add my name to Amendment 65, tabled by the noble Baroness, Lady Cumberlege, that we are debating. Along with all the government amendments, it will enable the progress of the commissioner’s appointment. I join others in congratulating the noble Baroness, Lady Cumberlege, and the Minister, the noble Lord, Lord Bethell, for getting the patient safety commissioner accepted so quickly by the establishment.
The critical issue is to be independent, and to be seen to be independent by example. As the noble Baroness, Lady Finlay, mentioned, both the children’s and the victims’ commissioner have remained independent, and I am sure would be useful allies and candid friends in the world of commissioners—who, as the noble Baroness, Lady Cumberlege, underlined, are not regulators.
I look forward to the time when in every NHS healthcare setting there will be easily accessible information on the role of the patient safety commissioner, and the way to contact them. We welcome the department’s commitment to working at pace, and there are many parliamentarians here today who will be keen to ensure that it does just that.
As the noble Baroness, Lady Cumberlege, said, there is a time pressure to appoint the commissioner. I join the noble Lord, Lord O’Shaughnessy, the noble Baroness, Lady Bennett, and others, in their concern for the pace of the appointment. What body will have oversight of setting up the office of the patient commissioner? I wonder whether the Minister could tell the House when he would expect the office to be up and running—in a year, in two, or more?
Baroness Thornton (Lab)
My Lords, I can only join in with the congratulations that everybody has expressed in this debate today. I congratulate of course the noble Baroness, Lady Cumberlege, and support her—as we have from these Benches throughout. I also congratulate and thank the Minister, the noble Baroness, Lady Penn, and also somebody who I do not think has been mentioned but I do remember sitting giving his wisdom in the many discussions we have had, who is of course the noble Earl, Lord Howe. I think the team were very wise indeed to have him sitting with them.
I am not going to say very much because I think we are there with this. Most of the questions that needed to be asked have been asked: on speed, independence, resourcing and powers, and on the issue of “relevant person”, which several noble Lords mentioned. These are the key issues.
One issue that has not been mentioned—here I thank the PSA for its brief—is the need to ensure that there is no reduction in public protection in any other areas of government policy, and that the remit of the role should link closely with the work of the other bodies involved in patient safety.
Finally, I have to say that I agree with the noble and learned Lord, Lord Mackay of Clashfern, that there has to be a four-country element in this. As the role is intended to cover only England, there should be consideration of how the link with equivalent or complementary mechanisms will work in the other countries of the UK. Otherwise, we might find ourselves with a dissonance here, which will not be in patients’ interests.
Lord Bethell (Con)
My Lords, I will save my Hollywood thank-yous for the end of the process, but profound thanks will need to be said. I want to say specific thanks to those who have spoken in the debate on these amendments. There have been a large number of very thoughtful comments. The noble Baroness, Lady Thornton, and my noble and learned friend Lord Mackay both mentioned four nations and devolution. The noble Baroness, Lady Bennett, spoke on gender, my noble friend Lord O’Shaughnessy on industry advocacy, and the noble Baroness, Lady Ritchie, on Northern Ireland. It is a very long list, and I cannot address every contribution. What I will do instead is address what I think have been the key points in the debate on these very important amendments.
Amendment 65 was tabled by my noble friend Lady Cumberlege before the Government’s own. I am extremely grateful to her and her team, who have written to me expressing their thoughts. The government amendment would not have been possible without her continued engagement and that of other noble Lords whose experience and knowledge have been essential in shaping the Government’s thinking. Although there are differences between our amendments, we are agreed on the fundamental point that we must create a patient safety commissioner in order to give the voice of patients its rightful prominence. My noble friend Lord O’Shaughnessy has made that point extremely clearly and effectively.
More broadly, I hope that the amendment in my name assures my noble friend Lady Cumberlege and the House of the seriousness with which the Government takes the report First Do No Harm. The Government will continue to review this report. We made a Written Ministerial Statement on the report and its recommendations yesterday, and will respond to the whole report shortly.
A patient safety commissioner, as proposed in Amendment 65, would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. The Government entirely agree that listening to patients is essential to preventing the sorts of issues highlighted in the report. On this, our visions for the patient safety commissioner are as one.
However, Amendment 65 in the name of my noble friend Lady Cumberlege differs in specific ways. Her proposed new subsection (2) provides that the Cabinet Office would host and fund the patient safety commissioner. My noble friend has argued here and in Committee—and, indeed, in her report—that this would be necessary to safeguard the independence of the commissioner. I simply do not agree. It is common practice for commissioners to be sponsored by the government department with relevant policy responsibility, and it is entirely unclear to me what the benefit of sponsorship elsewhere would be. The process of public appointments is set out clearly; there is no question of undue influence by the sponsoring Secretary of State. The process is there—in fact, it is public. Nor does the identity of the sponsoring department amend or change the powers and functions of the commissioner; it is simply how the body is supported.
There are also differences in the way in which my noble friend’s intention is executed. In her report, she was clear that working with other bodies was necessary and, as I would hope, obvious as part of any commissioner’s remit. However, Amendment 65 is unclear as to how the commissioner would interact with other regulatory bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and any other persons, including regulators and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants. These bodies also have their own routes for reporting. For example, as we know from the vaccines rollout, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme.
Without differentiation between taking receipt of direct reports to further a broader investigation and acting as an ombudsman, Amendment 65 might create a body overwhelmed by patient reporting and investigating individual cases. The noble Lords, Lord Patel and Lord Hunt, both referred to past agencies here, but where the best route to resolution sits elsewhere. The report itself said that the commissioner should not investigate individual cases, yet this boundary is absent from the amendment.
Proposed new subsection (7) enables the commissioner to require information from public bodies and others for the purposes of producing and laying before Parliament reports regarding patient safety, but “other” would extend to private individuals—a very expansive group indeed. The amendment tabled by my noble friend provides for the commissioner to make reports only to the Secretary of State and Parliament, and not to a range of bodies as in the government amendment. Nor does my noble friend’s amendment provide for what would happen if these individuals did not respond.
“Relevant person” is a broad definition. I am confident that it will enable the commissioner to engage with the organisations necessary to fulfil their functions effectively. In addition, proposed new paragraph 3(1)(b) of Schedule A1 would enable the commissioner to receive information from and consult
“any other person the Commissioner thinks appropriate”.
This provides the commissioner with all the relevant tools necessary. A vital difference between my amendment and the proposals of my noble friend is that, in mine, provisions are made for the patient safety commissioner to make reports and recommendations to relevant public authorities or persons, and for that authority or person to have a duty to respond to these; I think that is vital.
The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)
I have received one request to ask a short question. I call the noble Baroness, Lady Cumberlege, to ask a short question for elucidation.
Baroness Cumberlege (Con) [V]
My Lords, I want to say one or two things very quickly. I thank those who have spoken; it has meant such a lot to me. The noble Baroness, Lady Jolly, and the noble Lords, Lord Patel and Lord Hunt, have been there since the very beginning of this journey.
I say to the Minister, as I should have said at the very beginning, that I will withdraw my amendment. I have no wish to take it further. I do think that the Cabinet Office would have provided us with more independence, but my noble friend the Minister said at the very beginning that this was a red line and it was no good my pursuing it. I took that hint and I have not argued it anywhere. Hearing the Minister talk about independence today—getting it on the record—has been really important. However, as the noble Lord, Lord Lansley, said, of course influence matters as well, and I take that.
I will say a very quick word about the timetable, which is critical. In our recommendations we wanted to set up a task force to implement this under the aegis of the Department of Health and Social Care. That has been rejected by Ministers. That is a tremendous pity. Noble Peers are concerned about the timetable; so am I.
It has been said that this has been very quick. No, it has not. Those of us who have run companies know what “quick” means: if your company is to survive you have to act very quickly. This is not quick. I will put pressure on through other means, particularly the all-party group, to get this implemented as soon as possible, because people are suffering. People are in dire straits and we have to stop this awful damage that is being done to lives. The quicker we can do this, the better. I am sure my noble friend will agree with that.
I know when I am beaten, but I also know what needs to be done. I do not want to go through the point of view of the Cabinet Office, but it is absolutely critical that this appointment is made speedily, because people are suffering and we should avoid that if at all possible. I believe that the patient safety commissioner will grasp this issue and ensure safety, which, as my noble friend the Minister said, has run through the Bill. I thank him for that, but it will not happen until this appointment is made. I am afraid that I will press very strongly on that.
I thank all noble Lords for taking part. I wish I could go through this in detail, but it is not my remit to do so. I thank noble Lords so much for their support.
Lord Bethell (Con)
I thank my noble friend for her very kind and generous words, and for making it clear that she will not move her amendment. I reassure all noble Lords that their words are on record and will have a bearing and influence on the development of the patient safety commissioner as it is rolled out.
My noble friend’s question was about timing and speed. I hear her admonishments loud and clear. She knows that once we have committed to something we will deliver it. I ask for her forbearance. There is a global pandemic on. I cannot guarantee that this is the number one priority because we need to do the vaccine and we have to get Britain back on its feet. Those are distractions that I cannot hide from the House, but I reassure my noble friend and all those involved in the debate that a commitment has been made very clearly and we are now moving to deliver it.
The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)
We now come to the group beginning with Amendment 2. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in the group to a Division must make that clear in the debate.
Clause 1: Power to make regulations about human medicines
Amendment 2
Baroness Thornton
Member’s explanatory statement
This amendment provides a sunset provision for Part 1 of the Bill requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 2 and 3 of the Bill, and the amendments in the name of Lord Patel requiring consolidated legislation.
Baroness Thornton (Lab)
My Lords, in moving Amendment 2 I will speak also to Amendments 27 and 40 in my name. I also support the amendments in the names of the noble Lords, Lord Patel and Lord Kakkar, and of the noble and learned Lord, Lord Mackay.
This amendment would provide a sunset provision for Part 1, requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 2 and 3 and the amendments in the name of the Lord, Lord Patel, requiring consolidated legislation. We discussed all these issues in Committee. Through discussion, the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, and others have joined together to put this together as a suite of amendments, which makes sense.
At Second Reading, the noble Lord, Lord Blencathra, said:
“Thus it grieves me to say that the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy. Of course, it is not unique; it is just one more Bill stuffed full of Henry VIII clauses but devoid of substantive content. It is the barest skeleton, all to be filled in with negative secondary legislation.
I am speaking in my capacity as chair of the Delegated Powers Committee. We considered the key clauses—Clauses 1, 8 and 12—and concluded that they contain inappropriate delegations of power. We say that
‘the Government have failed to provide sufficient justification for … the Bill adopting a “skeleton bill” approach, with Ministers given very wide powers to almost completely re-write … regulatory regimes’.”—[Official Report, 2/9/20; col. 415.]
Here we are some distance away from that remark. Indeed, the question we must ask is: have we succeeded? Is the Bill less atrocious now than at the beginning when the DPC was so scathing?
All of us, in particular the Minister, the noble Baroness, Lady Penn, and the Bill team, have listened and improved the Bill. The Government have worked hard to meet some if not all of the Constitution Committee’s and the Delegated Powers Committee’s recommendations.
We believe that this suite of amendments, in a way, builds on those improvements that have already been made to the Bill. They propose a very simple objective that was articulated from the very beginning. It is neither democratic nor safe to run medicines, devices and veterinary medicines through regulation alone in the long run. Our regulatory framework needs to be in primary legislation. This must be achieved in a timely fashion, hence these amendments. Sooner or later—and there is agreement on this—there will need to be consolidation in primary legislation. We would prefer it to be sooner. We think that some agreement is necessary on this.
While I recognise the need to get this legislation on the statute book, the Minister must know about the disquiet that some of this has caused and the need to address the issues of accountability in regulation. The truth is that while we are very pleased to now have affirmative regulation, it is very rare for that to be rejected once it reaches Parliament, however unsatisfactory it might be. In fact, we have learned a great deal about regulation over this year of Covid regs.
The amendments in my name and those of the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly, would amend Parts 1, 9 and 14, which concern the three objectives of the regulation of medicine, medical devices and veterinary devices, with a three-year sunset provision. In Committee, I proposed that there should be consolidation of regulatory legislation within a two-year period, so I hope the Minister might recognise that we have been quite generous here because we have now extended that to three years.
Other noble Lords who are much better qualified than I will discuss the merits of the group. I look forward to hearing their discussion. In the meantime, I beg to move.
Lord Patel (CB) [V]
My Lords, I support the amendments in the name of the noble Baroness, Lady Thornton. As she said, they should be read in conjunction with my Amendments 26, 39 and 63 on the need for consolidating legislation, which I will come to in a minute.
As has previously been debated, the Bill confers an extensive range of delegated powers relating to medicines, veterinary medicines and medical devices. Previously, the power to create relevant secondary legislation in the UK was derived from the European Communities Act 1972. Those delegated powers were simply to allow the implementation of laws in the UK that have already been consulted on, debated and scrutinised at EU level and by our own EU committees in the Lords.
The powers in the Bill are such that areas of policy that previously would have been subject to greater scrutiny at EU level may now be amended without similar levels of scrutiny in the United Kingdom. They do not, as such, represent an equivalent conferral of power to the legislature seen under the previous regulatory arrangements.
The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)
After the next speaker, the noble and learned Lord, Lord Mackay of Clashfern, I will call the noble Lord, Lord Kakkar.
Lord Mackay of Clashfern (Con) [V]
My Lords, I strongly support the amendments dealing with consolidation. I regard it as very important that the legislation that controls medicines, medical devices and veterinary medicines is consolidated in a way that makes it possible for an interested person easily to achieve knowledge of the regulations. After all, when you think of how important medicine is—we have just had a considerable debate about its safety—it is important to make sure that those who administer and operate the system know the rules. If you do not know what the rules are, the chances are that you will be misled into thinking that you know when you do not know at all. Therefore, it is important to make sure that we do everything we can to lay before those who practise these arts the true rule that has been set down, and it should be possible for them to reach it without too much research into a number of statutory instruments.
We just need to think for a moment about the current virus regulations. I have had occasion to look at them from time to time, and it is quite difficult to follow what is required at a particular moment in England, Scotland or other parts of the United Kingdom. If that is the position in relation to the virus, it is obvious that the general position in relation to these sciences as a whole will be even more difficult. Therefore, I regard it as vital—indeed, as a fundamental duty of government—to ensure that the regulations on these important matters are clear and the rules accessible.
I am not very keen on the sunset clause because, if it operated without consolidation, we would be in a pretty difficult position. Therefore, I regard it as vital to require consolidation.
I am aware of the difficulty of consolidation. For a short time, I was the chairman of the committee on consolidation and, when it sat, it was extremely difficult to get a quorum because people did not find the exercise interesting. But unfortunately, although it might not be very interesting or novel, in the sense that you are not doing anything very new, it is absolutely vital to allow the system to work properly. So I regard it as important that that is put into the statute as an obligation. If we are allowing the Government to legislate in these important areas by statutory instrument —the criticism has been levelled that they are doing so too much—that should be replaced in a reasonable time. Three years is probably quite reasonable, but I am very willing to hear whatever is said about that. I regard it as very important that this is an obligation on the Government as a condition of getting away with this method of legislating quickly in this area.
Lord Kakkar (CB) [V]
My Lords, it is a pleasure to speak in support of Amendments 29, 36 and 63 in the name of my noble friend Lord Patel, to which I have added my name, and broadly for the principles of the other amendments in this group. This is a critical area of public policy, as we have heard in this debate and in the excellent debates on these questions in Grand Committee. We have also heard that the regulations—the legislation attending medicines, medical devices and veterinary medicines, and their regulation in our country —have appeared on the statute book as a result of facilitations through the European Communities Act 1972. These represent in many ways a haphazard patchwork of regulation, created over time, with good intention, but obviously with the need to be consolidated and brought to a clear and precise place, as we heard from the noble and learned Lord, Lord Mackay of Clashfern, in such a way that any party interested in this vital area, which impacts on the lives of every citizen, can do so with simplicity, understanding obligations, understanding their rights and protections and being able to act confidently with regard to the rule of law.
The current regulations represent a challenge, and as a result of our departure from the European Union, there remains much contemporary regulation, agreed at the European level, with specific reference to clinical trials and medical devices, that has yet to be incorporated into domestic legislation, once again representing an important challenge with regard to the framework within which we are to proceed.
The Government rightly have stated that patient safety is at the forefront of their thinking when it comes to regulations regarding medicines and medical devices. To bring clarity will improve safety and will also achieve the Government’s other stated objective of ensuring that our country can continue to lead globally in the life sciences. We have seen the benefits of that leadership during the Covid pandemic, in terms of innovation, the application at scale and pace of that innovation for the benefit of our citizens, and the sharing of that knowledge globally.
Therefore, it is difficult to understand why Her Majesty’s Government would reject the opportunity to commit to consolidating legislation so that simplified, clear, effective and intuitive regulatory regimes exist in our country and can deliver the objectives that we all agree upon. In Grand Committee, we heard from the noble Lord, Lord Lansley, an interesting proposition that the Law Commission might be approached to support the task of consolidating legislation in this area of public policy. We have heard from the noble and learned Lord, Lord Mackay of Clashfern, that when he chaired a committee of consolidation there was little interest in dealing with some of the more demanding and exacting elements with the fastidious nature that is required to create effective consolidated primary legislation. Has the Minister had an opportunity to explore whether the Law Commission might be approached on the basis of the Law Commissions Act 1965, to determine whether it would be in a position to propose and engage with the consolidation of legislation regarding medicines, medical devices and veterinary medicines, as part of its forthcoming 14th programme under the obligations and opportunities afforded by the Law Commissions Act?
Baroness Masham of Ilton (CB) [V]
My Lords, I support these amendments. It seems totally sensible to consolidate legislation so that it is not fragmented and some medicines do not get missed. Medicines and medical devices are vital to some people. We depend on many of our medicines and devices coming from abroad, so bringing legislation together for human and animal medicines will help prevent mistakes. We are an island and crossing the borders has already caused problems with filling in the forms. With much-needed medicines there should not be a risk of not receiving them.
Lord Lansley (Con) [V]
My Lords, I am very pleased to follow the noble Baroness, Lady Masham, who rightly emphasises the importance of accessible and understandable legislation in this area. There are two issues. As my noble and learned friend Lord Mackay of Clashfern said, there is the question of the sunset clause and the question of the preparation of consolidated legislation.
On Amendment 2 and a sunset clause, I believe that we should reserve the imposition of sunset clauses for legislation where we anticipate that those powers may not be needed in future. This is not the case with this legislation. With the end of the transition period we require our own domestic legislation for medicines, veterinary medicines and medical devices, so these regulations and these powers will be required.
The points made by the noble Baroness, Lady Thornton, quite legitimately, about the framework—the rather skeletal nature of the Bill as introduced to this House—must be dealt with in other ways, and in the group led by Amendment 4, we have substantive changes which make it a framework rather than simply a skeleton, and give us greater assurance about how the powers are structured in the Bill. I hope that if she reflects on it the noble Baroness will realise that shutting down these powers three years after Royal Assent would be a very taxing imposition. It would probably mean that in less than a year and a half, Ministers would be thinking about the reintroduction of legislation. We would risk the powers in this Bill being shut down in order for a Bill very like it to be introduced in a couple of years’ time. I see no intrinsic purpose in that, so I cannot support Amendment 2.
I do however want to specifically refer to the other issue of consolidation and Amendments 26, 39 and 63, in the name of the noble Lord, Lord Patel. There is a general proposition that people agree that, notwithstanding that additional regulations are going to have to be made in the weeks and months ahead using these powers, they will continue for the time being to be a complex mix of powers. Some will use this legislation, some will be in retained EU law and some will be in existing and other statutes and regulations.
What we want, as my noble and learned friend Lord Mackay of Clashfern quite rightly emphasised, is legislation in this important area that is understandable and accessible. These are not regulations for the benefit of lawyers; they are regulations for the benefit of practitioners, so they need to be very clear. The noble Lord, Lord Kakkar, helpfully and kindly referred to the points I made in Committee about the role of the Law Commission. As I understand it, indeed, I think it is well to remember two things about this. First, Law Commission members are the experts in the process of codification and simplification. Consolidation of legislation is valuable, but it is even better for it to be codified and simplified so that the end result is far more accessible and understandable to practitioners.
So I would very much recommend that we proceed by asking the Government to put the areas of human medicines and medical device regulation, and perhaps veterinary medicine as well, into the work programme of the Law Commission. As I understand it, the 14th programme of work for the Law Commission will be the subject of discussion between the Government and the Law Commission up to the spring of 2022. The work programme of course will happen subsequently. So I do not think any rigid timetable should be imposed. I hope that the noble Lord, Lord Patel, would not insist upon a three-year limit or his amendment for this purpose because I hope that, at the end of this process with the Law Commission, we will end up with something much better that is brought forward as a Law Commission Bill—which can have an expedited process of scrutiny and passage through both Houses. As a former Leader of the House of Commons, and therefore responsible for the Government’s legislative programme, I say that all the evidence tells me that, if a requirement to insert a Bill into the Government’s legislative programme can be avoided, it should be.
We have been there with a Law Commission Bill on the regulation of clinical professions and professions allied to medicine, which is still waiting for legislation, because it included not only codification and simplification but substantive changes to the policy—so I am afraid that it is still waiting. So let us not go down that route; let us do the very sensible thing rightly initiated by the noble Lord, Lord Patel, which is call for consolidation, making sure that it is not about changing policy but about making the legislation work effectively for the benefit of the various practitioners and those who depend on them. And let us work through the Law Commission. I hope that, if the Minister were to tell the House that he and the Government were willing to proceed in that direction, without a timetable in place, the noble Lord, Lord Patel, would not press his amendment when the time comes.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, rather like the noble Lord, Lord Lansley, I see this as a group of amendments in two parts. The argument for consolidated legislation from the noble Lord, Lord Patel, was very ably supported by the noble and learned Lord, Lord Mackay, and I very much support it. For those working in the health service or in industry, trying to wrestle with all the elements of legislation that cover health is very difficult indeed, and the case for consolidating legislation every so often is a very powerful one. I very much hope that the Government will take note of this, bearing in mind of course that there have been strong arguments from NHS England for a further NHS reorganisation Bill, which might be coming within a short space of time. On that issue in particular, the reorganisation of the NHS, the need to consolidate legislation following such a Bill becomes very persuasive indeed.
Where I do not really agree with the noble Lord, Lord Lansley, is on his remarks on Amendment 2 and his suggestion of a sunset clause. He argued that the problem with that is that you shut down the powers and therefore the Government need to produce another Bill, because we obviously need a regulatory regime. Sticking to the three years in my noble friend’s amendment would mean that work would have to start within 18 months. That does not argue against the principle of a sunset clause, although there can be debate about the length of time in which the new Bill needs to be enacted.
The fact is that this Bill conveys a huge number of delegated powers to Ministers. In a pungent analysis, the University of Birmingham points out that, while delegated powers may be needed to ensure responsiveness to the EU transition period and to meet the challenges of technology change, they should not be used indefinitely or relied on to implement matters of policy. This is the problem. If we take this Bill and we do not have some changes in the future, Ministers ever after will be able to ram changes to medicines and medical devices regulation through the House, and the amount of scrutiny in relation to secondary legislation is limited.
The Delegated Powers and Regulatory Reform Committee was very clear in criticising Ministers for failing to provide a sufficient justification for parts of the Bill adopting a skeletal approach. The recent report from the House of Lords Constitution Committee also said that it recognises
“that the existing powers to amend these complex regulatory regimes will cease to have effect on 31 December 2020 and that alternative arrangements are required. If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses.”
That surely must be right.
At Second Reading the Minister suggested that sunset clauses would emasculate the Bill, and in Committee he said that a sunset clause
“will not change the very good reasons why delegated powers are necessary.”—[Official Report, 19/10/12; col. GC 327.]
I think we come then to the fundamental argument: that many noble Lords disagree with the extent of delegation that is going to be given to Ministers for all time. The only proper defence against that is to agree to the kind of amendment my noble friend has proposed in relation to a sunset clause. For that reason, I very strongly support her.
Lord Naseby (Con) [V]
My Lords, in the past I have had the privilege of working with two pharmaceutical companies, a US pharmaceutical company Upjohn and Reckitt pharmaceuticals. I think that as a country we face a unique opportunity at this point caused by Brexit and a situation where we have a major industry which has all the potential to be a world leader. But this point in time is going to go away unless we act. This is a watershed Bill. It creates an opportunity to enhance the role of the UK Medicines and Healthcare products Regulatory Agency. The industry and all of us should want the UK to be an attractive market for investment in medicines, medical devices and therapies for all our UK patients. It creates an opportunity to make significant improvements in UK clinical research environments and, very importantly, it increases the commercial trial activity to make the UK the number one destination for life sciences supporting UK public health.
Baroness Jolly (LD) [V]
As the noble Lord, Lord Hunt of Kings Heath, and others have said, these amendments relate to sunset provisions and consolidated legislation. As we have already heard, the Bill is largely a skeleton Bill and allows the Secretary of State or a relevant authority to make legislation by statutory instrument on policy issues relating to human medicines, veterinary medicines and medical devices. Can the Minister confirm whether the SIs referred to will come before the House? Will he also confirm that the SIs we see will live up to the expectations of the noble Lord, Lord Blencathra, and his committee?
It is important that there is a limit on how long the delegated powers should last. The amendments in the name of the noble Baroness, Lady Thornton, would mean that, after the suggested three years have elapsed, the policy objectives of the Government would be clearer and they could return with primary legislation. The amendments in the name of the noble Lord, Lord Patel, would require the Government to publish the consolidated primary legislation in draft form. We support these measures but, for the intervening period, we believe that the powers should be subject to the additional scrutiny required by my noble friend Lord Sharkey’s amendments in the next group.
Lord Bethell (Con)
My Lords, I thank noble Lords for an extremely powerful session on these amendments. I confess that I completely share the aspiration voiced by many noble Lords about Britain having the best possible legislation on life sciences in the world. As the Life Sciences Minister, that is a natural ambition, but it is also a real possibility, and it is what we are working towards at the department, and through the Bill. But I have severe reservations about whether this approach is the right mechanism, and I would like to address those directly.
The noble Baroness, Lady Thornton, has tabled Amendment 2, which relates to the sunset clause, and with this amendment it would be convenient to speak to Amendments 26, 27, 39, 40 and 63. I will come to Amendment 2 shortly but, first, I cannot say that Amendment 26 is a big surprise. The noble Lord, Lord Patel, who authored it, indicated as much when he and other noble Lords discussed these matters after the excellent debate in Grand Committee. The intent of his amendment is to require the Government to publish draft legislation within three years—legislation that consolidates medicines and medical devices regulation. I understand the arguments made during Committee, and again here today, that the regulation could benefit from clarification and those arguments made on how secondary legislation could be used. The amendments in the name of the noble Baroness, Lady Thornton, go further. They would append a sunset clause after three years—I repeat, three years—requiring not draft legislation but passed legislation.
I start by addressing the timing put forward. The noble Lord, Lord Patel, asks for the Government to publish draft legislation within three years of Royal Assent. I assume that he intends this consolidation effort to include changes made under the delegated powers in the Bill, including policy that may be made to, for example, take forward a national falsified medicines scheme. The noble Baroness’s amendment would have the delegated powers lapse entirely, leaving us without the ability to amend or supplement the regulatory regimes at that point. In reality, three years between Royal Assent and draft legislation ready for publication that consolidates the existing legislation and includes any changes made under the Bill is just not long enough. Each change to the regulatory regimes will take time. Public consultation must be conducted and amending regulations must be laid, debated and so on. We do not intend—in fact, it would not be possible—to front-load policy changes into the first half of 2021, let alone 2021 at all.
Noble Lords have spoken to the importance of consultation. I say it would not just be the Government front-loading legislation; it would be about asking the affected sectors to engage with a lot of consultation very quickly and in parallel. That does not seem the right way to go about it at all. It inevitably means that the sorts of exciting policy changes that support our life sciences sector and protect patients will take an enormous amount of time to stand up. Developing and consulting on policy proposals that require legislative changes takes time, as does the drafting of any proposed legislation. Before getting to the point of drafting the legislation and so on, you need to have made an assessment of what it would be appropriate to consolidate —and that takes time.
The Human Medicines Regulations 2012 were the product of a consolidation exercise that required extensive consultation. Consultations were run while explanatory documents setting out changes so far, and so on, were all prepared before the regulations were made. Let me be clear on the timescale involved in that exercise. A concept paper was issued by the MHRA in 2009. There was an expectation that consolidating human medicines regulations, including looking at the Medicines Act 1968, would take around three years to complete. That concept paper was put out to consultation; a response was published and further consultation took place in 2010.
The first complete draft of the regulations was published in August 2010 and a number of specific consultations also run in that year. A further consultation, following the consultation on the draft regulations of August, was run between October 2011 and January 2012. Three years is the time it takes to do the comprehensive exercise that the noble Lord, Lord Patel, alludes to in his amendment, and that exercise did not involve making up new primary legislation in the first place: it resulted in the Human Medicines Regulations 2012. The noble Lord has extended his amendments to medical devices and veterinary medicines as well.
The noble Lord cannot mean us to start a review the day after this Act is given Royal Assent, with the intention of bringing forward proposals within three years. There would be no legislation made under the Act to assess. I cannot see an exercise of seeing what to consolidate and then preparing the drafting taking less than a year altogether. In fact, it would more likely take much longer if the consolidation is intended to be as far-reaching as the noble Lord and others have very powerfully indicated. Taken together, the noble Lord’s amendments would mean that the process would need to start by 2022, but not all the legislative change to be brought forward under the Bill’s powers would yet be made and in effect.
I anticipate that a consolidation exercise as proposed by the noble Lord would wish to consider the practical effects and operation of such a complex and comprehensive body of legislation. In order to do that, we would need time for the secondary legislation to be made to deliver policy. Industry then has to comply with revised regulatory changes and the MHRA needs to assess how it works. This does not, as the noble Lord may recognise, amount to a realistic exercise. We will not have all the pieces to assess before he asks us to conduct the assessment and also provide an alternative. Change takes time. The standstill period for medical devices, for example, lasts two and a half years, in recognition of this, so while some changes are likely to be made to the regulatory regimes within three years, some will not. When his proposal amounts to no more than a year of operable amending legislation to assess and consolidate—perhaps less—it is therefore impracticable.
This issue is compounded by the noble Baroness’s Amendments 2, 27 and 40, which would introduce a sunset clause to the regulation-making powers in Parts 1, 2 and 3 of the Bill, in effect creating a new cliff edge at the end of three years, after which the existing regulatory regimes cannot be updated. If what the noble Baroness seeks is similar to what the noble Lord, Lord Patel, seeks—an assessment of whether secondary legislation is the right place for the regulatory regimes—I say to her that the means simply do not fit the ends. Introducing a cliff edge in legislation is unhelpful. It forces legislation on to the timescale of a sunset clause. It does not allow for pandemics or for the consideration of new developments that arise and need to be addressed.
The noble Baroness’s amendments would further compress the timescale, stripping out another year. Working back from a sunset clause of three years’ time, we would need Royal Assent of a new Act by then. Let us be generous and provide for a year of parliamentary scrutiny. We began this Bill in February last year; it is January now and we must allow parliamentary drafters to do their job of translating policy intent into clauses. The noble Baroness and the noble Lord have both argued in favour of a very different drafting approach: let us give them, say, a year. While that may seem a long time, I suggest that many noble Lords have experienced the challenges of drafting amendments. There are questions about intent and about the choice of language, and these would apply to tens and possibly hundreds of clauses. Suddenly, that time is not very long at all. That then leaves us with a year from Royal Assent to begin the drafting process—not even the assessment process. All the problems I have already mentioned, including the inability to set up a regime to assess and not only pass legislation but implement that legislation, apply, but much more urgently.
We must also consider the impact on those who are being regulated. The arguments I advanced in Committee on the uncertainty that this would create for businesses, manufacturers and, importantly, patients apply very gravely but would become even more critical. In effect, we would be making regulation in 2021—potentially substantive, bold new regulation to protect patients from harm and ensure the highest standards of safety for medical devices—but we would also be saying that this would be immediately under review, and potentially completely rewritten within three years. The new policy to be delivered by these regulatory changes would not be able to come into force, be implemented and enforced before we would be back here again. I simply cannot think that this is good regulation.
I am sympathetic to the issue of how Parliament assesses our plans. There are, of course, avenues open to Parliament to consider whether it wishes to express a view to the Government on any particular topic. We have Select Committees to scrutinise government policy and we have provided for a reporting requirement in the Bill that gives Parliament the opportunity to reflect on the legislation we have made under the Bill in the first two years and any plans we have at that point to make further changes in response to concerns and proposals raised in relation to it. There are institutions such as the Law Commission that can be called upon to take a view on whether legislation is the right legislation, or too complex. However, if noble Lords want me to say, “In three years, we will have made changes under this Bill that are right to consolidate, and we will be in a position then to review and assess and produce something for Parliament to look at,” I simply cannot give them that assurance; nor can I say anything similar to the noble Baroness.
We need to make changes to the regulatory regimes and follow the full and thorough processes to do so, including public consultation and, most likely, draft affirmative amending regulations. We need to have them working, understood and operable by industry and the regulators. Getting that up and running is where I think we need to direct our resources, before we can think about reviews of how it works. To that end, I hope the noble Baroness understands why I am not able to concede here. I hope she feels able to withdraw her amendment and that the noble Lord will not feel compelled to press his.
Baroness Thornton (Lab)
I thank the Minister for that. The words, “Yes, Minister” came to mind. It was a very long, wordy way of saying no, but I suppose he had to say it. I thank the noble Lords, Lord Patel and Lord Kakkar, the noble and learned Lord, Lord Mackay, and the noble Baroness, Lady Jolly, for their support and their speeches, as well as my noble friend Lord Hunt and other noble Lords. I particularly agreed with the noble Lord, Lord Naseby. Although we may disagree about sunset clauses, he absolutely hit the nail on the head about the need for consolidation. We link these together because we think there needs to be a time limit.
The Minister said absolutely nothing about what he thinks may happen next. It is simply not acceptable, and the House of Lords scrutiny committees—the Constitution Committee and the Delegated Powers Committee—said that it is not acceptable, democratic, accountable or even safe to continue to run this area of public policy simply by regulation. Since the Minister and the Government have not brought forward anything that actually tackles that problem, that is what this suite of amendments seeks to do. All the discussion we have had in the past hour tells me that we are right to do this.
I say to the noble Lord, Lord Lansley, who mentioned the Law Commission during our discussions about this, that that is a bit of a phantom. We all know that the Law Commission works on a three- to four-year cycle. It is a law unto itself: the Government cannot instruct the Law Commission to do anything, quite rightly. That may or may not be the right way forward, but it could take 10 or 15 years: it certainly does not hurry itself. So, in theory it is quite a nice idea, but I suspect that it would probably not work within the time limits we have before us.
I listened carefully to the Minister. It was a classic explanation of why something cannot be done and, on that basis, since the Minister seems to think that nothing can be done, I beg to test the opinion of the House.
The Deputy Speaker (Baroness Garden of Frognal) (LD)
My Lords, we now come to the group beginning with Amendment 3. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in this group to a Division must make that clear in debate.
Amendment 3
Lord Sharkey
“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Lord Sharkey (LD) [V]
My Lords, the amendments in this group are in my name and the names of the noble Baroness, Lady Andrews, the noble Lord, Lord Forsyth of Drumlean, and the noble and learned Lord, Lord Judge. I am grateful for their support and regret that the noble Lord, Lord Forsyth, cannot be here today. He is currently chairing a meeting of the Economic Affairs Committee.
The purpose of the amendments is to replace the use of the affirmative SI procedure in Parts 1, 2 and 3 of the Bill with the super-affirmative procedure. This is to restore an element of meaningful parliamentary scrutiny to a Bill that so conspicuously lacks it. This is a skeleton Bill. Parts 1, 2 and 3 contain no policy detail and effectively give Ministers carte blanche to decide policy. They give the Minister almost unfettered power to remake our human medicines, our veterinary medicines and our medical devices regimes.
Our DPRR Committee and the Constitution Committee were extremely critical of this approach. On Second Reading, as the noble Baroness, Lady Thornton, has reminded us, the noble Lord, Lord Blencathra, chair of the DPRRC, and speaking for it, said that
“the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy.”
He went on to say:
“Parliament is effectively bypassed; that is a sick joke of good law.”—[Official Report, 2/9/20; cols. 415-16.]
Parliament is bypassed largely because the affirmative SI procedure does not allow for real scrutiny. We cannot amend SIs, and the House has voted down affirmative SIs on just four occasions in the last 70 years.
The Constitution Committee was clear in its 2018 report, The Legislative Process: The Delegation of Powers, when it said:
“Without a genuine risk of defeat, and no amendment possible, Parliament is doing little more than rubber-stamping the Government’s secondary legislation. This is constitutionally unacceptable.”
The affirmative SI procedure does not constitute meaningful parliamentary scrutiny.
By contrast, the super-affirmative SI procedure is designed and used to deliver a measure of real scrutiny. Erskine May, in part 4, paragraph 31.14, characterises the procedure as follows:
“The super-affirmative procedure provides both Houses with opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. (It should be noted that the power to amend the proposed instrument remains with the Minister: the two Houses and their committees can only recommend changes, not make them.)”
In Committee, I set out at some length the details of how our super-affirmative procedure could work. In her response, the Minister helpfully summarised that the
“procedure would require an initial draft of the regulations to be laid before Parliament alongside an explanatory statement and that a committee must be convened to report on those draft regulations within 30 days of publication. Only after a minimum of 30 days following the publication of the initial draft regulations may the Secretary of State lay regulations, accompanied by a further published statement on any changes to the regulations. They must then be debated as normal in both Houses and approved by resolution.”—[Official Report, 19/10/20; col. GC 376.]
According to the Library, the last recorded insertion in a Bill from a super-affirmative procedure was by the Government themselves, in October 2017, in what became the Financial Guidance and Claims Act. In Committee, I noted that when they are not doing it themselves, the Government traditionally object to the use of the super-affirmative on all or any of three grounds. The first is that it is unnecessary, because the affirmative procedure provides sufficient parliamentary scrutiny; the second is that it takes too long; and the third is that it is cumbersome. The Government did not depart from tradition. In Committee, they used all three objections.
The first objection, that the affirmative procedure provides sufficient scrutiny, is plainly and simply wrong, unless of course the Government regard no effective scrutiny as sufficient. The second objection, that it takes too long, is to misread its purpose. It is the case that the super-affirmative procedure takes longer, but that is because it contains provisions for real scrutiny, which necessarily takes time. This is not a negative; it is the merit of a procedure and the point of it. I should point out here that any emergency or urgent need will not trigger the super-affirmative procedure. The Bill now allows for the “made affirmative” procedure to be used in such cases.
The third objection raised by the Minister was that the super-affirmative procedure could be cumbersome and involve a disproportionate use of parliamentary time. She gave the example of the minor change to the Human Medicines Regulations 2012 to illustrate the point. This was a very helpful observation, and we are grateful for it. It would obviously be wrong to take up parliamentary time on minor changes, but, accordingly, we have revised our amendments since Committee to take account of this. The amendments now before us apply the super-affirmative procedure only to regulations that introduce what the Secretary of State considers to be either significant new policies or significant changes to existing policies. All other SIs can be dealt with as currently specified in the Bill.
This is a skeleton Bill. The noble Lord, Lord Hodgson of Astley Abbotts, chair of our Secondary Legislation Scrutiny Committee, had something to say about this type of Bill in a 4 January article in Prospect magazine:
“First and foremost, parliament should continue to be vigilant about the balance of power that is at the heart of our constitution. The right of the legislature (parliament) to resist any encroachment on its powers by the executive (government) is central to our democratic system. … parliament should continue to object to the use of ‘skeleton bills.’”
He proposes that the Government:
“Put the appropriate level of detail into primary legislation and avoid skeleton bills.”
It is obviously too late to do that with this Bill, which allows Ministers to take powers and make policy before they have decided what that policy is. Secondary legislation was never intended as a means of making policy. Using secondary legislation to do that, as the noble Lord, Lord Blencathra, so clearly put it, bypasses Parliament.
Our proposal restores a measure of parliamentary scrutiny where there are proposed significant new policies or significant changes to existing policies. It is activated only by significant policy changes. It amounts to meaningful scrutiny without removing the final decision from Ministers. It does not get in the way of emergencies or urgent need, but it does prevent Parliament being bypassed. This is an important test of the balance between the Executive and the legislature and an opportunity for Parliament to assert its right, and its duty, to scrutinise. Subject to the Minister’s response, I intend to test the opinion of the House. I beg to move.
Lord Judge (CB) [V]
My Lords, I apologise to the House; this is the first time I have spoken on this Bill and I have not been able to speak earlier in the proceedings, so I will try to be brief. I also assume that, notwithstanding the recent vote on sunset clauses, the Minister’s response during the debate indicates that the Government will not be very interested in leaving it in the legislation.
This Bill’s importance is obvious. It is hardly regulation light; to the contrary, in the modern way, it has a banquet of regulation-making powers which would, as the debate has shown, enable the Minister to extend policy and create policy by statutory instrument. For that purpose, I need simply refer to the observations of the noble Lord, Lord Patel, in the previous debate.
In the 30 December debate on the Bill on the trade agreement with the EU, I suggested that, now that all that was done finally, we in this House at any rate needed to focus on the sovereignty not of the Prime Minister or the Executive but of Parliament over the Executive, and proper parliamentary control over the legislative process. We are, as has been discussed, no longer bound to implement EU directives—hence, in part, this Bill. We should decide now—and if not now, when?—to brake, or at any rate better to control, the damaging, wide-ranging, regulation-making powers which now regularly come our way.
Time and again, the cross-party committees of the House have complained about, for example, skeleton Bills, Henry VIII powers and inappropriate delegated powers. Time and again, in Bill after Bill, the pleas—convincing, constitutional and persuasive—have been totally ignored. A cascade of regulation-making powers continues its unabated flood in every Bill that comes before the House, and this Bill is such an example.
That is not the end of it. The consequences are vividly described in the report of the Secondary Legislation Scrutiny Committee, dated 17 December 2020, just a few days before Christmas. It contains devastating criticisms of risks to proper scrutiny currently observed by that committee. I commend its reading to the whole House. In the first year of this Session, we had 901 statutory instruments. Of those relevant to this Bill, the number from the Department of Health alone was 126. No one in the report has suggested that the department’s work is exempt from its wide-ranging, broad criticism.
The wider use of the super-affirmative process would ensure better parliamentary scrutiny and control of the Executive, which for too long have simply ignored the constant urgings of the parliamentary committees in this House, in particular, as this Bill shows, the recently expressed concerns of the Constitution Committee and the Delegated Powers Committee. One day they will ask why they bother. They do so only in the hope that, one day, the Executive of the day will take notice.
As these pleas have been ignored and have failed, and, as is perfectly plain, as I indicated at the outset, the Minister’s reservations and distaste for consolidation and sunset clauses were absolutely manifest, this amendment will secure that, for this Bill and for this department, with these wide-ranging and important powers, the super-affirmative level of control should be exercised. The time to exercise it is now. It is time that the power is exercised more frequently.
Baroness Andrews (Lab) [V]
My Lords, it is a pleasure to follow the noble and learned Lord, Lord Judge, and his magisterial assertion of parliamentary sovereignty, which I entirely agree with. I am pleased to support the amendments in the name of the noble Lord, Lord Sharkey; at the same time, I apologise to your Lordships’ House for not having been able to do so in Committee.
In his opening statement on this amendment, the noble Lord made an irresistible case in principle, as well as explaining with great clarity the process by which a super-affirmative order enables effective parliamentary scrutiny in a way that the simple affirmative procedure—however the Government argue it—cannot. In using it, the implementation of this extremely important Bill becomes a less risky and unpredictable affair.
On Second Reading, I said that the Bill was good in many ways but that, as a skeleton Bill, it created unnecessary risks. Despite the Government’s amendments and their very recent and welcome response to the DPRRC’s scathing report—I am very pleased to say I am a member of that committee—they have still not strengthened the process of parliamentary scrutiny in such a way that should satisfy either the DPRRC or this House.
It is worth reflecting that our wrath as a committee was directed as much at the casual flimsiness of the reasons offered and the false dichotomies between primary and delegated legislation that were set up as at the sheer and extraordinary sweep of the powers across the whole fields of medicine and veterinary science. “Free rein” was one of the milder terms the committee used. Failing at least to take the option of a super-affirmative procedure on these delegated powers still in effect gives the Government free rein. We would be able to challenge the statutory instruments but not change them, however strong the grounds, weighty the evidence or serious the anxieties and risks.
It is significant that, in their response to the committee published this week and in their amendments, the Government recognise that there are risks in the breadth of the powers, but to remove those risks they have merely tightened focus, improved transparency in some cases and assured us that those who use the powers will do so with great care. While any movement was welcome, the Government have refused to acknowledge what is right and proper here—as both the noble Lord, Lord Sharkey, and the noble and learned Lord, Lord Judge, have said, and as the committee made clear—which is a way to engage with and not bypass Parliament.
While under many circumstances the affirmative order is accepted as an appropriate level of scrutiny, it is most certainly not in this case, particularly when the Government choose not to accept that the powers were designated as inappropriate in the first place by the scrutiny committee. A super-affirmative order at least gives Parliament the opportunity to press for further thought, advice and amendment as initiated by the Government. As the noble Lord, Lord Sharkey, said, the amendment has been trimmed so that it deals only with significant changes. This is hardly revolutionary; it is in fact the least that one could insist on, but it is significant. It acknowledges that risks persist but can be reduced and that changes are made to prevent perverse consequences. Surely, in a Bill of this significance, that cannot be too much to ask.
The arguments that the process is too long, slow and cumbersome were dealt with by the noble Lord, Lord Sharkey, in Committee and today. They are but the most recent reiteration of the arguments we hear all the time when we put the case for primary legislation in the face of inappropriate delegation, where speed and technical detail are usually deployed frivolously. They are hardly powerful or relevant when considering the scope of these regulations.
I regret to say that, in their short career, this Government have shown in different ways that they do not welcome interrogation and fear scrutiny. A confident Government would welcome both as a way of avoiding mistakes and creating precedents which in Opposition they could not change. This is a modest opportunity to strengthen this Bill and I hope the amendments will secure the support of the House today.
Lord Naseby (Con) [V]
My Lords, I disagree with this amendment. I had the privilege of being the Chairman of Ways and Means and Senior Deputy Speaker in the other House from 1992 to 1997—possibly, legislatively, one of the most challenging periods. I certainly found that MPs were highly creative in their interpretation of the rules of debate and in holding the Government to account.
Noble Lords have only to read Erskine May to see that we have two procedures for SIs that are normal and have been with us for decades: the negative procedure, where no amendments can be taken in your Lordships’ House; and the affirmative resolution. The affirmative resolution is not just a weak tool that puts us on the side; it is a very powerful tool if used properly by Members of Parliament and those of your Lordships’ House who take an interest in these matters. They can ensure that the Government of the day have to listen.
Frankly, I find that the super-affirmative procedure does no more, really, than involve an additional stage of scrutiny where Parliament has considered a proposal for a statutory instrument before the statutory instrument is formally presented. Today this procedure is used for statutory instruments that are considered to need a particularly high level of scrutiny. Quite frankly, we have Select Committees, in the other House in particular, dedicated to particular departments, and there is a very active Select Committee on health matters.
In addition, yes, there are some specialised categories of statutory instruments that are used for those particular purposes, and they can be considered under the super-affirmative procedure. But these statutory instruments usually amend or repeal Acts of Parliament. Examples would include legislative reform orders, localism orders, public bodies orders, regulatory reform orders and remedial orders. It is not usual to have them as part of the primary legislative process.
It is time that we as politicians understood that this country will be successful only if we get on and understand the needs of British industry. It has to have some certainty that things are going to proceed at pace, not be delayed even further because some noble Lords feel that they want to have another bite of the cherry. We already had quite enough bites, in my judgment, on this Bill as we worked through it, and it is being done very thoroughly. It has been done in Committee and is being done on Report. But we have to understand that this all adds to delay and, even worse, possible confusion in the commercial world.
I think adequate procedures are already available. All this does is stretch the thing out for very little marginal benefit. I personally will vote against this proposal with enthusiasm.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I must say that I very much disagree with the noble Lord’s remarks. If we want certainty, we need legislation that is well grounded and which has had thorough scrutiny in Parliament. The problem with this Bill is that it essentially gives a blank cheque to Ministers to change the regulatory regime for medicines and medical devices. If this was just to deal with the aftermath of Brexit, that, of course, would be understandable. But it was made clear in Committee and at Second Reading that the Government are wedded to this way of doing legislation. As the Minister said in Committee,
“this is a modern and fast-changing industry … we may still need to preserve our ability to amend and update regulations.”—[Official Report, 19/10/20; col. GC 328.]
The noble and learned Lord, Lord Judge, referred to two of our most distinguished Select Committees. We need to return to what our Constitution Committee said:
“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made … The Government has not provided the exceptional justification required for this skeleton approach.”
As the noble and learned Lord, Lord Judge, has said, the Government have form. We are increasingly seeing the use of skeleton Bills and Henry VIII clauses. We really must come to a point where we say to the Government that we will not put up with this any longer.
I listened to the Minister in the last debate: what did he offer the House in respect of further scrutiny? It seemed to me he offered a debate or two, and that was it. The Government do not have an answer; they are refusing to budge on a principle which I believe is fundamentally wrong.
The noble Lord, Lord Naseby, talked with joy about the effectiveness of affirmative statutory instruments. This is nonsense. I think eight SIs have been defeated in your Lordships’ House in history; the last one led the Government to threaten to abolish the House of Lords. Unfortunately, the affirmative procedure is hardly any better than the negative procedure, and they do not allow this House to really exert any change on the orders going through.
We have to stand up on this matter. It is much more important and much wider than the issue of medicines regulation. I very much support the amendment moved so effectively by the noble Lord, Lord Sharkey.
Baroness Jolly (LD) [V]
My Lords, these amendments, led by my noble friend Lord Sharkey with eminent cross-party support, replace the affirmative procedure for delegated powers in the Bill with the super-affirmative procedure.
Because of the skeleton nature of the Bill, outlined in the previous group, it is key to ensure that Parliament is able to properly scrutinise regulations made under the Bill. The super-affirmative procedure, which affords a committee of either House the opportunity to comment on a draft of the regulations and make representations, is in our view the best way to do it.
The past year has made clearer than ever the need for outward-facing health policy with public health and safety at its heart. The regulations brought forward under this Bill are central to doing this, and the highest level of scrutiny is needed to ensure their success.
One of the first things I had to learn when joining the House was the sovereignty of the House. My 10 years in your Lordships’ House have taught me to spot Henry VIII powers and call them out. As the noble Baroness, Lady Andrews, said, these amendments are hardly revolutionary, so I urge the Minister to accept them.
We need well-grounded legislation, and this Bill gives the department carte blanche to do what it likes. The amendments tabled by my noble friend give Members of the House the opportunity to scrutinise in a proper way and that, after all, is what the public expect of us.
Baroness Thornton (Lab)
The noble Baroness, Lady Jolly, and I are not in a competition about who can speak most briefly, but we have promised the Minister that we will—I overshot my promised three minutes by a minute in an earlier speech.
I say from these Benches that we will support this amendment and we are very pleased to be doing so. I reread the debate and discussion in Grand Committee, and I was actually so impressed with my remarks that I am nearly tempted to read them out again, but I will not do so. I also have to say that the whole debate was very good and important.
As my noble friend Lord Hunt says, this is not just about this Bill; this is about how the Government intend to move forward in terms of legislation and policy and subject themselves to appropriate scrutiny. That is what this amendment is about, in our view, and that is why we will support it.
Lord Bethell (Con)
My Lords, I am afraid I will breach the convention on short speeches, but only because this has been an incredibly powerful debate. The points were made very thoughtfully, and I am grateful for the fact that they were made briefly. I want to tackle them head on and perhaps, I hope, persuade the noble Lord, Lord Sharkey, to back off from these amendments.
Lord Sharkey (LD) [V]
I am very grateful to all those who have spoken in support of these amendments. Skeleton Bills always limit parliamentary scrutiny, and this Bill is no exception. The Minister in his more than three-minute speech has exaggerated enormously the difficulties with the reach of our proposal. I disagree, for example, with the notion that our proposal blocks the use of the “made affirmative” procedure. It is clear that the Government are wedded to the idea of taking powers to make policy before they have decided what that policy is, and that is at the heart of the matter. This inevitably means bypassing Parliament and we should resist. I would like to test the opinion of the House.
The Deputy Speaker (Baroness Henig) (Lab)
We now come to the group beginning with Amendment 4. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in this group to a Division must make that clear in the debate.
Amendment 4
Lord Bethell
“(2) In making regulations under subsection (1), the appropriate authority’s overarching objective must be safeguarding public health.”Member’s explanatory statement
This amendment provides that the appropriate authority’s overarching objective in making regulations under Clause 1 must be safeguarding public health.
Lord Bethell (Con)
My Lords, one of the key qualities of this place is bringing to bear years of expertise in refining legislation. From those involved in life sciences to ex-Health Ministers, we have between us cumulative decades of experience. In moving this amendment, it may be convenient if I speak also to Amendments 6, 8, 9, 11, 29, 30 to 33, 42 to 45 and 47.
I am very grateful to all noble Lords who spoke at Second Reading, who have written, who have met with me and who spoke in Grand Committee on the fundamental points that we are discussing now through Amendment 4: how we ensure that we have the powers needed to make regulatory changes to the bodies of law that govern medicines and medical devices; how we ensure that the changes are swift and safe, and support the continued availability of medicines and devices; how we ensure that essential changes are practicable in a fast-paced environment; and how we provide confidence in the checks and balances built into the framework in which these powers can be exercised.
The amendments that I have tabled are the result of detailed talks. I pay tribute in particular to my noble friend Lord Lansley, the noble and learned Lord, Lord Woolf, and the noble Baroness, Lady Thornton. Their amendments in Grand Committee can be seen as the seeds from which my amendments have grown. I say “my amendments” but I view them as a collective effort—an evolution from our discussions in Grand Committee and refined through cross-party conversation. I will come to and address the noble Baroness’s amendments to my amendments, where I hope I can provide further assurances.
As I have said before, this Bill is a framework Bill. It is so because we must have powers that allow us to work with the comprehensive and established regulatory regimes that already exist. We must also have the means to respond effectively, swiftly and appropriately to questions asked. My noble friend Lord Blencathra and his committee asked us very politely to look again at our drafting, and noble Lords suggested that the Bill needed to move from a skeleton Bill to a true framework Bill.
Amendments 4, 6, 8, 9 and 11 make a number of important changes to the regulation-making powers in Clause 1. They provide for the overarching objective sought by my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf. When exercising the power to make regulations, they are to be made in pursuit of the objective of safeguarding public health. That provides all the benefits that my noble friend set out in Committee—an objective test. I do not propose to dwell long on this, as my noble friend explained it so eloquently when he proposed his own amendment then.
However, the noble Baroness, Lady Thornton, has put forward Amendment 5, which would alter the wording of that overarching objective. This would amend the objective from safeguarding “public health” to safe- guarding
“the health and safety of the public”.
This was, as she knows, the original language of the government amendment in Grand Committee. I expect that the noble Baroness is querying rather than pressing us on this drafting. I say to her that, in the spirit of collegiate drafting, we have adopted the language proposed by my noble friend Lord Lansley. He made a good argument in Committee; we have listened. It was repeated during our conversations outside Committee, and we saw this amendment as a product of the whole House rather than simply the Government. I hope that that answers her questions here.
Turning back to the government amendments, they update the considerations that must be given regard to in pursuit of that objective. Noble Lords did not find the clarification of “attractiveness of the UK” clear enough. A number of alternatives were proposed, setting out the sorts of activities that noble Lords thought were good things to promote. My amendment does away with “attractiveness” and supplies a consolidated list of the sorts of activities that we hope the UK will be seen as a favourable place to undertake. This is absolutely in line with the Government’s intention to support the life sciences sector that we have now and to encourage innovation and interest in the UK as a good place to do business in future.
Among others, my noble friend Lady Cumberlege, the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Thornton, made salient points about the importance of safety. While there has never been any intention that making the UK attractive to the life sciences sector should make patients less safe, we have provided for a clear and unambiguous lock on patient safety—that is, as part of the decision-making process behind regulatory changes, if proposed changes have an impact on the safety of human medicines, the appropriate authority may make those changes only if the benefits outweigh the risks.
This is very clear. There may, as I said earlier during the Bill’s passage, be instances where we do need to make changes that deregulate to ensure the supply of medicines. We have made changes to address the rollout of a vaccination programme; that is absolutely the right thing to do. It requires an assessment of the risks by the experts and requires the benefit—a benefit that the noble Lords who spoke to me at length on this agreed was present—to outweigh the risks. Equally, there is regulatory change that may have no impact at all on safety.
In Amendments 12, 34 and 48, the noble Baroness, Lady Thornton, presses me on the criteria for making this assessment of risks and benefits and on whether the Government will publish that assessment. On the latter point, I can assure her that the amendments made in Committee entirely provide for this. We have already committed to publishing our initial assessment of proposals when we go out to public consultation. That will be the first exposure of our thinking on all aspects, not just risks and benefits. It will be open for persons who respond to that consultation to disagree with us. On the basis of that consultation, we will publish an Explanatory Memorandum when we lay the regulations. There will be ample opportunity to check our homework.
On the criteria, it will not be news to the noble Baroness when I talk of the challenge of specifying a single set of criteria that could apply for the assessment of the risks and benefits of all changes, when regulations may make vastly different changes to the existing regimes. I know that we spoke about these issues with other noble Lords during the discussions preceding Report. I simply do not think that this is necessary or helpful. When the Secretary of State makes amending or supplementary regulatory changes, the Minister will take advice, including from the host of experts inside the MHRA and the VMD, whose day-to-day responsibility it is to protect safety. We have all heard from the excellent Dr June Raine on the importance of safety. It makes sense to take a sensible approach to assessment, particularly in the light of the fact that we will set it out in the ways I have spoken to.
I am very pleased that we have arrived at a formulation that works. It is practicable and good legislation at the same time. Amendments 29 to 33 repeat this set of changes in relation to the regulation-making powers at Clause 9 for veterinary medicines—with an important distinction. The difference relates to how the overarching objective is formulated. This reflects the material differences and choices made for the regulation of veterinary medicines, such as reserving certain medicines for use in humans to avoid further antimicrobial resistance. It is right that we have an objective but that that objective works in this context. It is also right that the same lock on safety is applied.
Amendments 42 to 45 and 47 would apply the same framework to the regulation-making power in Clause 14 in relation to medical devices. When making amending and supplementary changes to the regulation of devices, it provides a separate but similar list of activities that we would wish to be seen as favourable, including the addition of carrying out research on medical devices. In the light of our debate in Committee and the debate we have ahead of us on the importance of medical technologies, this inclusion is absolutely right.
I do not propose to take significant time speaking to Amendments 73 and 94. They both make minor changes, but for an intent with which I do not think any noble Lord would disagree. In the interests of clarity, Amendment 73 would require a consultation on regulations under Clauses 1, 9 or 14 to include a summary of the assessment of the person making the regulations of all matters mentioned in these clauses. Amendment 94 serves to clarify the commencement of the definition of “human medicines provision” at Clause 5.
Baroness Thornton
Member’s explanatory statement
This amendment provides that the appropriate authority’s overarching objective in making regulations under Clause 1 must be safeguarding the health and safety of the public.
Baroness Thornton (Lab)
As I said to the noble Lord and the Bill team yesterday, these are probing amendments and I do not have any intention of pressing them. That is because I accept that the Minister and the Bill team have done a very good job of making this part of the Bill work much better.
It is always worth rehearsing in the Chamber some of the arguments that we have had outside the Chamber, because people often go back to the Hansard record to ask why we changed words from this to this. That is why the noble Baroness, Lady Jolly, and I put down some of these amendments. We have had some extremely useful discussions outside the Chamber, as we should have done, so I hope the noble Lord understands that that is why these amendments are being put today.
Under my Amendment 5, the overarching objective in making regulations under Clause 1 must be safeguarding public health. This is a probing amendment on the difference between “public health” in the government amendment before us today and the “health and safety of the public”, which was the phrase used in the amendment introduced in Committee. It is worth explaining why we accept that that change was sensible.
It is my understanding that “public health” is a broader and more subjective concept that may encompass economic interests, or may relate to increased pharmaceutical investment and innovation, and other factors beyond health and safety, which may conflict with them in some circumstances. Does the Minister agree that we have to explain the less strong commitment that is included in the Bill? Safeguarding public health is also not the same as protecting the safety of medicines and medical devices. It is very important that we are clear about that in the powers given to the Secretary of State in determining what would contribute to safe- guarding public health.
I congratulate the drafters on changing “attractiveness” to “favourability” and “benefits” and “risks” in my Amendments 12, 34 and 48. These amendments seek to probe the criteria that determine whether benefits outweigh risks and require the assessment to be published. The government amendments in this group replace the consideration of UK attractiveness with reference to it being a “favourable” place in which to conduct clinical trials and manufacture and research new medicines, medical products and services. The theme that runs through the whole of this legislation, as has been mentioned by many noble Lords, is that that is the place we want to be in, and the country we want to be, as we move forward.
Proposed new subsection (3A) looks like an attempt to allay concerns, stating that, where regulations impact on safety, they may be made only if the benefits outweigh the risks. It is worth putting on the record the discussion that we had about benefits and risks. Risk and benefit analyses are a well-established feature of clinical trials regulations and ethics committees, but they normally have more well-defined parameters than simply a risk-benefit assessment, yet these are precisely the regulations that these powers will allow to be made. This is why we need to make sure that we are clear what we are talking about here. This comes back to scrutiny and the need for the ability to scrutinise the Government’s assessment of risks and benefits in making regulations. These arguments pertain to Clause 9 for veterinary medicine and Clause 14 for medical devices. That is why we wanted to have this discussion.
Lord Sharkey (LD) [V]
My Lords, I welcome the amendments in this group. They add clarity to the obligations laid on the Secretary of State in making regulations under Clause 1(1) and its counterparts.
I particularly welcome Amendment 12 in the names of the noble Baroness, Lady Thornton, and my noble friend Lady Jolly, as it seems particularly important. It requires the Secretary of State to publish the criteria used in determining the benefits and risks caused by regulation and to set out how they have been weighed against each other. This amendment touches on the whole issue of transparency in devising regulations. The level of transparency that Amendment 12 requires should certainly apply to the factors listed in the Minister’s Amendment 9. These factors, which the Secretary of State must have regard to, are the safety of human medicines, the availability of human medicines and the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to carry out research related to human medicines, conduct clinical trials, or manufacture or supply human medicines. These are all clearly important, and I am glad that the Minister has added manufacturing to this list, as I suggested in Committee.
The list contains three rather vague notions: “likelihood”, “favourable” and “being seen as”. For all these terms, we need to know what definitions will be used and what evidence will be required in support. For “being seen as”, the question arises: being seen as by whom? What weight will be given to different views from different sectors? If, for example, it turns out that academic researchers and pharma companies have different views about the favourability of the UK, how are they to be weighted? On “likelihood”, could the Minister say whether he considered the word “desirability” instead, which seems closer to what we want here?
I hope the Minister is able to give reassurance on the points I have raised and that he accepts the merits of Amendment 12 and its counterparts.
Lord O'Shaughnessy (Con)
My Lords, I will make three quick points about the government amendments in this group, which I broadly welcome. The first relates to Amendments 4 and 42, where the Minister has clearly listened carefully to the forceful arguments made by my noble friend Lord Lansley, the noble and learned Lord, Lord Woolf, the noble Baroness, Lady Jolly, and others in Committee. I am delighted that he has.
For those of us who have not been involved in the discussions, and following on from the points that the noble Baroness, Lady Thornton, made about why language from the European regulation has been adopted—“safeguarding public health”—it would be helpful if my noble friend could explain, on the record, why that language has been chosen. That is particularly the case given that he expressed some reluctance in Committee, bearing in mind that the regulations being referred to also had some relevance to operating the internal market, not simply medicines safety. It would be good to hear from him on that.
Secondly, on Amendments 8 and 44, unlike other noble Lords I did not believe that there was a suspect motivation behind the use of the word “attractive” by my noble friend and the Bill team, or any desire to reduce stringency to attract investment. But I would be grateful if my noble friend could confirm that the Government remain as determined as ever, if not more so, to grow the UK’s life sciences sector, and that it was never their intention to lower regulatory standards to achieve this.
Thirdly, on Amendments 9 and 45, I commend my noble friend on the subtle but important changes already referred to by the noble Lord, Lord Sharkey, in Clauses 1(3)(c) and 14(3)(c), especially the inclusion of manufacturing and broader medical research. The salience of these two parts of our overall supply chain has come to the fore during the pandemic, which has demonstrated our strengths in basic science but, unfortunately, exposed our weaknesses in manufacturing resilience. It seems right that this should be explicitly recognised in the Bill and I commend my noble friend for making those important changes and for demonstrating, once again, his ample appetite for listening and acting.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I will save up some of my time for my next amendment, Amendment 7, so I will be very brief. I will chiefly speak to the non-government amendments in this group. It is encouraging that the Government have taken onboard so many of the contributions from Committee, but that shows what an unbaked condition the Bill came to us in.
To address the somewhat related Amendments 12, 34 and 48, all in the name of the noble Baroness, Lady Thornton, we are talking about publication of the data, information and assessment of benefits versus risks. We heard powerfully from the noble and learned Lord, Lord Judge, and many others in the previous group of amendments how great a concern there is about a lack of scrutiny of this whole procedure in the House. Public scrutiny is surely the best scrutiny of all. I commend all those amendments to the House.
Amendment 5 is very interesting. My innate reflex is to go towards public health as a systems-thinking, sustainable development goal kind of approach to looking at the whole. But to build on the remarks the noble Baroness, Lady Thornton, made in introducing the amendment, which is also back by the noble Baroness, Lady Jolly, when we talk about the immensely financially powerful and often very opaque pharmaceutical industry, with its very large multinational companies, we have to worry about what lawyers call equality of arms and the degree to which economic and financial arguments might be deployed in potentially damaging ways. I am interested in the Minister’s response to Amendment 5, but I can certainly see the strength of the argument of the noble Baroness, Lady Thornton.
Baroness Cumberlege (Con) [V]
My Lords, I will speak to government Amendments 11 and 47, and those that follow on from them, Amendments 12 and 48 from the noble Baroness, Lady Thornton. The first lot refer to medicines and the second to devices. But first I thank the Minister for his strong emphasis on safety in all the amendments. He certainly has listened to noble Lords. In Committee we stressed the objective of making sure that the Bill is a safety Bill. I believe that safety now permeates throughout the Bill, which is so encouraging, and I thank him and his colleagues for that.
Although I welcome the government amendments, I really do not envy a Secretary of State’s task in weighing up the risks versus the benefits. This will require the wisdom of Solomon. At least once the Bill is enacted we will have the data, which is all-important and has just been referred to. Our review’s report shone the light on our frustration of not knowing what was happening to whom, by whom, when and where. This will, of course, become apparent, which will be very useful once we have these processes in place.
But we are still left with weighing up the benefits versus the risks. Surely this depends on where the threshold is set concerning any medicine or medical device. For instance, if 99 people benefit from one of these products but one dies, what weight do we give to the 99—or, perhaps more importantly, to the one who died? Does the Minister see thresholds as important? If so, does he envisage the application of a threshold for an individual medicine or device, or would there be a threshold to cover a similar range of products, or indeed a more overriding policy? I am not quite sure how this will be tackled.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege. She posed a very tough question to the Minister. I could not help reflecting on her report and the issues around surgical mesh, where we clearly had a situation where for some women the surgical mesh operation was successful and seemed to be effective, but for others it had devastating consequences.
The question of a threshold is surely very important. I doubt very much that the medical device regulation we have is up to dealing with it. It would be good to know from the Minister how the Government will take forward discussions in this area, which of course involves ethical as much as safety considerations. Generally, though, I very much welcome the government amendments. I think that my noble friend’s amendments add to the debate.
I have always wanted the UK to be safe in terms of medicine and medical devices and outcomes, but I also want this country to be attractive to pharmaceutical and medical device companies to research, develop and launch their products in the UK. The UK’s record in the current crisis, in the development of both vaccines and treatments, is second to none. I hope that it will be a huge boost to our future attractiveness. But as I have raised on a number of occasions, one of the big problems we have in this country is the general slowness of the NHS to adopt new medicines and new treatments. If we really are to be attractive and have a favourable climate, we have to get around that. We have to be seen, particularly post Brexit, as not only a place that has fantastic scientists and clinicians, and a very good science base—in fact, a brilliant one—but where the NHS is itself innovative, forward thinking and keen to use new medicines and treatments. That is a huge challenge. It would be good to hear the Minister respond and spell out how he thinks we can make this country safe, but attractive too.
Lord Lansley (Con) [V]
My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who again has raised an important issue. The amendment in this group which more broadly encompass all those elements that go to make the United Kingdom a favourable location for research and the manufacture and supply of medicines gives us an opportunity to make sure that we have got that right.
I support the government amendments in this group and add my thanks to those expressed to the Minister and the Bill team for the immensely constructive way in which they responded to the amendments that we brought forward in Committee and in many related discussions. At Second Reading, the noble and learned Lord, Lord Woolf, and I were worried that the Bill was skeletal. We wanted to put a bit of flesh on its bones and make it more of a framework Bill—I think that is a bit of a theme. In the spirit of the remarks of the noble Baroness, Lady Thornton, it might be helpful if I briefly explained what we were trying to achieve, and how these government amendments appear to have responded well to that.
First, even following the initial changes, the structure of the powers was not objective; they were that the relevant Minister was satisfied that the regulations met certain requirements. What we were looking for from the outset was an objective test. My noble friend Lord O’Shaughnessy asked what that objective test was and why we chose to continue with the structure of safeguarding public health? The short answer is that it is because that is the objective in the European Union regulation; it is not an objective in that context which relates to the internal market provisions. To have moved away from the objective of safeguarding public health would run the risk of it being interpreted as somehow different from the past objective on the basis of which decisions had been made and regulations pursued. That seemed entirely appropriate as an encompassing and overarching objective for all these related requirements. I am happy that the Government’s amendment has taken that forward as an objective measure against which the regulations, the use of these powers, can be tested.
Secondly, we wanted to make sure that safety was built into the structure of regulation-making powers. We had an extremely helpful debate about that, and I think that it was clear that, while we wanted to make safety central to what was being achieved, it would not be appropriate to make it an overriding objective. That would have led to the regulator being required effectively to eliminate risk. That brings me to the point made by my noble friend Lady Cumberlege. We then came to the further question of how, if safety is the issue, we then manage the test of whether benefits outweigh risks, sufficiently so for regulations to be proceeded with. The answer is that the objective is not to eliminate risk; it is to eliminate harm. We must make a distinction between those two things.
Making safety the overriding objective would have meant us having to eliminate risk. At the moment, we balance benefits and risks, not benefits and harms. When my noble friend Lady Cumberlege asked her question, I think she was suggesting that we were having to balance benefits and harms, whereas on pretty much every occasion the regulator is asked to undertake an authorisation they have to balance benefits and risks, because we can never eliminate risk. The question is: can we quantify it? That is what the trials and the data are meant to enable us to do—to quantify the benefits and risks. In making an authorisation, can we make sure that we have avoided harm but at the same time realised those benefits?
These amendments get us to that balance. They enable us to give an objective test against which the powers can be measured; they enable us to put safety clearly at the heart of the thinking about how the powers are to be used, and they enable the regulator to undertake that appropriate measurement of benefits and risks. I support the amendments and appreciate the way in which we have arrived at this place by constructive discussion.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I welcome Amendment 5 and others in this group. I echo the noble Baroness, Lady Thornton, in complimenting both the Minister and the Bill team on their expert handling of this part of the Bill.
I find the sentiment behind Amendment 12 attractive and endorse entirely the words of my noble friend Lady Cumberlege and others who have supported her in wanting to avoid “harm”. The idea of a threshold, as solicited in Amendment 12, seems helpful. I have a question for my noble friend the Minister to which I would be grateful for a response. We are told in the explanatory statement that the amendment would require the Secretary of State
“to publish the criteria that will be used by the appropriate authority”—
obviously not yet set up—
“to determine whether the benefits of regulations that may impact on the safety of human medicines outweigh the risk”
and
“to allow for greater transparency and scrutiny.”
My noble friend said that the Government intended to publish the initial assessments. It would be helpful to know when that would be.
There currently seems to be a gap in the law; for example, as regards the vaccinations—I know that this was debated earlier today. The Government have unilaterally extended the time between the first dose and the second dose of Pfizer and AstraZeneca vaccines from three weeks—21 days—to up to 12 weeks. No other European country that I am aware of has done this. It is true that Denmark is looking to extend it to a maximum of between four and six weeks, which is nearer the initial three-week period. I presume that, if what is proposed by Amendment 12 were law, the Government would be obliged to publish the arguments in the interests of transparency, openness and scrutiny as to how they had reached that decision. If that were the case, I would be minded to support Amendment 12.
Otherwise, I welcome Amendments 4 and 5 and others in the group, which look to establish the overarching objective as being public health. I like the formulation of words that the Government have hit on and hope that they will stick with it. I shall be interested to hear how my noble friend responds, but, as I see it, there is some merit in Amendment 12.
Baroness Jolly (LD) [V]
My Lords, this has been a fascinating debate. We all want the UK to be a manufacturing centre for pharmaceuticals and valuable medical devices. The amendments in this group relate largely to the overarching objective of regulations made under the Bill.
It was argued in Committee that the Government needed to be clearer about the intent of the regulations and what the guiding principles would be. I am pleased that they have accepted this, and a number of amendments in this group provide that the appropriate authority’s overarching objective in making regulations must be safeguarding public health.
The noble Baroness, Lady Thornton, and I put down an amendment to change “public health” in the government amendment to
“the health and safety of the public”.
That was not an “angels dancing on the head of a pin” moment. Public health could have a very narrow definition in a health and social care context—we think of local government and Public Health England. However, our wording describes the issue that we are discussing. It is much broader than the “public health” definition, which is too narrow. Health and safety should be at the centre of what is used in treatment. The abuse of this was illustrated by the noble Baroness, Lady Cumberlege, who gave us perfect examples in her report. Mesh is technically a device and sodium valproate was the medicine. They were both abused, and their use was inappropriate. They hurt and damaged a lot of people, predominantly women, for a very long time—some people, for ever.
Now we have a workable framework in which to put both medicines and medical devices in the context of the health of the public, and that is extremely welcome.
Lord Bethell (Con)
My Lords, I completely concur with the noble Baroness, Lady Jolly. This has been a fascinating debate but I will restrict my comments to a few specifics in answering some of the questions raised by noble Lords. I shall start by talking briefly about risks and benefits, which I hope will provide further reassurances to noble Lords regarding their questions on these points.
A regulatory change that, for example, makes changes similar to those made to ensure the smooth vaccination programme for Covid-19, will require different assessment to those that change the medical devices regulatory regime to step up scrutiny of medical devices. The noble Lords, Lord Patel and Lord Kakkar, spent some time in Committee speaking to the importance of medical device regulation, and I agree with them. The amendments that I have tabled are silent on whether the impact on safety must be negative or positive to have the “lock” kick in. It applies to both.
However, it will come down to what the change is in order to determine what constitutes a risk in that scenario versus a benefit. That is obvious in the case of the Covid vaccine rollout. There is greater benefit to a smooth rollout of the vaccine programme than the risk of increasing the number of healthcare professionals who can deliver it. Risks can be mitigated, and they should be. Changes can also be highly technical. They may affect the safety of medicines or medical devices in a minor way but not to the same degree or extent as other changes. It would be impracticable to develop criteria that apply in all circumstances to all regulatory changes.
In response to my noble friend Lord O’Shaughnessy, I should reassure him that it is not our intention to in any way water down or reduce standards in the life sciences area. Instead, it is our intention to use this legislation to champion the UK’s wonderful life sciences sector.
We have often spoken of safety—I thank the noble Baroness, Lady Thornton, for her words on that matter—and of the vital importance of the regulator putting this at the heart of its work. Our regulator is stuffed full of scientists and experts. They are able to support the Secretary of State in making that assessment, based on the evidence. Would this change impact the highly regulated safety considerations, and are they the right ones to make? We need to empower those experts to make those recommendations, in specific circumstances. I hope that noble Lords agree with me that the Bill is better for the changes that we have already sought to make, that the questions behind these further changes are answered, and that we have reached a point of conclusion.
Baroness Thornton (Lab)
That debate was definitely worth having, notwithstanding the fact that the noble Lord, Lord Lansley, explained the process that we had gone through when discussing what to do and how to improve the Bill regarding these aspects. They were important discussions. The noble Lord, Lord O’Shaughnessy, asked pertinent questions that the Minister has answered and are now on the record. I thank the noble Baroness, Lady Jolly, for explaining why we felt that it was important to have this discussion. I also thank other noble Lords for their remarks and the support they have given. I beg leave to withdraw my amendment.
Lord Bethell
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name substituting Clause 1(2).
The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)
We now come to the group consisting of Amendment 7. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this amendment to a Division must make that clear during the debate.
Amendment 7
“(ba) the protection of the environment;”
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I thank the noble Baroness, Lady Jolly, for her support. This is the survivor of a suite of amendments that I moved in Committee. About half an hour ago I tweeted out the Hansard link to that for anyone who is interested, and a link to an article I wrote at that time in the Ecologist. The amendments were all about the environmental impacts of medicines and medical devices, including the impacts of packaging.
Responding for the Government, the noble Baroness, Lady Penn, suggested that the environmental issues of packaging, and the issues around medical devices, would be covered elsewhere, notably in the Environment Bill. She did, however, acknowledge the importance of these issues. Some of those amendments related particularly to anti-microbial resistance, and the noble Baroness, Lady Penn, noted that this
“has been placed on the National Risk Register of Civil Emergencies as a ‘longer term trend’ likely to change the overall risk landscape for the UK over the coming decades.”—[Official Report, 26/10/20; col. GC 62.]
I think that is an acknowledgement by the Government of the importance of these issues around anti-microbial resistance. But we are starting to see much bigger issues: we have heard and seen the Government acknowledge in other contexts the cocktail effects of drugs and chemically active compounds in the natural environment.
I am not convinced by the argument presented by the noble Baroness, Lady Penn, about the other amendments. Since this is Report, I decided to focus on this one single amendment, for which I think the Government have—unintentionally—made their own case very strongly, by ways which I will come to at the end of my comments.
To briefly set out the case for why the Environment Bill and general environmental legislation will not cover medicines, the fact is that human medicines are highly biologically active substances, that are in the human body and pass through it. The medics will tell you that they need to be at still very high concentrations when they pass out of the human body to ensure that they have medical effectiveness. They are also metabolised in the human body in the natural world, in both anaerobic and aerobic environments. It is highly unlikely that normal legislation about waste—normal environmental legislation—will be able to deal with that, let alone its impact on the human microbiomes, and the microbiome all around us.
If we think of bringing this back to the practical: the manufacturer of baked beans might be regulated about the impacts of the tin or the impacts of consumption on human health, but in normal food safety or environmental health impact assessments, the broader impact of that consumption of baked beans is probably not going to be taken into account.
I am aware that your Lordships’ House might find me often citing some fairly technical science, and I am afraid I am going to do it again. Just as one example, I am going to cite a 2018 article from Frontiers in Microbiology. The title of the article is “Antibiotic Effects on Microbial Communities Responsible for Denitrification and N2O Production in Grassland Soils.” Your Lordships’ House might note that I have been spending lots of time at the Oxford Real Farming Conference recently.
To quote from that article, it says that
“the acute effects of tetracycline on soil microbial community composition and production of nitrous oxide … and dinitrogen … as the end-products of denitrification”
are
“an increase in the fungi:bacteria ratio and a significant decrease in the abundance”
of bacteria carrying a certain gene. Those who follow these issues will know that that has significant climate change impacts, but it also has very serious soil impacts.
Before I make my next comments, I should perhaps declare my membership of the APPG on Human Microbiome. The human microbiome that we have on our skin, in our lungs and in our gut also has impacts on the microbiome all around us, and the medicines that we take have an impact on both of those—that is, the microbiome of everything from bees to bats. Perhaps Covid-19 will help us understand the complexity of the systems that we are dealing with.
The fact is that past generations have left us with a poisoned planet. Historically, various diseases were treated were mercury. Many poisons have also been used as medicines, and of course many chemicals were used and are now widespread in the environment and are having enormous impacts. A story came out this morning about the fertility of male porpoises living off the UK being affected by polychlorinated biphenyls—PCBs—which were phased out decades ago but are still having impacts today. We are talking here about systems thinking.
I believe that the Government are, unintentionally, making their own argument for this amendment. I point noble Lords to page 6 of the Bill and Part 2, Chapter 1, covering veterinary medicines. Clause 9(2)(c) refers to
“the protection of the environment.”
Here, we are talking about the authority that makes the regulations on veterinary medicines having to be sure that it promotes the protection of the environment.
On page 1, we find the almost matching subsection under Chapter 1 on human medicines. The first two paragraphs of Clauses 1(3) and 9(3) are the same, then Clause 1(3)(c) goes on to talk about the UK being
“an attractive … place in which to conduct clinical trials or supply human medicines.”
But there is something missing—words about protecting the environment.
Therefore, with this amendment I have chosen simply to take the Government’s own words, as used in the part of the Bill on veterinary medicines, and say that we have to apply the same oversight and approach to human medicines as to veterinary medicines.
I come back, as this debate so often has done, to the brilliant report of the noble Baroness, Lady Cumberlege, First Do No Harm. I would say that the Government have accepted that principle in putting the clause on environmental impacts in the veterinary medicines section of the Bill. I really cannot see how they can justify not doing the same for human medicines.
I have previously called only one vote in your Lordships’ House—on what one might call the “grand matter of principle”, which was about freedom of movement—but at the moment I am feeling very inclined also to call a vote on this amendment. We are in a situation where our planet is at its limits—right at its edge. We are all on the edge: our life is on the edge. We cannot keep saying about the environment, “Oh, we’ll include that in a nice little silo in the Environment Bill.” We have to look at the impacts of everything that we do. The impact of human medicines on the environment is significant, as is the impact of veterinary medicines.
I will listen very carefully to what other speakers and the Minister have to say, and I shall be very interested in hearing the Minister’s explanation for the veterinary medicines and human medicines sections of the Bill being different. However, at the moment, I am certainly inclined to test the opinion of the House on this amendment. I beg to move.
Baroness Masham of Ilton (CB) [V]
My Lords, I thank the noble Baroness, Lady Bennett of Manor Castle, for tabling this very important amendment. For a long time, I have been interested in the growing resistance to antibiotics. The residue of many of them, used for both humans and animals, pass into the environment by different routes. One route is through sewage, which is then processed and goes back into the land where animals graze, and then enters the food chain. Flooding causes contamination and can cause infections through escaping sewage, and this can give rise to environmental and public health matters that need addressing.
Baroness Jolly (LD) [V]
My Lords, this amendment would require the appropriate authority to have regard to the protection of the environment when making regulations about human medicines. We have left the EU and need to be sure that our replacement regulations are fit for purpose. Many of us have spent a lot of time checking that these replacements are in such a fit state; but, while the health and safety of patients remain paramount, it is reasonable and, indeed, important, given the climate crisis, to consider the environmental implications of any policy stemming from these regulations.
The manufacture of human and veterinary medicines, and medical devices, does not happen in an environmental vacuum. Manufacturers have a duty to protect their environment—and manufacturers of medicines will need to be open about how they deal with chemical and other waste. I live in Cornwall where oestrogen has found its way into local rivers, ecosystems and oysters. Wastewater from pharmaceutical manufacturers could also find its way into local waterways. Will the Minister outline how this is dealt with by regulators, and how it is covered by the Bill?
Much waste from pharmaceutical plants is toxic and dealt with appropriately by manufacturers but, in a Brexit world, the regulation regime will have different regulations from the very strict ones that applied when we had to follow EU regulations. We can buy our medicines and medical devices from all over the world; we know that not everyone has the same high environmental standards governing manufacture that we have. What criteria are appropriate in the commissioning and purchasing of medicines from the rest of the world? Can the Minister please outline for us the nature of discussions with regulators about these issues?
Lord Hunt of Kings Heath (Lab) [V]
My Lords, this debate follows a very interesting one in Committee, in which the noble Baroness, Lady Bennett, posed some searching questions about the potential for designing new drugs that are less harmful for the environment, whether in their composition, their impact when they escape into the environment, or in their packaging. Today, she also argues that the expectation of this approach should be built into legislation.
In Committee, the noble Baroness gave some very interesting examples. I was particularly interested to hear that in Sweden—
The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)
We appear to have lost connection with the noble Lord, Lord Hunt. We will give it a few seconds. We have now reconnected but we missed about 30 seconds of his speech; perhaps the noble Lord could take us back about 30 seconds.
Lord Hunt of Kings Heath (Lab) [V]
I thank the noble Lord; that is a temptation to be eagerly accepted. I was referring back to what the noble Baroness, Lady Bennett, said in Committee and the example in Sweden of Stockholm county council, which grades medicines on their environmental effects. Doctors can choose to prescribe a drug that is less harmful in relation to the environment where that option exists.
We have also had the 2014 report by UK Water Industry Research, which found that in most of the 160 sewage treatment works studied, several common drugs were present in the final effluent in concentrations high enough to potentially affect ecosystems. The noble Baroness, Lady Jolly, referred just now to the amount of pharmaceutical effluence entering waterways, and according to a 2018 study by the Delft Institute for Water Education, that could increase by two-thirds before mid-century.
In Committee, my noble friend Lady Wheeler referred to the Environment Agency also having found examples of contaminated hospital waste being illegally exported to developing countries such as Malaysia for disposal. What steps are we taking to prevent the illegal export of such waste and ensure that we dispose of our own waste in this country? There are also concerns about the use of incinerators for hospital waste and the health impacts on those living nearby. We must ask whether the Government are doing enough to ensure that chemists and GPs’ surgeries provide a secure depository for unused medicines, so that they do not contaminate the water supply by being washed down the sink or ending up in landfill.
The noble Baroness, Lady Bennett, said today that the Government’s approach has been to say that legislation is already on the statute book regarding the impact on the environment more broadly, including legislation to address the impact of producing and disposing of manufactured goods such as medical devices. But there is a persuasive argument that we should go further and that it is appropriate that in this Bill on medicines and medical devices there should be a way of ensuring that the environmental impact is not a damaging one. I hope that the Minister can respond with a positive reflection that this is an area that needs further exploration.
Baroness Penn (Con)
My Lords, when considering Amendment 7, tabled by the noble Baroness, Lady Bennett of Manor Castle, I draw the attention of noble Lords to our earlier discussion on the government amendments to this clause, introducing the requirement that safeguarding public health is the overarching objective when making regulations. The clause sets out a number of important factors that the appropriate authority must have regard to, and it is important to note that this is by no means a closed list of factors to be taken into account when making regulatory changes. I recognise that the intention is to put this important issue at the forefront of our minds, and that the factors involved in environmental protection, while broader than the remit of this Bill, may indeed be relevant as something to have regard to—and in those situations, this will happen. Let me explain.
In Committee, the noble Baroness raised important points about tackling the causes of environmental damage and listening to relevant stakeholders. As she knows, the Bill now includes Clause 43, which states that a public consultation must be carried out before regulations are made. This would provide an appropriate platform for relevant stakeholders in the production, distribution and consumption of human medicines, including manufacturers, healthcare practitioners and patients—and the noble Baroness will surely think also of campaigners—to raise their concerns and provide suggestions regarding regulations, which may include factors involving environmental protection. We would all agree that considering the environmental impact of what we do is important, but the power in Clause 1 is restricted to amending and supplementing the law relating to human medicines.
However, as I have reassured the noble Baroness previously, that law does not stand in isolation. The regulations made under this Bill must be considered within the wider context of other existing legislation that makes provision for environmental protection and access to medicines and healthcare services. The collective picture of legislation across the statute book ensures that environmental concerns are taken seriously. It includes provisions around packaging, safe management of medicines waste and medicines disposal. An example is the Environmental Protection Act 1990, which makes provision for the safe management of waste. This Act, which must be complied with by community pharmacies, imposes a duty of care on any person who disposes of controlled waste to take all reasonable steps to ensure that it is not disposed of in a manner likely to cause pollution of the environment or harm to human health.
I also reassure the noble Lord, Lord Hunt, on that point with regard to the management of waste and the noble Baroness, Lady Jolly, on the fact that the Government have made a clear commitment that, post Brexit, our environmental standards will not be reduced. As the noble Baroness, Lady Bennett of Manor Castle, pointed out, the upcoming environment Bill will be a further opportunity to debate many of those matters in detail.
On the question put by the noble Baroness, Lady Bennett, of why the environmental impact of veterinary medicines has been included in the Bill, whereas the environmental impact of human medicines is not specifically provided for, the situation with veterinary medicines is slightly different. The environmental safety aspects of the regulatory framework on veterinary medicines relate to their potential impact on the terrestrial and aquatic ecosystems and their flora and fauna—soil, micro-organisms, fungi, algae, plants, invertebrates, fish, et cetera—so veterinary medicines occupy a slightly different space in our regulatory framework. I also point out to her that animals receiving veterinary medicines form part of the human food supply chain, so that is also taken into account.
I hope that the noble Baroness has heard sufficient from me to be persuaded that, while the issue of environmental protection is of course vital, the law in this area is already well established and, in the light of this, that she will feel able to withdraw her amendment.
Baroness Bennett of Manor Castle (GP) [V]
I thank the Minister for her answer and the noble Baroness, Lady Masham of Ilton, for her support for the amendment and her full reflections on the importance of antimicrobial resistance—something that we will be talking about a great deal in the coming years. The contribution of the noble Baroness, Lady Jolly, was also hugely valuable, in that she complemented by looking at aspects that I had not taken up. She mentioned manufacturing not happening in an environmental vacuum, and in particular the issue of hormones such as oestrogen, and also focused on imported medicines and medical devices and their global impact—something that I talked about in Committee but had not talked about tonight.
I thank the noble Lord, Lord Hunt, for his interest in and attention to what I said in Committee, and for his patience with the technology. I will take what he said as something of an expression of support for the intention behind this amendment.
I have two specific questions to press the Minister on further. She spoke about the processes of overseeing production and distribution, but she did not refer to, and was apparently not thinking about, issues around how research is regulated and how manufacturers are expected to look at the environmental impact of drugs when they are researching and making choices about which drugs to pursue. Secondly, the Minister said on veterinary medicines versus human medicines that it is there for veterinary medicines because of the impact on the terrestrial and aquatic ecosystems, the soils, et cetera. I go back to what the noble Baroness, Lady Masham, said about the impact of sewage. Human waste impacts very much on the ecosystems that the Minister acknowledged that veterinary medicines need to take into account.
Baroness Penn (Con)
On the first point—considering environmental impacts in terms of research—obviously safety is one of the things primarily considered when looking at research on medicines. There is then separate provision in legislation for the safe disposal of any medicines that are not used. So we look at the safety of their use in humans and, through separate legislation, address the safe disposal of any medicines via that route.
That is also relevant to the second point on how human medicines can enter the ecosystem. I will write to the noble Baroness with further detail on that, but veterinary medicines are in a slightly different position, since we look at veterinary medicines for their impacts on animals but also have to think about their wider impact on the environment in terms of their position in the food chain. The safety standards on human medicines are much higher, because we look at their impact on patients taking them directly.
Baroness Bennett of Manor Castle (GP) [V]
I thank the Minister for her answer. I am aware this may not be entirely popular in the House, but I really feel this is an important issue the Government have not got to grips with. I am aware we have a long evening ahead of us, but none the less, I would like to test the opinion of the House.
Baroness Penn
Member’s explanatory statement
This amendment omits the word “attractive” from Clause 1(3)(c).
(i) carry out research relating to human medicines,(ii) conduct clinical trials, or(iii) manufacture or supply human medicines.”Member’s explanatory statement
This amendment clarifies the meaning of Clause 1(3)(c).
The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)
We now come to the group consisting of Amendment 10. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to push this amendment to a Division must make that clear in debate.
Amendment 10
Baroness Sheehan
“(d) the importance of prioritising the protection of human rights including citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966;(e) the public health safeguards within the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights which include but are not limited to the right to grant compulsory licences and the freedom to determine the grounds upon which licences are granted.”
Baroness Sheehan (LD) [V]
My Lords, I rise—metaphorically—to move Amendment 10 in my name and those of the noble Baroness, Lady Bennett of Manor Castle, and the noble Lords, Lord Alton of Liverpool and Lord Crisp. It is a pleasure to have their names on an amendment to ensure that affordable medicines for all must be a consideration when regulations are made with respect to human medicines.
The price of a medicine is often determined not by the cost of production but by artificial and opaque determinants by big pharma. Egregious examples of price gouging abound. With such opportunities for eye-watering profits, the temptation to protect them is great. Big pharma has developed myriad unethical practices to do just that. Many of these were detailed in Committee by a number of noble Lords; I do not propose to repeat them today. However, I do not want to skate over the consequences. People, even those under NHS care, suffer and/or die because of a lack of medicines that are available but not affordable.
Let me give a couple of examples. The row over the cystic fibrosis drug Orkambi went on for three years, with the NHS held to ransom, as the manufacturer Vertex refused to lower the price to an affordable one. A House of Commons debate on Orkambi was finally triggered after an online petition reached more than 100,000 signatures. A threat by the government Minister to invoke a compulsory licence, known in the UK as a Crown use licence, to allow the manufacture of the drug by a third party at a more reasonable price was all it took for Vertex to reduce its price. It is estimated that, in those three years, more than 200 people died here in the UK for lack of a drug that should have been affordable much earlier. Let us just think about that for a moment.
Just last year, we had the unacceptable behaviour of Gilead over remdesivir, then thought to be the only effective drug against Covid-19. At the height of last year’s spike in cases, rationing of the drug had to be put in place in the NHS because the US had bought up all available supplies of the drug. Australia, Canada and Germany have revised their national patent laws to enable them to issue compulsory licences to respond to Covid-19 more effectively. Here, the Commons International Trade Committee made this recommendation:
“The Government should also evaluate the case for enabling compulsory licensing of therapeutic drugs or vaccines in respect of COVID-19 to make them available as quickly, widely and cheaply as possible.”
Can the Government assure us that they will invoke a Crown use licence without hesitation if necessary? I hope that the Minister can give that assurance at the Dispatch Box; we have had some conversations about this. If she does so, there will be no need for me to seek the opinion of the House.
I want to move on to the subject of non-exclusive voluntary licensing. Even though he is not at the Dispatch Box, I thank the noble Lord, Lord Bethell, for his letter in response to the questions asked in Committee. In that letter, he restated the Government’s view that non-exclusive voluntary licensing is providing enough incentives to create new inventions and accelerate the development of health technologies.
However, evidence from European studies shows that over half of newly patented drugs have no added therapeutic value. Have the Government carried out any reviews into whether patents are incentivising research and development into the drugs and health technologies that the public need? For example, are pharmaceutical companies putting resources into the development of vaccines for new virus threats as they emerge, and into vaccines against existing diseases such as TB and HIV? Are they working at full throttle to develop a new generation of antibiotics that will be effective against antimicrobial resistance? I am grateful to the noble Baroness, Lady Bennett of Manor Castle, for bringing this up in her earlier speech this afternoon. However, is it these companies’ job to safeguard public health? Can we rely on them to do it on our behalf? We need a review to know whether they are doing it.
If there are no plans to carry out this useful investigation, will the Minister give an assurance that she will advocate for one? That will go some way to reassuring me and other noble Lords that the Government’s confidence in the existing system of patents to deliver the public health goods to safeguard us all is justified. It will also go some way towards answering those who believe that the current model works only to the advantage of unscrupulous pharmaceutical companies, whose sole raison d’être is to garner extreme profits.
To summarise, my two asks of the Government are, first, whether they will give an undertaking of their willingness to use Crown use licences and, secondly, whether they will meet me and other interested parties to explore terms for a government review into whether big pharma meets public health needs.
I would like to say a few words about the supply of vaccines for Covid-19. In his letter to me and the noble Lord, Lord Alton, the Minister, the noble Lord, Lord Bethell, stated that the Government are exploring the role of the WHO’s COVID-19 Technology Access Pool, or C-TAP, to see whether it can improve access to vaccines. Please can they get a move on? Events of the past several weeks have shown us with pinpoint clarity that we are in a race against time, as new and more transmissible variants emerge.
The fact is that UK support for the Medicines Patent Pool and the eventual agreement of pharmaceutical companies to share their patents on antiretroviral drugs made the production of more affordable drugs possible. This transformed the HIV response; we need to do the same again now. We need the UK Government to support the C-TAP and get companies to share their technologies, otherwise the situation we have with shortages of vaccines in the UK will continue—not just here but everywhere, to the detriment of us all. If, however, companies refuse to share their vaccines, medicines and tests then the UK Government, and all Governments, must use their legal rights to implement the public health safeguards within the TRIPS Agreement. At the very least, that means invoking compulsory licences.
If the Government are serious about getting this vaccine to everyone in the UK and the rest of the world, they must also support the TRIPS waiver so that unhelpful intellectual property protections on Covid-19 tools can be removed. The TRIPS waiver is a proposal put recently to the WTO TRIPS council by South Africa and India, meaning that certain parts of the TRIPS Agreement should be waived for the duration of the pandemic to help us all combat its effects, because this would allow countries to collaborate in the research and manufacture of vaccines, medicines and tests to meet global demand.
With almost 2 million lives lost due to Covid-19, this is no time for restrictions in manufacturing capacity in the name of pharma profiteering. We know the power of the pharmaceutical lobby, and the influence it can bring to bear, but in this crisis human rights must take priority over intellectual property rights.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, it is a great pleasure to follow the noble Baroness, Lady Sheehan, and to join the noble Lords, Lord Alton of Liverpool and Lord Crisp, in backing her important amendment. The introduction the noble Baroness provided was powerful and comprehensive, so I will not speak at length. I endorse the two asks she put to the Minister; it is important that we hear very clear, direct answers to them.
As the noble Baroness powerfully put it, there is a contest between public need and private profit, and we know that the reality of how our current system works is that private profit comes first. That means that human rights and public health trail behind. We know that so much of our healthcare system has been dragged in the direction of the disastrous US model, the most extreme example on the planet of a private, profit-driven healthcare system that has disastrous outcomes for massive costs. We also know that there are healthcare systems around the world that spend even less than we do but have a very fair and reasonable distribution of resources and money.
We often talk about these issues in moral terms; we must make sure that everyone has these medicines, and I endorse that moral approach, but in the context of the Covid-19 pandemic, nationally and globally, we must come back to the phrase, “No one is safe until everyone is safe.” It is in everyone’s interest that everybody in the UK and around the world has access to the best possible medicines and medical devices and that the research effort and all that wonderful power of human ingenuity are put into the best possible causes and results for public health, for the good of us all.
Lord Alton of Liverpool (CB) [V]
My Lords, I spoke at some length on this issue in Committee and am delighted that the noble Baroness, Lady Sheehan, has given us the opportunity to explore it again. She has done so with her usual thoroughness and thought. I am also pleased to follow the noble Baroness, Lady Bennett, who spoke so well. The noble Lord, Lord Bethell, has exchanged letters, as the noble Baroness, Lady Sheehan, referred to; that has been extremely helpful, as she intimated, and I think will avoid the need for a Division, but it is right we explore this issue thoroughly.
I will not repeat all the detailed arguments made in Committee, but, in headline terms, Amendment 10 is being considered in the context of exclusive intellectual property rights which can in some circumstances create monopolies, leading to high prices and supply issues for medicines and medical devices. We are seeing those issues come to the fore in the Covid-19 response.
In an Oral Question that I asked on the Floor of your Lordships’ House on 30 November to the Trade Minister, the noble Lord, Lord Grimstone, I argued that in the context of hundreds of millions of Covid vaccines being held in the United Kingdom and the significant sums of public money invested in developing new drugs and treatments, notwithstanding the need to generate funds to enable future research and development, when companies such as Gilead repurpose drugs such as remdesivir and charge $2,340 for a Covid treatment that Liverpool University estimates can be done for $9, the Government should invoke their powers in such circumstances to use Crown licences to prevent patent monopolies impeding access to medicine, to ensure equitable access, prevent exploitative profiteering and recognise that affordable drugs and their fair distribution are a public good that this country should be at the forefront in providing.
Baroness Walmsley (LD) [V]
My Lords, I support this amendment. When we discussed this issue in Committee, I raised the matter of Section 57A of the Patents Act 1977 and the Minister pointed out that compensation needs to be awarded to a patent holder for any loss of profits as a result of the use of a Crown use licence and argued that this should be set against the potential savings that purchasing more affordable generic alternatives enabled by a Crown use licence could bring about. Tonight, I repeat that this has never been tested in court.
The noble Baroness, Lady Sheehan, and the noble Lord, Lord Alton, mentioned Orkambi. The fact is that if the Government had issued a Crown licence and Vertex had decided to take the Government to court for compensation, the Government would probably have won the case, because they had a very strong case. Any reasonable person would have concluded that three years of failed negotiations showed that Vertex could not make the case that the NHS would definitely have bought the product from them had a Crown use licence not been issued. Had they taken the thing to court, the Government would probably have won the case, and the fact that they did not means that they really missed an opportunity to set a useful new precedent by fighting an interpretation that would render the entire Crown use provision next to useless.
I shall add just a few words about the Covid-19 pandemic. Many countries, such as Germany, Hungary, Canada and Australia, have made alterations to their patent laws to make issuing a compulsory licence easier, in the interests of public health. That is because, in those countries, it is accepted as a valuable tool that can help overcome pricing and manufacturing barriers to accessing crucial vaccines, medicines and diagnostics which could help save millions of lives. Will the UK Government follow this example, set a precedent, next time the opportunity presents itself, and make the necessary changes to our law to make it easier, not more complex, to use our legal right of issuing a Crown use licence to protect public health?
Lord Crisp (CB) [V]
My Lords, I am very pleased to add my name to the amendment in the name of the noble Baroness, Lady Sheehan. I shall be brief and limit myself to one central point, because the arguments have been put so well by noble Lords who have already spoken. At its heart, this amendment is about achieving the right balance between the public interest and private interests. In this particular context, it is clear to me that the Government should commit themselves clearly to safeguarding the public interest and to taking action on—let me stress this—those rare occasions when it will be necessary.
This is particularly vital, as other noble Lords have said today and on earlier occasions, because, sadly, there is a history of price gouging and exploitation of the public. There has also been lack of transparency and, of course, one should also note that the development of many treatments and vaccines have benefitted from public investment. I hope the Minister will be able to make the commitments that the noble Baroness, Lady Sheehan, has requested.
Baroness Jolly (LD) [V]
My Lords, the purpose of this amendment, tabled by my noble friend Lady Sheehan, with cross-party support, is to ensure that fair and affordable access to medicines for all must be a consideration when regulations are made with respect to human medicines. This is key for two reasons. The first is to ensure that medicines, including on the NHS, are available at a fair price. We know that the NHS buys medicines at an industrial scale and is very able to be tough in its bargaining to get a good deal for the taxpayer. The second is that the British Government used to play a pivotal role, through DfID, in helping many across the world in the eradication of polio and other life-changing or life-threatening diseases. Will the Minister outline what criteria are used now that DfID has been subsumed by FCDO?
On Covid-19, collaboration on the production of vaccines is critical. What is being done by the Government to collaborate in this life-saving mission? Time is of the essence. Can the Minister tell us where we are now and outline what support is going to those who have neither the contacts nor the money to fund these vaccinations? Our economy has taken a serious hit, but we have a moral duty to support those with no industry, and so no income. I endorse all the comments from the noble Lord, Lord Crisp, who has many years’ experience of these issues—many more than I have. I would be grateful if the Minister could answer my questions.
Baroness Wheeler (Lab)
My Lords, I too congratulate the noble Baroness, Lady Sheehan, on another important speech on this key issue and the dogged way she has pursued her arguments and key questions to the Minister. I thank her for sharing her response letter of 7 January to the Minister, which clearly sets out the issues she is still pressing the Minister to address, and I am looking forward to the response from the noble Baroness, Lady Penn, on these matters. I also welcome the very expert and thoughtful contributions from other noble Lords both today and in Committee on this issue, drawing on their extensive professional and international experience and knowledge.
As my noble friend Lady Thornton made clear in Committee, we support this amendment. The reassurance from the Minister during Committee about the Government’s commitment to collaborating with public and private partners in the UK and globally to promote affordable access to vaccines and medicines for all is welcome. Also, we are grateful for their continued commitment to the UK’s obligations on the WHO TRIPS agreement and the DOHA declaration, which provide important flexibilities that support access to medicines and are especially vital during public health emergencies such as the Covid-19 pandemic that is so engulfing us today.
Noble Lords are right to underline the deep concerns of patient groups on the issue of fair and free access to medicines. I remind the House that the Royal College of Physicians, the Faculty of Pharmaceutical Medicine, the British Association of Dermatologists and other key stakeholders have called for a review of the processes for issuing sole manufacturing licences and consideration of the use of price control mechanisms in relation to costs of production to increase access to medicines at fair prices. The Government’s assertion that non-exclusive voluntary licensing provides incentives for developing new medicines and health technologies is not borne out by recent evidence on newly patented drugs, as the noble Baroness, Lady Sheehan, has pointed out.
On vaccines, and our participation as a country in the global sharing and effort, access to the Covid-19 tools accelerator COVAX advance market commitment needs continuing support from the UK and wealthier nations. The promise was for matched funding if the £1 billion target was reached by the end of last year. Can the Minister update the House on this, and what will be the UK’s contribution? Is there any further information on the role the UK will play in the WHO’s proposed Technology Access Pool, C-TAP?
Finally, on funding of research and development, a number of noble Lords raised the issue of the absence of analysis of, and data on, how much public and private money goes into the development of new vaccines and medicines. The Minister referred to the VPAS voluntary pricing scheme negotiated with the industry, which runs alongside the statutory pricing scheme, the NICE appraisal process and the commercial NHSI arrangements. The scheme is designed to support patient access to innovative medicines and expires next year, so these coming months will provide a crucial opportunity to commence a detailed review on how the research and development of medicines are actually funded. This would not only strengthen the Government’s negotiating position but lead to greater transparency in the UK’s future relationship with the pharmaceutical industry, which we all want to see.
Baroness Penn (Con)
My Lords, first, I would like to address the issue of patient and clinician access to affordable medicines in the UK. Patient and clinician access to affordable medicines is at the core of the NHS and this country’s healthcare policy. This Bill will not diminish that. Indeed, a safe and innovative regulatory regime for medicines and devices will support that outcome, although patient access is not dealt with directly in this Bill. The Government have recourse to a number of mechanisms to ensure that patient and clinician access to affordable medicines is upheld. For example, the price of branded medicines is controlled by the 2019 voluntary scheme for branded medicines pricing and access. The National Institute for Health and Care Excellence also continues to ensure cost-effectiveness for medicines purchased by the NHS.
As the noble Baroness, Lady Sheehan, has noted, in line with the flexibilities in the TRIPS agreement, the Government also retain the right to order Crown use of patented medicines under Section 55(1)(a) of the Patents Act, where collaborative approaches are not successful or we determine that it is in the public interest. I should emphasise that this would be used only in very narrow circumstances, such as an emergency. The UK has an internationally renowned IP system, which cultivates an innovative pharmaceutical sector, attracts generics manufacturers, and ensures that the NHS has access to the most cost-effective options. We will continue to work with these stakeholders to provide cost-effective access to Covid-19 therapies and vaccines, in the UK and globally, on a voluntary basis.
Baroness Sheehan (LD) [V]
My Lords, this has been a stimulating debate and I sincerely thank all noble Lords and noble Baronesses who have taken part. That very much includes the Minister, who responded with her customary courtesy and thoughtfulness.
I thank the noble Baroness, Lady Bennett of Manor Castle. As ever, she brought up the issue of human rights and how they must not be trumped by intellectual property rights—sentiments I agree with 100%.
I thank the noble Lords, Lord Alton of Liverpool and Lord Crisp, who raised a question central to the whole issue of intellectual property rights: who actually pays for the investment in drug development? This is shrouded in secrecy and we must try to shed some light on it. I hope that we can explore that in discussion when we have the meeting the Minister has very kindly agreed to. Drug development is done not just by private companies; taxpayer-funded research and R&D institutions play a huge part, as do philanthropic organisations and NGOs.
I am very grateful to my noble friend Lady Walmsley for raising Section 57A, which the noble Lord, Lord Bethell, brought up as a defence against using compulsory licensing. It is a moot point, as my noble friend said. I think that the argument the Government used would in fact nullify the whole concept of Crown use.
I thank my noble friend Lady Jolly for the focus she placed on the major challenges developing countries face, even more so now that DfID no longer exists and 0.7% has been reduced to 0.5%.
I thank the noble Baroness, Lady Wheeler, for her words. She was absolutely right to draw attention to the collated briefing of the Royal College of Physicians and its partners in highlighting prices in the NHS for both generic medicines and those that enjoy patent rights.
I thank the Minister, and I will take her up on her offer of a meeting in due course. I beg leave to withdraw the amendment.
Baroness Penn
“(3A) Where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”Member’s explanatory statement
This amendment provides that the appropriate authority may make regulations that may have an impact on the safety of human medicines only if the authority considers that the benefits of doing so outweigh the risks.
The Deputy Speaker (Lord Bates) (Con)
We now come to the group consisting of Amendment 13. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press the amendment to a Division must make it clear in the course of the debate.
Clause 2: Manufacture, marketing and supply
Amendment 13
Lord Hunt of Kings Heath
(o) the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in relation to human medicines.”Member’s explanatory statement
This amendment would enable regulations under Clause 1(1) to make provision about the use of human tissues or cells in relation to human medicines.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I am delighted to move my amendment, which follows constructive and very helpful discussions with the Government. I am particularly grateful to the noble Lords, Lord Bethell and Lord Ahmad, the noble Baroness, Lady Penn, and their officials for their help, and to my fellow sponsors, the noble Baronesses, Lady Finlay and Lady Northover, and the noble Lords, Lord Ribeiro and Lord Alton, for the huge support they have given. I should also mention the enormous help I have had from Victoria Ledwidge of the end transplant abuse in China campaign.
The world is increasingly aware of China’s forced organ harvesting from prisoners of conscience. This horrific crime of forcibly removing the organs from living victims—a process leading to inevitable murder— has recently been found by the China Tribunal to be happening extensively.
Millions of Chinese citizens are currently detained in labour camps. UN experts estimate that at least 1 million Uighurs are being held in camps in the region of Xinjiang. Elsewhere throughout China, other ethnic and religious minorities are also being held in labour camps, such as Tibetan Buddhists, Falun Gong practitioners and Christians. This modern-day slavery has been entering the UK supply chain, and there is no doubt that we are currently complicit. I must say that I welcomed the Statement made today by the Foreign Secretary.
Last year, the China Tribunal concluded:
“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one – and probably the main – source of organ supply”
and that:
“In regard to the Uyghurs the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”
I hope the Government will seek to put pressure on the World Health Organization to take this seriously.
Domestically, the Bill provides an opportunity to prevent British complicity in such crimes and to send an important message to other countries. My amendment is designed to deal with gaps in current UK human tissue legislation. Currently, the Human Tissue Act does not require appropriate consent for imported human tissue. In addition, imported human tissue for use in medical research does not require traceability. Currently, neither the Human Tissue (Quality and Safety for Human Application) Regulations nor the Human Tissue Act require appropriate consent for imported human tissues for use in medicines. My amendment gives powers to Ministers to put this right. I should explain that the words “tissues” and “cells” are terminology which encompass all the human material that is used for the purposes of medicines. This includes organs.
The amendment would not include the prohibition of the dreadful travelling circus of Real Bodies exhibitions, nor would it include medical equipment manufactured and exported from the UK for the purpose of extracting or preserving human organs if exported to China. The noble Lord, Lord Alton, will come back to that point, and I know he has had some very helpful discussions with the noble Baroness, Lady Penn.
None the less, the passing of my amendment would be a significant action. By giving Ministers the power to make regulations, this is a specific act by the UK in relation to the abhorrent practices in China that I have spoken of. Of course, we need to see those regulations introduced and passed through Parliament. But, internationally, the UK’s action will be seen as a marker and a real signal to other countries.
Baroness Finlay of Llandaff (CB) [V]
My Lords, it is a great pleasure to follow the noble Lord, Lord Hunt of Kings Heath, on this very important amendment. It is an example of how, with high moral standards, the Ministers involved have been listening. With others, I wish to sincerely thank the noble Lords, Lord Bethell and Lord Ahmad of Wimbledon, and the noble Baroness, Lady Penn, who have listened to very difficult information and accepted the important responsibility we have on the world stage.
Baroness Northover (LD) [V]
My Lords, praise will be ringing in Ministers’ ears from the first group of amendments, concerning the patient commissioner, in the name of the noble Baroness, Lady Cumberlege. There is praise again for listening on this issue.
The noble Baroness, Lady Penn, had the task, in the first instance, of rebutting the original amendment. I, for one, asked her to read the China Tribunal report to get a strong sense of the horrendous problem that was part of the context for this amendment. You could see that she was listening, and subsequent engagement has been very useful, as the noble Baroness, Lady Finlay and the noble Lord, Lord Hunt, have said. I am glad that the ministerial team has responded. It comes on the day that the Foreign Secretary has made a Statement in the Commons that focuses on human violations against the Uighurs.
I pay tribute to the noble Lord, Lord Hunt, for consistently, and with great political skill, taking forward this issue, as he has done on the scandal of the “Real Bodies” exhibitions. I also pay tribute to the others who have worked in this area, including the noble Baroness, Lady Finlay, and the noble Lords, Lord Ribeiro and Lord Alton. This is a terrible problem and one that it would be easy to turn away from, but those noble Lords simply do not do so.
We need to make further progress across this area, and I am sure this will be taken forward. Forced organ harvesting, which according to the China Tribunal has happened on a mass scale in China, is a horrific crime. Organs are removed from living victims by doctors in state-run hospitals for transplantation, inevitably killing the victim in the process.
As the noble Lord, Lord Hunt, said, the China Tribunal concluded that many victims were Falun Gong practitioners. A brutal and systematic crackdown on Falun Gong was initiated in 1999, with the Chinese leadership ordering their eradication. Many disappeared without trace, which was when China’s organ transplant trade rapidly increased. As we now recognise, in recent years there has been a similar crackdown on the ethnic-minority Uighurs. They have been put into re-education camps and have endured forced labour, brainwashing, rape and torture. The China Tribunal stated:
“In regard to the Uyghurs, the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”
Our amendment aims to ensure that no human tissue or cells that have been sourced from victims of organ harvesting can be used in human medicines or enter the UK medical supply chain. This is the first time the United Kingdom Government will enact legislation in this area, and we must hope that it sends a strong and clear message internationally. Thus far, as the noble Lord, Lord Hunt, said, it is enabling, but the Government will know that many will be monitoring this area. We need to see those regulations in place.
I note the weakness of the HTA assessment of the “Real Bodies” exhibition, on which I am sure the noble Lord, Lord Alton, will expand, and its acceptance of what it was told, seemingly at face value. The noble Baroness, Lady Finlay, also, rightly, pointed to this. The amendment that we are agreeing today will help move things forward. I am grateful to the Government and their lawyers for working on this, although, clearly, we will all need to be vigilant and there is still much to do.
Lord Ribeiro (Con) [V]
My Lords, like the noble Lords who have spoken before me, I thank the Minister and the Government for accepting our amendment. I believe it sends a powerful message, not only to China but to other countries such as Pakistan and India, to which I referred in my speech of 28 October in Committee. In discussion with the Foreign Office, through the noble Lord, Lord Ahmad, we were reassured that the diplomatic strategy would be to continue lobbying as many countries as possible on the issue of human rights and the immoral practice of forced organ harvesting. With the noble Baroness, Lady Finlay, we undertook to raise awareness with the British Medical Association and the surgical royal colleges.
It is worth noting the World Health Organization’s Guiding Principles on Human Cell, Tissue and Organ Transplantation. Any programme such as the kidney pairing exchange, which makes it possible to utilise kidneys that are biologically incompatible between patients and their genetically or emotionally related donors, must follow and respect the WHO’s Guiding Principles of practice, particularly principles 3 and 5, which are worth quoting.
Principle 3 says:
“Live donations are acceptable when the donor’s informed and voluntary consent is obtained, when professional care of donors is ensured and follow-up is well organized, and when selection criteria for donors are scrupulously applied and monitored. Live donors should be informed of the probable risks, benefits and consequences of donation in a complete and understandable fashion; they should be legally competent and capable of weighing the information; and they should be acting willingly, free of any undue influence or coercion.”
Principle 5 states:
“Cells, tissues and organs should only be donated freely, without any monetary payment or other reward of monetary value. Purchasing, or offering to purchase, cells, tissues or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned.”
In 2017, the World Health Assembly supported a concept of financial neutrality to protect vulnerable people from being exploited. That is the essence of what this amendment achieves, and I am grateful to the Government and to the noble Lord, Lord Bethell, and the noble Baroness, Lady Penn, for endorsing it. I hope that they will maintain their pressure on the WHO to end these practices.
Lord Alton of Liverpool (CB) [V]
My Lords, I start, as others have done, by thanking the noble Baroness, Lady Penn, and the noble Lord, Lord Bethell, for the way in which they have engaged with noble Lords such as the noble Lord, Lord Hunt, who has put so much work into this—along with the noble Baronesses, Lady Finlay and Lady Northover, and the noble Lord, Lord Ribeiro—in trying to draw our attention to the enormity of the depredations that have occurred in China through forced organ harvesting. It is very productive that, this evening, the Government have been able to come forward with an amendment that has been agreed with the sponsors of the Committee amendment, having listened to the argument. I am especially grateful, as others have been, to the noble Baroness, Lady Penn, for the way in which she has engaged.
I will come back in a few moments, if I may, to two other issues that I have raised with her but which are not included in this amendment. They concern consent and the equipment that could be used in the extraction, freezing and harvesting of organs in China, and the question of whether, if British companies were involved in the production of such equipment, there is anything that we could do to forestall that.
On consent, the noble Baroness, Lady Northover, mentioned that, thanks to the noble Baroness, Lady Penn, we have now seen the reports of the Human Tissue Authority of 2018 following its visit to the National Exhibition Centre in Birmingham to examine the plastinated bodies that had been taken there. These were corpses that had been put on public display—what the noble Lord, Lord Hunt, referred to as part of a sort of travelling circus. A second exhibition was held later in the year.
It was extraordinarily naïve—at best—that no more probing was done into the origins of those bodies or how consent could possibly have been given from unknown, anonymised sources. Of course, it leaves the question hanging in the air of whether these were people who had been executed—they probably had been. Sadly, we know that that is the fate of many people, whether they are Falun Gong practitioners or people from different denominational minorities or faith communities, including the Uighurs. We have heard much already this evening, as well as in the Statement from the Foreign Secretary, Dominic Raab, in the House of Commons this afternoon, about the plight of 1 million people who have been incarcerated because they will not conform to the diktats of the Chinese Communist Party.
It is extraordinary that such things can happen in the 21st century, but they are happening. That is why we have to be vigilant and do what we can to prevent the exploitation of people who are caught up in these circumstances. I think particularly this evening of a young woman called Zhang Zhan, who was arrested as a citizen journalist. She is a lawyer by background and had gone to Wuhan to investigate the origins of the coronavirus. She has been languishing in a jail ever since, for some of the time on hunger strike. We know that many dissidents—people who have spoken out against the regime—including lawyers, have been arrested, and some have disappeared, never to be seen again.
Therefore, it is crucial that we discover the origins of the bodies that are used in these sorts of exhibitions and displays, which I personally believe should be prohibited in their entirety. The idea that they can be paraded for macabre purposes should fill people with a sense of disgust. The anonymity of the cadavers should have made the Human Tissue Authority see that this was an issue that it should not just have turned a blind eye to. It is not good enough simply to say that we have a strong regulatory authority. We do: we have strong regulations, many of which came out following the scandal at Alder Hey in Liverpool. However, since then, we have failed to plug the loophole that I and others identified in 2018. We used that phrase—a loophole—in a letter to the Times, but it also appeared in an article in the Lancet. There was a loophole that needed to be filled when it came to organs and tissues from outside the United Kingdom.
The amendment goes some way to addressing that but I think that there also needs to be further regulation on the issue of consent. I also feel—and I would like to press the Minister on this—that we must do more about the export of equipment from the United Kingdom that could be used in forced organ harvesting. Maybe this could be done through export licence control. I noticed in the Statement to the House of Commons this afternoon and in the letter that has been circulated to Peers this evening by the right honourable Dominic Raab, the Foreign Secretary, that he talks about there being a review of export controls as they apply to the situation in Xinjiang. He says that these measures are among the most stringent being implemented globally to help ensure that supply chains are free from forced labour.
That is welcome, but how ironic it would be if, in stopping coming into this country things that have been manufactured by slave labour in Xinjiang, we permitted the export of things to Xinjiang and elsewhere in China that were being used in the extraction, freezing and transportation of body parts in order to enable China to promote one of the biggest organ industries in the world. The noble Baroness, Lady Finlay, was right to say that we also need to do far more about the phenomenon of people travelling to other parts of the world to take organs from others. That kind of organ tourism is something that the British Government need to do more about.
That is all that I want to say. I look forward to hearing the reply from the noble Baroness, Lady Penn.
Baroness Jolly (LD) [V]
My Lords, this has been a detailed, depressing debate and I feel completely powerless. I pay tribute to the noble Lord, Lord Hunt of Kings Heath, for his phenomenal tenacity on this and to the noble Lord, Lord Alton, for his tireless work. I am sure others do just as much and I do not know about it.
Amendment 13, led by the noble Lord, Lord Hunt, and signed by my noble friend Lady Northover and the Minister, would enable regulations under Clause 1(1) to make provision about the use of human tissues or cells in relation to human medicines. The amendment pushes the Government to respond to the horrifying practice of forced organ harvesting that evidence suggests is taking place in China. The account of organ banks by the noble Baroness, Lady Finlay of Llandaff, was chilling. Liberal Democrats, among others, have been vocal about the appalling human rights violations faced by the Uighurs. The amendment would be an important step in the right direction, and we urge the Government to do all they can to put an end to this practice.
It is most unusual for a Minister on a Bill to be included as a signatory to an amendment. It should send a real signal that our Government do not support this appalling treatment of minorities, and I commend him on this stance. I would be grateful if the Minister, in summing up, could tell us whether there is anything we could practically do on this matter.
Lord Collins of Highbury (Lab)
My Lords, I too thank all noble Lords who put their names to this amendment. It truly reflects the cross-party concern on this issue. I pay particular thanks to my noble friend Lord Hunt and the noble Lord, Lord Alton, who have been absolutely persistent in raising this at every level. We have debated this not only on this Bill but in other debates in this House.
I thank the noble Lord the Minister and particularly the noble Baroness, Lady Penn, for the regular meetings she has had with noble Lords to listen to our concerns. The fact that they have both listened and acted is a reflection of the good work this House can do in not acting in a partisan way. We have put the issue first and delivered on it. I am also grateful to the noble Baroness for the way she has gone to the limit of this Bill’s scope. I recognise that the Bill’s scope has placed limitations on us, but it does not stop us speaking about and delivering on the political issue that my noble friend and the noble Lord, Lord Alton, have raised. I am particularly pleased to thank everyone concerned.
I will pick up a couple of points. One of the big political issues that started my noble friend’s concern was the exhibitions we saw. The idea that consent could be given by dead or dying prisoners in China is absolutely ridiculous. We should never accept it and should continue to ensure that we strengthen regulation in that regard. It will be ongoing work.
I also pick up a point that both my noble friend Lord Hunt and the noble Lord, Lord Alton, raised in Committee; in fact, we raised it at Second Reading. We named two companies involved in supplying organ-preserving devices to mainland China. This could explain how organs are being transported around China, supporting this obnoxious practice of harvesting organs.
I was pleased to read the statement made by Dominic Raab in his announcement that the Government will conduct an urgent review of export controls, specifically as they apply to the situation in the Xinjiang Province, to, as he said,
“make sure that we are doing everything that we can to prevent the export of any goods that could directly or indirectly contribute to human rights violations in that region.”
We have heard in our debates in this House that that is potentially going on, and I hope that the Minister will be able to respond that she will work with both the FCDO and the International Trade Department to ensure that the concerns raised today will be reflected the review that Dominic Raab has promised. I hope she will take that up and, as raised by both the noble Baroness, Lady Northover and my noble friend Lord Hunt, the China tribunal’s conclusions about the nature of the practice that has been going on and the fact that the Uighurs and Falun Gong practitioners are its main victims.
As we have said in many debates, the Communist Party of China and the Government of the People’s Republic have denied all claims about this, despite the evidence of the tribunal, and have relied on the WHO clearing them of wrongdoing. Of course, we know that that is because the WHO does not have an independent expert compliance assessment mechanism: it relies on the Government of China and the Chinese Communist Party simply saying that it does not happen. I know that the noble Lord, Lord Ahmad, has been consistent and persistent in raising this issue and it has been raised with the WHO, but I hope the Minister will be able to respond today that we will continue to raise it through the organ of the WHO.
In conclusion, I repeat what has been said by all noble Lords. The importance of this amendment is not simply the specific points of law that it will address. The most important thing the amendment and this debate tonight does is send a very clear message that we will not tolerate such appalling acts against humanity and will deliver for the people of China, not for the Communist Party of China.
Baroness Penn (Con)
My Lords, I begin by thanking all noble Lords for their valuable and ongoing engagement on the matters raised by Amendment 13. Throughout the Bill’s passage, we have heard numerous passionate and heartfelt speeches on the allegations of organ harvesting in China and how the UK seeks to guard against complicity in any such practices. Anyone listening to speeches made by noble Lords in Grand Committee or this debate cannot have failed to understand the considerable strength of feeling behind those concerns. My noble friend Lord Bethell and I have greatly welcomed the thoughtful and constructive discussions on these issues.
Earlier today, the Foreign Secretary made an announcement setting out an ambitious package of measures that will help to ensure that no British organisations, whether public or private, are contributing inadvertently to human rights violations in Xinjiang. This demonstrates that we will not stand by as violations there continue. We will never hesitate to stand up for human rights as a force for good in the world.
The Government’s position is clear: if true, the practice of systemic, state-sponsored organ harvesting would constitute a serious violation of human rights. The China Tribunal report has been carefully considered by the FCDO and adds to a growing body of evidence about the disturbing situation that Falun Gong practitioners, Uighurs and other minorities face in China.
Given the considerable interest in these and related concerns over human rights violations in China, my noble friend Lord Ahmad, Minister for South Asia and the Commonwealth, has met repeatedly a number of noble Lords with particular interest in these matters over recent months. I trust that these discussions have provided some assurance of the Government’s absolute commitment to strong UK action. The Minister, is, I know, committed to ongoing engagement in coming weeks.
During Grand Committee, the noble Lords, Lord Hunt and Lord Alton, made clear their view that the WHO should be further engaged to take more robust action and to provide greater transparency on organ transplant practices in China. I am pleased to tell noble Lords that continued efforts by FCDO Ministers to engage the WHO on these matters have led to a valuable meeting between senior officials at the UK Mission in Geneva and Jane Ellison, executive director for external relations at the WHO. These discussions have opened up dialogue with key international partners on organ harvesting allegations, which we are committed to continuing.
Crucially, noble Lords may know that my noble friend Lord Ahmad has committed to meeting Sir Geoffrey Nice QC in the coming months to discuss further the findings of his report. The FCDO is, I know, absolutely committed to considering carefully all and any evidence presented on allegations of organ harvesting in China. I want to take the opportunity on behalf of the Minister for South Asia and the Commonwealth to thank my noble friend Lord Ribeiro and the noble Baroness, Lady Northover, for their role in engaging international medical organisations on these matters.
I now turn to the specifics of the amendment tabled in the name of the noble Lord, Lord Hunt, to which I am pleased that my noble friend Lord Bethell has put his name. The amendment provides absolute clarity that the powers in Clause 2 of the Bill can be used to make regulatory changes about the use of human tissues or cells in legislation relating to human medicines.
While it is important to be absolutely clear that the use of imported tissue in any medicines on the UK market is extremely limited—there is only one licensed medicinal product in the UK that uses donor-derived tissues, and that tissue is sourced from within the EU—we are all in agreement that we would not want the UK medicines industry compromised by the use of human tissue or cells sourced through human rights violations. The amendment will ensure that we have the power to take action to amend or supplement provisions governing the use of human tissues in medicinal products in the Human Medicines Regulations 2012 or the Medicines for Human Use (Clinical Trials) Regulations 2004 to help assure the integrity of tissues and cells used in UK medicines if necessary.
The drafting, an iteration of the wording of a similar amendment tabled by the noble Lord, Lord Hunt, in Grand Committee, delivers important clarity on a number of points. In particular, the specific reference to both tissues and cells provides certainty on the scope of materials captured. The reference to definitions of those terms under the Human Tissues (Quality and Safety for Human Application) Regulations 2007 ensures consistency with wider UK legislation.
I am also assured that this drafting allows for provisions to encapsulate the full stream of activities in the regulation of medicines that could relate to the use of tissues and cells. Of course, as with any such provisions brought forward under Clause 1 of the Bill, this would be informed by public consultation, a critical step in ensuring the full consideration of an appropriate approach and mitigating against any unintended consequences—for instance, for the supply or development of medicines in the UK.
Finally, I recognise that noble Lords have raised a number of other important, related questions on how we safeguard domestic practices from being at risk of compromise by human rights violations overseas. In these discussions, we have sought to be completely clear with noble Lords on the limitations of what can be done under this Bill. However, let me reassure noble Lords that concerns have not gone unheard.
First and foremost, on the consent standards applied to tissues imported for the purposes of public display, I am pleased to announce that we will take forward work to strengthen the Human Tissue Authority’s code of practice on public display for imported tissues. Although such imports are rare, we are committed to ensuring that when tissues are imported from outside the UK for the purposes of display, the consent standards applied are clear, firm and enforceable.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, this has been a short but incredibly important debate. In addition to the noble Lords that I have already thanked, I pay tribute to the noble Baroness, Lady Jolly, and my noble friend Lord Collins, for their sterling support throughout the passage of this Bill. It is much appreciated.
I stress that this amendment is not the definitive response to the horrific abuse taking place in China. It is enabling legislation, and there is much to do, as the noble Baroness, Lady Finlay, said. We need greater vigilance over exports. Transplant tourism is another area of real concern.
The noble Baroness, Lady Northover, and the noble Lord, Lord Alton, spoke about the HTA and its rather relaxed approach to the “Real Bodies” exhibitions. I find it extremely embarrassing that one of these exhibitions took place in Birmingham, but I am glad that the Commonwealth Games are coming to the city next year and that it has adopted a robust ethical policy which, if extended to the National Exhibition Centre in the future, would ensure that we would not see these exhibitions again.
The noble Lord, Lord Alton, has identified a number of other areas, to which the Minister responded to today, and the noble Lord, Lord Ribeiro, spoke very forcefully about the role of the World Health Organization. Again, I am very glad that the Government and the FCO in particular are talking closely to the WHO about it.
The noble Baroness, Lady Penn, sent a number of very important messages at the end: the revision and toughening up of the HTA’s code of practice and licensing procedures; and she talked about exports of medicines and devices. These are all welcome. However, we cannot be complacent. As my noble friend Lord Collins says, we cannot as a country show any tolerance towards these barbaric acts. This amendment is significant, particularly because it shows that the UK, with the support of government Ministers, is taking it seriously, and I am very grateful to all noble Lords who have helped to make this happen.
The Deputy Speaker (Lord Alderdice) (LD)
We now come to the group consisting of Amendment 14. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press the amendment to a Division must make that clear in the debate.
Clause 3: Falsified medicines
Amendment 14
Lord Clement-Jones
Member’s explanatory statement
This amendment would narrow the use of data in relation to falsified medicines to that which ensures patient safety.
Lord Clement-Jones (LD) [V]
My Lords, on 4 November in Grand Committee, the noble Baroness, Lady Thornton, and my noble friend Lady Jolly introduced amendments designed to limit the ambit of the information-gathering powers under Clause 3, which deals with falsified medicines. I raised the subject at Second Reading but was unable to be present for the debate in Grand Committee.
The Minister, the noble Lord, Lord Bethell, said in resisting the amendments:
“We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.”
It was not at all clear what the Minister meant by “exploring creative uses of information”, and in fact it was quite concerning given that these have not been set out anywhere in any consultation document. However, he went on to say:
“I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.”—[Official Report, 4/11/20; col. GC 326.]
Of course, as the result of the very welcome government Amendment 4, the safeguarding of public health is the key objective, and by Amendment 6, Clause 1(3) has been tightened up too. However, having carefully considered these amendments and the Minister’s previous response, I must still question his interpretation of Clause 3 and how it interacts with Clause 1. Clause 3(1)(b) currently says that the regulations may make provision about
“the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.”
At best there is a conflict between the two clauses, and at worst Clause 3 is open-ended and gives the Government far too much discretion in the scope of regulations under Clause 3.
In the discussions we have had with the Minister between Committee and Report—for which I am grateful—it became clearer that we need to ensure that this information regarding falsified medicines is used for limited purposes. The Minister cited a whole range of possible uses for the data, which came as a considerable surprise. As I said earlier, there has been no industry consultation, despite considerable ambition on the department’s behalf. That is why in this amendment we have tied the purpose to “ensuring patient safety”. What possible objection could there be to this limitation? Why would the Government want any wider scope, especially if the Minister believes that Clause 1 already provides a limitation?
I have now seen the brief announcement issued by the department on the consultation on the regulations to be carried out on a new national scheme. It says:
“We are committed to public consultation around the need and details of any national scheme, as well as a specific consultation on the use of data collected as part of any scheme.”
That lacks detail, to say the least.
Many noble Lords have been briefed by the Company Chemists’ Association about the commercial sensitivity of this data. As my noble friend Lady Jolly said in Grand Committee:
“The Department of Health and Social Care already has access to a very wide range of data on the sales of medicines, and their use in the UK, under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. These require manufacturers, wholesalers and pharmacies to provide summaries of products sold and prices paid. Ministers can request more detailed information if required.”—[Official Report, 4/11/20; col. GC 324.]
Given this access and the known sensitivities about falsified medicines directive data, it is unclear why the department has included this sweeping provision in Clause 3(1)(b). I described this as “legislative creep” at Second Reading. It goes well beyond the EU falsified medicines directive of 2011 and the associated delegated regulation of 2016. Of course, this was not acknowledged in the Commons by the Minister, Jo Churchill. As a result of the efforts of several noble Lords, the changes proposed to the FMD provisions are now out in the open—but that does not make it any more acceptable.
This might seem rather a specialised part of the Bill, but clarity about the scope of Clause 3 is vital if we are to have confidence that a suitable scheme for falsified medicines data will be put in place that does not go well beyond the current scheme in terms of the sensitive data that is collected and used. I hope the Minister can do better than last time in giving greater assurance about the ambit of Clause 3 so that I do not need to divide the House. I beg to move.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to support the noble Lord, Lord Clement -Jones, and my noble friend Lady Thornton. I urge the Minister to respond, as the noble Lord asked, on how Clause 3 will actually be used. It did not help that the Explanatory Notes made no mention of what the noble Lord described tonight and at Second Reading as “legislative creep”.
We have had submissions from a number of organisations that make the point that the wording goes beyond the current EU legislation, which was carefully implemented after extensive consultation with the relevant bodies. That is from the Company Chemists’ Association. The ABPI said that the falsified medicines directive was introduced as a barrier to counterfeit and falsified medicines entering the supply chain, thus reducing the potential risk of harm to patients, that the ABPI and its members have worked to fund and implement the falsified medicines directive, and that any future considerations under this clause must include full consultation with industry.
So there is general concern in the industry about how the clause will be used. We know that the department already has access to a wide range of data on medicines sales and use in the UK under the Health Service Products (Provision and Disclosure of Information) Regulations. Given this and the known sensitivities around falsified medicines data, I am still unclear why the department wants to extend the purposes for which data is collected under a future UK system. I know that we were very privileged—
Baroness Penn (Con)
My Lords, unfortunately the noble Lord cut out again briefly. If he could rewind about 30 seconds, that would be appreciated.
Lord Hunt of Kings Heath (Lab) [V]
I am sorry, I have had a very poor connection tonight. Can you hear me now? All I was going to say was this: we were privileged to have a discussion with the noble Lord, Lord Bethell, and his officials before Christmas. The impression I had was that this is regarded as a useful clause to be used at some point in the future when a clearer purpose has emerged. I do not think that this is the way we should go forward. Like the noble Lord, Lord Clement-Jones, I hope the Minister can give some assurances tonight about how this clause and the information stored will be used.
Baroness Jolly (LD) [V]
My Lords, this amendment, led by my noble friend Lord Clement-Jones, would narrow the use of data in relation to falsified medicines to that which ensures patient safety. The use of patient data is a really delicate issue. As currently drafted, Clause 3 allows for regulations to be made about
“the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.”
The Minister has said that we want to explore creative uses of information. I am not quite sure what the general public would think of that statement. I am not quite sure what I think of that statement. As my noble friend Lord Clement-Jones has said, this is an incredibly wide remit granted to the Government. Restricting it to information that ensures patient safety, as in the amendment, will help protect patients’ information. In his summing up I would like the Minister to outline how this amendment will work in practice, and we will consider whether this might be brought back at Third Reading.
Baroness Thornton (Lab)
I am grateful to the noble Lord, Lord Clement-Jones, for his full and comprehensive explanation of the background thinking behind this amendment. It is clearly important that we understand and have clarity about the scope of Clause 3, and it is that clarity we seek from the Minister this evening. As my noble friend Lord Hunt said, we are urging the Minister to respond about how Clause 3 might be used. It is not good practice when you are law-making to put something in a Bill that might just come in useful at some point. The House probably needs a wider explanation and reassurance about this clause and how it will be used.
Lord Bethell (Con)
My Lords, I am enormously grateful for that helpful debate. Let me try to provide some of the clarity and reassurances noble Lords have sought. Amendment 14 to Clause 3 would add constraints to the use of data collected as part of the operation of any national falsified medicines scheme. I understand that the intention of Amendment 14, in the name of the noble Lord, Lord Clement-Jones, is to prevent the use of data collected for any additional use other than for the purpose of ensuring patient safety. We discussed this at length in Committee and afterwards, and I am grateful to the noble Lord and to other noble Lords who have given up their time to discuss this important issue. I know that the noble Lord has returned to this because he thinks it is worth continued debate, so I would like to reassure him that we have thought very carefully indeed about the power in Clause 3(1)(b).
I will start with the context of the power to use information collected as part of any potential future national falsified medicines scheme. First, it is important to note that the overarching principles of the Bill set out in Clause 1 also apply to, and are constrained by, the powers in Clause 3.
Amendment 4 in my name would ensure that in making regulatory changes under Clause 3—not just around how information will be used—the appropriate authority’s overarching objective must be safeguarding public health. In making that assessment, one of the things the appropriate authority must have regard to is the safety of medicines. Further, we have provided for a clear and unambiguous lock on patient safety; that is, as part of the decision-making process behind regulatory changes, if proposed changes have an impact on the safety of human medicines, the appropriate authority may make those changes only if the benefits outweigh the risks.
Secondly, of course, any regulations providing a framework for the use of the information will be subject to parliamentary scrutiny under the draft affirmative procedure. So, the scope of Clause 3(1)(b), which is the focus of our discussion, is not unfettered. I have discussed previously the statutory requirement to consult before making regulatory changes. Powers at Clause 3(1)(a), (2) and (3) will provide us with the means to make the regulatory changes to establish a verification system, if appropriate. As part of the effective operation of any such system, information will need to be collected. It is only once we have established the need for a verification system, and how it could work, that we can fully consider how the information it collects could be used to deliver additional benefits for the UK and for patients. Clause 3(1)(b) and (3) enable us to make appropriate best use of the data collected as part of a national focused scheme and ensure that the appropriate authority must have regard to the importance of ensuring that information is retained securely.
I want to reassure noble Lords by being as clear as I can that the data in question is that which would be collected for the prevention of the supply of falsified medicines—that is, as part of the operation of any verification scheme. I reassure noble Lords that we could not expand the data being collected using Clause 3(1)(b) as part of a verification scheme. However, we want to maximise the use of data collected as part of any verification scheme where it is in the public interest. In this, we would be learning from the EU scheme, which, for example, allows data to be used beyond patient safety for reimbursement purposes and in delivering a solution that works at a national level. I reassure the Chamber by being as clear as I can be that the powers in Clause 3 do not include the collection of patient data. As with the current European scheme, there are no plans for any future national falsified medicines system to collect patient data.
My concern is that putting such a limit on the use of information at this time could constrain or limit options ahead of our engagement with stakeholders. Critically, it may not allow for the data to be used for all potential research purposes. We are not in a position at this moment, ahead of our engagement with stakeholders, to list all the potential ways in which data sources might be combined for research and wider public health purposes, which can go beyond patient safety. We want to be guided by our stakeholder engagement and not to restrict that process unnecessarily before we have had a chance to hear how this data could be used for public interest purposes.
We are also proposing a staged approach to engagement and consultation. We are committing to a clear and separate consultation and engagement: first, a consultation around the need for and details of any system concerned with the prevention of falsified medicines; and secondly, a specific consultation around other uses of the data collected under Clause 3(1)(b). As I have said, any regulatory changes that will provide a framework for the use of the information would be subject to parliamentary scrutiny under the draft affirmative procedure.
I believe that by developing these proposals through consultation and engagement, we are improving our policy-making and its subsequent implementation. I remind the House that we have no scope for changing these provisions at Third Reading, so if the noble Lord, Lord Clement-Jones, wants to press the matter, he will need to do that today, but I hope instead that he will have had enough clarity and reassurances from the Dispatch Box to be able to withdraw his amendment.
Lord Clement-Jones (LD) [V]
I thank my noble friend Lady Jolly, the noble Lord, Lord Hunt, and the noble Baroness, Lady Thornton, for their helpful contributions and support today. I also thank the Minister for his reply; I regard it as something of a curate’s egg, but I recognise the thought that has gone into it, particularly his statement on the overarching principles in Clause 1 governing Clause 3 and the fact that the benefits must outweigh the risks in any scheme. He talked about the affirmative procedure; I very much hope that we will retain the super-affirmative procedure, which encourages me that there will be greater scrutiny of any new framework.
The Minister also spoke about the statutory duty to consult on proposals and the duty to secure data. He said that no patient data was being used and that, at the end of the day, the essence of this is to maximise the use of data where it is in the public interest. He gave research as an example that might be outside patient safety—I doubt it, but he thought it might be interpreted as going beyond patient safety. I was very struck by the noble Baroness, Lady Thornton, saying that there was an element in this of having a power that might come in useful; indeed, the Minister almost repeated that in saying, “We’ll see what data we have collected.”
I take some comfort from what the Minister has said. We have had some very productive debates and some important amendments secured, so I will not press this amendment today. However, the noble Lord probably has to suffer the potential of being immortalised on a Pepper v Hart basis if there is any subsequent dispute about the width of regulations made under this clause and whether Clause 1 limits the scope of Clause 3. I am sure he looks forward to that. In the meantime, I beg leave to withdraw my amendment.
The Deputy Speaker (Lord Alderdice) (LD)
We now come to the group consisting of Amendment 15. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this amendment to a Division must make that clear in debate.
Amendment 15
Lord Field of Birkenhead
“Entitlement of a doctor to prescribe medicinal cannabis products
The appropriate authority must by regulations make provision to—(a) grant authorisation to place on the market of the United Kingdom high quality, standardised medicinal cannabis products for prescription by a doctor (including, for the avoidance of doubt, by a general medical practitioner),(b) permit doctors to prescribe medicinal cannabis products, and any device or article that is required in the administration of such products, and(c) require the relevant regulatory and advisory bodies to obtain and evaluate relevant scientific and medical literature and data, including on long-term patients’ experience in connection with cannabis for medicinal use (as well as the potential for such use) with particular reference to—(i) the efficacy and therapeutic value of medicinal cannabis products,(ii) matters pertaining to the safety of medicinal cannabis products, and(iii) the medical conditions (indications) in respect of which medicinal cannabis products may be administered and used.”
Lord Field of Birkenhead (CB)
I beg to move this amendment in my name and those of other noble Lords whom I count as friends. It is quite clear what the amendment is about; we list it at the very top:
“Entitlement of a doctor to prescribe medicinal cannabis products”.
It is an enabling clause to allow that to happen. The debate today is not really about whether we have been clever enough to draft an amendment which will satisfy the Government, but about whether there is the will in Government to make a change that will affect a large number of people in this country, myself included, who use cannabis as a product to counter pain.
We have heard the urgency in today’s discussions, and Oral Questions, to look at the plight of those little children whose brains are shaken to bits and beyond repair if they do not have access to this product. I would not want to be in the ministerial positions which have to decide how many more days those children must wait before their parents can obtain supplies which will abate the terrible effects of these endless fits, which come like the second hand on a clock, devouring their intelligence and ability to lead a proper life.
The debate is about whether the Government will make this change so that those doctors who wish to prescribe medical cannabis products are free to do so. We are not doing so in a form which, I hope, anybody could consider as irresponsible. We know that there need to be checks and that there are dangers with all medical products. But we have seen recently a wonderful example of the political will which decided that as soon as a vaccine was ready to distribute, providing that safety was ensured, that drug would be rolled out. I hope one of the things we will get from this evening’s short but important debate will be a commitment from the Government that the speed shown to protect the whole population from Covid will similarly be displayed when we come—I hope at some stage soon—to agree the distribution of medical cannabis via the NHS rather than privately.
Baroness Meacher (CB) [V]
My Lords, I have added my name to the amendment moved by my noble friend Lord Field of Birkenhead. I want to give it my strongest possible support, as Ministers will expect of me.
In November 2018, the significant medicinal properties of cannabis were finally recognised after 50 years of misinformation—I can only call it that—about the plant. At that time, around 1 million patients thought, “Oh my goodness, we’re going to be able to obtain our medicines free of charge through the NHS.” How wrong we all were. I think I am right in saying that only three prescriptions have been written under the NHS since that date; in my view, that is some indication of the degree of misinformation over so many years.
The epilepsy crisis illustrates powerfully that the right medical cannabis is essential for the treatment of severe epilepsies that are resistant to standard medications. I understand that Ministers know this well and are doing what they can behind the scenes. I know that the noble Baroness, Lady Walmsley, will focus strongly on this particular issue.
I want to mention an economic point, if you like. Until his parents so brilliantly found medical cannabis, dear Alfie Dingley’s terrible emergency ICU admissions —nearly every week—were costing the NHS around £100,000 a year. That included his consultant cost, GP costs and medications. The reality is that this amendment could save the NHS hundreds of millions of pounds. It is absolutely crazy to make this so difficult.
The aim of our amendment is to ensure that medications such as Bedrolite, which saved Alfie’s life—I do not think that that is an exaggeration—could receive marketing authorisation, thus immediately resolving the problem for Alfie and other children like him. The fact is that Bedrocan products have been used very successfully for decades, showing that they are both safe and effective.
As my noble friend Lord Field of Birkenhead said, the amendment would solve the problem not only for epileptic children, terribly important though that is, but for the very many people who suffer severe chronic pain, particularly neuropathic pain. It would open the way for cannabis products with a track record of efficacy and safety to be given marketing authorisation and prescribed by GPs as licensed products. That is what we want to achieve here.
I want to make a few further comments. I hope that I am reflecting correctly the comment of June Raine, the chief executive officer of the MHRA, in a Zoom meeting in which we were both involved. She seemed to suggest that, finally, she understood that the MHRA needs to take real-world experience much more seriously. If this is what she meant, I applaud her most strongly; I have been waiting for a senior person in the MHRA to take that view for some time.
If a patient has many years of experience of medical cannabis and has found that it really helps them when other products had not done so, surely this experience should be taken very seriously, not only by the MHRA but by doctors too. Cannabis should be prescribed for the patient in question and other patients with similar conditions. I therefore plead with the Minister, the noble Lord, Lord Bethell—for whom I have the greatest respect on a whole range of issues—to encourage the MHRA to revisit its rules for assessing the efficacy of medical cannabis, to take account of the real-world experience I have mentioned.
I am not talking about a few patients or a few weeks of trying something out—not at all. The fact is that 78 medications prescribed within the NHS have never been through random control trials. It is simply not true to say that medical cannabis products must go through such trials. The complexity of the cannabinoids in cannabis is such that RCTs tend to lead to suboptimal products being approved as single cannabinoids when in fact several cannabinoids and some terpenes might be a great deal better.
Another aspect of real-world experience is the research undertaken in other countries. The National Academies of Sciences, Engineering and Medicine published the report The Health Effects of Cannabis and Cannabinoids in 2017, more than three years ago. It was a review of global research into the efficacy of cannabis medicines. Already, three years ago, it was able to conclude:
“There is substantial evidence that cannabis is an effective treatment for chronic pain in adults”.
Since then, the WHO has finally recognised the medicinal value of cannabis. More and more countries are also recognising the facts about this important medicine. The UK is now lagging behind the English-speaking world. It is really time to catch up, and I hope that our Minister can help us.
My last point concerns our own police forces. Many have now moved ahead of the Government in deciding not to arrest patients who have a few plants in their kitchen to supply themselves with their medicines, or even those who get such medicines from illegal dealers—let me tell you, that is the last thing patients want to do. The police know perfectly well that it is cruel to add a criminal offence to all the pain that these patients already go through.
I hope that the Minister will be willing to meet the noble Lord, Lord Field, and I, ideally with June Raine, to discuss the best way forward. I believe that to improve access to medical cannabis for patients, Ministers will need to adjust the regulations that currently restrict that access and prevent GPs prescribing medicines that patients so desperately need.
Baroness Walmsley (LD) [V]
My Lords, I am honoured to follow the noble Lord, Lord Field, and the noble Baroness, Lady Meacher. I too have put my name to Amendment 15.
Before I specifically address the amendment of the noble Lord, Lord Field, I would like to acknowledge the Minister’s reply to my Oral Question earlier today about the negative effect of Brexit on the legal supply of Bedrocan, and probably other cannabis medicines, to patients in the UK. He knows that this is a life-changing and life-saving medicine, so he will understand that patients and their families are very anxious. Can he assure me that they will be kept informed about progress on sorting this out? They and their clinicians were very worried by his suggestion that there needs to be compromise on both sides. There can be no question of compromise; it would be dangerous to try to substitute this medicine for a different formulation, extracted from a different strain of cannabis.
In response to the DHSC’s suggestion to pharmacists that one cannabis medicine can easily be replaced by another, I will quote from evidence that I have received from Evan Lewis, director of the Neurology Centre of Toronto. He is a clinician with extensive experience of medicinal cannabis for adults and children, and has said:
“It is imperative that children who are benefiting from a particular medical cannabis product are not changed to another product. There is significant variation from one product to the next, and many unknowns as to how all the cannabinoids interact with each other to treat seizures”.
He goes on to say that swapping backwards and forwards between products can be extremely dangerous and is often ineffective. This misunderstanding nicely illustrates some of the problems we face in our campaign to make the benefits of cannabis medicines more widely available to UK patients on the NHS.
On the wider issues in Amendment 15, the key issue is how evidence is obtained about the safety and efficacy of these medicines. I see the Government’s fixation with random-controlled clinical trials as a real barrier to progress in the field of cannabis medicine. When scientists are trying to investigate any issue, they always use procedures that are appropriate to the material being investigated and to answering the question asked. When you have a very small patient cohort, such as the cohort of children with drug-resistant epilepsy, it is impossible to have a meaningful clinical trial. Besides, when giving a placebo to half the sample could be life-threatening, it could be unethical.
As the noble Baroness, Lady Meacher, said, many drugs and medical devices are already used on an anecdotal basis. For example, as she said, 78 drugs are available and in use in the NHS that have no random control trial. The vagal nerve stimulator, which is successfully used to prevent seizures in some epileptic patients, also has no RCT in relation to it. There are many drugs used on children that have not been tested in clinical trials for use in children. Indeed, some of them were used on Alfie Dingley and the other children who now receive cannabis medicines before they fortunately discovered the benefits of the latter.
Baroness Masham of Ilton (CB) [V]
My Lords, I thank the noble Lord, Lord Field of Birkenhead, who moved this amendment so movingly. This debate has gone on for many years.
It has been found by parents that medical cannabis can help some children who have multiple seizures due to epilepsy. I need to know: has NICE approved it? If it is waiting for more research, there will have to be more people using medical cannabis so that the information can be collected. If it is helping, doctors who understand the problems need to be the people who prescribe it. It should be carefully monitored. If it gives better quality of life, why should it not be prescribed? I hope the Minister will do his best to see that it is.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I am really grateful to the noble Lord, Lord Field, and the noble Baronesses, Lady Meacher and Lady Walmsley, for sponsoring this amendment and for the powerful speeches they have given.
Last week, I heard Hannah Deacon talk on the “Today” programme about her son Alfie and the devastating consequences of Brexit and the impact of the inability to import Bedrocan from Holland. I know the Government have been active, and I very much hope the Minister will be able to report progress tonight.
That is the immediate issue, but of course there is then the long-standing issue that, when Parliament agreed to the legalisation of medical cannabis under prescription, there was a distinct impression that NHS patients would receive medical cannabis where appropriate. It is very clear that the NHS is not prepared to do that. The small number of prescriptions and the approach of the various bodies that advise the health service on commissioning make it abundantly clear that, unless Ministers intervene, patients will simply not be able to get these products in a legal way.
I say to Ministers that, with the campaigns, it is obvious there will be increasing noise, increasing concern. They really will have to step in and find a way of getting access to these products for patients. It is inevitable that it will happen, and it is better than they do this now rather than wait for another three, four or five years. I remind them that, when the legislation went through, the Home Secretary at the time said:
“We have now delivered on our promises … we will work with the NHS to help support specialists in making the right prescribing decisions.”
That simply has not happened.
I suggest four approaches: first, the All-Party Parliamentary Group on Medical Cannabis under Prescription believes that the only way to help families at the moment, and to make sure the policy does not stall completely, is to set up a small fund called something like the medical cannabis access fund, which can be used to help those families, until the blockage on NHS prescription eases.
Secondly, we have to come to the issue of research. I know the Minister is frustrated—he repeated this today—because he thinks the companies producing these products should come forward and undertake clinical trials and tests. I am not an expert, but I have listened very carefully to noble Lords and to advice that I have received, which suggests that randomised control trials are very difficult in this area. In that case, surely the Government should revisit the NHS England report, Barriers to Accessing Cannabis-based Products for Medicinal Use on NHS Prescriptions. The report looked at the issue of research, and said that there should be randomised controlled trials but, alongside this:
“NHS England and NHS Improvement and NIHR in conjunction with the specialist network will work together to determine an appropriate alternative study design that will enable evidence generation for those patients who cannot be enrolled into a standard RCT.”
I gather that this has not happened. The Minister really should inquire into this. It would basically be an observational study; it would allow medical cannabis to be prescribed for large numbers of people and for proper research to be undertaken. I suggest to him that it would be a way forward, so that the current frustration of so many patients is responded to in a sympathetic but also practical way.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, we started this debate today with widespread plaudits to the Government for listening to very strong campaigns to have a patient safety commissioner. Indeed, the noble Baroness, Lady Cumberlege, who has been so instrumental in this, commented on the importance of that person listening to patients. We have to draw the parallels here because we have heard—as a community, as a society, and as a Parliament—from the parents of children who desperately need these medicines but are unable to access them. Those patients are not being listened to. We really do have to ask ourselves the question of why that is happening and what kind of political block or ideological barrier exists so that we are not seeing action in this area when it is so clearly, urgently needed.
When we were talking about a patient safety commissioner, I commented on how effective campaigning has been in that area. There is also a very effective campaign called End Our Pain, which has been working with families trying to access this medicine. It has been doing a great job, but the Government have not been doing their job in delivering on the campaign. I give credit to the noble Lord, Lord Field of Birkenhead, and all the other people who have signed this amendment, which is very much cross-party and across the House. As the noble Lord said, we have a division here—a human rights issue, referred to in the amendment tabled earlier by the noble Baroness, Lady Sheehan. People, or families, who can afford it, are able to access this medicine; those who need NHS support for it cannot. We should not be tolerating that situation in Britain at any time, particularly in 2021.
I have a direct question for the Minister. I have been looking at what assessment the Government might have made of the impact of current policies and the lack of financial support for vulnerable families. I should be happy to be corrected and perhaps told that an assessment is under way, but the most recent information that I was able to find was from September last year, when Liz Saville Roberts MP asked a Written Question in the other place about whether such an assessment had been made—and the answer was no. I will be brief, because the issues have been well set out by the noble Lord, Lord Field, and others. However, I ask the Government what assessment they have made of the impact of their current policies.
Baroness Jolly (LD) [V]
My Lords, today’s final amendment, tabled by the noble Lord, Lord Field of Birkenhead, and signed by my noble friend Lady Walmsley and the noble Baroness, Lady Meacher—all long-term campaigners on this issue—would require regulations to be introduced to allow doctors to prescribe medicinal cannabis products. I know that the movers of the amendment have been campaigning for ever—probably as long as I have been in the House—and can be excused their despair at the inactivity of GP prescribers.
The Home Office changed the status of medicinal cannabis two years ago, after a long campaign, but it has not been widely prescribed. The need for clarity on this matter was brought to the forefront by the news that nine year-old Alfie Dingley, whose use of medicinal cannabis has greatly improved his health, is no longer able to access his medication from the Netherlands due to Brexit. The Lib Dems have long been advocates of making medical cannabis accessible to those whose health would greatly benefit from it, and we support this amendment.
Will the Minister tell us what she can do to persuade the medical profession that cannabis has real medicinal value? Why are doctors deaf to children such as Alfie, and why are children such as Alfie and his parents left in the lurch? I hope that the Minister will be able to accept the invitation from the noble Baroness, Lady Meacher, to join her in a meeting with Dr June Raine, the chief executive officer of the MHRA.
Baroness Thornton (Lab)
The noble Lord, Lord Field, will know from this afternoon’s Question that I have huge sympathy on this issue, and I also completely recognise the frustration that exists around this subject. As I said earlier, “Come on, Prime Minister: if you can solve Brexit, in your own terms, I am sure that you will be able to solve this one, too.”
“Irresponsible” is not a word I would use to describe the noble Lord, Lord Field. He was very temperate in his introduction of the amendment. It is shameful, as the noble Baroness, Lady Meacher, said, that only three prescriptions have been issued properly by the NHS for free use. That means there is something is seriously wrong here. I thank my noble friend Lord Hunt, who is quite correct: this does require political muscle. The noble Baroness, Lady Bennett, is quite right, because this issue also completely exposes the inequalities we see in our society, whereby people who are fortunate enough to be able to afford to buy cannabis products can do so, while those who cannot, cannot, and then they suffer the consequences of that—literally. The noble Baroness, Lady Jolly, mentioned despair, and I agree with her.
So I do think that, as a result of this short but very potent debate, the Minister needs to commit at least to the meeting with the MHRA and the movers of the amendment.
Baroness Penn (Con)
My Lords, Amendment 15 in the name of the noble Lord, Lord Field of Birkenhead, deals with a topic that has been discussed at length in both Houses. The noble Lord spoke eloquently in Committee, sharing his experience of medicinal cannabis and the benefits he obtains from it.
I will first address a separate but related matter that a number of noble Lords raised concerning the supply of certain cannabis-based medicines from the Netherlands. I know that the noble Baroness, Lady Walmsley, and others in the House have received distressing calls from patients and families who have relied on these imported medicines. The Parliamentary Under-Secretary of State for Prevention, Public Health and Primary Care, Jo Churchill, met Alfie Dingley’s family and the patient group End Our Pain on Saturday to provide reassurance and an update on the action that we are taking.
I reassure noble Lords that we are working urgently with the Dutch Government to find a solution that will enable patients to access the medications they need. I cannot discuss the details of the proposals today, but I commit to provide noble Lords with a further update when I can.
Returning to the matter at hand, I reassure noble Lords that the issues raised by the noble Lord, Lord Field, in his amendment sit firmly with the Department of Health and Social Care, not the Home Office. While I am pleased that the noble Lord finds some relief with this medicine, the fact remains that the vast majority of cannabis-based medicines have not been assessed by the MHRA for safety, quality and efficacy, nor by the National Institute for Health and Care Excellence for clinical and cost effectiveness. I believe that that is the nut that the noble Lord is trying to crack with his amendment. We are also trying to crack it as a Government, but from a slightly different approach.
As the noble Baroness, Lady Meacher, noted, the Government changed the law on 1 November 2018, to reschedule cannabis-based products for medicinal use in humans. This moved these products from Schedule 1 to the Misuse of Drugs Regulations 2001—no legitimate use—to Schedule 2, to permit the lawful prescribing and supply of cannabis-based medicines when certain criteria are met. In particular, cannabis-based medicinal products can be prescribed by one of three routes: as a “special medicinal product”, subject to the “specials regime” contained in the Human Medicines Regulations 2012, prescribed by a specialist medical practitioner; as an investigational medicinal product for use in a clinical trial; or as a medicinal product with a marketing authorisation.
Given that there is insufficient evidence on the safety, quality and efficacy of these unlicensed medicines, it is entirely appropriate that these products are subject to these stringent conditions. It would be inappropriate to establish parallel arrangements or to subject medicinal cannabis to any less stringent assessment than is the case for other medicines used for serious or chronic conditions. To do so would undermine the integrity of our medicines regulation in the UK. Also, it would run counter to the noble Lord’s objective to see the placing on the market of high-quality, standardised cannabis-based medicinal products that are safe and effective.
As noble Lords heard in Committee, we have removed some of the barriers to how these products are imported into the UK and we now see a wider range of products available to prescribers. I reassure noble Lords that we are also taking steps to improve the body of evidence available. NHS England and NHS Improvement have made good progress to establish a national patient registry for patients receiving medicinal cannabis. This has been developed with clinicians and aims to cover all clinical indications and all licensed and unlicensed medicinal cannabis products prescribed on the NHS and privately. The registry will be an important step forward in the collection of uniform data to support monitoring and evaluation of prescribing activity, patient safety and clinical outcome data. This data, and that produced from clinical trials, will help inform future NHS commissioning decisions. The registry is currently being piloted, with a view to further rollout next year.
On clinical trials, the National Institute for Health Research and NHS England are working together to set up a programme of two randomised controlled clinical trials. These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to inform future NHS commissioning decisions for the many hundreds of patients in the UK with refractory epilepsy. This is a pioneering area of research and we hope the trials will start as soon as possible. However, I must emphasise that industry also needs to step up and invest in robust clinical trials to improve understanding of how patients might benefit from these products.
I must say to noble Lords that it is not the job of the independent regulator to generate evidence. To do so would undermine the independence and objectivity of medicines regulation in this country, including the pharmacovigilance of medicines. The safety of the public will always come first, and the producers of medicinal cannabis must be prepared to subject their products to scrutiny by the MHRA and by NICE.
When marketing authorisations are sought, they will be dealt with by the regulator, as with any other medicine, taking into account their herbal origin. The MHRA offers, and has given, regulatory and scientific advice to companies and researchers to support their research and development of these products. I reassure noble Lords that the MHRA is committed to using the latest techniques and takes a patient-centric approach to medical regulations.
Regarding further discussion of this with the MHRA, I will take that request away. I think we all welcomed June Raine’s approach in the meeting with Peers last year on this Bill. I am also conscious at this exact moment in time of the pressures on the MHRA to support our national effort on vaccination rollout. I am sure we will get a positive response, but there might be a small issue around timing that we will have to take away and address.
As we have seen with the Pfizer and BioNTech Covid vaccine, and, indeed, with the other Covid vaccines that have come online, the MHRA upholds the highest standards and will authorise the use of medicines only following the most rigorous scientific assessment. This is essential to ensure that the public can have trust in the regulator and the medicines they use. Licensed products, such as Sativex for multiple sclerosis and Epidyolex for rare epilepsies, have gone through this process and are proof that cannabis-based products can meet the high standards of quality, safety and efficacy that we rightly expect in the UK.
On that basis, and on the basis of the Government’s ongoing efforts to ensure that we have a strong evidence base to provide further access to these medicines, I ask the noble Lord, Lord Field, to withdraw Amendment 15.
Lord Field of Birkenhead (CB)
My Lords, I can willingly agree to that last request. I think if we put it to a Division we might not win, so what is the point of closing doors when the Minister was busy opening them? I am immensely grateful to her for that.
As the House can see, many people can do two things at once—both speak and keep their masks in place. I fail that test. But I want to thank those who have participated—the noble Baronesses, Lady Meacher, Lady Walmsley, Lady Thornton, Lady Masham, Lady Jolly, Lady Bennett and Lady Penn, and the noble Lord, Lord Hunt—for their contributions in taking this debate further.
If I may, I will end on a cheerful note. Let us suppose that, in the next few days, the Prime Minister finds the time to look at this issue and decides that the Government’s line will be different. We know that the people who have had to defend the line tonight would then put another case to us, and I hope that that case will be put very shortly.
Safety is, of course, crucial. However, we have just experienced the introduction of the Oxford vaccine and other vaccines. Presumably they went through randomised controlled trials, so those can be accomplished very quickly. I hope that, when the Prime Minister changes his mind, we will move to testing the safety of these products as quickly as we have the vaccines. Just as the vaccines offer us hope of life after Covid, I hope that we will see a quick response for those millions of people who are not free to obtain their cannabis on the NHS but who, like me, are lucky enough to be able to buy it. I hope that we will move very quickly and resolutely. One way of levelling up is to make these products—once their safety has been established—free for everybody on the NHS.
Medicines and Medical Devices Bill
Thursday 14th January 2021
(3 years, 10 months ago)
Lords ChamberRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 154-II(Rev) Revised second marshalled list for Report - (12 Jan 2021)
15:22 - Division conducted remotely on Amendment 18 - Ayes: 312 / Noes: 249 - Amendment 18 agreed.
Baroness Thornton
“Strategy for tackling vaccination disinformation
(1) Within one month of the day on which this Act is passed, the Secretary of State must prepare and publish a strategy outlining plans to prevent the promotion of disinformation related to human vaccines.(2) The overarching objective of the strategy must be safe- guarding public health.(3) The strategy must be laid before Parliament.(4) In formulating the strategy under subsection (1), the Secretary of State must include proposals to—(a) build public trust and encourage uptake of vaccines;(b) require social media companies to promptly remove disinformation related to vaccines that has been reported to them by an appropriate authority, employees or other social media users, including financial and criminal penalties if they fail to act; and(c) prohibit social media users or companies from directly profiting from vaccine disinformation through advertising revenue.”Member’s explanatory statement
This amendment requires the Secretary of State to publish a strategy for tackling anti-vaccination disinformation within one month of the Bill passing.
Baroness Thornton (Lab) [V]
My Lords, this amendment requires the Secretary of State to publish a strategy for tackling anti-vax disinformation within one month of the Bill passing, to safeguard public health. The strategy should include proposals to build public trust and encourage uptake of vaccines, require social media platforms and companies to promptly remove anti-vax disinformation, and prevent profiting from vaccine disinformation through advertising revenue. The context to this amendment is the problem that lies designed to erode trust in vaccines and persuade people not to protect themselves and their families are being broadcast to millions of people online every day.
Covid-19 has been a “growth opportunity” for anti-vaxxers, according to research by the Centre for Countering Digital Hate, which estimates that the largest English-language social media accounts promoting vaccine scepticism have increased their followers by nearly a fifth over the past year. Intelligence assessments suggest that while the majority of anti-vax propaganda seen by UK internet users comes from within Britain, a small proportion of it is being amplified or initiated by hostile states, notably Russia.
Whereas the normal vaccine debate is largely limited to the parents of young children and teenagers, the Covid-19 pandemic is a rare instance where the entirety of a society has to choose whether they wish to be vaccinated. The spread of disinformation online presents a “real and present danger” to vaccination efforts. This is why action must urgently be taken to tackle anti-vax campaigns and build public confidence to save lives.
Disinformation is distinct from legitimate scientific questions and scrutiny, although valid concerns can be and often are manipulated. Disinformation encompasses the full spectrum of—
Baroness Penn (Con)
My Lords, we appear to have lost the connection to the noble Baroness, Lady Thornton, so I suggest that we adjourn for five minutes.
Baroness Thornton (Lab) [V]
My Lords, I think I am back now. I apologise: I have no idea what happened then, but the trusty old iPad is coming in useful. I think that when I lost my link I was talking about media companies, so I will pick up with that.
Despite the Government’s and social media companies’ announcement last week of new measures to tackle the issue, dedicated anti-vaccine groups with hundreds of thousands of members on social media are still churning out disinformation—100,000 Facebook users and 180,000 on TikTok. Although the Government have talked about online harms for a long time, it is unlikely that that legislation will have Royal Assent in time to help with this.
Finally, the situation was made clear in the Question in the House yesterday from my noble friend Lady Lawrence about the BAME community and the vaccine being rolled out. She said:
“I have heard messages from the black community about their mistrust of and lack of confidence in the vaccine. I ask Her Majesty’s Government: what proportion of those taking part in the vaccine trials were black, Asian or from ethnic minorities before the rollout?”—[Official Report, 13/1/21; col. 725.]
That was amplified by the noble Baroness, Lady Warsi, who made the point that, although BAME communities were initially less likely to accept a Covid vaccine than white communities, when they had the opportunity to discuss their concerns with healthcare professionals, they were more likely than white communities to be persuaded to have the vaccine. Is the noble Lord familiar with that polling, and will he follow it up? I beg to move.
Baroness Altmann (Con) [V]
My Lords, first, I apologise to the House because this is the first time I have spoken on this Bill, so I will not detain the House long. However, I support the aims of the amendment. This is something I have felt strongly about for some years.
Tackling anti-vax disinformation can be life-saving, and continuing to promote anti-vax messaging can be so damaging to public health as well as individual health. As the noble Baroness, Lady Thornton, rightly said in her excellent introduction—I am grateful to her for tabling the amendment—the online anti-vax messaging problem is growing. It is not just from a tiny minority in any one country; there could be systemic efforts to damage public health in our country and others. Given that those minority views can be spread, potentially to the severe detriment of the public and those who perhaps tend to support those views, believe them or be convinced by them, I should be very grateful if my noble friend would explain to the House the Government’s position. What do they believe they can do to combat the anti-vax messaging, not least as we are in the middle of this dreadful pandemic, for which the way out seems to me and many others to be to vaccinate as much of the population as we can, as soon as we can, to enhance their protection? Therefore, this is a very important and live issue, given the dreadful consequences that the pandemic is having not only on health through the virus itself, but on other aspects of public health and the country’s wider ability to support our beloved NHS.
Baroness Masham of Ilton (CB) [V]
My Lords, I am speaking on the telephone, as something went wrong with my iPad.
I support Amendment 16, which is tackles anti-vaccination disinformation. For some years, this has created a problem. For example, there has been an epidemic of measles in many countries because many people, including the growing number of vegans, mistrust vaccines. Clear messages should go out about the benefits of vaccines and how they work. Some vaccines are very complicated and difficult to develop, but they are desperately needed for diseases such as HIV, TB and malaria.
Regarding these important coronavirus vaccines, I hope that the Government will be very careful that disinformation is not going out to the public about the Pfizer vaccine. Many health workers and elderly vulnerable people have had one dose, and the second dose should be given in three weeks’ time. People have signed up to that, as there are written instructions to do so, but the Government are trying to delay the second dose by up to three months, which is not recommended by Pfizer-BioNTech or the regulator.
There is a risk that with only one dose, people may become carriers and the virus may become resistant to the vaccine. The Doctors’ Association is not happy about the Government’s idea of a three-month delay. More careful monitoring and research is needed, but these mixed messages are extremely unhelpful. I hope that the Government will realise that people need to trust the information they receive.
Baroness Cumberlege (Con) [V]
My Lords, I congratulate the noble Baroness, Lady Thornton, on her comprehensive introduction, expressing the urgency of the situation, which was also stressed by the noble Baroness, Lady Masham, in another interesting contribution for which I thank her. This is a difficult and hugely important issue, and it needs serious consideration on two counts. We have to look beyond the present situation with anti-vaccine campaigners and decide very carefully what is information and how we should combat damaging information being spread. Secondly, how do we reserve the right of the individual to use social media to express their personal views?
I spent six years on the Press Council, dealing with complaints. It was taxing, but today the print media is regulated to a greater extent. Even then, accountability for what should be published and what should not lay with not only the journalist who had written the article but with the editor and, in some newspapers, the owner.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege, and I join her and other speakers in thanking the noble Baroness, Lady Thornton, for tabling the amendment, which I think is largely intended to start a debate and get some focus on this terribly important issue.
My approach to the whole issue of disinformation about harmful content on the internet is slightly different from those of some of the other speakers. We need to take the same approach as we do with the vaccine, which is to think about vaccination being better than treatment—prevention being better than cure. Ensuring good public communication, information and education about Covid and many other issues is the best possible way in which to take on misinformation, rather than after the fact—after the infection—and then trying to treat it. As soon as one starts trying to combat such messages, it is difficult to avoid repeating them. As any communications professional will tell you, you are then trapped in a difficult cycle of raising the issue up the agenda and raising it up the hashtags.
When we are talking about problems on the internet more generally, we need much broader education on media literacy and critical thinking throughout our education system. That will not help us in the immediate future but, when we are talking about Covid, we can think about the nature of the Government’s communications and public information campaigns that will, in effect, inoculate people against the disinformation so prevalent in cyberspace. We need calm, factual, often quite detailed information that will educate the public about what is going on.
It is telling that we have seen a great deal of hunger among the public for briefings involving senior scientific officers and advisers. Some of them now have their own fan clubs and T-shirts. There is a real hunger for that kind of quality of information with clear scientific facts. That needs to come from all levels of the Government, including the politicians, not just the technical people. Let us trust the public with more information, data and facts, and with more of the difficulties and uncertainties, than we do now.
If one looks at the messaging in countries such as New Zealand and Germany, one can see that the level of detail and facts, and the quality of the information, given to their publics is much better than ours. Nearly every time there is a major government announcement or bit of advice, I see good technical people, senior professors and consultants on social media screaming in frustration about the quality of the presentation, data and messaging. I am talking not just about the shape of the graphs being wrong or whatever; we need to get the whole of government communications much better. That is the best way in which to tackle all these issues.
We all, even those of us with a scientific background, have learned a great deal more about IgG versus IgM versus IgA antibodies. A huge amount of information is out there, as is a hunger among people to find it. We must make sure that the good sources are there. That is the best way to tackle this problem when it comes to Covid and, indeed, much more broadly.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, this is an interesting debate and I am grateful to my noble friend Lady Thornton. We know that there is a problem with vaccine uptake, which is linked to anti-vaccine sentiment—though not necessarily always.
Looking back over the past few months, I note that there was in November a survey by Savanta ComRes on behalf of ITV News that found that almost 70% of people in the UK would like to receive a vaccination. More recently, in December, the Royal Society for Public Health published a poll showing that 76% of people would take the vaccine but, significantly, that only 57% of people from BAME backgrounds would do so. There was also a lower response among lower-income groups.
No doubt the Minister will give us figures, but my understanding is that the initial results on vaccine uptake are encouraging. However, we cannot be complacent in the face of the pernicious anti-vaccine sentiment around. Even before the pandemic, vaccine hesitancy was described by the WHO as one of the top 10 threats to global health.
We are interested in what the Government are doing. Last month, we debated this issue and the noble Baroness, Lady Evans, the Leader of the House, referred to the work of a central government unit on it. I should like to hear from the Minister about what is happening. We clearly need strong pro-vaccination campaigns, and the majority of people who may be described as vaccine hesitant are not necessarily anti-vaccine. Most people who are hesitant can be persuaded by good public health messages.
However, as my noble friend and other noble Lords have said, there has been a huge amount of misinformation across social media in the past few months. This is obviously cited by survey respondents as an area of concern when it comes to levels of trust in those delivering public health messages. As Scientists for Labour pointed out, since the recovery from the false findings around the MMR vaccine and autism from Mr Andrew Wakefield, the UK overall now ought to be in a good place when it comes to routine vaccine uptake. For example, the HPV vaccine has a consistent uptake of between 80% and 85%, which is an excellent return for a vaccine that is not part of early childhood schedules.
We do not have too much in the way of well-organised anti-vaccine groups, unlike the USA or, indeed, even the Republic of Ireland, so the likelihood is that the UK population will show less hesitancy about recently introduced vaccines compared with other countries. But the level of misinformation out there is high and we have to learn lessons from other recent vaccine scares. Clearly the Government have a huge challenge in making sure that the uptake of the vaccine is as high as possible—which is why I welcome this debate and the amendment, and very much look forward to the Minister’s response.
Lord Naseby (Con) [V]
My Lords, I declare an interest in that I am married to a retired general practitioner.
I congratulate the noble Baroness on her proposed new clause. Whether the detail is correct is another matter, but the principle that she is promoting is absolutely right. I make my observations as someone who, before he came into politics, was a senior director in the fifth-largest advertising agency in the world. I was actually handling the UK Government’s COI account—that is, the general one for specific purposes.
I have four observations. First, all misinformation must be refuted immediately, wherever it occurs—whether it is in the main media or other media. That is not just social media; it includes radio, TV, print, posters, et cetera. Secondly, every medical professional body must make it unequivocally clear that disinformation must be refuted. Thirdly, I suggest that all medical outlets should provide a clear statement, in poster format, for hospitals, surgeries, clinics and pharmacies. Fourthly, consideration should be given to how best to communicate with schools, universities and colleges.
In conclusion, we must all remember the terrible harm that was done to the MMR—measles, mumps and rubella—programme, largely by one pioneering rogue doctor. Against that background, I plead with the Minister to ensure that we have a robust new clause and a plan, worked on now so that it can be communicated instantly, if possible.
Baroness Jolly (LD) [V]
My Lords, I support this amendment to require
“the Secretary of State to publish a strategy for tackling antivaccination disinformation within one month of the Bill passing.”
The noble Baroness, Lady Thornton, has picked a fascinating, current topic, and the noble Baroness, Lady Bennett of Manor Castle, posed some pointed questions about the quality and effectiveness of the messages. I look forward to the Minister summing up on these points.
Misinformation is not new. I remember websites being used many years ago to persuade parents to ensure that their children had their childhood vaccinations at the appropriate time, and it is paramount that the Government take a robust stance against anti-vaccination disinformation. Research from Oxford University suggests that 12% of the UK population is “strongly hesitant” about taking the vaccine, with a further 16% unsure. Together, that makes 28%, a very significant proportion of the population—over a quarter. We are putting all our efforts into stopping the spread of this virus. This means that if the 28% avoid vaccination, they will run the real and severe risk of catching the virus; not only that, we will run the risk of catching it from them, so undoing all the benefits of the programme.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, what a helpful and instructive debate, and I thank all noble Lords who were involved.
In December 2020, we witnessed a landmark moment in our battle against Covid: the launch of an effective and safe vaccination programme, which has yielded great results. Thankfully, confidence in vaccines remains very high across the UK. None the less, some citizens have questions and there is a prevalence of misinformation. It is therefore absolutely and entirely right that we should answer those questions in the spirit of constructive dialogue, which is exactly what we seek to do.
I completely share the aspiration of the noble Baroness, Lady Bennett, for Covid to be an inflection point in a business model moving away from late-stage acute medicine toward prevention. Vaccines play an absolutely critical role in that, and this could be a profound legacy of this awful disease.
Despite all this, I completely recognise that we have also seen a range of baseless and sometimes absurd narratives being shared, particularly through social media platforms. It is completely unacceptable that a minority of people seek to exploit legitimate questions about vaccines and spread dangerous lies about vaccines for their own malicious reasons and profit.
Noble Lords will agree that it is vital that both misinformation and disinformation about vaccines are tackled. Before I address the Government’s response on how we will handle these two challenges, I pay tribute to the cross-party alignment on this issue and the spirit in which the noble Baroness, Lady Thornton, moved her amendment. Noble Lords from all sides of the House have shown a strong commitment to tackling anti-vax conspiracies and I express profound thanks for this tremendous collective effort, of which we can all be proud.
Throughout this pandemic, we have remained committed to transparency around the vaccine and to ensuring that people have access to accurate information about the virus and vaccines. DHSC is leading extensive cross-government communications activity, providing advice and information to anyone who has questions about the vaccine.
I do not think it would be helpful for me to run through our efforts in this area in detail, but I reassure noble Lords that we have worked, and continue to work, extremely hard to rebut false information online. In March 2020, we stood up the Counter Disinformation Unit, bringing together cross-government monitoring and analysis capabilities to tackle misinformation and disinformation. The Government have worked tirelessly to act wherever false and harmful content appears on social media platforms, either by flagging the content to the platforms or through direct rebuttal on social media via our Rapid Response Unit.
We are particularly committed to dialogue with and the protection of communities that might be particularly susceptible to disinformation and which, coincidentally, are particularly vulnerable to the virus. I thank all those involved in those efforts, including ministerial colleagues and noble Lords. I note the reference by the noble Baroness, Lady Thornton, to my noble friend Lady Warsi’s optimistic update in this area.
I turn to the point the noble Baroness’s amendment makes about requiring social media platforms to remove and demonetise anti-vaccination content. My noble friend Lady Cumberlege’s points on this are extremely valid. The Government have already secured commitments from platforms such as Facebook, Twitter and Google to the principle that no company should profit from or promote anti-vaccine misinformation and disinformation, and to respond to that content much more swiftly. We are holding platforms to these commitments and have set a series of policy forums in motion, bringing together platforms, academia and civil society organisations to better develop responses to online misinformation and disinformation. These forums are chaired by my ministerial colleagues in DCMS, to whom I give thanks. I attend them and can report back that they have a constructive and thorough approach.
I understand the concern that noble Lords have about anti-vaccination content and the harm it causes. I stress that the Government are totally committed to working with the platforms and other key stakeholders to combat that content and to build public trust in our vaccination programme. I point noble Lords to the continued high rates of Covid-19 vaccine uptake that we see, which have been achieved in part by our effective approach to tackling vaccine misinformation and disinformation. We are not complacent; we are on the case. Therefore, for that reason, I hope that the noble Baroness, Lady Thornton, sees the Government’s efforts in this area and feels able to withdraw her amendment.
Baroness Thornton (Lab) [V]
I thank the Minister for that comprehensive answer. I particularly thank what I can describe only as a bouquet of Baronesses—the noble Baronesses, Lady Altmann, Lady Bennett, Lady Masham and Lady Cumberlege—for their support. I say to the noble Baroness, Lady Cumberlege, fear not: if I had intended to have a Division on this I would have given her pre-warning, do not worry. I also thank my noble friend Lord Hunt for his pertinent questions and the noble Lord, Lord Naseby, for his four action points, which were instructive and useful.
This has been a useful debate that has been worth having, because we have so few opportunities to knock around issues that we all agree on and really want to support the Government to get right. That is why I tabled the amendment. I am very happy with the response to it and I beg leave to withdraw the amendment.
The Deputy Speaker (Lord Faulkner of Worcester) (Lab)
We now come to the group beginning with Amendment 17. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in the group to a Division must make that clear in debate.
Clause 7: Disclosure of information in accordance with international agreements
Amendment 17
Lord Bethell
Member’s explanatory statement
This amendment and the amendment in the Minister’s name to add a definition of “relevant person” to Clause 7 restrict the persons to whom information may be disclosed in reliance on Clause 7(2).
Lord Bethell (Con)
My Lords, in moving Amendment 17 I will speak also to Amendments 19, 22, 23, 25, 35, 37, 38, 55, 56 and 58 to 62. All amendments in the group deal with the sharing of information outside the UK where this is required to give effect to an international agreement or arrangement.
I have listened to the concerns raised by noble Lords as to further safeguards that could be provided in relation to Clauses 7, 12 and 37(5), and the amendments made in Grand Committee. I am enormously grateful to noble Lords who have met and spoken to me and my team over the weeks between Grand Committee and Christmas. Their further explanations and collaborative spirit have been enormously valuable. I can say confidently that this collaboration has definitely improved the drafting of the Bill.
It is worth saying first that the Bill introduces powers for international information sharing only where it is pursuant to international agreements or arrangements concerning the regulation of human medicines, medical devices or veterinary medicines. As such, we are starting from a place where it is in the public interest for data to be shared to support the safety of human medicines, medical devices and veterinary medicines in the UK and globally.
As I explained in earlier debates, information sharing with other regulators plays an absolutely critical role in the work of the MHRA and the VMD to protect patient safety and to support international collaboration. For example, in medical device safety investigations, international information sharing allows for better signal detection and gathering of evidence to support the safety of medical devices available on the UK market. It is worth saying that failure to share that data has been one of the contributing factors to many patient safety issues. However, it is right that we ensure that when the MHRA and the VMD share information they do so with the appropriate persons. These amendments will ensure that.
Nevertheless, I have heard the concerns about the use of the term “persons” and whether this may be subject to broad interpretation. Noble Lords will agree that including in the Bill an exhaustive list of named organisations we share data with is not practical. Therefore, we have amended Clauses 7, 12 and 37 to include a definition of “relevant person”. These amendments clarify the types of persons outside the UK that information may be shared with. In short, they make it clear that these clauses do not offer a “blank cheque”.
We also heard concerns from noble Lords in Committee about the sharing of patient-identifiable information internationally. Clauses 7 and 37 already include safeguards to protect personal and commercially sensitive information, and there are additional safeguards in data protection legislation. However, we are keen to provide additional reassurance. That is why we have tabled further amendments that ensure that patient-identifiable information can be shared only if patients have provided consent.
In the vast majority of cases patient information is anonymised before being shared. These amendments account for the rare instances where it is necessary to share patient-identifiable data internationally to support our commitment to uphold patient safety; for example, in sharing patients’ concerns with an international regulator about a clinical trial they are taking part in in another country.
Finally, Amendments 22, 37 and 59 seek to clarify that the information-sharing powers in the Bill do not limit the circumstances in which information can be shared under any other enactment or rule of law. Such housekeeping amendments can be found as standard in many Acts and will ensure that the powers in the Bill cannot be construed as replacing existing statutory, prerogative or common laws of disclosure, which is not the intention. In introducing these amendments we seek simply to remove any potential confusion over what the powers in the Bill are intended to deliver.
I say again that I am enormously grateful to all noble Lords for their constructive challenge and thoughtful contributions on this subject. International information sharing is fundamental to the effective functioning of the MHRA and the VMD, but it is of vital importance that data is shared with care and that the appropriate safeguards are in place. I believe that our amendments deliver this balance. I beg to move.
Lord Patel (CB) [V]
My Lords, before I address the amendment from the noble Baroness, Lady Thornton, I reciprocate by thanking the Minister enormously for the many meetings he and his colleagues have had with all of us who are trying better to understand what the Government are trying to do with the Bill, particularly with these amendments. I agree that there are times, including in clinical trials—I have done this—when there is a need to share information with people involved in trials not only in the United Kingdom but overseas. I will come back to that in a minute.
Lord Clement-Jones (LD) [V]
My Lords, it is a pleasure to follow the noble Lord, Lord Patel. I support and will speak to Amendments 18, 36 and 57, which have been so well introduced and explained by him, and which I have signed, and will speak to my own Amendment 20.
We have had discussions on this Bill and the Trade Bill about health data and trade issues. The two Bills are intimately connected, and this amendment is very complementary to Amendment 11, passed on Report of the Trade Bill on 7 December. There was no debate or discussion about the new Clauses 7 and 12 and the new subsection in Clause 37 when they were introduced in Grand Committee. On both counts it is therefore vital that we get to grips with them today. I welcome the Minister’s new amendments, which he has spoken to and which take us a step further in terms of patient consent, definition of information and relevant persons. But I have signed, and these Benches support, the additional amendments to those clauses and subsection put forward by the noble Baroness, Lady Thornton, to ensure that we further tighten these provisions. Specifically, we want to tie this to international co-operation on pharmacovigilance or in monitoring the performance and safety of medical devices, and a public interest test put around the disclosure of health data, for all the reasons put forward by the noble Lord, Lord Patel.
As I said when the House debated these issues on Report of the Trade Bill and later passed the amendment, NHS data is a precious commodity, especially given the many transactions between technology, telecoms and pharma companies concerned with NHS data. I cited a recent report in which EY estimated that the value of NHS data could be around £10 billion a year in the benefit delivered, and the fact that the Department of Health and Social Care is preparing to publish its national health and care data strategy shortly, in which it is expected to prioritise the
“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes.”
I mentioned too that, while acknowledging that the UK is a leading player in the fields of life sciences and biosciences, health professionals have strongly argued that free trade deals risk compromising the safe storage and processing of NHS data in much the way that the noble Lord, Lord Patel, has mentioned.
Through the amendment to the Trade Bill from the noble Baroness, Lady Thornton, and likewise this amendment, the objective is to ensure that it is the NHS, not US big tech companies and drug giants, that reaps the benefit of all this data. This is especially important given what the Ada Lovelace Institute called in its report, The Data Will See You Now, the “datafication” of health, which, it says, has profound consequences for who can access data about health, how we practically and legally define health data, and our relationship with our own well-being and the healthcare system. Health information can now be inferred from non-health data, and data about health can be used for purposes beyond healthcare. Harnessing the value of healthcare data must therefore be allied with ensuring that adequate protections are put in place in trade agreements, if that value is not to be given or traded away.
At the time, I raised questions about the provisions of the UK-Japan trade agreement, and there is no doubt that these questions will linger unless an amendment of this kind, to both this Bill and the Trade Bill, goes forward.
There have been many shortcomings in the sharing of data between various parts of the health service, care sector and Civil Service. The development of the Covid-19 app and the way that the Government have procured contracts for data management with the private sector have not improved public trust in their approach to data use. That is why clear safeguards are needed to ensure that, in trade deals and international agreements, our publicly held data is safe from exploitation where it is not for public benefit.
On Tuesday, the Minister heavily emphasised the public interest test that he wanted to see applied to the sharing and use of Clause 3 information. The data covered by Clauses 7, 12 and 37 is even more important. He used the same language today and in correspondence, so I hope he can accept these amendments. As the noble Lord, Lord Patel, has said, we also want to see the aspect of patient consent clarified.
I turn briefly to Amendment 20. I welcome the Minister’s Amendment 19, but Amendment 20 is designed to get the Minister to further clarify what is meant by “consent” in Clause 7. Informed consent is very much a familiar concept in healthcare, especially in treatment and trials, and, indeed, that is effectively the definition on the NHS website. It depends on capacity, explanation, understanding and it being voluntary. That is why my amendment would insert the word “informed”, to make it abundantly clear that, at the very least, that is what is intended here. I look forward to the Minister’s reply.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to follow the noble Lord, Lord Clement-Jones, and I welcome the opportunity to debate this important group of amendments. I welcome the government amendments, but feel that my noble friend Lady Thornton’s amendment is very important, as indeed are some of the others in this group.
I have always been strongly in favour of using patient information. It is a rich source of data for scientists to pursue in the search for medical advances. We all benefit, and I am sure that the great majority of the public see this and are agreeable to information being shared. But we must have appropriate safeguards, and that is why the government amendments to restrict the persons to whom information may be disclosed, and the addition of a definition of patient information and the need for individual patient consent, are all very welcome.
My understanding, however, is that information pertaining to patients can be shared where it has been rendered non-identifiable. As the University of Birmingham has commented, this may be in line with current data protection principles but there is still a danger of a care.data-type problem, in that the provisions might allow the Government to share with “relevant persons”—as they are now called—outside the UK information they hold on patient data through NHS bodies without consent when anonymised. The noble Lord, Lord Patel, referred to some of the issues with care.data. The stricter definition of patient information may address some of the concerns that the definition of patient data—being restricted to identifiable data—left anonymised data open for use or barter as part of international agreements. Part of this broader concern is that aggregate data can reveal patterns that may allow for re-identification, especially for small patient clusters in respect of rare diseases and conditions.
Lord Freyberg (CB)
My Lords, I was privileged to speak at some length about the provisions of this Bill in Grand Committee, and I thank those who supported the amendments in my name, which concerned the role of cutting-edge, data-driven medical devices. The Minister has since reassured me of his intention to further explore their implications in the course of a consultation exercise about their definition and regulation over the coming year. Like the noble Lord, Lord Patel, I want to put on record my gratitude for the way that he has facilitated these discussions.
The amendments that I rise to support today seek to protect patient information, including what is properly “special category data” in the Data Protection Act 2018, which is crucial in the development of new pharmaceutical products and medical devices.
Of course, it goes without saying that efforts to facilitate the flow of data in the context of the ongoing health emergency are vitally important. These are extraordinary circumstances in which we find ourselves. Today, however, we must take steps with an eye to the long term; steps that will introduce legal provisions to prevent a situation that might give rise to undue concern or restrict scrutiny of matters pertaining to patient safety in the future, both at home and overseas.
I am certain that the Minister is well aware of public sentiment concerning privacy and data protection, which are, of course, not limited to the healthcare domain. Maintaining the trustworthiness of organisations that function as stewards of the nation’s healthcare data is paramount, and a carefully considered approach to patient safety is needed to preserve that trustworthiness, as the Government move to improve upon and forge new international arrangements.
The Minister’s amendments make it mandatory for consent to be provided where patient information is being shared with territories outside the United Kingdom. The noble Baroness, Lady Thornton, has tabled clarifying amendments to ensure that the purpose for which patient information is being shared is limited to patient safety and its scrutiny. For these reasons, I support Amendments 18, 36 and 57, to which I have added my name.
Lord Lansley (Con) [V]
My Lords, I am very glad to follow the noble Lord, Lord Freyberg, who has made some very cogent points, both in that speech and when we discussed these clauses in Grand Committee.
I want to make two points. The first is about the structure of Amendment 18. I am not entirely sure that I understand why pharmacovigilance has been singled out in the amendment as a reason why disclosure should be made, as distinct from, for example, public health co-operation or the pursuit of research. Indeed, the Minister referred to the sharing of information in relation to international clinical trials as a very good example. If one were to legislate in this form, it would be inevitable that the reference to pharmacovigilance would be regarded as having additional weight, and the absence of reference to other purposes for which information would be shared would be regarded as less important. I am not sure that that would be at all helpful to have in statute.
My other point is in relation to Clause 7(5). Government Amendment 22 refers to and introduces a provision that assists in understanding the relationship between this legislation and other enactments concerning the disclosure of information. Clause 7(5) states:
“Nothing in this section authorises a disclosure of information which … contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section)”.
Noble Lords may recall the Trade Bill and, in particular, the debate we had on the Trade (Disclosure of Information) Act just before Christmas and new year. We passed legislation the purpose of which was, among other things, to ensure that we clarified the relationship between that enactment and others that authorise disclosures of information or, in some circumstances, prohibit such disclosures. The particular basis for the structure of that Bill was to clarify a situation where there is a statutory gateway and other enactments that put constraints on the disclosure of information.
In subsection (5) it is clear that if someone is considering a disclosure that might contravene the data protection legislation, that legislation must be considered alongside the powers in this legislation. That enables them to satisfy the test in the Christian Institute and others v The Lord Advocate 2016 Supreme Court decision, as referred to in my noble friend Lord Grimstone’s letter to us about the Trade Bill. In the Trade Bill, though, as is the case in this Bill, we have reference both to the data protection legislation and to the Investigatory Powers Act. In the Trade Bill, amendments were introduced on Report to ensure that the saving reference—that is, when determining whether a disclosure would contravene the legislation, it takes into account the powers in this section—was applied to both the data protection legislation and the Investigatory Powers Act. However, in this legislation—Clause 7(5)(b) —the saving reference is applied to the data protection legislation but not to the Investigatory Powers Act.
My question, which I am sorry I have not had an opportunity to give the Minister notice of, as I have started working through these issues only very recently, is this. Having dealt with this matter on the Trade Bill, I would have thought that both these subsections should have the saving reference that allows the question of the contravention of those Acts to be considered, including reference to the powers in this Bill. I wonder if he would agree.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I am delighted to follow my noble friend, who speaks with such great authority both as a former Secretary of State for Health and as someone who has followed the Trade Bill and the Trade (Disclosure of Information) Act so closely.
At the risk of dancing on the head of a pin, the amendments in this group are quite close, and the Minister set out every reason why we should support his Amendment 17. He said that information would be shared only in the circumstances where there is perceived to be a public need. The amendments and explanatory statement of the noble Baroness, Lady Thornton, refine that by saying that, in the context of giving effect to an international agreement or arrangement concerning the regulation of human medicines, it should be disclosed only provided that it is in the public interest to do so. A number of noble Lords have spoken with great eloquence and passion on these issues, including the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, and my noble friend Lord Lansley. I have to say that I personally would draw the line at disclosing information for a commercial need as opposed to a public one.
I have a particular question about Amendment 19, which clearly states that patient information cannot be disclosed where the patient could be identified and that that information cannot be given without their consent. I remember that I was once asked to participate in a study; I signed the form and was delighted to do so, and never heard any more about it. I would just like to know how Amendment 19 would work in practice. At what point, and by whom, would the patient be contacted if that information was about to be disclosed and their consent sought?
I have reservations about this group. I remember the important debate that we had on the Trade Bill in this regard, and I am delighted to see that those issues are being considered in the context of this Bill as well. I have two concerns that I hope can be allayed. The first is that public need should not be deemed to collude with commercial need where it might not be in the interests of the patient. The second is about informed consent: how will the patient be consulted within the provisions of Amendment 19?
Baroness Cumberlege (Con) [V]
My Lords, this has been an interesting and well-informed debate, and I am quite reluctant to enter into it. I support government Amendment 19 and particularly Amendment 20 tabled by the noble Lord, Lord Clement-Jones. I hope I have got this right, although I am very happy to be put right if I have not. As I understand it, Amendments 19 to 25 concern consent, relating very specifically to the disclosure of information in accordance with international agreements. This is information that I think a relevant authority such as the MHRA holds in connection with human medicines.
As I listened to the noble Lord, Lord Freyberg, he raised a question in my mind about devices. We know that pharmaceuticals are much more closely regulated than devices have been, so can the Minister tell us a bit more about instances where there is a comparable agreement, and perhaps an amendment, for medical devices? I want to know whether they are on all fours with pharmaceuticals. I suspect not. Having listened to the noble Lord, Lord Freyberg, I think that there is more to hear on this.
Lord Naseby (Con) [V]
It is a pleasure to follow my noble friend Lady Cumberlege, who has gone into great detail on these amendments. As far as I can see, these are mainly government amendments, plus some from other parties, and they are all broadly to be welcomed. The question I ask myself is: where are the boundaries to be set?
Very helpfully, the Minister, in his opening statement, explained in some detail the extent of information-sharing outside the UK and gave the example of the safety of medical devices. Having listened to my noble friend and the others who have contributed, I am still not quite sure about Amendments 18 and 20. I can see where they are coming from and can understand what is behind them but on this occasion I will have to listen to the Minister. These are sensitive areas and certainly we in the upper House should listen. I am also not entirely clear from the Minister’s statement at the beginning what the implications of Amendment 22 are. There has already been a good deal of coverage and I will not add to it further.
Baroness Jolly (LD) [V]
These amendments relate to the use of data and information sharing. The noble Baroness, Lady Thornton, my noble friend Lord Clement- Jones and the noble Lord, Lord Patel, have put their names to some of them. The noble Lord, Lord Freyberg, outlined clearly in the context of trade and health the power and value of data. Data is a hugely rich source for research but also a hugely valuable commodity, so we need safeguards.
Concern was raised in Committee about the level of protection in the Bill for patient information, as regulations are able to make provision about the disclosure of such information. I am grateful to the Minister for being so willing to look at this again.
The Government have responded in two main ways: with the introduction of a definition of “relevant person”, thereby narrowing the definition of whom data can be shared with, and by defining what is meant by patient information. As the noble Lord, Lord Patel, explained, Amendment 24 in the name of the noble Baroness, Lady Thornton, strengthens the definition of patient information to protect information that could identify a patient, rather than just information that does.
Amendments 18, 36 and 57, led by the noble Baroness, Lady Thornton, and supported by my noble friend Lord Clement-Jones and others, would allow a relevant authority to disclose information to a person outside the UK only where required for the purpose of giving effect to an international agreement or an arrangement concerning the regulation of human medicine, provided it was within the public interest so to do. Those three amendments all pass the test put forward by the noble Baroness, Lady McIntosh of Pickering, concerning public good.
Amendment 20, from my noble friend Lord Clement-Jones, would take the Government’s amendment on patient consent further by ensuring that consent given in relation to identifiable information was informed consent. The noble Baroness, Lady Cumberlege, has just raised the issue. We should not need this. Informed consent should be the default but, as it clearly is not, I support my noble friend’s Amendment 20.
Similarly, Amendment 21, in the name of the noble Baroness, Lady Thornton, would ensure that patient information could be shared by an appropriate authority only if the individual to whom it related had given their explicit consent.
These amendments strengthen the Bill and therefore patient outcomes. I will listen to the Minister to see what plans the Government have to satisfy noble Lords on this group.
Baroness Thornton (Lab) [V]
My Lords, I thank all noble Lords who have taken part in this debate. I will speak to the amendments in my name, and give notice that I will test the opinion of the House on Amendment 18, along with Amendments 36 and 57, all of which are supported by the noble Lords, Lord Patel, Lord Freyberg and Lord Clement-Jones. This is unless—of course, I always live in hope—they are agreed to by the Minister.
Turning to the other amendments in my name in this group, I just want to put on record how grateful we are on our Benches for the way that the Minister and the Bill team have worked on these important issues, and how much we support the amendments that he has tabled. We do not see these amendments as in opposition; we see them as amplification and clarification.
Amendment 24 is a probing test for whether aggregate data could identify individuals through de-identification or de-anonymisation practices. The Government’s amendments define patient information as data that
“identifies the individual or enables the individual to be identified (whether by itself or in combination with other information)”.
This represents a welcome tightening up of the definition to include scenarios where contextual information might allow de-identified data to become identifiable. This is very important given that aggregate data can reveal patterns which allow for reidentification, especially for small patient clusters as in rare diseases and conditions. Given the rapid development of sophisticated technology, my Amendment 24 probes the test for whether anonymised aggregate data could identify individuals through this. I hope the Minister will be able to assure the House that the appropriate safeguards and checks are in place.
Amendment 21 would ensure that patient information
“can only be shared by an appropriate authority if the individual to whom it relates has given their explicit (‘opt-in’) consent.”
We welcome the Government’s requirement for consent to share patient information. However, they have not specified how this consent mechanism will work in practice. This amendment in my name would ensure that important distinction, which has been mentioned by many noble Lords across the House. Other noble Lords have also mentioned care.data, which, because of a lack of clarity about the use of data, did not work. I hope the Government will be able to assure us that explicitly informed consent will be sought and secured.
Under Amendment 18, followed by Amendments 36 and 57, data would be disclosed to persons under international agreements or arrangements only for pharmacovigilance or if “in the public interest”. I hope the public interest bit answers the question from the noble Lord, Lord Lansley. I thank the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, my noble friend Lord Hunt and other noble Lords for their support for this suite of amendments.
Overall, the government amendments narrow discretion and set out in more detail the purposes for the information-sharing powers. However, in our view they still potentially allow for the disclosure of patient data without consent to commercial partners for undefined, and therefore unknown, purposes to be settled as part of international agreements or trade deals. That is why the helpful read-across to the Trade Bill by the noble Lords, Lord Freyberg, Lord Clement-Jones and Lord Patel, is so important. We recognise that information-sharing and disclosure may be necessary to allow smooth functioning and support internationally on pharmacovigilance, for example, but remain concerned that NHS data—which has been described as a treasure trove, worth perhaps £9.6 billion—could be bartered as part of commercial interests in trade deals.
Amendment 18, along with Amendments 36 and 57 in my name, would allow the Secretary of State to disclose NHS data only under the terms of an international agreement or trade deal for pharmacovigilance, of if it is otherwise in the public interest. We believe “the public interest” is a legitimate test that would offer reassurance that substantive and ethical issues relating to the sharing of data would at least be considered. I hope the Minister will recognise the value of this amendment; otherwise, as I say, I would like to test the opinion of the House.
Lord Bethell (Con)
My Lords, we are enormously grateful to the noble Baroness, Lady Thornton, and the noble Lord, Lord Clement-Jones, for their Amendments 20 and 24 to one of my own amendments to Clause 7. These amendments seek to ensure that patient information can be shared by an appropriate authority only if the individual has given their explicit or informed consent, respectively. I completely recognise the commendable intent behind both amendments to safeguard and protect patient safety. Their intentions are benign but they are absolutely not necessary.
My lived experience for the past year has been completely aligned with the words of the noble Lords, Lord Clement-Jones and Lord Freyberg. Data is absolutely key. I have spent my time outside the Chamber working on little else: clearing the path for patient recruitment to clinical trials, so that therapies can be designed to save lives; getting data on long Covid patients from primary care to those researchers and clinicians who are trying to help them, which is an extremely complex and onerous task; getting central tracing data to local infections teams, which means transferring it between various jurisdictions; getting people to record the tests they take, which is a legal requirement but legally and technically difficult to implement; and getting test results from those who have taken them into their GP records. Most bizarrely, to me at least, I have been getting data-sharing agreements in place so that local authorities, which are crying out for the data—as their representatives here in this very Chamber cry out to me at the Dispatch Box for it—can access the dashboards with those legal agreements; or getting the data on those who may need support isolating into the hands of those charities and local authorities which are keen to support them.
Every step of the way, there has been an onerous set of legal, ethical and bureaucratic barriers. Speaking on the back of that experience, I wonder whether scientific deduction and patient safety are sometimes sidelined by other considerations. I therefore warn about measures that are driven by prejudice or secondary principles, rather than the priorities of trying to save lives and pursue science. Their unintended consequences can have a profound, stifling effect on patient safety, medical research and innovation, and on the effective running of a modern healthcare system. I can think of so many incidents where the need for data-sharing agreements, legally obtuse patient consents and all sorts of rarefied ethical reviews have caused major life-threatening obstacles and troubling issues in our response to Covid.
I know that the measures in these amendments are well intended, but I assure noble Lords that they are not necessary. For instance, Clause 7 accounts for the rare instances where it is necessary for the MHRA to share identifiable patient information internationally to support our commitment to upholding patient safety. I take this opportunity to assure noble Lords not only that this will be done only with the informed consent of the patient but that the practical implementation of some of the very measures in this Bill, such as the medical information system, will require these kinds of measures. It seems counterproductive for us to be undoing the benefits of our own information system.
Amendment 21 in the name of the noble Baroness, Lady Thornton, seeks to broaden the definition of patient information to include information that could enable identification. I reassure the noble Baroness that the MHRA absolutely follows the Information Commissioner’s gold standard practices on patient data anonymisation. In order to be truly anonymised under GDPR, sufficient personal data is always stripped out so that, not only can the individual not be identified, but reasonably available means could also not enable the recipient to re-identify the individual. As such, if patient information to be shared still enables the patient to be identified, for example due to the unique nature of their condition, the amendment in my name will provide sufficient protection by requiring that patient’s consent be sought before sharing their information. The MHRA keep anonymisation processes under review in line with the ICO’s guidelines and continue to monitor advances in data technology.
We have heard from the noble Baroness, Lady Thornton, and the noble Lords, Lord Patel and Lord Clement-Jones, on their Amendments 18, 36 and 57, which seek to limit the purpose for which information can be shared internationally under the powers. It is important to highlight that we could only disclose information under this power where disclosure is required in order to give effect to an international agreement or arrangement concerning the regulation of human medicines, medical devices or veterinary medicines. In that regard, the clause already allows disclosure only for a particular purpose. As international co-operation in this area is important and a good, even necessary, thing, such agreements or arrangements would be in the public interest by default. The UK meeting its international obligations under these agreements and arrangements would be even more so. Furthermore, the MHRA and VMD do not share information for commercial gain—on that point I want to be absolutely categoric. Therefore, I am persuaded that these amendments are accordingly unnecessary.
We have introduced a number of amendments to these powers to clarify the types of person with whom information can be shared and, for those instances when it is necessary to share identifiable patient data internationally, introduced a lock that ensures that data can be shared only with consent. These amendments are, of course, in addition to existing data protection legislation and ICO guidance. I can assure the noble Lords that we are not complacent when it comes to the safe and appropriate use of patient data. We understand that, as technology advances, we will need to continually review the way in which we anonymise data to ensure that it remains just that.
I hope this provides noble Lords with assurance that the Bill and the additional amendments in my name provide robust safeguards to protect patient information, alongside long-standing data protection legislation already in place, and that they will not press their amendments.
Baroness Thornton
“( ) Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—(a) it is required as part of international cooperation for pharmacovigilance; or(b) it is in the public interest.”Member’s explanatory statement
This amendment would allow a relevant authority to disclose information to a person outside the UK where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicine provided it is within the public interest to do so.
Baroness Thornton (Lab) [V]
I beg to move, and I wish to test the opinion of the House.
Lord Bethell
“(4A) Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.”Member’s explanatory statement
This amendment and the amendment in the Minister’s name to add a definition of “patient information” to Clause 7 prevent Clause 7 authorising the disclosure of information from which patients can be identified without their consent.
The Deputy Speaker (Lord Russell of Liverpool) (CB)
Does the noble Lord, Lord Clement-Jones, wish to move Amendment 20, as an amendment to Amendment 19?
Lord Clement-Jones (LD) [V]
[Inaudible]—very much about informed consent, but, nevertheless, I will not move the amendment.
Lord Bethell
“(5A) This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”Member’s explanatory statement
This amendment provides that Clause 7 does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.
Lord Bethell
““patient information” means information (however recorded) which—(a) relates to—(i) the physical or mental health or condition of an individual, (ii) the diagnosis of an individual’s condition, or(iii) an individual’s care or treatment,or is (to any extent) derived directly or indirectly from information relating to any of those matters, and(b) identifies the individual or enables the individual to be identified (whether by itself or in combination with other information);”Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name adding a new subsection (4A) to Clause 7.
Lord Bethell
““relevant person” means—(a) the government of a country or territory outside the United Kingdom;(b) a person who exercises functions on behalf of such a government;(c) any other person who exercises functions or provides services relating to human medicines in a country or territory outside the United Kingdom;(d) an international organisation that exercises functions or provides services relating to human medicines.”Member’s explanatory statement
See the explanatory statement to the first amendment to Clause 7 in the Minister’s name.
The Deputy Speaker (Lord Russell of Liverpool) (CB)
Does the noble Lord, Lord Patel, wish to move Amendment 26?
The Deputy Speaker (Lord Russell of Liverpool) (CB)
Does the noble Baroness, Lady Thornton, wish to move Amendment 27?
Baroness Thornton (Lab) [V]
I thought these amendments were part of the group that was passed on Tuesday?
Baroness Penn (Con)
The noble Baroness is correct that Amendment 27 is consequential to an amendment agreed on day 1 of Report, so she may wish to move it.
Baroness Thornton (Lab) [V]
I think Amendment 26 is similar, possibly. We may need some guidance from the clerk. Was Amendment 26 also related to the group of amendments that were agreed on Tuesday? I apologise; it is always difficult to do these things when you are not actually in the Chamber.
Baroness Penn (Con)
My understanding is that Amendment 26 is also consequential to amendments passed on day 1 of Report, so we may wish to ask the noble Lord, Lord Patel, whether he wishes to move his amendment, which is consequential to previous amendments agreed.
The Deputy Speaker (Lord Russell of Liverpool) (CB)
I will go back to Amendment 26. Does the noble Lord, Lord Patel, wish to move Amendment 26?
The Deputy Speaker (Lord Russell of Liverpool) (CB)
Does the noble Baroness, Lady Thornton, wish to move that amendment?
Baroness Thornton
“Requirement for draft consolidated legislation: human medicines
The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to human medicines.”Member’s explanatory statement
This new Clause, and the other consolidation amendments in the name of Lord Patel, would require the Secretary of State to publish draft consolidated legislation within three years to streamline the existing regulatory framework. These amendments are linked to the amendment providing for a three year sunset provision in the name of Baroness Thornton.
Baroness Thornton
Member’s explanatory statement
This amendment provides a sunset provision for Part 2 of the Bill requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 1 and 3 of the Bill, and the amendments in the name of Lord Patel requiring consolidated legislation.
Baroness Jolly
“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Lord Bethell
Member’s explanatory statement
This amendment provides that the appropriate authority’s overarching objective in making regulations under Clause 9 must be to promote one or more of the following: the health and welfare of animals; the health and safety of the public; the protection of the environment.
Member’s explanatory statement
This amendment is consequential on the amendment to Clause 9(2) in the Minister’s name.
Member’s explanatory statement
This amendment omits the word “attractive” from Clause 9(3)(c).
(i) develop veterinary medicines, or(ii) manufacture or supply veterinary medicines.”Member’s explanatory statement
This amendment clarifies the meaning of Clause 9(3)(c).
Lord Bethell
“(3A) Where regulations under subsection (1) may have an impact on the safety of veterinary medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”Member’s explanatory statement
This amendment provides that the appropriate authority may make regulations that may have an impact on the safety of veterinary medicines only if the authority considers that the benefits of doing so outweigh the risks.
Lord Bethell
Member’s explanatory statement
This amendment and the other amendment to clause 12 in the Minister’s name restrict the persons to whom information may be disclosed in reliance on Clause 12(2).
Baroness Thornton
“( ) Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—(a) it is required as part of international cooperation for pharmacovigilance; or(b) it is in the public interest.”Member’s explanatory statement
This amendment would allow a relevant authority to disclose information to a person outside the UK where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicine provided it is within the public interest to do so.
Lord Bethell
“(5A) This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”Member’s explanatory statement
This amendment provides that Clause 12 does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.
““relevant person” means—(a) the government of a country or territory outside the United Kingdom;(b) a person who exercises functions on behalf of such a government;(c) any other person who exercises functions or provides services relating to veterinary medicines in a country or territory outside the United Kingdom;(d) an international organisation that exercises functions or provides services relating to veterinary medicines.”Member’s explanatory statement
See the explanatory statement to the other amendment to Clause 12 in the Minister’s name.
Lord Patel
“Requirement for draft consolidated legislation: veterinary medicines
The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to veterinary medicines.”Member’s explanatory statement
This new Clause, and the other consolidation amendments in the name of Lord Patel, would require the Secretary of State to publish draft consolidated legislation within three years to streamline the existing regulatory framework. These amendments are linked to the amendment providing for a three year sunset provision in the name of Baroness Thornton.
Baroness Thornton
Member’s explanatory statement
This amendment provides a sunset provision for Part 3 of the Bill requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 1 and 2 of the Bill, and the amendments in the name of Lord Patel requiring consolidated legislation.
Baroness Jolly
“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
The Deputy Speaker (Lord Russell of Liverpool) (CB)
My Lords, I should inform the House that, if Amendment 45 is agreed to, I shall not be able to call Amendment 46 by reason of pre-emption, and that the debate on the group beginning with Amendment 46 will be postponed and take place on Amendment 66.
Amendments 42 to 45
Lord Bethell
“(2) In making regulations under subsection (1), the Secretary of State’s overarching objective must be safeguarding public health.”Member’s explanatory statement
This amendment provides that the Secretary of State’s overarching objective in making regulations under Clause 14 must be safeguarding public health.
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name substituting Clause 14(2).
Member’s explanatory statement
This amendment omits the word “attractive” from Clause 14(3)(c).
(i) carry out research relating to medical devices,(ii) develop medical devices, or(iii) manufacture or supply medical devices.”Member’s explanatory statement
This amendment clarifies the meaning of Clause 14(3)(c).
Lord Bethell
“(4) Where regulations under subsection (1) may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if the Secretary of State considers that the benefits of doing so outweigh the risks.”Member’s explanatory statement
This amendment provides that the Secretary of State may make regulations that may have an impact on the safety of medical devices only if the Secretary of State considers that the benefits of doing so outweigh the risks.
Baroness Jolly
“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
The Deputy Speaker (Lord Russell of Liverpool) (CB)
We now come to the group beginning with Amendment 50. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in this group to a Division must make that clear in debate.
Amendment 50
Lord Bethell
“Advisory committee
(1) The Secretary of State may by regulations establish, and make other provision about, a committee to advise the Secretary of State on such matters relating to medical devices as the regulations may specify.(2) The regulations may (among other things) make provision about—(a) the membership of the committee;(b) the establishment by the committee of sub-committees;(c) matters to which the committee may, or must, have regard;(d) cooperation between the committee and the Commission on Human Medicines, and other bodies with expertise in relation to medical devices.(3) The provision mentioned in subsection (2)(a) may include—(a) provision about the number of members, their appointment, and the circumstances in which a person ceases to be a member;(b) requirements as to the independence of members from the Secretary of State;(c) provision about the payment of remuneration and allowances to members.”Member’s explanatory statement
This new Clause would enable regulations to be made creating a statutory committee to provide advice to the Secretary of State in relation to medical devices.
Lord Bethell (Con)
My Lords, in moving Amendment 50, I shall speak also to Amendments 64 and 96. We have spoken extensively about the critical importance of patient safety and the need to improve medical device safety in bold new regulations going forwards. The need for medical device scrutiny to the highest standards was expressed by noble Lords throughout Grand Committee and, of course, in the report of my noble friend Lady Cumberlege. We recognise that improved and strengthened post-market surveillance and vigilance is essential. Equally, it is critical that we take further steps to strengthen oversight and increase transparency behind regulatory decision-making. Amendment 50 would support those efforts.
This new clause provides the Government with the power to create a statutory committee for independent expert advice on matters relating to medical devices. Historically, systems for post-market surveillance for medicines and medical devices have evolved differently. However, given scientific and technological advances and the kinds of innovative products and treatments becoming available, whether classed as medicines or medical devices, there is now need for greater assurance of equally high standards of surveillance, to ensure the upmost protection of patients.
The Commission on Human Medicines, which has a statutory basis in the human medicines regulations, provides an expert independent view to the MHRA on human medicines. It is visible and is underpinned by a statutory footing in the Human Medicines Regulations 2012. There is a parallel set of experts for medical devices. The Devices Expert Advisory Committee, or DEAC, advises the MHRA on medical devices but does not have an equivalent statutory footing.
Amendment 50 would change this. Subsection (1) provides a delegated power to establish a committee to advise on matters relating to medical devices. The aim is to strengthen the vigilance system for medical devices. A statutory committee for medical devices will support structured decision-making and formal accountability, allowing for clear roles and responsibilities for independent expert advice. This will strengthen the MHRA’s ability to manage safety issues which are identified in clinical use even more effectively, ensuring that timely decisions are made and appropriate action taken to protect patients.
Proposed new subsection (2) provides that regulations may include, among other things, provision about membership, matters which the committee may or must consider, and establishment of sub-committees. This subsection also allows for provision to be made regarding co-operation with other bodies with medical devices expertise and the Commission on Human Medicines, allowing for join-up and best use of our experts.
Proposed new subsection (3) lists matters that regulations under proposed new subsection (2)(a) in relation to membership may cover. This includes the number of members, their appointment, the circumstances in which they cease to be members, and requirements as to independence from the Secretary of State. Proposed new subsection 3(c) allows for provisions to be made about payment of remuneration and allowances to committee members.
The amendment also amends Clause 41, enabling regulations relating to the advisory committee to make consequential provisions. Pursuant to Clause 45, regulations are to be made by statutory instrument and subject to the affirmative procedure. We consider it appropriate that Parliament has the opportunity to scrutinise regulations made under this power, given that the placing of this committee on a statutory footing will be a key element of enhancing the safety of medical devices. These regulations will be subject to all the requirements in Clause 45: public consultation and use of the affirmative procedure; and allowing patients, and other stakeholders, to comment before regulations are made to establish the Committee.
Those regulations will set out clearly, and transparently, how the statutory committee would provide advice where the regulator identifies that there is a need for scientific, technical or clinical advice. They will set out requirements to engage patients in the advisory system; for timeframes for advice on safety concerns to be issued; and requirements to communicate publicly about new and emerging risks. Rightly, the public want more transparency and accountability in regulatory decision-making. They want clearer, greater communication and explanation relating to the performance of healthcare products in clinical use. Patients deserve clear and up-to-date information on the safety of healthcare products from credible and authoritative sources. This statutory committee will meet that need. A statutory devices advisory committee will give confidence to patients, as well as clinicians and the public, that the regulator will take account of expert views on medical devices in a fast-moving area of life sciences. It will create an equilibrium in the level of external advice informing regulatory decisions across all healthcare products.
There are two other amendments in my name in this group and I do not intend to dwell on them, as they are only minor and technical. Amendment 96 provides for consequential changes to allow the DEAC to be commenced. Amendment 64 makes a technical amendment in relation to the time limits for bringing prosecutions for an offence. Time limits already exist but, as part of the clarification of the enforcement regime in Part 3, changes were made to break the link between consumer protection legislation and medical devices, and to streamline the enforcement regime. Due to an oversight, the current time limit was removed but not then reinstated by the Bill into the medical device regulations. Without this change, the system would not function correctly. I beg to move.
Amendment 51 (to Amendment 50)
Baroness Wheeler
Member’s explanatory statement
This would require the Secretary of State to make regulations to creating a statutory committee to provide advice in relation to medical devices.
Baroness Wheeler (Lab)
My Lords, I thank the Minister for moving Amendment 50 enabling regulations to be made to establish the medical devices advisory committee to advise the Secretary of State and to place the existing Devices Expert Advisory Committee on a statutory footing. We welcome this proposed new clause to the information system requirements as an important step towards bringing more transparency to the devices system and ensuring that the regulator seeks independent expert advice on the safety of devices.
As will be seen from Amendments 51, 52, and 53, however—I am moving Amendment 51 on behalf of my noble friend Lady Thornton—we want the requirement on the Secretary of State to establish the MDAC as a “must do” commitment, rather than the “may” in proposed new subsections (1), (2) and (3) of the amendment in relation to: the need for the regulations; providing advice; and making key provisions, such as how independent members should be from the Secretary of State. I know that numerous debates have been held during the course of legislation going through this House about the differences between “must” and “may”. However, “must” is surely the necessary language to require the Secretary of State to establish the committee and ensure its independence.
The Government’s briefings on the amendment—and the Minister today—as well as referring to the committee providing independent expert advice, emphasise that this will include “the views of patients”, complementing the work of the patient safety commissioner and giving patients a voice within the system of regulating medical devices. Through every stage of the Bill, noble Lords have underlined the importance of consultation with patients and end-users of medicines and medical devices. Can the Minister explain the thinking behind not including a subsection in the amendment which underlines the importance of the patient’s voice and perspective? I would also be grateful if he could tell the House what he considers will be the impact on the advisory role and scope of the change to a statutory footing for the committee.
We acknowledge the need for the two technical government Amendments 64 and 96. On Amendment 64, I note the explanation from the Minister today, and in his briefing letter to Peers of 5 January, of the need to reinstate provisions in the Medical Devices Regulations 2002 extending time limits for bringing proceedings in relation to medical devices offences. Amendment 96 is a necessary consequential amendment in relation to the added clause on the MDAC under Clause 18, bringing the whole clause into force two months after the Bill is passed.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I am glad to be able to take part in this debate, which allows the House to have a preliminary discussion about the future of medical devices regulation. I certainly welcome the establishment of an advisory committee, but I also welcome my noble friend’s amendment which makes sure that the rather tentative “may” is replaced by “must”. The Minister’s amendment is rather open-ended. It does not specify what matters it will advise the Secretary of State on, nor does it give any indication of the likely balance of membership. This is important because, as I have said, there has been some concern over quite a few years that the regulation of medical devices is not up to the mark, nor sufficiently protective of patient safety. The report by the noble Baroness, Lady Cumberlege, has identified some weaknesses. In that regard, I declare my interest as president of GS1 UK, the bar-coding association.
We received a very helpful briefing from Professor Muireann Quigley and colleagues at the University of Birmingham, pointing to the rather confused state that medical devices regulation is in. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 came into force at the end of the EU exit transition period. These amend the Medical Devices Regulations 2002 to mirror key elements contained in EU regulations 2017/745, on medical devices, and 2017/746 on in vitro diagnostic medical devices. The aim of that was to make sure that there was good regulatory alignment between the UK and EU, as well as between different parts of the UK’s own regulatory framework. This Bill, when enacted, will provide an opportunity to mandate a more streamlined legislative approach. That would benefit all stakeholders, including industry, businesses and patients.
At present, the MHRA has no involvement in the pre-market phase of medical device development and there is a question as to whether it ought to have. Birmingham University colleagues are certainly proposing a proactive regulatory role for devices that is more akin to that for medicines. This would be clinically focused and, as they say, at least as stringent as the new EU medical devices regulations. Under that proposal, manufacturers could be required to apply to the MHRA before marketing their device. The MHRA could also assess the application in a way that is proportionate to the risks. It is proposed to take account of relevant factors, such as evidence-based supply, approvals in other jurisdictions and post-marketing surveillance plans. I know that that view may not necessarily be shared by industry, which would, perhaps, be concerned about the cost and delay in achieving licensing. However, we can expect a pretty intense debate about medical device regulation in the future.
Lord Lansley (Con) [V]
My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who asked some relevant and useful questions about this while welcoming the new clause and the advisory committee on medical devices as a statutory body. I join him in that and think it is a very welcome move on the Government’s part. The analogy with the Commission on Human Medicines is helpful. As regards translating the Devices Expert Advisory Committee into a statutory role, in effect, in the process, as the noble Lord, Lord Hunt, suggested, there is considerable scope to think about how the Government’s new and expanded roles in the regulation of medical devices can be supported by the advisory committee.
I have a number of points. The first reflects the point made by the noble Lord, Lord Hunt, which is that the MHRA has an enviable reputation as a regulatory authority for the approval of medical devices. If I recall correctly, among the European regulatory bodies something like 40% of the most important or significant medical devices were authorised by the MHRA. Other regulatory authorities in other countries will seek to supplant that. However, our reputation should enable us to establish an international position, and I hope that the advisory committee will not be confined to expertise from within the United Kingdom. There is a lot to be said for positioning the MHRA as a body providing internationally recognised authorisations for medical devices, and its scientific evaluation in that respect should be something that others look to. I therefore hope that that will assist if we have some international participation in the advisory committee structure.
Secondly, I recall, not least in the context of the vexed experience of the PIP breast implant issues back in 2010-11, that the role of notified bodies is very important. Hitherto they have, in essence, been regulated by the European Commission, not by the UK Government, but they fall to be UK-regulated in future. There are not many of them, but there is considerable benefit in there being an advisory committee sub-committee which is focused on the work of the notified bodies. That was the weak link that probably led to the PIP breast implant problems. The regulation is all very well but we have to have bodies that we are confident are able to deliver on these things. The few notified bodies we have in this country are highly respected but we want to make sure that that is maintained even as further notified bodies are authorised.
Thirdly, I recognise that the Devices Expert Advisory Committee has leading clinicians from Scotland and Wales in its membership. However, this must be a UK advisory function, as the MHRA is. I wonder whether it would be appropriate for there to be in addition a Northern Ireland representative on the committee and for there to be perhaps some specific mechanisms to ensure that Scotland, Wales and Northern Ireland are represented in the regulations that establish the advisory committee.
I have one further point, which is that I hope that the various categories of medical devices are very carefully examined and the relevant expertise is available in relation to those. So, for example, on digital devices it is important that we have not only the clinical expertise to deal with the safety of medical devices we have at the moment but the technical expertise in the advisory committee to understand how digital devices will work in the future. That must also be the case in the special interests section related to in vitro diagnostic devices. I hope that that also will have its own special advisory committee function.
Baroness Masham of Ilton (CB) [V]
My Lords, I am pleased to follow the noble Lord, Lord Lansley. I support Amendments 51 to 53 because it is important that the new clause will read “must” instead of “may”, so that the advice on medical devices will be clear and should be followed. “May” means it can be optional and makes the regulations weaker, and people might miss important aspects of care. There is no doubt that clear, correct information is the way to better patient safety. In many ways, communication within the National Health Service should be improved.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I am delighted to follow the noble Baroness, Lady Masham, and earlier speakers in welcoming this group of amendments. I support government Amendments 50, 64 and 96 and welcome the placing of the advisory committee on a statutory footing, and particularly that the affirmative procedure will be used.
My question goes to the nub of Amendment 50—in which regard, if this is correct, Amendments 51 and others in this group will not be needed. Is it for the Secretary of State to decide what goes in the regulations on which presumably Parliament will be consulted under the affirmative procedure?
I can quite understand that the use of “may” appears to be discretionary, leaving open what should be included. Having got this far, it would be helpful to understand the thinking behind the use of “may” in Amendment 50, which indicates that this may be discretionary, whereas clearly it appears to be the will of the House that this is mandatory.
Baroness Jolly (LD) [V]
My Lords, we support these amendments from the Government and from the noble Baroness, Lady Thornton, which relate to the creation of a statutory committee to provide advice to the Secretary of State. Government Amendment 50 would allow the creation of such a committee in relation to medical devices, and the amendments in the name of the noble Baroness, Lady Thornton, in this group would require the Secretary of State to create the committee in Amendment 50, as the Government’s amendment states only that the Government “may” create the committee, not that they must.
No Secretary of State should be above independent advice. Amendment 50 is no bad thing, and of course any advisory committee on a statutory footing should consist of patients as well as experts. I understand that there might be kickback on the amendments in the name of the noble Baroness, Lady Thornton, but a Secretary of State will rarely have expertise in medical devices, so an ad hoc independent committee to inform, advise and warn would be very valuable. A lot of thought will need to be given to working out its terms of reference. We therefore support Amendments 51 to 53. As the noble Lord, Lord Lansley, said, it will also be critical to ensure how this committee will work alongside the MHRA.
Lord Bethell (Con)
My Lords, I am enormously thankful for that constructive debate. This change to the Devices Expert Advisory Committee should be welcomed. It provides for if not equivalence then equality between the medicines and medical devices regimes. It provides for transparency, which we value enormously, and it indicates our direction of travel, the step change and the commitment to patient safety that the MHRA will enshrine.
As has been noted, the committee already exists. It currently meets, and it has an impact and an effect, but these measures mean that it will be strengthened. This change is put forward not solely by the Government; it was a recommendation in the review authored by my noble friend Lady Cumberlege. It adds to the collective picture of improvements that we are making, from future regulation of devices to the medical devices information system. I reassure my noble friend Lord Lansley that we have a profound commitment to creating a regulator in the MHRA that has international influence. I say to the noble Lord, Lord Hunt, that patient representatives are already on the DEAC. As Dr June Raine made clear in her briefing to noble Lords, she and the MHRA are massively committed to the patient safety agenda and to mobilising the patient safety voice through instruments such as the DEAC but not solely through it.
It is a delegated power, but one that I hope noble Lords agree is contained. It will allow us to ensure that the structure and focus of the committee can be kept under review to make best use of its impact, and the regulations will be subject to public consultation and all the steps therein.
The noble Baroness, Lady Thornton, has tabled Amendments 51 to 53 to the government amendment, which would change the nature of the regulations such that they “must” rather than “may” be made. However, as I have set out, the committee already exists; it functions now. It will be strengthened by the regulations. We are committed to a more structured decision-making process that improves transparency. There is no equivocation or doubt; these regulations will be made.
The powers provided by Amendment 50 in my name will enable movement towards a more transparent, proactive, whole-life cycle approach to vigilance. Fundamentally, they will make a difference in the oversight of medical devices to the benefit of patients and patient safety.
I am grateful to noble Lords who have continued to shine a light on the importance of device safety. I hope that this additional tool in the arsenal demonstrates continued commitment and that I have provided sufficient reassurances for the noble Baroness to feel able to withdraw the amendment.
Baroness Wheeler (Lab)
I thank the Minister for his response and all noble Lords and noble Baronesses who have taken part in this useful debate. The points made by my noble friend Lord Hunt and the noble Lord, Lord Lansley, about the future role of regulation were particularly pertinent, and we look forward to seeing how it develops.
I understand the Minister’s response in relation to “may” or “must” and heard loudly his reassurance that there is no doubt that the committee will be established or be upgraded. That being the case, I am happy to withdraw the amendment.
Lord Bethell
“SCHEDULE A1 FURTHER PROVISION ABOUT THE COMMISSIONER FOR PATIENT SAFETYPrinciples relating to core duties
1_(1) The Commissioner must prepare and publish a set of principles to govern the way in which the Commissioner will carry out the Commissioner’s core duties.(2) The Commissioner—(a) may revise the principles, and(b) must publish any revised version.(3) The Commissioner must carry out a public consultation in preparing or revising the principles.Involvement of patients
2_(1) The Commissioner must take reasonable steps to involve patients in the discharge of the Commissioner’s core duties.(2) The Commissioner must in particular take reasonable steps to— (a) ensure that patients are aware of the Commissioner’s core duties and of how they may communicate with the Commissioner, and(b) consult patients, or persons who appear to the Commissioner to represent the interests of patients, on matters which the Commissioner proposes to consider in the discharge of the core duties.Supplementary functions and information
3_(1) For the purposes of carrying out the core duties, the Commissioner may—(a) make a report or recommendation to a relevant person;(b) consult or receive information from patients or any other person the Commissioner thinks appropriate;(c) request information from a relevant person;(d) share information with a relevant person.(2) A relevant person to whom a report or recommendation is made under sub-paragraph (1)(a) must provide a response to that report or recommendation within such period as the Commissioner may reasonably require.(3) A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner to provide information within such period as the Commissioner may reasonably require.(4) Nothing in this Schedule authorises a disclosure of information which contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this Schedule).(5) In this paragraph—“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;“health care” means all forms of health care provided for individuals, whether relating to physical or mental health, and including ancillary care;“relevant person” means—(a) a person who exercises functions of a public nature, relating to medicines or medical devices, so far as those functions are exercisable in relation to England;(b) any other person who, in the course of providing health care, provides services relating to medicines or medical devices in relation to England.Individual cases
4_(1) The Commissioner may not exercise functions in relation to an individual case.(2) But sub-paragraph (1) does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue.Amendments to primary legislation
5_(1) In Part 1 of the Table at the end of paragraph 3 of Schedule 1 to the Public Records Act 1958 (definition of public records), at the appropriate place insert—“Commissioner for Patient Safety.”(2) In Part 3 of Schedule 1 to the House of Commons Disqualification Act 1975 (offices disqualifying for membership), at the appropriate place insert—“Commissioner for Patient Safety.”(3) In Part 6 of Schedule 1 to the Freedom of Information Act 2000 (other public bodies and offices: general), at the appropriate place insert—“The Commissioner for Patient Safety.”(4) In section 71 of the National Health Service Act 2006 (schemes for meeting losses and liabilities etc of certain health service bodies), in subsection (2), before paragraph (h) insert—“(ga) the Commissioner for Patient Safety,”. (5) In Part 1 of Schedule 19 to the Equality Act 2010 (authorities subject to the public sector equality duty), in the group of entries under the heading “Health, social care and social security”, at the appropriate place insert—“The Commissioner for Patient Safety.”Regulations about appointment and operation
6_(1) The Secretary of State may by regulations make such provision as the Secretary of State considers appropriate with regard to the appointment and operation of the Commissioner.(2) Regulations under sub-paragraph (1) may (among other things) contain provision for and about—(a) the Commissioner’s terms of office;(b) remuneration or other benefits;(c) the provision of financial or other assistance, including staff, accommodation, equipment or other facilities, for the Commissioner;(d) requirements to prepare business plans;(e) requirements to prepare reports;(f) requirements to lay documents before Parliament;(g) requirements to provide documents to the Secretary of State or other persons specified in the regulations;(h) the conferring of functions on other persons in relation to the Commissioner;(i) the appointment of a board to provide advice to the Commissioner.”Member’s explanatory statement
This amendment makes further provision about the Commissioner for Patient Safety established by the amendment in the Minister’s name to insert a new Part before Part 1.
Lord Bethell
Member’s explanatory statement
This amendment and the amendment to clause 37 in the Minister’s name adding a definition of “relevant person” restrict the persons to whom information may be disclosed in reliance on Clause 37(5).
“(5A) But subsection (5) does not authorise a disclosure of patient information without the consent of the individual to whom that information relates.”Member’s explanatory statement
This amendment and the amendment in the Minister’s name to add a definition of “patient information” to Clause 37 prevent Clause 37(5) authorising the disclosure of information from which patients can be identified without their consent.
Baroness Wheeler
“( ) Where information is disclosed in accordance with subsection (5) such disclosure will only be permitted where—(a) it is required as part of international cooperation in monitoring the performance and safety of medical devices; or(b) it is in the public interest.” Member’s explanatory statement
This amendment would allow a relevant authority to disclose information to a person outside the UK where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicine provided it is within the public interest to do so.
Lord Bethell
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name adding a new subsection (5A) to Clause 37.
“(9A) This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”Member’s explanatory statement
This amendment provides that Clause 37 does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.
Member’s explanatory statement
This amendment omits an unnecessary definition.
““patient information” means information (however recorded) which—(a) relates to—(i) the physical or mental health or condition of an individual,(ii) the diagnosis of an individual’s condition, or(iii) an individual’s care or treatment,or is (to any extent) derived directly or indirectly from information relating to any of those matters, and(b) identifies the individual or enables the individual to be identified (whether by itself or in combination with other information);”Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name adding a new subsection (5A) to Clause 37.
““relevant person” means—(a) the government of a country or territory outside the United Kingdom;(b) a person who exercises functions on behalf of such a government;(c) any other person who exercises functions or provides services relating to medical devices in a country or territory outside the United Kingdom;(d) an international organisation that exercises functions or provides services relating to medical devices.”Member’s explanatory statement
See the explanatory statement to the first amendment to Clause 37 in the Minister’s name.
The Deputy Speaker (Lord Faulkner of Worcester) (Lab)
Does the noble Lord, Lord Patel, wish to move to move his Amendment 63? Lord Patel? We cannot hear the noble Lord.
Baroness Penn (Con)
The noble Lord may wish to know that the amendment is consequential on an amendment passed earlier on Report, so he or a fellow signatory may wish to move it.
Amendment 63
Baroness Wheeler
“Requirement for draft consolidated legislation: medical devices
The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to medical devices.”Member’s explanatory statement
This new Clause, and the other consolidation amendments in the name of Lord Patel, would require the Secretary of State to publish draft consolidated legislation within three years to streamline the existing regulatory framework. These amendments are linked to the amendment providing for a three year sunset provision in the name of Baroness Thornton.
Lord Bethell
“(2A) In respect of an offence under this regulation—(a) a magistrates’ court in England and Wales may try an information laid before the earlier of—(i) the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and(ii) the end of the period of three years beginning with the day on which the offence was committed;(b) a magistrates’ court in Northern Ireland may hear and determine any complaint made before the earlier of—(i) the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and(ii) the end of the period of three years beginning with the day on which the offence was committed;(c) in Scotland, summary proceedings for the offence may be commenced before the earlier of—(i) the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and(ii) the end of the period of three years beginning with the day on which the offence was committed.(2B) For the purposes of paragraph (2A)(a)(i), (b)(i) and (c)(i)—(a) a certificate signed by or on behalf of the prosecutor and stating the date on which such evidence came to the prosecutor’s knowledge is conclusive evidence of that fact, and(b) a certificate stating that matter and purporting to be so signed is to be treated as so signed until the contrary is proved.” Member’s explanatory statement
This amendment ensures that prosecutions for an offence under new regulation 60A of the Medical Devices Regulations 2002 can be brought before the earlier of one year from the prosecutor thinking there was sufficient evidence to justify a prosecution or three years of the commission of the offence, as is currently the case with regard to equivalent offences under section 12 of the Consumer Protection Act 1987.
The Deputy Speaker (Lord Faulkner of Worcester) (Lab)
We now come to Amendment 66. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press the amendment to a Division must make that clear in debate.
Amendment 66
Lord Hunt of Kings Heath
“Availability of medicines and medical devices for human use on the National Health Service
(1) The National Institute for Health and Care Excellence must have regard to the need—(a) to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices,(b) to support early patient access to effective new medicines and medical devices, including by accepting a greater degree of uncertainty and risk in recommending their use,(c) to ensure patients with rare diseases have access to medicines and medical devices that they need, and(d) to support the use of curative therapies involving medicines and medical devices.(2) The Secretary of State must lay a report and impact assessment before both Houses of Parliament setting out how the National Institute for Health and Care Excellence has implemented its duty under subsection (1), in particular in its manual on process and methods for developing NICE guidelines.”Member’s explanatory statement
This new Clause would require the National Institute for Health and Care Excellence to ensure that its recommendations support the NHS in the ways described in subsection (1).
Lord Hunt of Kings Heath (Lab) [V]
My Lords, before I start, perhaps I may make the point to the clerks that the noble Baroness, Lady Thornton, needs to be unmuted every time the Deputy Speaker goes through the amendments so that she can move them or not. It is very frustrating; we can see it happening, and it is impossible for us to come in on this situation. That is why there is such a hiatus.
My Amendment 66 concerns NICE’s current view of its methods and processes as part of the agreement on the voluntary scheme for branded medicines pricing and access, happily known as VPAS. If NICE is to maintain its global relevance, it is critical that the methods review delivers tangible changes to ensure that it can fairly and effectively assess the true value of innovative medicines.
The UK life sciences sector is at a crossroads. Without meaningful intervention from the Government, exiting the EU obviously presents significant threats to the attractiveness of the UK. We know that global boardrooms take a holistic approach when considering where to place their investment, including the attractiveness and speed of the commercial environment—we have debated these earlier in the Bill. The ability quickly to launch medicines and technologies into our market and to get medicines quickly to the patients who need them is one of the main factors that shape boardroom sentiment on future investment, alongside the quality of scientific research and the possibility of collaboration. It was the Labour Government who set up NICE to do that: to get innovative new medicines and devices to the NHS and implemented as quickly as possible.
But the UK risks missing out on a wave of breakthrough therapies, with the potential to transform outcomes, if the NICE review does not lead to meaningful change in the way it does its business. Not only do we risk losing our reputation as a leader at the cutting edge of medical science but, more importantly, patients will not be able to assess the most innovative treatments available elsewhere. So NICE’s approach to appraising value must take into account the strategic benefits of the NHS remaining at the forefront of medical innovation and demonstrate that the UK Government are committed to supporting a thriving, world-leading life science sector post Brexit.
In relation to my amendment, I would like to raise issues of barriers to new innovative technologies, such as gene therapy. Gene therapy is a prime example of a medical technology that the UK should embrace, and, indeed, the Government have rightfully lauded the UK’s efforts in this regard. But a procedure called the discount rate, used by NICE to adjust for future costs and health benefits when valuing treatments, discriminates against one-time therapies that offer potential long-term health benefits over many years, such as gene therapies. NICE almost always uses a 3.5% rate. It can apply a lower 1.5% rate for therapies that offer longer-term health benefits, but it has chosen to do this only on exceptionally rare occasions. I wonder whether the Minister will commit to working with NICE to review the circumstances in which the policy solution can be applied to unlock the potential of such innovations.
The VPAS was negotiated with the aim to secure a triple win for patients, government and industry. But NHS England’s current bespoke commercial agreements significantly undervalue innovation, and this is something global boardrooms look at for evidence in the NICE review—that speedy access to new medicines will be improved.
Why should the Government commit to doing an impact assessment of the changes? Well, warm words and promises from Ministers are not enough; we need a clear commitment from them that they will place the emphasis on NICE to ensure meaningful action. In Committee, the Minister argued that my amendment was not necessary, and that the issues I raised were already dealt with in existing legislation and were outside the remit of the Bill. She went on to say:
“NICE, like the rest of the health system, is constantly keeping methods under review to ensure they are appropriate and support the speed of innovation in the life sciences sector,”
and she agreed about the need to get new innovations into the hands of patients quickly. In so doing, she referred to the methods and process manual produced by NICE
“in consultation with a range of stakeholders, including industry and academics.”
She said:
“NICE will publish a revised manual and related impact assessment when that process is completed.”—[Official Report, 26/10/20; col. GC 52.]
Is that sufficient?
The Ethical Medicines Industry Group has identified that medicines and medical devices often face challenges when being assessed by NICE, due the rigid focus on cost-effectiveness. Failing to consider other factors, such as the benefits of treatment in reducing health inequalities or the wider impacts on quality of life, often hinders patients’ ability to access innovative life-saving treatments. The EMIG argues that introducing a health inequalities modifier would be critical to demonstrate that NICE recognises the importance of reducing the high levels of unmet medical needs in the population and to benefit the most disadvantaged and underserved patient groups. There is strong support for the introduction of this modifier among experts involved in the development of the consultation, with a document noting that there is evidence that people are willing to generate less health overall if the health is generated in disadvantaged groups, particularly for socioeconomic disadvantage.
My amendment seeks to build on expert support to ensure equitable access to innovative treatments for conditions that are not adequately treated, to drive down health inequalities and benefit the most marginalised patients. I argue that NICE must also review its appraisal system for rare disease treatments to ensure that the system in place enables patient access. Inherently, rare disease treatments serve small patient populations, and generating sufficient data to meet NICE’s cost-effectiveness requirements is often challenging.
I have received a briefing from another organisation, Global Blood Therapeutics, on sickle cell disease. It argues that, in relation to the UK’s most prevalent genetic disorder, SCD treatments are currently limited to managing the condition rather than addressing the underlying causes. But there is hope that a new range of therapies may change this.
On occasion, NICE has also considered treatments which may not meet its traditional cost-effectiveness thresholds but which would have a significant impact on health inequalities. But consideration of health inequalities remains rare, and I think that this needs to be revisited. If NICE is truly committed to designing an appraisal process which reduces health inequalities and provides equitable access for the most disadvantaged patients, the introduction of a health inequalities modifier, as set out in my amendment, is vital.
The UK life science sector faces a great challenge. It is a huge asset. We have to ensure that organisations such as NICE play their part in making sure that the NHS and the UK are attractive for major investment in the future. In a nutshell, that is the crunch point of my amendment. We have as well to make sure that its methodology deals with health inequalities sufficiently. I beg to move.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I declare that I am vice chair of the NICE review committee. Amendment 66, moved by the noble Lord, Lord Hunt of Kings Heath, aims to ensure early access for NHS patients to medicines and medical devices. This must also involve ensuring that results of safety and efficacy from devices in real-time use—as well as in trials—are registered, published and then considered again in real time, a process that I hope will be helped and promoted by the patient safety commissioner role.
Noble Lords will remember that in Committee I tabled, along with the noble Lord, Lord Hunt of Kings Heath, an amendment to ensure provision for the development of a new rapid provisional two-year licensing procedure. The intention behind that amendment was to ensure that patients could more quickly access potentially life-saving medicines and medical devices.
I sincerely thank the Minister and his team for meeting with me on this, and for the other meetings they facilitated. I am reassured that the approval processes from the MHRA over device development are due to be revised completely over the coming year, with improved and streamlined processes, and I hope that today the Minister can confirm this, even with a timeframe, so that we can move forward quickly.
We have a unique opportunity to develop devices and roll them out to the NHS, but it is important that approval processes do not slow down or block patient access to improvements in treatment and management over a wide range of conditions, particularly rare disorders. Evidence from real-time use is crucial, and development and improvement can become a virtuous circle when that is rapidly fed back—so we become the intellectual innovation hothouse for our future prosperity, while also benefiting our patients. The UK can then be seen as a favourable place to develop, approve and supply medicines and medical devices.
Speeding up and widening approval processes, including two-year provisional licensing that I have been advocating with the Royal College of Physicians, would ensure that developing a new device from beginning to end—taking an idea from conception to supply—all in the UK is seen as an attractive prospect. Otherwise, we continue to risk new devices beginning their innovation journey in the UK, then being taken abroad part-way through the development process and marketed back to the UK. Keeping the entire process in the UK, with different models of fast-track approvals and provisional approvals, will allow better oversight of the safety and efficacy of devices during early access, with ongoing monitoring in real-time use. That would then facilitate moving into appropriately costed long-term approval processes.
We can innovate in the UK and stop intellectual capacity being outsourced. We can protect the safety of patients while getting them access to the latest treatments. It is patients who will suffer if we do not get this right, which is why the proposals in this amendment are so important.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I am delighted to follow the noble Baroness, Lady Finlay, and speak on this group of amendments. I can see that the noble Lord, Lord Hunt, speaks with passion and some considerable knowledge and experience of NICE. But I am concerned and would just like to understand, as we have established that patient safety absolutely has to be paramount, that patient safety could not be compromised through either of the two amendments—Amendments 46 and 66—in this group.
The noble Baroness, Lady Finlay, set out in the earlier amendment in Committee a two-year licensing procedure and, now that we have obtained an assurance that the approval processes are to be revised, I would imagine that the same procedure as set out under Amendment 66 should be considered as part of that review and revision of the processes. I would also like to further understand how a role for NICE as set out in Amendment 66 actually fits in with the Bill before us today and, in particular, the role as set out, and just agreed, of what the advisory committee should be.
My concern is absolutely that patient safety has to be paramount—first, foremost and bottom line. In my view, what is sought to be set out in these two amendments in this little group should be best done as part of an overall review of the processes to which the Government, as I understand, are already committed.
Baroness Masham of Ilton (CB) [V]
My Lords, I am grateful to my noble friend Lady Finlay of Llandaff for alerting me to the fact that government Amendment 45 pre-empted our Amendment 46. They were grouped on different days, but I am pleased that others were thinking on the same wavelength.
I am very happy to support Amendment 66 in the name of the noble Lord, Lord Hunt of King’s Heath. The availability of medicines and medical devices is top of my priority list. In fact, antibiotics have saved my life on several occasions. It is important that NICE adheres to health equality: everyone who needs medicines or medical devices should be treated equally and there should be no delay. Unfortunately, with this devious coronavirus, this has not happened, but we hope for better days.
Having experienced a member of my family dying, I know that sometimes it seems worth trying anything that might help and that is in the research process. There are many really rare diseases which need orphan drugs; they can be a lifeline to the individual. I hope that NICE will consider them without delay and realise their importance and value to these small patient groups. It is so frustrating when patients in Scotland and other European countries can get medicines and medical devices, when those in England cannot; patients here have to wait—unless the public come to their rescue by crowd funding.
Many users of devices also need instruction on their use, and staff and patients need training. Personal medicine is so important and patient safety is absolutely paramount.
Lord Lansley (Con) [V]
My Lords, I am most grateful to the noble Lord, Lord Hunt of King’s Heath, for his amendment and for the way he introduced it. It very helpfully allows us, at this very important moment, to take stock of how we secure the availability of medicines—although the legislation does not relate to NICE, and I am sure it will not surprise the noble Lord, Lord Hunt, that I do not think it is appropriate for us to legislate to tell NICE how to do its work, given its independent statutory constitution. None the less, the Bill is about the availability of medicines, and it is really important for us to identify how the NICE processes can assist in ensuring that we get medicines to those who need them.
I shall say a few words about the NICE processes. First, let me address the objective, from my point of view. When I was Secretary of State, I advocated a process called “value-based pricing”, which was to try to understand that not only were there quantitative factors measured in quality-adjusted life years—QALYs —which, if one were able to secure them, gave one a quantitative basis for understanding the value of a new medicine, but that in addition there were other qualitative aspects, which I described as the societal benefits and the innovation benefits. I still think that this is the right approach.
In the international context, many countries are trying to escape the potential downward spiral of reference pricing, where everybody is trying to pay less than the average. The net result, if we carry on down that path and if the American Administration pursue that path, will be that we end up with inadequate support for the industry for the development of new and innovative medicines.
What we need to do is to value innovation and support the industry for the value it delivers. However, we do not measure it precisely in those terms. When we look at our current structure in this country, we need to understand that there is an opportunity created by what is known as VPAS—the voluntary pricing and access scheme. If it is genuinely the case, and we have argued that it should be, that the industry has accepted a constraint on the overall growth of the medicines budget in the NHS, and if it is clear that, if that growth is exceeded, there will be a rebate and that rebate does indeed return to benefit patients, through the NHS or the innovative medicines fund, so promoting access to new medicines, then we will arrive at the point where both NICE and NHS England should be working together to try to secure the best value from that drugs budget. I think they should be working together to ensure that, where there is a mandate for a new medicine, it is one which is supported by, not imposed upon, NHS England. That is increasingly where we should be aiming to arrive: at a combined thought.
What goes into value-based pricing matters enormously as well. The noble Lord, Lord Hunt, referred to some of the important aspects. First, it is about societal values. For example, if we can deliver a health gain among the parts of our population where health outcomes are poorest, then we should ascribe additional value to that health gain. A modifier for health inequalities is consistent, for example, with the statutory responsibilities of the NHS to seek to address and reduce health inequalities.
Unmet medical need makes a difference. Incremental effectiveness of medicines is important, but to have a medicine available for those who thought that there was no opportunity for treatment available to them from the NHS can make an enormous difference, and I think we should ascribe additional value to that. Medicines which deliver innovative benefits—for example, which have a whole new mode of action—can lead to subsequent treatments, and we should have a method of qualitatively understanding where those innovations, even if they may not have dramatic incremental benefits, none the less give us long-term potential. We should reflect that in the price that we are prepared to pay.
Indeed, as the noble Lord, Lord Hunt, said, we should not apply a discount rate to quality-adjusted life years that is directly comparable with the discount rates that are applied to revenues over time. I think people's time preference for quality-adjusted life years is not so dramatically higher for gain now as opposed to gain in the future; there is a much greater degree of equivalence between health gain now and health gain that people will derive in future. That would certainly assist in promoting medicines that slow the progression of disease and help us to manage longer-term morbidity in our older population, which would be immensely helpful.
There is a whole range of such matters and there are many more one could talk about, but it is really important to distinguish between NICE’s job in undertaking a health technology assessment, which I think should be moved from the purely quantitative to the qualitative. It should include, for example, relying not only on randomised control trial data but understanding observational data and the data we receive from the use of the innovative medicines fund to see how well medicines work and what benefits and outcomes they can deliver—sometimes in relatively small populations for rare diseases—understanding that in practice and incorporating it in its assessment.
We need to support NICE in delivering what is regarded internationally, I hope, as a gold standard of health technology assessment. We need to understand that that is separate and distinct from the business of what price the NHS should pay and on what basis the industry and we, as payers for new medicines, should agree, understanding that our objective must always be to ensure that safe, effective and high-quality medicines are available to the NHS and patients.
Baroness Jolly (LD) [V]
My Lords, these amendments relate to NHS access to medical devices, and Amendment 46 from the noble Baroness, Lady Finlay, would ensure early access for NHS patients to medical devices and allow monitoring of safety and efficacy in real-time use. This amendment is pre-empted rather by the Government’s amendment, which removes the concept of attractiveness.
Amendment 66 from the noble Lord, Lord Hunt of Kings Heath, would require NICE to ensure that its recommendations support the NHS in the ways outlined in subsection (1) of the proposed new clause. This includes ensuring access to new medicines and medical devices for patients with rare diseases. Those of us who have been involved in rare diseases will be all too well aware of the problems of access to appropriate treatments for so few patients.
The interesting thing about this debate is that two of the House’s big health thinkers have been speaking, and both the noble Lord, Lord Hunt of Kings Heath, and the noble Lord, Lord Lansley, have given us a really good big-picture look which takes us slightly above legislation.
The noble Lord, Lord Lansley, spoke of social and innovation benefits and the need to value innovation, but with innovation does not always come success: we may have to try again. He spoke about the innovative medicines fund and the necessity for NICE and NHS England to work together. When it is put like that, it sounds very straightforward: why is that not normally happening? He talked about the importance of value-based pricing and getting the best value from the drugs budget—which, after all, is finite. He also talked about the health technology assessment, which is of course qualitative, not quantitative. I valued the contribution of this debate on the fourth group of amendments, and I will read it again with great interest.
Baroness Thornton (Lab) [V]
The noble Baroness, Lady Jolly, is quite right: two of our health big thinkers have laid out the issues here. My noble friend Lord Hunt gave a wonderful introduction to Amendment 66, which covered the reasons why it is important and what it will do. The noble Lord, Lord Lansley, took us on a journey through how health inequalities can be addressed. The point, and the reason the amendment is on the Marshalled List today, is that it does not always work like that. Implementation is key. As the noble Baroness, Lady Jolly, said, requiring NICE to support NHS access to new medicines and medical devices seems kind of obvious. The challenge for the Minister here is how to use this legislation and this discussion to make what we think is obvious work better.
Baroness Penn (Con)
My Lords, I know the noble Lord, Lord Hunt of Kings Heath has a long-term interest in and commitment to the work of NICE and, as such, will know that NICE’s remit is set out in other legislation. I do not intend to rehearse the arguments on why we do not see that as strictly for this Bill. Instead, I hope to provide some reassurance on the issues he raises with his amendment.
The noble Lord will be aware that NICE’s methods and processes for assessing the cost-effectiveness of medical technologies are internationally respected and have been developed over almost 20 years through periodic review, including extensive engagement with stakeholders, and the latest iteration of that process of periodic review of its methods is ongoing. NICE finished the first phase of its consultation on the case for change to its methods on 18 December 2020. There will be a second consultation on the case for change to its processes in the spring. The result of those will inform the final consultation on the updated methods manual in summer 2021. I hope that the noble Lord is reassured by the consultative nature of that process in considering the issues he raised.
Subsection (1)(a) of the new clause proposed in his amendment would require NICE to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices. Subsection (1)(b) would require NICE to accept a greater degree of uncertainty and risk in recommending their use. I reassure the noble Lord that NICE is already considering both of those as part of its review, and they were both consulted on as part of the consultation on the case for change that ran from 6 November to 18 December 2020.
In that consultation, NICE noted that there may be a case for a modifier that considers health inequalities. However, further work is needed to explore how this could be defined and implemented in a health technology evaluation, and under which circumstances. This will be done in NICE’s second consultation running from February to March. Such a modifier could consider the types and sources of inequality, as well as how a modifier should be applied—qualitative or quantitative. It could also consider whether such a modifier covers technologies that directly reduce inequalities—for example, by specifically targeting or providing additional benefits for a disadvantaged group; or whether indirect effects might also be considered—for example, if a technology has uniform benefits across groups, but the condition disproportionally affects a disadvantaged group. At this stage, it is not clear that there is sufficient evidence for a health inequalities modifier, but it is being explored, and will be explored further in the second stage.
I hope that level of detail on the consideration that NICE is undertaking helps to reassure the noble Lord, but of course it would not be appropriate to pre-empt that review, and we want to encourage all stakeholders to respond to it.
In addition, I remind the noble Lord that a requirement to have regard to reducing health inequalities is already imposed on NICE under Section 1C of the National Health Service Act 2006. This applies to NICE as a non-departmental public body of the Department of Health and Social Care.
Proposed new subsection 1(c) would require NICE to have regard to the need
“to ensure patients with rare diseases have access to medicines and medical devices”.
The noble Baroness, Lady Wheeler, noted some concern during Grand Committee as to why NICE did not propose a rarity modifier in its methods review. A rarity modifier was considered by NICE prior to publication of the consultation document. However, stakeholders noted that rare diseases would be covered by the proposed severity modifier, which more accurately reflects society’s values. Although there is of course overlap between severity and rarity, not all rare conditions are severe and some severe conditions are more common. Of course, the consultation was an opportunity for all stakeholders to express their views on this point. As noted previously, NICE is also consulting on changes, such as a more accepting attitude towards uncertainty in some situations, which should benefit medicines for rare diseases.
Where there is uncertain evidence relating to a medical technology—I appreciate this can be a challenge for rare diseases—NICE and NHSE&I have developed managed access agreements. NICE has already recommended six topics for use subject to a managed access agreement outside of cancer. NHSE&I continues to use its sophisticated commercial capabilities to negotiate deals with industry that enable patients to access the most innovative new medicines and ensure that the NHS gets good value.
Proposed new subsection 1(d) would require NICE to have regard to supporting
“the use of curative therapies involving medicines and medical devices.”
The word “curative” should be used with caution, as there is no standard definition of what might be meant by it. For example, in some cases it may mean a significant amelioration in symptoms, in others that the treatment pathway is different or more tolerable.
While I appreciate that recently launched advanced therapy medicinal products hold great promise by targeting the specific cell or genetic defect, the data on long-term effectiveness is often immature at the time of marketing approval. Further, we need flexibility to respond quickly and effectively to developments in life sciences. We want to avert a situation whereby an effective therapy is not guaranteed funding because it did not meet the legal definition of a “curative therapy”. However, I think that the noble Lord was more trying to get at our support for some of these innovative approaches. Again, this is being looked at in the review of NICE’s methods.
NICE’s working group has explored whether there is a case for changing the approach to discounting, which the noble Lord asked about, in particular the impact on technologies with long-term benefits such as one-time gene therapies. This is a complex area that needs to take into account the policy-level need to support particular types of technologies or circumstances, the limitations of the current criteria for non-reference case discounting, and the effects and any accompanying policy and affordability challenges of any change. This will be covered by the second stage of the NICE methods review. Again, while we would not want to pre-empt that review, all stakeholders are encouraged to respond to it.
Briefly, proposed new subsection (2) would require the Secretary of State to lay a report and impact assessment before both Houses of Parliament, setting out how NICE has implemented its duty under proposed new subsection (1). As I said in Grand Committee, NICE will publish its revised methods and process manual, including its impact assessment, on its website for all to access, including parliamentarians, once the process has been completed. That is the correct forum.
I will briefly address Amendment 46 in the name of the noble Baroness, Lady Finlay, which touches on similar issues—the importance of access to medical technologies, the future medical devices regulatory regime, and the critical nature of medical device safety. I pay tribute to the noble Baroness’s work through her engagement with Ministers and our officials in developing government Amendment 45, which provides greater clarity on the types of activity we would intend to encourage through appropriate regulation. That includes, in respect of medical devices, carrying out research, developing medical devices, or manufacturing and supplying medical devices.
The Government support the agenda for early access to medical devices for NHS patients, as demonstrated through other mechanisms such as the rapid uptake products programme, managed by Accelerated Access Collaborative, and the medtech funding mandate, due to launch in April.
The second stated purpose of the noble Baroness’s amendment—to allow monitoring of the safety and efficacy of medical devices in real-time use—is already achieved by regulations that may be made under Clause 15(1)(i) and (j), so the mechanism to deliver this is already in place. In addition, Clause 18 empowers the Secretary of State to make regulations for the establishment of a medical device information system by NHS Digital, which will support the monitoring of patient outcomes and patient safety.
The noble Baroness also asked about the timeframe for future devices regulation made under the Bill. I assure her we will consult on this issue this year.
I hope the reassurances I have provided, here and during Committee, are of comfort to noble Lords and that the noble Lord, Lord Hunt of Kings Heath, feels able to withdraw his amendment.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I wanted to stimulate a debate on the NICE review and it certainly succeeded, because we had a very high-quality debate. I am very grateful to the Minister for what was a comprehensive and encouraging response, in a number of ways.
I will start with the noble Baroness, Lady Finlay, because she made a powerful speech and argued very convincingly for the speeding up of approval processes, alongside speeding up the introduction to the National Health Service of proven, innovative new medicines and treatments. The noble Baroness, Lady McIntosh, asked about patient safety, but my amendment and, I believe, that of the noble Baroness, Lady Finlay, would do nothing to undermine patient safety. In the first place, the Minister has already tabled an amendment to Clause 1, which we debated on the first day of Report, which gives priority to considerations of patient safety. It is clear from the explanation given for Amendment 46 from the noble Baroness, Lady Finlay, that her proposals for a preliminary licence would allow for monitoring of safety and efficacy in real time. That could be a real bonus indeed.
I thought that the noble Baroness, Lady Masham, asked the fundamental question: why are we so slow to introduce new medicines and devices? Why are we behind so many other developed countries?
The noble Lord, Lord Lansley, gave a very thoughtful contribution. He is absolutely right to argue that we need more support for innovative medicine. The tragedy is this. We have the excellent VPAS agreement whereby, essentially, industry accepts that if the cost of medicines goes above a certain agreed level it will pay a rebate back to the Government, or ideally the National Health Service. If this worked properly the resource going back would be used for innovation, but for reasons that I have never quite understood the money does not seem to go back directly in an identifiable form to the NHS. We have the bizarre situation where, locally, the NHS worries about its drug costs. When it goes above a certain level there is a rebate, but unfortunately that rebate does not seem to find its way back in a tangible, transparent form, to the NHS. We have not created out of the agreement the kind of win-win situation that surely was envisaged when the previous voluntary agreement was first developed.
The noble Lord, Lord Lansley, mentioned one of the big issues: the need for NICE and NHS England to work together. I do not get the impression that they do work together that well, because NHS England regards most innovation as costly and therefore tries to dampen it down. I agree with the noble Lord, Lord Lansley: we need a much better partnership where we build in value for innovation and dealing with inequalities—one where NHS England would actually be on board.
The noble Baroness, Lady Jolly, and my noble friend Lady Thornton talked about this being a big-picture debate. Of course, this is not something that can be solved by an amendment to a medicines Bill, but Parliament ought to debate these important issues and, at the very least, raise some issues that the review should undertake to address.
The Deputy Speaker (Lord Faulkner of Worcester) (Lab)
We now come to the group consisting of Amendment 67. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this amendment to a Division must make that clear in the debate.
Amendment 67
Lord Hunt of Kings Heath
“Medicines and Medical Devices Redress Agency
The Secretary of State must, by the end of the period of 12 months beginning with the day on which this Act is passed, bring proposals before Parliament to establish a Redress Agency for those harmed by medicines and medical devices.”
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I want to come back to the debate on clinical negligence and the recommendation made by the noble Baroness, Lady Cumberlege, in her report for a redress agency. I declare my interest as a member of the GMC board.
We have reached a very serious position, with an exponential rise in clinical negligence costs. Twenty years ago, contingent liability was £3.9 billion; it is now £83 billion. Even allowing for inflation, I hardly think that we have become 20 times more negligent over that period. Indeed, the Minister, Nadine Dorries, told the House of Commons in a Written Answer last November:
“The continued rises in clinical negligence costs are eating into resources available for front-line care”.
It is not delivering for patients and their families, either. There are huge delays in getting cases settled and huge lawyers’ fees, in a quite remarkable situation where the NHS ends up paying damages in 80% of litigated clinical negligence claims. There is something wrong in the way we deal with these cases.
There have been endless reviews over the past 20 years, but precious little has happened. Seventeen years ago, an NHS redress scheme was unveiled by the then Chief Medical Officer, Sir Liam Donaldson. Legislation followed in 2006 but, 14 years later, it has yet to be implemented—and I doubt it ever will be. Since then, there has been much debate about the sustainability of Section 2(4) of the 1948 Law Reform (Personal Injuries) Act, which essentially promotes increased costs because it provides that
“there shall be disregarded, in determining the reasonableness of any expenses, the possibility of avoiding those expenses or part of them by taking advantage of facilities available under”
the NHS. In other words, the NHS tends to pay twice.
In 2017, the department and the Ministry of Justice commissioned the independent Civil Justice Council to draw up a new claims handling process for clinical negligence claims of up to £25,000, together with proposals for fixed recoverable costs for these cases. The report was published, with recommendations, in October 2019. Since then, there has been silence.
In that context, the noble Baroness, Lady Cumberlege, argued in her report First Do No Harm for a redress agency to be set up on an avoidable harm basis, which looks to systematic failings rather than blaming individuals. This, she thought, would encourage reporting and provide faster resolution for claimants. She argued that this
“would provide a standing structure to administer decisions using a non-adversarial process. This model is simple for patients to access as there is one point of contact. This structure enables flexibility to adapt and respond to situations as they arise.”
The proposed scheme of the noble Baroness, Lady Cumberlege, is well intentioned and has popular appeal. I recognise that details need to be spelled out in relation to eligibility, qualifying criteria or conditions of entitlement for her proposed redress scheme. Of course, causality is at the heart of any consideration of patient safety remedy. Causation is at the heart of tort. The Vaccine Damage Payments Act 1979 is limited to persons disabled as a result of vaccination. Even the NHS Redress Act 2006, to which have just referred, is concerned with arrangements for redress in relation to liability in tort. The noble Baroness’s approach is of course quite different from that.
The noble Baroness the Minister in Committee was not enthusiastic. In the past 48 hours we have heard the Government’s response that they have,
“no current plans to establish a redress agency”,
as set out in the recommendations of the noble Baroness, Lady Cumberlege. The reply went on to say:
“The government and industry have previously established redress schemes without the need for an additional agency.”
Well, that is a rather disappointing dismissal and misses the point, because the noble Baroness was essentially calling for a wholesale reform of the current clinical negligence system. I urge the Minister to reconsider this matter.
Can we really go on with the exponential rise in costs to the NHS—a system in which it loses 80% of cases that reach the courts, and where huge delays take place in patients getting access to an outcome? The system is completely bust. We need a new one and I hope that the Minister will, with his colleagues, consider what action needs to be taken to improve the current situation. I beg to move.
Baroness Cumberlege (Con) [V]
My Lords, I warmly thank the noble Lord, Lord Hunt. His determination is awe-inspiring. I am so pleased that he has not left this issue mouldering on the Committee Floor but has picked it up again.
I understand what the noble Lord said about the Government not being enthusiastic. However, I have known other issues on which the Government have been less than enthusiastic. It is the way in which we put forward persuasive arguments—although setting up this agency will take a lot of work, with a lot of detail to be considered. However, other schemes have been successful. I think about the one in my area—thalidomide. That trust is still running and getting redress for people who need it. So I strongly support the amendment of the noble Lord, Lord Hunt.
In our review, we tried to achieve a very simple and accessible structure for patients through the proposed redress agency. In an update on our recommendations, the Minister in the House of Commons, Nadine Dorries, said that the Department of Health and Social Care had delivered ex-gratia payments with individual schemes without the need for a redress agency. Indeed it has.
There are four or five schemes for infected blood alone, with eligibility based on whether the patient was a haemophiliac with HIV; a haemophiliac with hepatitis C; a non-haemophiliac with HIV; or a non-haemophiliac with hepatitis C. These different schemes addressed what type of payment should be awarded according to the patient’s need. What we—I am talking about my team and I—were advocating is a single point of contact for avoidably harmed patients. We felt very strongly that they had suffered enough without the necessity of finding out how to access the schemes that are relevant to them. The noble Lord, Lord Hunt, has said that something is wrong. He is right: it is wrong. This is not the way to help people who have been seriously harmed.
The problem is that, without a redress agency, each ex gratia scheme starts from scratch, which we felt was grossly inefficient. We need a standing administrative structure, funded by contributions from manufacturers and the state—both have a responsibility. At the moment, litigation is the only route, as the noble Lord, Lord Hunt, has said, for injured people to get serious compensation. We know that the process is very damaging to people. They do not like going to court, they do not like having to put forward all the information that is absolutely necessary—and sometimes not so necessary—and they do not like the fact that it is an adversarial system. We felt that the redress agency could remove the need for adversarial litigation that focuses on blaming individual doctors and nurses. The agency would be non-adversarial and would look at the systems failings that led to avoidable harm. This would help develop an open culture in healthcare and facilitate learning—we are not good at that. We know that the same mistakes happen over and again, and we felt that this was another tool to ensure that there would be much less of that.
Gathering information in one place—the agency—would make it so much easier to learn from the data that is collected and would strengthen the ability of the healthcare system to learn from the mistakes made. We have only to look at the cost of litigation of some £83 billion a year—I was very interested in what the noble Lord, Lord Hunt, said. We know that, often, the majority of those costs go to the law firms, not the individuals who have suffered so grievously. We felt that it would be much better if those huge sums of money, which are much needed by the NHS, should be used with a redress agency, which would have other advantages, as I have just outlined. A stand-alone agency, with a single entry point, would be a much better and more cost-effective way to award redress to those who suffer such avoidable harm—and many of them suffer for decades.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, it is again my great pleasure to follow the noble Baroness, Lady Cumberlege, and the noble Lord, Lord Hunt of Kings Heath. I am pleased to attach my name to Amendment 67 in the name of the noble Lord.
I do not think the noble Baroness, Lady Cumberlege, will mind if I explain why I am coming in on Amendments 67 and 68 in particular. It is because I was in a meeting and asked her what her next priority would be after the broad achievement of the patient safety commissioner. She said that the redress agency was in her mind as the next priority, which is why I have chosen to make it a priority in this Bill, in which I have become considerably more involved than I was originally expecting.
Like the noble Lord, Lord Hunt, did, I have to describe the Government’s response to the noble Baroness’s review as very disappointing. Simply very curtly saying:
“The Government and industry have previously established redress schemes without the need for an additional agency”
really does not engage with the arguments put by the noble Baroness in her report or reflect the strong support seen in the British Medical Journal editorial on 20 August, which expressed growing support for the entire review but particularly for the idea of a redress agency.
Lord Lansley (Con) [V]
My Lords, I am very glad to follow the noble Baroness, Lady Bennett of Manor Castle, and prior to her the movers of Amendment 67. I welcome the fact that we have this opportunity to say something about redress. Amendment 68 is to follow in the next group, and I think it important to distinguish between the need to establish a scheme of redress where the NHS or government have been responsible for something which subsequently turns out to have damaged or harmed people, and the need to establish a scheme to provide proper support to those who have been harmed. That has been done on an ex gratia basis but, if the Government sought to do so, I think it would be possible to commence the NHS Redress Act 2006 and to establish such redress schemes under a statutory footing. It is not necessary to pass legislation to make that happen.
Those are different and distinct from the process of recognising that those harmed as a result of clinical negligence or failures in treatment processes should be able to secure a remedy and redress. I say remedy advisedly because often, in my experience of talking to people who have been harmed as a result of clinical negligence—these are often cases involving harm to babies during birth—it is as important to understand what happened, to accept where responsibility lies and to understand that others will not suffer in the same way, as it is to secure redress, compensation and support, which is often support for the child throughout their life. We need to understand that that is what we are talking about, not just the question of compensation.
I am slightly surprised by Amendment 67. I wonder what we think NHS Resolution is, if not an agency within the NHS with responsibility for securing redress for those who have been harmed as a result of clinical negligence. We need to recognise the need for, and I hope the Minister will tell us that the Government have not abandoned thought of, further reform. Certainly, when we were in opposition, we argued during the passage of the NHS Redress Bill that there should be a fact-finding phase. We argued that, rather than having an adversarial process with expert witnesses and all the associated costs, we should have a phase during which a claim is brought and the facts are established on an independent basis. That could lead to arbitration procedures and a settlement, rather than court-based proceedings, and we might escape some of the burden of cost. We should remember that nearly half the total cost of compensation in the clinical negligence process through NHS Resolution is actually legal fees. If we can escape some of that through an independent fact-finding phase, an arbitration process and financial settlements which recognise the support that the NHS and taxpayers give to those who have been harmed and have enduring problems and disabilities as a result, we might escape some of the burden of cost.
As the noble Lord, Lord Hunt, said, the potential contingent liability—not on an annual basis, but in the future—has risen to £83 billion. It is an enormous sum. The amounts paid by way of premiums to NHS Resolution are a significant aspect of the cost of NHS providers. There continues to be a good argument that the Government should consider this area still in need of reform.
Baroness Jolly (LD) [V]
This amendment from the noble Lord, Lord Hunt of Kings Heath, supported by the noble Baronesses, Lady Cumberlege and Lady Bennett, would require the Secretary of State to introduce proposals for a redress agency for those harmed by medicines and medical devices. As the noble Lord, Lord Hunt of Kings Heath, said, the concept of a redress agency for those harmed in such a manner has been around for many years but has not been realised. However, in the light of the Cumberlege report, which has been a great catalyst for innovation, the Government must see that now is the time. This is a really practical and common-sense move that would provide support and relief for patients while also avoiding the need for costly litigation on both sides, saving the NHS a considerable amount of money which could be better spent.
The NHS has a duty to give proper support to those in its care who have been harmed. As the noble Lord, Lord Lansley, said, there needs to be independent fact-finding, leading to a resolution process. He cited the NHS Redress Act 2006. I ask the Minister to reflect on this debate and to speak to his right honourable friend the Secretary of State, perhaps using his charm to persuade him to think again.
One advantage of being at home for this debate, in front of your own computer in your own study, is the opportunity quickly to look online to see how easy it is to find the relevant website. It took me a couple of searches before I came up with NHS Resolution, but it was not hugely helpful or intuitive. Therefore, would the Minister also feed that back to the Secretary of State and the people who manage these schemes?
Lord Bethell (Con)
My Lords, the noble Lord, Lord Hunt of Kings Heath, raises matters in Amendment 67 that he raised in Grand Committee. I completely recognise that they are of enormous concern right across the House. One could say that it is the £83 billion question. I know he is an advocate, as indeed are many noble Lords, of the conclusions of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege, and I commend him and other former Health Ministers in this place.
In Committee, we had a very helpful, substantial and informative discussion on the concept and merits of a redress agency. I know that the noble Lord indicated that he would return to these matters if it seemed likely that we were unable to give an update on the way in which the department is responding to the review. I understand that he seeks further assurances and I shall attempt to give them.
As I set out in Committee, we are determined to ensure the safety of medicines and devices so that harm is less likely to happen in the first place, and, when things do go wrong, we are committed to fair redress arrangements that work for all. However, for the reasons that I set out in Committee, we do not believe it is necessary to create a new body for the purpose of providing redress for medicines and devices.
First, routes already exist if patients believe they were harmed by medicines or medical devices. They can bring a legal claim in the courts either against the manufacturer on the basis of product liability or against the actions of an NHS provider or clinician.
Secondly, the Government and manufacturers already have the ability to set up redress schemes when necessary, and in fact they have done so already, where appropriate, without ever establishing an additional agency. Setting up an overarching redress agency could become an unnecessary addition to an already complex landscape.
Thirdly, we do not believe that a redress agency in this country would necessarily make products safer or drive the right incentives for industries which are usually directed from a global level. It is a fact of life that any extra costs to firms could impact the attractiveness of the UK as a place to market and manufacture products —something that we are committed to supporting.
The noble Lord, Lord Hunt, asked what, in the absence of wholesale changes, we are doing to improve things. Since its strategy, Delivering Fair Resolution and Learning From Harm, was launched in 2017, NHS Resolution has successfully reduced the number of cases going to litigation. In its 2019-20 accounts, it reported that 71% of claims are now resolved without court hearings, which is extremely encouraging.
This has been accompanied by a significant increase in the use of ADR—alternative dispute resolution, referred to by my noble friend Lord Lansley—with over 1,000 mediations undertaken by 31 March 2020, with a success rate of around 80%. This is again encouraging. As a result of the strategies employed on ADR and early resolution, overall time to resolution of cases had reduced since the NAO report by an average of 26 days. The new early notification scheme for obstetric cerebral palsy has ensured that many early admissions of liability and interim payments can be made to families within months. In answer to my noble friend Lord Lansley, we keep the whole arrangement under review and assess options all the time.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, again, this has been an interesting debate. As was said by the noble Baroness, Lady Cumberlege, there are persuasive arguments to change the current approach to redress and clinical negligence more widely. I agree with the noble Baroness, Lady Bennett, that the Government’s response was short and not really sweet.
The noble Lord, Lord Lansley, is right to draw a distinction between schemes of redress and wider clinical negligence issues. The noble Baroness, Lady Cumberlege, has a later amendment dealing with specific recommendations on redress for the patient groups that she examined in her report. I took her argument for a redress agency to have much wider implications and considerations. The noble Lord, Lord Lansley, expressed surprise at the wording of my Amendment 67. I simply sought to bring this back, so that we could have a wider discussion, as well as deal with the issues raised around the three patient groups in the noble Baroness’s report.
I have never understood why the redress Act was put on the statute book but never implemented. It is clear from talking to experts that it is regarded as flawed, but it is interesting that no Government have picked this up. Equally, we all accept that redress schemes for individual patient groups are an appropriate way forward. However, we are left with a system for clinical negligence that I simply do not believe works.
I heard what the Minister said about improvements for NHS Resolution, but the fundamental argument is that the system is getting more and more expensive—the £80 billion-plus question, as the Minister said. For patients and their relatives, it can be a daunting process, even though, as he said, more can be dealt with prior to going to court. But when the cases do go to court, NHS Resolution tends to lose them. We go back to the size of awards, where the issue, in essence, is that the NHS has to pay twice because of the way that the 1948 legislation was drafted.
At the end of the day, surely we need a thorough review of the whole issue of redress and clinical negligence. I can see that the Government do not yet accept the recommendations of the noble Baroness, Lady Cumberlege. In the end, we have to start with a clean sheet of paper to see if we can do better by patients, the NHS and all the individuals affected. Having said that, I beg leave to withdraw my amendment.
The Deputy Speaker (Lord Russell of Liverpool) (CB)
We now come to the group consisting of Amendment 68. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this amendment to a Division must make that clear in debate.
Amendment 68
Baroness Cumberlege
“Redress schemes
The Secretary of State must, by the end of the period of three months beginning with the day on which this Act is passed, bring proposals before Parliament to establish redress schemes for those avoidably harmed by—(a) hormone pregnancy tests,(b) sodium valproate, and(c) pelvic mesh.” Member’s explanatory statement
This new Clause would require the Secretary of State to create redress schemes for those who have already suffered avoidable harm related to the medicines and medical devices specified in the new Clause, and would thus implement one of the recommendations made in the report of the Independent Medicines and Medical Devices Safety Review.
Baroness Cumberlege (Con) [V]
My Lords, it is interesting that these two amendments reflect each other, but I wanted them to be separate. The debate that we have had on the agency has been really interesting.
The noble Lord, Lord Hunt, has just talked about a further review of the whole system, which probably needs doing, but I am dealing all the time—through emails, letters and phone calls—with people who are suffering now. Rather than wait for a really good scheme, which I hope a redress agency would be, I feel that we should be compassionate and really understand how people are suffering today. They will suffer tomorrow. They have suffered for decades. It is time that they had some redress to help them in the very difficult and complicated lives that they lead, with huge suffering. It is not just the individual: it is the family and it is the children, especially with sodium valproate. One must think of the home. It is therefore important for society that we as a Government understand and are happy to supply some redress now.
I thank my noble friend Lord O’Shaughnessy, the noble Lord, Lord Hunt, and the noble Baroness, Lady Bennett, who have put their names to this amendment. I look forward very much to hearing what they have to say.
In the two and a half years that we spent travelling the country, listening to tragic stories from women and their families, there was absolutely no doubt in our minds that avoidable harm had been inflicted on those who openly, honestly and with great dignity told us their life stories. I have frequently mentioned what they and their families have told us, but I will spare your Lordships on this occasion because I do not need to reiterate it. Your Lordships know what we found. It is all in our report, First Do No Harm, if you want to dig a bit deeper. Hormone pregnancy tests, sodium valproate and surgical mesh are three interventions that have caused avoidable psychological harm in some patients. It is also clear that surgical mesh has caused significant physical harm and that sodium valproate has caused physical and neurodevelopmental harm.
Having listened to these ruined lives, we believe that the state and manufacturers have an ethical responsibility to provide discretionary payments to those who have experienced avoidable damage in these three interventions. Each of them should have its own scheme and tailored eligibility criteria. When we have, as I hope we will, a redress agency, these schemes can be subsumed into the agency.
I make it clear that these payments are not intended to cover the costs of services that are already available free of charge. I am thinking of healthcare and social security payments, and in some cases education for children. This is rather for other needs, which could include things such as travel to medical appointments—we have heard a lot about the costs of that—respite breaks or emergency payments, when a parent has had to stop working to cover the care needed for that child or members of the family.
Patients have waited far too long for redress, some for decades, and any scheme must be set up promptly, as soon as possible. However, it should be structured so that it can be incorporated into the redress agency in future. Individuals who obtain compensation through litigation or out-of-court settlements—and we have heard of some, particularly from Johnson & Johnson and the Scottish pelvic mesh settlement—will not need recourse to these schemes. It is over and above what is already supplied by the state or is totally inadequate. So we are not setting a precedent: ex gratia payments have made by the Government to those suffering from infected blood, for example, as I mentioned in the last debate, as well as variant CJD and other areas, where treatments have caused avoidable damage.
In responding to the report’s recommendations, the Patient Safety Minister, Nadine Dorries, said that our recommendation that these schemes should be established is still under consideration. I am very heartened by her words, which give me—and, much more importantly, those who are suffering—cause for hope that the Government will do the right thing.
I ask my compassionate and noble friend the Minister if he could give us more information on this. If it has not been ruled out of court, can he tell us what plans are made to ensure that these schemes become a reality, and very soon, because they are much needed? I beg to move.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I shall be brief, since I am following the powerful case put by the noble Baroness, Lady Cumberlege, for Amendment 68, to which I am pleased to attach my name, along with the noble Lords, Lord O’Shaughnessy and Lord Hunt. This is not a lesser amendment than Amendment 67 but a more limited one. As the noble Baroness said, agreeing Amendment 68 would not stop Amendment 67 from happening in future. The scheme for each individual could be rolled into a broader redress agency. I join her in welcoming the initial response to her report from the Government, which says that proposals such as that in Amendment 68 remain under consideration.
The case has been made—and I am not sure that I am allowed to do this post Brexit, but I note that in France the Government already pay into a fund for valproate damage. There are other cases around the world which reflect what already happens in other instances of medical disasters that have been acknowledged.
I commend the amendment to your Lordships’ House. I do not think that we will be pressing it to a vote tonight, but I hope that the consideration that the Government continue to give will turn into action very soon.
Lord O'Shaughnessy (Con) [V]
My Lords, it is a privilege to be able to support and put my name to the amendment in the name of my noble friend Lady Cumberlege. As has so often been the case in this Bill, where she leads, others follow, and I entirely endorse everything that she and the noble Baroness, Lady Bennett, have said. My reason for supporting the amendment is simple: as my noble friend made clear today, there are tens of thousands of women, men and their families who are suffering from the impact of licensed medicines and medical devices that have been wrongly used.
My noble friend’s landmark review gives voice to so many people who have been ignored for too long; that is what gives it such moral power and makes the force of its arguments so irresistible. Within the final report of her review is a clear recommendation for ex gratia redress schemes to be established for those affected by the HPT, mesh and valproate scandals. To my mind, this recommendation is neither radical nor extraordinary: such schemes have been set up in the past—for the victims of thalidomide and contaminated blood. Indeed, this is a common-sense proposal, and it is urgent—because the suffering of so many continues to this day, as my noble friend pointed out.
I have spoken in the past of two women—Janet Williams and Emma Murphy—whose lives, and whose children’s lives, have been changed for ever by in utero exposure to sodium valproate. They were interviewed as part of a recent Channel 4 documentary on the challenges they face in day-to-day life, the guilt they have been made to feel and their struggle to be heard. Janet and Emma’s honesty and tenacity have been an inspiration to me since I met them, and I defy anyone to watch that programme and not be moved to tears.
I was also contacted recently by another lady, who has been harmed by mesh. Her name is Susan Morgan, and, with her permission, I convey her story. She described to me being on,
“a hideous journey that was thrust upon me without consent”,
suffering grievous, painful and irreparable damage due to a mesh that can now never be removed. Sadly, she has lost nearly everything in dealing with the consequences of this terrible, avoidable injury, and she asks only that
“the burden of fear and worry be removed so that I can find some peace”.
Therefore, I ask my noble friend the Minister: are the redress schemes proposed in the review of the noble Baroness, Lady Cumberlege, under serious consideration, as my honourable friend Nadine Dorries said in the other place earlier this week? I hope so. If so, when will they be introduced? Only a robust answer will be enough to satisfy those supporting this amendment. I close by imploring my noble friend to move quickly: these victims cannot wait any longer—their pain is real, and their need is urgent. Of course, a redress scheme will not change or right every wrong that has been done to Susan, Janet, Emma and thousands like them, but perhaps it might bring them some peace.
Baroness Jolly (LD) [V]
Amendment 68, in the name of the noble Baroness, Lady Cumberlege, requires the Secretary of State
“to create redress schemes for those who have already suffered avoidable harm”
related to hormone pregnancy tests, sodium valproate and pelvic mesh. The Minister has told us that there will be no redress agency. The noble Lord spoke passionately about suffering without redress. A significant amount will need to be paid through NHS Resolution to the women affected by these three interventions. Who will ensure that the women affected receive proper recompense? As the noble Baroness, Lady Cumberlege, has said, they have had to pay out for travel for treatment and payment for carers, and they are seriously out of pocket for what they originally thought was standard, straightforward NHS treatment.
I fear that, if there is no scheme, the NHS will have to pay more than it would through a properly managed redress scheme. This and the previous amendment are powerful signals to the Government that they must act on this issue of redress. I hope that, in summing up, the Minister will be able to share the Government’s plans with us. If they have no plans, what would he suggest that these women should do? The noble Lord, Lord O’Shaughnessy, put the case very powerfully.
Lord Hunt of Kings Heath (Lab) [V]
I very much agree with the noble Baroness, Lady Jolly, that this afternoon we have given a powerful signal to the Government. Certainly, from these Benches, we very much support her amendment and her efforts to get redress for people who were grievously damaged by procedures undertaken in the National Health Service.
The noble Lord, Lord O’Shaughnessy, talked about one woman’s experience of the impact of surgical mesh, and the huge pain and damage inflicted. I was very grateful to him when I had a Question on surgical mesh, which he answered, as watching it from the Gallery were a group of women from Sling the Mesh, who I had brought in. He gave a lot of time to them afterwards; perhaps it paved the way to the inquiry established under the chairmanship of the noble Baroness, Lady Cumberlege. Like him, meeting those women and talking to them about what they had suffered made me absolutely determined to do anything I could to raise the issue.
We were very fortunate that the noble Baroness, Lady Cumberlege, accepted the chairmanship of this inquiry, given the quality of her team and the extraordinary lengths to which she went to produce its very fine report. Anyone who has met the people involved and listened to the suffering that they have undertaken is left with a feeling that it is awful. Something must be done for them and I very much hope that the Minister will be sympathetic.
Lord Bethell (Con)
My Lords, what a moving and heartrending set of speeches on a very important amendment, which I take extremely seriously. It raises the issue of establishing a specific redress scheme for those medicines and medical devices considered by the review: sodium valproate, the use of pelvic mesh and hormone pregnancy tests. The stories in the review, which have been told here this afternoon, are extremely moving on every single level. I cannot but pay testimony to those who have conducted the campaign and given evidence about their own personal suffering—and who, quite reasonably, look for some form of redress.
I completely understand why my noble friend Lady Cumberlege has raised this issue and why she and other noble Lords have asked for progress on her review. I also completely understand the importance that she and her team attach to this recommendation. They rightly spent considerable time drawing on a wide range of complex evidence before reaching their recommendations. The Government feel it is only right that we also give that incredibly helpful report our full consideration before responding to its recommendations. I remind noble Lords about the timeline for a response to these kinds of reviews, which we have gone over before. I think we are well within the normal response time for such reviews, Covid notwithstanding.
In order to determine whether redress schemes should be established, the Government have a duty to ensure that the final decision is fair for patients and for citizens more generally—not just the patients and citizens affected by the three treatments that my noble friend Lady Cumberlege alluded to, but all citizens and patients; you cannot favour someone over another. This requires extremely careful consideration of any proposed scheme but also the precedent that any decision sets for future policy-making. We spoke in the previous debate about the £83 billion problem. That kind of financial impact has a profound bearing on this kind of discussion.
My noble friend Lady Cumberlege asked when the Government will respond to her review. The Written Ministerial Statement of 11 January sets out the Government’s interim response. I emphasise to anyone who may be confused that it is just an interim response to the report of the IMMDS review. We currently plan to respond to the report later this year; that is a commitment made by my honourable friend Nadine Dorries, the Minister in the other place. The report took over two years to compile and we therefore consider it absolutely vital for the sake of patients, especially those who have suffered greatly, to give this recommendation the full consideration it deserves.
The noble Baroness, Lady Bennett, asked why the Government have established redress schemes in the past but are unwilling to commit to the schemes proposed in this amendment. I think that one is too early to call. It is right and proper for the Government to carefully consider proposals for redress schemes on their own merits to ensure a fair outcome for patients, and citizens more generally.
The noble Lord, Lord Hunt, asked why it is taking so long to consider the recommendations. The report took over two years to compile, so we need to consider it very carefully. I do not want to use the Covid pandemic as a catch-all excuse, but the reality is that our hospitals are overwhelmed; the Department of Health has doubled in size in the last six months and even with that it is overworked and overstretched. The resources and capacity to respond to this kind of report are, I am afraid, distracted on other matters of national health crisis. However, I reassure the noble Baroness, Lady Cumberlege, and other noble Lords who have spoken that work is under way and we will set out the Government’s response to this report later this year.
I could not help but be enormously moved by the testimony of the noble Lord, Lord O’Shaughnessy. In essence, he asked why the Government do not recognise that the patients highlighted in the report of the medicines and medical devices review suffered unavoidable harm, particularly those who took hormone pregnancy tests. The Government absolutely do regard their suffering most seriously indeed and are considering the contents of the report. I am restricted in what I can see regarding hormone pregnancy tests in particular, given the live litigation, but I want to make clear the Government’s position regarding a causal association between HPTs and adverse outcomes in pregnancy. The scientific evidence has been reviewed on a number of occasions, most notably by the Commission on Human Medicines expert working group on HPTs, which, as noble Lords will know, reporting its findings in November 2017. The EWG concluded that the scientific evidence did not support a causal association and that remains the Government’s position.
Just as Covid-19 impacted the publication of the report, it has also had an impact on the timing of our response. I know, and recognise, that that is enormously frustrating. The Government are committed to responding and I assure the noble Baroness, Lady Cumberlege, that work is under way. Our upcoming full response will address recommendation number four. We are moved by the stories; I am totally and utterly sympathetic to the situation that the patients affected by these conditions find themselves in on a day-to-day basis. They are still living through it today. I would like to regard myself as a compassionate person, but it is not appropriate to make policy on this kind of matter through primary legislation. For that reason, I ask my noble friend to withdraw her amendment and await the Government’s full response to her report.
Baroness Cumberlege (Con) [V]
My Lords, I am so grateful to noble Lords who have taken part in this debate. It has been quite short, but it is very important. As the noble Baroness, Lady Bennett, said in the previous debate on the agency, she has been involved with this Bill in a way that she did not anticipate. She has been such a stalwart, coming to my rescue on occasions, and supporting so much of what has been in the Bill from other sources. I thank her for all of that. The noble Lord, Lord O’Shaughnessy, made a powerful speech about the individuals he has met. We know Susan Morgan well; we have worked with Janet and Emma and many others who have led their own organisations. We think of patient groups as being a few people who got together—when we did not have lockdown—to have coffee and just discuss life generally. That is not the case.
One of the groups I know has 8,500 members—from all over the world, in fact. Other groups have an equal number of members, or numbers of that order. So these are important organisations. They know what it is to have real research. They come up with not just experiences; they beaver away at all our institutions, they look at what they are producing and they challenge. They are so valuable. In the way they work, when they are people who are in considerable pain—very often, they have complicated and difficult lives, having to deal with constant pain—they are thinking of others all the time. That really is so uplifting.
The Deputy Speaker (Baroness Barker) (LD)
My Lords, we now come to the group beginning with Amendment 69. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in this group to a Division must make that clear in debate.
Amendment 69
Baroness Wheeler
“Northern Ireland and regulatory divergence
(1) The Secretary of State must make an annual report to Parliament on areas of regulatory divergence between Northern Ireland and the rest of the United Kingdom in matters covered by this Act.(2) Where the Secretary of State has identified areas of potential regulatory divergence between Northern Ireland and the rest of the United Kingdom, the Secretary of State must set out plans to mitigate the adverse effects of such divergence in the annual report.” Member’s explanatory statement
This new Clause would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK.
Baroness Wheeler (Lab)
My Lords, I am moving the amendment in the name of my noble friend Lady Thornton, which revisits the issue of regulatory divergence between Northern Ireland and the rest of the UK in matters covered by the Bill, and the need for an annual report to Parliament on this matter. The amendment also places an obligation on the Secretary of State specifically to report on plans to mitigate its adverse effects.
The Government will know that there is huge concern on this issue, strongly reflected in our Committee debates through our amendment and an amendment from the noble Lord, Lord Patel, calling for an annual report. The issue was also raised in consideration of the medicines and medical devices statutory instruments before Christmas and in the deliberations on the Northern Ireland protocol and the Trade Bill.
However, I welcome the Government’s amendments in this group to Clause 44, which extend reporting obligations to apply in respect of regulations made by a Northern Ireland department and to regulations under Clause 18 on the health and social care information systems. In particular, Amendment 85 specifies a Northern Ireland department and the Northern Ireland Assembly as an appropriate legislature and relevant authority in relation to regulations made under the Act.
We also welcome the Government’s acceptance of the arguments put forward by noble Lords and the Delegated Powers and Regulatory Reform Committee on the need for parliamentary scrutiny before and after delegated powers are exercised, and the introduction of a two-yearly reporting requirement in large parts of the Bill. I note that government briefings commit to the reports containing a summary of how the regulations have operated over the period under consideration, including any concerns from stakeholders and the Secretary of State’s response, as well as outlining plans for further changes.
I am speaking also on Amendment 78, in the name of my noble friend Lady Thornton, supported by the noble Baroness, Lady Jolly, which in Committee we submitted for inclusion in the provisions under the previous Clause 41 on consultation but which now amends the reporting requirements in Clause 44. Our amendment specifies cohorts that must be consulted in preparation of a report to Parliament, including patients and their representatives, and other key industry stakeholders from healthcare, pharmaceuticals, veterinary and medical research organisations, and healthcare providers and regulators.
Once again, we come back to the importance of ensuring that patients and end users are part of and involved in consultation and reporting relating to existing and potential new medicines, veterinary medicines and medical devices. The stark lessons from the Cumberlege review, the Ockenden review and many other reviews that we have had are that patients’ voices must be heard.
For the record, we feel that the Government’s reporting requirements amendment falls short of providing the reassurances that we sought in Committee, because the relevant authority still has ultimate discretion over whom it consults. This could mean that any report could be skewed or biased by those chosen at the discretion of the Government. That is why our Amendment 78 details the key stakeholders that should be consulted.
In response to that amendment, I am sure that the Minister will come back to the often stock response to the inclusion of specific stakeholders in the Bill, namely that this would be too rigid and burdensome, and would inadvertently rule out contributions from those accidentally not listed. However, in the context of a very complex Bill and the history of often poor communications with stakeholders, I urge the Minister, if she is not happy with our list, to consider a broader amendment at Third Reading that would provide the reassurance that is clearly needed.
I come back to the key issue of regulatory divergence between Northern Ireland and the UK and reporting on this matter. Marketing, authorisation and trading processes on medicines and medical devices between Northern Ireland, the EU and the UK are complex issues, and many remain unclear. The Northern Ireland protocol and the provision for ongoing discussions to resolve key issues mean continued uncertainty for businesses, health services and patients. In this context, an annual rather than a two-yearly report to Parliament would have been more appropriate, particularly highlighting the problems arising from regulatory divergence, and the plans and progress on addressing them.
This is not the time or occasion to go into detail on the issues covered in Committee. However, in Committee the noble Lord, Lord Patel, highlighted many key matters and concerns arising from the MHRA’s guidance on regulating medical devices from 1 January 2021, issued in September 2020, before Committee. I know that the MHRA has been pretty busy of late with the vital Covid-19 vaccination authorisation, but can the Minister tell us when it is envisaged that the MHRA guidance will be updated and reissued?
We have sought and been given reassurances from the Minister that the MHRA’s staffing, resourcing and capacity have been substantially increased to meet its new obligations. It is a much-respected body, but, as we have said, it faces huge challenges under its new role, and we suspect that the £13 million additional funding provided to it by the Government up to the end of March 2021 will be just a pump-priming starter in the light of all that needs to be done. The Minister’s reassurances over the MHRA’s strategic development plans and the Government’s commitment to further funding are welcome, but this is something that we will need to keep a close watch on. I beg to move.
Lord Patel (CB) [V]
My Lords, from the outset it has been clear that there was a potential for regulatory divergence in Northern Ireland from the rest of the UK for medicines and veterinary medicines, since they are referred to separately in the Bill as reserved matters in Northern Ireland. However, it has been made clear in the last quarter of 2020 that interaction with the Northern Ireland protocol makes that divergence inevitable for medical devices as well.
Guidance published by the MHRA in October, which I referred to previously, and statutory instruments laid before Parliament in the final months of 2020, set out two different systems of market authorisation and registration, among other issues, and distinguished between the Northern Ireland and Great Britain markets for medical devices and medicines alike. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland, while CE marks will cease to be recognised in the Great Britain market from July 2023 unless the products in question are from manufacturers based in Northern Ireland.
There are essentially two paths for manufacturers based in Northern Ireland to bring a medical device product into the Great Britain and Northern Ireland markets. The first is to go through UK-based approved bodies for their assessment and market authorisation, which will be approved for both the Great Britain and Northern Ireland markets but will not be recognised in the EU. The second is to submit an application to approved or notified bodies in the EEA to gain a CE mark and thus access to the markets of Great Britain, Northern Ireland and the EU without further needing to apply to a UK body for approvals for the Great Britain market.
By contrast, manufacturers based in Great Britain will need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland, but will need to undertake the separate task of setting up an EU-based responsible person and apply separately for a CE mark in the EU. It appears that the recognition of a CE mark on a medicine or device coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. What is not clear is the extent to which this dual system between Northern Ireland and the rest of the UK will diverge in substance.
For these reasons and many others, the Government should clarify the position. The amendment would provide greater transparency on potential regulatory divergence, with a commitment to mitigate it where possible. Of course, I will not be surprised if the Minister does not accept the amendment, and neither do I think the noble Baroness will divide the House on it, but whether we agree with it or not, I hope the Minister will agree that somebody has to have some way to recognise what this divergence will do. Who will that be? Would she agree that this will be needed in due course?
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to follow the noble Lord, Lord Patel.
What does one say to the people of Northern Ireland? They voted to remain in the EU, their vote was ignored by the DUP, and they have been duped by the Government, who continue to deny that there is a border in the North Sea—when today we are debating ample evidence of such a border. As the noble Lord, Lord Patel, identified, the distinction the MHRA is now having to make between the EU market, the British market and the market for Northern Ireland, as well as the bureaucracy involved and the cost for British-based companies, is undeniable.
These two very modest amendments seek to ensure that Parliament gets a regular report on how this is working in relation to medicines and medical devices regulations, and that various bodies should be consulted. However, over and above that, the Minister owes the House some explanation of how we have ended up in this bizarre situation, where Northern Ireland, which wanted to be in the EU and wanted to be listened to, has ended up in this rather parallel existence, with a border down the North Sea, food shortages in its supermarkets, and in a right mess. I hope the Minister can answer that.
Baroness Jolly (LD) [V]
My Lords, the amendments in this group relate to reporting requirements and consultation. The noble Lord, Lord Hunt of Kings Heath, has just put the political case very clearly; the noble Lord, Lord Patel, looked at the technical and regulatory issues; I will look at the practical issues around health services on the island of Ireland.
Amendment 69 from the noble Baroness, Lady Thornton, would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK. Can the Minister tell us when the first report would be published, whether the Republic would be part of this consultation, and if not, why not? The noble Baroness, Lady Thornton, and I tabled this amendment to require the relevant authority to consult with patients and healthcare and industry stakeholders when preparing a report under Clause 44.
Divergence is inevitable. The situation for healthcare on the island of Ireland could become extremely complicated. In the past, patients have travelled north or south to receive treatment wherever the appropriate treatment is available. Will citizens from Northern Ireland and the Republic have to use the new GHIC, or do the Government have an agreement with the Republic so that business as usual will be the new norm—no change?
Government Amendments 75 to 77 and 79 to 85 extend the reporting requirements under Clause 44 so that they apply to regulations made by a Northern Ireland department and in respect of regulations under Clause 18. However, we cannot ignore the Republic when we talk about health in Ireland.
Baroness Penn (Con)
My Lords, we now turn to the way in which reports are prepared and made on the exercise of the regulatory-making powers in the Bill.
Amendment 69 in the name of the noble Baroness, Lady Thornton, would make changes to the existing requirement to report, introduced in Grand Committee. It proposes that an additional report be made by the Secretary of State to Parliament, this time on regulatory divergence with Northern Ireland introduced as a consequence of future regulations. I understand the noble Baroness’s intent. I heard the concerns raised in Grand Committee about the potential impact of regulatory divergence. The Government take that seriously. However, I will explain why this amendment is not necessary to address it.
As a reminder, the amendments made in Grand Committee provided for a reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 9(1) and 14(1)—one that was both forward- and backward-looking. Those reports must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. It will necessarily draw Parliament’s attention to regulations that have been made.
Parts 1 and 2 of the Bill relating to human and veterinary medicines are matters transferred to Northern Ireland. As such, legislative consent was secured for the Bill earlier in its passage, but as amendments were made during Grand Committee, further legislative consent was sought. At Northern Ireland’s request, government Amendments 75, 76, 79, 80, 81, 82 and 85 in this group replicate the existing reporting obligation for Northern Ireland. This means there will be a report laid in Parliament every two years on what new regulations have been made and any plans to make further related regulations. A separate report will be laid before Northern Ireland. Between our report and the report laid before the Northern Ireland Assembly, any areas of regulatory divergence between the UK and Northern Ireland regulatory regimes will be made clear. Therefore, it would be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for human and veterinary medicines and medical devices.
In addition, where there are concerns about the implementation of the protocol and its impact on patients and animals in Northern Ireland, there are formal channels in place. Officials meet regularly in the Ireland/Northern Ireland Specialised Committee. The Specialised Committee reports to the Withdrawal Agreement Joint Committee and provides advice on decisions to be taken by the Joint Committee under the protocol.
Before the end of the transition period, we raised with the EU through its specialised committee the issue of the falsified medicines directive and regulatory importation requirements for medicines moving from Great Britain to Northern Ireland after 1 January. We agreed with the EU a pragmatic one-year, time-limited approach to implementing these regulations that ensures no disruption to the flow of medicines to Northern Ireland. I say this to reassure noble Lords as to the effectiveness of those mechanisms under the protocol.
Noble Lords made a number of comments on the issue of regulatory divergence and I thought I would dwell on it briefly. The noble Lord, Lord Patel, gave a good description of future provisions regulating devices between Northern Ireland and Great Britain. He is wrong to say that the Bill lays out Northern Ireland separately because of this. It does so because medicines and veterinary medicines in Northern Ireland are the responsibility of the Northern Ireland Assembly and are therefore devolved. However, divergence may be an issue for the future, not least because the EU may change its own regulatory regime under the protocol that Northern Ireland will follow, and the UK may make changes here as well.
To reassure noble Lords, we have agreed a standstill period of two years for medicines and veterinary medicines and two and a half years for devices, during which we will continue to recognise EU regulations in these areas. This means that there is time for adequate consultation on regulations made under this Bill, for consultation on any future changes and for these mechanisms to operate properly. Divergence may be a matter for the future, but we have reporting to Parliament and public consultations on any regulations made under this Bill to address those questions.
The noble Lord, Lord Hunt, asked how we ended up here. I think that question is slightly wider than the purview of this Bill. I have quite a lot of lived experience of how we ended up here and I do not intend to recount that now.
I hope the amendments I have referred to in the name of my noble friend Lord Bethell, coupled with these other, existing arrangements, make the amendment tabled by the noble Baroness unnecessary.
Government Amendments 77, 83 and 84, also in the name of my noble friend, are made in the same light of expanding reporting obligations. In the interests of transparency and scrutiny, amendments have been made to extend the obligation to include regulations made under Clause 18—the regulation-making power in relation to the medical devices information system. We have made this change to make clear our absolute commitment to transparency, to giving Parliament continued visibility, to understanding the assessment made of any proposals or concerns raised as to how the regulations have been working, and to ensure that the regulation-making powers specifically containing provisions that may ensure or affect device safety and post-market surveillance are treated equally.
The noble Baroness, Lady Thornton, again seeks to test us on the preparation of the reports with Amendment 78, which would add a list of stakeholders to be consulted under the obligation. Again, this is unnecessary. If her concern is that the stakeholders listed may be ignored, I reassure her that the reports must summarise concerns raised, or proposals for change made, in relation to regulations enforced during the reporting period. That information will come from engagement with relevant stakeholders. Therefore, I do not think it necessary or proportionate to add a list of specific stakeholders to be consulted for each report, which will be a summary of public consultation that will already have been responded to.
I must say to the noble Baronesses, Lady Jolly and Lady Wheeler, that the Government will not return to this issue at Third Reading, so if they wish to press it, now is the moment. However, with the number of avenues already available, I hope that they are reassured that their amendment is not needed and will not wish to press it.
Baroness Wheeler (Lab)
I thank the Minister for her response. I shall not go into details now, but we know that there will be significant issues of regulatory divergence, as the noble Lord, Lord Patel, my noble friend Lord Hunt and the noble Baroness, Lady Jolly, have stressed. We know that it is an issue about which we will have to be very watchful. In the circumstances we currently face, an annual report would have aided the process of working through the issues and encouraged understanding of the plans to address them and the progress being made.
On Amendment 78, the Minister is obviously not going to oblige me with a tidying-up amendment at Third Reading to underline the importance of the patient voice. I think that is a mistake; it would have been helpful. However, I beg leave to withdraw Amendment 69.
Lord Bethell
“(1) This section applies to regulations under a power in Part A1, 1, 2 or 3, apart from regulations under paragraph 9 of Schedule 1.”Member’s explanatory statement
This amendment is consequential on the Minister’s amendments to insert a new Part before Part 1 and a new Clause after Clause 18, and would enable regulations under powers in those provisions to make consequential and other connected provision.
Member’s explanatory statement
See the explanatory statement for the other amendment to Clause 41 in the Minister’s name.
Lord Bethell
Member’s explanatory statement
This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety. It requires the Secretary of State to carry out a public consultation before making regulations about the Commissioner.
Member’s explanatory statement
This amendment would require a consultation in relation to regulations under Clause 1, 9 or 14 to include a summary of the assessment of the person making the regulations of all matters mentioned in Clause 1, 9 or 14 (as the case may be), including new subsections (3A), (3A) and (4) inserted by amendments in the Minister’s name into Clauses 1, 9 and 14 respectively (overall assessment of risk-benefit analysis).
Member’s explanatory statement
This amendment provides for the definition of “relevant authority” to apply in relation to regulations under new Part A1 (the Commissioner for Patient Safety) and the new Clause tabled in the Minister’s name to appear after Clause 18 (advisory committee), as well as in relation to other regulations under Part 1, 2 or 3.
Lord Bethell
Member’s explanatory statement
This amendment and the other amendments to Clause 44 in the Minister’s name extend reporting obligations under Clause 44 so they apply in respect of regulations made by a Northern Ireland department and in respect of regulations under Clause 18.
Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.
Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.
Lord Bethell
Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.
Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.
Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.
Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.
Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.
Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.
“(5) In this section—“appropriate legislature” means—(a) in relation to a report of the Secretary of State, Parliament;(b) in relation to a report of a Northern Ireland department, the Northern Ireland Assembly;“relevant authority” means—(a) in relation to regulations made under section 1(1) or 9(1) by the Secretary of State (whether acting alone or jointly with a Northern Ireland department), the Secretary of State; (b) in relation to regulations made under section 1(1) or 9(1) by a Northern Ireland department (whether acting alone or jointly with the Secretary of State), the Northern Ireland department;(c) in relation to regulations made under section 14(1) or 18(1), the Secretary of State.”Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.
Lord Bethell
Member’s explanatory statement
This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety.
Member’s explanatory statement
This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety.
Baroness Jolly
Lord Bethell
Member’s explanatory statement
This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety. It provides for regulations about the Commissioner to be subject to the draft affirmative procedure.
Baroness Jolly
“Super-affirmative procedure
(1) For the purposes of section 1(1), section 9(1), section 14(1) and section 18(1), the “super-affirmative procedure” is as follows.(2) The Secretary of State must lay before Parliament—(a) a draft of the regulations, and(b) a document which explains the draft regulations.(3) Where a draft of the regulations is laid before Parliament under subsection (2), no statutory instrument containing the regulations is to be laid before Parliament until after the expiry of the 30-day period. (4) The Secretary of State must request a committee of either House whose remit includes health, science or technology to report on the draft regulations within the 30-day period.(5) In preparing a draft statutory instrument containing the regulations, the Secretary of State must take account of—(a) any representations,(b) any resolution of either House of Parliament, and(c) any recommendations of a committee under subsection (4), made within the 30-day period with regard to the draft regulations.(6) If, after the 30-day period, the Secretary of State wishes to make regulations in the terms of the draft or a revised draft, he or she must lay before Parliament a statement—(a) stating whether any representations, resolutions or recommendations were made under subsection (5);(b) giving details of any representations, resolutions or recommendations so made; and(c) explaining any changes made in any revised draft of the regulations.(7) The Secretary of State may make a statutory instrument containing the regulations (whether or not revised) if, after the laying of the statement required under subsection (6), a draft of the instrument has been laid before and approved by a resolution of each House of Parliament.(8) In this section, reference to “the 30-day period” in relation to any draft regulations is to the period of 30 days beginning with the day on which the original draft regulations were laid before Parliament.(9) For the purposes of subsection (8) no account is to be taken of any time during which Parliament is dissolved or prorogued or during which either House is adjourned for more than four days.”
“Super-affirmative procedure: Northern Ireland
(1) For the purposes of section 1(1), section 9(1), section 14(1) and section 18(1), the “super-affirmative resolution procedure” in the Northern Ireland Assembly is as follows.(2) The Department must request a committee of the Assembly whose remit includes health, science or technology to report on the draft order within the 30-day period.(3) A Northern Ireland Department must take account of—(a) any representations,(b) any resolution of the Assembly, and(c) any recommendations of a committee under subsection (2), made within the 30-day period.(4) If, after the 30-day period, the Department wishes to make an order in the terms of the draft, it must lay before the Assembly a statement—(a) stating whether any representations were made under subsection (3)(a); and(b) if any representations were so made, giving details of them.(5) The Department may after the laying of such a statement lay before the Assembly for approval by affirmative resolution the draft order in its initial form, or a revised draft order together with an explanation of the changes made.(6) In this section, reference to the “30-day period” in relation to any draft order is to the period of 30 days beginning with the day on which the original draft order was laid before the Assembly.(7) For the purposes of subsection (6) no account is to be taken of any time during which the Assembly is dissolved or adjourned for more than four days.”
Lord Bethell
“(ba) section 5(4),”Member’s explanatory statement
This amendment would commence the definition of “human medicines provision” from the day on which the Bill is passed.
“(za) Part A1,”Member’s explanatory statement
This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety. It provides for those amendments to come into force two months after the Act is passed.
Member’s explanatory statement
This amendment is consequential on the Minister’s amendment to insert a new clause after clause 18, in Chapter 2 of Part 3, and provides for the new clause to come into force two months after the Bill is passed.
Lord Bethell
Member’s explanatory statement
This amendment would add a limb to the long title in relation to the new provisions tabled in the Minister’s name for the purpose of establishing a Commissioner for Patient Safety.
Medicines and Medical Devices Bill
Thursday 21st January 2021
(3 years, 10 months ago)
Lords ChamberRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 163-I Marshalled list for Third Reading - (18 Jan 2021)
Lord Sharkey
Member’s explanatory statement
This amendment is to correct the drafting.
Lord Sharkey (LD) [V]
My Lords, Amendments 1 to 8, in my name and that of my noble friend Lady Jolly, are to correct drafting. None of them, individually or collectively, alters the meaning or substance of the parts of the Bill that they would amend. I beg to move Amendment 1.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
The noble Lord, Lord Sharkey, made his points cogently on Report. We do not intend to oppose the amendments on the Marshalled List, as they are technical tidying amendments, consequential on those in the name of the noble Lord, Lord Sharkey, that were passed on Report.
Lord Sharkey
Member’s explanatory statement
This amendment is to correct the drafting.
Lord Sharkey
Member’s explanatory statement
This amendment is to correct the drafting.
Member’s explanatory statement
This amendment is to correct the drafting.
Member’s explanatory statement
This amendment is to correct the drafting.
Member’s explanatory statement
This amendment is to correct the drafting.
Member’s explanatory statement
This amendment is to correct the drafting.
Member’s explanatory statement
This amendment is to correct the drafting.
Lord Bethell (Con)
My Lords, the Bill before us is quite different from the one we started with, but it is no doubt much better. That is entirely because of the huge value of your Lordships’ challenge and scrutiny. We have held over 50 meetings and considered 249 amendments, and the result is a tribute to the care and patience of noble Lords, for which I give profound thanks. It is also, if I may say so, a tribute to the workings of the hybrid House, which have kept legislation moving under difficult circumstances.
We would not have reached this position without the thoughtful, collaborative and constructive input of noble Lords, to whom, I pay tribute—in particular, to the noble Baronesses, Lady Thornton and Lady Wheeler, on the Opposition Front Bench, together with the noble Lord, Lord Hunt, and the noble Baronesses, Lady Jolly and Lady Walmsley, and the noble Lord, Lord Sharkey, on the Liberal Democrat Benches. I also thank, from the Cross Benches, the noble Lords, Lord Patel and Lord Alton, and the noble Baroness, Lady Finlay. They have all brought their immense experience and wisdom to our debates, to improve this legislation. And when it comes to wisdom and experience, I must also pay tribute to those from these Benches, especially my noble friend Lord Lansley, my predecessor, my noble friend Lord O’Shaughnessy, and my noble and learned friend Lord Mackay of Clashfern, who have all been of enormous help in enabling us to arrive at a consensus across the House. My noble friend Lord Howe has been a generous mentor, and my noble friend Lady Penn is a superlative Whip, both shepherding the process charmingly, discreetly and effectively.
I thank most emphatically my noble friend Lady Cumberlege. She has spoken of the importance of compassion, of the voices she has listened to, and of the paramount importance of patient safety. I have heard her, and I support her endeavour. She has the support of the House in her efforts, and we have collectively made significant progress towards her admirable goal.
I also thank officials on the Bill team, particularly Alice Clouter, and those in my private office, particularly Tilly McEwan. They have all worked tirelessly and expertly. I cannot give thanks to all the other champions in the House who have made influential interventions, but I am definitely very grateful to them.
I cannot hide my excitement about the future. While the Bill process is near its conclusion, we are at the end of the beginning of an exciting new regulatory system—a system that protects patients and enables innovation. It is with that vision of the future, as well as my gratitude to all, that I beg to move.
Baroness Thornton (Lab) [V]
My Lords, at this stage of the Bill, we take a few moments to congratulate ourselves and thank those who have made it possible to get this far. First, I thank my own Bill team, who have worked so hard, particularly Rhian Copple in the Lords Opposition office, and my noble friends Lady Wheeler and Lord Hunt—and, indeed, my noble friend Lady Andrews and others, who popped up here and there to support us.
We should all congratulate ourselves because, despite the conditions in which we have worked this autumn and winter, we have managed to build effective communications which have made it possible to make considerable progress in improving the Bill in many ways, as the Minister said. I think we can say that we did our job, as the revising Chamber.
The fact that we ended up with only three Divisions on Report is a testimony to way in which the Minister, the noble Lord, Lord Bethell, his Whip, the noble Baroness, Lady Penn, and his adviser, the noble Earl, Lord Howe, and the very hard-working Bill team led by Alice Clouter, handled the Bill. They listened, they discussed, they considered and they revised, which is really all that one can ask. This is the Minister’s first Bill, and I congratulate him on leading his team and handling what is always a baptism of fire for any Minister.
I am delighted to agree with the Minister and say that we are sending back a very different, and much improved, Bill. We have managed to address many of the big-ticket items, ranging from data sharing to human tissue, and, ultimately, patient safety. I thank participants across the House. Like the Minister, I mention in particular the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, the noble Lords, Lord Freyberg and Lord Clement-Jones, and the noble Baroness, Lady Cumberlege. I also thank everybody else who has taken part in the many discussions and given us the benefit of their wisdom, particularly the noble Lords, Lord Lansley and Lord O’Shaughnessy.
First Do No Harm paved the way for the creation of an independent patient safety commissioner, and I think that changed the way in which the Bill was handled, because it is now, as it should be, a patient safety Bill. For that, I really wish to congratulate the noble Baroness, Lady Cumberlege.
Finally, I want to thank the organisations who have given us their support and expertise, which is particularly important for those of us in opposition. I am very grateful to the DPRR and Constitution Committees for their insightful scrutiny, which sometimes is painful for the Government but is almost always helpful to us; the Lords Library; and, for us, the University of Birmingham, the British Dietetic Association, Advanced Accelerator Applications, the Association of British HealthTech Industries, Cancer Research UK and, in particular, the BMA. I am very grateful for the expert briefs that they have given us.
Stakeholder engagement will remain key for many years to come, for while the Bill will soon pass—as the Minister said—the task of creating a post-Brexit medicines and medical devices regulatory regime is far from finished. I look forward to working with stakeholders and the Minister to make sure that we move forward in the best possible fashion. We have given ourselves a good start.
Baroness Jolly (LD) [V]
My Lords, Bills come and go. This Bill started its life as one to tidy up regulatory issues to do with the new post-EU world. In 10 years’ time, the Medicines and Medical Devices Bill is one I may not list as one of the most important I have worked on; I hope that the forthcoming mental health Bill will fit that spot. If remembered at all, it will be for the introduction of a commissioner for patient safety, born out of the First Do No Harm report by the noble Baroness, Lady Cumberlege.
There will need to be changes in the House of Commons to make the Bill really fit for purpose. The Minister has indicated the Government’s intention to lay amendments, and I am grateful to him for involving Peers in that process. When does he anticipate Second Reading in the Commons?
As the Minister and the noble Baroness, Lady Thornton, said, many people make a Bill, and they do not all sit in the Chamber. In particular, I thank both the Minister and the noble Baroness, Lady Penn, for giving us time to talk to the Bill team and allow them to explain new government amendments. Of course, I should not forget the noble Baroness, Lady Thornton, and her team; the noble Lord, Lord Patel; my noble friend Lord Sharkey; staff in opposition offices; and others who certainly made the Bill better, turning it into a workable piece of primary legislation.
Baroness Cumberlege (Con) [V]
My Lords, I could not let this opportunity pass without expressing my gratitude to all those who have played such a vital part in drafting, scrutinising and improving this important Bill. I know that it will now return to the other place. I wish it a fair wind and hope that we will soon see it enacted.
Throughout, noble Lords from all sides of the House have, quite rightly, focused on using the Bill to strengthen patient safety. Safety is now threaded throughout the Bill. I do so welcome that; it is something that the noble Baronesses, Lady Thornton and Lady Jolly, have both just mentioned. We have enshrined a very important safety recommendation in the Bill: we will now have a proper database to record the medical devices that are used and on which we and patients will be able to track their outcomes and detect safety more quickly. I cannot overstate just how important that is. Without this data, the healthcare system has been flying blind.
I have been very touched by the kind and thoughtful expressions of support from so many noble Lords in general debates and, in particular, for my amendments, which were triggered by the recommendations in First Do No Harm. The report enshrined in me that, at every opportunity, we must be reminded that the NHS is run for the people and is paid for by the people. Right now, the NHS is demonstrating a total commitment to saving lives and defeating this deadly virus—a virus that, as it sweeps around the world, devastates lives, livelihoods, education, personal budgets and a national aspiration for a better world.
In the dark days of the Second World War, Beveridge was preparing for a better Britain. In these dark days, there is a need to make plans—not just to return to what was there before but to look forward to something better. I believe that the patient safety commissioner will provide something better and will improve patient safety and healthcare as a whole. I was thrilled that so many of your Lordships lent me their support in calling for this; I know that their voices made all the difference. I thank the Minister and the noble Baronesses, Lady Thornton and Lady Jolly, for their generous remarks today.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I am delighted to follow my noble friend Lady Cumberlege; I pay fulsome tribute to her and the team that, through her leadership, produced the report, First Do No Harm, from which we see this Bill. I would like to join her and others in paying tribute to my noble friends Lord Bethell, Lady Penn and Lord Howe, who I had the honour to work with, as a humble bag carrier, in the other place.
In recalling my interest with the Dispensing Doctors’ Association, I would like to make one plea to the Minister as this Bill proceeds to the other place. For clinical trials and patient safety, which is the focus of the Bill, which I wholeheartedly support, we need to rely on patients making their data available and giving consent for it to be used for clinical purposes. During the passage of the Bill, I raised what has now been seen in Denmark—a huge reaction against patient data having been abused and used for commercial purposes against the wishes, and without the consent, of patients. Were that to happen here, it would detract from the fundamental good of this Bill and the wider public benefit to the NHS and future patients of sharing the clinical data that permeates this Bill. I urge the Minister, therefore, to look seriously at the practical question that remains of how patient consent will be obtained and confidentiality respected, particularly in meeting the requirements of clinical need. But I am delighted to have played even a small part in the passage of this Bill, and we look forward to its passage through the other place.
Lord Patel (CB) [V]
My Lords, I am delighted to have this opportunity to express my thanks to the Minister—the noble Lord, Lord Bethell—the noble Baroness, Lady Penn, and all the other noble Lords who have been taking part in this legislation, in particular those who spoke to and supported my amendments from all sides of the House.
Much has already been said about what we have achieved. I know that time is running short, so I will try and be brief. Of course I congratulate, first and foremost, the noble Baroness, Lady Cumberlege, for achieving what I had tried before—getting patient safety on statute. I did not have her tenacity or clout. So, many congratulations to her and, I believe, the commissioner for patient safety, who will make patient safety stronger in the whole of the health service.
I am very grateful to the Minister, the noble Lord, Lord Bethell, to the noble Baroness, Lady Penn, and to the noble Earl, Lord Howe, for the many meetings they arranged with us to hear our concerns and find solutions. I know it is a privilege for me to speak in person, but I hope all my colleagues on the Cross Benches—more than 12 of them—who took part in the Bill will feel I can speak on their behalf to thank Ministers and all other noble Lords.
I am also grateful to members of the Bill team, who were very helpful at the many meetings that the Minister arranged. And I am grateful to outsiders, in particular the University of Birmingham faculty of law, which worked very hard to produce the details of the legislation. Thank you all.
Lord O’Shaughnessy (Con) [V]
My Lords, there is not much more to say that has not already been said by other noble Lords. I just wanted to use this opportunity to thank and pay tribute to particular groups. The Bill team and private office, which have worked so hard to produce this legislation, are amazing in what they do and often unsung. It is important we recognise them.
Secondly, I thank those patients and patient groups who have provided so much moving information and testimony that has informed our work. After all, we serve them, and I hope and believe that we have served them through improving this Bill in this House in the way we have.
Thirdly, I pay particular tribute to my noble friend Lady Cumberlege. When I was in government and we commissioned her report, I could not have dreamed that she would have done such a thorough job and carried it with her customary tenacity, to the point where we have, on statute, the commitment to a patient safety commissioner. It is such an important step forward and it will make a massive difference to the lives of hundreds of thousands of people in this country. For that, we should all be proud of this step—and she in particular should be.
Finally, I thank the Minister—my noble friend Lord Bethell—the noble Baroness, Lady Penn, and the noble Earl, Lord Howe, but particularly the Minister; he has performed with absolute aplomb in the difficult 10 months since he became a Minister. He has so much on his plate, yet throughout this process he has listened, engaged and acted in a way that does him enormous credit, and I really want to pay tribute to him for everything he has done.
I share the Minister’s optimism that, having produced this Bill, we can produce a regulatory system for the UK outside Europe that is the envy of the world, that makes sure that every company, every charity and every researcher who wants to bring a transformative therapy into a health system will come to us because of what we are able to do and how we are able to bring them through into mainstream treatment, just as we are doing with vaccines and have done with the recovery trial. That is the template, and I look forward to working with my noble friends and other noble Lords to make that happen in the months to come.
Lord Bethell (Con)
My Lords, I am extremely touched by the kind words of noble Lords and pay tribute once again to the hard work of all those concerned. I look forward to the future—to, as my noble friend Lord O’Shaughnessy said, the opportunity for patient safety and innovation to be enhanced by this Bill. In that spirit, I beg to move.
Medicines and Medical Devices Bill
Wednesday 27th January 2021
(3 years, 9 months ago)
Commons ChamberRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Commons Consideration of Lords Amendments as at 27 January 2021 - (27 Jan 2021)
Madam Deputy Speaker (Dame Rosie Winterton)
I must draw the House’s attention to the fact that financial privilege is engaged by Lords amendments 1 and 54. If any amendment engaging financial privilege is agreed to, I will cause the customary entry waiving Commons financial privilege to be entered into the Journal.
Before Clause 1
Establishment and core duties etc
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
I beg to move, That this House agrees with Lords amendment 1.
Madam Deputy Speaker (Dame Rosie Winterton)
With this it will be convenient to discuss the following:
Government motion to disagree with Lords amendment 2.
Government motion to disagree with Lords amendment 3.
Lords amendments 4 to 10.
Lords amendment 11, and Government amendments (a) to (d) thereto.
Government motion to disagree with Lords amendment 12.
Government motion to disagree with Lords amendment 13.
Government motion to disagree with Lords amendment 14.
Lords amendments 15 to 21.
Lords amendment 22, and Government amendments (a) to (c) thereto.
Government motion to disagree with Lords amendment 23.
Government motion to disagree with Lords amendment 24.
Government motion to disagree with Lords amendment 25.
Lords amendments 26 to 29.
Government motion to disagree with Lords amendments 30 and 31.
Lords amendment 32, and Government amendments (a) to (c) thereto.
Lords amendments 33 to 39.
Government motion to disagree with Lords amendment 40.
Lords amendments 41 to 47.
Government motion to disagree with Lords amendment 48.
Government motion to disagree with Lords amendment 49.
Government motion to disagree with Lords amendment 50.
Government amendments (a) to (c) in lieu of Lords amendments 2, 3, 12 to 14, 23 to 25, 30, 40 and 48 to 50.
Lords amendments 51 to 56.
Jo Churchill
I am extremely pleased to be back at the Dispatch Box to speak to this Bill. It is a changed Bill since we last looked at it but one that still has the patient at its heart. I am pleased that it comes back to us with the same spirit of consensus and collaboration that it left us with.
Since we had the Bill’s Third Reading, the pandemic’s evolution and the importance of the regulation of clinical trials, the roll-out and regulatory approval of a vaccine, and the ability of healthcare professionals to get medicines into patients has bought into sharp focus precisely how essential this Bill is. The Government made a number of amendments to the Bill through the other place in response to Committees of the House, the report of the independent medicines and medical devices review, led by Baroness Cumberlege, and, importantly, as a result of genuine, cross-party discussions on how to make this Bill better.
I am glad to say that the Bill still—and for those who know me, this is my passion—puts patients first: patients who will have the opportunity to trial new treatments; patients whose safety is paramount; patients who need to see quick and effective action from regulators in the event of an emergency. The Bill that left us on Report had a new change to it, anticipating Baroness Cumberlege’s report. The medical device information system, which will transform post-market surveillance of medical devices and improve the ability to track down patients and prevent harm, followed talks across this House and in the other place. I reiterate my thanks in particular to the hon. Members for Washington and Sunderland West (Mrs Hodgson) and for Central Ayrshire (Dr Whitford) for their contributions to that effort.
We said on Report that we awaited the conclusions of the Cumberlege review and that we would take steps when the review was published. I can tell the House now that we have, and Lords amendment 1 establishes a Patient Safety Commissioner—a champion for patients in relation to medicines and medical devices. I pay tribute to all those who have spoken here and in the other place of the impact of harm on patients and on women—those who have not been listened to whose stories are difficult and heart-wrenching. Much was said during the Bill’s passage in the other place about the whole system change to enshrine the voice of patients at the heart of the process and our commitment to it. The Patient Safety Commissioner will act within and outside the system. They will be an advocate for patients and ensure that the patient voice is primary. The commissioner will be able to seek information, make reports without fear or favour and expect responses, and, more importantly, get change.
Lords amendments 1, 41, 47, 54 and 56 together provide for both the appointment of a Patient Safety Commissioner and regulations to support this appointment. I congratulate Baroness Cumberlege and her team, and thank her and others who contributed to getting this into the Bill so quickly after her report.
Lords amendment 31 provides for a small but important change that was also recommended in that review: a power to put the devices expert advisory committee on to a legislative footing.
I am very conscious of the passion and commitment shown by the hon. Member for St Helens South and Whiston (Ms Rimmer) when we were last discussing the Bill. She has shown admirable determination. I am pleased to draw her attention to Lords amendment 8, which the Government were happy to support in the other place. That important amendment provides for provisions about the origin and treatment to be made in relation to the regulation of human medicines.
We have had two reports, one from the Delegated Powers and Regulatory Reform Committee and one from the House of Lords Constitution Committee.
Alex Norris (Nottingham North) (Lab/Co-op)
It is a pleasure to resume proceedings on this Bill, and we are now very close indeed to the finish line. For us and, I think, for all Members, this has always been about patient safety and about making sure that people of the United Kingdom have the best access to medicines and medical devices. The exchanges so far have been of a high quality in both content and tone. As the Minister has characterised, the Bill started as a skeleton, but it is certainly thin no more. There is much in there that will make a significant difference to our country.
I have been proud to take the lead for the Opposition since the Committee stage, and I thank my predecessor in the earlier rounds, my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson), for setting the tone for us. I am also grateful to the Minister for her level of engagement and for giving us generous access to her officials and the Government in general throughout this process. The stages of the Bill through the Commons were of a high quality, and clearly considerable progress has been made in the other place, which we consider today.
I welcome the Government’s concessions on the Bill, and I congratulate my colleagues in the other place, particularly Baronesses Thornton and Wheeler and Lord Hunt, on their hard work on and dedication to securing these vital amendments. That hard work will ensure that the Bill will promote patient safety and privacy, as well as proper consultation and scrutiny. I might even be mischievous enough to say that I tabled a number of these amendments in Committee, but I was unable to get them accepted at that point. I am therefore delighted to see them accepted at this stage.
We will support the Lords amendments where the Government have indicated their support, and where they have tabled amendments in lieu we will accept those as a reasonable compromise. I therefore do not intend to divide the House this evening. Similarly, I do not intend to speak to all 56 amendments, but I might cover a few of the pertinent major themes.
The Minister was right to say that in previous exchanges I challenged her to demonstrate that safeguarding public health and, critically, patient safety was uppermost, and that is reflected in Lords amendments 4 and 5. I knew from the outset that that was the Minister’s intention, and I think the amendments improve and make the Bill clearer, as well as future-proofing it for future Ministers and—dare I say it?—future Governments. It is important that that was done, and we appreciate that.
On Lords amendment 1, it is welcome that the Government have heeded the second recommendation in the Cumberlege review, and legislated for an independent Patient Safety Commissioner. We were lucky to have a review as seismic as that one, which crystallised many decades of suffering and pain for lots of people who had been crying in the darkness and ignored for a long time. That report was a cathartic moment, but it cannot remain just a report, and the fact that we had primary legislation that was the perfect vehicle for the independent Patient Safety Commissioner was a real blessing. I am pleased we were able to find a way to include that.
Mark Tami (Alyn and Deeside) (Lab)
Does my hon. Friend agree that many of the people he said were in the dark often felt that they were on their own, and it was only when groups were set up that they realised otherwise? Many doctors were telling them there was not a problem.
Alex Norris
Yes, and I met as many of those groups as I possibly could. That commonality in the story of people often being ignored and left alone, or told that they were wrong, lying or making it up, added insult to the significant injuries that they had suffered. That collective action was a big part of people getting their salvation and securing that review which then vindicated them so strongly. That is so important. The presence of the independent commissioner will ensure that patient wellbeing is prioritised and there will be a voice for those citizens. That is an essential step forward to ensure that our wonderful national health care system is responsive and hears challenging messages, even if perhaps it does not always want to. That will give people a voice, which is important.
We welcome the amendments on transparency and accountability, and I pay tribute to the hon. Member for Central Ayrshire (Dr Whitford) for her leadership at other stages of the Bill. Frequent reporting will ensure that the system is monitored and accountable, which is good. With Lords amendment 31 the Bill will provide for the establishment of the independent statutory device expert advisory committee, to ensure that the regulation of devices is transparent, and that decision making is better structured and more accountable. That can only be a good thing. Making urgent regulation subject to positive affirmation, as in amendment (a) in lieu, will allow the regulatory system to respond to changing situations, while ensuring proper accountability and scrutiny.
As the Minister says, amendment (b) in lieu sweeps up and replaces the Lords amendments that relate to sunset clauses and clauses on the super-affirmation procedure. It was not quite what I was after, but I think it is a pretty fair deal. It is certainly more than I thought I would get—perhaps I should not say that before the amendments have been made. As a former trade union negotiator, I always thought that going in and getting 60%, 70% or 80% for our members was a pretty good outcome, so we will certainly take that. The five-year review is a good thing as it gives the Government more time—those arguments were well made by the Minister, and on reflection I think they are right.
At the root of this, the Secretary of State is acquiring significant powers, and it is right to review that as well as to have scrutiny down the line, and an opportunity for right hon. and hon. Members to determine whether the system might need consolidating or restructuring. That is vital to improve the quality of the regulatory system. I am really pleased that we got there, and with where we have arrived. I welcome the opportunity in Lords amendment 8 for the use of human tissue in medicine to be further regulated, thus preventing the NHS from being compromised by the trade in harvested organs, including those from ethnic minorities and political prisoners in authoritarian states. My hon. Friend the Member for St Helens South and Whiston (Ms Rimmer) will be pleased with that inclusion. It is her hard work that made that happen, and I commend her for it, as she battled away. She feels strongly about this, and what has come out is very positive indeed. As I say, I commend her greatly for that.
Anthony Mangnall (Totnes) (Con)
It is a pleasure to follow the hon. Member for Nottingham North (Alex Norris), and to have followed the Bill from afar. It is a shining example of cross-party support, and to see it emerge from a skeleton Bill into a framework Bill is a credit to everyone who participated in Committee and in the House of Lords, and to Members across the House.
It is, in short, a pleasure to be able to speak in this debate, and I support Lords amendments 1 and 54. The creation of a commissioner for patient safety has long been sought, and it will not only enhance the fact that the NHS is viewed as one of the safest healthcare systems in the world but will reinforce the view that it is an organisation that can learn from its mistakes. One such mistake is the unconsented and experimental use of TVT mesh. The intent was for the best of purposes, but in fact it caused utter devastation, both physically and emotionally, to those who suffered adverse side effects. Those effects went unreported and were misdiagnosed for a great length of time, and change was down to people such as Janet Peck and Susan Morgan—two of my constituents and victims themselves—who fought hard for action to be taken. Their determination and hard work have resulted in the excellent report by Baroness Cumberlege, which calls for the appointment of a Patient Safety Commissioner, which the Bill seeks to put in place, to ensure that scenarios such as those surrounding TVT mesh become never events.
The Minister for Patient Safety, Suicide Prevention and Mental Health gave a heart-felt and meaningful apology to those who have been failed by medical treatments as outlined by the Cumberlege report last year. The new position will be welcomed by patients and practitioners alike, and I hope that the Minister responding to the debate will go further and explain the commissioner’s remit and the parameters of their work, and how recruitment will find a suitable person to report back. I welcome the fact that the Government will respond further to the independent medicines and medical devices safety review. Finally—much of what I wanted to say has already been said—I pay tribute to Susan and Janet. Their fortitude and determination have helped to shape the Cumberlege report and shape this Bill and, as we have already heard, their repeated efforts to ensure that patient safety is put first have allowed the Bill to be created in such a way that it will have a long and meaningful impact on those who seek the best service possible from the NHS. As has already been said, the cross-party support is a credit to this House. I congratulate all Members who have taken a significant step in helping to shape the Bill.
Ms Marie Rimmer (St Helens South and Whiston) (Lab) [V]
In 2018, the imported bodies of political prisoners and human rights abuse victims in China were on display in Birmingham. It was supposed to be a Real Bodies exhibition, to inform the public about biology, yet in reality it was a barbaric travelling circus. The British public unknowingly paid £15 each to view the remains of these poor souls.
Since I learned of that horrific display, I have become determined to work on behalf of these human rights abuse victims to end forced tissue and organ harvesting. Our nation and the people who live here must not be complicit in the brutal acts of the Chinese communist regime. The first step is to put a stop to the importing of tissue and organs of human rights abuse victims. Currently, neither the human tissue regulations nor the Human Tissue Act 2004 requires appropriate consent for imported human tissues to be used in medicines. After several attempts to bring forward an amendment to achieve this, both here and in the other place, the Government have finally included a negotiated amendment in this Bill, which I welcome.
That amendment provides the opportunity to prevent complicity in this crime within the UK medicine industry, and gives Ministers the powers to do the right thing. It is important to stress that the amendment has not dealt with the issue of organ transplant tourism, or the issue of plastinated unclaimed bodies being imported and commercially displayed, as we saw in Birmingham. The amendment is a welcome start, but it is only the beginning; there is much more to do.
I hope the House will forgive me if I place my thanks on record, as securing that amendment has been a long, drawn-out battle across both Chambers. First, I congratulate Lord Hunt of King’s Heath for persevering so tenaciously, along with his co-signatories Lady Finlay, Lady Northover and Lord Ribeiro. I also thank Lord Alton and Lord Collins for their tireless efforts on this issue. Finally, I thank my hon. Friend the Member for Nottingham North (Alex Norris) for his support and advice.
One of my predecessors as MP for my home town, St Helens, was Sir Hartley Shawcross, the chief British prosecutor at the Nuremberg trials. Just like the Nazis he prosecuted for, among many reasons, using human beings for medical experiments, I hope and pray that one day, those responsible for these despicable, heinous acts will be prosecuted for their crimes against humanity, for that is what forced organ harvesting is. Last year, the China tribunal, led by Sir Geoffrey Nice QC, a former lead prosecutor at The Hague, concluded that
“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one—and probably the main—source of organ supply”,
and that
“In regard to the Uyghurs the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”
The amendment sends a very clear message that we will not tolerate such appalling acts against humanity and that we will deliver for the people of China, not for the Communist party of China. Let the amendment truly mark the beginning of a new relationship with China—a relationship that is not naive. Today, Holocaust Memorial Day, is the day when the world says “Never again” to genocide. Let this be the start of the Government putting those words into practice.
Jim Shannon (Strangford) (DUP) [V]
I thank the Minister for all the work that she has done on the Bill, and I commend the hon. Member for Nottingham North (Alex Norris) for his dedication.
The Bill seeks to address the regulatory gap by introducing dedicated regulation-making powers covering the fields of human medicines, including clinical trials of human medicines, veterinary medicines and medical devices. That is clearly absolutely necessary, and the most pertinent reason is one about which I wrote to the Secretary of State for Health and Social Care just last week: the ability of my young constituent Sophia Gibson to have continued access to her medication post Brexit. Her family were informed that there would be issues sourcing the medication—medicinal cannabis—that has made such a difference to her life. Her parents began their battle, still traumatised from their last battle to source this life-saving medication, and we began to work on it. The Secretary of State and the Northern Ireland Department of Health have worked hard, and initial reports are that we will produce the medication here, in co-ordination with the lab that creates it in the Hague. That is good news, although I await confirmation. It would appear that this is just one story that is working out, but it flags the necessity of the United Kingdom of Great Britain and Northern Ireland creating and prescribing our own medications. That is why this legislation is vital.
I echo and support wholeheartedly the comments of the hon. Member for St Helens South and Whiston (Ms Rimmer) in relation to the commercial forced organ harvesting that is happening in China against Falun Gong members, Christians and Uyghur Muslims. We need to address that, and I know that the Minister and other Ministers have that responsibility. It is very worrying, and I echo the hon. Lady’s comments about that.
I know that the thousands of people who believe that their quality of life has been affected by mesh, for example, will wonder why this legislation has not been in place before. I ask for clarity that the aim of the Bill will be achieved and that it will allow for much greater scrutiny and accountability in the world of medical devices.
The Lords amendments make a few suggested additions to the Bill. There is an understanding that we must allow our medical field the ability to produce medication and medical devices, but also that it must be better regulated and offer better protection to those who rely on these devices. The Bill extends to England, Northern Ireland, Scotland and Wales. Parts 1 and 2, relating to human medicines and veterinary medicines respectively, are within the legislative competence of the Northern Ireland Assembly. A legislative consent motion has been sought for those parts, and I welcome that following close on the heels of this debate.
Our goal is not simply to pass continuity legislation post Brexit but to improve and upgrade our legislation, and that is what the Bill achieves. The Government indicated in the background briefing to the Queen’s Speech and in a press release that they intend to use these powers to support the development of medicines and medical devices in the NHS and amend prescribing power. That needs to happen, and it needs to happen now; will the Minister confirm that that is the case? The Government stated in the explanatory notes to the Bill that they intend to use these powers to keep the existing regulatory frameworks updated, while consolidating the enforcement regime for medical devices. In addition, the Bill will provide the Secretary of State with the ability to impose civil sanctions as an alternative to criminal prosecution for breaches of the medical device regime.
I have long worked with those who believe that the use of mesh in their bodies has caused substantial harm—not just females and ladies, but males. I have had a number of meetings with them about that. We are all aware that, when something is termed a medical device and not a medication, the testing is less stringent. The civil sanctions will provide the emphasis that we all want to see, to ensure that any device placed in a person’s body has been tested to a high standard before widespread use. I commend the Government, and I commend all Members for their contributions.
Jo Churchill
When taking a Bill through the House, we always hope that it will be one that hon. Members from both sides can understand, support and improve. Our intention to have a gold standard of medicines and medical device regulation in this country, and to put the patient at the heart of it, has been long understood and has very much formed the foundation stone of the Bill.
I am very grateful for the support of hon. Members here; the spirit of collaboration is how we get this Bill done now—today. I would like to address one or two of the questions that hon. Members brought up. I reiterate my thanks to the hon. Member for Nottingham North (Alex Norris). He was right when he said that the timing of the Cumberlege report was fortuitous. In this House, we have been able to make sure that patient safety has been addressed. He was also right to say that it was a collective effort, and he and other Members were right in saying that the Bill very much reflects the voice of campaigners who often feel that their voices go unheard. Today, they have not gone unheard.
Jo Churchill
Indeed.
This has been a long time coming, and Members from both this House and the other place have been involved. I pay particular tribute to Janet Peck and Susan Morgan, the constituents of my hon. Friend the Member for Totnes (Anthony Mangnall), and their quiet determination to make sure that their challenges were seen and noticed. The Government then took the right decisions in helping them make sure that this does not happen to others. That was the right thing to do.
The hon. Member for Nottingham North asked me to address two or three points. We plan to respond in full to the report later in 2021. It has been incredibly impactful and has already served to put patient safety at the top of the agenda for the whole health and care system. If it had not been for the covid-19 pandemic, I think we would be discussing little else than patient safety because of the Bill before us. Just as covid-19 impacted on the publication of the report, it has impacted our response time. But I assure the hon. Gentleman that that response will come later in the year.
The hon. Gentleman also asked about the speed of the appointment of a patient safety commissioner. I very much want the right person. I cannot give a precise time, but I want to underscore the importance of patient safety and our belief that the patient safety commissioner will and must be effective in amplifying the voice of patients and improving patient safety in the use of medicines and medical devices. I hope that the process will not take too long, but we must appoint the right person, who will truly give the right voice.
On hub and spoke, which the hon. Gentleman and I both agree is so important, there will be a full public consultation. The Government will then report to Parliament, and include a summary of the concerns raised in the public consultation. To ensure that we get the right model to assist pharmacy going forward, we intend to be totally transparent.
To the hon. Member for Strangford (Jim Shannon), I can give an unequivocal yes. We have a thriving life science sector in the UK, contributing over £80 billion a year to the economy and over a quarter of a million jobs. We want to ensure that the UK remains an important market for medicines and medical devices, and to bring products to market here.
As I close, it is perhaps unusual to be pleased that there have been quite so many changes or challenges on a Bill, but I think they have been the right changes and the right challenges. To that end, I thank all hon. Members who have challenged and who have assisted in those changes. I also thank all those who have assisted behind the scenes—the Bill team, my officials and so on. We have arrived at a Bill that I think carries the support of all sides and of both ends of the Parliament, and one where patients, the sector and the public can understand how we do good work and how this Bill will work for them.
Lords amendment 1 agreed to, with Commons financial privileges waived.
Lords amendments 2 and 3 disagreed to.
Lords amendments 4 to 10 agreed to.
Government amendments (a) to (d) made to Lords amendment 11.
Lords amendment 11, as amended, agreed to.
Lords amendments 12 to 14 disagreed to.
Lords amendments 15 to 21 agreed to.
Government amendments (a) to (c) made to Lords amendment 22.
Lords amendment 22, as amended, agreed to.
Lords amendments 23 to 25 disagreed to.
Lords amendments 26 to 29 agreed to.
Lords amendment 30 disagreed to.
Lords amendment 31 agreed to.
Government amendments (a) to (c) made to Lords amendment 32.
Lords amendment 32, as amended, agreed to.
Lords amendments 33 to 39 agreed to.
Lords amendment 40 disagreed to.
Lords amendments 41 to 47 agreed to.
Lords amendments 48 to 50 disagreed to.
Government amendments (a) to (c) made in lieu of Lords amendments 2, 3, 12 to 14, 23 to 25, 30, 40 and 48 to 50.
Lords amendments 51 to 56 agreed to, with Commons financial privileges waived in respect of Lords amendment 54.
Medicines and Medical Devices Bill
Tuesday 2nd February 2021
(3 years, 9 months ago)
Lords ChamberRead Full debate Medicines and Medical Devices Act 2021 Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 167-I Marshalled list for Consideration of Commons amendments, disagreements and amendments in lieu - (29 Jan 2021)
The Deputy Speaker (Lord Duncan of Springbank) (Con)
My Lords, hybrid proceedings will now resume. There are no counter-propositions, so the only speakers are those listed and the Minister’s Motion may not be opposed. Short questions of elucidation from listed speakers after the Minister’s response are permitted but discouraged. A Member wishing to ask such a question must email the clerk. We will now begin.
Motion A
Lord Bethell
That this House do not insist on its Amendments 2, 3, 12, 13, 14, 23, 24, 25, 30, 40, 48, 49 and 50 and do agree with the Commons in their Amendments 50A, 50B and 50C in lieu.
“(3) The procedure for making regulations under Part A1, 1, 2 or 3 is to be determined in accordance with this table and subsection (4)—
If the regulations contain provision madein reliance on | the regulations are subject to |
section 5(1)(a) | the negative procedure |
section 10(1)(a) | the negative procedure |
section 14(1)(a) | the negative procedure |
paragraph 9 of Schedule 1 | the negative procedure |
section 6 | (a) the made affirmative procedure, where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health |
(b) the draft affirmative procedure in any other case | |
section 15 | (a) the made affirmative procedure, where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health |
(b) the draft affirmative procedure in any other case | |
any other provision of Part A1, 1, 2 or 3 | the draft affirmative procedure |
(5) Where regulations are subject to “the negative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations is subject to annulment in pursuance of a resolution of either House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they are subject to negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations is subject to—
(i) annulment in pursuance of a resolution of either House of Parliament, and
(ii) negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954.
(6) Where regulations are subject to the “draft affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they may not be made unless a draft of the regulations has been laid before and approved by a resolution of the Northern Ireland Assembly, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of—
(i) each House of Parliament, and
(ii) the Northern Ireland Assembly.
(7) Where regulations are subject to the “made affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations—
(i) must be laid before Parliament after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they—
(i) must be laid before the Northern Ireland Assembly after being made, and
(ii) cease to have effect at the end of the period of 40 days beginning with the day on which they are made unless, during that period, the regulations are approved by a resolution of the Assembly, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations—
(i) must be laid before Parliament and the Northern Ireland Assembly after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament and by a resolution of the Assembly.
(8) In calculating the period of 40 days for the purposes of subsection (7)(a)(ii) or (c)(ii) in relation to Parliament, no account is to be taken of any time during which—
(a) Parliament is dissolved or prorogued, or
(b) either House of Parliament is adjourned for more than 4 days.
(9) In calculating the period of 40 days for the purposes of subsection (7)(b)(ii) or (c)(ii) in relation to the Northern Ireland Assembly, no account is to be taken of any time during which the Assembly is—
(a) dissolved,
(b) in recess for more than 4 days, or (c) adjourned for more than 6 days.
(10) If regulations cease to have effect as a result of subsection (7) that—
(a) does not affect the validity of anything previously done under the regulations, and
(b) does not prevent the making of new regulations.”
“Part 4A
Report on Operation of Medicines and Medical Devices Legislation
Report on operation of medicines and medical devices legislation
(1) The Secretary of State must, before the end of the relevant period, publish a report on the operation of medicines and medical devices legislation.
(2) The report must, in particular, include an assessment of whether—
(a) some or all medicines and medical devices legislation should be consolidated or otherwise restructured,
(b) provisions of medicines and medical devices legislation should be included in regulations or Acts of Parliament, and
(c) powers to make regulations should be modified or repealed.
(3) In preparing the report, the Secretary of State must take into account any report relating to the operation of medicines and medical devices legislation made by a Parliamentary Committee.
(4) The Secretary of State must lay a copy of the report before Parliament.
(5) In this section—
“medicines and medical devices legislation” means—
(a) the law relating to human medicines within the meaning of section 7 (interpretation);
(b) the Veterinary Medicines Regulations 2013 (S.I. 2013/2033);
(c) the Medical Devices Regulations 2002 (S.I. 2002/618);
(d) Parts 1 to 4 of this Act; (e) regulations made under those Parts;
“Parliamentary Committee” means a committee of the House of Commons or of the House of Lords or a joint committee of both Houses;
“relevant period” means the period of 5 years beginning with the day on which this Act is passed.”
“(ha) Part 4A.”
Lord Bethell
That this House do agree with the Commons in their Amendments 11A, 11B, 11C and 11D.
(a) the disclosure is”
(b) the relevant authority considers that the disclosure is in the public interest.”
Lord Bethell
That this House do agree with the Commons in their Amendments 22A, 22B and 22C.
(a) the disclosure is”
(b) the relevant authority considers that the disclosure is in the public interest.”
Lord Bethell
That this House do agree with the Commons in their Amendments 32A, 32B and 32C.
(a) the disclosure is”
(b) the relevant authority considers that the disclosure is in the public interest.”
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, with the leave of the House, I beg to move that the House do agree with the Commons in their Amendments 11A to 11D, 22A to 22C, 32A to 32C, and 50A to 50C en bloc. I pay tribute to noble Lords on all sides of the House in reaching consensus on the issues dealt with in these amendments. They were put down in the other place after cross-party discussions and I believe they reflect the aims and agreement of the House.
Amendments 11A to 11D, 22A to 22C and 32A to 32C all make minor amendments to Lords Amendments 11, 22 and 32. These amendments, in the name of the noble Baroness, Lady Thornton, made further changes to the clauses allowing the MHRA and the VMD to share information with relevant persons, such as regulators, outside the UK. Lords Amendments 11, 22 and 32 create a new safeguard that information could be shared only when in the public interest or for pharmacovigilance. I thank the noble Baroness very much for her remarks on Report. She made it very clear that the reference to pharmacovigilance was illustrative. Pharmacovigilance is very important, but it is also very much in the public interest and so does not need to be included outside the reference to the public interest. It is already captured. The Commons amendments therefore remove the reference to pharmacovigilance and the purpose of the amendments remains.
The majority of the Commons amendments deal with the variety of ways that noble Lords sought to create means to bring the Bill, and the principles of the Bill, back before Parliament in the future. Three methods were put forward and, in fact, noble Lords eloquently pressed the point on all of them. Lords Amendments 2, 13 and 24, which were tabled by the noble Baroness, Lady Thornton, put forward a sunset on delegated powers. Lords Amendments 3, 14, 25, 30, 48 and 49, which were tabled by the noble Lord, Lord Sharkey, put in the super-affirmative procedure. Lords Amendments 12, 23 and 40, in the name of the noble Lord, Lord Patel, put forward the idea of bringing forward consolidated draft legislation within three years. I do not intend to repeat my arguments against all three; I have said throughout this Bill that we have been listening carefully to all noble Lords who have put forward very clearly their continued concerns.
Commons Amendments 50A, 50B and 50C are an alternative, which I believe we can agree avoids the issue of introducing a “cliff edge” for legislation—and potentially patient safety—but importantly provides the reassurances that noble Lords quite reasonably sought. They collectively create an obligation for the Secretary of State to prepare a report on the operation of the legislation within five years of Royal Assent, and the amendments specify the considerations that must be addressed in that report: first, whether the legislation should be consolidated or restructured; secondly, whether legislation ought to be in regulations or in Acts of Parliament; and, thirdly, whether any of the powers to make regulations should be modified or repealed.
This would mean actively considering all the questions raised by noble Lords. It would give the time needed for making changes to the current legislation governing medicines and medical devices using the Bill’s powers, and allow for those changes to bed down and for those complex areas of law to reach a steady state, before considering these important issues.
The Secretary of State must also take into account any report of a parliamentary committee in preparing that report. This would mean that if any committee—whether your Lordships’ Delegated Powers and Regulatory Reform Committee or the Health Select Committee in the other place—decided to take a view on the operation of the legislation in the intervening time, its conclusions and considerations would have to be taken into account. If any committee should choose to do so, perhaps on the basis of the post-legislative memorandum that must be prepared within three to five years of the Bill being enacted, Parliament will have expressed a view before being presented with the Secretary of State’s report.
I think this is a satisfactory compromise. It meets the principle of parliamentary review without the practical impact on patient safety of powers lapsing. It ensures that Parliament has the ability to express a view and for that view to be heard, without asking for review before it is practicable. Amendment 50A makes the necessary changes to reinstitute the parliamentary procedure changes made at Lords Committee stage, in place of the super-affirmative.
I hope that noble Lords will be content to accept the amendments from the House of Commons. I beg to move.
Lord Patel (CB) [V]
My Lords, I am extremely grateful for the amendments that the Government have brought from the Commons. I am grateful to the Minister and his team for working so diligently with the rest of us, and to all noble Lords who supported my amendments. It is not unusual—but it is infrequent—for the votes that the Government did not get through in the Lords to be reconsidered in the Commons and brought back as government amendments. I am very content that the amendments that the Government have brought are very satisfactory and I congratulate them. I thank the noble Lord, Lord Bethell, the noble Baroness, Lady Penn, the noble Earl, Lord Howe, and the legal team for working with us throughout the Bill. That is all I am going to say.
Baroness Jolly (LD) [V]
My Lords, I too shall be brief and I too am grateful to the Minister and his team for giving Peers an opportunity to see the Commons amendments to the Bill before they were tabled, so that we might give some feedback. One of the things that has made this Bill a pleasure to work on is the open way in which political parties and Cross-Benchers have worked together, as well as the way that the Minister and his team have worked with us. We particularly welcome the clauses that have come to us from the Commons; they make the Bill a more explicit and effective piece of legislation than when it was debated either in Committee or on Report in this House.
Baroness Thornton (Lab)
My Lords, I am very grateful to the Minister and his team for the manner in which they have engaged and worked with us throughout the passage of this Bill, particularly at this final stage. The amendment in lieu is a good compromise that reflects the need for scrutiny to be at the heart of the Bill. It provides a mechanism to examine the powers of the Act in five years’ time and will open the door for the restructuring and consolidation of the post-Brexit medicines and medical devices regulatory regime. We believe that this will prove both desirable and necessary, and look forward to working with the Minister on such issues when the time comes.
We welcome the requirement that the Secretary of State must specifically consider whether this should be in the form of primary or secondary legislation and hope that this will lead to policy being put into a future Bill rather than scrolled away in regulations. The Secretary of State will also have to take account of all parliamentary committee reports. This would include post-legislative scrutiny undertaken by a Select Committee, as well as the DPRRC and Constitution Committee, whose oversight played a crucial role in reshaping a skeleton Bill into a framework Bill; I thank the noble Lord, Lord Lansley, for explaining that to us all. I hope the Minister can assure me that stakeholders will also be consulted. I am sure that that will be the case. It is very important, given that they are the end users of the legislation, and for the report to have value and credibility it must reflect the experience of regulators, industry, patients and medical professionals.
Finally, the tidying-up amendment that retains the requirement to share information in the public interest is an important provision because it will allow for substantive and ethical issues relating to the sharing of public data to be considered. This is of the utmost importance, given the role that the NHS and patient data may have in future trade deals.
Lord Bethell (Con)
My Lords, I do not intend to repeat much of what I said at Third Reading. Many thanks to the noble Lords who have contributed to the changing shape of the Bill. From Committee to ping-pong, we have listened, heard proposals for change and brought workable, practicable compromises forward.
I wish to repeat the remarks made by the noble Baroness, Lady Thornton. She congratulated all of us on the effective communication that has made it possible to make considered progress on this Bill, despite all the challenges that Covid-19 has presented us with. This a very fair assessment; I agree with it completely. From the report of my noble friend Lady Cumberlege to the demonstrated expertise of our medicines regulator, the MHRA, we have seen the importance of patient safety, clinical trials, our life sciences sector and effective regulation bear out in our hospitals, clinical trials and patient community.
I look forward to the debates ahead of us on the regulations that will be made under the Bill. They will be important, as we set forward on our course for the best possible regulatory regime for the UK, with the patient at its heart.
The Deputy Speaker (Lord Duncan of Springbank) (Con)
Noble Lords will be pleased to know that no one has requested to speak after the Minister.
Royal Assent
Thursday 11th February 2021
(3 years, 9 months ago)
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