All 10 contributions to the Medicines and Medical Devices Act 2021

Mon 2nd Mar 2020
Medicines and Medical Devices Bill
Commons Chamber

2nd reading & 2nd reading: House of Commons & Money resolution & Money resolution: House of Commons & Programme motion & Programme motion: House of Commons & Ways and Means resolution & Ways and Means resolution: House of Commons & 2nd reading & Programme motion & Money resolution & Ways and Means resolution
67 interactions
Tue 23rd Jun 2020
Medicines and Medical Devices Bill
Commons Chamber

3rd reading & 3rd reading: House of Commons & Report stage & Report stage: House of Commons & Report stage & 3rd reading
23 interactions
Wed 24th Jun 2020
Medicines and Medical Devices Bill
Lords Chamber

1st reading (Hansard) & 1st reading (Hansard): House of Lords & 1st reading
Wed 2nd Sep 2020
Medicines and Medical Devices Bill
Lords Chamber

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
108 interactions
Mon 19th Oct 2020
Medicines and Medical Devices Bill
Grand Committee

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
110 interactions
Tue 12th Jan 2021
Medicines and Medical Devices Bill
Lords Chamber

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
149 interactions
Thu 21st Jan 2021
Medicines and Medical Devices Bill
Lords Chamber

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
19 interactions
Wed 27th Jan 2021
Medicines and Medical Devices Bill
Commons Chamber

Consideration of Lords amendments & Ping Pong & Ping Pong: House of Commons
17 interactions
Tue 2nd Feb 2021
Medicines and Medical Devices Bill
Lords Chamber

Consideration of Commons amendments & Ping Pong (Hansard) & Ping Pong (Hansard): House of Lords
13 interactions
Thu 11th Feb 2021
Royal Assent
Lords Chamber

Royal Assent & Royal Assent & Royal Assent (Hansard) & Royal Assent: Royal Assent (Hansard) & Royal Assent (Hansard) & Royal Assent: Royal Assent (Hansard) & Royal Assent (Hansard) & Royal Assent: Royal Assent (Hansard) & Royal Assent
1 interactions

Medicines and Medical Devices Bill

2nd reading & 2nd reading: House of Commons & Money resolution & Money resolution: House of Commons & Programme motion & Programme motion: House of Commons & Ways and Means resolution & Ways and Means resolution: House of Commons
Monday 2nd March 2020

(1 year, 10 months ago)

Commons Chamber
Read Full debate Medicines and Medical Devices Act 2021 - Government Bill Page Read Hansard Text
Second Reading
Matt Hancock Portrait The Secretary of State for Health and Social Care (Matt Hancock)
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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.

Desmond Swayne Portrait Sir Desmond Swayne (New Forest West) (Con)
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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 Portrait Matt Hancock
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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 Portrait Steve McCabe (Birmingham, Selly Oak) (Lab)
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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 Portrait Matt Hancock
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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 Portrait Ben Everitt (Milton Keynes North) (Con)
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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 Portrait Matt Hancock
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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.

Philippa Whitford Portrait Dr Philippa Whitford (Central Ayrshire) (SNP)
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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 Portrait Matt Hancock
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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 Portrait Jonathan Ashworth (Leicester South) (Lab/Co-op)
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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 Portrait Matt Hancock
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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 Portrait Jonathan Ashworth
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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.

Luke Evans Portrait Dr Luke Evans (Bosworth) (Con)
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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 Portrait Jonathan Ashworth
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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 Portrait Chris Green (Bolton West) (Con)
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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.

Philippa Whitford Portrait Dr Whitford
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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 Portrait Chris Green
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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 Portrait Munira Wilson (Twickenham) (LD)
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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 Portrait Chris Green
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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.

Luke Evans Portrait Dr Luke Evans
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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 Portrait Chris Green
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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.

Philippa Whitford Portrait Dr Whitford
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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 Portrait Chris Green
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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.

Philippa Whitford Portrait Dr Philippa Whitford (Central Ayrshire) (SNP)
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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 Portrait Chris Green
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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.

Philippa Whitford Portrait Dr Whitford
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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.

Lisa Cameron Portrait Dr Lisa Cameron (East Kilbride, Strathaven and Lesmahagow) (SNP)
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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.

Philippa Whitford Portrait Dr Whitford
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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 Portrait Jim Shannon (Strangford) (DUP)
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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?

Philippa Whitford Portrait Dr Whitford
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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 Portrait Jim Shannon
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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?

Philippa Whitford Portrait Dr Whitford
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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.

Luke Evans Portrait Dr Luke Evans (Bosworth) (Con)
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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 Portrait Jim Shannon
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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.

Luke Evans Portrait Dr Evans
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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.

Philippa Whitford Portrait Dr Whitford
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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?

Luke Evans Portrait Dr Evans
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The hon. Lady makes a good point. I have no problem with that, provided that those doing the tests are also doing the follow-up and ensuring that the patient who has had the test has had counselling before, during and after it.

Philippa Whitford Portrait Dr Whitford
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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?

Luke Evans Portrait Dr Evans
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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 Portrait Ben Everitt
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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.

Luke Evans Portrait Dr Evans
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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.

Marie Rimmer Portrait Ms Marie Rimmer (St Helens South and Whiston) (Lab)
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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 Portrait Jim Shannon
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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.

Marie Rimmer Portrait Ms Rimmer
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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 Portrait Anne Marie Morris (Newton Abbot) (Con)
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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 Portrait Liz Twist (Blaydon) (Lab)
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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.

Philippa Whitford Portrait Dr Whitford
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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 Portrait Liz Twist
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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 Portrait Munira Wilson (Twickenham) (LD)
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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.

Sharon Hodgson Portrait Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
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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.

Jo Churchill Portrait The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
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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.

Alistair Carmichael Portrait Mr Alistair Carmichael (Orkney and Shetland) (LD)
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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 Portrait Jo Churchill
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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.

Neil Hudson Portrait Dr Neil Hudson (Penrith and The Border) (Con)
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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 Portrait Jo Churchill
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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.

Marie Rimmer Portrait Ms Rimmer
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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 Portrait Jo Churchill
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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:


(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

3rd reading & 3rd reading: House of Commons & Report stage & Report stage: House of Commons
Tuesday 23rd June 2020

(1 year, 6 months ago)

Commons Chamber
Read Full debate Medicines and Medical Devices Act 2021 - Government Bill Page Read Hansard Text
Consideration of Bill, as amended in the Public Bill Committee
New Clause 1
Information systems
‘(1) The Secretary of State may by regulations make provision about the establishment and operation by the Health and Social Care Information Centre (“the Information Centre”) of one or more information systems for purposes relating to—
(a) the safety and performance, including the clinical effectiveness, of medical devices that are placed on the market;
(b) the safety of individuals who receive or are treated with a medical device, or into whom a medical device is implanted;
(c) the improvement of medical device safety and performance through advances in technology.
(2) The regulations may (among other things) make provision—
(a) specifying descriptions of information in relation to medical devices which may or must be entered or retained in an information system established under subsection (1);
(b) requiring information to be provided to the Information Centre for the purposes of its functions under the regulations;
(c) about the use or disclosure of information contained in an information system established under subsection (1);
(d) requiring the Information Centre to have regard to specified matters in exercising its functions under the regulations.
(3) The provision mentioned in subsection (2)(b) may include provision—
(a) requiring specified persons or descriptions of persons to whom subsection (4) applies to provide information of a specified description to the Information Centre;
(b) about the manner in which, and the time at which, those persons must provide that information;
(c) enabling the Information Centre to require specified persons or descriptions of persons to whom subsection (4) applies to provide to it in a manner, and at a time, determined by the Information Centre—
(i) information of a specified description;
(ii) information for specified purposes;
(iii) any other information that the Information Centre considers it necessary or expedient to have for the purposes of its functions under the regulations;
(d) about any procedural steps the Information Centre must follow in requiring a person to provide information to it;
(e) requiring specified persons or descriptions of persons to whom subsection (4) applies to record or retain information which they are, or may be, required to provide to the Information Centre under the regulations;
(f) in relation to the enforcement of any requirement imposed by or under the regulations.
(4) This subsection applies to any person who provides services, or exercises any powers or duties, relating to medical devices.
(5) The descriptions of information specified in the provision mentioned in subsections (2)(a), (3)(a) and (3)(c)(i) may include—
(a) unique identifiers associated with medical devices;
(b) information in relation to individuals mentioned in subsection (1)(b);
(c) information about any procedure carried out in relation to a medical device (including information about any person involved in carrying out the procedure).
(6) The provision mentioned in subsection (2)(c) may include provision about—
(a) the analysis by the Information Centre of information contained in an information system (whether alone or in combination with other information) for the purposes mentioned in subsection (1) or for other purposes;
(b) the publication by the Information Centre of information contained in an information system;
(c) the disclosure (other than by way of publication) of information contained in an information system to specified persons or descriptions of persons, or for specified purposes;
(d) the use or further disclosure by any person of information disclosed to them under the regulations.
(7) The provision mentioned in subsection (3)(f) may include provision applying any provision of Chapter 2 of this Part (enforcement), with or without modifications, in relation to a requirement imposed by or under the regulations.
(8) In this section, “specified” means specified in regulations under subsection (1).’”—(Jo Churchill.)
This new clause would give the Secretary of State power to make regulations providing for a database of information in relation to medical devices to be established and managed by the Health and Social Care Information Centre. The clause would be inserted after Clause 15.
Brought up, and read the First time.
Nigel Evans Portrait Mr Deputy Speaker (Mr Nigel Evans)
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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 Portrait Jo Churchill
- Hansard - - - Excerpts

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.

We all recognise that medical devices are not subject to the same comprehensive regulatory system of pre-market assessment that medicines are. The Government also recognise that the system could be made stronger in respect of how devices are purchased, used and reviewed. The issue is incredibly important. Like me, Members across both Houses are anticipating the forthcoming report from the independent medicines and medical devices review, which looked into significant matters, with an expectation that it might make recommendations in this area. I put on the record that I am deeply sympathetic to patients and families affected by the issues covered in the review. That is why I am keen to take action now, when we know that there are gaps that we might close in the regulations made under the powers in this Bill, rather than wait.
New clause 1 introduces a power for the Secretary of State to create a medical device information system through regulations for the purposes of the safety and performance, including the clinical effectiveness, of devices; the safety of individuals who receive or are treated with a medical device; and the improvement of medical devices’ safety and performance through advances in technology.
The new clause has a number of detailed subsections because there are a number of considerations that Members will wish to know are being taken into account in the light of the productive discussions that have been had in this place and elsewhere about the important question of patient safety and the system’s capacity to protect us all.
To be clear, some of the matters covered by the clause can be dealt with already, under the Health and Social Care Act 2012. That Act established the Health and Social Care Information Centre, otherwise known as NHS Digital, and allows for the Secretary of State to issue a direction, asking NHS Digital to collect data in respect of the NHS in England. It is under that Act that the Secretary of State sought to act late last year, by issuing a direction to NHS Digital to begin to collect data with regard to implanted devices in England so that we could begin to build a picture.
However, this issue affects the whole UK and patients in all four nations. Devices are also implanted in private institutions by providers who are under no obligation to provide data to a central system if they are not working under contract to the national health service.
In their amendments in Committee, Members referred to device registries. We have a number of existing device registries in this country and a global exemplar in the National Joint Registry, which describes its own mission as
“Working for patients, driving forward quality”.
It collects information on operations to monitor the performance of certain implants and the effectiveness of different types of surgeries, improving clinical effectiveness and benefiting patients, clinicians and the sector as a whole. That works for patients, at a local level, who receive devices under the aegis of a registry. But not all higher-risk devices have a registry, and some registries will generate insights or patterns that are of use to other types of implants or devices—or, indeed, to improving regulation and the safety of devices as well as our system responses.
Data is fundamentally a driver of change. It is how we identify trends and draw links between individual issues to find patterns. It is by bringing data together that we see a bigger picture that can drive our response. The new clause seeks to create the legal backbone for future data collection and construct an information system to support existing and new registries in the future.
Members will be concerned about how data is safeguarded, how it might be used and by whom, and I will come to that shortly. But it is worth reflecting and understanding that the benefits of this system will be broad.  Such a system would monitor the performance of devices and ensure that patient outcomes can be tracked.  The longer-term aim is to intervene earlier, through clinical analysis of the data in the information system, to prevent patient harm before it happens by enabling the healthcare system to flag concerns, drive clinical system and regulatory action where appropriate, and use alternative and better devices and procedures to mitigate risk to UK patients. It would support the registries, both present and future, to take action underpinned by the national data from all four corners of the United Kingdom.
Such a system, subject to safeguards, could allow for the sharing of certain types of information with clinicians, the regulators, the NHS and other healthcare partners in the longer term. That would improve the data available on medical devices, as part of post-market surveillance. As a result, the UK’s regulator, the Medicines and Healthcare products Regulatory Agency, will be better able to take action early and more effectively as part of its regulation of devices on the UK market.
New clause 1(2) sets out some of the matters that regulations that establish this system might make provision for. It enables provision to be made so that the information is provided to NHS Digital in order that it can carry out its functions under the regulations. It enables provision to be made about using or disclosing the information, and for NHS Digital to have regard to certain matters, such as the need to reduce burdens on healthcare institutions when exercising its functions.
Subsection (3) clarifies subsection (2) by asking a private provider of, for example, breast implants to supply data to the information centre and to do so in a manner and in such a time that is provided for in the regulations. Along with the UK-wide nature of the power, it would ensure that we have a national picture that would support the aim we are all here to drive forward.
Subsection (4) makes it clear that anyone whose services, powers or duties relate to medical devices can be specified in the regulations and thus required to provide that information to NHS Digital for the purposes of the information system. That is important, as we would not wish to inadvertently have a gap as technology and procedures move on.
Subsection (5) sets out that the kind of information we might expect to require is retained and entered in the information system. The first and most immediate use of the information system must be to ensure that if there is an issue with a device it is possible to find and then notify a patient. To support that, the unique device identifier must be retained, along with the details of the patient into whom the device has been implanted, through, for example, their patient record, and the information about any procedure that has taken place, including the name of the clinician who has implanted it. This was raised in discussions and the provision is, if you like, an indication at the outset of what we would expect to capture, but subsection (5) does not limit us to that if consultation takes us further.
Subsection (6) deals with the disclosure and analysis of information. There was considerable discussion on Second Reading, led by the hon. Member for Twickenham (Munira Wilson), on the need to trust how data is used and analysed in order for such a system to be supported by patients. Subsection (6) is therefore critically important in being transparent at the outset that it would be necessary not only to capture the information, but to ensure that it can be used to identify patterns or trends to determine whether a patient’s experience of a device is personal and highly specific to their particular circumstances, or whether there is something clinicians or regulators need to do to improve the way in which that device can be used.
Patients are absolutely critical. They want to know that their data is protected, and subject to data protection legislation and other safeguards. They wish to know that they can be traced in the event of a problem with a device, and that the healthcare system professionals they interact with may know their surgical history as part of any future or ongoing procedures. They also wish to know that system change will be informed by their experiences—that their voices will be heard and change will occur as a result.
I recognise there is a lot of concern in this place and in the other place as to how we ensure sensitive information is kept securely and processed for legitimate reasons only, and that there are strict safeguards on who has access to it. I wish to assure Members now that this legislation is here to provide the backbone for future regulation. The benefit of secondary legislation is that we do not have to have all the elements in place immediately, but we can put building blocks together of data to access it slowly over time, with the proper process of consultation with patients, clinicians and devolved Administrations and consensus behind the most appropriate course of action to build the longer-term vision that I have set out. We have specified the kind of things the regulation under this amendment might enable us to do, but we will need to return to Parliament with the detail. I can commit now that it is our intention that the consultation on regulations will indeed involve considering voices of patients at its heart.
Enabling provision to be made in secondary legislation means that any information system can be updated to reflect collaboration with existing and future clinical registries, so that the processes for data collection remain streamlined, avoid duplication and reduce the burden on organisations providing the data. Future amendments to the secondary legislation governing the operation of any information system will ensure that the system remains as effective as possible at monitoring the safety of medical devices, but while that is the future, we do intend to ensure through regulations that, in the short term, data are subject to appropriate safeguards such as anonymisation by NHS Digital, and able to be shared within the NHS system and with the regulator so that patients get the benefit immediately of improved product safety and the comfort of knowing they can be traced if there is information that they need about their specific advice. That can and should be in place before we are in a position to put in place the vision of a system of clinical registries.
We have spoken to Ministers from the devolved Administrations, and there is broad agreement about the need for improved tracking of medical devices. The benefits for product and patient safety that an information system could bring is beyond party politics. It is the right thing to do for patients. IT projects are notoriously difficult and I think it would be difficult, if not impossible, to put one in legislation in detail. We have sought to strike the right balance between detail on what might be in the regulations in the interests of transparency, and enough flexibility to respond properly to the consultation on what the future should look like with those most affected by this. It is absolutely critical that this works, not least for clinicians who will need to record the information. We have published a detailed document setting out the long-term aspiration and some of how we would like to get there to accompany the amendments and to support Members’ scrutiny. I hope the amendment has support from all sides of the House.
Let me turn to the minor and technical amendments in the name of the Secretary of State. These are very small matters. Amendments 2, 3, 4, 5, 6 and 7 and 18 all make minor changes in order to enable new clause 1. Amendments 8 to 17 make minor and consequential amendments to enable regulations made under the powers in the Bill subject to the negative procedure to be combined in a single statutory instrument with regulations under powers which are subject to the affirmative procedure, or with regulations under powers in other legislation which are subject to the negative procedure. Allowing for different provisions to be combined in a single statutory instrument makes for greater efficiency within the parliamentary timetable.
I move now to amendments tabled by the hon. Members for Nottingham North (Alex Norris) and for St Helens South and Whiston (Ms Rimmer). I thank them for tabling them and hope that I can engage as much as possible with the points raised. Amendments 21, 22 and 23 are similar to those put down—
Alex Norris Portrait Alex Norris (Nottingham North) (Lab/Co-op)
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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 Portrait Jo Churchill
- Hansard - - - Excerpts

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.

Patient safety is critical, and through the Bill we are trying to do what is important for patients. The Bill includes changes such as adding prescribing professions for veterinary medicines, reflecting the desire to make medicines as accessible as possible while not compromising animal safety or the safety of the person administering the medicine. This could mean allowing a physician to prescribe a medication outside its licensed purpose, because it will give a better clinical outcome for that patient in those circumstances than no drug at all or a drug that will be harmful alongside another medicine that they are already taking. The Bill is about patient safety, but it is also about a combination of factors that deliver on behalf of patients.
Not all regulatory changes are made with the intention of changing the way in which a device or medicine makes its way to the patient, or are about whether the substance or device is safe to a patient. In 2013, changes were made to the Human Medicines Regulations 2012 so that brokers, importers, manufacturers and distributors of active substances could apply to make oral representations to the Medicines and Healthcare Products Regulatory Agency to have certain decisions, such as a decision to vary or suspend their registration, reviewed. That made no palpable difference to the safety of patients, but it did make a regulatory change that could be said to respond to the attractiveness consideration. Regulations are not the only route to protect patients. In addition, the MHRA, the NHS and the Department of Health and Social Care have multiple points at which the safety of medicines and patient safety are addressed and considered.
The NHS also has ways to interact with the regulator, such as the yellow card scheme, to raise patient safety concerns that can result in suspension of the use of medicines and devices. That is an example of our regulatory regimes in action, fulfilling the primary purpose they were created for: protecting patient safety. In addition, NHS Improvement established a patient safety strategy in July 2019, which it will continue to develop in consultation with clinicians and patients. There are also patient safety managers in hospital trusts, as well as leadership within DHSC responsible for ensuring patient safety. Those examples, in addition to the consultation required under the Bill, will feed into the decisions that are made when making regulations under the Bill, ensuring that consideration of any impact on the safety of medicines and medical devices is always well informed.
When it comes to the considerations set out in the Bill to be taken into account before making regulations, it is our view that there need be no hierarchy, because the combination of all three considerations provides the best outcomes for patient safety—the safety of the medicines and devices themselves, the availability of those medicines and devices, and a UK market that will encourage the continual development of innovative, more effective and, importantly, safe medicines and devices. It is not a choice between having safe medicines and a strong and secure supply chain, nor is it a choice between having safe medicines and being an attractive place for the development of new medicines. Those considerations go hand and hand and must continue to do so, so that our regulations continue to ensure that safe and effective medicines reach UK patients and that our vibrant life sciences sector is supported.
I was grateful to the hon. Member for Nottingham North for the points he made in Committee. We agree on the need to send a clear message about the importance of patients. We also agree that patients—be they human or animal—should and must come first in our consideration of regulatory changes that affect them, and that consideration must include the safety of medicines and devices, alongside availability and attractiveness of the UK market, to ensure the best outcomes for patients, which is what we are both working for.
Turning to sunset clause in amendment 20, the hon. Gentleman’s amendment is intended to limit the operation of the Bill to a three-year period after Royal Assent. It is similar to the one tabled in Committee. The practical consequence of a sunset provision is that, at its end, the Government would be compelled to return to Parliament with new legislation. There has been much consideration in this House and elsewhere of the extent of these powers in legislation, particularly legislation designed to ease our way out of the transition period and into the UK’s regulatory autonomy. The hon. Gentleman himself has said that the arrangements in the Bill could be said to reflect current arrangements, and I would argue that the arrangements in the Bill—there must be consultation before regulations may be made and they must be laid in draft before the House and subject to the affirmative procedure—are a significant increase in parliamentary scrutiny of any changes to the current framework.
The hon. Gentleman said in Committee that he wished to see proper consultation across the sector in order to set up a world-class, safe and effective regulatory regime. I would say that that is precisely what we wish to achieve through the Bill as it is drafted. Proper consultation does not mean simply the act of providing evidence to Parliament; rather, it is the ongoing consideration of changes to regulations that affect the sector. That is precisely what clause 40 is intended to produce.
The hon. Gentleman concluded in Committee by making two points, and I hope that I can address them both here. First, he asked whether this provision—the ability to make regulatory change via secondary legislation —would mean a diminution in protection. I would say absolutely not. This is not about reducing UK standards; it is about ensuring we can modify and adapt our regulatory regime so that we can take account of new technologies and ensure effective regulation that keeps pace with innovation. We have approached the drafting of the Bill with the intent of creating legislation that will stand for some time, and that is why we have focused on which regulations may be made to amend or supplement existing legislation. It is also why we have sought to consolidate the enforcement regime so that it is transparent and clear to companies and the MHRA how we ensure operation within the law.
The hon. Gentleman also asked whether the Government could accept that the liberty to make bold changes by the using delegated powers in the Bill should not give the Government the chance to make any changes they wanted. It is right that we take a sensible and proportionate approach to regulatory change. Small changes, such as adding Braille to packaging, are common sense, but I agree that changes such as how we approach community pharmacy and novel technologies are something else. I can assure him that we have no intention of making bold changes to regulations without full consultation and bringing the issue back to the House with the expectation that we will be expected to justify those changes.
The amendment would mean returning to primary legislation within three years. In practical terms, that would be likely to mean within two years, given the need to have sufficient parliamentary time for the passage of the Bill. There are two months after Royal Assent before we can make the regulations, other than in emergencies, and those regulations are subject to a statutory consultation and then the affirmative procedure, which all takes time. This would mean that we would have 18 months, at most, of practical operation of the legislation before we had to go back to its principles. We would not know, for example, whether the civil sanctions regime had had the desired material effect, as it would simply not have had enough time to run. We would cease being able to disclose pertinent safety information from the MHRA to the NHS, and it would be unclear whether the registers facilitated by clause 13—or, indeed, the medical device information system introduced by the new clauses—would be able to continue to operate, or whether we were starting from scratch. Some regulatory changes take years to put into effect. Manufacturers, companies, hospitals and so on must expend financially on preparing for them, putting them into effect and sustaining them. We would like, as much as possible, to be certain that any regulatory change we have introduced in the UK is sustainable and ongoing. It is key that we get this right.
The Bill’s drafting, and our approach to making transparent the kinds of changes one might expect from the delegated powers, have been carefully thought out. Our approach has been consistent with the recommendations of the Delegated Powers and Regulatory Reform Committee in relation to the Fisheries Bill in the last parliamentary Session, 2017 to 2019. We have, in fact, gone beyond the work of that Bill and produced six illustrative draft statutory instruments. We have recognised the need for Parliament to have a greater role and, other than in specific circumstances, the affirmative procedure applies and is supported by a mandatory obligation to consult.
This is not a stopgap Bill to get us through the transition period. It is a proportionate approach to regulating an industry that moves quickly, with regulators who wish to take effective action and who are renowned for working with the industry in the best interests of patients, such as during covid. We can get this right now, and not suggest to industry, the regulators or patients that this is not the right answer for the future of regulation such that Parliament would need to revisit it swiftly by applying a sunset clause.
I turn to amendment 19, which was tabled by the hon. Member for St Helens South and Whiston. I recognise the great passion with which she spoke about this amendment in Committee. In particular, she raised the issue of human organs used in the development of medicines and medical devices where consent has not been obtained, and the matter was raised specifically in relation to China. I thank her for the additional context that she has shared on the amendment both in Committee and through subsequent correspondence. However, these issues are not best addressed through primary legislation dealing with the regulatory framework for human medicines in the UK. I have written to the Minister for Asia regarding the issue and asked him to hold a meeting to discuss the matter further, and I believe that the relevant offices are in communication.
Comprehensive legislation that governs human organs and tissues for transplantation or the manufacture of medicinal products currently exists in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004. The safeguards provided by this legislation ensure the appropriate quality, safety and origin of human tissues by setting out requirements around the donation, procurement, testing, processing, storage and distribution of organs, tissues and cells intended for human application. The requirements apply to any products that are administered to humans and, crucially, include requirements around consent and the traceability of human tissues and organs. Amendment 19 would not provide for future amendments to be made to the legislation governing human tissues.
Although I am entirely sympathetic to the concerns of the hon. Member for St Helens South and Whiston, I reassure Members that the current legislation provides extensive safeguards to ensure the ethical and appropriate use of human tissues in medicines and medicinal products. Equally, although I am sympathetic to the hon. Member’s intentions, I do not believe that the amendment would have the intended effect. I look forward to hearing further contributions from hon. Members.
Alex Norris Portrait Alex Norris
- Hansard - - - Excerpts

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.

I want to take this opportunity to talk about the Cumberlege review. I had rather hoped that the remaining stages of the Bill might fall after the review reports on 8 July. That is important, because the report could have a profound impact on how we view the Medicines and Healthcare Products Regulatory Agency and on how we view the past and what we need to do in the future. Presumably, proceedings in the other place will fall after that date, so I hope the Minister will at least be able to commit not only that the Government will engage seriously with that review—I am sure they will—but that crucially they will be willing to make amendments to this Bill or changes more generally to the MHRA through other legislation, regulations or in other ways to ensure that it is fit for the future and addresses the challenges that come up in that review.
Turning to the amendments in my name, this is a simple Bill and the sunset clause that amendment 20 would introduce reflects that. The Bill takes our current arrangements as governed by our previous membership of the European Union and transplants them into UK law—so far, so simple. It then hands the Secretary of State the power to amend those arrangements as they wish via secondary legislation. The Minister and I agree on a great deal of things—probably the vast majority of things—but our views diverge on whether that power is a downgrade from where we are. While I accept that the democratic deficit in the European Union is the face that launched a thousand undergraduate essay ships, there are nevertheless multiple independent stages across the Commission, the Parliament and the Council. Whether or not that is a good process is for the birds for us now, but if nothing else, there are lots of eyeballs to pick up mistakes.
Under the Bill, we will have a Secretary of State governing high-risk medicines and medical devices, with decisions essentially ratified by a Committee or occasionally, perhaps, on the Floor of the House, where the Secretary of State will have a majority come what may. I think in any terms that is a diminution, and the Government will need to be mindful of that.
All amendment 20 asks is that the Secretary of State returns to Parliament after having had the powers for three years and resets the arrangements, creating an holistic new status quo, as we are doing now. That is not to say that the status quo would then be locked in for ever—it would have to be a moving picture—but it would just give us an understanding in the round of all regulations and allow Parliament to have a full consideration, rather than doing it bit by bit. Given how much scrutiny will be coming out of the process, the measure is not onerous. Nevertheless, I accept that a sunset clause is an inelegant solution so I do not intend to press the amendment to a vote. It is the best we have as an Opposition, and I hope that the Government will bear it in mind in the other place.
Page 4 of the Government’s impact assessment says that before a medical device enters the UK market, the domestic notified body—for us, that is the MHRA—must sign it off and say it is safe. It must then be signed off by two other notified bodies from other member states. That is a triple lock. Under the Bill, it will be just the MHRA and the Minister. That is a high wire, and it leaves the potential for a lot of harm.
A sunset clause—I would probably rather characterise it as a reset clause—would allow us to consider or evaluate one particularly critical by-product of the Bill that I can guarantee every Member will hear about from their constituents, if they have not done so already. If colleagues comb the Bill or do a ctrl+f search looking for the words “hub and spoke”, they will not find them. They can be found only on page 10 of the Government’s impact assessment at paragraph 42. Buried deep in there is the idea that the Government may—or do—plan to change the age-old principle that the pharmacy that dispenses is the pharmacy that distributes, either at the counter or via home delivery.
Paragraph 42 raises the idea that instead, mobile deliverers will be able to partner with dispensing pharmacies to deliver their prescriptions for them or, more likely, be able to dispense and deliver on their behalf, leaving pharmacists to pick up new clinical responsibilities. There are very strong valid arguments on both sides of the issue. I cannot tell the House with certainty how I would vote if asked to pick a side at this very moment. Some say that the measure will destroy community pharmacy and others say it will unleash community pharmacy into the brave new world.
I can tell the House this: it is the most profound reform to community pharmacy in our lifetimes. It is delicate and it is important. Our constituents care about it, as do our local businesses. The Bill opens it up. I would even say that the impact assessment pre-judges the matter, and it is not even on the face of the Bill. That is why the Bill needs a sunset clause. We know we have to support the Bill’s Third Reading, or we will not have a regulatory regime for medicines and medical devices, but how on earth did we get to the point where we are practically committing to an entire new model for pharmacy along the way? I cannot understand that, and I hope the Minister will respond to that in summing up and make a strong commitment to the broadest possible consultation on the matter, because we will have to tread very lightly indeed.
On amendments 21, 22, and 23, when Paul wrote to the Corinthians, 13:13, he spoke of three things you discover as you grow up. We are entering wedding season now—happily we are allowed to do that again—so Members will recognise this message:
“And now these three remain: faith, hope, and love; but the greatest of these is love.”
Similarly, on clause 1(2) of the Bill, there are three things when it comes to human medicines—or, in the case of my other amendments, veterinary medicines or medical devices: safety, availability and attractiveness of the UK market. Surely, the greatest of these is safety.
I know the Minister has a strong personal commitment to patient safety, so I still cannot quite understand why in the Bill it is seen as equal to the attractiveness of the UK as a driving force of the Secretary of State’s decision making. I reckon we could stand in Members’ Lobby all day without finding an hon. Member who would make attractiveness a coequal priority with patient safety. I am keen to hear what legal advice she has had on this point. Are we certain that there is not a vulnerability facing a future Secretary of State who is said to have prioritised patient safety over the attractiveness of the UK market for litigious and exceptionally powerful pharmaceutical companies? I do not intend to push this to a Division, but I would be keen to hear her reflections on this point and ask that it be considered in the other place.
Amendment 19, which stands in the name of my hon. Friend the Member for St Helens South and Whiston (Ms Rimmer), deals with an exceptionally important issue. Again, there would be complete unanimity that human tissue harvested without consent is repulsive and that we in this country would want nothing to do with it—I have no doubt on that at all—but we also know that globally it is happening, and so it is incumbent on us all to make sure we are certain that such tissue does not enter the UK for the purposes we are discussing today. I listened carefully to what the Minister said in Committee. She provided a good deal of reassurance—and she has provided further reassurance this afternoon—but it is clear from correspondence from campaigners since that there might yet be gaps in the current arrangements and that we must act either today or in the other place.
Finally, I turn to the remaining Government amendments. As I said in Committee, I find it reassuring when there are Government amendments, because it means they are still reading their own Bill, which is a very good thing—I see it as a point of strength. I do not have any quarrel with these remaining amendments, but I want to make a final point about the use of secondary legislation powers, which the entire Bill is built on. This point is made clear on page 10 of the delegated powers memorandum. Not only is the Secretary of State reserving for himself significant powers via secondary legislation, but many are via the negative procedure. Examples include: labelling, prohibiting, advertising and the fees regime governing human medicine—an awful lot of very important things, and all at the stroke of a pen before Parliament has even said a word about it. I cannot help wondering whether the Government should be careful what they wish for. This is a high wire they have stepped out on to.
That summarises the Opposition’s views on the amendments. They are good amendments, both the Government and the Back-Bench ones, and I hope the Government will give the Opposition amendments strong consideration either today or at a later stage.
Marie Rimmer Portrait Ms Marie Rimmer (St Helens South and Whiston) (Lab)
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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 Portrait Jim Shannon (Strangford) (DUP)
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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.

I am pleased to follow the hon. Member for St Helens South and Whiston (Ms Rimmer). We are good friends and have a similar staunch interest in the issue of organ harvesting, which she addressed in her speech. I am greatly concerned about the fact that China seems to undertake almost commercial organ harvesting, including those of Falun Gong, those of people of Christian belief and those of Uighur Muslims and many others. I very much want to see all the protections that the hon. Lady has asked for, and I look forward to the Minister’s response.
Back before the 2017 election, I had occasion to be in hospital for three operations. If for nothing else but that one thing, I realised not only how good the NHS is and how well its people work, but also how unfashionable those surgical gowns are. It really scares me to think about it, never mind anything else, but that is the nature of life.
We are all aware that the Bill is an important piece of legislation. It is part of the drive to achieve the ambition to maintain the UK’s position as a world leader in science and research beyond the Brexit transition period. That is also referred to in the background notes. The Queen’s University research facility is world-class and is part of the team who are driving the search for a covid-19 vaccine, backed by the £20 million Government grant to find a vaccine and understand the virus. Sometimes it is not said, but it should be said and I say it now, that the Government have done some great work. It is in the nature of life that we sometimes say what has not been done, but let us give credit for what has been done; it has been really good stuff.
The Patrick G. Johnston Centre for Cancer Research and the Wellcome-Wolfson Institute for Experimental Medicine are both internationally recognised and acclaimed for the work that has been done there. Having been there many times in person, I cannot help but be impressed by the leading world-class facility at Queen’s University in Belfast. There is more that can be achieved, and I hope the Bill will free up the Queen’s researchers to reach their potential. Perhaps the Minister would confirm that that would be the case. Queen’s University leads the field.
It is important that we do not just maintain current standards. I believe that the Bill will enable us to raise standards above and beyond—retain what we have and, hopefully, do better. I am so proud of what we have achieved in this country and confident that we can go further in the future. The Bill is therefore essential. However, future regulations enabled by the Bill must also ensure that patients are not disadvantaged and that the UK remains an attractive market for the international industry. I want to ensure that that is the case and I am sure it will be, but as the Minister will confirm, there is a fine balance to be achieved between regaining our sovereignty, which is of utmost importance—and which I support totally—and ensuring that we are still competitive and able to work closely with the global market. I believe that we can achieve that, just as, last week, I spoke on the importance of assuring the future of the aerospace industry by means of regulations that enable continued easy access to the EU but also give the best protection for our own industry.
One of the questions that came up in my discussions was mentioned by the Minister. For years I have had a particular interest in rare diseases. I want to confirm that those with rare diseases will still have access to the specific clinical trials relating to their rare diseases. The Minister says, rightly, that the legislation will affect all of the United Kingdom of Great Britain and Northern Ireland, and that all four regions will be part of that. I have had some correspondence from the British Heart Foundation—an organisation which I highly respect, and is highly respected by all of us in the House. We appreciate the level of work that it undertakes to benefit people throughout the whole of the United Kingdom of Great Britain and Northern Ireland.
The BHF communicated with us about the Bill and I ask its questions, which are as follows. Close UK-EU collaboration is protected through full alignment with the EU clinical trials regulation, allowing patients access to vital pan-EU clinical trials regulation and encouraging industry to continue to invest in UK science and research. Will that continue? Patients currently have quick supplies of crucial medicines through close participation in the European Medicines Agency licensing process; will that continue? From 2004 to 2016, the UK collaborated with other EU countries in 5,000 clinical trials—the third-highest number of joint clinical trials with EU countries—and we were playing our part, as we often do, above and beyond. The outcome of the trials has been impressive, and we must ensure that co-operation without capitulation is the key. The UK ranks in the top four of EU countries for cardiovascular disease clinical trials, according to the 2017 analysis, with 586 CVD trials registered in the European clinical trials database. In 2016-17, the BHF spent 24% of its research income on clinical research, 31% of this on clinical trials and the rest on epidemiology, genetic studies and so on. The UK supplies 45 million packs of drugs to Europe every months and 37 million packs of drugs come the other way. We need to ensure that this can continue.
Despite having a number of bilateral trade agreements with the EU, it is estimated that Switzerland gains access to new medicines, on average, 157 days later than the EU27. In Australia and Canada, new medicines come to market, on average, six to 12 months later than in the EU or the USA. This is a very great concern of the BHF that I understand. However, it must also be remembered that as we are at the cutting edge of many of these technological and medicinal advances, we will not necessarily be delayed in our procurement of medicines that could not happen at all without our involvement. We need to ensure that we keep pressing on with our research and sharing information and communication on mutually beneficial projects.
I welcome the Minister’s commitment in her opening speech with regard to data protection for patients—that is sensible and helpful. That was another of our concerns, but she has already answered it, so I thank her. I am absolutely in agreement with the stated aims of the Bill: making it simpler for NHS hospitals to manufacture and trial the most innovative new, personalised and short-life medicines as their usage increases and they are taken up in local clinics and theatre; increasing the range of professions able to prescribe and supply certain medicines, making the most effective use of the NHS workforce where recommended by experts; and developing more innovative ways of dispensing medicines in local pharmacies. May I ask the Minister a very specific question that I, some of my colleagues and others in Northern Ireland are wondering about? In relation to the protections provided through this Bill, can she advise on what impact the Northern Ireland protocol will have on the medicines transferring between mainland UK and Northern Ireland? We want to ensure a seamless, transparent, easy system, and it will be important that this is the case. [Interruption.] I am almost at the end, Madam Deputy Speaker—I give you my word that I will keep within the time limit.
It is also essential that we remove unnecessary bureaucracy for the lowest-risk clinical trials to encourage rapid introduction of new medicines while still maintaining safety. That is crucial for the wellbeing of our patients in all of the United Kingdom of Great Britain and Northern Ireland. This is a marvellous opportunity. Our research and development needs to keep us as world-leading innovators, and yet the foundation of all of this must be the safety of the patient—that is paramount. I know that that is the Minister’s intention, and it would certainly be mine. It is my belief that we can achieve this and still share communication and projects with EU countries. I am supportive of this Bill—I want the Minister to know that—and hopeful for our future in this field. We can have safety, security and co-operation without mindless red tape, and I hope that that is exactly what this Bill will do. I welcome it as the Minister prepares to reply.
Rosie Winterton Portrait Madam Deputy Speaker (Dame Rosie Winterton)
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I call Tim Farron. [Interruption.]

Tim Farron Portrait Tim Farron (Westmorland and Lonsdale) (LD)
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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 Portrait Jim Shannon
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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 Portrait Tim Farron
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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.

A lack of co-ordination, damaging bureaucracy and the absence of consistent investment have left us lagging behind Europe in a treatment for which, ironically, we lead the field in innovation. Our machines should be replaced every 10 years, but a survey undertaken by Action Radiotherapy revealed that there are machines up to 17 years old. Replacing them would work out at about £400 per patient—the same as a single night’s stay in hospital. This is a highly curative cancer treatment, so I call for swift action to ensure that we stop lagging behind. A ring-fenced central funding pot to replace machines more than 10 years old would secure fast and uninterrupted patient treatment, solve the £140 million backlog in machine replacement costs and secure the treatment’s future.
Recognising the gap between approval and access also means recognising that access to treatment can mean physical access. People in Westmorland face a three-hour round trip for radiotherapy, and many of the elderly and extremely ill choose not to make the trip at all—they choose shorter lives because they cannot face the longer journeys. It is essential that we invest the £250 million for new network treatment delivery centres to bring treatment closer to home and avoid long travel for the 3.5 million people who live farther away than the recommended 45-minute maximum travel time. For us, that would mean a long-overdue radiotherapy centre at the Westmorland General Hospital in Kendal.
Access to innovative treatment is essential, and it must be in no way be diminished at the end of the transition period. However, that is only half the picture: access and approval must be followed by a co-ordinated and effective roll-out to patients. We cannot tolerate red tape leading to life-saving innovation being left unused in hospitals, just as we cannot risk having reduced access to those innovations in the first place.
If we claim to value the lives of the British public, we owe it to them to get this right and ensure they have easy access to the best and most effective treatment. That means ensuring a close deal with our neighbours and tackling our home-grown bureaucracy, which is more than capable of stifling innovation and costing lives.
Jo Churchill Portrait Jo Churchill
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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 Portrait Patrick Grady (Glasgow North) (SNP)
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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 Portrait Jo Churchill
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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


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


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


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.

Rosie Winterton Portrait Madam Deputy Speaker (Dame Rosie Winterton)
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I will now suspend the House for three minutes.

Sitting suspended.

Medicines and Medical Devices Bill

1st reading (Hansard) & 1st reading (Hansard): House of Lords & 1st reading
Wednesday 24th June 2020

(1 year, 6 months ago)

Lords Chamber
Read Full debate Medicines and Medical Devices Act 2021 - Government Bill Page Read Hansard Text
First Reading
The Bill was brought from the Commons, read a first time and ordered to be printed.
House adjourned at 7.41 pm.

Medicines and Medical Devices Bill

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020

(1 year, 4 months ago)

Lords Chamber
Read Full debate Medicines and Medical Devices Act 2021 - Government Bill Page Read Hansard Text
Second Reading
Moved by
Lord Bethell Portrait Lord Bethell
- Hansard - - - Excerpts

Relevant documents: 19th Report from the Delegated Powers Committee. 10th Report from the Constitution Committee.

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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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 Portrait Lord Hunt of Kings Heath (Lab)
- Hansard - - - Excerpts

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 Portrait Baroness Barker (LD)
- Hansard - - - Excerpts

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 Portrait Lord Patel (CB) [V]
- Hansard - - - Excerpts

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 Portrait Lord Lansley (Con)
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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 Portrait Lord O'Shaughnessy (Con)
- Hansard - - - Excerpts

My Lords, I declare my interests as set out in the register, in particular as an adviser to Intuitive Surgical, to 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 Portrait Lord Collins of Highbury (Lab)
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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 Portrait Baroness Northover (LD) [V]
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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 Portrait Lord Alton of Liverpool (CB)
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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 Portrait Baroness Cumberlege (Con)
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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 Portrait Baroness Andrews (Lab)
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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 Portrait Baroness Walmsley (LD) [V]
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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 Portrait Lord Ramsbotham (CB) [V]
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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 Portrait Lord Ribeiro (Con) [V]
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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 Portrait Lord Turnberg (Lab) [V]
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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 Portrait Lord Clement-Jones (LD)
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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 Portrait Baroness Butler-Sloss (CB) [V]
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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 Portrait Baroness Bennett of Manor Castle (GP) [V]
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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 Portrait Lord Balfe (Con)
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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 Portrait Lord Bradley (Lab) [V]
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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 Portrait Baroness Burt of Solihull (LD)
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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 Portrait Baroness O’Loan (CB) [V]
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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 Portrait Lord Brennan (Non-Afl)
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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 Portrait Baroness Whitaker (Lab) [V]
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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 Portrait Lord Sharkey (LD)
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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 Portrait Lord Woolf (CB) [V]
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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 Portrait Lord Sheikh (Con) [V]
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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 Portrait Lord Brooke of Alverthorpe (Lab)
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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 Portrait Lord Rennard (LD) [V]
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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 Portrait Lord Kakkar (CB)
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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 Portrait Baroness Redfern (Con) [V]
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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.

Baroness Garden of Frognal Portrait The Deputy Speaker (Baroness Garden of Frognal) (LD)
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The noble Lord, Lord Gadhia, has withdrawn from the debate, so I now call the noble Baroness, Lady Sheehan.

Baroness Sheehan Portrait Baroness Sheehan (LD)
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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 Portrait Lord McColl of Dulwich (Con) [V]
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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 Portrait Baroness Penn (Con)
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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 Portrait Lord McColl of Dulwich (Con) [V]
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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 Portrait Baroness Uddin (Non-Afl)
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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 Portrait Baroness Masham of Ilton (CB) [V]
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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 Portrait Lord Willis of Knaresborough (LD) [V]
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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 Portrait Lord Mancroft (Con)
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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 Portrait Lord Bhatia (Non-Afl) [V]
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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 Portrait Baroness Finlay of Llandaff (CB) [V]
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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.

Sitting suspended.
Lord Blencathra Portrait Lord Blencathra (Con) [V]
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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 Portrait Baroness Watkins of Tavistock (CB)
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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 Portrait Baroness Ritchie of Downpatrick (Non-Afl) [V]
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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 Portrait Baroness Hollins (CB) [V]
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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 Portrait Baroness Blackwood of North Oxford (Con)
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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 Portrait Baroness Morgan of Drefelin (CB) [V]
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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.

Baroness Garden of Frognal Portrait The Deputy Speaker (Baroness Garden of Frognal) (LD)
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The noble Lord, Lord Darzi, has withdrawn, so I now call the noble Lord, Lord Freyberg.

Lord Freyberg Portrait Lord Freyberg (CB)
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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 Portrait Lord Mackay of Clashfern (Con) [V]
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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.

Earl of Devon Portrait The Earl of Devon (CB) [V]
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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 Portrait Baroness Jolly (LD)
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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 Portrait Baroness Thornton (Lab)
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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 Portrait Lord Bethell (Con)
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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.

Bill read a second time and committed to a Grand Committee.
House adjourned at 7.18 pm.

Medicines and Medical Devices Bill

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020

(1 year, 3 months ago)

Grand Committee
Read Full debate Medicines and Medical Devices Act 2021 - Government Bill Page Read Hansard Text
Committee (1st Day)
Relevant documents: 19th Report from the Delegated Powers Committee, 10th Report from the Constitution Committee
Clause 1: Power to make regulations about human medicines
Amendment 1
Moved by
1: Page 1, line 6, at end insert “for a period of three years beginning with the day on which this Act is passed.”
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 Portrait Baroness Thornton (Lab)
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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 Portrait Lord Patel (CB) [V]
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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.

I turn to my Amendment 141, also in this group, which I am obliged to speak to now, as I am allowed to speak only once. It is supported by the noble Lord, Lord Pannick, and the noble and learned Lord, Lord Mackay of Clashfern. I am sorry that they are unable to speak today, as they may have made more important legal points.
As touched on in previous statements, these delegated powers conferred on the Secretary of State make provisions amending or supplementing the existing law on medicines and medical devices, in effect to grant powers to amend substantive areas of public policy and law without the scrutiny afforded by primary legislation. Delegated powers may be needed to enable responsiveness through the uncertainty caused by Brexit and potentially rapid technological changes, but they should not be used indefinitely or relied on to implement matters of policy.
Previously, the power to create relevant secondary legislation in the UK derived from the European Communities Act 1972. Those delegated powers were simply to allow the implementation of law in the UK that had already been consulted on, debated and scrutinised at both EU level and by our committees. The powers in the current Bill are such that areas of policy that would previously be subject to greater scrutiny at EU level may now be amended without similar layers of scrutiny by the United Kingdom Parliament. They do not represent, as the Government have argued, an equivalent conferring of power to the legislature, seen under the previous regulatory arrangement, as I have just pointed out.
This point was highlighted by the House of Lords Select Committee on the Constitution in the delegated powers report. It recommended that while delegated powers are appropriate to make provision for minor and technical matters, it is essential that primary legislation is used to legislate for policy and other major objectives.
This amendment does not set out to sunset the entire Bill. While this might make some sense, a number of provisions, including those relating to consolidation and the amendment of enforcement powers, can appropriately be scrutinised in the present. These provisions set out substantive law and do not grant further delegated powers in and of themselves and as such are the proper subject of parliamentary scrutiny now.
If, as was agreed earlier, the Government return with streamlined and consolidated legislation for medicines and medical devices, those provisions might be subsumed within such legislation anyway. This amendment instead sets out a sunset clause on Clauses 1, 8 and 12, which grant the broad delegated powers and essentially serve to circumvent proper parliamentary scrutiny.
The noble Lord, Lord Pannick, wants me to say that, had he been here, he would go back to the report of the Constitution Committee of 29 July. At paragraph 9 the report concluded:
“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 these powers. Government has not provided any justification required for this skeleton approach”.
Concerns about the Government’s use of skeleton Bills, including this Bill, were expressed in a long letter to the Cabinet Secretary from the chairs of the House of Lords Secondary Legislation Scrutiny Committee, the Constitution Committee and the Delegated Powers and Regulatory Reform Committee. They have found the Government’s use of skeleton Bills containing broad delegated powers to be inappropriate.
The Government’s amendments, referred to in a letter dated 13 October from the Minister, do not in my view address the substance of the concerns. It is all very well to alter the safeguards that apply to the making of delegated legislation, moving away from the negative resolution procedure, defining the purpose of regulations, requiring consultations and imposing a reporting requirement, as the Minister set out in his letter, but none of this addresses a fundamental concern, which is that Ministers should not have the discretion to decide on primary policy choices. That should be a matter for full parliamentary debate. Regulations that might be debated for 90 minutes, where there is no power to amend, are a totally inadequate substitute. The powers granted in this Bill will be a gross act of legislative and executive overreach, hence the need for a time limit on certain parts of the Bill through a sunset clause.
Baroness Jolly Portrait Baroness Jolly (LD) [V]
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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 Portrait Lord Hunt of Kings Heath (Lab)
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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 Portrait Lord Kakkar (CB) [V]
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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.

The reality is that these complex regulations are dependent upon each other. For any individual wishing to course this landscape, they will have to be able to read different regulations with regard to each other because each ultimately relies upon and refers to other elements of the regulatory framework. Therefore, it seems intuitive that at this time, when we are forced to look at the landscape of regulation for medicinal products for human use, for medical devices and for veterinary medicinal products, we take the opportunity to properly consolidate regulation. In that way, we can have a contemporary, well-designed framework of regulation for medicines and medical devices which is thought through, builds upon what we have established over the past 40 years, deals with inconsistencies and allows us to come together with a framework that is meaningful and protective of public health and the safety of patients—providing the opportunity for those wishing to bring innovation to our country to do so understanding the regulatory obligations clearly—and that ensures that members of the public can understand the legislation that is in place to protect them and their interests.
Therefore, I strongly urge Her Majesty’s Government to consider these amendments seriously. A three-year timeframe seems a perfectly reasonable one in which to move towards consolidated legislation. In addition to all the benefits that I have already laid out, there is an additional benefit: ultimately, this Parliament should be working towards improving legislation and the context in which it is presented to our fellow citizens. This is an ideal opportunity to address a vital area that touches on the lives of every citizen and to deal effectively with matters that have built up over a long period and do not necessarily sit well together, through the opportunities presented to us by coming out of the European Union and, therefore, the terms of the European Communities Act and all that has been enacted and codified as a result.
Lord Lansley Portrait Lord Lansley (Con)
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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 Portrait Baroness Walmsley (LD) [V]
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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 Portrait Lord O'Shaughnessy (Con)
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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 m