Medicines and Medical Devices Bill

Matt Hancock Excerpts

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 Commons Chamber

Second Reading

[The Secretary of State for Health and Social Care (Matt Hancock)]

I beg to move, That the Bill be now read a Second time.

While the world grapples with the challenge of coronavirus, it is vital that we do not lose sight of the important long-term reforms that we must make. Medicines and medical devices are evolving faster than ever. Not long ago, we could only record an ECG with hospital-grade equipment; now we can do it at home with a cheap device linked to our phone. Already, artificial intelligence is being used to discover new drug compounds. Now that we have left the European Union, we need a regulatory system that is nimble enough to keep up with those developments while maintaining and enhancing patient safety. That is what this Bill will achieve.

The aims of the Bill are fourfold. First, it gives us the means to depart from EU rules and regulations in future, moving at a faster pace, if that is what we choose to do as an independent, self-governing nation. Secondly, it ensures that we can easily amend regulation through secondary legislation without having to bring a new Bill before the House every time we need to revise the rules. That means our system of regulation will be flexible and responsive, quick to adapt to innovation and quick to respond when a safety issue emerges. Thirdly, the Bill will strengthen patient safety by strengthening the Medicines and Healthcare Products Regulatory Agency, our world-class medicines and medical devices regulator. That includes giving it powers that were not available under the EU, including over registration of devices and disclosure. Fourthly, the Bill will ensure that we strike the right balance between capturing the benefits of innovation without compromising patient safety.

[Sir Desmond Swayne (New Forest West) (Con)]

All those objectives of the Bill require a level of investment to bring about the innovations that we seek. The Prime Minister made a commitment of £200 million in September. How much private sector money does the Secretary of State expect that to leverage? What is our ambition?

[Matt Hancock]

We do not have a figure for medicines and medical devices specifically. As a nation, we have a goal that we should reach 2.4% of GDP spent on research. We are increasing the medical research budget; for instance, we are doubling the budget for research into dementia. As my right hon. Friend rightly points out, the public budget for research is only one part of it. There is huge private sector and charitable sector investment —for instance, from the Wellcome Trust. The Bill will allow research money—whether it comes from the public sector, private sector or third sector—to go further and get medicines and medical devices to NHS patients faster, as well as supporting our life sciences sector.

[Steve McCabe (Birmingham, Selly Oak) (Lab)]

I recognise the Secretary of State’s support for innovative medical technology. I am interested in the registers to which he referred, covered in section 13 of the Bill, and in particular the need to ensure that we get the maximum benefit without their being too onerous. Will he give an assurance that there will be some kind of consolidation where there are multiple registers in the same field and that we will only collect information that is specific to the subject stated for the registers?

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[Matt Hancock]

It is almost as though the hon. Gentleman has read my speech. That is the broad intent of that part of the Bill. I will come to it in more detail in a moment, and I am glad about the constructive tone that has been adopted across the House when discussing the Bill.

As I said, the fourth purpose of the Bill is to get innovation while not compromising patient safety—indeed, I would argue that we will enhance patient safety by being able to use modern techniques. It will do that by requiring the Secretary of State to have regard to the safety of medicines and medical devices; to the availability of medicines and devices, because sometimes getting availability as fast as possible is crucial for both innovation and patient safety; and to the attractiveness of the UK as a place to conduct clinical trials and bring medicines and medical devices to market. I will come on to clinical trials in more detail.

Let me turn to the main parts of the Bill. The first part, covering clauses 1 to 7, gives us the ability to update the law relating to human medicines—for example, to reflect changes in manufacturing methods or new types of product. We need that ability because coming down the track are cutting-edge personalised medicines that a hospital might literally have to assemble at the patient’s bedside. Those include gene therapies, medical gases and 3D-printed tablets—bespoke treatments so tailored to the individual that they will only be produced once, with a shelf life that might be measured in minutes. It is just not appropriate to regulate those kinds of treatment in the same way as a mass-produced factory drug, with mandatory batch numbers and packaging information. The Bill gives us the flexibility to respond to those developments. It also allows us to make changes to the regulation of clinical trials, ensuring that we are a globally attractive market to test new drugs and treatments.

But the Bill is not just about the latest science and innovation. It also means that we can update the rules on things such as labelling requirements—for instance, whether the leaflet in a pill packet should have a digital equivalent; rules on how online pharmacies ensure that medicines reach their intended customer; and rules on how the medicine brokerage market works.

We have said that we want to do more to boost the role of our brilliant community pharmacists, and the Bill helps us to do exactly that. It will allow us to remove the barriers to hub-and-spoke dispensing once EU rules no longer apply. Large companies such as Boots already do that, but the law as it stands prevents small, independent pharmacies from joining this kind of arrangement if the hub is not part of the same retail business as the spokes. That is an unnecessary barrier for smaller businesses in the pharmacy sector, and the Bill means that we can remove those barriers.

It also allows us to continue to add to the range of healthcare professionals who can prescribe medicines, which will relieve pressure on the frontline NHS, and it gives us the ability to make rapid changes to regulations to ensure the availability of and access to medicines in an emergency; I am sure we can all understand right now why that is important. Nothing in the Bill changes all the regulations immediately. Instead, it is about getting ahead of the game and giving us the power to make these changes as and when we need to, suitably scrutinised by Parliament.

The next part of the Bill concerns veterinary medicines. It broadly replicates the first part, giving us the ability to amend or supplement the Veterinary Medicines Regulations 2013. Changes could include, for instance, how veterinary medicines are supplied and the information that must be supplied with them. It sets out that, in making new regulations, we have an obligation to consider the safety of the medicines in relation to animals, humans and the environment. These are important matters, not least for me as the Newmarket MP. The Bill will ensure that we have a veterinary medicine system that is fit for purpose.

The third part of the Bill deals with the medical devices regulatory framework, covering everything from MRI scanners to embolisation coils and pacemakers to prophylactics. Like the first part, it allows us to fast-track a new diagnostic test in response to an emerging disease.

[Ben Everitt (Milton Keynes North) (Con)]

Is this not an example of how, having left the EU, we can now move at a much faster pace on a lot of regulatory things that are really important to our constituents?

[Matt Hancock]

Yes, that is right. This Bill empowers us to be able to move faster. Essentially, it empowers the UK to build a life sciences regulatory framework that is the best in the world—of course, working with EU partners, but also with partners from right around the world—and all with the intention of getting the most innovative products, as quickly as possible and as cost-effectively as possible, into the NHS. That is the goal of the entire Bill. It is a benefit of Brexit, but it is also worth doing in its own right.

The measures to strengthen innovation with respect to diagnostic tests again strengthen patient safety, because they strengthen the role of the Medicines and Healthcare Products Regulatory Agency. This includes, for instance, allowing us to legislate to create a comprehensive statutory register of medical devices in the UK. Such a register could be held by the MHRA, and we would make it compulsory to register a device along with information such as who manufactures and supplies it. This would mean that the MHRA could conduct post-market surveillance of devices in the UK, making it easier to trigger device recalls where a safety concern arises.

Indeed, we will enhance patient safety by giving the MHRA a new power to disclose to members of the public any safety concerns about a device. This was not possible while we were part of the EU. Previously, if an NHS trust raised a concern about a device and asked if similar reports had been received elsewhere, too often the MHRA was restricted in sharing that information; nor could it always routinely share information with the Care Quality Commission or other NHS national bodies. This Bill gives us the ability to share vital information about reporting patterns with the NHS family, and where necessary with the public, with enforcement powers that will be proportionate, transparent and suitably safeguarded.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I do not recognise the Secretary of State’s description that it was not possible to inform NHS bodies of concerns about machinery or devices. In my 33 years on the frontline, we received daily information about anything that was considered a danger or a failing, so I do not recognise that.

[Matt Hancock]

In some cases it was possible to share that information but not in all cases, and it will be possible now. I have no doubt that the hon. Member, like others on the frontline, will have received some information, but the MHRA is currently limited in the information that it can share with other NHS bodies. We are removing the limits on that information sharing, which of course needs to be done appropriately, but should not be set in primary legislation.

Our goal is this: we want the UK to be the best place in the world to design and trial the latest medical innovations. This Bill gives us the powers we need to make that happen. It will mean that the NHS has access to the most cutting-edge medicines and medical devices, with enhanced patient safety; it will help our life sciences seize the enormous opportunities of the 2020s, supported by a world-leading regulator; and it will help us pave our way as a self-governing independent nation. I commend the Bill to the House.

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[Jonathan Ashworth (Leicester South) (Lab/Co-op)]

We do not intend to divide the House on the Bill this evening. We understand the need for the Bill because its purpose is for the UK Government to take the powers they need as a result of Brexit. In that respect, we broadly support the principles of the Bill, and we offer to work constructively with the Government on strengthening and improving aspects of it. I have a couple of remarks to make that are related to this, but not to the exact contents of the Bill.

May I start by saying that we all know, not least because of the coronavirus outbreak, that disease knows no borders and defeating disease cannot be done in isolation? International co-operation and research and development are vital and must be accelerated, not hindered. Will the Secretary of State—or indeed the Under-Secretary of State for Health and Social Care, the hon. Member for Bury St Edmunds (Jo Churchill), in her winding-up speech—explain or comment on the press reports today suggesting that the UK is not seeking to participate in the EU pandemic preparedness measures, which may obviously help in relation to coronavirus and other future outbreaks?

I am of course talking about the early warning and response system. It was suggested in The Daily Telegraph today that No. 10 had overruled the Secretary of State. Since then, a former Minister, Baroness Blackwood, has told Sky News:

“My advice while I was in there was that I thought it was absolutely appropriate that we should stay engaged with that system… I think this is something that the EU would want to maintain and we as Britain should seek to maintain.”

I agree with her. I believe it would be foolhardy to pull out of something like this at the best of times, but to do so at the time of an outbreak such as this is surely putting narrow dogma before the public health of the country. I would be grateful if the Minister responded on that.

Secondly, we also learned at the weekend that the UK will not participate in the unified patent court, which will make developing medicines here in the UK more expensive, not cheaper and easier, and it may make doing clinical trials here less attractive. The Government have done lots of briefing on this Bill, but over the weekend they slipped it out while briefing trade magazines that the UK will not be seeking involvement in the unitary patent system. Again, that is disappointing, and I would welcome some remarks from the Minister on that front when she sums up.

However, this Bill is important, and we do not want to see anything that undermines what has been built up over many years in the United Kingdom. We do have much to be proud of in the field of medical innovation. We have long history of taking a leading role in scientific advance and novel trial design. Indeed, the recent deal to give NHS patients early access to a new cholesterol treatment demonstrates that the UK is already a world-leading destination in which to develop cutting-edge treatments. We want to build on that, not undermine it.

Members across the House will be aware that our pharmaceutical industry is the single largest private sector investor in UK R&D and provides many jobs across the country for many of our constituents. We should be proud of that sector and of the contribution that life sciences make in providing access to the most cutting-edge treatments. We should be proud that they are vital to economic growth, enhance UK productivity and ensure prosperity for the future.

Yet while the opportunities before us to develop medicines and medical devices are transformative—both saving lives and radically improving the quality of life for those with the most debilitating of conditions—we also know that things can go wrong. There must never be any compromise on patient safety. Patients put their trust in practitioners, literally trusting them with their lives, and they rightly expect medicine and medical devices to be safe, yet too often in recent years the system has failed patients.

For many years, long before I acquired the health brief in my party, I worked closely with a constituent, Emma Friedmann, who has campaigned for justice for women whose children were impacted by sodium valproate. Members from across this House have spoken with passion and eloquence on behalf of women affected by Primodos. Equally, we have heard heartbreaking stories in this House about the surgical mesh scandal. My hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson), the shadow Minister, has been one the leading campaigners on this issue, along with colleagues across the House. We eagerly anticipate the Cumberlege independent medicines and medical devices review, but there have been other scandals too—breast implants, hip replacements—that are not necessarily covered. We would welcome an update from the Minister about that review and some remarks on whether the Government expect to implement its findings.

My point is that a robust regulatory framework for medical devices to protect patients and users is paramount. We will be testing this Bill to ensure that it provides the safety standards that our constituents deserve, while at the same time ensuring it is forward looking enough to be the correct framework to capture the fast pace of innovation in this field, which the Secretary of State mentioned. However, I believe that the existing regulatory framework has become complex and, arguably, unwieldy.

The House will be aware that much of the regulatory landscape derives from EU directives that have been implemented in domestic legislation. At the end of the transition period, these frameworks will be preserved as retained EU law, but as I understand the Bill, the Secretary of State is proposing to take delegated powers to allow these existing regulatory frameworks to be updated without the need for primary legislation. The Bill requires the Secretary of State, as he said, to have regard to the safety and availability of medicines and medical devices, as well as to the attractiveness of the relevant part of the UK with respect to the life sciences sector. We argue that that attractiveness clause could benefit from some definition, and it would allay concerns if the Government accepted an amendment in Committee to indicate that the Secretary of State, or some other appropriate authority, would always prioritise safety.

The overall effect of the provisions is to confer on the Secretary of State an extensive range of delegated powers to make regulations that span the manufacture of medicines, marketing and supply, falsified medicines, clinical trials, fees, information and offences, and emergencies. That extensive range of powers risks inadequate scrutiny of what will become major policy decisions, and in Committee Labour will press Ministers to support time-limiting those delegated powers.

[Matt Hancock]

I am sure that this debate will continue in Committee, but for clarity, those delegated powers existed under the European Communities Act 1972. The Bill proposes to replace existing delegated powers from the 1972 Act with new powers to make such regulations under the new Act. This is not a new set of delegated powers; it replaces one set with another—indeed, the Bill replaces those powers with clearer safeguards on those matters to which the Secretary of State must have regard.

[Jonathan Ashworth]

That is a welcome clarification, but I am sure the Secretary of State will agree that it is important that decisions made in this field are properly scrutinised through the usual procedures. We are keen to ensure that by tabling an appropriate amendment in Committee.

We are leaving the EU, but Labour Members consider it essential that we stay closely aligned with it on medicine regulation. With that in mind, the Government should clarify their attitude to new EU regulations such as the in vitro diagnostic medical devices regulation, which is due to be implemented in 2022. As I understand it, that regulation will not automatically apply to the UK. Is it the Government’s intention to align with it? The EU tissue and cells directive is being reviewed. Do the Government intend us to align with it? To ensure that the UK remains a world leader in scientific research and discovery, it is vital that we align with guidelines on clinical trials. Otherwise, patients could miss out on participating in trials and the UK could find it harder to access funding.

Effective joint working with our European partners has been vital for the NHS over recent years on everything from infectious disease control to the licensing, sale and regulation of medicines. Patients in the UK can access EU-wide trials for new treatments and the UK has the highest number of phase 1 clinical trials across the EU, as well as the highest number of trials for rare and childhood diseases. It is vital for improving health outcomes in the UK and EU that the UK continues to access those networks. Otherwise, we run the high risk of patients with rare diseases being adversely impacted.

The Bill contains provisions to extend the range of professions that can prescribe medicines, thereby allowing additional health care practitioners such as paramedics and midwives to be given restricted prescribing rights. We welcome those provisions and, assuming that their competencies have been assessed in the same way as those of other prescribers and that equal safeguards are in place, we support that sensible and timely reform. Will there also be plans for a consultation on the future prescribing rights of physician associates and surgical care practitioners?

I will not say too much about part 2 of the Bill, other than to confirm that any measures that help in the battle against anti-microbial resistance have Labour’s support. Part 3 is about medical devices. I have already commented on the use of delegated powers, and as I said at the outset, patient safety must be the priority and we will look to strengthen regulation in that area. Unlike medicines and drugs, many surgical innovations can be introduced without clinical trial data or centrally held evidence. That is a clear risk to patient safety, and it undermines public confidence. Manufacturers are often in charge of testing their own products after faults have developed and they can shop around for approval to market their products without declaring any refusals.

Two years ago, freedom of information requests to the Medicines and Healthcare Products Regulatory Agency revealed 62,000 adverse incident reports that were linked to medical devices between 2015 and 2018, and more than 1,000 had resulted in death. Most devices are cleared through a pathway that allows new products to inherit the approval status of “substantially equivalent” products already on the market. In some cases, after lengthy chains of equivalence-based approvals, the new devices scarcely resemble the original version. Indeed, a study in The BMJ in 2017 found that the family tree of 61 surgical mesh products related to two original devices that were approved in 1985 and 1996. Unless we fix that and put patient safety at the heart of the regulatory framework, patients will suffer and lack confidence.

We know the Secretary of State is a great champion of and has promoted many health-based apps. We need a robust and sophisticated mechanism to evaluate app-based healthcare for use in the NHS, and in Committee we will look to strengthen the regulation of that. We welcome what appear to be plans for a devices register, and I took note of what the Secretary of State said in his interaction with my hon. Friend the Member for Birmingham, Selly Oak (Steve McCabe). We believe, however, that such a register must provide comprehensive data on who, where, how and why devices were implanted, and by whom, so that any recall could be quickly enacted.

To achieve that, we encourage Ministers to strengthen the Bill by reflecting provisions in existing EU regulation and to ensure there are unique device identifiers, such as serial numbers on medical devices that are labelled with tracking information, as well as the power to track the use of those devices, so that the NHS can find and notify affected patients if and when problems arise. By the same token, the Government must reassure us that with such a register it is practically possible to cover all devices, including everything from implants to bone screws, software, apps, mesh, medical cannulas, pacemakers and so on. That is an extensive list of different devices, and I would be keen to hear how such a register could be implemented practically.