Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Lord Bethell
That the draft Regulations laid before the House on 24 July be approved.
Lord Bethell (Con)
My Lords, I am confident that all noble Lords have a shared intention to protect and improve the safety of patients using medicines, while enabling their access to the most innovative treatments. As my noble friend Lady Manzoor stated previously:
“Our regulator, the Medicines and Healthcare products Regulatory Agency, MHRA, has over 30 years’ experience as a leading regulator in the EU. This expertise and experience is globally recognised and respected; we want to ensure that this continues, to the benefit of UK patients. It is with this at the forefront of our minds that the UK’s plans for the regulation of medicines … in a no-deal scenario have been developed”.
As my noble friend set out on 7 March 2019, it is important to reiterate our aim to retain a recognised regulatory system, which ensures that,
“patients in the UK and the EU continue to have timely access to safe and effective medicines”.—[Official Report, 7/3/19; col. 758.]
The system for regulating medicines is currently set out in EU legislation, and we have made legislation to ensure that our national regulatory system continues to function without any detriment to our ability to protect the public health in the event of the UK leaving the EU without a deal. We will then be considered a third country by the EU and, in this scenario, the UK regulator will take on the functions currently carried out by the EU. Additional changes are now being made through the SI in areas the Department of Health and Social Care has identified would benefit from further clarification. This is being done in response to comments from stakeholders, including industry and the life sciences sectors, and from internal review.
The changes proposed do not in any way represent changes in any underlying policy; rather, they are technical in nature, correcting minor drafting errors and omissions, and seek to ensure only that the original policy intention is delivered in legislation. The amendments proposed by this SI continue to be based on the department’s priority to ensure timely availability of safe, effective medicines and medical devices, while minimising disruption to patients and businesses, and to ensure that the regulator can continue to protect public health.
Noble Lords will note that the original regulations were developed through close consultation and co-operation with stakeholders, and that the department has published an impact assessment. After a period of informal consultation in August last year, the MHRA published an initial proposal for the UK’s medicines regulation framework and followed this up through a four-week public consultation in October. The feedback from that consultation—which received about 170 responses—led to revised proposals, which were published in January, and informed the development of the system that will come into place in the event of no deal. Noble Lords will have seen the published impact assessment, which was developed by experts at the MHRA and influenced by responses to the consultation. Noble Lords will want to be reassured that none of the proposed amendments change this impact assessment.
I will now give some specific detail of the arrangements set out in this SI. The majority of the changes being made are technical in nature and have arisen as we have reviewed the legislation and identified areas requiring changes to the legal text to ensure that it gives effect to the published policy. There are no new policy changes introduced in this SI.
This SI makes the following amendments for medicines specifically. First, it makes clear the requirements for a responsible person for import and RPI and for a wholesaler’s licence to hospitals importing human medicines directly from a country on an approved list for their own use. Secondly, it clarifies that UK generic applications can rely on data supplied in relation to medicinal products whose EU marketing authorisations were cancelled pre-exit on grounds other than safety, quality and efficacy. Thirdly, it gives additional detail in relation to the process by which companies may make representations to the Commission on Human Medicines about decisions on rare disease medicines and paediatric matters. Fourthly, it provides for a temporary exemption, subject to a specified condition, from the obligation to maintain a UK pharmacovigilance system master file for companies whose UK authorisations are included in an EU file. This also includes the condition that information required by the licensing authority be provided by the marketing authorisation holders on request. Fifthly, it clarifies that the temporary exemption as to the geographical location of an appropriately qualified person for pharmacovigilance applies to all marketing authorisations and herbal registrations that a company holds, whether granted before or after exit day. This is provided that they are covered by a single pharmacovigilance system in respect of which there is the same qualified person. Lastly, it adds the Republic of Korea to the approved list of countries with equivalent regulatory standards for the manufacturing of active substances on exit day. This is to reflect the updates to the EU list since the no deal SI was made.
For medical devices, there are some changes resulting from amendments made by the EU to the underlying medical devices regulations since the no-deal SI was made via the recently published corrigendum. The changes range from grammatical and reference corrections to a change concerning what is included in the transitional arrangements. Two further changes are inserted to ensure that products mainly used for cosmetic purposes are required to comply with common specifications and to require the information registered with the MHRA about medical devices to be updated by the manufacturer.
In conclusion, in the event of no deal these regulations will put in place technical changes that will ensure that the UK’s medicines regulations legislation continues to function effectively after exit day. These provisions will minimise any impact on patients and businesses and will ensure the timely availability of safe, effective medicines in the UK market.
Baroness Thornton (Lab)
I thank the Minister and welcome him to the world of EU health statutory instruments and their amendments—whether it is just for today or for a longer period. I also thank him for his explanation. I really hope that the Government have managed to get it right this time—I am not quite sure whether I have visited this twice or three times in the last year or so.
This statutory instrument comes into force immediately before exit day to correct the defects and omissions in the Human Medicines (Amendment) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. They come into force on exit day and, as the Minister described, amend our various regulations to ensure that they are fit for purpose in the case of the UK crashing out of the European Union without a deal.
As noble Lords know, EU law provides that the EU medicines regulatory system—of which the UK is currently a part—ensures, for example, the recognition of prescriptions across the EU and EEA, provides for the monitoring of the safety of medicines and incentivises the development of medicines to treat rare diseases and children. EU law also provides for an EU regulatory system for medical devices and in vitro diagnostic devices. This provides a conformity and safety before these things can be placed on the European Union market—so they are very important.
I have a few questions. First, it is said:
“The new Medical Devices Regulations … and in-vitro Diagnostics Regulations … have been applied directly in UK law since May 2017 and will be fully implemented in the EU from May 2020 and May 2022 respectively”.
So my question is: what is happening to them in the meantime? If we leave the European Union in six weeks’ time, will these things still be implemented or not? I just want to know whether my reading of that—from the Explanatory Notes in this case—is right.
Lord Rennard (LD)
My Lords, I begin by declaring my interests as in the register. My work with the British Healthcare Trades Association has identified concerns among the manufacturers of medical devices about what might happen with the future regulation of their products as a result of Brexit.
The regulation of medical devices and medicines is, of course, very necessary to protect patient safety, and it enables businesses to sell their products in the UK market, the much larger EU market and overseas. The evident need for the technical amendments that we are now considering suggests that the Government’s preparations to leave the EU are being made in great haste. It is also clear from them that there will be no benefit to anyone in changing the basis of the existing provisions for the regulation of medicines and medical devices.
Most countries recognise the great worth of current EU standards when they consider whether to allow products to be imported and sold to their citizens. If we leave the EU on 31 October, existing products that have been approved by the EU regime will of course continue to be approved, but surely problems will arise with new products as standards diverge in future—as inevitably they will. Will the Minister therefore say something about the potential impact of this legislation on the innovation of medicines and medical devices? British businesses will in future have to apply for licences to UK authorities if they want to sell new products here, and they will also have to seek approval from EU bodies if they wish to sell those new products in the European market and in the many other countries that already respect EU standards. This will mean two application processes, a potentially longer wait for approval and two sets of costs incurred in securing approval for new products.
Does the Minister accept that some businesses will feel inhibited in seeking approval for new products on that basis, that they might be tempted just to continue trying to sell old products that have already been approved, and that such inhibition might have a damaging impact on patient care and on the capacity of businesses to grow, especially if they seek to export new products? Will the Minister say something about how this impact on innovation might be ameliorated?
Most fundamentally, will the Minister confirm that leaving the EU on a no-deal basis will mean that we deny ourselves, and the rest of the EU, the benefits of sharing costs and expertise concerning the regulation of medicines and medical devices? Furthermore, does he accept that in the long run we need to work towards greater worldwide acceptance of standards to avoid new products requiring the approval of multiple agencies in the UK, the EU and elsewhere?
Lord Lansley (Con)
Perhaps I may add a few words on the subject of medical devices. I apologise that I was not able to be here to talk about these regulations earlier in the year, but I would like to say something about the regulation of medical devices now. The world has slightly moved on and, from my own point of view, that is rather helpful. I want to focus on medical devices in particular.
I remember the 2017 European regulations, to which the noble Baroness, Lady Thornton, referred and which will come into effect next year for medical devices and in 2022 for in vitro diagnostics. The ones on medical devices stemmed from the breast implant activity from way back when I was Secretary of State. I remember a conversation with my then French counterpart, Xavier Bertrand—now, I think, in charge of the Nord-Pas-de-Calais region. In response to that activity, his contention was that we had to change EU regulation so that all medical devices went through exactly the same authorisation process as all medicines. That would have been a complete disaster for the industry. Happily, that did not happen, but these regulations represent a considerable tightening of the risk classification processes under the EU regulations.
I think that the answer to the question from the noble Baroness, Lady Thornton, is that the intention—I think it is already in our regulations in preparation for a no-deal exit, if necessary—is to continue to recognise EU regulations for medical devices and in vitro diagnostics, and to recognise them in the future. Clearly, we would do that under a transitional process with the withdrawal agreement and I think our intention is to do so in any case. That means that, if we leave and are treated as a third country, we will recognise a CE marking from the European Union but it will not recognise an authorisation made in the United Kingdom. It will not be a mutual recognition process, which ideally is what we are aiming for and which a transition process under the withdrawal agreement would have enabled us to negotiate for a future relationship. That is much to be wished for.
This is not a small deal. In the European Union context, something like 40% of the highest-risk medical devices in Europe have in the past been authorised by the UK’s Medicines and Healthcare products Regulatory Agency. Approaching 50% of bodies requiring a certificate of conformity have gone to UK notified bodies, so the UK notified bodies are in an extremely strong position and, as a necessity of our leaving the European Union, to some extent they will lose that position. For example, the British Standards Institution will be a notified body in the United Kingdom, but it is also a notified body in the EU by virtue of being based in Amsterdam—as indeed the European Medicines Agency has gone to Amsterdam. There is a transition process which, unfortunately, is not the one under the withdrawal agreement but one away from the United Kingdom, which is to be regretted.
The point I particularly want to make today—and all of this will be well known to the Minister and the department, and I am not asking him to comment on all of it—is about the combination of changes all occurring at one time. We may leave the European Union at the end of October or at the beginning of next year. In either case, it is very close to the point at which the medical device regulation comes into force in May 2020. The European Union is not ready. In a report published by KPMG a couple of weeks ago, only 27% of the 200 manufacturers of medical devices sampled said they were ready for the changes in the regulations next May. They may be ready by May, but they have had quite a lot of notice and are finding the new requirements very difficult.
The European Commission has recognised this and given a grace period for a number of products to enable the introduction of the new requirements to be pushed off to 2024. Frankly, at this stage it would be in our interests to encourage the European Commission to extend that grace period for all products through to 2024. New products coming in would be required to be certified in line with the new regulation, but all existing products would be grandfathered through and given until 2024 to go through the process. At the moment, there are only five notified bodies in the whole of the European Union, and that is not enough. If we leave at the end of next month without a deal, UK medical device manufacturers will have to go to notified bodies in the European Union to secure authorisation for their products within the EU—they cannot place them on the market by virtue of a United Kingdom authorisation. There are a range of coincident changes, and the more we can do at the moment to try to encourage the European Commission to push all existing products off from the requirements of this new regulation into 2024, the better it will be. I hope our Government, even if they seem to have taken the rather perverse decision not to engage with the European Commission while we are planning to leave, should engage with the European Commission and ask for this to happen.
Perhaps the European Commission might even embrace the thought that they were not ready, because the new Commission President, Commissioner Ursula von der Leyen, has decided to shift the responsibility for medicines and medical devices from DG Grow to DG Santé. Perhaps DG Santé, recognising that it has this new responsibility in the midst of all this transition—yes, even more—can say that the starting point is to put in place an extended grace period for all manufacturers, given the lack of capacity in the EU notified bodies system in the short run.
I do not expect my noble friend to reply on that, but I hope he will at least say that he will encourage the department to see whether it and the MHRA might engage their counterparts in the European regulatory system with that view in mind.
Lord Bethell
My Lords, I thank noble Lords for a stimulating debate in the exciting area of medical SIs. I also thank noble Lords for the warm welcome they have given me. It is a thrill to be here.
The noble Baroness, Lady Thornton, put it very well: this SI is technical but vital. It is vital for those who depend on these medicines and devices for their health and well-being. It is also important for the businesses in Britain that the noble Lord, Lord Rennard, referred to, which have exciting, innovative and important inventions that they are trying to sell on a world stage. Getting this right is a big priority for the Government.
When I look through the SI and the detailed changes it includes, I must admit I have a slightly different sensation. As a neophyte, what I find remarkable is how small and detailed the changes are, and how much hard work must have gone in to getting this right—or more or less right—in the first place. I commend the House for the contribution it made to the scrutiny of these important SIs when they came before us earlier this year and also the officials who have turned an incredibly difficult challenge of Brexit into something that is clearly workable and has passed the scrutiny of a large number of organisations.
Safety and security are massive priorities for the Government; I very much want to convey that to the House. The Government are fully committed to a system of medicines and medical device regulation that intelligently balances patient access to new, innovative, world-leading products on the one hand with an assurance of acceptable safety. The MHRA will have in place a suite of licensing routes for medicines and vigilant systems for medicines and devices. We are committed to offering a competitive regulatory environment to ensure that the UK has access to medicines and devices meeting high standards of safety and efficacy. This SI makes technical amendments to achieve these aims, which are important and necessary.
I will take a moment to answer a couple of the questions that came up. The noble Baroness, Lady Thornton, asked about resources and regulations taking effect. I reassure her that, as I stated, this SI makes minor changes to the SI made earlier this year. The Government are confident that the hard work put in by the MHRA has made it ready for this challenge. It has an impressive roster of staff in place to step up to the work.
The noble Baroness also asked about EU legislation currently in force and what will happen when we leave the EU. The noble Lord, Lord Rennard, asked similar questions. I reassure noble Lords that all relevant EU law will be retained EU law for the purposes of the European Union (Withdrawal) Act 2018. Much of it has already been transposed, including the human medicines regulations and the medical devices regulations.
Questions were raised about the important NAO report, which the Government take very seriously. I reassure the House that the Government are taking every possible step to ensure the uninterrupted supply of medicines in the event of a no-deal Brexit so that patients continue to receive the medicines they need. We are working closely with suppliers to put in place stockpiles, reroute supply chains and ensure medical freight companies are ready for any changes to customs procedures.
Our guidance to suppliers is that there should be at least six weeks’ stock of prescription-only medicines, pharmacy medicines and medical devices. However, stockpiling is only one part of our approach, as some medicines have short shelf-lives or are tailored to individual patients. An example of the kind of measure we are putting in place is that we have supported suppliers to test and secure new routes. We are working closely with the Department for Transport on precuring our own dedicated health channels for critical products needed within a 24 to 48-hour timeframe.
The noble Lord, Lord Rennard, asked particularly about duplication. The UK has put in place an innovative licensing route to ensure that companies, particularly innovative companies, have a route to market that is efficient, cost-effective, speedy, effective and trusted. This allows them to produce their products on to the UK market at the same time as the EU. They will simply have to provide the MHRA with the same information as they do to the EU. The architecture for this was designed specifically to avoid duplication.
The MHRA intends to provide free scientific advice for UK-based small and medium-sized enterprises and to introduce a new targeted assessment, as well as an accelerated assessment route to enable licensing more quickly than the EU. It is very much part of the principle of the Government’s approach to Brexit that we want to have a competitive regulatory environment, particularly in life sciences, that gives companies the chance to compete effectively on the world stage.
My noble friend Lord Lansley reminds us that huge changes in this exciting industry have nothing to do with Brexit at all. In fact, Brexit is not the only challenge. There are massive regulatory innovations across the industry. He makes a strong argument to delay the implementation by the EU of new medical device regulations. I reassure my noble friend that I will certainly pass this up the line and ensure that the MHRA is made aware of his concerns.
This SI is detailed and was put before the House promptly before the summer. I believe that we all agree that it is important in its intent. For that reason, I beg to move.