Human Medicines (Amendment etc.) (EU Exit) Regulations 2020
(4 years ago)
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Lord Bethell
That the draft Regulations laid before the House on 20 October be approved.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, we all believe that we must protect the safety of patients, while preserving their access to new and innovative medicines. The instruments that we are discussing today, on the UK’s regulation of medicines and medical devices, will ensure that there is a functioning statute book at the end of the transition period. This could not be more important in the context of the Government’s Covid-19 response.
The instruments are generally technical in nature and broadly achieve three things: first, they make minor amendments to existing regulations to take account of the implementation period agreed under the withdrawal agreement; secondly, they implement the Northern Ireland protocol; and, thirdly, they implement certain changes to the regulatory regime in Great Britain to ensure that the regulatory framework is up to date and functioning correctly at the end of the transition period.
These regulations do not prevent the need for future changes but they do preserve the solid foundation of the UK regulatory environment to protect patient safety and to allow the UK to remain a world leader in science and innovation. I will set out some of the key changes in the medical devices SI and then the medicines SI. However, as the SIs are long and technical, I trust that noble Lords will understand that I will not address all elements in the time we have available.
The medical devices instrument will allow CE-marked medical devices to be placed on the Great Britain market for a period of two and a half years. This will ensure continued access to medical devices for patients, while providing time for industry to adapt to future regulations. The Government have created their own new product safety marking—the UK conformity assessed, or UKCA, marking—which will be used across goods regulation in Great Britain. The SI sets out that the UKCA marking can be used for devices certified in accordance with the regulations and placed on the market in Great Britain from the end of the transition period.
The instrument makes a change to the 2019 medical devices SI, which would have inserted into domestic law provisions of the EU medical device regulation, or MDR, and the in vitro diagnostic medical devices regulation, the IVDR. By not including these provisions, we can develop our own system based on patient access, international standards and public health considerations.
The report of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege, has made it clear that we must do more to protect patient safety. The Government wholeheartedly agree. We will use the opportunity of leaving the EU to develop a robust, world-leading regulatory regime which prioritises patient safety, innovation and international best practice, using the powers of the Medicines and Medical Devices Bill.
Throughout recent constructive debates on the Bill, I have listened carefully to my noble friend Lady Cumberlege and other noble Lords. We listened to concerns and have incorporated the medical devices information system into the framework for a future regulatory system. We are also in discussion on a number of other important regulatory issues, the details of which I will not go into now for the sake of brevity. I look forward greatly to the public consultation on this future regime next year and to working closely with the life sciences and healthcare sectors on these important considerations.
I now turn to the human medicines SI. From 1 January 2021, the Northern Ireland protocol will apply, so marketing authorisations granted by the EU will continue to apply in Northern Ireland. However, medicines placed on the market in Great Britain must be authorised through the UK national route.
The human medicines SI allows the MHRA to have “regard to” decisions made by EU member states on products approved via decentralised and mutual recognition procedures when considering whether to authorise those products in Great Britain. This policy will ensure that the MHRA can continue to take effective regulatory and safety action on these products.
The medicines SI will ensure that new and existing medicines continue to be on the UK market after the end of the transition period, so that patients are still able to access them in a timely manner. This will be achieved by allowing recognition of decisions by the EU Commission to grant marketing authorisations for centrally authorised products. These products will receive a GB marketing authorisation.
Both the SIs we are discussing today uphold the Prime Minister’s commitment to unfettered access for Northern Ireland’s businesses to the whole of the UK market. The SIs include transparency requirements for medicines and medical devices moving from Northern Ireland to Great Britain, which will allow the MHRA to maintain oversight of products on the GB market and thus protect patient safety.
For medical devices, the transparency requirements mean that non-UK manufacturers placing devices on the UK market will be required to appoint a UK responsible person. The UK responsible person will be required to register devices with the MHRA in accordance with a transitional timetable set out in the regulations. Registration requirements will also apply to GB and Northern Ireland-based manufacturers. Both SIs make changes to ensure that the relevant EU laws will continue to apply in Northern Ireland after the end of the transition period, fulfilling the requirements of the Northern Ireland protocol. I reassure noble Lords that this Government will continue to regulate medicines and medical devices in a way which works for the whole United Kingdom, including, of course, Northern Ireland.
The MHRA will continue to regulate medicines and devices in Northern Ireland. This will ensure continuity for patients and for businesses. Moreover, the Medicines and Medical Devices Bill, currently passing through this House, will provide the powers for future changes to the UK’s regulatory system. Within this, and having tabled an amendment in my name, what is now Clause 43 requires a public consultation on regulatory change before making use of the relevant designated powers in the Bill. The consultation process will help to ensure that the interests of the all interested parties, including devolved Administrations such as Northern Ireland, continue to be fully considered. Officials have kept the devolved Administrations informed of the drafting of this instrument and I am grateful for their continued collaborative approach. In particular, I thank the Minister of Health in Northern Ireland, Robin Swann, who agreed—despite policy for human medicines being a devolved matter—to the human medicines SI being signed solely by the Secretary of State for the Department of Health and Social Care.
To inform the industry, we have published a number of guidance documents which go into further detail on the changes included in the SIs on GOV.UK. In addition, an accompanying series of webinars were held where officials engaged directly with 11,500 industry representatives and provided them with an opportunity to ask questions. My officials also meet regularly with top industry companies and key trade associations, including the Association of the British Pharmaceutical Industry, the BioIndustry Association and the Association of British HealthTech Industries.
It is important to note that these instruments amend pre-existing EU exit legislation made in 2019. A full consultation process was conducted for this pre-existing legislation. Moreover, full impact assessments were conducted for this underlying legislation. As the nature of the changes in the instruments that we are discussing today are in many instances technical, the impacts of these SIs above and beyond the existing legislation do not meet the threshold for further impact assessments and hence these are not provided for. These instruments will ensure that the UK’s exceptional standards of safety and quality regulation of human medicines and medical devices are maintained and enhanced. At a time when we have never been more reliant on all the elements of our public healthcare system for our survival, we must support this. I beg to move.
Lord Blunkett (Lab)
My Lords, I was going to make an esoteric and wide-ranging speech on the relationship between the protocol, the MHRA and the European Medicines Agency and wow the gathered hundreds of online Peers in order to demonstrate my technical knowledge, but I have abandoned that in favour of saying something very brief on the relationship between these regulations and the Bill to which the Minister has already referred, and on today’s announcement about the purchase of the Pfizer BioNTech vaccine.
I genuinely congratulate the Minister—he must have had nightmares over the last eight months of Questions and Statements on PPE, test and trace, and everything else—on actually managing to find the time to be entirely on top of, and extremely impressive in, the process of taking through the somewhat delayed legislation on medical devices. I also congratulate him on his willingness to be flexible. It is easier to be flexible with one’s own side, but I actually am impressed that he, on behalf of the Government, has been able to respond so effectively to the superb campaign of the noble Baroness, Lady Cumberlege, in relation to the protections that we debated in Grand Committee. I know that my noble friend on the Front Bench has done a sterling job in supporting and working on that.
I want to test out this afternoon—in relation to what we are debating, because it is directly related to it, although it will be the subject of a Statement tomorrow—the extraordinary misunderstandings that appear to exist not just on the twittersphere, which you would expect because the very word “Twitter” brings that to mind, but in social media and the broadcast media as well. These relate to the relationship between the MHRA and the European Medicines Agency, and the relationship between what is possible now and what might change following the final conclusion of whatever deal is done at the end of the transition period in respect of our exit from the European Union at the end of December.
Perhaps the Minister—and this is a kind of run-out for tomorrow, seeing as there are so few of us gathered together—could confirm that the MHRA has powers, and has used them already when we were, and remain in the transition period, members of the European Union, in circumstances where it was appropriate to act swiftly when the European Medicines Agency was taking a longer period of time to come to a judgment on the efficacy of a particular procedure or vaccine. Regulation 137, I think, relates to this. Would it not be nice if we could join the German ambassador in welcoming international collaboration, rather than always having to believe that when we borrow someone else’s horse we should get commended for riding it in in front of the others? I am very supportive of what has been done; I believe that the MHRA has done its job thoroughly and efficaciously. It is excellent that we have been able to move quickly, not least because we might be able to transport the vaccine during December, before whatever chaos exists from 1 January. It is a great move forward; we should all celebrate it, but we should do so within the context of the reality of the situation, the knowledge of what existed already, the relationship of continuity after 1 January and the celebration of international collaboration to tackle the virus which, after all, is a pandemic.
Lord Goddard of Stockport (LD) [V]
I do not intend to take up too much of the time of the House, but I want to make a couple of comments and ask the Minister three questions about the SIs and the context in which they sit. These instruments are technical in nature, but the subject area—the regulation of medicines and medical devices—is a key issue for millions of people across the United Kingdom.
It is clear that in a no-deal EU exit scenario, the UK’s current participation in the European regulatory network for medical devices would end. The MHRA would then take on the responsibility for the UK market currently undertaken through the EU system, to ensure the continued safety of patients. The instruments are designed to enable the regulation of medical products and devices across the UK to be continued beyond the implementation period, so the regulations need maximum scutiny.
The EU and the UK markets for medicines and medical devices are closely linked, and enormous numbers are involved. I doubt whether the general public have any idea of the scale. According to the Association of the British Pharmaceutical Industry, every month at least 45 million packs of medicines are exported from the UK to the EU, and 37 million packs are supplied from the EU to the UK. The UK still also relies heavily on the EU for its supply of medical devices, with more than half its £5 billion budget for imported medical technology being spent on devices originating from the EU.
From January 2021, changes to legislation on these issues will no longer flow through from updates at EU level. I therefore hope that the Government will explain clearly how this vital supply chain will be not only maintained but improved. A number of issues in relation to the Medicines and Medical Devices Bill have raised concerns about the Government’s approach to the future regulation of medicines and medical devices. I will pick out just three for the Minister to consider.
The first issue is patient safety. There is a balance to be struck between innovation and patient safety. The Government need to provide assurances that patient safety will be an overarching consideration in their approach to new devices, some of which have been controversial in the past. The scandal of the women affected by mesh implants is an obvious example of where things have gone wrong.
The second issue is about alignment and collaboration. The EMA centralises the process for licensing and the monitoring of drug safety. Pharmaceutical companies could prioritise the EEA market over the UK market if the processes diverge too far, leading to delays in medication and medical devices being available in the UK.
The third issue—to me, possibly the most important—is patient data. The Government need to provide assurances that patient data will be protected and used appropriately. That should be front and centre of their approach, to give confidence that patient data will be protected and will not be shared with third parties.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, it is a pleasure to follow the noble Lords, Lord Blunkett and Lord Goddard, with another northern perspective. The noble Lord, Lord Blunkett, made a good choice of location today, being in your Lordships’ House rather than in Sheffield, because here the emergency services are dealing with an unexploded World War II bomb just up the road from me. I thank those emergency services workers. This is a reminder that all our essential services and workers have so many things to deal with at the moment, including all the medical professionals dealing with the complexities that we are discussing today.
I agree with the noble Lord, Lord Blunkett, about the importance of acknowledging international collaboration. Whether we are talking about vaccines or medical research, the nature of science today is innately collaborative, and we need to keep that in focus.
I also agree with the noble Lord that the Minister has been highly informative and helpful to your Lordships’ House right through the pandemic. That has built trust, which is so crucial. I hope that the Government will ensure that the information they provide is always accurate and trustworthy—as other representatives, I am afraid, have not been today, in their claims that exiting the EU made it possible to approve the vaccine so quickly.
Turning to the detail of these complex and detailed instruments, I decided to engage in the debate because I have also been heavily involved with the Medicines and Medical Devices Bill. As the Minister said in his introduction, it is clear that these instruments and the Bill are closely interrelated. It is also clear from our debates on the Bill, and from the report by the noble Baroness, Lady Cumberlege, that we need a great deal of improvement in our regulation and oversight of medicines and medical devices.
These statutory instruments also address the issue of falsified medicines. With fake medicines estimated to cost the pharmaceutical sector about €10 billion, and considerable evidence that the Covid-19 pandemic has accelerated that problem, this is truly a key issue.
I shall address four key points. The first is the Northern Ireland complexities, with which the SIs are heavily involved. The second is the extra costs for the NHS, and potentially for private patients, for medicines and medical devices. The third is falsified medicines, which I have already mentioned, and the fourth is the risk of shortages in the immediate post-transition period and the later post-transition period.
In relation to the first point, about Northern Ireland, the Explanatory Memorandum says, at paragraph 7.10:
“To ensure unfettered access only benefits NI businesses, these regulations require that:
a) only an NI business should be able to apply for a licence from MHRA … and
b) the market authorisation holder … will need to be located in NI.”
It will have to provide information and data, and take
“legal responsibility for the medicine once on the GB market, including access to a suitably qualified person for UK regulators to interact with on ongoing safety monitoring … related to those medicines”
and medical devices. My first question for the Minister is: are there enough qualified, appropriately registered, people in Northern Ireland for those roles? Secondly, are small independent businesses, such as small pharmacies in rural areas, ready for this situation?
As of early November, a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021 has been agreed, which means that the current batch testing, importation, and falsified medicines directive requirements will remain in place for another 12 months. December 2021 is not very far away. Are these regulations future-proofed? Will they still cover the situation in 12 months’ time?
The Explanatory Memorandum also notes all the extra costs—for example, £18,000 for a new active substance, £10,000 for a complex abridged application, and so on. Can the Minister provide any information on what extra costs the end of the Brexit transition period will bring, for drugs both for the NHS and for people with private prescriptions?
On the third point, about falsified medicines, in October the Royal Pharmaceutical Society wrote to the Health Secretary, Matt Hancock, asking for “robust plans” to be put in place
“to help authenticate the legitimacy of medicines”.
The RPS also said:
“We are concerned that removal of these safeguards could leave the UK vulnerable to an influx of counterfeit medicines, impacting on patient care in the UK and across the EU”.
Can the Minister provide assurances on that point?
Finally, I want to ask about shortages. In August the Government recommended that pharmacies and hospitals build up a six-week stockpile before 31 December. Is the Minister confident that that is in place, given all the many other pressures from Covid-19, normal winter illnesses and the general pressure on our medical systems? In the shorter long term, at the end of those six weeks, will the supply be secured? Can we be confident that we will have the medicines we need?
Baroness Wheeler (Lab)
I thank the Minister for introducing the regulations, and other noble Lords for their contributions and key questions on these two important instruments. I also thank my noble friend Lord Blunkett for the speech he decided not to make. As noble Lords have said, it is timely to discuss these instruments now, as we take stock of the Medicines and Medical Devices Bill Committee discussions and outcomes, await Report dates and deliberations, and meanwhile continue the so far helpful discussions on a number of key issues taking place between the Minister, ourselves and other noble Lords involved with the Bill.
For the record, the Bill has changed substantially as a result of government amendments agreed in Committee —not by consensus among participants, as we normally would have expected, but by the Government’s insistence that it was necessary to agree the amendments in Committee to comply with the requirements and timescales for consultation on the Bill with the Department of Health in Northern Ireland and the Northern Ireland Assembly.
We are now working our way through the “new” Bill to assess the full impact of this departure from established procedure and, in particular, the response from the Government to the deep concerns of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee on the use of delegated powers across a range of provisions in the Bill. I note that the Government have not formally responded to these committees, as is also usual practice, other than broadly commenting in the course of their response on individual proposed amendments, or in general correspondence from the Minister in his letter to Peers of 13 October and to the noble Lord, Lord Lansley, of 18 October. Can the Minister tell the House if he plans to respond to the committees, explaining not only how their concerns have been addressed but by which specific government amendment? This information is pretty crucial to all involved as we continue to discuss the Bill with Ministers prior to Report.
The regulations today are confirmed through the affirmative procedure instruments. I would be grateful if the Minister can today confirm that the Government will use this procedure in all regulations on human medicines and medical devices, as also promised in his letter of 13 October.
We have had a good, if short, debate on these SIs, which are long, complex and technical, but which we recognise as a necessary step towards ensuring that people are kept safe when using medicines and medical devices after the end of the implementation period for exit from the EU. I will not repeat the content and purpose of the regulations, which have been well explained by the Minister and other noble Lords and also documented in the very helpful Explanatory Notes and Library briefing, and by the most helpful summary of all, in my view, the Commons Minister Edward Argar’s bullet-points letter of 20 October. In the main, the key issues are the ones we have closely examined in Committee, and which continue to be under discussion.
I want to reinforce and add to the questions raised by some noble Lords. First, on the landmark Cumberlege report, I referred earlier to the helpful discussions taking place on the implementation of this vital review, in particular the establishment of a patient safety commissioner. The Minister referred to these discussions, but he knows that a clear statement of commitment from the Government is needed on this and is long overdue. Can he update the House further on the progress of the discussions? The Minister in the Commons promised strengthened regulations to do more to protect patients, and to use the powers in the MMD Bill for this. He said that plans are in development which will take into consideration both international standards and global harmonisation in the establishment of our future system. I look forward to further information from the Minister about these budding plans and the timescale for when we can expect information and consultation on them.
My noble friend Lord Blunkett touched on the powers of the MHRA in relation to vaccines, and the powers generally in the Bill. There have been deep concerns about how the MHRA is to be staffed and resourced to meet the huge challenges of its future role as the UK regulator of all medicines coming into Great Britain and Northern Ireland. It is a much respected body, but its capacity and expertise will need to be hugely expanded to meet its new obligations and duties. The £13 million in additional funding from the Government up to the end of March 2021 will, I suspect, be just a pump-priming starter. Can the Minister tell the House the planned annual budget for the MHRA up to the end of year three of its operation under its extended remit?
The conformity assessment—the UKCA mark—will be available for industry to use for medical devices placed on the market in Great Britain from the end of the transition period. Is the Minister confident that manufacturers have been given sufficient time and guidance to prepare for the UKCA marking?
What assessment have the Government made of the impact these new regulations could have on the number of approved medical devices in the next few years? According to GlobalData’s pipeline products database, there are more than 17,000 active medical devices currently in the pipeline, with approximately 42% of these devices in the early stages of development. The high proportion of products being developed in the EU and UK indicates that a vast majority of devices will be caught in transitioning approval processes, which may lead to a temporary decline in the volume of approved devices—and, indeed, to the delays that noble Lords have talked about. Many companies are already struggling with the demands of the medical device regulations, including the increased costs. Does the Minister share my concern that this, coupled with the additional authorisation process required to reach the UK market, may lead to delays or deter companies from selling their products in the UK altogether?
Under these regulations, the UK will continue to recognise the CE marking on medical devices and in vitro diagnostic devices which have demonstrated their conformity with EU regulatory requirements, until July 2023. Will the UKCA marking be recognised by the EU? Can the Minister confirm whether the EU falsified medicines directive, referred to by the noble Baroness, Lady Bennett, will apply in the UK after Brexit? If not, packs of medicine intended for the UK that are not compliant with the directive may not be lawfully dispensed in Northern Ireland.
The complexities businesses face are considerable and have been exacerbated by the Northern Ireland protocol, which requires companies seeking marketing authorisation to be able to sell a new medicine in the UK to continue to follow EU procedures in respect of Northern Ireland. Can the Minister confirm whether a single marketing authorisation will suffice or whether new companies will have to obtain a double “EU plus UK” marketing authorisation to sell throughout the UK?
For those of us deeply concerned about the risks of regulatory divergence on medicines and medical devices between Great Britain and Northern Ireland, can the Minister tell the House about the specific work that is being done, in response to the Bill and these regulations, to mitigate the adverse consequences of possible divergence in the medium and longer term? One has to look only at the timely and expert analysis of the noble Lord, Lord Patel, of the MHRA guidance on this issue in Committee to see that there are key issues that remain unclear and unresolved, and deep confusion around how the dual systems will work in the future.
Lord Bethell (Con)
My Lords, I am enormously grateful for the penetrating and thoughtful questions on this important set of SIs. There were far too many for me to be able to cover them in all the detail they deserve this afternoon, but I will undertake to write to noble Lords if I have failed to address any specific questions.
I start by sharing with the noble Lord, Lord Blunkett, the very positive vibe he gave out about the vaccine. He is entirely right that I have been at this Dispatch Box answering questions on PPE, test and trace and all manner of government challenges, but today is a great day. I do not want to bang on about it, but it is a huge relief to see the authorisation of this vaccine: it is a huge triumph for medical science and a massive breakthrough for humanity. I cannot help emoting so positively on it.
On the precise procedures used, I reassure the noble Lord that, in fact, the procedures used for the authorisation of this vaccine were exactly the same as those we could have used, and do use, under current EU regulations—as he probably knows. Those will change at the end of the month, but, as he probably knows, in October, we brought in specific regulations to allow us to have this opt-out procedure. I pay tribute to the EMA, which is a fantastic regulator with which we intend to work extremely closely. I pay enormous tribute to the MHRA, which has worked with phenomenal diligence, enormous scientific insight and great precision and confidence in order to get this authorisation done so promptly. Dr June Raine, who runs the MHRA, has done a fantastic job, and we should be extremely proud of the role of British regulation in this matter.
On a serious point, this incident demonstrates some of the benefits that will come to Britain’s life sciences industries from the transition. As noble Lords will know very well, we are not planning a massive divergence from either the EMA or the cohort of other regulators—the FDA and others—on a large number of matters. In fact, we have a huge amount of respect for our partners in other countries, especially the EMA. However, in the areas of innovative medicine, where there are new techniques and novel science, and where thoughtful, rapid processing makes a huge impact on the velocity of innovation and where expertise and scientific insight are particularly important, Britain can make a difference. This is where the MHRA will help not only British industry but all of humanity. I very much look forward to reporting back to the House on the progress that we can make in that area.
There have been a large number of questions from noble Lords on whether we are ready for these changes. I assure all noble Lords that we are in great shape. We are in constant liaison with industry and I have regular phone calls, meetings, webinars and bilaterals with industry to ensure that things are in good shape. When it comes to batch testing, which was raised by the noble Baroness, Lady Wheeler, the stockpiling of medicines, and the other matters raised, I can assure noble Lords that we are indeed in good shape. The noble Baroness asked specifically about our conversations with the DPRRC; I cannot give precise answers to her detailed and very reasonable questions, but I will write to her.
I am particularly abreast of the matter of stockpiles, having presented to the Project Defend board earlier today for three hours. I assure noble Lords that the Government are considering the resilience of the country as we approach not only the transition, but also the ongoing pandemic and the winter, simultaneously. We are in very good shape. There is a nationwide, government-wide project to ensure that we are truly resilient. In terms of health provisions, this means not only having stockpiles, but also strengthening our relationships with our suppliers, ensuring the provenance of those supplies and, where necessary—I emphasise that—building up domestic supply. Phenomenal progress has been made regarding medicines and devices, as well as PPE, which typically one associates with production in Asia. We are currently producing more than half our PPE in the UK, and it is possible that we will be producing more than that.
The noble Baroness, Lady Wheeler, is entirely right about the MHRA. We have a winning organisation there, but the emphasis and pressure on it going forward will be extremely important. I assure her that I have regular meetings with the MHRA through the spending review, and its financial plans have been gone through with a fine-toothed comb. Both the MHRA management and the policymakers at the department are reassured that the budgets and the human resources are in place for the MHRA to step up to that challenge.
These are important regulations. I am extremely grateful for the scrutiny that noble Lords have given them and, in that spirit, I commend them to the House.