Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
Baroness Manzoor
That the draft Regulations laid before the House on 23 January be approved.
Relevant document: 16th Report from the Secondary Legislation Scrutiny Committee (Sub-Committee B)
Baroness Manzoor (Con)
My Lords, I am confident that we have a shared intention to protect and improve the safety of patients using medicines and medical devices, while enabling their access to the most innovative of treatments. 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, medical devices and clinical trials in a no-deal scenario have been developed. Before I set out these plans, it is important to restate our aim to retain a close working partnership with the EU, in order to ensure that patients in the UK and the EU continue to have timely access to safe and effective medicines and medical devices through the co-operative network we have built over the years.
As described in the published Explanatory Memoranda, the system for regulating medicines, medical devices and clinical trials is currently set out in EU legislation. These SIs have been laid to ensure that our national regulatory system continues to function appropriately in the event of the UK leaving the EU without a deal.
In developing these regulations, my department’s priorities have been to make sure that timely availability of safe, effective medicines and devices continues whilst minimising disruption to patients, businesses and ongoing trials, and to ensure that the UK regulator is able to continue to protect public health.
The House will note that these regulations have been developed through continued close consultation and co-operation with stakeholders. After a period of informal consultation, in August last year the MHRA published an initial proposal for the UK’s medicines, medical devices and clinical trials regulation framework, and then followed this up through a four-week public consultation in October. The feedback from that consultation, which received around 170 responses, led to revised proposals, which were published in January and inform these SIs.
Wherever possible we have sought to maintain existing arrangements to ensure continuity and to minimise any disruption. In medicines, the UK regulator already operates a national licensing route and some 90% of medicines used by patients within the UK will already have a national licence. These licences will continue to be valid. Noble Lords will know that in leaving the EU without a deal, the UK will no longer be part of the European Medicines Agency, so this legislation also provides for the automatic conversion of all existing centrally authorised product—CAP—licences into UK licences to ensure continuity for patients.
Given that the system for clinical trials is currently based on national decision-making—both in Europe and globally—in some key areas we have not had to make any substantial change. For example, the ability of the UK to participate in multinational trials, in the EU or the rest of the world, will not change. The data gained from trials in the UK can still be used internationally, deposited in international repositories and be accessed by others.
On devices, the UK is currently a part of the EU system of conformity assessment for medical devices. This system sets out the standards for pre-market and post-market assessment of medical devices and the MHRA is the competent authority within the UK. These standards will not change and this SI will ensure that UK law aligns with EU regulations in this area after we leave.
In other areas, we have faced a choice regarding the UK’s regulatory requirements, and in those instances we have sought to maintain current arrangements while ensuring the regulator still has sufficient ability to protect public health. For example, for medicines we will continue to recognise batch-testing of medicines in the countries we recognise today.
To ensure continuity of the existing clinical trials landscape and to maintain the UK as an attractive, open environment in which to conduct clinical trials, the MHRA will continue to recognise a sponsor or legal representative established in an approved country, which on exit day will include all EU and EEA states. We will continue to recognise existing UK clinical trials approvals and will require the same information requirements as the EU for any new applications for multistate trials in the UK.
We will continue to recognise the CE mark on medical devices and in vitro diagnostics which have demonstrated their conformity with EU regulatory requirements. We will do this for a time-limited period while we consider the need to revise the UK system of regulation.
However, there are a few areas where it has been necessary to add a new requirement as a result of the UK no longer being part of the wider European regulatory framework for medicines. For example, the new requirements for medicines are to ensure that medicines do not enter the UK supply chain without having been certified by a qualified person. Therefore, we are creating a new position within the wholesale licence-holder regime of a responsible person for import, or RPI. This person will be responsible for providing assurances that such certification is in place.
As to the new requirements for clinical trials, the MHRA is putting in place a new national IT system for clinical trial submissions and safety reporting. This portal will also be important to maintaining the transparency of clinical trials by allowing the MHRA to publish information on UK trials as is currently done on international registries. The MHRA is communicating with trial sponsors to update them on how to use the new submissions portal.
As to the new requirements for devices, we will ensure that all new medical devices and in vitro diagnostics being placed on the UK market are registered with the MHRA by establishing a new national database of all devices. Manufacturers based outside of the UK will be required to have a UK-based responsible person who is legally responsible for deficiencies or required improvements in those devices. There will also be a transitional period to enable industry to implement these requirements.
The Government are working towards securing a deal. However, in the event of no deal, these regulations will put in place a pragmatic solution that ensures the UK’s medicines, medical devices and clinical trials regulation legislation continues to function effectively after exit day. These provisions will minimise any impact on patients and businesses and ensure the timely availability of safe, effective medicines on the UK market.
The devolved Administrations have been consulted during this process and they support these regulations, which apply across the UK. I beg to move.
Baroness Wheeler (Lab)
My Lords, I thank the Minister for introducing these three EU exit instruments on human medicines, medicines for human use in clinical trials and medical devices, two of which are long, complex and tortuous documents full of technical guidance and information and new schedules—so much so that the relatively short and straightforward clinical trials SI comes as light relief. Thank goodness for the Explanatory Notes.
It is hard to see how even the most enthusiastic advocate of separating ourselves from the EU and going alone on such crucial medical treatment and patient safety issues and provisions on which we have worked for so long in partnership with the EU, to mutual benefit, can view these instruments with any enthusiasm, clarity and certainty about the efficacy and quality of what is to replace the current arrangements, particularly in the event of a no-deal Brexit.
The human medicines and medical devices regulations were considered in the Commons yesterday, and a range of issues and concerns were raised that will need to be addressed. There is no time today to raise all these issues, but I can assure the Minister that we will vigorously pursue these key matters at every opportunity in the future. The regulations we are discussing now are nearly or over 200 pages long, cover several EU directives and cannot possibly be read in the time left before so-called Brexit day, let alone debated and scrutinised sensibly. We therefore place on record our deepest concerns that the process for these regulations is not as accessible and transparent as it needs to be.
The first SI, on human medicines, makes amendments to legislation and the regulation of medicinal products for human use. It allows the UK licensing authority, acting through the MHRA, to operate the functions previously carried out by the European Medicines Association and other EU bodies and procedures and to function as a stand-alone regulator in the event of a no-deal EU exit.
Sadly, as a direct consequence of Brexit, the European Medicines Agency has relocated to Amsterdam. Indeed, it closed its London offices at the start of this month. However, we know that in a post-Brexit scenario, deal or no deal, there must be a strong and close relationship and alignment with the EMA to protect UK patients’ swift access to new medicines. As Cancer Research UK has pointed out, without an agreement to participate fully, licensing could be disrupted and there could be serious delays in life-saving medicines reaching UK patients.
Paragraph 2.5 of the Explanatory Memorandum to the statutory instrument contends that the MHRA as a stand-alone regulator will be able to,
“ensure patient access to safe and effective medicines as well as monitor the ongoing safety of those medicines and where necessary to protect patients”.
Can the Minister explain how this is to be achieved, particularly in the transition period when the new UK processes and structures are being established, or in a no-deal scenario?
I understand that the MHRA will not be able to act as the lead authority on marketing authorisation applications for new drugs in the transition period. Without the ability to act as a lead assessor, there could be ramifications for patients around Europe, given the loss of MHRA capacity and expertise, which could undermine the UK’s world-leading life sciences environment.
With regard to supply, it is imperative that we retain the uninterrupted movement of medicines and medical supplies between the UK and EU in any eventuality. Pragmatic government and industry planning to secure the supply of medicines in the short term is vital, but any delays in cross-border supply as a result of new customs or regulatory checks would be damaging, especially for novel medicines that are not easily stockpiled.
Specifically on serious shortage powers—SSPs—this contingency legislation enables regulations to be made to modify the application of the 2012 regulations to deal with a serious shortage of medicinal products, which, as we know, is a matter of great public interest. That would replace the regulation-making power in the European Communities Act 1972 for certain limited purposes and ensure that the Government continue to have the power to make temporary changes to the 2012 legislation in a no-deal scenario. Is this not yet another example of Ministers being given Henry VIII powers over regulations if they think there is an urgent need because of shortages? Does the Minister anticipate a doomsday scenario in which it will be necessary to use these powers, or are the Government saying that they do not anticipate any problems but need the powers anyway? Will the Minister outline how the process will be handled if there are shortages and what scrutiny will be available for decisions made under it? Will the Minister also say how the Government intend to secure the supply of novel investigational medicinal products—IMPs—used in clinical trials? The regulations for them are also under consideration today. Many of the IMPs used in CRUK trials would prove very difficult to stockpile and would suffer from delays at borders, causing significant disruption to trials.
Finally on the first set of regulations, will the Minister acknowledge the serious concerns in the NHS and in the pharma and biotech industries about the MHRA’s announcement that the falsified medicines directive will not apply in the UK under a no-deal Brexit? Not only would we have no access to key EU-wide safety databases and checking systems, but the tougher rules to ensure that all medicines are safe and that trade is rigorously controlled will not apply to us. We were told last month that the Government were evaluating the options for a future framework. Will the Minister explain how interim arrangements will work to protect patients from fake medicines? Will she also respond to the warnings from the UK pharmaceutical and biotech industries about a no-deal Brexit increasing the risk of counterfeit medicines entering the UK and EU supply chains, and the UK becoming a target for counterfeiters? How are the Government going to ensure that the UK and the EU will co-operate on protecting citizens from counterfeit medicines and prevent fake or fraudulent medicines entering the legal supply chain?
Lord Warner (CB)
My Lords, I want to start by providing the House with a few vital statistics on these three life sciences statutory instruments. On my bathroom scales this morning, they weighed in at a little over 2 kilograms. There are 416 pages of statutory instrument and 132 pages of explanatory memorandum, including impact assessments. There are now just 22 days for those working in the life sciences industry to understand how they might be affected by these SIs if our beloved Prime Minister inadvertently drives the Brexit car over the cliff on 29 March. The one thing that I can congratulate the Government on is that the MHRA has done its best to consult the industry on these SIs and has done a reasonably professional job on risk assessments. I want to concentrate on the first two SIs, although I share many of the concerns about all the SIs voiced by the noble Baroness, Lady Wheeler.
No doubt the Minister, like other Members of your Lordships’ House, has read every page of these documents. I make no such claim, but I have tried to understand the impact assessments and have had the benefit of some very helpful briefing from the industry, especially the BIA.
It is very clear that, despite the expertise and professionalism of the MHRA and the industry, they have been left with ludicrously little time to master a massive amount of new detail and system change, particularly as many of the companies in this sector are SMEs. These SIs create a great deal of additional red tape and running costs. They have already taken funding and resources away from research and development, and, as the impact assessments show, this will continue into the future.
I start with the clinical trials statutory instrument and the assurances given by the noble Lord, Lord O’Shaughnessy—an ex-Minister for whom I have great respect and who has wisely removed himself from the scene. In a speech that he gave in July 2017, he said:
“In the event that it is not possible to reach a deal that secures ongoing, close collaboration between the UK and Europe, we will set up a regulatory system in the UK that protects the best interests of patients, and supports industry to grow and flourish. We will ensure that our system is robust, efficacious and does not impose any additional bureaucratic burdens”.
Fine words, but what we have before us today fails to meet those three guarantees that the noble Lord, Lord O’Shaughnessy, gave on behalf of the Government back in the heady days of July 2017.
Regulation 18 of the clinical trials SI will add another layer of red tape and runs totally counter to what I will call the “O’Shaughnessy assurances”. Specifically—here I quote the BIA briefing:
“Industry does not understand the need for the requirement for an additional UK-based quality assurance system to verify QP certification of investigational medicinal products (IMPs) imported from EU/EEA countries on the approved country list given that the clinical trial sponsor is responsible for ensuring the integrity of the IMP supply chain”.
Therefore, it is saying to the Government, “You’ve introduced something which is not necessary”.
It gets worse. I am told that the August 2018 government technical notice on the batch release of medicines and IMPs stated that the UK would unilaterally recognise EU batch release for IMPs. Therefore, despite the assurances given to the industry in 2017 and 2018, the Government have now added a new layer of red tape that will reduce the benefit for the sector of that batch release recognition. This, in turn, will impact adversely on the attractiveness of the UK as a location for clinical trials. Perhaps the Minister can explain to us and to the industry why there has been this last-minute change of policy.
I now turn to the human medicines SI and will address, first, the issue that I raised during debate on earlier SIs in Grand Committee—the start date for market exclusivity. It is proposed that market exclusivity will start on the date of authorisation of the drug in the EU or in the UK, whichever is earlier. The Government claim that this will encourage companies to submit applications for innovative products to the UK as soon as possible. The BIA says something different. It says that many of its members take a totally different view from that of the Government and that that will delay market authorisation in the UK, thereby reducing company revenue because of a shorter period of exclusivity. This would also reduce the access of UK patients to innovative medicines. Perhaps the Minister can say why the industry’s view has been rejected by the Government.
The impact assessment on this SI very honestly sets out a raft of reasons why a separate UK regulatory system will increase the costs of securing UK market authorisation for new drugs. These are not my words; they are in the impact assessment. The cumulative effect of these duplicated costs on pharmaceutical companies is likely to be considerable, as the MHRA makes abundantly clear. The assessment goes on to say:
“It is likely manufacturers would seek to recoup these additional regulatory costs through price increases, which would affect NHS budgeting and spending choices”.
The assessment also cites independent analysis suggesting that there could be delays in new, innovative medicines coming to the UK market once the UK has legislated to become a stand-alone regulator.
Baroness Manzoor
My Lords, I thank the noble Baroness, Lady Wheeler, and the noble Lord, Lord Warner, for their valuable contributions to this debate. I take the opportunity once again to reassure the House that, as a Government, we are fully committed to a system of medicines and medical device regulation which intelligently balances patients’ access to new, innovative and world-leading products. I reassure the noble Baroness that we will continue to work in close partnership with the EU. I stress again that the fundamentals of how medicines and medical devices are regulated and how clinical trials operate will remain the same; I say this very clearly to the noble Lord. We have sought to maintain existing arrangements for the UK’s regulatory system wherever possible rather than create new ones.
I want to answer a number of the questions put to me. At the heart of the questions raised by both the noble Baroness and the noble Lord was the issue of the regulator. I stress that the MHRA brings real expertise to many areas, including the licensing of medicines, pharmacovigilance and clinical trials regulations. This expertise already provides benefits to patients across the UK and the EU. As I said in my opening comments, the MHRA has over 30 years of knowledge as lead regulator on over 3,500 medicines on the EU market. The expertise of its licensing, devices, inspections, batch release and pharmacovigilance regime is globally recognised and respected. We want to ensure that this expertise and our shared experience continues to be of benefit to UK and to EU patients.
On medicines, the MHRA is globally recognised, as I said, for its experience and typically undertakes a significant proportion of EMA pharmacovigilance work and safety referrals. This is already a national route for the licensing of medicines in the UK and, where we collaborate with the EU over licensing, most products ultimately receive a UK rather than EU-level licence.
Clinical trials are managed nationally in the UK by the Medicines and Healthcare products Regulatory Agency. This will remain the case in the event of no deal. The UK will continue to recognise existing approvals for both regulatory and ethics approval—the noble Baroness asked about that—and there will be no need to reapply. She also asked how we will ensure that false medicines do not enter the UK market. I reassure her that the UK’s strict regulatory controls govern the sale, supply, manufacture, distribution and advertising of medicinal products. The potential harm of falsified medicines to patient health is taken seriously across the Government. Combating the real and present threat posed by falsified medicine products will continue to be a priority for the MHRA. The majority of the falsified medicines directive was implemented in 2013 and would remain in UK law even after a no-deal exit. The Government want to retain a close working relationship with the EU, as I have said, to ensure public health across the EU and UK.
The noble Baroness asked about MHRA skills and expertise in relation to any gaps. I have already indicated the MHRA’s immense expertise, and this will not cease. We will continue to ensure that, if there are any gaps, they will be looked at carefully. She asked how the Government would use serious shortage powers in regulations to ensure medicines supply. She will be aware that the Human Medicines Regulations are made under the European Communities Act 1972. If we leave the UK without a deal, we can no longer make regulations under that Act. The amendments made by this SI are necessary so that, if we are faced with a serious shortage of medicines and the need arises to temporarily modify the Human Medicines Regulations to ensure that patients get their medicines, we can do so.
The department has well-established processes for managing and mitigating shortages in collaboration with manufacturers, suppliers, clinicians, the NHS and the Medicines and Healthcare products Regulatory Agency. Temporary modifications to the regulations would be considered only where other options have been exhausted.
On the question of how we can ensure safe, effective medicines in the transition period, I say to the noble Baroness that provisions, including the transition provisions, have at their heart a recognition of the need for safe, effective medicines. The transitional provisions have been carefully developed with this in mind. While, wherever possible, they allow businesses time to adapt, this is not at the expense of safety, quality or efficacy. For example, wholesale dealers who import from the EEA will have two years to put in place responsible persons for import, but checks that qualified person certification has taken place will continue in the meantime.
The noble Baroness also asked about EU funding of clinical trials and participation. The UK will still be able to take part in multinational trials, as I said in my opening comments. The Government have previously confirmed that UK law will remain aligned as far as possible with the new EU clinical trials legislation, which is expected to apply from 2020. Of course, this will be subject to the usual parliamentary approvals.
Both the noble Baroness, Lady Wheeler, and the noble Lord, Lord Warner, asked about the supply of IMPs after exit. IMPs will continue to be supplied direct from the EU to UK sites as they are today and, as I have said, the UK will be able to participate in all multinational trials. The Government are actively working with organisations that run clinical trials to ensure continuity of supply of IMPs. We are also putting in place contingency plans including for access to the same prioritised shipping routes as are available for licensed medicines.
The noble Baroness asked about the review by my noble friend Lady Cumberlege and how these SIs will take account of the new arrangements. The MHRA has provided, and will continue to provide, all relevant information to the review. It has already made written and oral contributions. In the event of a no-deal exit, we will ensure that these regulations and their practical effect continue to form part of that process.
The noble Baroness also asked what plans and resources are in place for dealing with expanded roles for devices. I reassure her that there will not be any radical change in the MHRA’s role in relation to devices. This will be an expansion of what the MHRA already does and, as I said in an earlier response, it has plans to build up its skilled resources.
The noble Lord asked about the industry’s view on the market. There is currently a single EU-wide start date for data exclusivity, due to the reciprocal arrangements and other arrangements of centralised and decentralised procedures, which apply across the EU. Once the UK is no longer part of those arrangements, this single state would no longer apply automatically, and this has the potential to result in delays in new medicines being brought to the UK market.
Lord Warner
The Minister does not need to convince me; she needs to convince the industry. It is simply not convinced by the changes that have been introduced. These are the companies earning their living in this sector day to day. The Government have a lot of work to do to try to convince the industry that they have not damaged the exclusivity period for many of these biotech companies. They are the people who have done the briefing on this and the Government—not the Minister personally—have failed to convince them, just as they have failed to convince them by going back on the kind of assurances about no more bureaucracy that the noble Lord, Lord O’Shaughnessy, gave to the industry in July 2017.
Baroness Manzoor
My Lords, I would like to think that I am trying to convince the noble Lord as well as the industry. I reassure him that we work closely with industry and take its views seriously. As I was saying, maintaining the start of data exclusivity as the date of first authorisation in the UK or EU should incentivise parallel applications to the EU and UK and thus help to mitigate any risk of delays in innovative products being brought to the UK for licensing. This is an appropriate way to address, through the powers in the EU withdrawal Act, something that would otherwise present a risk to public health in the UK. However, we have committed to reviewing this position and of course we will continue to work with industry on this issue.
There were a number of other questions; I will go through those very quickly to ensure that I have not missed anything. The noble Lord, Lord Warner, and the noble Baroness, Lady Wheeler, asked what assessment of impact on EU researchers and clinical trials there will be. The Government recognise the need for accessing highly skilled researchers and the clinical trials research delivery workforce. The Government have published our immigration White Paper and are working with stakeholders to ensure that, after exit, the system will support researchers and clinical trials. Of course we recognise that the clinical trials research delivery workforce is important.
I have a brief note on the comments from the noble Lord regarding industry. As I said in my opening comments, it is a priority for the Government to ensure that the UK continues to be a competitive destination for life sciences companies from around the world, in any Brexit scenario. The Government are committed to maintaining our world-renowned strength in science and research and plan to increase R&D expenditure to 2.4% of GDP by 2024. Since the referendum, we have seen many signs of industry’s continued confidence in the UK. In 2017, we received the highest level of life sciences investment in Europe, and worldwide were second only to the US. In the same year, UK biotech initial public offerings raised twice as much money as in 2016. That is a strong vote of confidence.
I end by stating very clearly that the effect of these three sets of regulations is to ensure continuity in the area of medicines, medical devices and clinical trials in a no-deal EU exit. The department has sought to minimise any disruption to patients and industry; to make sure that UK regulators can still protect public health; and to ensure that the UK’s life sciences sector contributes, and continues to be a world leader in clinical research and the pharmaceutical sector. This legislation does not prevent future changes we may wish to make to ensure that the UK maintains a competitive regulatory environment and remains one of the best places in the world for science and innovation. With the assurances I have given, I hope that the House will approve these important SIs. I commend them to the House.