Draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
Draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
(Limited Text - Ministerial Extracts only)
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The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)
I beg to move,
That the Committee has considered the draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.
The Chair
With this it will be convenient to consider the draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.
Jackie Doyle-Price
It is a great pleasure to serve under your chairmanship, Mr Robertson. In the event of a no-deal Brexit, I am confident that every Member of this House has a shared intention to protect and improve the safety of patients who use medicines and medical devices and, at the same time, enable access to the most innovative of treatments.
Our regulator, the Medicines and Healthcare products Regulatory Agency, otherwise known as the MHRA—not the last acronym that we will rely on this afternoon—has over 30 years’ experience as a key regulator in the EU. Its expertise and experience is recognised and respected globally, and we want to ensure that that continues to the benefit of UK patients. It is with that at the forefront of our minds that the UK’s plans for the regulation of medicines and medical devices in a no-deal scenario have been developed. Before I set out those plans, it is important to reiterate our real aim of retaining a close-working partnership with the EU to ensure that patients in the UK and the EU continue to have timely access to the safest and most effective medicines and medical devices through the co-operative network that we have built over the years.
As is described in the explanatory memorandums, the system for regulating medicines and medical devices is currently set out in EU legislation. The draft statutory instruments have been introduced to ensure that our national regulatory system continues to function appropriately in the event that the UK leaves the EU without a deal. In developing the regulations, the Department’s priorities have been to ensure that the timely availability of safe and effective medicines and devices continues, to minimise disruption to patients and businesses, and to ensure that the UK regulator is able to continue to protect public health.
Members will want to note that the draft 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 medicines and medical devices regulation framework, before following that up with a four-week public consultation in October. The feedback of the 170 responses to that consultation led to revised proposals, which were published in January and informed the draft SIs.
I will set out some details of the arrangements and how we have sought to maintain continuity and minimise disruption. First, wherever possible, we have sought to maintain existing arrangements, which should obviously be the first port of call to ensure a smooth transition in the event that we leave the EU without a deal.
With respect to medicines, the UK regulator already operates a national licensing route. In fact, about 90% of medicines used by patients in the UK already have national licences, which will remain valid. The provisions deal with the outstanding 10% of medicines. In the event that the UK leaves the EU without a deal, it will no longer be a part of the European Medicines Agency. The draft regulations therefore provide for the automatic conversion into UK licences of all centrally authorised products and licences, to ensure continuity for patients. One such product is ritonavir, which is a drug for treating patients affected by HIV type-1. The draft legislation deals with specialist products that are not in the national licensing system.
With respect to devices, the UK is already a part of the EU system of conformity assessment for medical devices. That system sets out the standards for pre and post-market assessment of medical devices, and the MHRA is the competent authority within the UK. Those standards will not change, so the draft devices regulations will ensure that UK law aligns with EU regulations in this area after we leave. That is the straightforward part.
In other areas, we have faced a choice regarding the UK’s regulatory requirements, and in those instances have sought to maintain current arrangements while ensuring the regulator still has sufficient ability to protect public health. For example, we will continue to recognise batch testing of medicines in the countries we recognise today, which include those in the EU and European economic area. By that, we mean that by becoming a third country we would be seen as importing, rather than as part of the single market. If medicines have been tested by a trusted regulator, we would accept that testing.
We will continue to recognise the CE mark on medical devices and in-vitro diagnostics that have demonstrated their conformity with EU regulatory requirements. It is intended that that recognition will be time limited while we consider the need to revise the UK’s system of regulation, linked to the development of new international trading arrangements that the Government are now pursuing. However, any subsequent change would clearly need to be brought before Parliament. For the time being, we plan to maintain the existing arrangements.
There are a few areas in which it has been necessary to add a new requirement as a result of the UK no longer being part of the European regulatory framework. Examples for medicines include a new regulatory hurdle to ensure that medicines do not enter the UK supply chain without having been certified by a qualified person. We are creating a new position within the wholesale licence holder regime, known as a responsible person for import, or RP-I—not to be confused with another RPI. That person will be responsible for providing assurances that such certification is in place, which is a function of having to maintain a national regulatory system with integrity, given that we can no longer rely on the EMA regime.
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 for all devices. Obviously, that will be a new cost for business, and the fee will be £100. Manufacturers based outside the UK will be required to have a UK-based responsible person who acts on their behalf to carry out specific tasks, such as registering with the MHRA. There will be a transitional period to enable the industry to implement those requirements.
In conclusion, in the event of a no deal, these draft regulations will put in place a pragmatic solution that ensures the UK’s medicines and medical devices regulation legislation continues to function effectively after exit day. The provisions will minimise any impact on patients and businesses and ensure the timely availability of safe, effective medicines on the UK market.
Jackie Doyle-Price
I thank the hon. Members for Ellesmere Port and Neston and for Central Ayrshire for their probing questions. They have both made compelling arguments. I recognise their concerns about scrutiny, but we are where we are. The Government have to make provision for a no-deal scenario, even though we remain determined to leave the EU on 29 March with a deal. None the less, we need to put these statutory instruments in place to deal with the event that that does not happen. Both hon. Members asked probing questions, and I shall try to address all of them. I am sure I will miss some, but I promise to write to them both with full answers to the points they have raised.
Overall, there are concerns about the costs to businesses, patients and taxpayers, all of which need to be addressed. However, I should be up front about this. Clearly, there will be a cost to business. One reason why Margaret Thatcher was such a big believer in the single market was that a single-market regime would reduce costs to business. Therefore, unilaterally leaving the single market will increase costs. We need to be frank and honest about that. We also need to be frank and honest that some of those costs will be passed on to taxpayers and patients. That is a given, but it underlines why we are determined to leave with a deal and minimise any disruption, recognising that we want to make the best out of this scenario for Great Britain.
Some issues were also raised about resources and personnel in respect of the MHRA, which I will come on to. I appreciate that hon. Members feel that they have not had sufficient opportunity to scrutinise this. However, I can assure the Committee that the proposals have been taken forward by MHRA in full consultation with business with a desire to minimise disruption and additional cost, and with a full view to planning to ensure that MHRA is equipped to deal with it. Much of the machinery is in place, given MHRA’s role in being such a key player within the EMA.
As I mentioned in my opening remarks, the Government’s approach has been to minimise burdens on business while enabling the most robust action for the UK to protect public health. As I have said, I acknowledge that that will place costs on business. The hon. Member for Central Ayrshire explained the disproportionality of EMA costs with regard to what might be replicated with the MHRA. She is absolutely right about that. I can tell her that the fees have been developed based on existing processes. For example, the targeted assessment fee is based on the existing MHRA incoming mutual recognition fee. Furthermore, the MHRA regularly reviews its fee levels and will continue to do so. There is a commitment from the MHRA to review the overall system of fees to the industry following exit with no deal so that we can maintain that they are fair and proportionate to business.
Dr Whitford
Obviously, the MHRA uses a trading fund now and must basically wash its own face financially. Will the Government provide more direct funding to the MHRA or is it envisaged that all of the costs will still be recouped from fees?
Jackie Doyle-Price
On day one of exit under this scenario, the MHRA will, as the hon. Lady says, continue to wash its own face. As to what might materialise subsequently, that would be subject to further discussion. I would not rule out anything at this stage. We are trying to ensure that the business can continue as usual on 30 March if we leave without a deal, but—let us set this in stone—that is if that is the result on 30 March. If we end up in that scenario, we will of course want to make sure that we have got things working effectively. It is also true that we will have to see how relationships work in practice. We can already see that some market practices are preparing for a no deal; others are not. We have said what we are prepared to do to recognise what has happened and what is licensed and goes through the regulatory system in Europe. We are being quite open about accepting that.
The hon. Lady mentioned batch testing, for example. We cannot be sure the same will happen in Europe. We will have to monitor how that works out in practice before setting in stone what the future regulatory regime will be. I come back to my original point: this is for day one of exit to keep the show on the road.
Dr Whitford
The Minister talks about preparing for a no deal, but as the EMA does not have associate membership, most of what is being put in place will be required, deal or no deal.
Jackie Doyle-Price
That is right. As I have said, we are seeing that some parts of industry are preparing for that scenario on the basis that there will be no associate membership. Having left in that scenario, if we look broadly at how the MHRA discharges its functions and how it is funded, at this stage we are looking at it continuing as usual and washing its own face. The hon. Lady mentioned that we could use some of the Brexit dividend to meet the cost. All of that is completely wide open at this stage. This measure is really just to keep the show on the road.
We have put some expectations down in terms of review. Most of the commitments we have made are to review all of the operations within two years. As for any conclusions we reach, we will come back to Parliament to institute any change if that is what we wish to do, but that would be done very much in consultation with industry and in a transparent way, recognising that all Opposition Members are not entirely satisfied. Clearly, we will go back to business as usual when it comes to scrutiny of these matters. Again, I cannot say often enough that I do not want that eventuality to materialise. It is my determination that we leave with a deal.
There was a reference to the impact on SMEs. The MHRA is taking steps to ensure that the burden on them is minimised. It will look at things such as fee waivers for some products to encourage further research and innovation. Again, that recognises the real concern about that.
Justin Madders
I know that we have asked a lot of questions, but there is almost a contradiction in what the Minister has just said. She expects the MHRA to wash its own hands still, but talks about fee waivers in some circumstances. If it is a trading fund, and there are new obligations on it, I am not sure how all that will realistically work.
Jackie Doyle-Price
I trust the MHRA to manage its own finances and take a proportionate view as to what is an appropriate fee, because it has the day-to-day contact with businesses. Overall, it will still be expected to settle its budget on the basis of the fee income that it incurs. That still gives it the freedom to do that, if that is in the sector’s strategic interest.
We have responded to some of the representations made by business about the potential additional costs. One reason that we introduced the responsible person for import assurance procedure was to minimise, as effectively as possible, the burden on the trading of the wholesale sector. Again, that recognises that where things have been checked and have gone through an appropriate European regulatory procedure, we should be satisfied that that is good enough for us. I am confident that that pragmatic approach will be repeated as the MHRA takes the matter forward.
Several points were made about the MHRA’s ability to take on new roles. The UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The MHRA has real expertise in many areas, including pharmaco- vigilance and clinical trials regulation, which provides benefits to patients across the EU. I am confident that the EU will want to retain access to that expertise. That also shows that the MHRA has the expertise and human resources to discharge those roles. It has 30 years of experience as a lead regulator, it has led on the registration of more than 3,500 medicines, and it is globally recognised for its expertise. None the less, it will manage the demands on its service and I have every confidence in its ability to do so.
The hon. Member for Ellesmere Port and Neston raised the issues of continued access to medicines and of reviewing the fees. The statutory instrument provides continuity for patients and businesses by providing for existing EU licences to be automatically converted into UK licences, which should give continued access to medicines and will be done at no cost to industry. It also puts in place a new licensing route that will allow the MHRA to accept the same information from companies that apply for an EMA licence and that will allow the UK to grant a licence in the same timeframe as one would be received today.
Effectively, we will follow and replicate what the EMA does. There has been much talk of the UK being rule takers and hon. Members might suggest that there is no change here. That recognises, however, that we are in a global marketplace for medicines and that we all want to have access to the best medicines. In practice, there is much shadowing and sharing of expertise in this area. That raises a question that we do not have time to debate this afternoon, but there is much to be gained from international co-operation in this area.
Obviously, we want to make sure that the UK remains an attractive market for new medicines and for innovation. As I said earlier, we will review the fees set out in the SI within two years to make sure that they remain competitive and fit for purpose, and that they deliver the objectives that we want to achieve through the regulatory system.
The hon. Gentleman laid down a challenge; he said that the regulations go beyond a simple technical implementation of the directives into UK law and raise new powers for the Secretary of State. Clearly, the regulations are made under section 8 of the European Union (Withdrawal) Act 2018, which gives Ministers powers, where appropriate, to take additional powers. However, the changes are the minimum necessary to maintain continuity while protecting the health of UK patients while we are outside the EU, although clearly there is concern about issues of supply, as the hon. Member for Central Ayrshire mentioned.
We do not anticipate needing to use the Henry VIII power. We are confident that the regime that we have set out will ensure continuity of supply. However, in the event that that did not happen, provision would be needed. The power is a safeguard to be used in the case of serious shortages. I would not choose to describe it as a Henry VIII power, but I recognise the right of Opposition Members to do so. It is limited to temporarily modifying the effects of the human medicines regulations, for a limited time or purpose. As has been mentioned, the statutory instrument would use the negative procedure, but it could obviously be annulled. However, it would be used only where existing processes had been exhausted.
The hon. Member for Ellesmere Port and Neston raised the question whether any particular medicines would be at risk, and also mentioned prices in that regard—a concern that I think the hon. Member for Central Ayrshire will share. Clearly the MHRA consulted on the issue, and that informed its analysis. Any potential increase in medicine prices will depend on the extent to which costs are passed on to the consumer; but we shall bear the matter in mind, with regard to future medicines price negotiations. It is something that we shall have to keep an eye on at this stage. It is difficult to quantify. None the less, we have made clear commitments to the public about what they can expect, and about ensuring a continuous supply of medicines, and we shall have to find ways to deliver on those commitments.
Dr Whitford
Is the Minister aware that the Royal College of Radiologists has now produced emergency guidance to nuclear medicine departments, simply because the UK Government did not, on the potential threat of shortage of radionuclides and radiopharmaceuticals, both for scanning and for cancer treatment?
Jackie Doyle-Price
I was not aware of that, but I encourage everyone to participate in the dialogue, because in such an event the whole system would need to be ready. I shall perhaps come back to the hon. Lady on that specific point because, although much of our no-deal preparation is happening within the confines of Whitehall, it is not all being shared publicly.
I emphasise that there have been massive conversations with industry, including those in the life sciences industry—and with charities—about the changes, to make sure that everyone is prepared.
Dr Whitford
The Minister says that preparation is happening in Whitehall that is not being shared with the public, but we are talking about the president of the Royal College of Radiologists. The people who actually deliver scans have not had any guidance from the Government. That is not scaremongering. They have to be ready for something that could happen in a few weeks. They are talking about delaying patients, planning light weeks, and when the molybdenum will arrive, because those things cannot be stockpiled. Why has there not been guidance to the NHS about how to prepare to deal with shortages of radionuclides?
Jackie Doyle-Price
My understanding is that those conversations have been taking place. However, the hon. Lady is right that the very nature of those products, which cannot be stockpiled, has brought complications. I fully expect the president to be involved in those conversations. I do not have that knowledge to hand now, but I will write to her afterwards, to give her some reassurance.
We had two waves of consultations on the draft instruments. For the last, in October, we issued a consultation that received 170 responses, through which we ended up with the proposals before us. Again, these are subject to further consultation with the industry.
It is obviously a priority for us to make sure that Britain remains a competitive location for life sciences companies, and we are committed to maintaining our renowned strength in science and research. Since the referendum, we have seen many signs of the industry’s continued confidence in the UK. In 2017, we received the highest level of life science investment in Europe, and were second globally only to the US. That illustrates the confidence in our regulatory system, which is why we are confident that the MHRA is well up to the task given to it by the draft statutory instruments.
The hon. Member for Ellesmere Port and Neston gave an impressive illustration of what he described as the confusion regarding the various dates at which parts of the draft regulations will come into effect and the complexity of some of the references within them, and he posed legitimate questions on how business would understand and prepare for them. However, as I say, we have produced detailed guidance to support everyone in interpreting the draft instruments, and the MHRA does not expect anyone to navigate this alone and will be there to give advice. That support is partly reflected in the length of time that businesses will have to prepare for and implement these measures. We will ensure that that dialogue continues.
The hon. Gentleman also raised questions about market access and legal accountability, and whether we will have sufficient people to discharge that role for the industry. We believe that those skills are already in place, bearing in mind that a lot of companies will already have to fulfil these functions with the EMA, particularly when exporting. We do not anticipate that this change will be disproportionately onerous on business. However, we have given the industry 21 months to implement that aspect. To make sure that only genuinely qualified people undertake that role, anyone who vouches for a medicine that is then potentially harmful to patients faces a maximum two years’ imprisonment. The sector has sufficient integrity to engage only properly qualified people; to do otherwise would be foolhardy.
Questions were asked about the degree to which UK consumers could be protected from false medicines. To reassure Committee members, the falsified medicines directive, implemented in 2013, will remain in UK law, even in the event of a no-deal exit. We will make sure that we continue to apply the same protections as before. We obviously want to retain a close working partnership with the EU on medicines regulation, and I think that we will be able to share expertise and information on such issues over and above any potential mutual recognition of regulations. We will all benefit from that information sharing. Issues were also raised about the wholesale sector. We will obviously continue to ensure that the MHRA keeps a good eye on that and makes sure that that regulatory regime is fit for purpose.
Turning to some of the comments about the devices, we will continue to recognise the CE mark on medical devices. It is also fair to say that the existing regulatory regime has perhaps been seen as rather liberal in its approach—the hon. Member for Central Ayrshire alluded to this when she referred to mesh—and it has been subject to some revision at EU level. Certainly, we want to follow what is happening with that review and consider whether there are any further improvements we would wish to make to that CE mark system.
To those colleagues who thought that leaving the EU might lead to a bonfire of regulation, I say that, clearly, when it comes to medical devices, some of which remain within the body for a length of time, we should not stint in our approach to the protection of patients. Patient safety should be the primary objective, notwithstanding the importance of maintaining a competitive marketplace. Patient safety is crucial.
There are estimated to be around 600,000 medical devices available on the EU market, many of which have not been produced in the UK or approved by UK-notified bodies. It would be quite a big undertaking for the MHRA to license those products, but we will increase our market surveillance by requiring all new devices being placed on the UK market to be registered with the MHRA after exit day by the manufacturer or a UK responsible person, in accordance with the transitional timetable. Our emphasis is patient safety first and foremost, while doing our best to improve access to the market. We will require, as the hon. Member for Ellesmere Port and Neston said, all overseas manufacturers to register those products here with the MHRA themselves.
We have also had some discussion about the RP-I. That is a new role; the hon. Gentleman asked how many will be required and where we will find them. We are giving the industry a two-year transition period, to give it the opportunity to register those persons with the MHRA, and it will depend on the number of wholesalers who intend to import products from the EEA. We are satisfied on the basis of the discussions we have had with the industry that that two-year implementation period is appropriate, and there has been consultation on exactly what sorts of skills those persons should have, with the intention that they should fill the regulatory gap caused by our removal from the EMA, but without putting undue burdens on the industry.
Justin Madders
In essence, the Minister is saying that, having consulted the industry, the general view is that there will be sufficient people in place with the right skills within 21 months. If that is the case, that explains the position, but is there a fall-back position if that does not transpire?
Jackie Doyle-Price
As I say, that timescale has been arrived at between the MHRA and the industry. On that basis, I would not anticipate a problem, but we will have to monitor that none the less, bearing in mind that we are effectively introducing a new regime and any market adjustments that happen in that intervening period will have an impact on it. A lot can happen in those 21 months. We are effectively altering the terms of trade, and we cannot be sure of all the consequences of that, but the MHRA will maintain that close dialogue with the industry to ensure that we are being sufficiently responsive.
The hon. Gentleman also mentioned the national database of all devices. The fee for establishing that database will be £100 for each device. Manufacturers outside the UK will be required to have a UK-based responsible person, who would act on behalf of that manufacturer to do things such as registering the product. Again, there will be a transitional period to enable the industry to implement those changes.
Some questions were asked about access to medicines. Obviously, we want to make sure that UK patients have access to life-transforming drugs at the same time as people in Europe. Whether we might be placed at a disadvantage by being outside the EMA has been a real concern. We want to ensure that when a drug is registered with the EMA, we consider it at the same time, so that there is no advantage for any manufacturer in delaying entering the UK market because it would not get any ongoing benefit from that, in terms of protective rights on intellectual property. We would effectively start the clock at the same time as the application with the EMA to give an incentive to enter the UK market as soon as possible. Again, we will wish to monitor how that works in practice.
We will assess whether countries from which a registered importer operates might change over time, and whether that needs scrutiny by Parliament, on the basis of whether the technical standards in that country are consistent with ours. Obviously, that would be a constantly moving feast. The MHRA is ideally qualified to make a judgment on that, but I would expect it to do that with sufficient transparency to allow any challenge to take place.
I apologise if I have not addressed all the points that have been made this afternoon. I will write to hon. Members. I reassure all hon. Members that the Government are fully committed to a system of medicines and medical device regulation that intelligently balances patient access to new, innovative and world-leading projects. As part of these measures, the MHRA will have in place a suite of licensing routes for medicines and vigilance systems for medicines and devices. The Government also place enormous value on the contribution to public health of the research charities, industry and the life sciences sector as a whole, and as such, the MHRA will continue to support innovation in the life sciences through its innovation office and scientific advice.
We remain committed to offering a competitive regulatory environment to ensure that the UK has access to the safest and most effective medicines in the world. As I said, we have tried to replicate the current regime, but there has been a need to add additional requirements for industry to deal with the fact that we are leaving the EMA and its regulatory structure. We have done so in the most competitive way possible, while maintaining patient safety and remaining the best place in the world for science and innovation.
Question put and agreed to
Resolved,
That the Committee has considered the draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.
Draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Resolved,
That the Committee has considered the draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.—(Jackie Doyle-Price.)