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Moved by Baroness Brinton
36: After Clause 37, insert the following new Clause—“UK participation in the European medicines regulatory network (1) It is the objective of an appropriate authority to take all necessary steps to implement an international trade agreement, which enables the United Kingdom to participate fully after IP completion day in the European medicines regulatory network partnership between the EU, the EEA and the European Medicines Agency.(2) A Minister of the Crown must lay before each House of Parliament a progress report on the objective in subsection (1) within 4 months of this Act being passed, and subsequently at intervals of no more than 2 months.”Member’s explanatory statementThis new Clause would require the Government to seek to maintain participation in the European medicines regulatory network as part of its negotiations for the future relationship with the EU.
My Lords, I am moving Amendment 36 as my noble friend Lady Jolly cannot be in her place tonight, given that the arrangements for today changed at very short notice. I thank the noble Lords, Lord Warner and Lord Davies of Stamford, for supporting the amendment.
As a member of the European medicines regulatory network, the UK enjoys a wide range of benefits, including access to a vast network of expertise and the ability to draw on specialists from across member states. It is particularly important in the recruitment of participants for clinical trials, especially for rare diseases. As a lone state we would not have a large enough patient population to carry out meaningful research and produce meaningful evidence. Within the EMRN, the shared reporting of side-effects means that NHS clinicians have instant access to important data regarding the safety of medicines they prescribe to their patients. These benefits cannot be recreated outside this network and if we are to continue to benefit from them, the Government must negotiate continued participation following the UK’s departure from the European Union.
The European Medicines Agency has already relocated to Amsterdam. If we leave the EMRN we will be leaving a body that constitutes 25% of the global pharmaceutical market to be a stand-alone country that makes up only 3% of that market. Pharmaceutical companies will have to submit separate applications to the MHRA to gain UK marketing rights. Evidence shows that countries such as Switzerland, Canada and Australia all receive applications for drug licensing after the EMA, with an average delay of six months. The sad fact is that the UK will not be seen as a priority, and patients will inevitably see delays in accessing new medicines.
There is no way for the Government to replicate the expertise of the EMA and the power of the single market. Therefore, it is essential that the Minister commit to the UK negotiating the MHRA’s full participation in the EMA marketing authorisation on a similar basis to EEA countries’ regulators. Will the Minister confirm that the Government will commit to making this a priority in negotiations? The United Kingdom’s departure from the EMA will damage patients in the UK, who will be collateral damage of our leaving the EU. This is not something that the UK public ever voted for.
Given the discussion on Amendment 34 on more general reciprocal rights, I ask the Minister a further question, of which I have given her advance notice, on the lack of mention of reciprocal health arrangements after leaving the EU. The European Union Committee report, Brexit: the Revised Withdrawal Agreement and Political Agreement, which came out on Friday, notes the lack of any mention of reciprocal health arrangements and says, in the section on mobility on pages 56-57, that clarity is needed on how this will work. Specifically, paragraph 252 says:
“There is no reference in this section of the Declaration to reciprocal healthcare”.
Paragraph 257 says, in bold type:
“We are concerned at the omission of any reference to reciprocal healthcare, including the European Health Insurance Card, as a means of facilitating mobility. We call on the Government to set out, as a matter of urgency, its plans for maintaining reciprocal healthcare arrangements in the context of the future relationship.”
In paragraphs 173 and 174 there is also specific reference to reciprocal healthcare in Northern Ireland and the Republic. I will not repeat it now, but it makes the point that that is vital.
Can the Minister explain why there is no mention of reciprocal healthcare in the Bill and confirm explicitly to the House that the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, which many of us worked on, provides for such reciprocal arrangements? Perhaps most importantly, can she confirm that the Government will stand by that Act and not amend or repeal it? I beg to move.
My Lords, I support this amendment, to which I have given my name, which has been moved so clearly by the noble Baroness, Lady Brinton. I do so as a former Life Sciences and Pharmaceuticals Minister who has stayed in touch with this sector since my time as a Minister.
The UK life sciences ecosystem has thrived, with an EU pharmaceuticals regulator based in this country and a strong medicines research base working closely with other European researchers. Over the years a strong pan-European research collaboration has grown up, which has benefited UK jobs and NHS patients. Every month, 45 million packs of medicines move from the UK to the EU and 37 million packs come the other way. The pharmaceuticals sector invests more in R&D than any other—20% of all UK business R&D. This is an industry with an annual turnover of £60 billion and exports of £30 billion. It employs 63,000 people, of whom 24,000 are working in high-paid jobs in R&D.
I say this because all of this is now at risk of lasting damage, particularly if there is not enough time to agree a well thought out deal during the transition period. There is now the prospect of a very clunky regulatory system, with companies having to deal with two regulators—the EMEA and the MHRA—if they want market authorisations in both the EU and the UK. The Government are saying that they want the UK market authorisations to be obtained first, but the EU is the bigger market and some companies think that they may end up with shorter IP protection in the larger market if they do what the Government ask. A dual regulatory system is likely to mean higher costs, driving up NHS prices and damaging patient access to new drugs. It will mean fewer joint research projects benefiting from EU funds, and UK-based companies are less likely to find the UK Government replacing the lost R&D funds from the EU. Over time, we may well see fewer clinical trials being done in the UK.
That is why this amendment is important. It offers the possibility of repairing some of the damage done by Brexit to UK life sciences and UK-based pharmaceuticals and biotech companies. We need to do our utmost to restore some basis for extensive collaboration and research work between us and the EU in the life sciences, and we need to do the best we can to make the regulatory processes as smooth as possible if we want people to continue to do pharmaceuticals research in this country. The Government have been slow to appreciate the damage they have been doing over the last three years to this British success story. Passing this amendment would start to repair some of the damage.
My Lords, my two colleagues have made a powerful case for the European Medicines Agency. They are perfectly right. The consequences of getting rid of it—of leaving the EU structure—are very serious. There are two parties involved in any introduction of a new ethical compound to the market. One is a pharmaceutical major—and by “major” I mean household names that the House will be familiar with: Pfizer, Merck, Eli Lilly, AstraZeneca, Glaxo, Boehringer, Bayer, Sanofi, Roche—I have left out two or three and a couple of Japanese ones, but you can count them on the fingers of three hands or so. The second is a regulatory agency that provides registration, which is of course the key to licensing, prescribing and selling freely a drug in the jurisdiction concerned.
People who know a lot about this subject may be surprised that I have not mentioned smaller pharmaceutical boutiques, because it is well known that most new drug registrations in the past 20 years have been for compounds identified and developed in small boutique companies. However, those companies never get involved in the registration process. They cannot possibly afford it. The registration of a new compound typically costs about £1 billion a throw. The clinical trials that must be randomised and which last for years are particularly expensive. No boutique can face that; nor will a boutique have the resources to market a drug. Those two roles remain in the hands of the pharmaceutical majors.
All that is necessary to understand what might happen if we leave the European Medicines Agency. The Government will have four choices if we do. The first is to do nothing at all, which would have the consequence of new compounds not being registered in this country. They would not be available for prescription and British patients would not have them. I assume that the Government will exclude that possibility. The noble Lord, Lord Warner, suggested another possibility: building up the domestic registration agency, perhaps along the lines of the European Medicines Agency or the FDA in the United States, and opening it for business. I am prepared to predict that that new agency would go broke within 12 months. It would not get any customers because pharmaceutical majors that have already spent £1 billion getting registration for the European Union or the United States will not want to spend another £1 billion going through registration for a country that has a mere 3% of the sales of ethical pharmaceutical products. They would not use it.
I suppose that the Government could decide to set up an agency with softer criteria, less demanding rules and lower registration costs, and attract business in that way. I think it inconceivable that any reputable scientist in this country—we have wonderful scientists in pharmacology, biochemistry and, of course, medicine —would agree to work on that basis and to give up the professional standards for which they are famous. At that point, the only thing that the Government could do would be to act as a kind of passenger on the system and say, “Well, if a drug has been registered by a reputable registration agency in, say, the United States or the European Union, we will just follow that”, and, without any procedures at all, allow that particular drug to be marketed in this country. That would also be an extraordinary move on the part of a country that has played such a major role in drug registration in the past. Surely it would be an extraordinary result for a Government concerned about national sovereignty if we became entirely dependent on an organisation over which we have no influence whatever, as we would no longer be involved in its management structure or its strategic thinking. That would be very bad news.
The purpose of my intervention is quite simple: to ask the Government what they would do if they left the European Medicines Agency at the same time as they left the European Union, which is quite unnecessary. As far as I know, there is no basis for expelling a member. I do not think that there is any political interest in trying to expel the United Kingdom, anyway. So we would have to take the initiative and resign, if we wished to resign. Equally, we could do nothing and remain part of the European Medicines Agency, with all the advantages that my two colleagues have set out this evening.
My Lords, let me say how much I welcome the amendment moved by the noble Baroness, Lady Brinton.
When I had the temerity to raise this issue and all the others raised by the noble Baroness on Monday at Second Reading, I sought information and assurance on a range of healthcare matters. I think we can say that I got the bum’s rush from the Minister when he answered my questions. In fact, he did not answer them at all. I hope we might fare better this evening.
The medical research sector has been clear that continued close co-operation should be a priority in the negotiations. Indeed, the Government have recognised the international nature of the life sciences sector. They are committed to aligning as closely as possible with the European Union clinical trial regulation when it comes into effect, safeguarding vital UK-EU clinical trials. Indeed, the political declaration also refers to continued co-operation with the European Medicines Agency, which would help ensure that patients in the UK have swift access to the newest medicine. However, the political declaration has no legal standing, so the noble Baroness, Lady Brinton, is quite right to repeat in the Committee the concerns expressed by the European Union Committee. As it stands at the moment, we cannot see that the European Medicines Agency will continue to benefit patients in the UK.
For some treatments, those of rare diseases, a single authorisation at EU level is vital in providing for cost-effective licensing and distribution of medicines for small populations. If the UK is outside the EU market and companies are required to pay again for separate MHRA licensing, as well as an appraisal by NICE and equivalent bodies in the devolved nations, there must be real concern that some treatments for rare diseases may become not financially viable to launch in the UK, therefore risking patient access entirely.
I know that the Minister absolutely understands all this, so it is very important that she reassures the Committee that these issues will not just be taken into account but will be part of the negotiations and will be successful.
My Lords, I welcome the opportunity to discuss this important issue, and I thank all noble Lords for their, as always, thoughtful and expert contributions. During the Government’s preparations for EU exit, this House has discussed on a number of occasions the great value of the UK’s life sciences industry and the importance of ensuring that it remains—as the noble Lord, Lord Warner, rightly said—one of the most productive health and life sciences sectors in the world. As noble Lords will know, this sector alone contributes over £74 billion a year to the UK economy and employs close to 250,000 people. I contest the argument that it has recently been damaged. A report just today shows our leading position in cell and gene therapies, in which ongoing UK trials represent 12% of global trials and have increased by over 45% in the last year alone. That is in the context of Brexit.
The Committee is right that this is a crucial sector to the delivery of healthcare treatments to patients across the UK and will continue to be so in future. We must get this right. I assure noble Lords that the quality and safety of patient care is paramount in the department’s and our partners’ EU exit plans. This has been visible in our extensive efforts and preparations to ensure that the supply of medicines and medical products into the UK remains uninterrupted following the UK’s departure from the EU. This led to the department’s multilayered approach to put in place in the case of a no-deal exit from the EU. It was a substantial approach, which included work to procure additional freight capacity and to ensure buffer stocks and stockpiling; working closely with industry to improve trader readiness; and collectively helping to ensure visibility in the supply chain and, therefore, much more robustly ensuring continuity of supply processes.
While no-deal planning has been stood down, there is no question but that this work will stand us in good stead going forward, given the strategic importance of the supply of medicines and medical products in all scenarios—as the noble Lord, Lord Warner, pointed out. In fact, we are finding that the learning from this work is already helping us to better manage routine shortages, which are becoming increasingly common globally.
During our preparations for EU exit, we have at all times worked closely with our delivery partners. We are committed to doing so in future. Their support, expertise and hard work have been invaluable and will remain so as we enter the next stage of negotiations.
Turning to the amendment moved by the noble Baroness, I hope noble Lords will understand that we cannot accept this proposed new clause. The amendment was originally proposed in the other place and was not accepted there. I do not want to impute motive, but following debate, the sponsor in the other place chose not to move his version of the amendment to a vote there.
I wish to reassure the Committee on some of the questions raised, because it remains our objective to work closely with our EU friends, as we do at present, to ensure that patients continue to have access to safe and effective medicines and reap the rewards of our new relationship with the EU. Our overarching aim for medicines and medical devices regulations at the end of the implementation period is underpinned by the following commitments, which I have given before: patients should not be disadvantaged, which speaks to questions raised around rare diseases in particular; innovators should be able to get products to the UK market as quickly as possible; and the UK should continue to play a leading role in promoting the health of the public. We are in a better position than some of the countries—
All this is fine PR speak. All these principles sound splendid, but what are the Government actually going to do? The answer cannot be simply, “We will stay close to the European Medicines Agency.” Does that mean that we will leave that agency, not leave it or have some new, structured relationship with it?
As always, the noble Lord gets to the point. As my noble friend Lord Callanan said, the exact relationship with agencies will be subject to negotiation. I have set out the core principles which will be part of our negotiation, and I would also point out the key assets which we bring to the table. The MHRA has real expertise in many areas —licensing of medicines, pharmacovigilance, clinical trials regulation—and already provides benefits to patients across the UK and the EU.
Regarding the points on clinical trials, raised by the noble Baroness, Lady Brinton, as part of EU exit negotiations, we are working to ensure that we will continue to have the best possible environment to support clinical trials. Our overall aim is to ensure not only that patients in the UK have access to the best and most innovative medicines but that we improve UK trials applications—so that they continue to be authorised by the MHRA and ethics committees, as they are now—and that the UK’s ability to participate in multinational trials will not change. We will also have a simpler way of allowing a single application to a single national decision in the UK, which we have been working on very hard.
The Government have set out the key principles of the UK’s negotiations with the EU in their manifesto, and as part of the political declaration. However, as has been said this evening in response to similar amendments, a statutory negotiating objective in primary legislation, as proposed in this amendment, is neither necessary nor the constitutional norm. We cannot accept a statutory reporting requirement either, but the Government will support this House in fulfilling its crucial role of scrutinising the actions of the UK Government during negotiations. The Prime Minister committed at Second Reading in the other place that Parliament will be kept fully informed of the progress of these negotiations. We will have many challenging and robust debates in this place as well, where your Lordships will hold us fully to account on the progress of those negotiations with the EU.
It is important to note that our approach to negotiations with the EU in this area is set out in the political declaration and the Government’s mandate, but this is only one part of our overall support for the life sciences sector. This commitment is also clearly demonstrated through the medicines and medical devices Bill, which was published in the Queen’s Speech and which we will have a lot of debate about in this place. The Bill is to ensure that the UK remains competitive and at the cutting edge of innovation, to the benefit of patients. I look forward to discussing those provisions with the House later this year. I hope that I have reassured the noble Baroness on the Government’s intentions, and on how we intend to take this forward, and on that basis I urge her to withdraw her amendment.
Before the Minister sits down, may I tell her that I passed my question about reciprocal healthcare through to the Whips Office? I also asked in my speech whether the Healthcare (European Economic Area and Switzerland Arrangements) Act would remain in place unamended, which would reassure the EU Committee on its concerns at the fact that there is no mention of reciprocal health rights anywhere in the withdrawal agreement.
I apologise to the noble Baroness; I passed over that note in my response to the debate. Where the UK, a member state, an EEA or EFTA state or Switzerland is responsible for the healthcare of those in scope of the social security co-ordination part of the agreement, such individuals will be entitled to reciprocal healthcare cover from their competent country. This includes EHIC cover for people with full social security co-ordination rights under the agreements, and cover for people who have previously worked in the UK, another member state, an EEA or EFTA state or Switzerland before the end of the implementation period. Obviously, the specifics in future will be subject to the negotiations that will be forthcoming. I hope that that answers the noble Baroness’s question, and she will feel that she can withdraw her amendment.
I am grateful to the Minister for her comments, and to other colleagues for their contributions. I am particularly grateful to the noble Lords, Lord Warner and Lord Davies, for their expertise, and especially for the intervention by the noble Lord, Lord Davies. The Minister is always courteous, and always gives us her best brief, but I am not reassured at all on the issue of the EMRN, partly because. although there was plenty of talk about trying to maintain the excellence in life sciences, there was no response to the question of how, with only 3% of the pharma market, we would be able to play the same role as we currently do in the EU, with 25%. There was also a complete failure to respond to the major concerns that everybody expressed about patients not being able to access drugs because we suddenly become a very minor player. On that basis, I will withdraw my amendment this evening, but I will consider whether to lay something for Report.
On the other matter, concerning reciprocal healthcare, again, I am not quite as positive as I think the Minister would like me to be. I remain concerned that the phrase “no-deal planning” was mentioned in the context of both parts of my speech. We on this side are concerned about the impact on UK citizens abroad, and on EU citizens here, of the loss of reciprocal healthcare arrangements. That is really worrying. But I am pleased to hear that there is some reliance, at least in the transition period, on the healthcare arrangements Act. I beg leave to withdraw the amendment.
Amendment 36 withdrawn.