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I beg to move,
That this House
has considered the future of medicines regulation.
What a pleasure it is to see you in the Chair, Mr Davies. I am very pleased that you have been elevated to the Panel of Chairs. Yesterday, the European Parliament agreed to move the European Medicines Agency from London to Amsterdam. Today, we are asking the Minister to tell the British Parliament what will happen to medicines regulation in this country after we have left the European Union. My concern arises from the fact that I have a GlaxoSmithKline plant in Barnard Castle in my constituency that employs 1,200 people. Winston Churchill decided that production should take place in the middle of the Durham countryside, so it would not be hit by Hitler’s bombs; I certainly hope that it will also survive the Government’s Brexit.
I congratulate my hon. Friend on securing this timely and important debate, and declare an interest as the chair of the all-party parliamentary group on off-patent drugs. Does she agree that, irrespective of what happens with the Brexit negotiations, the Government should guarantee that any patient who needs access to drugs will not wait any longer as a result of Brexit?
In one sentence, my hon. Friend gets to the nub of the issue; I will probably take 20 minutes to reach it. He is absolutely right. The problem is that the Government did not make a plan, and as yet have not resolved how they will regulate medicines from
We are therefore extremely interested to hear what the Minister will say, especially as two months ago there were leaks from the Department of Health that the Secretary of State was flirting with the idea that we should leave the EMA and join the American Food and Drug Administration. I was particularly surprised that that was being floated, because the Association of the British Pharmaceutical Industry has said consistently that it thinks that we should be aligned with EMA standards. Alignment with Europe on regulation of medicine does not simply mean having the same rules on exit day; it means having a mutual recognition agreement with the EMA, and continued alignment of future regulations as they change, which they inevitably will.
I congratulate the hon. Lady on what she is saying. Obviously, as a Brexiteer, I probably have a very different opinion about what will happen on
The hon. Gentleman truly is a gentleman, and I agree with him entirely. We want to see continued UK participation in EU regulatory and medicine safety processes as well. The ABPI has also said, reasonably enough, that it wants to maintain trading terms equivalent to being a full member of the customs union, and to have a common system for VAT.
In May, the EMA and the European Commission issued a statement saying that if the United Kingdom does not stay in the single market, stick with the EMA, or join the EEA—the European economic area—but goes for a clean break, drugs made in the United Kingdom will no longer be authorised for use in the European Union, and drugs made in the European Union will no longer be authorised for use in the UK. Tackling that would involve costly and time-consuming checks. It could even mean that the availability of drugs would diminish dramatically.
What response have the Government made to that statement? What practical steps have Ministers taken? All we have seen is a letter from the Secretary of State for Health and the Secretary of State for Business, Energy and Industrial Strategy to a newspaper, which said that they want a “close working relationship” with the EU, and that patient safety matters, as does certainty, long-term stability, and innovation. The letter said that Ministers will set up a regulatory system with competitive fee pricing. This afternoon, we would like the Minister to explain that.
Currently, the UK Medicines and Healthcare Products Regulatory Agency—MHRA—contributes to the EMA’s work, and the UK pays approximately a fifth of the overall costs. It is universally acknowledged that the MHRA could not take on the task of licensing all drugs without astronomical costs for the industry and the taxpayer.
Is part of the problem not that there appears not to have been a specific assessment of all the health-related impacts of leaving the EU?
I agree entirely. We tabled amendments when the article 50 legislation went through requesting impact assessments on many things, including the effect of possibly leaving the EMA, and we have not heard about them. That is extremely alarming, because it gives the impression that Ministers are basing decisions not on fact and analysis, but on prejudice and assertion—not a very good basis when it comes to health or economics.
This issue matters because life sciences and pharmaceuticals is one of the UK’s most successful industries. The combination of first-class scientific research in our universities and high-quality manufacturing means that we have been exceptionally successful. The life sciences employ 220,000 people—of which pharmaceuticals accounts for 90,000—in good quality, well-paying jobs. They are careers, not gigs. The industry is innovative and internationally competitive. In fact, it has the highest manufacturing gross value added, which means that every employee contributes £330,000 to the British economy every year. The value of our exports is £30 billion. Obviously, the industry wants to continue in those collaborations and develop new medicines.
One of the major costs in pharmaceuticals is research and development; another is complying with regulations. Inspections take several days, and internationally there are two dominant regulators: the EMA, which looks at about a quarter of all drugs globally, and the American FDA, which looks at about a third. Clearly, we do not want regulatory complexity, because that would simply add to costs. As Andrew Witty, the former head of Glaxo said, when the regulatory systems of 27 European countries were unified into one, that was a big deal.
Ministers need to keep in mind that the pharmaceutical industry is international and highly mobile. There is world-class production in France, Switzerland and America, and generics are made across the globe, in China and India. Senior executives answer to their shareholders; if it is cheaper to move, they will, so we need to do everything we can to keep costs down in this country. Quite honestly, I cannot understand why Ministers do not just commit to staying in the EMA—it is so obviously the cheapest and simplest solution—but their crazy ideological obsession with escaping the European Court of Justice means, to quote the Secretary of State for Brexit, “putting politics above prosperity”.
What is even worse is that Ministers are cutting across their own stated principles and are creating a highly uncertain environment. Business needs certainty to invest. For example, in my constituency, a new production facility was started a year ago. It will cost £120 million and will take four years to come into production. We are now only 16 months away from
The Prime Minister made things worse—I do not think she intended to, but she undoubtedly did—when, in her Florence speech, she said there would be a transition period. Everybody imagined that there would be time to look at what the post-Brexit regime would be, to have clear negotiations and to make a plan—to go through everything in a systematic way. Her insistence on putting the March date into legislation shrank that time overnight, from 40 months to 16 months.
Industry is taking decisions now. One plant has already closed in Southampton. GSK is implementing its contingency plans nationally, which include relocating some members of staff to other European Union countries. In Barnard Castle and Ulverston, it is reviewing the production of cephalosporins, which my hon. Friend John Woodcock will talk more about later in the debate.
But this is not just about jobs; it is also about health. Every month, the United Kingdom sends 45 million medicine packets to Europe and we receive 37 million medicine packets from Europe. Some 80 million people need those medicines. Border delays in the medical supply chain will affect not just the final product but intermediate production, especially where we are talking about time and temperature-sensitive drugs, such as for cell and gene therapy. More than 2,600 final products have some stage of manufacture in the UK. Delays as they cross the border during production could mean the loss of lives. That is why the Association of the British Pharmaceutical Industry and its European counterparts wrote a joint letter to Monsieur Barnier, the European negotiator, and the Brexit Secretary of State, to sort this out promptly. Ministers should put patients and public health first, and should start co-operating with the European Union on solving this problem. Given the long lead times, they need to speed up the work and sort out the transition phase.
I have seven questions for the Minister. Will he rule out introducing a freestanding, new, regulatory structure? Will he rule out incorporating the MHRA into the American FDA? Will he confirm the Government’s stated aim of keeping British regulation aligned with the EMA’s European regulation? Will he tell us what moving the EMA and setting up a new regime will cost? Will he set out the legal basis for our continued co-operation and participation in the EMA system from
It is a pleasure to serve under your chairmanship, Mr Davies. I congratulate my hon. Friend Helen Goodman on securing the debate and on introducing the topic in such a comprehensive manner.
This debate is both timely and hugely important. It is timely due to the announcement yesterday that Amsterdam is to become the new home of the European Medicines Agency when it leaves London—a relocation that is necessitated by our departure from the EU, and which also symbolises the changing regulatory environment—and it is hugely important because, although the word “medicine” conjures up images of bottles of cough medicine being bought over the counter, it encompasses the whole range of drugs and pharmaceutical products used to treat the many different illnesses, diseases and chronic conditions that could affect each and every one of us over our life course.
If we think the EMA leaving London is bad, the potential implications of the UK leaving the EMA are far worse, and we should be clear—leaving the EMA is precisely what the Government envisage happening. As the Health Secretary said when he appeared before the Select Committee on Health in January this year, he does not expect us to stay in it. The Prime Minister’s ideological red line on European Court of Justice jurisdiction makes it impossible. The loss of 900 jobs and all the associated economic activity brought to our country as a result of the EMA being headquartered in London pales into insignificance when we contemplate the possible consequences of withdrawing ourselves from the EMA’s pan-European drug-licensing processes and its supervisory and compliance mechanisms, which have a key role in ensuring that medicines on the market here are safe and effective.
The Government have given little information about how their desired future close co-operation with the EU might work on medicines regulation. Indeed, as recently as July, the chief executive of the Medicines and Healthcare Products Regulatory Agency, the national regulatory body that works alongside the EMA in the UK, suggested that two options were being considered by the Government. One is a partnership approach, where presumably the UK would seek to mirror future EU authorisations in order to maintain regulatory equivalence going forward; the second is a stand-alone system, whereby the UK could diverge from EU regulations, perhaps aligning itself more closely with American, Australian or Canadian systems.
Would the hon. Lady agree that, whatever route the Government decide to take, one of the things that we must protect—this was alluded to earlier in the debate—is the excellence of the research and development facilities that we have across the United Kingdom? That must be paramount in the considerations by the Government, as we go beyond March 2019.
I agree with the hon. Gentleman, but when I speak to scientists at institutions across the UK, they are already seeing the effect of last year’s referendum result in terms of EU-wide partnerships being withdrawn and being harder to secure.
It would be helpful if the Minister could update us on which of the two approaches the chief executive of the MHRA talked about in July the Government now favour. It would also be helpful if he could tell us what discussions he has had with Ministers in the Department for Exiting the European Union or with the EU negotiating team about future co-operation on medicines regulation. Has the Minister or anyone from the Department of Health had contact with Australia and New Zealand about potential alignment with their regulatory systems?
I have a lot of questions for the Minister today. Can he be clear about the Government’s plans for the so-called transition period that the Prime Minister thinks will follow the conclusion of the article 50 negotiations? After all, it is a mere 16 months away. If pharmaceutical businesses will have to deal with only one set of changes, as the Prime Minister promised, presumably the licensing arrangements for new drugs will stay the same for that period.
I see two main problems in setting up some sort of stand-alone replica system to fill the gap vacated by the EMA if we leave the EU. First, will UK patients get the same quick access to new innovative drugs that come on to the market? Secondly, will UK patients benefit from the same high levels of safety and compliance checks that the EMA currently performs for already-authorised medicines in its role in enforcing standards in the pharmaceutical manufacturing process and at clinical trial sites?
I fear that we could see delays in new drugs being launched in the UK. If a small pharmaceutical company has to choose between paying to get a licence in the EU, which accounts for 25% of the global pharmaceutical market, and paying for one in the UK, which accounts for 3% of the global market, which will it choose? The UK is currently a priority location for launching new innovative treatments, but how long before we become a second-tier country?
What guarantees can the Minister give about the next phase of immunotherapies, which are three to four years away from coming to market? They are potentially twice as effective as current immunotherapies and could give cancer sufferers an extra three to four years of life. Will UK patients in a post-Brexit regulatory environment get them as quickly as they would if we were still part of the EMA? Can the Minister guarantee that adverse effects among uncommonly used drugs will be picked up as quickly if the expanded patient pool that would be available for checks across the EU is limited to the UK? Will the UK still have access as quickly to orphan drugs to treat the rarest of diseases, for which pharmaceutical companies have less of an incentive to develop products? What about the participation of UK patients in pan-European clinical trials, which are critically important, full stop, but all the more so for rare diseases and illnesses in children, for which the patient pool is smaller. At the moment, a quarter of cancer research clinical trials involve one or several European countries. Will we comply in the future with the new EU clinical trials regulations, which have been postponed and may not be implemented until March 2019?
The Minister needs to answer many questions if the Government intend to diverge from European processes, but there will be basic problems no matter what new system is put in place. How much will all of this work to reinvent the wheel and beef up our regulatory bodies cost? Will we have to ask UK taxpayers to pay a greater amount for this process, given that we currently share the cost with 27 other member states? What preparatory work has the MHRA done to ascertain what the impact of leaving the EMA will be on both its income and its future staffing requirements? What training of staff will need to be done so they can take on responsibility for tasks they have not previously performed? What impact will the relocation of the EMA have on medicines regulation across the whole of Europe?
I read the EMA’s Brexit preparedness business continuity plan yesterday, and I admit to having a feeling of utter shame about the disruption that our decision to leave the EU has forced on that agency. The huge upheaval will undoubtedly have an impact not just on this country but on others, too. As anyone who has ever moved office knows, projects get put on hold and the basics become harder to deliver.
There are so many questions to ask, and I am sure I have not touched on even half of them. I would like to finish with some more general observations. In 10 years’ time, when we have delayed access to new cancer treatments, compared with, say, France or Germany, will the fact that we have blue passports make up for it? Children with rare diseases will not be able to get new drugs as quickly or easily as they can now, but is that a price worth paying for coming out of the jurisdiction of the ECJ? This is all utter madness. Ministers can bang on about creativity in the negotiations all they like, but we need certainty and clarity. Pharmaceutical companies and patients need certainty and clarity, and the mums and dads of seriously ill children need that, too.
It is a pleasure to serve under your chairmanship, Mr Davies. It is unfortunate that I am following two superb contributions. I congratulate my hon. Friend Helen Goodman on securing this important and timely debate. She and my hon. Friend Heidi Alexander spoke powerfully and persuasively about the risks that the UK pharmaceutical industry in its entirety faces. I am not going to attempt to add to what they said and the questions they asked. Rather, I am going to focus on the cephalosporins business, which is carried out on three sites, two of which are in the UK—in the constituency of my hon. Friend the Member for Bishop Auckland and in Ulverston in my constituency, where there is a genuinely world-class sterile facility where the drugs are created. They are then placed in a powder form in Barnard Castle and in vials in Verona.
As the Minister is surely aware, there was great celebration in Ulverston, and it was heralded by the then Prime Minister and Chancellor, David Cameron and George Osborne, when David Cameron visited the day after the 2012 Budget and made a Budget roll-out announcement that GSK was going to be investing at least £350 million in a new biopharm pharmaceutical facility, largely as a result of the patent-box tax legislation, which the Conservative Government continued from Labour’s innovative tax policy, introduced by Prime Minister Gordon Brown. In July, GSK announced—out of the blue, for all intents and purposes—that it is going to pull that investment and scrap the entire project, leaving our community devastated. Not only that, but it is launching a strategic review of the existing cephalosporins business, which has been running for decades across both sites and is growing in profitability and potential.
Although cephalosporins are not a new product, they are well established. British manufacturing of such products in Ulverston and Barnard Castle, and across into the EU in Verona, has enabled them to penetrate new markets and benefit many more critically ill patients in hospitals. They are the very strongest antibiotics, and are typically used in hospitals for people with very serious vulnerabilities and infections. That business had and has a great future, but GSK has clearly signalled at a corporate level that it wishes to divest. Officially, that is a review of the business, but the company at the highest level is clear that it wants to find a new buyer.
When the company dropped its bombshell in July, it was clear and categoric that the decision was not as a result of Brexit. The company took care to say that, and we have to take it at its word. We can detect the thinking of the new chief executive officer, Emma Walmsley—a Barrovian, by the way, which has made the decision all the more stinging—that GSK wants to focus on fewer products, completely cutting some and potentially divesting itself of others. Although Brexit may not have triggered that deeply worrying blow to pharmaceutical manufacturing in the north of England, however, it is certainly a significant factor in whether we will be successful in finding a new buyer for the plant who is prepared to invest and to take the business to new heights, sustaining the employment of people in my constituency and in Barnard Castle, as well as creating more jobs in the decades ahead.
Every business, in no matter what sector, operates on the basis of wanting certainty and stability and of not liking uncertainty or the potential risk in what is at the moment the complete lack of clarity that the Government can give on the future of the regulatory environment for medicines in this country. I therefore really hope that the Minister is listening to what we are saying.
In another sector that is enormously important to our regional economy, civil nuclear, we do get a sense that, at the ministerial level at least, the Government are working hard to overcome this—I absolutely agree with my hon. Friends—absolutely nonsensical decision to rule out anything based on ECJ jurisdiction, thereby creating all the problems. We need to hear from the Minister that he is prepared to do whatever it takes to ensure that the transition is seamless. He should not only produce something a year down the line but give a level of certainty now, ready for GSK in Ulverston to attract new buyers to the site.
The Minister might be aware that I have formed the GSK Ulverston taskforce—which brings together community stakeholders and the site directors, with input from the Department for Business, Energy and Industrial Strategy and the local authorities—to ensure that we all maximise the chances of attracting a new investor. The decision will principally be a commercial decision, of course, but the Government can help in many ways. I would say that they have a duty and a responsibility to help, given the level to which they heralded the new jobs that have now been cancelled.
Other important areas include infrastructure, but I do not expect the Minister to go into those today. He can, however, acknowledge the difficulty that uncertainty causes to attracting new investors. I hope he will give more certainty today, and he should certainly undertake to go away and come back in short order to inform Parliament of what the relationship will be, so that the Government and we as a taskforce can better communicate that to the stakeholders.
Lord O’Shaughnessy—apologies, the previous Minister in the Lords has moved on. I thank the Minister here for the correction. I hope that he or Lord O’Shaughnessy will meet with me, my hon. Friend the Member for Bishop Auckland and other members of the taskforce. Lord Prior was really helpful when he spoke to me on the day of the announcement but there has been significant progress since then and many more challenges need to be met. If the Minister undertakes to make that happen, it will be very helpful.
I too congratulate Helen Goodman on securing such an important debate. Unfortunately, it is competing with the main arena, so this Chamber is not full.
I do not think that people yet recognise what the impact of Brexit on medicines regulation will be. The EMA represents all the countries within the European economic area, their drug-licensing bodies having come together in 1995, and it has been based here in London. That has been of huge benefit to London, not only as a result of the 900 jobs mentioned but as a result of world pharmaceutical industries—especially Japanese and other Asian ones—basing their European hubs here.
There is no question that the biggest challenge will be the impact on patients. The EMA assesses and licenses new drugs, and safety-monitors all drugs. It provides the service of pharmacovigilance. Recently we have had debates on the Primodos and valproate syndrome situations, where things have not been spotted early enough. For us to end up outside the European pharmacovigilance system will be a real danger.
Heidi Alexander alluded to the possible delay. As I raised in Prime Minister’s questions way back in January, countries such as Canada and Australia get access to new drugs approximately six months to a year after the UK. The reason why we get early access is that we are part of a market of 500 million, on a similar scale to America. Without that, we slide way down the pecking order.
I am hearing from pharmaceutical firms that it is not just the size of the UK population but the fact that accessing the NHS in the UK takes several years. Given the budget impact assessment that has been added for new and expensive drugs, some firms are beginning to say, “Well, it won’t just be six months to a year; it might be several years, because what’s the point of paying to go through the process early but getting knocked back?” We might have to wait until our price has dropped, in which case Canada, Australia, Japan and so on will all be ahead of us.
Patients get access to new drugs that are expensive through the cancer drugs fund or the New Medicines Fund for rare diseases in Scotland. They also have opportunities through individual patient treatment requests. If the drug is simply not licensed in the UK, however, accessing it would be really problematic.
The EMA has obviously been a driver and organiser of research. As was also mentioned by the hon. Member for Lewisham East, in particular with rare diseases, we would be trying to recruit for research from a population of 50 million instead of 500 million—there is no comparison from the point of view of getting answers. Purely because of such research, breakthrough drugs for rare diseases, in particular children’s congenital and rare diseases, have come on stream over the past 10 years.
The EU is the biggest research network in the world because of Horizon 2020 and all its forerunners. Until last year, the UK was its biggest beneficiary, but we have already slipped down the pecking order to behind Germany. People who lead international research teams are already being asked to step aside; they may take part and co-operate, but they may no longer be the principal investigator. The whole drive of academic, medical and clinical research in the United Kingdom is sliding down. The impact of that is significant.
There are a whole lot of different reasons. We have been talking about certainty, but universities and EU nationals need certainty. We have seen disruption to the EMA, which estimates it will lose 20% of its staff. Many have already left because they have been in limbo, like my husband, a German GP, for the past 16 months. They have therefore jumped before they might be pushed. Others might not choose to move to Amsterdam, even though it is quite an attractive place. As a member of the Scottish National party, I wish the people of Scotland had voted yes in 2014, because Edinburgh and Dundee would certainly be bidding to be a site for the new EMA, as we are also major pharmaceutical researchers.
The loss of the EMA from a business point of view is significant, but the main thing is the impact on patients and people. We will become a third country, and the idea that we can somehow leave the EU and yet keep all the bonuses that we have had is frankly naive. In my constituency I have Merck, a pharmaceutical company that develops drugs, although its main role is providing materials to other pharmaceutical industries—cell growth medium. It is therefore involved in all sorts of complex supply chains. This is just like aerospace. Components and ingredients move backwards and forwards as the drugs are constructed.
The other parts of Merck’s business are quality control and lot release. When drugs arrive in huge quantities they have to go through strict quality control testing, again under the EMA. Up until now such work has been carried out only inside the EU. Merck has three big BioReliance centres in Scotland, which carry out work for other firms. Other firms in my constituency such as GSK—again, I have a big plant—do that in-house. If they have to start moving some of that work to Europe—many pharmaceutical industries are already looking at having bases in Europe for their lot release work—other jobs tend to trickle after them, because gradually the refrain becomes, “We would do better to put everything in one place.”
I am sorry for John Woodcock, who is losing such a great production centre in his constituency. I wish him well in finding a solution, but in the current uncertainty it is really hard to see what kind of pharmaceutical business will open a new plant in this country. For the big global multinationals weighing up where to put future centres, they might put a small centre in the UK, but sadly they are likely to put their main centres on mainland Europe. We need to deal with these things going forward.
The issue of quality control means we could have drug shortages as well as job losses. Anyone on medication—I put my hand up; I am on multiple medication—will often be handed something in the pharmacy that could be in any one of the EU languages with a little sticker in English on the top. That is because drugs move around all the time. The most important thing is to ensure that we do not get into a no-deal Brexit. Ultra-Brexiteers keep standing up and saying that World Trade Organisation rules are not so bad and would be quite good and advantageous—but that is not the case from the point of view of drugs supply.
The 0% tariff drug list has not been updated since 2010, so on any new drugs developed in the past seven years there would be automatic tariffs. The potential of trying to hang on to things such as BioReliance jobs would simply be impossible because there would be no chance of negotiating mutual recognition agreements or parallel agreements. Going forward we need an assessment of the impact of Brexit on health: everything from EU nationals, the potential threats to health, reciprocity, right through to research networks and how we get our drugs.
What will the MHRA do? It provides about 25% of the assessments for the EMA and it therefore has expertise, but it would need funding if it was to replace the EMA for drugs within the UK. How would we attract big global firms to go through the process when they might not sell any real quantity to the NHS for several years? Would it be suggested that we simply would not charge them? If that were the case, how would we fund it? I assume that in the position of getting a sensible deal around Brexit, the MHRA would try to mirror everything from the EMA, but that simply would not solve all the problems.
We are still in a separate situation. The strength has been in co-operation. There was no discussion before the referendum and no recognition of the benefits we have had from the EU in the past 40 years. Those were never discussed and are being thrown away. The EMA did not increase bureaucracy, but decreased it. Imagine a small firm trying to go through 27 regulatory agencies in multiple languages. That will not happen. The EMA created one thing. The trials regulation system, due in the next year or so, does exactly the same for research: one trials portal.
We also have to tackle the issue of data protection and data sharing. If the UK sees Brexit as the potential to go off the reservation and cuts standards or is sloppy around data and sells the data or does not protect it, we will become a pariah, which will not do our patients any good. The issue is ideologically driven. Nobody with any sense of what brings the biggest benefit for patients within the United Kingdom would think of leaving the EMA. It is driven, as was said in the Health Committee in January, by the need to leave the European Court of Justice, the decision to leave the single market and the decision to leave the customs union. I have a simple plea: why don’t we just not do that? Why not just stay in the single market and accept that we need an arbiter, and that the ECJ is as good an arbiter as any other? We should hang on to the fantastic benefits that we have had from Europe for 40 years.
It is a pleasure to serve under your chairmanship, Mr Davies. I congratulate my hon. Friend Helen Goodman on securing this extremely important debate. It is sad there are not more Members here, but—as always—there are competing interests. She has been assiduous in asserting the rights of Parliament to scrutinise the terms of our exit from the European Union, and today’s debate is no exception to that.
In common with the vast majority of Members—whatever our views on the European Union—my hon. Friend spoke with a genuine desire to ensure that our departure happens on the best possible terms. I am sure we can all see that one priority is to ensure that our economy is able to thrive and that patients are able to access all the medical treatments that they need, as every hon. Member has said. Most of them also mentioned the decision to relocate the European Medicines Agency from London to Amsterdam. I do not know whether the debate was timed with that in mind, but it is certainly apposite.
When my hon. Friend began her speech, she said there had been no explanation, no policy statement, no impact assessment and no opportunity to debate the many issues we have discussed today. Of course, she has a considerable constituency interest in this subject area, but, as we have heard from most Members, the issue affects every single person in this country. The importance of it cannot be downplayed.
My hon. Friend said that regulation is one of the major costs to the industry. I share her frustration that we do not have a clear steer from the Government on what the future of that vital component of the industry will be. As she said, investment decisions are being made now and we are already beginning to lose out. I totally agree with her that the Minister should make it clear that we are putting patients and public safety first.
My hon. Friend Heidi Alexander gave a passionate and well-informed speech on the merits of the EMA. She summed it up very well when she said that the EMA’s leaving us is bad, but our leaving the EMA will be far worse. She was right to highlight the risk of delays for patients accessing new medicines. She said that business and patients need clarity, which is something that has come through clearly from all the Members who spoke today.
My hon. Friend John Woodcock spoke with great sincerity about the important business in his constituency. He is a fervent advocate of other businesses and sectors there, so we know that he will not let the matter lie. The announcement in the summer must have come as a real blow, given that Ulverston, and his constituency, are quite isolated from other populations, and in the light of the potential for damage to the local economy when so many high-skilled jobs are at risk. My hon. Friend will obviously want to ask the Minister to be clear about the assistance necessary to get the best from a pretty bad situation. The conversations that he will want to have with Ministers will be similar to those that every Member will have about industries in their constituencies affected by the Brexit decision.
Dr Whitford spoke, as always, with great authority on health matters. She highlighted the fact that we are already slipping down the pecking order, and spoke from personal knowledge. In addition to the certainty that patients and businesses need, she highlighted the fact that universities, as well as EU nationals, need certainty. We should not forget, either, the 61 people working for the EMA who may be transferring to Amsterdam. They, too, need certainty about their future. The hon. Lady noted the risk of tariffs being introduced on drugs that have come into the market in the past seven years, if we crash out of the EU on WTO terms. It would be useful to hear from the Minister whether any assessment has been made of the potential cost of the tariffs, and whether he envisages that that cost would be dealt with by the Department of Health, or that individual patients would be expected to pay more for the inevitable additional cost of the drugs.
I doubt whether, when our constituents cast their votes in the referendum, the many issues that we have discussed today would have been at the forefront of their minds. Regulation of medicine is an integral part of our relationship with the EU, but it was not mentioned on any buses. The closest that we got to any debate on the impact of Brexit on the health sector was the £350 million a week that would be spent in addition to existing expenditure. It is sad to see that no advocates of leave are here today to explain how the situation fits into the big picture that they were so keen to propound at the time. Of course it has become apparent since June 2016 and from today’s debate that there is a threat to jobs and investment in the science and research sector. As my hon. Friend Nick Thomas-Symonds succinctly pointed out at the start of the debate there is also a threat to access to new medicines; that is a serious unintended consequence. I certainly have not heard any Brexiteers suggesting that our current system is not advantageous to us as well as the other 27 EU member states. It is therefore difficult to overstate how critical the future of medicines regulation is to the economy and, more importantly, to the millions of patients in the UK who will need the medicines whether we leave the EU or not.
It might seem a long time ago now, but in July last year, just after she was appointed to her present role, the Prime Minister said:
“It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”.
That of course remains very much the case. As my hon. Friend the Member for Bishop Auckland said, we have been exceptionally successful in that sector. The industry has a turnover of more than £60 billion per year, generates exports worth £30 billion and gives us a trade surplus of £3 billion. It employs 220,000 people in this country, and 25% of the world’s top prescription medicines were discovered and developed in the United Kingdom. It is of huge economic importance, and it says something about the sorry state of affairs we are in that Members feel the only way to get any clarity on the future of that vital industry is to have Ministers come to Westminster Hall to debate the issues.
Together with the direct economic impact is the effect on millions of patients, who rely on our co-operation with the rest of the EU to get access to safe, effective and affordable medicines. As we have heard, 45 million patient packs of medicine a year move out of the UK to the EU and 37 million move in the opposite direction. That is an awful lot of movement on which we need the Government to provide clarity. Those benefits, and others that hon. Members have spoken about today, are under threat not only from the relocation of the EMA, but from our exit from the EU if that is not handled more carefully.
Losing the EMA from London is of course a huge blow, not just to the economy of London but to our pharmaceutical sector more widely, for the reasons we have heard. The benefit that it brings to any national economy is evident from the fact that 19 other cities across Europe were in the running to become its new host. In addition to the loss that we will experience from the agency’s physical removal, it also poses a number of challenges and threats to medicines regulation across the EU. Indeed, The Pharmaceutical Journal recently warned that
“a worst-case scenario could permanently damage the medicines regulatory system, leading to a public health crisis”.
Although the EU27 decided not to relocate the EMA in eastern Europe, after a survey of staff found that an alarming 70% to 94% of them would not be willing to relocate there, the move to Amsterdam could still present a risk, in the sense that the survey found that up to 40% of those currently employed at the agency would not be prepared to move.
As my hon. Friend the Member for Lewisham East said, it is not an easy process to move an office wholesale. Some things will stop, and there will be a loss of some highly skilled specialist staff, who will be difficult to replace. An EMA spokesperson said that
“while some job losses can be absorbed within the business continuity plan...beyond a critical threshold, the Agency will no longer be able to fulfil its mandate to protect the health of European citizens.”
I am sure that no one voted for that on
“these highly specialist staff are like trees: they take a long time to grow, and they put down roots.”
In the short term we may benefit from some of those specialist staff staying in the UK, possibly at the expense of the EMA and the future success of European regulation; but let us be in no doubt that in the long term it will be to our detriment, because we will struggle to attract the best.
Before the Brexit talks even move on to the future of medicines regulation, the Government have a duty to act now to protect our vibrant life sciences sector. One of the key reasons why so many countries were competing to host the EMA is that its presence makes pharmaceutical companies far more likely to locate to the host city. Many of those companies will have a UK base, and, as has been mentioned, will be beginning to think about future plans; so what steps are the Government taking today to persuade those companies to stay in this country, and not just to retain their staff but to make investment decisions that will benefit the economy? As my hon. Friend the Member for Bishop Auckland said, the industry is international and highly mobile, and we cannot afford to lose investment through the big hole of current Government policy. When we leave the EU, we will potentially face a divergence from the current medicines regulation system across Europe. The challenge for the Government is to keep that divergence to a minimum or eliminate it altogether.
One of the first issues, which we have already discussed, is the likelihood that the Medicines and Healthcare Products Regulatory Agency will lose up to a third of its income, as that comes from its work as a rapporteur body for the EMA. Can the Minister confirm that that funding gap will not have to be bridged from the existing, already insufficient Department of Health budget? What estimate has been made of additional resources that may be required in the worst-case scenario?
We have already heard that in July a letter from the Health and Business Secretaries in the Financial Times confirmed that the Government will prioritise achieving regulatory co-operation in the article 50 negotiations, and that was welcome, although, as the Financial Times is not a party to the negotiations, it could be argued, from a cynical point of view, that it was merely window dressing. We take it at face value, however, and as a clear commitment to try to achieve as much co-operation as possible. Perhaps when the Minister responds he will say what progress has been made since that time. Will he also say whether Ministers or officials from the Department of Health form part of UK representations in negotiations with the EU? I appreciate that he will not be able to go into some of the details, but given the shared desire across the House to make progress and achieve as much harmony as possible in that area, can he put some flesh on the bones and say what exactly the Government will seek to achieve as we move forward? The Minister will understand that the big pharma companies are looking for a clear indication of the likely shape of the future relationship as soon as possible, and as we have heard, decisions are being made now. I hope that he can shed some light and provide clarity on that when he responds.
Will the Minister address Members on the jurisdiction of the European Court of Justice? If it cannot be used to adjudicate on licensing appeals, as appears to be the Government’s position at the moment, how will the two systems closely interact? Is there any possibility of a joint adjudication process? Operating alone in our own separate market would be not only extremely costly, but inevitably disastrous for patients. If pharmaceutical companies are forced to go through a separate regulatory system, as well as the NICE process, just to access what will be, in the big scheme of things, a fairly small market, we could find ourselves at the bottom of the list when new medicines are released. Pharmaceutical companies might view the UK as a lower priority than getting drugs into the bigger markets of the US, the EU or Japan. That might be a particular concern where the potential market for medicines is naturally small, such as with those for rare diseases. As already stated, we are already becoming a less attractive market for the life sciences sector, both for companies in the UK and for future investment decisions.
That is a very serious and bleak picture, and I hope that when the Minister responds he can reassure the House that ideology will not trump the best interests of our economy and our health service. My hon. Friend the Member for Bishop Auckland had seven questions—I lost count of the number asked by my hon. Friend the Member for Lewisham East, but there were many. I have a few of my own, and hopefully they will be a little more straightforward to answer—yes or no will probably do for most of them. In particular, I would like the Minister to guarantee today that after
The Minister may not be aware that we held a debate on this subject just over a year ago, and many of the concerns raised then have been raised again today. All Members today have spoken with one voice about the need for clarity and certainty, and I hope that the Minister can provide us with that now.
I will do my best, Mr Davies.
I congratulate Helen Goodman on securing this debate. Medicine regulation is a critical issue that I know she has raised many times in the House. This is probably the quietest Westminster Hall debate that I have responded to, but that does not mean that it is not one of the most important—there are competing issues in the main Chamber today. The fun that we are missing!
Modern medicine is transforming. We are moving from an era in which drugs and devices were mass produced and marketed to millions of patients globally, to one in which new medicines and therapies will increasingly be designed and personalised for individual patients. The chief medical officer’s annual report earlier this year on genomics was a landmark piece of work, and it set out how that will revolutionise our ability to diagnose and treat illness in the future. It is within that context that we discuss medicines regulation. Put simply, if the future regulation of medicines does not keep up with the pace of development for those medicines, patients in the UK, and internationally, will not have access as quickly as they should to transformational new treatments. That would be a bad thing.
While answering as many questions as I can, let me outline the world-leading work of our domestic medicines regulation, the Medicines and Healthcare Products Regulatory Agency, as well as our plans for the future in the context of Brexit. The MHRA has been our national regulator for more than 30 years, and it has acted as the lead regulator for more than 3,500 medicines now on the EU market. It is recognised globally as an authority in licensing, inspections and batch release and through its pharmacovigilance—a great word—and medical devices regimes. It plays a leading role in protecting and improving public health through the regulation of medicines, medical devices and blood components for transfusion services. In addition, the agency hosts two organisations that, although little known, play an important role in supporting the development and use of medicines. The agency’s clinical practice research datalink uses anonymised NHS clinical data to keep patients safe and aid the development of new drugs, and the National Institute for Biological Standards and Controls develops global standards for the use and control of more than 90% of biological medicines used globally.
When preparing for this debate, it occurred to me that some of these issues apply also to animal health. Is there any responsibility for animal health in these institutions, or do we need to ask DEFRA Ministers about that separately, on another occasion?
I thank the hon. Lady; she is always there when we need her.
As I was saying, those skills and expertise have allowed the MHRA heavily to influence global practice and regulations, which is why I say it is a world leader. A majority of medicines available in the UK—around 90%—already receive a national UK licence issued directly by the MHRA. It also leads the assessment of more than 20% of new medicines licensed by the EMA, with particular expertise and specialism in more complex new drugs come on to market. Similarly, on medical devices, five of the EU’s 55 notified bodies are in the UK, and they undertake a disproportionate amount of work. We estimate that they assess between 50% and 60% of the highest-risk devices on the EU market—a big player.
The strengths of our world-leading regulator are similarly reflected in the UK’s life sciences sector. The UK has one of the strongest and most productive life sciences industries in the world, with more than 5,000 companies, more than 233,000 employees, and an eye-watering turnover of more than £63.5 billion each year. It also provides products that the NHS and patients rely on every day—I know that the constituency of the hon. Member for Bishop Auckland has seen the benefits of that productive industry.
GlaxoSmithKline announced this year an investment at its Barnard Castle facility in Teesdale, as part of a wider £140 million investment in the expansion of manufacturing HIV and respiratory medicines. However, we cannot be, and are not, complacent, and we must continue to work hard to support the industry, and we have done just that. The industrial strategy Green Paper was launched in January this year, and it set an “open door” challenge to industry to come up with proposals to transform their sectors through various sector deals.
I am grateful to the Minister for his exposition of the current state of life sciences in the UK, all of which we could probably find out if we typed a few words into Google. May I bring him to one of the first questions, which is of pressing importance? What will the regulatory environment be for pharmaceutical companies that wish to get a pan-European licence in April 2019, during the so-called transition period envisaged by the Prime Minister, following the conclusion of negotiations on article 50?
We should always try to be courteous to one another in this House, if we can manage that. To refer to the previous point, DEFRA is responsible for animal medicines policy; EMA covers both human and animal medicines. The Department of Health and DEFRA work incredibly closely together; therefore, DEFRA Ministers answer on applications for animals. I can assist with that at any time.
We are working with Sir John Bell and others in the life sciences sector to consider the industrial strategy in more detail, specifically what action can be taken by Government and industry in partnership through an ambitious sector deal. At the launch of “Life Sciences: Industrial Strategy”, the Secretary of State for Business, Energy and Industrial Strategy, who has been much spoken of already in this debate, reiterated the Government’s commitment to the sector by announcing the first phase of their investment—£146 million for leading-edge healthcare, which is expected to leverage more than £250 million of private funding from the industry.
Leaving the EU, with all its challenges, allows us to make fresh choices about how we shape our economy and presents an opportunity to deliver a bold industrial strategy that prepares us for the years ahead. Our approach to the EU exit negotiations for medicines regulation is focused on building on the strengths of the MHRA and the UK life sciences sector that I have just set out. As the UK leaves the EU, both parties will have the shared aim to protect the health of patients across Europe and to ensure the safe and timely access to medicines and medical devices that I know concerns hon. Members as it concerns me. It is in the interests of patients and the life sciences industry for us to find a way to continue UK-EU co-operation and to ensure continued sharing of data, even if our precise relationship with the EU will, by necessity, change.
Earlier this year, the Secretary of State for Health and the Secretary of State for Business, Energy and Industrial Strategy published an open letter in the Financial Times setting out Government’s aim to retain a close working partnership in respect of medicines regulation after the UK leaves the EU. Our approach is underpinned by three key principles, which are worth stating. First, patients should not be disadvantaged; secondly, innovators should be able to get their products into the UK market as quickly and simply as possible; and thirdly, the UK should continue to play a leading role in promoting public health.
Yesterday, obviously, the new location of the EMA was announced; in 2019 it will move to Amsterdam. Both the UK and the EU have a collective responsibility to make sure that the process is as seamless as possible, in order to minimise disruption to existing regulatory procedures and public health protection. There are no benefits to UK or EU patients in tearing up the sort of close working relationships that get crucial drugs on the market as fast as possible, share early alerts about problems with medicines or allow patients to benefit from new scientific discoveries earlier. As the Prime Minister has said, there is also no need to impose tariffs where we have none now, which is the case for medicines and medical technologies.
Continued collaboration is in the interests of public health and safety across the continent of Europe, and in the UK for our constituents, because we all know that health is different. Medicines and med tech are different from other consumer products. Patients who need an innovative treatment cannot simply pay more or consume less but otherwise carry on as they were, marginally worse off. We recognise that it could be the difference, as has been said, between life and death. We look forward to discussing these issues as early as possible with our EU counterparts as part of the negotiations.
I am grateful to the Minister for giving way. Mr Davies, I hope that it is not out of order to say that the Minister does not quite seem himself. If he is poorly, and my earlier remarks were somewhat curt, I apologise for them.
It would help everyone here to understand the Government’s overriding objective for medicines regulations in a post-Brexit environment. Do we intend to automatically follow EU authorisations in future, or does the Minister foresee divergence from EU regulations?
On a point of order, Mr Davies. If the Minister is struggling and feeling unwell, is there a way in which we could bring the debate to an earlier close and he could write to us in response to our questions? I am concerned by how he seems.
Thank you; I am not feeling unwell at all.
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 industries so that they can grow and flourish, as set out in the letter in the Financial Times. We will ensure that our system is robust and does not impose any additional bureaucratic burdens. Our successful past should give us confidence in achieving a prosperous future, whatever form that takes. I want to be clear that that is not a threat to the EU27. I must be honest and transparent in saying that if it is not possible to secure close collaboration, we will of course look to put in place an effective system and work with international partners in a way that best protects patients and supports industry and innovation.
I will attempt to answer some of the many questions that the hon. Member for Bishop Auckland put to me. I can rule out a free-standing structure incorporated into the FDA. She asked how much the EU expects us to pay towards the cost of relocating the EMA. The arrangements for withdrawing from the EU, including any financial settlement, is a matter for the withdrawal agreement, which she knows, as part of the ongoing article 50 process. The Government are absolutely committed to working with the EU to determine a fair settlement for Britain’s exit and the best deal for UK taxpayers. As part of the exit negotiations, the Government will discuss with the EU and other member states how best to continue co-operation in the field of medicines regulation, in the best interests of business, citizens and patients in the UK and the EU. I do not think that it would be appropriate, nor is it possible, for me to prejudge the outcome of those negotiations. There are many who would love that crystal ball, but I do not have it.
One can envisage a situation in which medicines are assessed in the European Union and in the UK and there is an agreement for mutual recognition between those institutions. That, one can picture. But what I cannot understand, if we are not all in one system, is how—down the track when medicines are used—if something goes wrong, the Europeans can have a claim on us or we could have a claim on them if we do not share the ECJ institutional machinery.
I share the hon. Lady’s concern. As I said, so much about this is still subject to negotiation. I cannot give her the exact assurance that she wants at this time.
The hon. Lady also asked about the EU exit transition. The Government are clear that we want to continue collaborating with the EU in the interest of protecting patient safety. The detail of any future relationship is, of course, subject to that negotiation. That is nothing new. We recognise completely that new arrangements can take time to implement, and we will work closely with the industry and key health system partners to ensure smooth implementation. The European Union (Withdrawal) Bill, which is going through the House at the moment, will ensure that a known legal framework is in place immediately after we leave the EU.
The hon. Lady talked about the Secretary of State “flirting” with leaving the EMA for the FDA. Earlier this year, the Secretaries of State for Health and for BEIS published a letter in the Financial Times setting out our aim to retain a close relationship in respect of medicines regulation. The FDA has been clear that it would not let another country “join” FDA processes even if we wanted to, but if we are outside EU processes, we will certainly look at how we can co-operate more closely with other global regulators.
Heidi Alexander asked whether we had had contact with Australia and New Zealand. The chief executive of the MHRA chairs the International Coalition of Medicines Regulatory Authorities, and we of course have had discussions through that group on a contingency basis with Canada, Australia and others about the potential for greater collaboration once we have left the EU.
The hon. Lady asked whether I can guarantee that the adverse effects of drugs will be detected quickly. She also asked about orphan drugs and clinical trials. Increasingly, information about the adverse effects of drugs is shared at a global level. The EMA collaborates with many third countries. There is no need for a broad deal to agree to share safety information. We want to continue collaboration with the EU on orphan drugs for rare diseases, which she rightly pointed out are a subset of the wider issue. If we are outside EU processes, we will need to consider incentives for orphan drug development, and we are doing that. Clinical trials all receive national approval today, and they will receive approval under the EU clinical trials regulation, which is due to come into force in late 2019. The UK will remain a leading centre for clinical trials. There is no reason why multi-country trials cannot include the UK after Brexit.
Several Members, including the shadow Minister, Justin Madders, asked about MHRA resources. Some 90% of medicines on the UK market already have a national licence from the MHRA; fewer than 10% come via work that we do for the EMA. We have world-renowned scientific assessors at the MHRA. Some work and workloads may change post-Brexit, but I do not think that claims of fundamental change are correct. MHRA has full contingency planning in place.
I know that the hon. Gentleman asked that question. I cannot confirm that today—I am sorry—but when I can, I will.
A couple of Members, including the hon. Member for Central Ayrshire, talked about the absence of impact assessments of the health implications of leaving the EU. I fully concur with Members’ concern that complex discussions about the future of medicines regulation were not at the forefront of the referendum campaign. That is obvious. That is the problem with referendum campaigns. That is about as far as a diplomatic Minister can go. Sadly, the subject did not feature on the side of any buses. However, as part of our work on preparing to make a success of our departure from the EU, we are carrying out a full suite of economic analyses, as any Government would be expected to do. That means looking at 58 sectors, including life sciences, and at cross-cutting regulatory, economic and social issues. It will of course take time to collate that information and ensure that it is informative and accessible. We will provide it to Parliament as soon as possible.
Is the Minister aware of whether an impact assessment is being done with regard to health, not as part of the economy but as a benefit to people in the UK?
There is a huge body of work going on in the Department about the impact of Brexit on every single area of every single Minister’s responsibility.
The hon. Lady asks me to visualise all the different scenarios for the current negotiations. We have been clear that we want a comprehensive deal. A number of Members mentioned that no deal is some sort of ideological obsession for some Government Members. That may be true, but they do not speak for Government policy. We are not looking for no deal; we are looking for a comprehensive deal.
John Woodcock asked about meeting my colleague Lord O’Shaughnessy. I cannot speak for my colleague’s diary, but I will speak to him. If he cannot meet the hon. Gentleman and his taskforce, I will. The hon. Gentleman always speaks passionately for his constituency, and I am more than happy to try to sort that out for him.
The hon. Member for Central Ayrshire raised a concern about safety data. That absolutely should always be shared at a global level. The MHRA leads about a third of the EU’s pharmacovigilance work. The EMA already shares data with third countries. It is in all our interests for that to continue. If we are outside EU regulatory procedures, we will ensure that the UK remains an attractive market and that regulation does not delay patient access. A number of Members expressed concern about that, and it is a concern of mine, which is why it is a priority for us.
Does the Minister recognise the data protection issue? Some people have suggested that the UK will be in a position to follow its own line on utilising data. Ending up on the outside as an untrusted country—or as an untrusted set of countries within the UK—would obviously kill our ability to take part in clinical trials and research.
It would. That is why, as the hon. Lady knows, we are working extremely hard not to be in that position. As ever, she makes her point well.
Whatever our future relationship with the European Union on the regulation of new drugs, the MHRA, our world-leading regulator—I have mentioned some of the reasons why it is world leading—will be empowered to protect patient safety both in the UK and internationally. We will also ensure, as everyone said, that patients are at the forefront of our thinking and do not get new drugs any slower than they do now.
I am grateful to all hon. Members who took part in the debate. The Minister clearly understands why medicines regulation matters and shares our interest in making it work, but I and other hon. Members asked many questions and, to be honest, the only conclusive answer that he gave was that we will not join the American FDA. I would therefore be grateful if officials provided us with written responses to those questions. I know that the Minister does not deal with this area on a day-to-day basis, but I am concerned that the Department seems to have made little progress since
Question put and agreed to.
That this House
has considered the future of medicines regulation.