European Medicines Agency

Philippa Whitford Excerpts

Wednesday 12th October 2016 Westminster Hall

[Jim Shannon]

I thank my hon. Friend for his comment. I was not aware until seeing the briefing pack that there had been a decrease in the pharmaceutical business over the past few years; I actually thought we were holding our own and moving forward. Brexit will give us the opportunity to move forward, so we should look positively upon where we are.

This debate is not simply an opportunity for remainers to highlight something that may be difficult to negotiate, with no desire other than to prove their opinion on Europe. There is nothing wrong with that—people have different opinions—but let us work together to ensure that we deliver.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Is it not possible that part of the reason why the pharmaceutical industry has gone down is that the clinical trials directive of 2001 was very bureaucratic? Following that, we had a fall of one quarter in trial research in the UK, particularly in oncology. That directive is due to be replaced in 2018 with the EMA’s new regulation, which will streamline it.

[Jim Shannon]

I thank the hon. Lady for her intervention and the knowledge she brings to this Chamber and the House. I hope that we can improve on what she refers to when we get into the Brexit negotiations, and through our negotiations outside Europe when article 50 is triggered next year.

Let us work together to allow the EMA and the MHRA to come to an arrangement to continue what has been a great partnership to date and has achieved many results. According to the Financial Times, the EMA outsources up to a third of its work to the MHRA, and that work is responsible for a third of the MHRA’s income. A report in The BMJ states that that work makes the UK an attractive location to carry out clinical trials. The hon. Lady outlined that in her intervention, and I know that the Minister will respond and the shadow Front-Bench spokesman will add his comments.

That relationship, which has been proven to work, does not have to die because the EMA may—I emphasise “may”—move its headquarters. Work must be undertaken to underline the fact that although we will not be in the EU, we will remain the best in Europe at this type of clinical work. We have many things to be thankful for in our experience of it. We all understand the red tape in Europe, and I find it very hard to believe that the only reason why the work was outsourced to the MHRA was the location of the EMA.

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[Dr Philippa Whitford (Central Ayrshire) (SNP)]

It is a pleasure to serve under you, Mr McCabe. I, too, pay tribute to the hon. Member for Cambridge (Daniel Zeichner) for obtaining the debate and for such an excellent opening speech, which laid out many of the key issues that we face.

In my constituency there is GlaxoSmithKline, which produces the largest amount of one of the key antibiotics used across the world. It is natural that there are concerns in my constituency and in that business. It is slightly tragic that we are having both of the debates on this issue today, instead of prior to the June referendum. Perhaps a little more airing of what we gain from the EU might have been helpful. Forty years of describing the EU in terms of straight bananas and bureaucracy has not been helpful.

In health, we have had nothing but gains. The two canards that were raised during the debate—people ahead of you in the queue to see the GP and £350 million a week on the side of a bus—have evaporated. Someone is much more likely to be treated by an EU national than to be squeezed out of an appointment in a hospital.

We have had nothing but health gains. The EMA is typical of everything the EU has done in many areas. Before 1995—prior to expansion, so we would be talking about 12 countries—we faced regulation in multiple languages across multiple countries. What we have seen in the EU is the development of harmonisation of regulation to the point where we have a single agency. Having one agency means, as the hon. Member for Cambridge said, that drugs get from research bench to patients much more quickly. The EMA monitors safety throughout Europe so that we can more easily pick it up when, in real-life use, there turns out to be a problem with a drug. It also helps to direct research into the big challenges that the population of the EU faces.

There has been a lot of discussion about the MHRA. It is clear that there would need to be significant investment in it. Even if we are still in the EEA or in a position to be part of the EMA, we will not have any influence. The MHRA does not just provide briefs and reviews. It was massive in influencing the structure and principles of the EMA, and such influence will be lost. The loss of influence over pharmaceutical firms that are here has been talked about. The chief executive of the Association of the British Pharmaceutical Industry has said that he foresees a major loss of inward investment in this country because of the loss of the EMA headquarters in London and because of our possible exit from the EMA.

Many such examples will come up in different sectors with regard to Brexit, but the EMA encapsulates all of it. It is not a separate bureaucracy telling us what to do. Twenty-eight countries were working together to find the slickest way to encourage quicker research and to bring it to some benefit. Research is a big part of this. It has been possible for the EMA to direct research on the challenges that the whole of Europe faces, such as antimicrobial resistance or modern plagues such as Ebola. As was mentioned, it supports research into rare diseases. One pharmaceutical firm or one academic unit would not access enough patients to ever get an answer. Across a population of 500 million, we have the real potential—we are already seeing that potential come through—to find answers to some of the horrific illnesses suffered by small groups in a population. “Suffering” is the right word, and we will lose the potential to find solutions.

Lots of drug companies do not bother trialling drugs in children because it is just too much hassle. The EMA has been able to push and say, “We need to have paediatric trials. We need to have trials in children.” That dovetails with the business of research across the EU, which has the biggest research network in the world. It is much bigger than in China and the US. The UK has led in benefiting from that. We put in £5.5 billion and get £8.8 billion out. The biggest share of research of all types through Horizon 2020 and framework 7 has been done in this country, and we are in danger of losing that.

The reason we lead in pharmaceuticals is not just because the headquarters is here; it is because of the dovetailing between academia, pharmaceuticals and universities, and the ability of researchers to move around. We have gained because English has become the language of research and science, because of America. So that has been a benefit that we have had. Of course that is a benefit that we will keep, but we are in danger of sitting out on a little rock all by ourselves.

There may be a delay if pharmaceutical firms have to go through a separate process with the MHRA, but what about British firms? What about the innovative medicines initiative, which encourages small and medium-sized enterprises and often works on the biological aspects of new medicines? They will face an absolute nightmare trying to sell their drugs in Europe. That is something that we are not giving remotely enough attention to.

I was a remainer. I am still a remainer and my population were remainers. Obviously, we are not happy with the idea of being taken out of Europe and of being taken towards such a hard Brexit, as the rhetoric has suggested in the past month. We need to realise what we may lose. We still have everything to fight for. What “Brexit means Brexit” actually means can still make a huge difference to what we manage to hang on to from the EU and what we lose completely. We need to ensure that the people who are at the table take account of this.

I worry because we are describing the EU as a shop. We are talking only about the single market and whether we will get access. Sometimes people mean that as a shorthand for everything else we have gained, but that allows us to be mentally sloppy and therefore allows someone to say, “Oh, good. We are like Canada. We have got access to the single market. Job done.” But it is not job done. The EMA was an example of Europe coming together, streamlining itself and finding a better way forward.

It has been recognised that the clinical trials directive of 2001 made it very difficult for the UK because the system became quite bureaucratic. The EMA has responded to that. The vastly streamlined clinical trials regulation starts in 2018. In fact, the EMA and the EU in this sector are getting rid of bureaucracy and making it easier for our companies and our academics to do research throughout Europe. Some 80% of all the top flight research of all kinds is international and multinational. If we do not allow the researchers to easily work with each other, we are cutting our noses off to spite our faces. We need to recognise that Europe has not just been about burning orchards or straight bananas. It has brought us huge gains in health and safety, in research and in getting drugs to patients. I call on the Minister to ensure that that message is brought home to the core Brexit team as strongly as he can manage.

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[The Parliamentary Under-Secretary of State for Health (David Mowat)]

It is a pleasure to serve under your chairmanship today, Mr McCabe. I congratulate the hon. Member for Cambridge (Daniel Zeichner) and all the other hon. Members who have brought their experience to bear in the debate. I am sorry to disappoint everyone by not being from the Brexit Department. I will pass that on to those who are in it, but as has been noted, they are otherwise engaged in the main Chamber.

One reason why I am particularly pleased that we have had this debate today—I regret that all the answers may not be clear in 11 minutes’ time—is that often when there is talk in the media about the Brexit negotiations we are about to have, we hear a great deal about the importance of financial services, the City and passporting, and of the need to get those things right and the terrible effect it will have on our economy if we do not. The fact that we have had this debate, and that the hon. Gentleman and others have talked about how important the medicines industry is to our economy—not just in Cambridge, Cheshire or Scotland, but right across the country—is a reminder of the importance of this issue and has rightly put it on the agenda. I am sure the hon. Gentleman will keep it on the agenda, as will Ministers from the Department of Health.

At the start of the debate, the hon. Gentleman quoted the Prime Minister, who said:

“It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”.

That is on the cover of a report, which I recommend everyone reads, on the structure and future of the life sciences industry post-Brexit. In a moment, I will talk a bit more about the work that the Office for Life Sciences is doing in that area. The pharmaceuticals industry is right at the centre point of where we need to be as a country in development work. It is an area that we are world-class in—an area of advanced manufacturing, which we need to be doing more of. We are leveraging the expertise and brilliant work in universities to actually make money, in a way that we do not do in all industries at all times. It is vital that we do not lose that.

I will repeat fairly quickly some of the statistics that we have heard on the structure of the industry. There are nearly 6,000 companies in the industry in the UK, and two of the major companies are GSK—located in many parts of the country, including Ayrshire—and AstraZeneca, which is located in Cambridge in particular. I have made the point earlier that a larger part of it was located in Cheshire a couple of years ago. Those are major, world-beating organisations, and for us to have an industrial future and a future as a country, we have to nurture them. In fairness, the thought that we would not do that is a nonsense. A fair challenge is to make sure that we do it right and keep it on the agenda, and I will try to address that today.

However, this is not a European industry, it is a global industry. AstraZeneca and GSK also have massive facilities in places such as Sweden and Philadelphia—all over the world. Of course it is absolutely essential that we get our relationship with the EU right. I think the point was made earlier that we have 3% of the EU market in terms of sales, although we are a lot bigger than that in terms of drug production and the importance of the pharmaceutical industry—it is probably more like 10%. GSK’s recent announcement of an £800 million investment in biologic and bioelectronic activity is to be welcomed.

The EMA was formed, as was generously mentioned, in 1995. There are 890 staff, the majority of whom are not from the UK; I think that only something like 60 are UK-based. The hon. Member for Heywood and Middleton (Liz McInnes) made the fair point that those people have families and futures, and asked how they are to be protected. The Prime Minister has said that we hope and expect that all EU nationals who work in the UK will stay here into the future. I have not heard any leader of any other country in Europe make the reciprocal point. I do not know if that is on the Labour party’s list of 171 questions, but it would be reasonable if it were. Having the EMA in the UK is of benefit to us not just because of those jobs but because, as Members have said, it is natural that people like to be close to their regulators. It would be reasonable to suppose that, although that might not be a decisive factor in many investment decisions, it would be a factor.

We also have the UK agencies: the MHRA, which covers medicines, and the Veterinary Medicines Directorate, which covers veterinary medical activities. They have 1,200 staff and 160 staff respectively. The point was made today that their activities are commingled with those of the EMA. Many of the EMA’s major committees are chaired by people from the UK, including from the MHRA and VMD. Equally importantly, the hon. Member for Central Ayrshire (Dr Whitford) made the point that 30% of its activities are done by the MHRA. The figure I have is 20%, but nevertheless, a significant amount of work done for the EMA is done in the UK. That is not just because of location—it is not just because the people who do that work are down the road. It is because they have the expertise, the science base and the people that are needed. Of course, with Brexit, all of that is up for discussion.

We have touched on the university sector, and I will not say a great deal about that. I have already made the point that the industry is an example of us successfully taking a sector with world-class, world-beating innovation and turning that into world-class, world-beating companies, in a way that we do not everywhere. It is of paramount importance that the sort of research that goes on in our universities continues. The Government intend to make sure that happens and, indeed, to increase it.

I have set out the regulatory and industry structure, but we are just about to impose Brexit on all of that. That is where we get into the territory of speculation and conjecture, and I apologise that I cannot be more definitive. Many of the questions that have legitimately been raised, in particular by the Labour spokesman, the hon. Member for Ellesmere Port and Neston (Justin Madders), will be central to any negotiation that the Government take part in. It is not possible for a Minister to address the House of Commons and say, “This is our position, these are our red lines, these are the things we are going to give a bit on and these are the things that really matter to us.” That would be nonsense. That is not how any of the commercial companies located in Cambridge or other places would deal with things. What we have to do—this is the role of Members here today—is make sure that the issues are raised with and understood by the negotiating team, because there will be trade-offs in any negotiation.

With respect to some of the Members who have spoken, I have to say that we do pay £20 billion a year to the EU. We may all vary in our view of how much value for money that provides, but the fact is the £350 million on the side of the bus was not an entirely made-up number. That did not influence how I voted in the referendum, but it was not an entirely made-up number. We pay £20 billion a year for the things that we get from the EU, one of which is the EMA and the activity around it. There is a dialogue to be had both on that amount of money and on issues such as the location of the EMA and all that goes with it. Of course, its location is one point to be discussed, and I have no idea how that will end up. The point has been made that it regulates not just for the EU but for Liechtenstein and Norway—I think there was another country as well, but I have not written it down. The UK could be another such country. For me to say it is an absolute line in the sand that the EMA must stay in the UK would be a nonsense.

A number of Members have asked what we are doing to prepare for the negotiations that will happen. That question can be divided into two parts: what are the agencies—the VMD and the MHRA—doing, and what are the Government doing? The agencies have set up groups looking at the opportunities and at how regulation might carry on into the future. A number of Members have made the point that there might be a time lag in medicines coming to the UK if they have to be regulated by more than one body, or if in the future the EMA does it separately from how we do it in the UK. That is really a decision for the UK. It is about how we choose to regulate, and that decision has not yet been made. It would be disappointing if that happened, and many of us will be working hard to ensure that it does not.

The Government have set out fairly clearly that we intend to underwrite EU payments to academic projects even after we have left the EU, to protect the important activity of research programmes. Through the Office for Life Sciences, we have set up a steering group charged with informing how we make the transition. The group is chaired by the Secretary of State, Sir Andrew Witty and Pascal Soriot from AstraZeneca, and over the next few months it will be responsible for informing our negotiating position.

I do not know how many colleagues know about the report, “Maintaining and growing the UK’s world leading Life Sciences sector in the context of leaving the EU”. I think it was put together by PricewaterhouseCoopers. It is a good start in setting out a number of issues we have heard about today and the importance of getting the process right. I very much recommend it. It does not answer all the questions, but it sets out the issues in areas such as trade, people, research, funding and regulation.

A whole string of points were made in Members’ contributions this afternoon. I do not want to spend too long on them, but the hon. Member for Cambridge mentioned that not being part of the EMA’s marketing authorisation might cause delays. That depends on how we set up regulation in this country, and there are a lot of choices. A lot of other countries, including Switzerland and Japan, regulate in different ways, and it would be premature for me to say too much about it. The hon. Gentleman also made the valid point that the EMA and the MHRA are completely intermingled, and that both benefit from the current arrangements. It is not just about the EMA contracting and hiring the MHRA. We do a lot of the work that leads to that top-level and highly professional European legislation.

The hon. Member for Strangford (Jim Shannon) reminded us that whatever we think, the country has voted and we are going to leave the EU. There is no ambiguity about that, and we have to make the most of it. That is a mature reflection, because it forces us to address the negotiations, and not to continue to go over what was on the side of the bus and all the rest of it. We are where we are, and we need to make the situation the best that it can be.

The hon. Member for Heywood and Middleton used her experience and knowledge as a research scientist to make a good speech. She made a point about people, which I tried to answer by reflecting on other EU states. She mentioned the Nobel prize winners’ remarks. I heard those remarks as well and thought that there was a slight irony in that they were asking us to remain in the EU and so on from the University of Chicago. That shows that we live in the world, not just in Europe, and we must reflect on that.

[Dr Philippa Whitford]

Those Nobel prize winners represent the last time we had a major brain drain, when, in the ’80s, we lost some of the best minds from the UK. That is one of the dangers: the people who want to be at the cutting edge will not see this as the place to be.

[David Mowat]

That is a fair point. It could be a danger. The point I was making was that they made the plea to remain in the EU from the United States, which is the leader in many aspects of science. I think we can agree that science is international—it operates in Japan, the US, the UK, Germany, France and elsewhere—and that, however we achieve Brexit, we should do what we can to avoid creating barriers to internationalisation.