European Medicines Agency

David Mowat Excerpts

Wednesday 12th October 2016 Westminster Hall

[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.

[Liz McInnes]

Will the Minister give way?

[David Mowat]

Maybe we cannot agree on that. I give way to the hon. Lady.

[Liz McInnes]

There is no irony in the comments of the Nobel prize winners just because they were made by British scientists working in the United States. That fact only emphasises how international science is. We must not fall into the trap of taking the line that was spread before the referendum:—that this country has had enough of experts. Those people are experts, and we should listen to what they have to say because they are the people who know what is going on. They know what the effect on British science will be if the EMA and its principles are lost.

[David Mowat]

We can agree that the scientific principles at the core of our world-leading science must not be lost in regulation. We can also agree that science is international. It is in all our interests, and in the interests of our communities and our children, that this country continues to do world-class science as part of an international collaboration. That is the Government’s intent and will.

I will finish by talking about our world-class industry.

[Jim Shannon]

I have asked a couple of questions about muscular dystrophy on behalf of my constituents. I do not expect the Minister to give me a response today, but I remind him gently to provide a written response and perhaps make it available to other hon. Members who are here.

[David Mowat]

Clearly when I used the word “finish”, people sprang into action. I will ensure that the hon. Gentleman gets a written answer to his questions on muscular dystrophy.

We do world-class science in this country. We must continue to do so, and to have a world-class pharmaceutical industry, with all that means for value added and input to the Exchequer. Governments are not the reason why we are among the best in the world in gene therapy and cell therapy, and they are not the reason why we have built £60 billion pharmaceutical organisations GlaxoSmithKline and AstraZeneca. It is important that we get the regulatory environment right, and the Department of Health and the Department for Exiting the European Union will ensure that the negotiations we are about to have address those issues.

[Dr Wollaston]

Does the Minister agree that the reason why we have such world-class expertise is the workforce? We must be absolutely clear and send a message to the world that, within our science and research community, we will not be maintaining a list of who is here from the EU and who is a British scientist. We must unequivocally send a message that Britain is open to scientists, researchers and the medical and healthcare workforce from around the world and the EU, not just from Britain.

[David Mowat]

That last intervention—I say “last” somewhat hopefully—unites us all. It would be ridiculous if the world-class science that we must continue to do compromised on matters like that. I completely agree with my hon. Friend’s point, and there is agreement across Government about that. If we need to make that clearer, we should.

I will finish now, as nobody is springing to their feet. I thank all hon. Members, particularly the hon. Member for Cambridge, for putting the issue on the agenda. It is right and important that the topic is at the forefront of our negotiations, and that we get the right answer in the end.