European Medicines Agency

Jim Shannon Excerpts

Wednesday 12th October 2016 Westminster Hall

[Jim Shannon (Strangford) (DUP)]

It is a pleasure to speak in this debate on a matter of great importance. May I congratulate the hon. Member for Cambridge (Daniel Zeichner) on securing it? As my party’s health spokesperson in Westminster, I have been contacted by pharmaceutical companies about this issue, and I will try to illustrate their concerns in the short time I have.

It was not difficult to predict the tone—I mean this respectfully—of those who are presenting a particular case about the EMA, given their concerns in relation to Brexit. I have a great deal of respect for Members’ opinions on Brexit, and while we must remember that the vote of each Member carries the same weight, I gently remind the House that the die is cast. The people have spoken, and the responsibility of ensuring that we are in the strongest possible position now lies with this House.

I very much welcome this important debate. It is interesting that while we are having this discussion in Westminster Hall, the main Chamber of the House is discussing parliamentary scrutiny of the UK leaving the EU. No doubt this issue will be brought up there. The EMA is one of the mountain of details that the Government must be aware of and plan for when we enter into negotiations for leaving the EU and establishing mutually beneficial trade agreements. The hon. Member for Cambridge set the scene clearly, and although we have different opinions on Europe and Brexit, I do not see any difference in what we are trying to achieve collectively on this issue. Our opinions, focuses and goals are similar, if not exactly the same. That is important.

I will begin with the statement made by the EMA after the referendum result in June. It made it clear that its work will continue as normal. As there is no precedent for a member state leaving the EU, the implications for the location and operation of the EMA are unknown. The EMA also stated that any decision about the location of the agency’s headquarters would be made by common agreement among member states.

The Brexit negotiation team—the Secretaries of State for Exiting the European Union, for International Trade and for Foreign and Commonwealth Affairs, and the Prime Minister—will need information to set out a strategy for dealing with this issue. The Secretary of State for Exiting the European Union and his team need the thoughtful consideration of those with an insight into this matter, so that they can strike the right way forward. It is important that we do that.

[Mr Gregory Campbell (East Londonderry) (DUP)]

The helpful debate pack we have from the Library indicates that the pharmaceuticals sector has unfortunately declined as a percentage of the economy in the past five or six years, when we have been in the EU. Does my hon. Friend agree that the outlook of every hon. Member, and throughout society in the UK, should be that we need to redouble our efforts to ensure that the line on that graph begins to go up, rather than continuing to decline?

[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.

[Jo Churchill (Bury St Edmunds) (Con)]

It is a pleasure to serve under your chairmanship, Mr McCabe. I want to return to the point made by the hon. Members for Cambridge (Daniel Zeichner) and for Central Ayrshire (Dr Whitford). The Government need to be aware of the connectivity between the university sector, the clinical trials sector, the pharmaceutical sector and beyond, and of the importance of where the EMA sits in that. I would be grateful for an assurance from the Minister that we are putting everything we can into ensuring that the situation is sorted effectively and quickly.

[Jim Shannon]

I thank the hon. Lady for her intervention and for the knowledge she brings to these debates. She is right in saying that we want a continuation of the good work with universities. Queen’s University Belfast has a partnership with pharmaceutical companies throughout the world, doing clinical trials and marvellous work, as do many other universities across the whole United Kingdom of Great Britain and Northern Ireland. We could do that even better, and we should be doing so.

It was because of the quality of service and the tendering process that we showed that this was the best place for the work to be carried out, and that will remain so no matter where the EMA locates its headquarters. I cannot blame the Republic of Ireland and other countries for putting down a marker that their country could be the home of the EMA when it is time for it to move. If this were an opportunity for business in my constituency, I would also be highlighting our ability to take the business on board. However, panic stations need not be manned tomorrow, because those countries are hoping that an opportunity will arise when we leave in the not-too-distant future.

It is clear that countries that are members of the EEA are covered by the EMA and have access to the centralised marketing authorisation procedure. That is important, as it may mean that the UK could continue to have that procedure after leaving the EU, but it will depend on the negotiations and the UK’s resulting position in the single market. If the UK did not become a member of the EEA, pharmaceutical companies would need to apply separately for marketing authorisations from the MHRA for a medicine they wished to supply in the UK. That will be covered the negotiations.

We must have faith in the negotiations and in those who have been tasked with the job. Let us support the Ministers who have been given that job and encourage them to move forward. I hope they will read the Hansard report of this debate. We are not in the main Chamber, but the contributions made here are important in formulating policy and moving forward.

I have been contacted by Muscular Dystrophy UK, which has asked me to ask some questions of those who will enter the negotiations so that they are recorded in Hansard. I am happy to do so. Will the Government ensure that there is a parallel approval system for new treatments, so that after the UK exits the EU, EMA approvals that are granted apply to the UK at the same time? Will the Government increase the capacity of the MHRA and the National Institute for Health and Care Excellence so that the regulatory and approval processes are faster and can cope with the growing number of emerging treatments for rare diseases in forthcoming years? It is important to underline the issue of rare diseases—I think every hon. Member in the Chamber today has spoken about it at some point. We are all aware of the need for medicines, investigations and work to find new medicines to heal people better.

Those questions need to be considered, and a constructive approach that accepts there will be a change and seeks to influence the way the change takes place is the best way forward as we begin to work on the details that will shape our new position in Europe outside the EU. Let us focus on that.

I am nothing if not a realist, and my decision to support Brexit was not made on a whim or through emotion. It was made after thoughtful consideration that on the whole, we can do better for our country than the way things stand. That will come about through massive change and an overhaul of systems, and this is one of the changes that must happen. The onus is now on the Government, and particularly the team that is working on the negotiations, to ensure that we address the matter and gain the best possible outcome. I thank the hon. Member for Cambridge for giving us the chance to make a contribution to finding the way forward and highlighting the work that must be done to ensure that our MHRA, and indeed our system for clinical trials, continues to encourage work to be carried out here. We need to cement partnerships so that we can make the United Kingdom of Great Britain and Northern Ireland a better place for pharmaceutical companies.

--- Later in debate ---

[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.