European Medicines Agency

Justin Madders Excerpts

Wednesday 12th October 2016 Westminster Hall

[Justin Madders (Ellesmere Port and Neston) (Lab)]

It is a pleasure to serve under your chairmanship, Mr McCabe. I congratulate my hon. Friend the Member for Cambridge (Daniel Zeichner) on securing this important debate and on the powerful and knowledgeable way that he made his case today. I share his disappointment that this matter is not being responded to by the Department for Exiting the European Union, but I understand that there are competing interests today. However, I hope that the Minister will undertake to raise the issues set out today with his colleagues in the Department and will answer some of the questions posed today.

I know that my hon. Friend the Member for Cambridge was and remains a passionate advocate for both the European Union and his constituency, and today he has channelled his disappointment at our impending departure from the EU into a well argued case to support key industries in his constituency. He spoke about the local interest that he has in this issue. The Cambridge biomedical campus is one of the most significant sites for medical research not only in this country, but anywhere in the world. Like him, I represent a constituency with an interest in the science and research sector, which could take on even more significance with the proposed Cheshire science corridor, which has the potential to create more than 15,000 new jobs by 2030, around a third of which could be in my constituency. Of course, I do not have to tell the Minister about that because the science corridor benefits Warrington as well as Ellesmere Port. Even before projects such as the Cheshire science corridor come to fruition, the north-west, as we have heard, is already one of the leading regions in the country for the pharmaceutical industry, employing about 18% of the total national workforce.

As my hon. Friend the Member for Cambridge said, the industry is a massive part of our country’s economy, with a turnover of more than £60 billion a year and exports worth around half of that. In 2014, it invested £4 billion in research and development: more than any other sector. It also employs some 220,000 people. I have set out those facts to paint a clearer picture of what is at stake in today’s debate and why it is so important that we begin to offer some clarity about what our plans are, not only for the future of the European Medicines Agency, but for pharmaceutical research, development and regulation more widely. I believe that the importance of the issue is reflected in the number of Members attending the debate, even though the bigger picture on our exit from the European Union is being debated in the main Chamber now.

I appreciate the tone that the hon. Member for Strangford (Jim Shannon) adopted. I think that he was saying that, wherever we came from pre-referendum, and whatever our views on the European Union, the vast majority of Members now want to ensure that our departure happens on the best possible terms. I regret the mischaracterisation of Members who request greater scrutiny and debate on the terms of exit as being involved in a Machiavellian plot to undo the referendum result. What Members are asking for is scrutiny, transparency and accountability on what is surely the most important issue that the country has faced in a generation.

My hon. Friend the Member for Heywood and Middleton (Liz McInnes) spoke from great personal experience. She was right to use the word “isolation”. We want to avoid becoming separate from the rest of the world in such an important area. She gave specific examples of the benefits of pan-European research on diseases such as cancer. The hon. Member for Linlithgow and East Falkirk (Martyn Day) raised important concerns about delays in approval, and the potential loss, on leaving the EU, of our involvement in pharmaceutical trials. He mentioned the concerns of the Japanese Government about the siting of their European bases in London. That echoes concerns that they have raised about other sectors.

The hon. Member for Central Ayrshire (Dr Whitford) clearly set out the fact that the EMA is not a body that tells us what we should do, which is how much of the European landscape is portrayed. It is part of a collaborative exercise across 28 nations, which have been making real progress. She also set out the financial benefits that this country has received from membership, and highlighted the important point about the difficulty that some smaller British companies may face in exporting their innovations, if we do not get the terms of exit right.

We all remember the famous promise, which several hon. Members have referred to, that the Brexit vote would mean £350 million a week being spent on the NHS. It is fair to say that it is accepted that that figure does not stand up and was misleading, but, as the hon. Member for Central Ayrshire eloquently pointed out, I suspect very few people who voted leave would have appreciated the threat that leaving means to jobs in the science and research sector and to speedy access to new medicines.

No one blames the Department of Health for those misleading claims. Indeed, I know from my own parliamentary questions that Ministers sought legal advice about the use of the NHS logo by the leave campaign. However, we are entitled to ask for more from Ministers on the near total absence of work to prepare for the possibility of a leave vote. For example, on 11 July, I asked the Secretary of State what assessment he had made

“of the potential effect on workforce numbers in the NHS of the UK withdrawing from the EU.”

I was told that no such assessment had taken place. On 6 September I asked what discussions the Secretary of State had had with the Home Secretary

“on the immigration status of NHS employees from other EU countries when the UK leaves the EU.”

I was told only that arrangements were being made for a meeting to take place at some point in the future. A similarly disappointing response from the Government on the issue was pointed out by my hon. Friend the Member for Cambridge, who noted that when asked about the future physical location of the EMA the Minister responded that it was “too early to speculate”.

We are not asking the Government to speculate; speculation is happening whether we like it or not. We are asking them to set out some concrete and substantive detail on what they plan to do. We have heard many times from the Prime Minister the words “Brexit means Brexit”, and that she is not prepared to give a running commentary. But investment decisions are being made right now, and if we cannot begin to provide some certainty we shall quickly find out that the UK and, in particular, places such as Cambridge and Cheshire will miss out on investment. It is about time we got some clarity on the Government’s position.

The first and most obvious point is the location of the EMA. We have already heard that countries from around the world are queueing up to offer it a new home. Having heard the benefits that it brings we can understand why they are forming an orderly queue. I know that the Minister does not want to speculate on what will happen, but will he at least set out whether, as part of the negotiations, he will take steps to try to retain the EMA headquarters in London, if that is possible? Will he also provide clarity about what steps the Government will take, if the EMA does relocate, to safeguard the headquarters of major international pharmaceutical and life sciences companies?

Beyond the future location of the EMA, there are wider issues about how medicines will be regulated in future, which could not only have an impact on investment but affect how quickly new medicines reach UK patients. Various hon. Members have mentioned that. Will we be able to safeguard the UK’s position as one of the leading locations for clinical trials in Europe? Clearly, a lot of Members feel passionately about that. Will the Government guarantee that the UK will continue to adhere to the EU regulatory framework on the authorisation and conduct of clinical trials? What assurances can the Minister give us that retaining access to the centralised marketing authorisation procedure will be a key part of our Brexit negotiations? Will the Government seek to negotiate continued access for UK research institutions to the innovative medicines initiative and other EU-funded research and collaboration programmes?

If the UK is left in the position of developing a separate regulatory framework from the EU, not only will that make it a much less attractive place in which to develop, manufacture and launch new products; it could also signify the end of accelerated access to treatments for patients in the UK, putting us to the back of the queue when new medicines are developed. Patients in Australia and Canada, where medicines are licensed nationally, have a comparative delay of six to 12 months before new medicines come to market. For people with rare conditions that could mean the difference between life and death.

European co-operation also provides some key benefits in terms of patient safety. One example is the European Centre for Disease Prevention and Control, which assists in our response to communicable diseases and pandemics. Another is the co-operation that reduces the risk of falsified medicines reaching UK patients. Can the Minister confirm that we will seek to continue to co-operate with our neighbours on those crucial issues?

What assessment has been made of the impact of the EMA’s leaving on the Medicines and Healthcare Products Regulatory Agency? As the hon. Member for Strangford said, work from the EMA is a substantial source of income for the MHRA, accounting for up to a third of its income. What provision has the Department made for the potential shortfall, particularly if the MHRA will have more responsibilities in future? As the hon. Member for Central Ayrshire said, in any scenario, it is likely that the MHRA will require further investment. What provision has been made for that?

This has been a wide-ranging and well informed debate. While we recognise that the issue does not begin and end with the physical location of the EMA and the 900 staff based there, there are at the heart of it, as my hon. Friend the Member for Heywood and Middleton said, 900 people—highly skilled and able to take their talents probably anywhere in the world—who face a future that is a vacuum. They will all have families and plans, and it is unrealistic to expect them to put their lives on hold for two or three years while things are sorted out.

I appreciate the Government’s reluctance to be drawn into making substantial commitments on the issues, but we run risks with respect to decisions about investment, future co-operation and, indeed, staff retention, if we do not begin to make our position clear. I hope that, when the Minister gets to his feet, we shall begin to get some certainty about the Government’s intentions as to seeking regulatory co-operation and, most importantly, safeguarding future investment in the sectors that we have heard about today.