Clinical Trials and Clinical Research Capability

Debate between Chris Green and Marion Fellows

Thursday 23rd May 2019 Westminster Hall

[Marion Fellows (Motherwell and Wishaw) (SNP)]

It is a pleasure to serve under your chairmanship, Mr Hanson. I congratulate the hon. Member for Bolton West (Chris Green) on securing this important debate. I particularly enjoyed his opening remarks on scurvy, and I thank him for reminding me about where the term “limeys” came from. He is obviously passionate and knowledgeable about this subject. I have quickly skimmed through some of the things he spoke about and, I have to say, I found very little to disagree with in his speech.

The hon. Gentleman said that Brexit will be challenging for many reasons, especially getting clinical trials properly conducted post-Brexit, particularly when, at the moment, no one knows what is happening. He pointed out something that had not crossed my mind: if we do not get those relationships right post-Brexit, the UK is too small a country to conduct positive and technically feasible trials in new and important areas.

The hon. Gentleman talked about the importance of harmonisation across Europe, and about something especially important to Scotland and to my party: the ability of people to move freely. We must take a European and a broader, transnational view at how much people working in the sector can bring to this country, and what UK nationals can bring back when they return from working abroad.

The hon. Gentleman also mentioned visa costs, another highly important issue for Scotland and the Scottish Government. Astonishingly, a visa for a researcher and their family can cost 11 times as much in this country as it would in France. That would be a no-brainer for a clinical researcher looking at where to go to further his or her career.

Clinical trials are essential for bringing new medicines to people. They test whether new treatments are safe and effective, and allow patients to access new medicines earlier. The UK regulatory environment for clinical trials is led by the Health Research Authority and the Medicines and Healthcare products Regulatory Agency. Wellcome, whose report I will mention later, found that more than 4,800 UK-EU clinical trials took place between 2004 and 2016. Around 40% of the trials currently run in the UK are being run with other member states. Clinical research supported by the National Institute for Health Research clinical research network has generated an estimated £2.4 billion and nearly 40,000 jobs. This is not an insignificant sector.

New legislation—the EU clinical trial regulation—will replace the EU clinical trials directive in 2020. Under the CTR, all trial applications, data and co-ordinated decisions from member states will be communicated through a single portal. Streamlined systems and communications will help to simplify compliance with the CTR, potentially saving researchers in the EU £600 million a year, as well as offering savings of £60 million a year to UK researchers.

Clinical trials are managed nationally in the UK by the MHRA, although some aspects of clinical trials are shared across the EU medicines regulatory network. For example, a clinical trial sponsor or legal representative for clinical trials in the EU should be based in the EU or European economic area. Currently, 40% of UK-based trials also have a site in the EU.

Wellcome’s report “Brexit and Beyond: Clinical trials” stated that the best option for trials is

“full UK participation in the EU clinical trials system”.

Wellcome found alternative options, but posited that all

“involve significant trade-offs that would have an impact on UK–EU clinical trials.”

The Scottish National party advocates a second EU vote. However, failing that, and failing full participation, the UK should meet its commitment to put the EU clinical trial regulation into law, and should remain aligned to the EU framework.

The UK Government stipulate that in the case of no deal, the MHRA would take on responsibilities currently undertaken through the EU system. However, Wellcome found that, even if the withdrawal agreement is voted through, which after the last few days seems impossible,

“the MHRA would not be able to lead on reviewing applications, a role known as being a ‘reporting Member State’.”

No deal would likely lead to significant uncertainty over the legal arrangements for clinical trials.

Brexit is already having a negative effect, with Reuters finding that the

“number of new clinical trials started in Britain last year was 25 percent lower than the average for 2009-16”.

It highlights Brexit as the reason for the fall in numbers. A total of 597 trials were initiated in Britain in 2017, against an average of 806 over the previous eight years. The UK Government have committed to exploring the option of full association to research and innovation programmes, but there are no guarantees of success.

[Chris Green]

As we were discussing before the debate, the United Kingdom is a world leader in research and development and, because of the excellence in the UK, we receive disproportionate funding from the European Union. Does the hon. Lady share my concern, and agree that, post Brexit, the UK Government need to maintain that enhanced level of funding?

[Marion Fellows]

I thank the hon. Gentleman for his intervention, and I agree. As we were discussing, Scotland punches above its weight per head of population. From memory, we receive 11% of Erasmus+ funding, which is more than we should. Again, that is because of the excellence of the research in Scottish universities, in conjunction with EU nationals and other universities across Europe.

Where are the UK Government currently in exploring the option of full association to research and innovation programmes with the EU? The Department of Health and Social Care wrote in August 2018:

“A scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely”.

Again,

“facts are chiels that winna ding”—

I will spell that for Hansard later. The ground is moving beneath our feet as we speak, just before the recess. It is vital that we do not leave without a deal, but—although we can all hope—a no deal is becoming more likely. We need to think very carefully. Can the Minister give us any reassurance that there will not be a no-deal Brexit? That is asking a lot, I know, but it has to be asked. The quote that I have been given is:

“Negotiations are progressing well and both we and the EU continue to work hard to seek a positive deal.”

Can the Minister provide an update on all negotiations taking place?

The Brexit Health Alliance brings together a range of health professional, patient, and health and care organisations. The highly influential group has called for a deal that delivers the closest possible alignment and regulatory co-operation between the UK and the EU with respect to medicines and medical devices, to guarantee patient safety and public health. I do not think that anyone in the Chamber would disagree with that. We really need to ensure that it happens.

We believe in Scotland that, at least in the short term, the best way to protect clinical trials in the UK and their future is to vote for the SNP today in the EU elections. The Government’s handling of Brexit could severely damage, if not ruin, the UK’s reputation as a world leader in medical research, having produced around 25 of the top 100 prescription treatments. The UK currently benefits from access to research funding from EU funding programmes such as Horizon 2020 and the Innovative Medicines Initiative.

Innovation and progress are impossible without funding, and it can take many years to get from funding to outcome. Reducing funding now therefore has a negative effect for the future. The UK Government confirmed that Horizon 2020 provides about €80 billion of funding, available over seven years—that is, until 2020—of which the UK has secured €5.1 billion of funding to date, which is 14.3% of the total. Europe is therefore really important to us. Although it has been confirmed that the UK will participate for the remainder of the programme, what will happen in any future programmes remains undetermined.

The Innovative Medicines Initiative has committed more than £5 billion to support large-scale, ambitious research. IMI-supported projects have generated more than 4,000 peer-reviewed projects. From 2008 to 2016, the UK received 28% of total IMI funding from the EU Commission—the largest amount for any country, totalling €302.8 million. UK academic institutions and small and medium-sized enterprises receive the highest levels of IMI funding of any country.

The UK is very successful at conducting clinical trials. It sponsors approximately around 1,500 trials that include other EU countries. Half of those trials will still be occurring in 2019. It is important to collaborate internationally, particularly for rare disease trials, because there are not enough patients in one country alone. Without large-scale drug or medical device approval processes, the approval of drugs and devices could be delayed, resulting in slower access to new treatments for patients. None of us wants that.

I congratulate the hon. Member for Bolton West on recognising the work of charitable institutions such as Cancer Research UK. It is really important to people throughout the UK that funding and collaboration does not cease, because people are waiting for answers to diseases, some of which have not yet been named. The idea of UK Research and Innovation has not been dealt with; the delegated legislation to deal with it has yet to come to the Floor of the House. We wait with bated breath to see whether the Minister can answer any of my questions to her today.