There will be no ‘magic bullet’ for the UK’s regenerative medicine industry if we leave the EU

Alex Faulkner is Professor in Sociology of Biomedicine and Healthcare Policy at the Centre for Global Health Policy at the University of Sussex.

Regenerative medicine – such as stem cell therapy and gene therapy – promises to revolutionise the face of future medical care. This area of medicine is a priority for the UK government – but how would leaving the European Union affect the UK’s position as one of the leaders in this highly competitive field?

To cut us off from the EU pool of talent, or to make participation and mutual benefit more difficult, would slow down innovation and access to EU markets within the UK. 

Embryonic stem cells stained blue as seen under a microscope. Photo courtesy of Nissim Benvenisty (CC BY 2.5).

We’ve already heard from members of the Royal Society, including Professor Stephen Hawking, writing to The Times arguing that Brexit would be a disaster for UK science in general. It’s clear that the healthy position of the regenerative medicine sector is in part down to us having a strong voice in Brussels. So where would leaving the EU leave our regenerative medicine research and business?

Firstly, as a country we benefit from sharing the limited expertise that exists in areas such as safety and product development, so to cut us off from the EU pool of talent, or to make participation and mutual benefit more difficult, would slow down innovation and access to EU markets within the UK. The fact is that the UK’s science base in this field certainly benefits from expert talent coming in from other EU countries, and Brexit would indeed make this more difficult.

It’s not only the pool of expertise that would suffer – we are also at risk of losing advantages that we do have. The European Medicines Agency (EMA), which makes the final decisions about authorising new regenerative and other medical products, is based in Canary Wharf in London. It employs about 700 people, and its location in the UK is an obvious advantage for UK developers.

Face-to-face meetings are increasingly important in a field of such high scientific uncertainty where knowledge has to be shared intensively amongst developers and regulators alike.

Face-to-face meetings are increasingly important in a field of such high scientific uncertainty where knowledge has to be shared intensively amongst developers and regulators alike. If we were to leave the EU the UK would lose the EMA to another country. Already, other national regulators in the EU such as those in Germany and Denmark are eyeing up the possibility of enticing the central EU agency to their own shores.

We would also certainly lose our position in shaping regenerative medicine regulation in the EU. This would be a great shame, not to say ironic, as the UK has played a significant part in creating these laws, such as the EU’s Advanced Therapy Medicinal Product Regulation. UK regulators and MEPs played a significant part in negotiating this Regulation, including its support for the medical device component of regenerative products – an important industry sector in the UK.

The UK would also suffer when science-based medical products reach the market. UK companies would have to negotiate separately with individual EU countries, and this would be negative not only for UK bio-businesses but also for patients across Europe who, if we remained as part of the EU, would be able to obtain vital products more quickly. 

Regenerative medicine is a highly complex, global, early-stage and evolving field in which the UK has a major stake.

Photo courtesy of South Florida Sun (CC BY 2.0)

In January 2016 the House of Commons Science and Technology Committee launched an Inquiry into the impact of EU regulation and policy on the UK life sciences, motivated by the Brexit debate. It has taken oral evidence from regulators, trade associations, companies, universities and medical scientists, and it is still open. Under very strong questioning, the overall message so far is somewhat in favour of remaining in the EU.

Of course it’s easy to prefer the devil you know to one you don’t, but the fact remains regenerative medicine is a highly complex, global, early-stage and evolving field in which the UK has a major stake. Needless to say, there are downsides to EU membership, such as cumbersome negotiation procedures, but as with other areas of innovative science and medicine in which the UK is strong, the arguments for Brexit don’t stack up for the regenerative medicine field.