Brexit Case Study

On June 23, 2016, the UK voted to withdraw from the European Union, raising many questions about the future of clinical trials. However, Brexit wasn’t the beginning of the conversation, and it certainly isn’t the end.

Before the vote, the “Leave Campaign” claimed that EU Clinical Trials Directive hindered innovation for Medical Devices in the UK. "Weaknesses in the 2001 Clinical Trials Directive significantly increased the administrative burden and cost of running academic clinical trials and saw a reduction in trials taking place in Europe." Stated a report from The Commons Science and Technology Committee. Even with the new rules of the MDR being implemented, people believe the UK’s freedom from the regulations of the EU would advance innovation significantly.

Others argued the opposite, in a letter to The Times Royal Society fellows commented that Brexit would be a “disaster for UK science”. The main reasons being: “increased funding has greatly raised the level of European science as a whole and of the UK in particular” and “we now recruit many of our best researchers from continental Europe, including younger ones who have obtained EU grants and have chosen to move here with them.”

So what have we seen so far? Challenges:

Investment and funding is a main concern for the industry. People are worried that

“Generally, the UK 's position in the clinical trials space has been improving with NIHR (National Institute for Health Research) support and much greater NHS commitment to clinical trials. There has been a concerted change in attitude toward clinical trials being relevant to activity of the NHS as well as the medical schools, which have always been interested in terms of trials. I think ultimately it would be a disaster if things like Brexit damaged that growth against our European