The past month saw Holland edge a head to head battle with Italy to host the European Medicines Agency. The move from London to Amsterdam exposes the depth of impact of Brexit. Although some Brits may struggle with being European, in the medical world we are tied together with an umbilicus – from research to regulation.
There is a clear loss of knowledge, insight and experience, with not all of the staff wanting to relocate to Amsterdam. But, the real impact of this relocation extends far beyond just changing the host city.
The reality that the UK will leave the EU will have very significant implications for how new medicines, devices and diagnostic tools are developed and approved in the UK. Many questions remain about how the UK will regulate new medicines after the tried and tested processed of the EMA no longer apply. There will be, much as the rest of Brexit, anxiety as the familiarity of known regulations, and how to navigate through them, are gone. In contrast, there is the opportunity to implement what is best about the EMA, in a model which could position the UK as an early adopter of medical innovation. Can the UK implement a regulatory pathway which is safe and effective whilst being responsive and agile, two phases that are rarely aligned with medical regulation?
Regulatory processes for new medicines, devices and diagnostic tools have developed over time to ensure that they work and are safe. Although they are sometimes complex and cumbersome, they have evolved deliberately.