UK to align with EU clinical trial rules after Brexit

The UK will align as closely as possible with EU rules on clinical trials following Brexit, the Government has said. 

It wasn’t clear how clinical research would be regulated when the UK leaves the EU. This led to concerns that the development of new treatments through clinical trials, including cancer drugs, could be harmed and patient access to trials reduced. 

Emlyn Samuel, Cancer Research UK’s head of policy development, welcomed the Government’s commitment to align with EU clinical trials regulation as closely as possible as “fantastic news”, saying it brings greater certainty to how clinical trials will governed in the future. 

What was the problem?

New EU rules on clinical research that will help researchers from different countries work together on trials will be implemented soon. But it wasn’t clear if these would apply to the UK after Brexit. 

The UK was a driving force behind designing the new EU regulations. But because of delays, the regulations aren’t in force yet and so weren’t covered by the EU Withdrawal Bill, which will transfer existing EU rules into British law.

This left a situation where EU and UK clinical trial rules might have been different. This would have reduced patient access to clinical trials, made collaboration harder, and left researchers uncertain over how they might work in future.

The House of Lords was therefore due to vote on an amendment, which CRUK supported, to the EU Withdrawal Bill to enforce these regulations in the UK after leaving the EU. 

But before the vote the Government committed to making future clinical trial rules the same as those of the EU. The amendment was then withdrawn.

Why does it matter?

International collaboration on clinical trials is vital to develop treatments as quickly as possible, especially for rare cancers and those that affect children. This is because individual countries might not have enough patients to run trials. 

Between 2004-16 the UK participated in nearly 5000 trials with other EU countries. The UK also led the third largest number of clinical trials, after Germany and Spain. 

Of the 200 trials directly funded by Cancer Research UK, more than a quarter involve patients from at least one other EU country. 

Samuel said that the Government’s commitment reduces the uncertainty, but isn’t the end of the story. 

“Continued collaboration with the EU on clinical trials is crucial for patients and researchers,” he said. “It’s now vital that UK and EU build on this commitment in negotiations to agree further key details about how we will work together on clinical trials in the future.”