EMA, UK Biotech

Drop in clinical trial numbers underscores drugmakers’ fears over Brexit that trace back over a year

A week ago, Recardio announced it would cut UK trial sites out of its upcoming heart drug study citing Brexit fears that quickly reverberated across the industry. It turns out that the little biotech was merely following a trend that already emerged last year.

In 2017, a total of 597 trials were launched in Britain — 25% lower than the average between 2009-16, according to an analysis by Fitch. In those eight years, the average number of new clinical trials was 806.

Sheuli Porkess

In light of the UK’s impending departure from the European Union — and in preparation for a worst case no-deal scenario — drugmakers including AstraZeneca, Sanofi and Novo Nordisk have begun stockpiling drugs to alleviate the impact of a possible interruption in drug supplies. But concerns about how the EMA, soon to be relocated from London to Amsterdam, will handle clinical trial data from the UK are relatively new and could spell longterm trouble for the R&D hub.

“We know from our members that Brexit-related uncertainty is a major concern when it comes to decisions about whether to set up trials in the NHS,” Sheuli Porkess, deputy chief scientific officer at the Association of the British Pharmaceutical Industry, told Reuters. “This is why it’s vital that we get a Brexit deal to keep the investment and skills in clinical trials here in the UK.”

Though Parliament voted in July to make it a negotiating objective for the UK government to seek its participation in the European medicines regulatory network, with negotiations between London and Brussels still shrouded in uncertainty, there’s little clue how — or whether — that would happen.

The Medicines and Healthcare products Regulatory Agency, formerly an affiliate of the EMA, will likely become the country’s top drug regulator post-Brexit. The degree of interaction it will have with the European system remains to be seen.


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