UK drugs watchdog warns it will struggle if Britain leaves EU

Mon May 23, 2016 10:02am EDT
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By Ben Hirschler

LONDON May 23 (Reuters) - A British vote to leave the European Union would disrupt and could well delay the approval of new drugs, leaving UK regulators struggling to cope, the chairman of the country's medicines watchdog said on Monday.

Michael Rawlins, who chairs the Medicines and Healthcare Products Regulatory Agency, said the UK watchdog would need to hire hundreds more staff to handle drug applications.

"We'd have to enlarge ourselves hugely because we'd have to evaluate all new drugs. Not only that, I don't know how it would be paid for," he told reporters.

Currently, the European Medicines Agency (EMA) approves new drugs for all EU countries. While Britain could continue to take part in the EMA system if it remains in the European Economic Area, like Norway, many advocates of a so-called Brexit oppose that option.

"That would leave us entirely on our own," Rawlins said. "Barmy!"

The head of research at top UK drugmaker GlaxoSmithKline said the hiatus would come at an especially bad time, given a raft of promising new treatments in company pipelines, including novel cancer medicines and gene therapies.

"The last thing anyone needs in the middle of that is regulatory uncertainty," said Patrick Vallance, GSK's president of pharmaceutical R&D.

The strong endorsement of Britain remaining in the EU, one month ahead of a British referendum, reflects the concerns of many scientists and company executives working in the highly regulated drugs sector.   Continued...