Will Brexit mean a controversial exit for drug regulation, too? Minister won't rule it out

George Freeman
U.K. Life Sciences Minister George Freeman

Will pharma’s Brexit fears come to pass? The U.K.’s life sciences minister, George Freeman, has set up a steering group to weigh in during breakup negotiations with the EU--and he’s not ruling out the idea of splitting Britain’s drug regulation away from the European Medicines Agency.

The steering group, chaired by GlaxoSmithKline CEO Andrew Witty and AstraZeneca CEO Pascal Soriot, will be tasked with considering “opportunities for the U.K. life sciences sector outside of the EU regulatory environment,” Freeman said during a press briefing in London Thursday morning.

Freeman’s most pressing message was that the EU system will stay in place for at least two more years while Britain negotiates terms for its exit. And the minister said his working group is in part designed to make sure that the life sciences industry has a voice in those negotiations.

With Witty and Soriot in the top chairs of this group--and “support” provided by the Association of the British Pharmaceutical Industry and the Biotech Industry Association--presumably pharma’s worries about a separate U.K. regulatory system will be heard.

One worry is the cost of such a system. The other is that new medicines would reach the U.K. only after they launch in Europe. “[T]he reality is that the U.K. process would come second”, ABPI CEO Mike Thompson recently told EP Vantage. “A rational decision from a pharma company would be to get registration in a market which will give 500 million patients access to the medicine versus 60 million patients.”

Generics makers aren’t thrilled by the idea of an independent regulatory body, either. They’d like Britain to stick with centralized EU oversight. “The U.K. generic and biosimilar medicines industry ... urges the government to do everything possible to maintain this European marketing authorisation system in the forthcoming negotiations with the European Union,” Warwick Smith, director general of the British Generic Manufacturers Association, said after the Brexit vote.

But Freeman and other leaders aren’t completely averse to the idea of charging Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) with regulating biopharma separately. And Freeman has some of his own ideas about bringing new treatments to the U.K.; his Accelerated Access Review project, scheduled for an unveiling in the fall, will set out proposals for changes to clinical research and pricing processes, among other things, pharmaphorum reports.

For instance, Freeman has suggested that the MHRA could work more closely with England’s cost-effectiveness watchdogs at the National Institute for Health and Care Excellence to speed coverage decisions for new drugs.

Britain will continue to be “influential” in the EU life sciences world, one way or the other, partly because of its strengths in clinical research, Freeman promises. But working independently could have its advantages, he said Thursday. “[T]here is an ambition if we are outside the formal EU regulatory process to make sure that we exploit that freedom,” he said.

The new steering group will first meet in September, according to the U.K. Bureau of Industry and Security. In the meantime, its members will be working on recommendations for regulation, intellectual property, research and trade. They’ll also be considering “people and skills,” to help prevent a “brain drain” of scientists and executives decamping for posts in Europe.

- see the EP Vantage post
- read the pharmaphorum coverage

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