Britain’s prime minister has called for the U.K. to remain part of the European Medicines Agency (EMA) after Brexit. The proposal chimes with the wishes of the biopharma industry, but it remains to be seen whether the European Union is receptive to the idea.
Prime Minister Theresa May discussed the U.K.’s future relationship with the EMA in a speech that gave the clearest picture of her position to date. May wants to “explore … the terms on which the U.K. could remain part of” the EMA and certain other European agencies. The prime minister sought to paint the arrangement as a win for both the U.K. and the EU.
“Membership of the [EMA] would mean investment in new innovative medicines continuing in the U.K., and it would mean these medicines getting to patients faster as firms prioritize larger markets when they start the lengthy process of seeking authorizations. But it would also be good for the EU because the U.K. regulator assesses more new medicines than any other member state. And the EU would continue to access the expertise of the U.K.’s world-leading universities,” May said.
Many people in the biopharma industry, which has lobbied for the retention of something like the status quo, agree with May’s assessment of the win-win nature of the U.K. staying in the EMA. Both of the U.K.’s main biopharma trade groups welcomed May’s comments, with BIA CEO Steve Bates saying “it’s good to see the PM articulating the practical dynamics of our industry.”
The big outstanding question is whether the U.K. can also win the support of EU negotiators. May acknowledged the U.K. would need to abide by the EMA’s rules and make “an appropriate financial contribution” to remain part of the agency. But also said the U.K. “could decide not to accept these rules.”
May accepts there would be consequences to diverging from EU rules but wants to retain the option to do so to appease the pro-Brexit wing of her political party, the media and the country at large. That puts May at odds with the EU.
Speaking the day before May’s statements, the EU’s chief negotiator Michel Barnier said that “in the absence of EU law that can override national law, in the absence of common supervision and a common court, there can be no mutual recognition of standards.” That position clashes with May’s desire to have the power to diverge from EU rules and to “resolve certain challenges related to the agencies through U.K. courts rather than the [European Court of Justice].”
The lack of precedent for the U.K.’s desired relationship with the EMA could also be a problem. May’s vision is for the U.K. to take “associate membership” of the EMA. Some European agencies, such as the European Aviation Safety Agency, already have associate members. But while the EMA works with countries outside of the EU, none of its existing relationships map perfectly on to May’s vision.
Countries outside the EU but within the European Economic Area (EEA), such as Norway, are part of the EMA. Switzerland, which isn’t in the EU or EEA, works with the EMA through bilateral agreements but the scope of that relationship falls short of that envisaged by May. Given the U.K. is unwilling to stay in the single market created by the EEA, it is questionable whether the EU will permit it to stay in the EMA.
Whatever the outcome, May has moved the discussion forward after 20 months in which it was unclear exactly what the U.K. wanted, let alone whether it could get it. May’s speech went some way to formalizing the position government ministers set out in a public letter last year. And it moved the U.K. further away from the bullish front it presented in the months after the referendum, when a senior minister dismissed the need to stay in the Europe-wide regulatory system.