Prime Minister Theresa May highlighted in a key Brexit speech on Mar. 2, 2018 that the government is exploring terms by which the United Kingdom could remain part of European Union agencies, including the European Medicines Agency, after its departure from the EU. “We would, of course, accept that this would mean abiding by the rules of those agencies and making an appropriate financial contribution,” she said.
May pointed out that EMA membership “would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritize larger markets when they start the lengthy process of seeking authorizations.”
She added that “it would also be good for the EU because the UK regulator assesses more new medicines than any other member state. And the EU would continue to access the expertise of the UK’s world-leading universities.”
The Prime Minister’s announcement was welcomed by the BioIndustry Association (BIA), a trade association for UK bioscience enterprises. “It’s good to see the PM articulating the practical dynamics of our industry…” Steve Bates, CEO of BIA, said in a press statement. He noted that the PM has also listened to BIA members who have consistently made the case that it is strongly in their interest to have a single set of regulatory standards that mean they can sell into the UK and EU markets.
The BIA is pleased that the UK government recognizes the benefits of regulatory cooperation for medicines. Although there is still much work to be done, Bates said that this is a positive step forward on the future of medicines regulation. “It is good to see the PM’s recognition of the importance of ensuring that these products only need to undergo one series of approvals, in one country,” he added.
Regulatory cooperation on medicines between the UK and EU will benefit patients in the UK as well as the 27 EU member states. This is also the UK government’s preferred outcome, as set out by the Health and Business Secretaries in a letter to the Financial Times in July 2017.