United Kingdom Should Remain an EMA Member, Says Theresa May

The Center for Biosimilars Staff

On March 2, UK Prime Minister Theresa May delivered a speech on the future of the United Kingdom’s relationship with the European Union, calling for the United Kingdom to remain a member of the European Medicines Agency (EMA), and saying that the United Kingdom could commit to abiding by the rules of the EMA and “making an appropriate financial contribution” to the agency.

On March 2, UK Prime Minister Theresa May delivered a speech on the future of the United Kingdom’s relationship with the European Union, calling for the United Kingdom to remain a member of the European Medicines Agency (EMA), and saying that the United Kingdom could commit to abiding by the rules of the EMA and “making an appropriate financial contribution” to the agency.

“Membership of the [EMA] would mean investment in new innovative medicines continuing in the [United Kingdom], and it would mean these medicines getting to patients faster as firms prioritize larger markets when they start the lengthy process of seeking authorizations,” said May. “But it would also be good for the [European Union], because the UK regulator assesses more new medicines than any other member state. And the [European Union] would continue to access the expertise of the [United Kingdom’s] world-leading universities.”

At the same time, May left open the possibility that the nation might not accept European rules on remaining part of the EMA: “Of course, Parliament would remain ultimately sovereign. It could decide not to accept these rules, but with consequences for our membership of the relevant agency and linked market access rights.”

In response to May’s speech, Bioindustry Association (BIA) CEO Steve Bates said that “It’s good to see [May] articulating the practical dynamics of our industry of the future,” and that “Her language reflects the work that the BIA has undertaken on regulatory cooperation since before the referendum, as well as the desire of patient, [National Health Service] Confederation and European coalitions.”

In delivering the Association of the British Pharmaceutical Industry’s (ABPI) response to the speech, Mike Thompson, ABPI’s chief executive, said, “Every month, 45 million packs of medicines move from the [United Kingdom] to the [European Union]—and 37 million come the other way. That is why the prime minister’s commitment to seek cooperation on medicines regulation would be the best outcome for patients, not just in the [United Kingdom] but across Europe.”

However, cautioned Thompson, cooperation on regulatory matters is only part of the challenge posed by Brexit; ensuring that the supply of medicines remains uninterrupted throughout the United Kingdom and EU territories is critical. Thompson went on to call for establishment of a transition period for the pharmaceutical industry to move to a new framework, and underscored the importance of securing the ability to freely trade and transport medicines across borders, to establish predictable access to funding for scientific research, to form an immigration framework that will allow for skilled professionals from around the world to work in the pharmaceutical industry.

Meanwhile, the EMA is preparing for its relocation from London, United Kingdom, to Amsterdam, the Netherlands, prior for March 29, 2019. Today, the EMA published a new, interactive tracking tool that shows the major milestones of and deliverables associated with the move, with the goal of “giving stakeholders and the public full visibility of the relocation project.”