The UK’s Prime Minister last week singled out the EU pharmaceuticals regulatory regime as one in which the UK could continue to participate post Brexit. The pharmaceuticals industry, which has been asking for continued alignment since the UK referendum, welcomes this development. However, the proposal and its apparent inherent contradictions – in the context of the ongoing EU/UK negotiations – may not provide enough clarity to allow pan-EU companies sufficient confidence in the post-Brexit landscape to put their contingency planning on hold.
In a speech delivered at London’s Mansion House on Friday 2 March, Theresa May has suggested that, following Brexit, the UK could become an “associate member” of the European Medicines Agency (EMA). She said that she understood that this would involve abiding by the rules of the EMA and “making an appropriate financial contribution”. Mrs May also said “associate membership of [such] agencies is the only way to meet our objective of ensuring that these products only need to undergo one series of approvals, in one country.”
It is encouraging to see that the UK puts a continued participation in the EMA on the Brexit negotiating table, but questions remain about the feasibility of an associate membership of the EMA when leaving the single market. Norway, Liechtenstein and Iceland are within the single market but have no decision making powers; and it is not only the political argument: Mrs May did not explain what it would mean to “abide by” the rules of the EMA, given she plans to give the UK parliament the ultimate right to accept or reject any piece of EU legislation. Having UK courts decide over matters that can influence the parameters in which EMA scientific assessments take place may simply be a deal-breaker for the EU.
Michel Barnier, the EU’s chief Brexit negotiator, reacted by welcoming the clarity of leaving the single market offered by Theresa May’s speech as well as the acknowledgement of trade offs by the UK’s PM. However, even if the UK were to accept concessions such as observer-only status to the EMA, renouncing the UK parliament’s privilege to reject EU pharmaceutical laws, and agreeing to the jurisdiction of the European Court of Justice in all EMA matters, it remains to be seen if the EU is able to agree to extend access to the EU pharma regulatory system to a country that will not be part of the single market.
For Mike Thompson, the chief executive of the ABPI, close cooperation on the regulation of medicines as proposed by May is only one part of the challenge. As highlighted by the BIA, 82 million patient packs travel between the UK and EU each month. Making sure the supply of medicines across the UK and EU is uninterrupted from day one of Brexit is essential for patient safety and needs to be a priority for negotiators.
The Brexit Health Alliance also praised this development. It has long called for certainty and cooperation to safeguard the future of research into new medicines and medical technologies, cautioning that around 750 UK-led clinical trials that cover multiple EU member states could be at risk without an urgent plan on how to approve and mange these multi-national trials post-Brexit. It warns that up to 120,000 prostate cancer patients throughout Europe could be affected, and flags the particular risk to research into rare childhood diseases such as neuroblastoma.