After British Prime Minister Theresa May spoke about the mutual benefits of the United Kingdom (UK) becoming an associate member of the European Medicines Agency (EMA) last week, the European Council has dismissed the idea and downplayed the likelihood of the UK staying in the regional regulatory network after Brexit.
May won strong support from the biopharma industry by calling for the UK to continue paying into and taking its lead from the EMA. However, since details of the Council’s draft guidelines for EU Brexit negotiators emerged, doubts about the viability of May’s proposal have hardened.
In draft guidelines, the EU body wrote that “the European Council further reiterates that the Union will preserve its autonomy as regards to its decision-making, which excludes participation of the United Kingdom as a third-country to EU institutions, agencies or bodies”. This statement suggests that the UK will be prevented from continuing to participate in the EMA after Brexit.
The guidelines also contain other negative implications for the UK and its biopharma industry. For example, the anticipated free trade agreement between the UK and the EU “cannot offer the same benefits as membership and cannot amount to participation in the single market or parts thereof,” which suggests it will become harder to move goods across the UK-EU border.
The UK could join Norway and other countries as a non-EU member of the EMA if the UK were willing to stay in the single market. However, it seems as though the UK wants to leave the single market and gain the power to “decide not to accept” EMA rules, which according to the European Council are not compatible with EMA membership.
The European Council document is currently only a draft, but its stipulations are in line with comments made by important EU figures on either side of May’s speech. If negotiations do progress as foreseen in the EU guidelines, the UK will need to have its own regulatory infrastructure in place by this time next year, if a transition period is not agreed.
To read the European Council draft guidelines, please click here.