Will UK stay in EMA after Brexit?

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

In the last weeks there were some rumours about the UK remaining member of the European Medicines Agency (EMA) even after leaving the European Union (the so called Brexit). Manufactures of medicinal products are strongly supporting such an approach ("Drug firms push for UK to remain part of EU medicines agency"). According a Sunday Express article, the "Prime Minister and the opposition have both demanded continued membership of the European Medicines Agency (EMA) after the country leaves the European Union". In this context, Theresa May said that "the UK and EU would both benefit from Britain's continued EMA membership".

Would this generally be possible?

The answer is 'yes'. Countries outside the EU but within the European Economic Area (EEA), such as Iceland, Norway and Liechtenstein, are part of the EMA. Switzerland, which isn't in the EU or EEA, works with the EMA through bilateral agreements and has implemented basic EU GMP and GDP guidance.

But looking at the current discussion, it seems unlikely that UK will be part of EEA. And bilateral agreements are not part of the discussion yet.

The European Commission has a strong response to other suggestions, which makes it clear that a non-member state can not enjoy the same benefits as a member. This is summarised in a respective draft guideline presented by Donald Tusk in a recent statement: "The European Council further reiterates that the Union will preserve its autonomy as regards its decision-making, which excludes participation of the United Kingdom as a third-country to EU Institutions, agencies or bodies".

The document even criticises these approaches as "cherry picking". In his statement, Tusk makes clear that "no Member State is free to pick only those sectors of the Single Market it likes, nor to accept the role of the EC only when it suits their interest. By the same token, a pick-and-mix approach for a non-member state is out of the question".