News about GMP/cGMP


Will the UK Be Part of EMA After Brexit? –EC and UK Follow Different Approaches

While Theresa May promoted the benefits of the UK becoming an associate member of the EMA, the EU took quite an opposite position. In a draft guideline published on 7 March 2018 the EU sets out how the EU council sees its future with the UK. A comment by the British newspaper “The Guardian” states that while the British government does Brexit by speeches the EU prefers releasing documents.

The UK biopharma industry supported May in her intention to further remain under the lead of the European Medicines Agency (EMA). She asked the EU for not getting the UK into trouble by moving it into trade models that are designed for much more distant and smaller countries.

And the EU?
The draft guideline reaffirms that being outside of the union could never be as good and profitable as being a member:

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” and the anticipated free trade agreement between the UK and EU “cannot offer the same benefits as membership and cannot amount to participation in the single market or parts thereof.

This means that moving goods across the EU-UK-border will definitely become harder. The European Council recalls that the four freedoms of the Single Market are indivisible and that there can be no “cherry picking” through participation based on a sector-by-sector approach, that would undermine the integrity and proper functioning of the Single Market.

The Council strengthens its position in an explicit way: One possibility for the UK is to join Norway and other countries as a non-EU member of EMA. But if the UK decides to leave the single market and take the power to “decide not to accept” EMA rules, it is clear that those desires are incompatible with EMA membership.

What happens next?
As complete trade talks will begin on UK’s final leave of the EU in March 2019, the final trade deal might take its time. This latest document also contains the EU’s well-known warning “Nothing is agreed until everything is agreed” which means that until a finalized divorce, no progress in trade talks will be made.

A final version of the 6-page-guideline will be discussed at the summit of European leaders by the end of March.


EU Council: EU draft guideline

The Guardian