European Council Hints That United Kingdom Will Be Excluded from EMA

Earlier this month, UK Prime Minister Theresa May gave a speech discussing the future of the United Kingdom’s relationship with the European Union. In her speech, May called for the United Kingdom to remain a member of the European Medicines Agency (EMA), which is currently being relocated from London, United Kingdom, to Amsterdam, Netherlands in preparation for Brexit.

In response, the General Secretariat of the Council sent a note on its draft guidelines to the Permanent Representatives Committee.

While the Council’s note reiterated the European Union’s determination to have “as close as possible a partnership” with the United Kingdom in the future, one that would cover trade and economic cooperation as well as other areas, such as security, defense, and foreign policy, it said that “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 role of the Court of Justice of the European Union will also be fully respected.” This assertion stands in contrast to May’s statement that the UK Parliament would “would remain ultimately sovereign” with respect to adopting or not adopting the EMA’s rules and regulations.

Furthermore, the European Council noted that it must “…take into account the repeatedly stated positions of the UK, which limit the depth of such a future partnership. Being outside the Customs Union and the Single Market will inevitably lead to frictions."

Importantly, the European Commission’s draft guidelines also noted the following:

• A non-member of the Union cannot have the same rights or benefits as a member.
• The freedoms of the Single Market are “indivisible,” and there will be no “cherry picking” allowed through participation based on a sector-by-sector approach, as this would undermine the integrity of the Single Market.
• The EU will preserve autonomy in regard to decision-making.

According to the Financial Times, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency is currently leading 35% of the EMA’s medicines safety monitoring programs, and about 40% of the evaluation of highly complex therapies.