No EMA Membership For UK After Brexit, Says European Council
Executive Summary
The European Council’s draft guidelines on the future UK-EU relationship say that the UK, as a third country outside the EU single market, will not be able to participate in any EU agencies after Brexit, dashing hopes expressed by the government that the UK could have “associate membership” of the EMA. However, the UK BioIndustry Association remains optimistic that some form of regulatory cooperation can be negotiated in the interests of all stakeholders.
The European Council says that the UK will not be able to take part in any EU agencies after Brexit, directly contradicting suggestions by prime minister Theresa May last week that the UK could seek “associate membership” of the European Medicines Agency after March 2019.
The statement is contained in the draft guidelines drawn up by the council on the future relationship between the UK and the EU, which have now been sent to the EU27 member states. It says: “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.”
The statement will disappoint those who were hoping for some form of role for the UK in the EMA despite its decision to leave the EU. May said in her Brexit speech on March 2 that securing “associate membership” of the EMA would ensure the agency retained the expertise of the UK regulator, the MHRA, and would “mean investment in new innovative medicines continuing in the UK and would mean these medicines getting to patients faster” because pharmaceutical companies prioritize “larger markets” when seeking marketing authorizations.
The proposal had been welcomed by UK industry bodies, with the Association of the British Pharmaceutical Industry and the BioIndustry Association saying the idea of EMA membership was worth exploring.” (Also see "UK Wants ‘Associate Membership’ Of The EMA After Brexit, Prime Minister Says" - Pink Sheet, 2 Mar, 2018.)
But it was always unlikely that the EU would be receptive to such an idea, given the government’s insistence on pulling out of the EU single market and the widespread view that the UK is trying to “cherry pick” those parts of the single market it wants to keep access to.
Before the guidelines were released, Stefaan De Rynck, an adviser to the EU’s chief Brexit negotiator, Michel Barnier, had said that EU agencies “operate in a context where single market principles operate” and that while their work is technical, “it can become political.”
De Rynck pointed out that there are only three third countries that participate in EU agencies across the board: "the three EEA members, and they have to accept all the rules.” The EEA (European Economic Area) countries are Iceland, Liechtenstein and Norway; the UK has ruled out EEA membership.
In a March 7 statement on the draft guidelines, council president Donald Tusk said: “No member state is free to pick only those sectors of the single market it likes, nor to accept the role of the ECJ [the Court of Justice of the EU] 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.”
On the idea of “associate membership” of the EMA, Els Janssens, senior associate at law firm Baker & McKenzie, told the Pink Sheet it was difficult to see how this would work in practice. Janssens added that there were also “inherent contradictions” in the UK proposing to become an “associate member” of the EMA while also stating that parliament will ultimately remain sovereign and rejecting the jurisdiction of the Court of Justice of the EU. “Such views are now supported by the European Council’s draft guidelines for negotiating the future relationship which were published yesterday,” she said.
“The Council rejects the idea that the UK as a third country outside the single market can participate in EU agencies after Brexit and states that the rights of the ECJ must be fully respected,” Janssens continued. “In the document the EU reiterates its position that 'cherry-picking' could not be tolerated. In simple words, Brussels’ position is: Either you are in or out and out means out. We note that the guidelines are still in draft form but we do not expect a change on this point.”
Given the latest developments, she added, “companies are strongly advised to keep their contingency planning firmly on track.”
BIA Disappointed But Optimistic
BIA CEO Steve Bates said the council guidelines were "disappointing as they fail to recognise the clear benefits to both the UK and EU of ongoing cooperation on medicines regulation." However, he was optimistic that some kind of accommodation might be reached, noting that the European Parliament has called for "particular action to be launched in the area of continued and safe access to medicines and medical devices for patients." The parliament "is not in the same place as the [European] Commission - these are initial draft negotiating positions from the council, as was last week’s speech from Theresa May for the UK," he noted.
Bates told the Pink Sheet that the EMA had "a myriad of relationships with countries outside the EU," and had "always had a pragmatic approach to forming and maintaining relationships with national regulators." Any lack of cooperation "could damage the supply of medicines moving between the UK and EU and vice versa and put patients at risk," he declared. "With the compelling need of patients at the heart of the argument, the BIA remains confident that a positive outcome on medicines regulation that benefits all can be negotiated."
Free Trade Agreement
Regarding the negotiations on the future relationship between the UK and the EU, Tusk said that because of the UK’s “red lines” on the single market, customs union and the European Court, “it should come as no surprise that the only remaining possible model is a free trade agreement.”
He continued: “I propose that we aim for a trade agreement covering all sectors and with zero tariffs on goods. Like other free trade agreements, it should address services. And in fisheries, reciprocal access to fishing waters and resources should be maintained.”
This positive approach, he said, “doesn't change the simple fact that because of Brexit we will be drifting apart. In fact, this will be the first FTA in history that loosens economic ties, instead of strengthening them. Our agreement will not make trade between the UK and the EU frictionless or smoother. It will make it more complicated and costly than today, for all of us. This is the essence of Brexit.”
This article has been updated with comments from the BIA.
From the editors of Scrip Regulatory Affairs.