This article is part of our special report European Medicines Agency: What’s at stake?.
The debate over where to relocate the London-based European Medicines Agency (EMA) after Brexit has divided the remaining 27 EU member states, despite calls for an urgent decision from the drugs industry and patient groups.
Newer EU members from Central and Eastern Europe have called for “geographical balance” in the relocation decision while older states say the primary concern should be ensuring its “business continuity”.
In June, European Council President Donald Tusk and European Commission chief Jean-Claude Juncker presented the procedure for relocating EMA and the European Banking Authority (EBA) after Brexit.
EU-27 leaders then endorsed the procedural arrangements at the June European Council summit.
The EMA is an EU regulatory authority which ensures that medicines available to more than 500 million citizens across Europe are appropriate and safe. The agency is currently headquartered in London but will have to move once the UK leaves the EU.
Hosting the EMA brings considerable economic benefits to the host city as the service employs more than 1,000 people, paid by the EU. Around 20 countries across the bloc have already stated their intention to host the EMA, so competition will be tough and proceedings complicated.
Member states have until the end of July to submit their bids to host the two agencies, based on particular criteria. The Commission will then review the bids by 30 September.
The final decision is expected in November and, according to the rules, a Eurovision-style voting process will take place. For many, this was the most suitable option considering the high number of candidate countries.
Commission sources have stressed that the UK would have no say in the process but would have to facilitate the transfer of the two agencies.
The question of “decentralisation”
The agreed upon EU document states that the relocation decision will be a combination of objective criteria and the “desirability of geographical spread”.
The accessibility of the location, the existence of adequate educational facilities for the children of EMA staff, as well as job opportunities for their family members, are among the objective criteria.
Some member states already host one or more EU agencies. Others, especially the newer members from Eastern Europe, have no agencies on their territory.
In the 2003 Joint Statement and Common Approach on Decentralised Agencies, EU leaders recognised the need to give priority to new member states when distributing the seats of new agencies that may be set up in the future.
In the case of the EMA, the Commission paper acknowledges that the procedure concerns relocation, rather than a new agency. However, it states that “the spirit of that leaders’ agreement should be taken into account”.
“A judge looks at both the letter of the law and the legislator’s will,” an EU diplomat commented.
Diplomatic sources from newer member states stress that they had initially hoped that bids from countries without any EU agencies would be given priority.
“The geographical equilibrium is crucial […] we have been vocal in supporting the decentralisation argument as all the big EU institutions are in the west,” the sources told EURACTIV.com.
“Don’t gamble with patients”
But some older member states underline that the EMA is an existing EU agency and should be treated as such. “When the initial discussion for the location of the EMA took place years ago, some states that are now members of the EU weren’t even there,” a source said.
In addition, a Western diplomat said emphasis should be placed on “business continuity”, ensuring the “continued functionality at the existing high level”.
“We have to focus on the role of the EMA, which is essential for health systems. It’s an expert field, one cannot gamble with the EMA ,” the diplomat said, adding that EU leaders should avoid a scenario in which patients pay the price for political games.
“Almost 20% of the work is being carried out by the British regulator […] If it ultimately goes to a country whose regulator does not have the capacity, then what happens if something goes wrong?” the diplomat warned.
The Commission has also called for a quick decision on both the EMA and EBA, as the two regulatory bodies must continue to “function smoothly and without disruption beyond March 2019”, when the UK is due to leave the bloc.
Patients and pharma
The pharmaceutical industry and patient groups also agree that a quick relocation of the EMA would be in everyone’s best interest.
In April, three patient groups (European Patients Forum, European Consumer Organisation and Rare Diseases Europe) sent a letter to the EU’s Brexit negotiator, Michel Barnier, and European Commissioner for Health and Food Safety Vytenis Andriukaitis, urging them to impress upon the Council the need to be “extremely vigilant in deciding on the optimal location”.
In June, the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the pharmaceutical industry operating in Europe, expressed its concerns regarding the EU leaders’ decision to postpone the talks on the EMA’s relocation.
The uncertainty over EMA’s location should end, “ensuring that transitional arrangements are in place for issues that may impact patient safety and patient health,” EFPIA said.
“It is a serious concern that the heads of states’ deliberations on the Agency’s future have not resulted in an early decision on its relocation: in the event of an obstruction or eventual failure, Europe possesses no backup option,” the industry group added.