Confidentially, EMA head Guido Rasi has said that a move from the U.K. to leave the EU was “a nightmare with immediate consequences,” although publicly the regulator has been keen to dampen concerns from behind a wall of silence.
Now, two weeks later, it has finally broken cover and said any decision to leave its current HQ in London will be down to the 27 remaining member states of the European Union and the U.K.--and not to itself.
The regulator is, behind closed doors, seeking contingency plans and had quietly backed the U.K. to remain a part of Europe. But the U.K.'s momentous decision late last month to leave the European Union, which will likely come in the next 2 or 3 years, has left the EMA’s future residency in jeopardy.
What leaving package the U.K. will be able to negotiate with the EU remains highly unclear (the country is currently also in the middle of finding a new prime minister and it will be up to them to get the best deal), and much depends on whether it remains a part of the European Economic Area.
If it does, it will likely be able to remain under the auspices of the EMA; if not, an entire new regulatory system for the U.K. will need to be created. Either way, very few people see the EMA being able to remain in a country that is not a fully paid-up member of the union.
The MHRA, the U.K.'s medicines regulatory body, already undertakes around one-third of the EMA's work on behalf of Europe--so if the U.K. goes it alone, untangling its processes would be difficult enough before assessing how easily it could take over the entire drug regulatory system for the U.K., given that since the mid-1990s most new meds have been approved centrally rather than through an individual country.
In a statement, the EMA said it welcomes noises coming from European countries vying to become its new home, but added that the decision on the seat of the agency “will however not be taken by EMA, but will be decided by common agreement among the representatives of the member states.”
It went on: “We are confident that the member states will take the most appropriate decision on EMA's location and arrangements in due course, taking also into account the complex political and legal environment generated by the outcome of the U.K. referendum.”
It added that there was “no precedent” for the situation it has now found itself in, reminding the industry that no member state has ever decided to leave the EU before, let alone one housing the EU’s central drug authority.
“The implications for the seat and operations of EMA depend on the future relationship between the UK and the EU. This is unknown at present and therefore we will not engage in any speculations.”
Meanwhile, in the face of Brexit, the biotech industry has done much to try to calm nerves, but there have been increasing warnings from academic life science research groups that leaving the EU could hit their grants longer term, as well as their ability to make R&D pacts.
- check out the EMA’s statement
Uncertainty for biotech as U.K. exits EU, prime minister to resign