Europe’s medicines watchdog is preparing to pack its bags and relocate from London, now that Britain has triggered the process of leaving the EU, and its executive director wants a decision on the agency’s new home as fast as possible.
The European Medicines Agency (EMA), employing nearly 900 staff, acts as a one-stop-shop for approving and monitoring the safety of drugs across Europe. Guido Rasi fears uprooting it could disrupt this work, unless done very carefully.
At stake is not only the smooth-running of the European Union drug approval process, which is vital for companies, but also public safety, should regulators fail to react to a side-effect problem or quality issue in a timely fashion.
“What I really fear is that something happens exactly during the transition phase – that is the real danger for public health,” Rasi said in an interview from his offices overlooking London’s old docks.
Relocating the EMA within the two-year window available before Britain leaves the EU in March 2019 will be tight and a stalled verdict by politicians on where it should go would aggravate matters.
“An even worse-case scenario would be a late decision,” Rasi said in his first comments since Prime Minister Theresa May formally began Britain’s divorce from the EU on March 29.
The EMA, the largest EU body in Britain, has been based in London since its birth in 1995 and it moved into new premises in Canary Wharf on a 25-year lease less than three years ago.
With an annual budget of 322 million euros ($344 million) and attracting 36,000 experts a year to London for its meetings, the agency is a prized piece of Brexit booty for other cities.
Countries vying to host the EMA include Italy, Denmark, Sweden, Spain, France, Ireland and Poland.
The relocation decision will be made not by Rasi but EU heads of state, meeting as the European Council.
“I can only look at the calendar and see when there is a meeting and hope that it comes very early,” Rasi said. “I know that the Council convene a meeting in June, so certainly there is the possibility for them to take an early decision.”
The uncertainty has already taken its toll. The EMA has lost several key staff and is finding it harder to attract recruits, while the number of applicants for its trainee program has fallen to 700 this year from a usual level of around 2,000.
Central to keeping staff and minimizing disruption will be picking a new location with good transport links and infrastructure. Rasi dismissed the need for a local science or pharmaceuticals industry base as “irrelevant”.
Brexit brings other challenges for Europe’s regulatory process, since experts from Britain’s domestic regulator, the Medicines and Healthcare products Regulatory Agency, take the lead in assessing around a fifth of all EMA drug applications.
Losing that input will mean redistributing the workload among the EU’s remaining 27 member states, although Rasi said he was “less concerned” about this than the relocation issue.
In practice, Britain stands to be the biggest loser from the regulatory decoupling, since the rest of Europe contributes 80 percent of the workload.
In a bid to limit the fallout, a joint task force of drugmakers and UK officials favor some kind of partnership deal with the EMA after Brexit, potentially allowing for mutual recognition of medicine approvals, which could help both sides.
Rasi said such an arrangement was theoretically possible but it would be up to EU governments to decide whether to offer such a deal, once Britain leaves the bloc and quits the single market governing free movement of goods, capital, services and people.
“To find a way to converge technically will not be difficult,” Rasi said. “Politically, it is beyond me.”
($1 = 0.9372 euros)
(Editing by Susan Thomas)
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