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 Cancer drugs and therapies for rare diseases could be particularly
affected by an exodus of key scientific and administrative staff
during the move, which has been triggered by Britain's decision to
leave the European Union. The European Medicines Agency (EMA) must
be headquartered in an EU country.
"Oncology is a good example. The pipelines are very promising for
new cancer options and if there is severe disruption those might be
delayed or prove impossible to approve," said EMA chief Guido Rasi.
Based in London since 1995, with a staff of around 890, the EMA acts
as a one-stop-shop for approving and monitoring the safety of drugs
across Europe.
Now it is about to be uprooted as a result of Brexit and a staff
survey last week found that between 19 percent and 94 percent of
employees were likely to leave after the move, depending on which of
19 possible locations is chosen.
At stake is not only the smooth-running of the European Union's drug
approval process - vital for both patients and companies - but also
public safety, if regulators fail to react to a side-effect problem
or quality issue in a timely fashion, Rasi said.
The EMA deals with more than a million reports of adverse drug
reactions every year. It also inspects manufacturers worldwide and
in recent years has suspended hundreds of drugs that fall short of
testing standards.
Most recently, the agency's safety role was highlighted when it held
a high-profile hearing on links between Sanofi's epilepsy drug
valproate and birth defects.
"Europe now is called on to decide not where to relocate an agency
but how to protect an activity that is crucial for public health,"
Rasi said in an interview.
NO BACK-UP PLAN
Because the work of regulating medicines is delegated by EU member
states to the EMA, there is no back-up plan if the agency is
relocated from 2019 in a city where it is impossible to operate
effectively due to staff losses.
Rasi said that in a worst-case scenario, the agency would simply no
longer be able to function. Drug approvals would grind to a halt and
Europe might have to import medicines - something that would require
new legislation.
Picking Amsterdam, Barcelona, Vienna, Milan or Copenhagen as the new
headquarters would be the best option for retaining staff, according
to the survey of its workers. Any of the other 14 sites would spark
large staff losses.
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All of the top five candidate cities favored by EMA staff are in
countries that already host one or more EU agencies. Some of the
lower ranking cities are in Bulgaria, Croatia, Slovakia and Romania,
where there are none.
Rasi said the scale of the potential staff exodus was "much worse
than anticipated" but reflected the upheaval facing employees, many
of whom have children established in London schools and working
spouses in the city.
"This has not been reflected upon enough," he said.
The European Commission on Saturday published its assessment of
different locations for the EMA and the smaller European Banking
Authority, which will also have to leave London because of Brexit.
The Commission did not rank the rival bidding cities, many of which
have lined up sweetheart deals to lure the two agencies.
EU leaders will make the final location decision on Nov. 20, but the
need to ensure business continuity could clash with another
cherished ambition of spreading the bloc's agencies more evenly
across Europe, particularly in eastern member states.
Relocating the EMA before Britain leaves the EU in March 2019, as
current plans dictate, involves a very tight schedule. In 2014, the
agency moved just 800 meters to a new office block within London's
Canary Wharf financial district - a shift that took three years from
signing a lease to moving in.
Rasi, at least, is committed to go wherever his political masters
send him. "The captain is the last to abandon the ship," he said.
(Reporting by Ben Hirschler, editing by Peter Millership)
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