FiercePharma | Eric
Palmer
The
European Medicines Agency, the drug regulator for Europe, is headquartered in
London. The problem is that the U.K. voted Thursday to leave the European
Union, meaning the EMA will now have to leave and find a new home. It is one of
the countless concerns that affect the pharma industry with Britain’s historic
vote to give up on European unity.
Over
the warnings of business leaders in pharma and all other industries, U.K.
voters by a 52% to 48% margin opted to quit the E.U. While the vote is not
even legally binding, U.K Prime Minister David Cameron has said he would
do as voters decided. He has pledged to resign.
The
financial reaction was immediate and messy. The London FTSE 100 index sank by
8%, the biggest fall in more than three decades, before recovering slightly to
trade down 5%. The broader FTSE 250 index has dropped 7.5%. The pound hit its
lowest level against the dollar in 31 years touching $1.3236, as investors
tried to puzzle through what the vote means for businesses.
While
the drops were dramatic, Evercore ISI analyst Mark Schoenebaum pointed out
to investors that most major drugmakers derive less than 3% of their revenues
from sales in the U.K.
And
not all investors were panicked by the decision. Pharma investment specialist
Neil Woodford said in a statement “in our view, it is not as negative a
development as the market's initial react appears to imply." Woodford, who
has backed a breakup of U.K.-based GlaxoSmithKline, acknowledges there
are uncertainties and challenges, but thinks the industry faces a lot more
than whether the U.K. is a member of the European Union. ”Many of the
greatest economic challenges that we face now and in the future, in my view,
dwarf the economic issues associated with today’s outcome.”
That
is the future but for now, everyone is focused on figuring out how their
particular concerns will be affected. Warwick Smith, director general of the
British Generic Manufacturers Association and the British Biosimilars
Association, in a statement pointed to the benefits that a single European
marketing authorization has had for drugmakers and Britain's National Health
System by reducing complexity and cost for drugmakers. He raised the possibility
that the U.K. would continue to work through the EMA.
“The
UK generic and biosimilar medicines industry therefore urges the government to
do everything possible to maintain this European marketing authorisation system
in the forthcoming negotiations with the European Union,” Smith said.
Global
legal experts Dechert parse the concerns in more concrete terms. The
firm pointed out that, besides being home to the European Medicines
Agency, the U.K. has provided a voice for industry at the EU table that will
now be lost.
On
a more practical level, Dechert said businesses must figure out what the move
means to trade agreements which affect their supply chains, and the tariffs
involved. For intellectual property, it said that trademark owners that have
relied on an EU approval may lose their protection until they can
convert to a U.K. trademark, which will come at additional cost. The vote may
affect the future of the “unitary patent,” which was to go into effect when the
Agreement on the Unified Patent Court went into force.
Dechert
does point out that not all these things have to be figured out immediately.
Once U.K. officially notifies the European Council its intention to leave,
EU treaties have a two-year time limit for the exit to begin and can be
extended if all sides agree. The treaties do not set a time limit for the U.K.
and EU to remake its relationship.
As for the EMA, there is little doubt that it will find a new home, even though it just moved into its new building two years ago. Already, officials in Italy, Sweden and Denmark have all expressed interest in taking over as host country, Politico reports.
One of those to step forward was, Luca Pani, director general of Italy’s drugs agency AIFA, Politico said. He pointed out that the current head of the EMA, Guido Rasi, is from Italy and spent his career at AIFA before being named director of the EMA. “We are firmly convinced that Italy would make an ideal candidate to host the European Medicine agency,” he told Politico earlier this year.
As for the EMA, there is little doubt that it will find a new home, even though it just moved into its new building two years ago. Already, officials in Italy, Sweden and Denmark have all expressed interest in taking over as host country, Politico reports.
One of those to step forward was, Luca Pani, director general of Italy’s drugs agency AIFA, Politico said. He pointed out that the current head of the EMA, Guido Rasi, is from Italy and spent his career at AIFA before being named director of the EMA. “We are firmly convinced that Italy would make an ideal candidate to host the European Medicine agency,” he told Politico earlier this year.
