12.2018 | THE SCIENTIST 61BIO BUSINESS© ISTOCK.COM, STUART RITCHIE
O
n June 23, 2016, Britain stunned
the world when a slight but signif-
icant majority of voters elected to
leave the European Union. The decision to
depart has left many businesses, including
pharmaceutical firms, rushing to prepare for
the changes that Britain’s exit, or Brexit, will
bring. “A vote to leave is the gamble of the
century,” David Cameron, then British prime
minister, wrote months ahead of the referen-
dum. “And it would be our children’s futures
on the table if we were to roll the dice.”
Brexit is scheduled for March 29, 2019.
The country’s planned departure from the
EU, an economic and political coalition of
28 European countries, has led to months of
messy negotiations, as politicians scrambled
to agree on how the relationship between the
UK and the EU will look post-Brexit. Little
progress was made for most of this period—
with no final agreement on Britain’s exit deal
yet approved.
Belonging to the EU means being part
of the single market, which allows peo-
ple, goods, services, and money to move
freely across member countries’ borders.
Although Brexit will likely mean relin-
quishing access to this market, UK and EU
negotiators have agreed that a withdrawal
deal should include a post-Brexit transition
period of two or more years to allow gov-
ernments time to work out and implement
the legislative details. But as talks have
stalled in the second half of this year, the
UK government has also warned of a “no-
deal” Brexit, in which Britain’s ties to the
EU would be immediately dissolved, mak-
ing it subject to tariffs on goods and addi-
tional border checks for its citizens.
Uncertainty about the UK’s future
relationship with the EU is a problem for
the pharmaceutical industry, where the
development of drugs and other products
depends on the political and regulatoryconditions of a country, and often requires
planning years in advance. “The time frame
since the UK voted to leave has been par-
ticularly challenging for our sector,” says
Alan Morrison, the vice president of inter-
national regulatory affairs at the American
pharmaceutical giant Merck & Company,
which has facilities all over the world.
“Product development can take ten to fif-
teen years, and manufacturing schedules
are also made significantly in advance.”
Life sciences firms are among the
biggest contributors to the British econ-
omy. A 2017 report by Pricewaterhouse-
Coopers noted that in 2015 they employed
482,000 people and contributed £30.4
billion (around $40 billion USD) to the
country’s GDP. And the industry has close
ties to the EU: millions of packs of medi-
cines travel between the UK and continen-
tal Europe on a monthly basis, and the UK
has long been home to the European Med-
icines Agency (EMA), the body responsi-ble for evaluating pharmaceutical prod-
ucts in the EU.
“A ‘no-deal’ Brexit would mean the big-
gest disintegration of the complex regu-
lated medicines market in Europe in terms
of regulation, cross border movement of
goods, comparative pricing, and intellec-
tual property,” Laura Collister, the Brexit
lead for the BioIndustry Association (BIA),
a trade group for life sciences in the UK,
writes in an email to The Scientist.
To mitigate the effects, drugmakers have
been readying themselves for the changes
Brexit may bring, Morrison says. “The posi-
tion from the industry has been to have busi-
ness continuity plans to address the whole
range of potential Brexit scenarios.”From London to Amsterdam
One of the biggest consequences of Brexit
for the biomedical industry is the relocation
of the EMA. In November 2017, the Nether-
lands won the bid to host the new EMA head-As Britain’s scheduled departure from the European Union approaches, drugmakers
are preparing for potential changes to regulatory procedures and border controls.BY DIANA KWONBracing for Brexit