62 THE SCIENTIST | the-scientist.com
BIO BUSINESSquarters, which has been located in London
since the agency’s inception in 1995. When
the EMA migrates to Amsterdam next spring,
it will take hundreds of its current staff, and
may implement changes to rules for medici-
nal products developed and tested in the UK.
“Whether you’re a small biotech with
one product or you’re a massive company
with hundreds of products, whether you’re
a US, European, or British company, we all
go through the EMA process” to market
drugs in the EU, says Corinna Peachey, a
senior director for corporate affairs at Eli
Lilly, an American pharmaceutical firm
with a strong presence in the UK. “There-
fore, anything that could delay that has an
equal impact on all of us.”
The extent of Brexit-induced changes
to the biomedical regulatory system has
yet to be decided. In a statement emailed
to The Scientist, EMA press officer Edo-
ardo Iannone notes that “the situation
with regard to medicines regulation post-
Brexit is part of the negotiations between
the UK and the European Union, in
which EMA has no formal role.”
This lack of clarity is a source of concern
for pharma. “What causes me the sleepless
nights is we actually don’t know how that
system is going to work,” Peachey says. The
best-case scenario, in her view, would be if
the UK’s Medicines and Healthcare products
Regulatory Agency (MHRA) stays closely
aligned with the EMA, maintaining a com-
mon system for licensing, clinical trials, and
drug safety monitoring, or pharmacovigi-
lance. In the worst-case scenario, she adds,
the UK would need to set up its own, sepa-
rate system for these activities, potentially
creating additional administrative hurdles
for licensing and delays in UK access to new
medicines and drug safety updates.
Under EU law, market authorization
holders—organizations granted permis-
sion to sell medical products—must be
located in the European Economic Area
(EEA), which includes EU countries plus
Iceland, Liechtenstein, and Norway. And
regulatory procedures such as quality con-
trol and pharmacovigilance must be carried
out at sites on EEA soil. Unless exceptions
are made under a Brexit agreement, prod-
uct licenses and sites for testing and certi-fication will be required to move from the
UK to an EEA country.
The British government is hoping to
maintain its connection with the EMA after
Brexit, according to an MHRA statement
emailed to The Scientist. “We want to retain
a close working partnership with the EU to
ensure patients continue to have timely access
to safe medicines.” And in an emailed state-
ment, a UK spokesperson for Swiss pharma-
ceutical firm Novartis writes: “It is vital that
appropriate transitional arrangements are
put in place after the UK leaves the EU in
March 2019 to ensure that patients in the
UK and across Europe can continue to access
their medicines without disruption.” Meanwhile, many pharmaceutical and
biotech companies are already taking action.
Since the referendum, “we’ve had to trans-
fer the centralized licenses for over 40 of our
products” that were held by Merck in the UK
to a Merck marketing authorization holder in
the EU, Morrison says. The process can also
involve “considerable” downstream changes,
he adds, such as modifying drug packag-
ing to meet new regulations. AstraZeneca
and GlaxoSmithKline, the UK’s two largest
pharmaceutical companies, have publicly
announced that they are spending tens of
millions of pounds making similar prepara-
tions. (Both companies declined to comment
on the record for this story.)
Nevertheless, an EMA survey of 180
market authorization holders suggests that
some drugmakers are not fully prepared for
Brexit. The analysis, published in September,
revealed that most companies were on track
to implement the required changes, such as
transferring licenses and ensuring drug safety
and quality control procedures can be carried
out at an EEA-based facility. But it also noted
that action required for approximately 6 per-
cent of medicines—25 products for human
and 14 for veterinary use—might not be com-pleted in time, meaning those products may
stop being available on the EU market.
Another area of concern pertains to the
EU’s new Clinical Trial Regulation (CTR), a
framework meant to streamline the appli-
cation and assessment process for clinical
research and provide public online access
to critical information, such as data on
drugs’ efficacy and safety. Although the UK
took part in developing the CTR, which is
set to be implemented in 2019, its scientists
may be unable to access all of its elements—
such as the shared online portal—once the
country has left the EU.
UK officials have indicated that the
country will sign on to the new regula-
tions, but “the key thing that needs to be
agreed on is that the UK could have access
to the EU clinical trials portal,” says Mike
Thompson, CEO of the Association of the
British Pharmaceutical Industry (ABPI).
Without access, UK scientists could still
submit clinical trial data from the UK for
licenses in the EU, but “there clearly will
be a level of administrative duplication.”
The EMA tells The Scientist in an
emailed statement that it “will continue to
accept clinical evidence generated in the
UK” as long as it meets EEA standards.
Nevertheless, uncertainty regarding post-
Brexit drug regulations has already halted
at least one clinical trial. In October, medical
research firm Recardio stopped UK-based
patient tests of a heart drug, dutogliptin, cit-
ing risks associated with proceeding while
regulatory issues with the EMA remain
unresolved. “This is the first clinical study
we are aware of to be suspended in Scotland
as a result of Brexit—and a very concerning
sign of what could happen,” a Scottish gov-
ernment spokesman told the BBC.Moving goods and people
Each month, approximately 82 million packs
of medicine flow between the UK and the
EU, according to a January report from the
Brexit Health Alliance, a coalition including
the National Health Service (NHS) and vari-
ous biomedical, research, patient, and public
health organizations. Any post-Brexit hur-
dles to the free movement of goods could
spell trouble for those supplies, potentially
leading to temporary drug shortages. Uncertainty regarding post-
Brexit drug regulations has
already halted at least one
clinical trial.