By Ben Hirschler | 18 April 2018
LONDON (Reuters) – A European decision to exclude Britain from the EU’s drug approval system from March 30 2019 – the day after Brexit – has raised alarm among drugmakers, who fear the abrupt change could disrupt medicine supplies to patients.
The move confounds hopes for continued joint cooperation via the European Medicines Agency (EMA), at least during a transition or implementation period until the end of 2020 when the UK will remain closely tied to the European Union.
Prime Minister Theresa May said in a speech on March 2 that London wanted to explore ways to keep Britain a part of EU agencies, such as the EMA.
The highly regulated drugs industry is particularly susceptible to Brexit, given the EU’s centralized system for approving and monitoring medicines. Brexit is already forcing the EMA to relocate from London to Amsterdam.
Now the EMA has appointed experts from other European countries to take over work currently undertaken by Britain’s Medicines and Healthcare products Regulatory Authority (MHRA) from next March.
Since the MHRA assesses around a fifth of EU medicines, drug industry leaders fear this sudden handover will cause disruption.
“Removing key expertise and reallocating work to other agencies who are not yet able to take on the work, and expecting them to increase their capability overnight is an increasingly reckless course of action proposed by the (European) Commission,” said BioIndustry Association CEO Steve Bates.
“In the interests of patients on both sides of the Channel, it is important that the EU retains access to UK expertise in a post Brexit medicines regulatory framework and that regulatory alignment is maintained to ensure continuity of medicines supply.”
Maintaining timely approvals for new drugs is crucial for pharmaceutical and biotechnology companies, which have dozens of experimental medicines due to be assessed by the EU regulator in the next couple of years.
Global drug companies, including UK-based GlaxoSmithKline and AstraZeneca have been vocal in calling for continued close EU-UK ties after Brexit. The issue is also important to many Japanese drugmakers that have made Britain their European base.
The MHRA confirmed it would no longer act as a so-called “rapporteur” for EU drug licensing or safety monitoring, although there has been no decision on long-term relations.
“It is important to note this only applies to the implementation period and there is no decision yet on the future relationship,” a spokesperson said. “The UK’s position on medicines regulation remains clear. We want to retain a close working partnership with the EU.”
The Association of the British Pharmaceutical Industry said it was clearly in the EMA’s interest to continue to draw on the expertise of the MHRA and it urged London and Brussels to come to an early agreement “in the interest of patients and public health”.