FRANKFURT (Reuters) – German drugmakers have been asked by the government to examine their supply chains for any vulnerability that could cause shortages of essential drugs in the event that Britain leaves the European Union without a Brexit deal.
A German flag flutters next to the ships at the loading terminal in the port of Hamburg, Germany March 15, 2018. REUTERS/Fabian Bimmer
More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction, industry figures show.
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has ordered the country’s main drug industry associations to gather information on the effect of a no-deal Brexit, a spokeswoman for the health ministry said.
“The Ministry of Health currently has no evidence that the exit of the United Kingdom will lead to any disruptions in the supply of medicines in Germany,” the spokeswoman said.
It is not yet clear when results will be available, she said.
Britain, which voted in 2016 to leave the EU, has served notice that it will quit the bloc next March but has yet to reach a deal on future trading relations.
The EU’s drugs regulator, the European Medicines Agency (EMA), on Wednesday said that it and national regulators had set up a task force to minimise supply disruptions arising for any reason over the next two years.
“The withdrawal of the United Kingdom from the EU is also likely to affect the availability of medicines in the EU,” it said.
The UK government has already asked British drugmakers to build an additional six weeks of medicine stockpiles to prepare for any no-deal Brexit – a target the industry has said will be challenging.
Germany is using BfArM’s quarterly “Jour Fixe” meetings with various stakeholder groups on drug shortages to prepare for Brexit.
BfArM in 2016 instated the meetings with groups representing drugmakers, physicians, pharmacists, drugs distributors as well as other government bodies to monitor and mitigate against drug shortages.
The meetings have dealt with shortages of treatments such as Mylan’s Epipen against allergic shock, branded as Fastjekt in Germany, as well as disrupted supply of blood pressure drug valsartan after batches produced in China had to be recalled due to toxic impurities.
Industry groups, which include German drugmakers including Bayer, Merck KGaA and Boehringer Ingelheim as well as foreign suppliers such as Teva and Roche, have been asked to consider the “worst-case-scenario of a hard Brexit without transition period”, according to meeting protocols.
The highly regulated drugs sector is one of the most vulnerable to Britain’s decision to leave the EU because of uncertainty as to how medicines oversight will function in the event of an abrupt exit next March.
That has sparked fears of drug shortages, and some companies including AstraZeneca, Sanofi and Novartis have said they plan to increase stockpiles in Britain in case of a no-deal Brexit.
Britain is set to leave that EU regulatory system and the Europe-wide drugs watchdog is moving from London to Amsterdam, prompting many drugmakers to prepare duplicate product testing and licensing arrangements.
Reporting by Ludwig Burger; editing by Jason Neely and Douglas Busvine