The EU institution’s experts insist there are “serious doubts” over whether 108 medications will still be on offer across the EU as a result of Brexit.
They warn the drugs – 88 designed for treating humans and 20 for animals – may have no authorisation because manufacturers haven’t taken the necessary steps to ensure their product is regulated for EU use.
Guido Rasi, the EMA’s executive director, said: “For every patient who can’t get his medication, this would be a disaster.”
UK-based manufacturers’s drugs will no longer be allowed for use across the EU27 in the event of a no-deal Brexit. As of March 29 2019, joint regulation for medicines would cease to apply.
This would also apply to European producers, whose product would be allowed for consumption in Britain unless the UK Government intervenes to recognise EU standards.
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The concerns have led to various pharmaceutical bigwigs to weigh in on the warnings surrounding no-deal Brexit.
A German-based licensing authority said Brexit cannot stand in the way of the delivery of medicines to patients.
Karl Broich, president of the Federal Institute for Drugs and Medical devices, said: “Brexit must not end to a delay in new drugs being made available or side effects of already approved drugs being tackled less vigorously.”
The pharmaceutical industry “urgently needs to do its homework,” he added.
“Businesses should not rely on transitional deadlines after the exit date, but act now.”
British pharmaceutical giant AstraZeneca is urging governments to carry out the right preparations to ensure the threat of medicine supplies grinding to a halt doesn’t become a reality.
The Cambridge-based drugs manufacturer has warned governments they must not allow a no-deal Brexit to stop supplies of medicines to the Continent putting patients at risk.
Bosses said its cancer, heart and lung drugs, which are made and quality-tested in the UK, would have to be evaluated twice to ensure they are allowed to cross the border after Brexit.
AstraZeneca has already spent £40 million ensuring its drugs can still be used across the EU in the event of a no-deal Brexit.
The firm is setting up a parallel operation in Sweden as part of its preparations, and is urging governments to follow their same meticulous campaign.
With its EU base, AstraZeneca believes is can maintain the supply of medicines in both the UK and on the Continent in the event of a failure to agree of reciprocal regulations.
Additional reporting by Monika Pallenberg