EU freezing UK out of drug safety scheme after Brexit

The European Medicines Agency is planning to freeze the UK out of its drug safety monitoring system after Brexit – despite the UK government’s aim to maintain a close working relationship.

Senior government figures like health secretary Jeremy Hunt still hope that the UK will be regulated by the EMA after Brexit, despite the stance of hard-line Brexiteers.

The Brexiteers do not want the UK to be subject to European Court of Justice rulings that would apply if the UK remains part of the EMA.

But with no deal in sight and deep divisions in the government over the country’s relationship with Europe after Brexit, EU officials are already assuming that there will be no agreement in place when the split officially takes place on 30 March next year.

The EMA is already moving from its headquarters in London to a new site in Amsterdam – and a document from the agency confirms that EU officials are working on how to kick the UK out of its Europe-wide drug safety network.

Since the beginning of the decade the EMA has been building the electronic safety monitoring system known as EudraVigilance, which looks for safety signals from drugs across the EU.

In the EMA’s latest operational plan for EudraVigilance, the agency said that it and the European Commission are assuming that on 30 March 2019, the UK will become a “third country” and will not participate in the agency’s work.

According to the document published earlier this month “this means that access to a number of systems and applications supporting the approval and safety monitoring of medicines across the EU would have to be closed to the UK as of that date.”

EMA staff are analysing potential changes needed to EudraVigilance and will implement them later this year, along with “change management” needed as a result of Brexit.

The document follows on from a meeting of EU regulators in March, who said preparation for a “hard Brexit” was the only logical course of action because of the lack of progress in negotiations.

At the moment the UK’s national drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) is still part of the EMA.

When asked for a comment about how the split from EudraVigilance will affect UK patients, a spokesperson referred to a statement from the government on the post-Brexit regulatory system for drugs and medical devices.

This states that “patients should not be disadvantaged; innovators should be able to access the UK market as quickly and simply as possible; and we will continue to play a leading role in both Europe and the world in promoting public health.”

But as yet there are no details about how the MHRA will monitor drug safety after March next year.

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