Heart drug trials halted over Brexit fears

The UK government has said it is 'confident' Britain will still provide a good environment for clinical trials beyond March after a study for a new heart drug was halted due to fears over Brexit.

US research firm Recardio was due to start a study of the drug dutogliptin on patients in Clydebank, Exeter and Leeds. However, it has suspended this UK arm of the trial due to concerns over how new medicines will be approved after Brexit.

The trial is also running in hospitals in Poland, Austria, Belgium, Bulgaria, Hungary, the Netherlands, Poland and the US.

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A Scottish Government spokesman said: “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.”

The UK government has said it is confident Britain will still provide a good environment for clinical trials beyond March after a study for a new heart drug was halted due to fears over Brexit. Picture: John Devlin.The UK government has said it is confident Britain will still provide a good environment for clinical trials beyond March after a study for a new heart drug was halted due to fears over Brexit. Picture: John Devlin.
The UK government has said it is confident Britain will still provide a good environment for clinical trials beyond March after a study for a new heart drug was halted due to fears over Brexit. Picture: John Devlin.

New drugs intended for use in the EU are evaluated by the European Medicines Agency (EMA), based in London.

The EMA is seeking to relocate to a different EU country after Brexit.

The Golden Jubilee Research Institute, which was informed by Recardio by email on 17 September that one of its research studies had been put on hold in the UK, said the company blamed Brexit.

“According to the company, uncertainty due to EU withdrawal, particularly drug and data release to the EMA, are completely unresolved and represent a significant risk,” an institute spokesman said.

“However, this may change when the regulatory situation has clarity.

“Like other NHS boards, we are working closely with the Scottish Government to ­prepare for Britain’s exit from the European Union in order to continue to provide a high-quality service for our patients and staff.

“No patients or staff are affected by the decision by Recardio to put this study on hold. Whilst we are ­disappointed if any clinical ­trial does not go ahead, we will continue to treat our patients in a safe, effective and person-centred way.”

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Scottish Labour’s health spokesman Anas Sarwar described the news as a “deeply troubling development”. He said: “It is now clear that the Tories’ utterly shambolic handling of Brexit is damaging not just our economic future, but our health service as well.

“Patients will now miss out on potentially life-saving ­treatment because of Theresa May’s inability to unite her own party, let alone the country. That should shame and appal every elected Tory, including Ruth Davidson.

“Only Labour will deliver a Brexit deal that will protect our health service, as well as jobs, services and hard-won workers’ rights.”

Scottish Conservatives health spokesman Miles Briggs said: “It is disappointing news that Recardio will be temporarily halting this important cross-UK drug trial.

“Since the UK voted to leave the EU I’ve never denied that we need to make sure that our NHS is protected and any potential issues are mitigated against ahead of the UK ­leaving.

“That is exactly what Scottish Conservatives have been working to try to help achieve.”

Recardio’s founder and president, Dr Roman Schenk, said uncertainty over Brexit had created a “very difficult” situation for his company.

A Department of Health spokeswoman said: “We are confident of reaching a deal with the EU that benefits patients and continues to deliver the best possible environment in which to support clinical trials.”