Recardio halts UK heart trial on Brexit uncertainty

According to a report by BBC News online, the firm was intending to evaluate dutogliptin at sites in Clydebank, Leeds and Exeter, but has now suspended all UK activities because of a lack of clarity on medicines regulation post Brexit, and concerns that data generated in the country would no longer be accepted by the European Medicines Agency as evidence for approvals.

The Golden Jubilee Hospital, one site at which the trial was to take part, told the BBC that Recardio informed its research team last month that UK trials were being put on hold, while those on the continent are to continue.

"Uncertainty due to EU withdrawal" and "completely unresolved" issues with the European Medicines Agency that "represent a significant risk" to its business were reportedly cited as reasons behind the move.

"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," a spokesperson for the Scottish government said, according to media reports.

"We are working hard to protect Scotland’s interests in spite of a lack of clarity and meaningful engagement from the UK Government over our future. With Brexit only six months away, we are doing all we can to plan and mitigate against as many of the significant uncertainties that exist for our health service."

Britain will leave the European Union on March 29, but the government is yet to agree the terms of withdrawal, leaving the future of medicines regulation highly uncertain at this late stage in the process.

The government has already said that as the incoming EU Clinical Trials Regulation (CTR) will not be in force in the EU at the time of Brexit, it will not be incorporated into UK law on Exit day.

"However, we’ll align where possible with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals," it recently stressed.

Also, in a statement to the BBC, the EMA said it "will continue to accept clinical evidence generated in the UK" after Brexit on condition that trials continue to meet European standards.

However, lack of progress on key issues such as these is fuelling fears that Brexit could potentially pose a significant obstacle for those wishing to develop medicines in the UK.

"We need to be clear that a ‘no deal’ scenario is not in the interest of patients," the Association of the British Pharmaceutical Industry said.

"Both sides must rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases and manage medicine safety."

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