Brexit uncertainty sees UK patients cut from heart attack drug trial
Concern over eligibility of British data post-March 2019 behind decision to pause study in England and Scotland
However, Recardio, the US-based company developing the drug, has shelved the UK arm of the trial over fears that data in Britain will no longer be acceptable to the European Medicines Agency (EMA) – which licenses drugs for EU use – after Britain quits the bloc.
Experts have repeatedly warned that leaving the EU means the UK will be put to the “back of the queue” for new drugs as manufacturers prioritise the large EU market, and half a million patients in clinical trials will be put at risk.
The lack of progress in addressing these issues ahead of the 29 March 2019 deadline is creating a “very difficult” situation for companies such as Recardio, its founder and president, Dr Roman Schenk, told the BBC.
But the government said it was “confident” the UK would still be a good base for trials after the March deadline.
The dutogliptin trial is running in hospitals in Poland, Austria, Belgium, Bulgaria, Hungary, the Netherlands and the US.
The Golden Jubilee Research Institute, near Glasgow, had been due to take part as well but was informed by Recardio by email on 17 September that this had been put on hold.
“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,” a spokesman for the institute said.
“However, this may change when the regulatory situation has clarity.”
While it was “disappointing” the trial would not go ahead as planned, they added that patients would still receive the same safe, effective, innovative care.
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.
“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.”
A spokeswoman for the Department of Health 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.
“We want to ensure that patients in the UK and across the EU are still able to access the most innovative and effective medicines.”
Additional reporting by PA