Biomed Middle East

Red tape is driving clinical trials abroad meaning British patients will suffer

A combination of complicated European laws and British rules has resulted in a dramatic decline in the number of clinical trials conducted here.

It means British patients are not benefitting from the cutting edge research being carried out in laboratories here, it has been warned.

Some estimates suggest the pharmaceutical industry is not investing a third of the money it was four or five years ago.

The problem is leading to a ‘brain drain’ where the best scientists are becoming disillusioned and moving abroad because of the difficulty of translating their work from the lab to the bedside.

Scientists, doctors and researchers are now waiting to find out how deep the cuts will be in the next Spending Review and what the outcome will be of changes to regulators.

Science spending is expected to be cut by 15 per cent of more by the Treasury later this month.

Prof Chris Mason, Chair of Regenerative Medicine Bioprocessing at University College London of University College London, told the Daily Telegraph: “For cell therapies you have to go through four or five different regulatory organisations, in America its one. The regulatory moat is getting too deep and too wide.

“We are a world leader in cell based therapies but we are lagging behind in translating this to patients.

“We are in danger of falling into the typical story of invention in Britain, commericialisation elsewhere and then we have tp buy it back at great cost.”

He said the NHS should see clinical trials as a good source of income and by running trials hospitals here would be the first to benefit their patients, which in turn could lead to more medical tourism from abroad and another source of income.

Exicting laboratory work is being done with growing tissues, and creating stem cell treatments for conditions like multiple sclerosis, heart condition, growing skin for burns patients and treating eye problems, he said.

Prof Rory Collins, Professor of Medicine & Epidemiology at the University of Oxford is sitting on a working group looking at the problem.

He said new rules that were supposed to safeguard the patient have failed, as seen with the Northwick Park ‘guinea pig trials’ which left one volunteer dubbed the Elephant Man after a severe reaction to a new drug.

Instead the rules have made it much harder and more expensive to set up trials in Britain.

He said: “Big pharma is pulling out and charity funding is being wasted because it is going on bureaucracy instead of research.

“It is becoming increasingly difficult for trials to be done with government or charity finding because the only people who can afford to them is industry and they are interested in new trials on their drugs but there are lot of old drugs that should be tested and looked at for new indications.”

He said if the current regulations were in force ten years ago many of the widely used drugs and therapies would not be available. “We’d be putting cardiac patients in a coronary unit and giving them morphine and waiting to see if they lived or died,” Prof Collins said.

“I am optimistic however, because government is recognising there is a problem,” he said.

In March, under the then Labour government, Andy Burnham commissioned the Academy of Medical Sciences to conduct an independent review of the regulation and governance of British medical research. This was endorsed by the coalition and is due to report later this year.

A spokesman for the Department of Health said: “The Government will cut the bureaucracy involved in medical research. We have asked the Academy of Medical Sciences to conduct an independent review of the regulation and governance of medical research.

“In the light of this review we will consider the legislation affecting medical research, and the bureaucracy that flows from it, and bring forward plans for radical simplification.”

Telegraph UK

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