Heather Tomlinson 

Medical research ‘stifled by rules’

A 'catastrophic' increase in bureaucracy from new European regulations has slowed the pace of medical research in the UK and will make academics reliant on funding from the pharmaceutical industry, researchers have warned.
  
  


A "catastrophic" increase in bureaucracy from new European regulations has slowed the pace of medical research in the UK and will make academics reliant on funding from the pharmaceutical industry, researchers have warned.

Small-scale clinical trials at British universities have become too expensive and the problems could eventually move research to eastern Europe and Asia, according to academics. It has also hit the clinical trials industry in the UK.

In the pre-budget report last week Gordon Brown repeated his mantra to focus on science for the future of the UK economy, and Tony Blair recently said he wanted Britain to become the "science capital of the world".

However, the Clinical Trials Directive introduced in May dictates that small studies in healthy volunteers must get regulatory authorisation, pay a fee and require substantial paperwork, whether they are by academics or drugs firms. "Now we have to go to all the expense and effort big pharma has had to go to," said Professor Steve Bloom, head of investigative research at Imperial College London.

"It is beyond our financial capability, so we will have to go to big pharma, but if [the drug] can't make money, they won't do it."

Prof Bloom has just completed trials on a modified version of an appetite-suppressing hormone. He says it would not have been possible under the new regulations. He is trying to commercialise this product. The government wants to increase the commercialisation of academic discoveries, but these will be reduced under the new rules, he said.

Professor Stephanie Amiel, at King's College London is researching the mechanism of diabetes rather than looking for new drugs, but this is now often classified as clinical trial work. "We have very limited resources ... a whole weight of legislation falls upon us in the same way it does on a multi-million pound industry," she said.

Professor Clive Adams, the head of adult psychiatry at Leeds University, said the proposals were "nigh on catastrophic" and Professor John Crown, at Dublin City University, said: "In the long term, it will move research abroad. The obvious places are Asia and eastern Europe."

The Department of Health said: "The safety of volunteers must be our priority."

 

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