Brussels red tape 'costs lives of cancer patients'
By David Derbyshire and Roger Highfield
Daily Telegraph (12/09/2003)

An explosion in red tape from Brussels and Whitehall is stifling research into cancer drugs and "almost undoubtedly" costing lives, Britain's biggest charity said yesterday.

Cancer Research UK accused over-zealous civil servants of creating suffocating levels of bureaucracy and warned that patients were already suffering. Over the last 10 years, the number of regulations controlling clinical trials for drugs had increased 40 fold.

Dr Richard Sullivan, Cancer Research's head of clinical programmes said the driving force for many "pedantic" rules came from Europe. "Brussels has become a regulatory super-state," he said.

It now took five times longer to get a breast or bowel cancer drug into trials than in the early 1990s, he told the British Association science festival in Salford.

"We absolutely agree that research should be carried out in a proper regulatory framework . . . but because of complex, contradictory and opaque regulations patients aren't being protected, they are being failed."

Today, scientists carrying out research using patients, their data or tissue samples must comply with 18 separate pieces of law. Since 1995 there have also been eight European directives and 18 pieces of UK legislation.

The crisis would get worse with a European directive on clinical trials in the next few years, he said.

Scandals such as Alder Hey, in which parents were not told that organs from their dead children were being kept, were the cause of some regulations. But some rules were so bureaucratic they even defined Egyptian mummies as "unauthorised human tissue samples", he said.

Prof Malcolm Stevens, of Nottingham University, said red tape was delaying trials of life-saving medicines, including a three-year hold up of tests on an experimental breast cancer drug, Phortress.

"That kind of delay is undoubtedly costing lives," he said.

"This is supposedly for the safety of patients, but I don't think they are concerned. We are dealing with people that in general have just a few months to live and they want to be the lucky ones in clinical trials."

The Department of Health said it was looking at ways to reduce red tape.