'Idiotic' EU Directive Accused of
Threat to Medical Research
by Ambrose Evans-Pritchard and Roger Highfield

Vital medical research is faltering across the European Union as the result of a poorly drafted law that has infuriated scientists.

Researchers fear that the EU's Clinical Trials Directive will impose a heavy burden of extra costs, complexity and paperwork on universities and hospitals carrying out low-budget studies of medical products.

The law was agreed in 2001 to harmonise EU standards, even though the existing code of conduct worked well. The directive, which came into force in Britain in May, has led to a Europe-wide freeze on a range of future trials planned by research groups, or caused a flight to more hospitable locations outside the EU.

Prof Richard Gray, the head of Birmingham Clinical Trials Unit, called the directive bureaucracy run mad.

"We have not undertaken any new projects for a year because of this," he said. "It's the most complete nonsense. Everybody is running around like headless chickens trying to work out how to cope."

More than 2,000 scientists have signed a petition calling for repeal of the law. A survey of more than 400 doctors found that only 40 per cent of respondents knew of the new directive. "It was quite shocking that so few knew about it and its implications," said Dr Neil Bacon, the founder and chief executive of Doctors.net.uk, which carried out the survey. "Doctors are starting to express concerns. It is clear that small, unfashionable trials won't be possible."

Almost 45 per cent of respondents said the directive would make them reconsider being involved in trials.

Britain is badly hit because roughly half all "phase-one" clinical trials in the EU are held here though complaints are pouring in from Italy, Spain, Ireland and Eastern Europe.

Prof Gray said the paperwork would deter doctors from referring their patients for trials, depriving the research bodies of their lifeblood in fields such as Parkinson's Disease, Alzheimer's, and cancer.

The worst affected would be the mass trials that often lead to a breakthrough in the hunt for cheap and easy treatments. These can involve as many as 70,000 people taking no more than a daily dose of aspirin, and rely entirely on goodwill and the volunteer spirit.

The law was intended for big drug firms which conduct high-cost trials with small numbers of people. It was made more draconian by Euro-MPs and ministers hoping to protect patients from abuse.

Dr Richard Sullivan, the head of Cancer Research UK, said it would raise the cost of academic and non-commercial studies by up to four times. "The idiots who designed this had no understanding of the vast amount of other research going on," he said. "It's not going to make the slightest difference to the big firms but it's awful for the little guys."

Privately, EU officials admit the directive was badly mishandled. They are preparing "flexible" guidelines that in effect urge governments to violate the law they have just introduced. British authorities are also searching for ways to soften the legislation.

Dr Brian Moulton, the head of Save European Research, said the law should be scrapped immediately. "Common sense will have to prevail somehow because you can't just let European research close down overnight - can you?" he said.
The Daily Telegraph, 4th October 2004

PHILLIP DAY'S COMMENT: There's no plainer example of the blind leading the blind and they both fall in a ditch. This story has less to do with scientists being thwarted as it does the meddlesome, nannying EU doing what it does best - wasting money, compromising efficiency and then telling everyone it's for their benefit.

And what of all this medical research on disease, the vast majority of which is a complete waste of time and money, since scientists are not concentrating on nutrition and lifestyle as causative and curative factors alike in these chronic, metabolic diseases.

Since the EU is a classic corruption of Big Business feeding off Big Government, it's hardly reassuring to know that even when politicians are fiddling, they are incompetent.

Further Resources
Health Wars by Phillip Day
The ABC's of Disease by Phillip Day

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