Brussels, 06 Oct 2004
The EU's Clinical Trials Directive is a poorly drafted law preventing vital medical research, claim UK scientists in an article published in the Telegraph.
According to the UK newspaper, scientists fear that the directive, which came into effect on 1 May 2004, will lead to significant extra costs and impose complexity and paperwork on universities and hospitals carrying out low-budget studies of medical products.
Critics elsewhere had already stated that although the directive's fundamental premise is commendable - to streamline and harmonise regulations governing clinical trials across the EU while protecting the trials' participants - the increase in financial and legal requirements would prove devastating. Many researchers also claim that the new law vests too much power in centralised systems and that it distances patients and healthcare professionals from decision making.
It would appear the directive has already led to the halt, across the EU, of a number of trials planned by research groups.
'Doctors are starting to express concerns,' Dr Neil Bacon, chief executive of Doctors.net.uk, who carried out a survey of more than 400 doctors, told the Telegraph. 'It is clear that small, unfashionable trials won't be possible,' he added.
Almost 45 per cent of the doctors who took part in the survey said the directive would make them re-evaluate their involvement in trials. Furthermore, over 2,000 scientists have signed a petition calling for the cancellation of the law.
According to the Telegraph, the UK is especially concerned by the law because almost half of all European phase I clinical trials take place in the UK. Professor Richard Gray, head of Birmingham clinical trials unit, said that increased paperwork would deter doctors from referring their patients for trials. This would deprive research bodies of their lifeblood in fields such as Parkinson's Disease, Alzheimer's and cancer, he added.
The worst affected would be the mass trials that often lead to a breakthrough in the search for cost-effective treatments, believes Professor Gray.
The original Commission proposals for the Directive were made more stringent by MEPS wanting to protect patients from abuse. 'The law is not going to make the slightest difference to the big firms but it's awful for the little guys,' said Dr Richard Sullivan, the head of Cancer Research UK, referring to the academic and hospital sectors that carry out many large clinical trials on behalf of big pharmaceutical companies.
According to Dr Sullivan, the Directive will increase the cost of academic and non-commercial studies fourfold.