Brussels, 13 Jan 2004
Some 1,500 researchers from across Europe are calling on the European Parliament and Commission to repeal the directive on good clinical practice, which they say will 'effectively end' public sector medical research.
The directive, adopted in 2001 and due to come into force in May, will require the sponsor of a clinical trial to assume total legal and financial responsibility for every aspect of its investigation. This will mean that an academic sponsor, rather than the state health service, would have to pay for all the drugs that a patient was receiving, even if only one component of their treatment was experimental, the campaigners argue
In a letter to be sent to every MEP and European Commissioner, the researchers state that: 'This directive places such high administrative expenses in the way of patient focused research that it will effectively end all clinical research except for those trials which are commercially inspired, and drug company sponsored.'
One of the campaign's founders, Professor John Crown of the Irish clinical oncology research group, believes that cancer research will be particularly hard hit. He questioned whether the academic trials that led to breakthroughs in childhood leukaemia and breast cancer would have taken place had the new rules been in place then.
EU Research Commissioner Philippe Busquin has acknowledged that the new rules may be problematic for public sector researchers, but insisted that the measures are necessary. He proposed that academic institutions and research agencies should establish a European platform to better finance cooperative trials of the more academic type.
Mr Busquin has also stressed the need for an appropriate research climate in order to encourage more companies to carry out medical research in Europe. He pointed to a worrying decline in research investment by pharmaceutical companies in Europe during the 1990s. However, the campaign organisers believe that the directive will have the opposite effect.
'The directive represents a solution which is not needed to a problem which does not exist,' reads the letter. 'The EU has made [a mistake] here, and public pressure will force its correction. The question is whether it will be corrected now before it costs lives, or later, after it has.'
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