Brussels, 25 Feb 2004
The European organisation for research and treatment of cancer (EORTC) has written an open letter to the EU's Member States calling on them to make modifications to the EU directive on implementing good clinical practice into clinical trials, and to use a Belgian proposal as the basis for this fine tuning.
The directive, adopted in 2001 and due to come into force in May, will require the sponsors of a clinical trial to assume total legal and financial responsibility for every aspect of an investigation. This will mean that an academic sponsor, rather than the state health service, will have to pay for all the drugs that a patient is receiving, even if only one component of their treatment is experimental.
The Commission believes, however, that the directive is necessary in order to create an appropriate research climate which encourages more companies to carry out medical research in Europe. The EU experienced a decline in research investment by pharmaceutical companies during the 1990s.
EORTC questions this view, and claims that the directive will prevent important research from being conducted. In addition to sponsorship, the organisation points to potential problems in relation to drug manufacturing for marketed drugs, fees for ethics committees and authorities, the provision of drugs for free, on-site monitoring and increased administrative work.
It is now too late to repeal the directive, but the 'detailed notes for guidance', produced by the Commission and aimed at addressing the directive's practical implementation, can be amended at any time. National authorities also have some flexibility regarding with regard to implementation.
Belgium has seen a comprehensive discussion on the directive between academia and other authorities, and has drafted a proposal for the implementation of the directive. The text highlights the importance of the contribution of academic research to public health without, according to EORTC, 'jeopardising the protection of the patients in terms of rights and safety.'
Although the text does not solve the sponsorship issue, it outlines specific circumstances under which non-commercial research should be considered.
'The blind implementation of the directive in Europe could drain interest in the health care sector, with more research being conducted outside of Europe,' states the letter. This is already the case for 'commercial' research (drug development) and EU Member States are about to set the rules to also push non-commercial research away from the European area.'
The 837 scientists who have signed the letter would like to see the Belgian text used as a basis for further discussion, and are calling for the establishment of a formal dialogue between academia, industry, competent authorities and the European Commission.
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