EU harmonises rules for trialsBMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7278.68 (Published 13 January 2001) Cite this as: BMJ 2001;322:68
The European Union has agreed new legislation setting out standards of good practice for clinical trials of medicinal products for human use. It is designed to allow the necessary research to take place, while ensuring maximum protection for trial participants.
Given the tendency to carry out clinical trials in several member states at the same time, the new rules will harmonise the different national administrative requirements that have to be met. Variations in existing procedures increase the burden on industry and lead to substantial delays in making new products available to patients.
The EU legislation harmonises not just procedures but also the protection of individuals, as it was feared that if this was left to national authorities to determine, it could open the door to “ethical dumping.”
The final details of the directive, which will be officially rubberstamped within the coming weeks, were agreed by the European parliament and EU health ministers shortly before Christmas.
German Christian Democrat MEP and medical doctor, Peter Liese, who steered the legislation through the parliament, is convinced it will bring benefits to both the pharmaceutical industry and to patients. “Necessary research in the interest of patients will be possible, but under strict rules for the protection of trial subjects, especially for persons not able to give legal informed consent, such as children and mentally handicapped people,” he said.
Before taking part in a clinical trial, the participant must give his or her written consent. The legislation also addresses the sensitive issue of research on people who are unable to express their wishes, such as children or patients with Alzheimer's disease. Such research may take place provided it has a direct benefit for the patient concerned.
Where children are concerned, the informed consent of the parents or legal representative must first be obtained. This must represent the child's presumed will and may be revoked at any time without detriment to the child.