Strasbourg, 12/12/2000 (Agence Europe) - With the adoption of the report by German Christian Democrat Peter Liese, the European Parliament strengthened in the context of codecision procedure, the Council's common position on the directive on good clinical practices when conducting clinical trials for medicines designed for human use. Most amendments introduced by Parliament aim to strengthen the provisions that guarantee respect of well-informed consent and the safety of those taking part in clinical testing, as well as those who aim to protect children and incompetent adults. Consent should be given in the form of a written decision, dated and signed. In rare cases, where a competent person is not able to write, consent could exceptionally be given orally in the presence of at least one witness. The Parliament also insists there should be a ban on all gene therapy trials that result in changes to the genetic identity of the participant. It strengthens the rules for authorising tests concerning xenogenic cellular therapy.
During the debate, Commissioner Erkki Liikanen pointed out that the European Commission subscribes to all these amendments. Most have already been negotiated with the Council which is now likely to finalise the act as long as it does not stray from the text amended by the European Parliament. Under these conditions, the directive harmonising the conditions for implementation of clinical tests could be definitively adopted during the Health Council in Brussels on Thursday.