Local view for "http://purl.org/linkedpolitics/eu/plenary/2000-12-11-Speech-1-088"
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"en.20001211.5.1-088"2
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"Madam President, I would like to join Mrs Patrie in warmly thanking our rapporteur, Mr Liese, for all his efforts to find a consensus. We are dealing with a particularly important directive here. It may contribute to improving clinical research in Europe and hence the welfare of millions of sick people. The sector is sensitive. It is a matter of scientific progress, but also ethics and morals: in short, value judgments.
Since the first reading, Parliament has concentrated on the protection of people incapable of giving informed consent to these clinical trials: children and adults with a mental handicap. These groups must remain within the scope of the directive. Excluding them would mean obstructing research into conditions specifically affecting them. In some cases scientific and experimental research is their only hope.
Besides, we know that empirically dividing the adult dose to treat children has already led to tragedy in the past. Then there is the opposite extreme, children not treated because, although the specific medicine to cure them exists, it has not been tested for them.
So we want these groups to benefit from advances in research, while laying down conditions for these trials which are as severe and strict as possible. That is the aim of Amendments Nos 36 and 37 in particular: full and objective information, adapted to children – a point I consider very important; informed written consent from parents or legal representatives; exclusion of any financial advantage; control of protocol by ethics committees. In these amendments we also refer, not once but twice, to the fact that the interests of the patient are always more important than those of science and society. Children and disabled people are fragile people who need maximum protection. But there must be no ban: these patients must not be shut out beyond the gates of hope research represents for them, sometimes the last thread still linking them to life.
One more word, on another point I consider highly important, I mean Amendment No 30 which concerns non-commercial clinical trials. It is crucial that the directive take account of this academic research. Nor must it be penalised. It is especially beneficial to the patients concerned. I am particularly thinking of cancer research, but there are many others."@en1
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