Local view for "http://purl.org/linkedpolitics/eu/plenary/2000-12-11-Speech-1-089"
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"en.20001211.5.1-089"2
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"Madam President, I am pleased that so many colleagues have emphasised how important it is to us – and this is, I believe, the central point in this debate – to protect particularly vulnerable groups of people, namely children and those who are unable to give informed consent, and to ensure that no research is carried out which is useful to others unless it is also of direct benefit to them.
I should, however, also like to remind you that it was the Green Group which made this proposal at the first reading, in the face of much resistance – including, I am afraid, from the current rapporteur. We did so in an amendment tabled at the time which many colleagues here supported and which provided that no research should be carried out on those unable to give written consent unless it was of direct benefit to them. It was only, in my view, this amendment, tabled by us, that made this important debate possible.
I should like to stress this once more: I am glad that the rapporteur has given ground on this point because it has allowed us to reach what I believe is a very good compromise. This compromise, which of course can be further improved upon by each Member State, constitutes a minimum standard, to ensure that we do not have a kind of ethical dumping in the European Union and to avoid a situation where it is possible to carry out research on those unable to give informed consent in one Member State and not in others.
I should also like to stress once more that this compromise goes beyond the proposals in the Council of Europe's Bioethics Convention, because we have much greater protection for patients, with a much stronger link to their own interests, for example, consent given by a representative can be revoked at any time.
I am also pleased, however, that we have succeeded in clamping down on germ-line gene therapy. It must be quite clear that clinical research which seeks to introduce germ-line manipulation by the back door must not be possible, because this would be a violation of human dignity. That is why I believe that this compromise is very good, particularly when you consider that the Member States are able to introduce even stricter rules. Through this compromise we are making it clear that there must be no ethical dumping at European level and that there must be no research which is of benefit to outsiders on those unable to give informed consent.
Finally, I should like to cordially request that the Council re-examine our amendment on placebos. Here, as you know, we have proposed that research involving placebos should only take place if it can be proved that there is no other way of monitoring effectiveness, because we wish to avoid research taking place if there is no direct benefit, but at the same time we wish to enable research to happen. That is why we made this proposal, and I should like to ask the French Presidency to kindly make a note to answer this question."@en1
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