Local view for "http://purl.org/linkedpolitics/eu/plenary/2000-12-11-Speech-1-087"
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"en.20001211.5.1-087"2
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"Madam President, ladies and gentlemen, this directive, before us today for the second time, falls within the delicate context of international competition in pharmaceutical research and major health challenges, particularly in paediatric medicine. It allows us to resolve the problem of clinical trials being held simultaneously in several Member States and at several locations.
The common position forwarded to us by the Council is some improvement on the Commission’s proposal and especially on Parliament’s first reading. There are several points we can agree with. Thus, the principle selected for starting a clinical trial is tacit authorisation from both the Ethics Committee and the competent authorities in the Member States. The opinion of the Ethics Committee is determinant as it comes first and the absence of a negative opinion in fact means the trial can begin immediately without loss of time.
Finally, we agree with the Council’s proposals on labelling medicines used in such trials.
On the other hand, some other points could be improved and I am glad the Council is prepared, as I understand it, to make a number of compromises.
I do not think there can be any question of compromise on the first point, which I consider essential. The consent of persons taking part in a clinical trial must necessarily be given in writing and if that is not possible, for example in case of temporary inability to write, a witness must be present when consent is received.
Secondly, consent must be informed, which means, in particular, that the person taking part must have been informed of the conditions under which the trial is to be conducted, the potential risks that he runs and his unrestricted right to withdraw from the trial at any time.
Finally – and I think this point is fundamental – we must ensure that the greatest possible protection is guaranteed to those who are not in a position to give their consent: the weakest, children and legally incapacitated adults. They must be able to expect direct benefit from the clinical trial. In particular, the opinion of minors must at least be listened to because account must be taken of their clinical and psychological characteristics.
It seems to me right not to include adults incapable of giving consent in clinical trials that could be carried out on adults who are capable. Finally, adults incapable of giving consent should only participate in trials that relate to the condition affecting them and causing their incapacity.
So, although there are still some points of disagreement with the Council, I would like to remind you that the result we are seeking to obtain through the adoption of this directive is the outcome of lengthy and fruitful compromise negotiations between Mr Liese, our rapporteur, whom I thank and congratulate on his inclusive and constructive approach, and the Council, which has proved cooperative and open to the amendments adopted at second reading in the Committee on the Environment, Public Health and Consumer Policy. So after what Mr Liese has just told us, I am very hopeful that we will rapidly reach an agreement allowing us to avoid a long conciliation that would be not very productive in the end."@en1
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