Local view for "http://purl.org/linkedpolitics/eu/plenary/2000-12-11-Speech-1-086"
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"en.20001211.5.1-086"2
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".
Madam President, Commissioner, ladies and gentlemen, medical research which is essential for patients must be approved quickly and with minimum bureaucracy, but at the same time ethical boundaries must be strictly respected and the subjects must be given maximum protection from abuse. This was the European Parliament's objective in the legislative procedure on clinical trials, and I believe that today we can say that this objective has been achieved.
In an informal trilogue last week, the Council told us that it could accept most of the amendments tabled by the lead committee and that there were a number of places where it wanted further drafting changes, which we can make through compromise amendments tabled by four groups tomorrow. For a long time, it seemed as though an agreement was going to be impossible. Positions here in Parliament were very far apart, but they were equally divergent between the Member States and the different institutions. We have now reached an agreement and I should like to thank all those involved for their part in achieving this: colleagues, the Commission, also the Council, and, in particular, the French Presidency.
The compromises which we have agreed greatly improve the common position from the European Parliament's point of view. There is clarification that, as a general rule, consent in a clinical trial has to be given in writing. There is clarification that interventions in the human germ line cannot be accepted. There is recognition that non-commercial clinical trials, which industry either cannot or will not support, are nevertheless important and that rules need to be drawn up for them. I am particularly pleased that we have struck a very good compromise on clinical tests on people who are unable to give legal consent themselves. This issue of research involving those who are incapable of giving informed consent has caused heated controversy in the Member States, as well as here in Strasbourg in the Council of Europe.
Positions also differed amongst those involved in this legislative procedure. Originally, the Council did not want to include any provision in the directive at all and wanted to leave it up to the Member States. The European Parliament decided at first reading that clinical trials of this kind should only be permitted if it could be shown that each individual clinical trial was of direct benefit to each individual patient. Now we have found a compromise, and I do not think that it is a compromise formula or a formulaic compromise; it is a proposal supported by the facts which provides a good solution to the problem, at least in this field.
As far as the direct benefit is concerned, investigators running clinical trials have to identify those cases where it is necessary to administer medical products and carry out the accompanying examinations in order to draw conclusions for future patients. This is an important condition which we make here in our report. Then a distinction has to be drawn between children and adults who are incapable of giving informed consent. Children's metabolisms have particular characteristics, which is why medicines which are administered to children also need to be tested on children in clinical trials. This is not the case in many areas at present. Children are given medicines which have only been tested on adults, which means that children are badly treated. The report aims to ensure that children in Europe receive better treatment in the future, that they suffer fewer side effects and are given the right doses.
We have drawn up very, very strict rules for this. The rules, which were drawn up in committee, which the Council will accept and which Parliament will hopefully adopt tomorrow, are stricter than those laid down by the Council of Europe in its so-called Bioethics Convention, but the rules explicitly permit research, and we think that this research – when it is conducted in accordance with the rules – is extremely important.
In this respect I am therefore happy with the compromise which has been reached. I am unhappy with two aspects. Originally at the first reading we had demanded a shorter deadline for authorising clinical trials, and I had hoped that the deadline of 60 days, which is provided for in the common position, would be reduced somewhat, at least for the national authorities. You see, I believe that it is perfectly acceptable to grant a rather longer deadline to an Ethics Committee, whose work is not the main job of the people who work there, but surely the authorities should be put under some pressure to start the work quickly.
Unfortunately, it was unlikely that a compromise would be reached on this basis in the Council, and I would therefore prefer to put the compromise struck with the Council to the vote rather than having a long conciliation procedure, with perhaps no agreement at the end. The situation is the same for the issue of whether the principal investigator should be a doctor or whether other professions should also be authorised. Parliament continues to want doctors to be the only ones to carry out clinical trials in all of the Member States because we believe that nurses and midwives should not be active in this sensitive area even if they have additional training, and neither should biologists or pharmaceutical chemists, who may only have worked in the laboratory and not have sufficient experience with patients. I must concede, however, that the Council was not prepared to compromise further here either. That is why we must, with a heavy heart, agree to this compromise. If we accept it we will still have a directive which guarantees therapeutic progress and which does not just leave the protection of patients in Europe as it is but improves it, and that is why I would plead in favour of this compromise."@en1
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