Local view for "http://purl.org/linkedpolitics/eu/plenary/2000-12-11-Speech-1-091"
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"Madam President, I want to thank the rapporteur, Mr Liese, and congratulate him on the excellent report he has presented, as well as the Committee on the Environment, Public Health and Consumer Policy on the work done.
In conclusion, the Commission can accept compromise Amendments Nos 28 to 43. It can also accept Amendments Nos 1, 2, 3, 6, 7, 8, 9, 10, 12, 13, 14, 16, 19, 21, 23 and 24. The Commission can also accept Amendments Nos 5, 11, 15, 17, 25, 26 and 27, in principle, but on the other hand, it cannot accept Amendments Nos 4, 18, 20 and 22.
The Commission would be happy if, after so much effort on the part of those concerned, we could achieve harmonisation, at Community level, of the requirements for conducting clinical trials. Indeed, this is particularly important for the protection of public health.
As you know, since 1965 Community legislation on pharmaceuticals has required medicines to obtain marketing authorisation before being put on sale. Authorisation is only granted if three fundamental criteria are met: quality, safety and effectiveness. This requirement responds to two essential objectives: the protection of public health and freedom of movement.
Conducting clinical trials, in accordance with the principles of good clinical practice, makes it possible to test the effectiveness and safety of medicines. Good clinical practice has been the subject of international harmonisation, in the form of guidelines adopted by the International Harmonisation Conference involving representatives of the European Union, the United States and Japan.
However, as these guidelines are not legally binding, they are applied very differently in the various Member States. This involves difficulties both for participants in clinical trials and industrialists who want to conduct such trials in the European Union.
That is what led the Commission to propose, in September 1997, a legislative framework, based on Article 95 of the Treaty, with the aim of harmonising the procedures applying to clinical trials in the European Union. The Commission modified its proposal in April 1999 to take account of the opinion of the European Parliament.
The common position of the Council, adopted in July 2000, is essentially based on the Commission’s amended proposal and incorporates most of the amendments suggested by the European Parliament and accepted by the Commission, which entirely appreciates the European Parliament’s concern in tabling amendments largely aimed at finalising the protection of the individuals taking part in clinical trials, especially children and adults incapable of giving consent.
Where it is essential for these groups to have medicines specially adapted to them, the challenge is to be able to carry out trials whilst ensuring their protection. In-depth work, carried out in full cooperation between the European Parliament, the Council and the Commission, has made it possible to draft a compromise which takes account of all the points raised and indicates where positions occasionally diverge.
The Commission can accept all the compromise amendments. In fact, they meet the Commission’s objectives, that is, the protection of public health in the eyes of those taking part in clinical trials, the need to facilitate the establishment of clinical trials within the European Union, and the need for the pharmaceutical industry to be competitive internationally."@en1
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