Strasbourg, 07/09/2005 (Agence Europe) - With a very comfortable majority, MEPs consolidated, on Wednesday in Strasbourg, the system that will make it possible in future to have medicines that are more suitable for children and whose adverse effects are correctly documented.
During the first reading of the proposal of regulation on the paediatric use of medicines, the European Parliament endorsed the report by French elected member of the UMP, Françoise Grossetête, practically without any changes. In so doing, it confirms the establishment of a reward - six-month extension of complementary protection certificate - for clinical trials on medicines with a view to obtaining medicines adapted for use by children. The mechanism, which was at the heart of the Commission's proposal, was the most discussed (see also EUROPE 8991). It corresponds to the system put in place in the United States to promote paediatric trials. The whole procedure will be managed by a paediatric committee that will be set in place within the European Agency for the Evaluation of Medicinal Products in London. The Parliament has, moreover, confirmed extension from ten to twelve years of the exclusivity granted to orphan medicines when they are indicated for paediatric use. It also sought to: (1) make the action of the paediatric committee more visible; (2) avoid futile clinical studies; (3) strengthen pharmaco-vigilance and (4) guarantee the setting in place of a support mechanism for paediatric research.
It is now up to the Council to speak. In so far as a majority of Member States had already taken a stance before the summer for the approach at the heart of the text, the vote in Parliament could open the road to final adoption of the regulation at second reading.