92003E0563

WRITTEN QUESTION E-0563/03

by Frédérique Ries (ELDR) to the Council

(27 February 2003)

Subject: Proposal for a regulation on paediatric medicines

In December 2000 the Council unanimously adopted a resolution calling on the Commission to propose regulatory measures to improve availability of paediatric treatment. The Council acknowledged that there was a genuine deficiency in this area of healthcare. The Commission undertook to respond to this call from the Council. Although the Commission several times confirmed this undertaking during the recent debates in Parliament on the occasion of the revision of the pharmaceutical legislation, the obligation to submit the draft paediatric regulation to an economic impact assessment once again raises the fear that there will be further delays in the publication of the text. The imperative deadlines that the European institutions will have to meet in 2004 could well delay the completion of this project.

Could the Council of the European Union undertake to deal with this subject as a matter of priority as soon as the Commission has informed it of the regulatory proposals?

Reply

(13 May 2003)

As the Honourable Parliamentarian recalls, the Council has shown its interest for this subject in the resolution of 14 December 2000 on paediatric medicinal products. In its resolution, the Council invited the Commission to make appropriate proposals as soon as possible in the form of incentives, regulatory measures or other supporting measures in respect of clinical research and development, taking account of the ethical aspects of clinical trials on children, to ensure that new medicinal products for children and medicinal products already on the market are fully adapted to the specific need of that population group, and taking into account also the internationally acknowledged standards for the protection of minors with regard to medical scientific research.

The Council awaits the Commission's proposals with interest and will, then, deal with this important dossier in a timely and effective manner.