WRITTEN QUESTION E-0564/03 by Frédérique Ries (ELDR) to the Commission. Proposal for a regulation on paediatric medicines.
Date: 2003-02-27
Institutions: European Parliament, Provisional data
Subjects: drafting of EU law, health policy, impact study, medicinal product, paediatrics, pharmaceutical legislation

C 192 E/202

Official Journal of the European Union

EN

14.8.2003

(2003/C 192 E/243)

WRITTEN QUESTION E-0564/03

by Frédérique Ries (ELDR) to the Commission

(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.

Does the Commission intend to submit a proposal for a regulation on this subject in the near future?

(2003/C 192 E/244)

WRITTEN QUESTION P-0626/03

by Peter Liese (PPE-DE) to the Commission

(25 February 2003)

Subject: European Commission’s proposal for a regulation on medicinal products for paediatric use

European Commission’s proposal for a regulation on medicinal products for paediatric use In its resolution
of 14 December 2000 on paediatric medicinal products (1), the Council invited the European Commission
to ‘make appropriate proposals as soon as possible’
in order to improve the availability of suitable
medicines for children.

Medicinal products for children need to be tested scientifically before widespread use. This can only be
achieved by ensuring that medicines which are likely to be of significant clinical value in children are fully
studied.

In February 2002, the European Commission launched its public consultations on ‘Better Medicines for
Children’. In the summary overview of responses in June 2002, it was stated that ‘an overarching concern
expressed throughout the comments was the urgency of this matter’. In its working plan for 2003, the
Commission announced the release of the legislative proposal by March 2003, more than two years after
the Council resolution.

Can the Commission guarantee that the proposal will be released without further delay so that there is at
least a chance of an adoption under codecision procedure before the enlargement of the European Union?

(1) OJ C 17, 19.1.2001, p. 1.

Joint answer
to Written Questions E-0564/03 and P-0626/03
given by Mr Liikanen on behalf of the Commission

(3 April 2003)

The Commission intends to present a final text of the proposal for a Regulation on medicinal products for
paediatric use as soon as possible. A first draft had been prepared in September 2002. On the basis of this
draft, the Member States and the European Medicines Evaluation Agency were consulted. This consultation
process took longer than expected as the Member States during the Pharmaceutical Committee of
November 2002 asked for a prolonged deadline for comments.