WRITTEN QUESTION E-0563/03 by Frédérique Ries (ELDR) to the Council. Proposal for a regulation on paediatric medicines.
Date: 2003-02-27
Institutions: European Parliament, Provisional data
Subjects: drafting of EU law, health policy, medical research, paediatrics, pharmaceutical legislation

18.9.2003

EN

Official Journal of the European Union

C 222 E/217

In short, the Conegliano local council directly transferred responsibility for the service to the CIT, which in
turn subcontracted part of the work to SAV.NO.

In the light of the above, does the Commission not consider that such measures are unacceptable since
they violate Community legislation on subcontracting the management of local public services?

Answer given by Mr Bolkestein on behalf of the Commission

(25 April 2003)

The Commission would like to inform the Honourable Member that it knows there are certain problems
with Italian legislation in the field of local public services which is incompatible with Community law on
public procurement and concessions. This legislation is currently the subject of an infringement procedure
under which the Commission recently sent a supplementary letter of
formal notice to the Italian
government.

With regard to the award of the waste management service in the municipality of Conegliano, the
Commission will ask the Italian authorities for detailed information which will enable it to assess whether
the case in question is part of the more general problem addressed by the aforementioned infringement
procedure.

(2003/C 222 E/246)

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.