WRITTEN QUESTION E-3401/01 by Anneli Hulthén (PSE) to the Commission. Research into the manufacture of paediatric medicinal products.
Date: 2001-12-21
Institutions: European Parliament, Provisional data
Subjects: child, medical research, medicinal product, paediatrics, pharmaceutical legislation, testing

6.6.2002

EN

Official Journal of the European Communities

C 134 E/229

For the EQUAL Community Initiative, the Commission defined mainstreaming as one of the key principles.
Mainstreaming relates to a process that includes identifying lessons, clarifying the innovative element and
approach that produced the results, their dissemination, validation and transfer. In order to organise
mainstreaming of EQUAL on a broader scale and in all directions, the Commission is currently establishing
European Thematic Groups at European level which will draw together and share the good practice which
has been identified by the Member States thus contributing to the development of European employment
and social inclusion policies.

(2002/C 134 E/242)

WRITTEN QUESTION E-3401/01

by Anneli Hulthén (PSE) to the Commission

(21 December 2001)

Subject: Research into the manufacture of paediatric medicinal products

The medicines that are the subject of current research and approval procedures are, almost without
exception, intended for adults and not for children. When children fall ill, they are often given the same
medicines as adults, albeit at lower doses. Such medicines have not been tested on children, however, the
reason being that children constitute a relatively small patient group and clinical trials are very expensive
to conduct in the case of medicinal products.

Medicines that work well for adults do not necessarily work as well for children. Children’s bodies are
growing, children have a higher metabolic rate than adults, and children are more sensitive to active
substances in medicines.

In December 2000, the Council adopted a resolution stressing that incentives were one possible route
Europe could take with a view to increasing the range of paediatric medicinal products.

What progress is the Commission making as regards devising measures to promote clinical research which
will result in better medicines for children?

Answer given by Mr Liikanen on behalf of the Commission

(28 January 2002)

The difficulties associated with the development of suitably adapted medicines for children is recognised by
the Commission.

In response to the Council’s resolution of December 2000, the Commission clearly indicated that it
recognised the problem and was prepared to take action in accordance with resource and priority
considerations.

The Commission is committed to the development of a new legislative proposal in 2002. A meeting with
Member States was organised on this subject in November 2001 and a consultation document is currently
under preparation in order to encourage input and discussion from all the stakeholders concerned.

(2002/C 134 E/243)

WRITTEN QUESTION P-3407/01

by Kyösti Virrankoski (ELDR) to the Commission

(5 December 2001)

Subject: Scope of the Waste Incineration Directive 2000/76/EC of 4 December 2000

In the Member States of the EU the use of waste oil for the production of heat energy is restricted,
particularly as regards small heating units. At the time, the reason for this was that it was not possible to
burn waste oil in small heating plants while complying with current emissions standards. However, oil