WRITTEN QUESTION E-1692/03

by Elly Plooij-van Gorsel (ELDR) to the Commission

(21 May 2003)

Subject: Paediatric medicine

Improved medicines developed specifically for children should be regarded as a priority. In December 2000 the Council called for a package of measures to be drafted as soon as possible to promote research and development in the area of paediatric medicine and effective medication. In February 2002 the Commission produced a consultation document on this subject. This gave rise to hope among the parties concerned (patients' organisations, scientific institutes and the pharmaceutical industry) that the necessary measures would be implemented rapidly and effectively. However, so far the Commission has still taken no action resulting in a specific proposal to the Council and Parliament.

In the United States measures of this kind in the area of paediatric medicine already exist, providing incentives for research and development since as long ago as 1997. As a result, the United States has a clear edge over Europe in the sphere of paediatric medicine.

1. Is the Commission aware of this situation?

2. If so, does the Commission not share the view that measures to promote research and development in the sphere of paediatric medicine should be taken as soon as possible?

3. If so, what initiatives or practical measures does the Commission envisage taking and on what timescale?

Answer given by Mr Liikanen on behalf of the Commission

(19 June 2003)

The Commission intends to present a final text of the proposal for a Regulation on medicinal products for paediatric use before the end of 2003. A first draft was prepared in September 2002. The Member States and the European Medicines Evaluation Agency were consulted on the basis of this draft.

The Commission has decided that this proposal should be among the 43 important proposals within the framework of the 2003 legislative and work programme, which should undergo an extended impact assessment. The extended impact assessment is an important element of the Commission's better regulation action plan.

The Commission has now started preparing this impact assessment and intends to conduct it as swiftly as possible in order to be able to adopt the proposal. It is anticipated that the impact assessment will be completed by the end of 2003. In the meantime, the Commission has established an informal working group of the Pharmaceutical Committee to discuss the informal draft proposal.

Concerning the research activities of the Commission in this sector, a number of research projects addressing issues of clinical trials in children, especially in the area of rare diseases which predominantly affect children, have already been supported or are supported.

Furthermore, the specific programme for the 6th Framework programme of the Community for research, technological development and demonstration activities, adopted on 30 September 2002, clearly indicates in its thematic priority Life sciences, genomics and biotechnology for health(1) that attention will be paid to childhood diseases and related treatments, whenever appropriate.

In this thematic priority, the following research actions are of particular relevance for that sector:

- Technological platforms for the developments in the fields of new diagnostic, prevention and therapeutic tools where rational and accelerated development of new, safer and more effective drugs including pharmacogenomics approaches are expected to deliver better therapies for children. An indicative topic on Medicines for children is already foreseen for the second call,

- Combating cardiovascular disease, diabetes and rare diseases and especially research activities on rare diseases which are expected to be naturally mostly dedicated to children,

- Combating resistance to antibiotics and other drugs which includes the development of vaccines and alternative therapeutic strategies to circumvent the problem of antimicrobial and other drug resistance will also undoubtedly be of interest for children,

- Studying the brain and combating diseases of the nervous system where the development of strategies for prevention and management of neurological and mental disorders and diseases is expected to have specific research action towards children,

- Studying human development and the ageing process, where the understanding of human development from conception to adolescence is expected to have application as regards child health.

The thematic priority 5 Food quality and safety is also expected to contribute to several aspects of child health and especially in the following research actions:

- Epidemiology of food-related diseases and allergies where epidemiological studies of the effect of diet, food composition and lifestyle factors on the health of children and the prevention or development of specific diseases, allergies and disorders will be tackled,

- Impact of food on health and Environmental health risks where specificity of children is clearly addressed.

(1) OJ L 294, 29.10.2002.