92000E1199

WRITTEN QUESTION E-1199/00

by Adriana Poli Bortone (UEN) to the Commission

(12 April 2000)

Subject: Medicines administered to children

Statistics published by the authoritative British Medical Journal show that 67 % of children in general paediatric wards are given at least one prescription for drugs which does not meet the criteria for which the drug was licensed.

According to the Mario Negri pharmacological research centre, this percentage can be as high as 86 % in Italy. In view of this, can the Commission say what steps it intends to take or might envisage to tackle this serious problem affecting children?

Can it also say whether any research is planned to improve scientific knowledge, so as to ensure efficiency and safety and a more rational use of drugs administered to children?

Finally, can the Commission say whether it is possible to promote and defend the right of children to be treated with drugs in accordance with evidence-based medicine?

Answer given by Mr Liikanen on behalf of the Commission

(29 June 2000)

The Commission is well aware of the matters the Honourable Member has raised. This is indeed a serious problem, concerning not only children but the whole population.

It is true that in the vast majority of cases, and in most areas of therapy, the medicines administered to children do not exist in a specially adapted pharmaceutical form and have not been the subject of clinical studies geared towards that category of patients. Nor do marketing authorisations make specific mention of administration to children. Yet the fact is that the criteria of efficacy and safety of medicinal products, and their rational use, must also apply to medicines administered to children.

As for the Community research effort, two activities under the Quality of life and management of living resources specific programme of the Fifth Framework Programme are intended to ensure that the therapeutic arsenal is used to maximum effect in health care.

The first is a key action concerning the Cell factory, aiming to promote the enhanced, safe and efficient production of therapeutic substances. The second is an activity of a generic nature designed to evaluate specific therapies in the hospital setting by means of large-scale clinical trials, thereby providing a foundation for using therapies in accordance with evidence-based medicine.

Research projects now under way following calls for proposals in 1999 are looking at the best possible therapeutic approaches to congenital metabolic disorders, congenital muscular dystrophy and rare haematological disorders more specifically affecting children. Unfortunately, the Commission did not receive any research proposals targeted more specifically towards the problem raised by the Honourable Member.

New calls for proposals are due to be launched in October 2000, and again in 2001 and 2002 on the dates published in the work programme. The Commission hopes these will attract research proposals geared towards the improvement, efficacy and rational use of therapies specially designed for children.