92000E0428

WRITTEN QUESTION P-0428/00

by Pietro-Paolo Mennea (ELDR) to the Commission

(11 February 2000)

Subject: Inclusion of a symbol on medicine packages showing which medicaments contain banned substances

Sport has an important role in society and may now be considered as an integral part of the culture of all Community countries:

- taking into consideration that it has an educational, cultural and recreational function recognised in the Amsterdam Treaty;

- it is important in safeguarding the health of athletes who practise various kinds of sport;

- it has been demonstrated that drug abuse has serious immediate and long-term consequences for the health and physical integrity of people, including sportsmen;

- the serious damaging effects vary according to the category of drugs used and other variables, such as the dose, the duration of treatment, the combining of different kinds of drugs and the presence of diseases which may aggravate the toxic effects;

- in general the risks inherent in taking such drugs are underestimated;

- a young athlete may be the final link in a chain of abuse and unlawful, even criminal, practices which often go undetected and unpunished;

- in view of the fact that most sportsmen do not know enough about the specific properties of medicaments; and

- that the Union must be at the forefront of the fight against doping.

Can the Commission say whether, in compliance with EEC directives and European drug legislation, it intends to oblige the pharmaceutical industries to include a symbol on the packaging of newly introduced drugs and clear warnings in the enclosed leaflets telling both doctors and sportsmen which drugs contain banned substances?

Answer given by Mr Liikanen on behalf of the Commission

(8 March 2000)

As stated in the Community support plan to combat doping in sport(1) the Commission feels that stepping up the supply of information on medicines is a highly important factor in the fight against the use of drugs in sport.

Article 12 of Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use(2) provides the Commission with scope for formulating certain special warnings for certain categories of medicinal product. Moreover, Article 2 of that same directive provides that the outer packaging (of medicines) may include symbols or pictograms designed to clarify certain items of information concerning a medicine, and which is useful for health education, to the exclusion of any element of a promotional nature.

As part of this, in order to provide further information on medicines containing active substances classified as drugs, the Commission put this matter on the agenda of the next meeting of the pharmaceuticals committee, which will be held on 22-23March 2000. The Member States and the European Agency for the Evaluation of Medicinal Products are represented on this. The Commission has drawn up a questionnaire enabling an inventory to be made of what has already been introduced at national level in certain Member States. The aim is to put forward harmonised entries on both the labelling and package leaflets for medicines that are intended to inform patients, and on the wording of the summary of product characteristics intended to provide information for professional healthcare providers.

(1) COM(1999) 643 final Communication from the Commission to the Council, Parliament, the Economic and Social Committee and the Committee of the Regions of 1 December 1999.

(2) OJ L 113, 30.4.1992.