91999E1674

WRITTEN QUESTION E-1674/99

by Marialiese Flemming (PPE-DE) to the Commission

(22 September 1999)

Subject: Self-medication

In a resolution on an industrial policy for the pharmaceutical sector adopted by the European Parliament on 16 April 1996 (A4-0104/96(1)), self-medication is described as an important element in a long-term policy for health. This position is in line with that adopted by the Commission, notably in its communication of 1 June 1994 regarding a programme of Community action on health promotion, information, education and training within the framework for action in the field of public health.

With Parliament's support, the Commission has been advocating wider use of responsible self-medication in recent years. This approach reflects people's willingness to take greater responsibility for their own health, and has already significantly eased the burden on social security schemes.

Does the Commission intend to continue to pursue this policy and further improve the regulatory framework for non-prescription medicines?

(1) OJ C 141, 13.5.1996, p. 63.

Answer given by Mr Byrne on behalf of the Commission

(26 October 1999)

The Commission shares the view expressed by the Honourable Member that responsible self medication and the existence of an appropriate regulatory frame for non-prescription medicinal products (over the counter (OTC) products) is an important issue which deserves particular attention. The Commission notes that Community pharmaceutical legislation already provides for a detailed legal framework concerning the placing on the market of medicinal products in the Community and that the current legal situation can be considered as satisfactory.

There is, however, always scope for improvement. According to Article 71 of Regulation (EEC) 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(1), the Commission will publish, before the end of 2001, a general report on the experience acquired as a result of the operation of the new marketing authorisation systems for medicinal products. This general report will be the basis for a review of Community pharmaceutical legislation including the rules applicable to OTC-products.

This comprehensive review of Community pharmaceutical legislation will have to consider issues of particular importance for OTC products including the functioning of the mutual recognition procedure (in particular the inclusion of legal status in the process of mutual recognition), the scope of products eligible for the centralised procedure, the classification of medicinal products into OTC and prescription-only products (currently included in Council Directive 92/0026/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use)(2) and the requirements and conditions for advertising of OTC-products (currently included in Directive 92/0028/EEC of 31 March 1992 on the advertising of medicinal products for human use)(3)

In addition, the Commission supports actions that promote the availability of sound advice and the dissemination of accurate information as regards self-medication, in the framework of its programme on health promotion, information, education and training. In this context special attention is being paid to strengthening the role of health professionals in the area of health promotion, including self-medication, and to better defining indications suitable for self-medication.

(1) OJ L 214, 24.8.1993.

(2) OJ L 113, 30.4.1992.

(3) OJ L 113, 30.4.1992.