92002E1729

WRITTEN QUESTION E-1729/02

by Jens-Peter Bonde (EDD) to the Commission

(17 June 2002)

Subject: Marketing rules in the EU

Is there any prospect of pharmaceutical companies being allowed to advertise their products even if those products are medicines available on prescription only?

Answer given by Mr Liikanen on behalf of the Commission

(11 July 2002)

The advertising of medicinal products for human use is regulated primarily by Articles 86 to 100 of Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(1).

Regarding advertising of medicinal products to the general public, Article 88, paragraph 1 of Directive 2001/83/EC provides that Member States shall prohibit the advertising to the general public of medicinal products, which are available on medical prescription only. The only exception to this strict ban is laid down in Article 88, paragraph 4 of the same Directive. This provision exempts vaccination campaigns carried out by the industry and approved by the authorities of the Member States from the general prohibition of advertising. Outside this exception, all kind of advertising of prescription-only medicines to the general public is strictly forbidden.

Regarding advertising of medicinal products to persons qualified to prescribe or supply such products, specific provisions are contained in Articles 91 to 96 of Directive 2001/83/EC. These provisions do not generally prohibit the advertising of medicinal products available on medical prescription only. Accordingly, pharmaceutical companies may advertise even prescription-only medicines to this category of persons.

In the specific context of television advertising, the particular ban of Article 14 of Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by Law, Regulation or Administrative Action in Member States concerning the pursuit of television broadcasting activities(2) has to be respected. It sets out that television advertising for medicinal products and medical treatment available only on prescription in the Member State within whose jurisdiction the broadcaster falls shall be prohibited.

At present, certain parts of the pharmaceutical legislation are under revision. The Commission's proposal(3) contains certain modifications of Article 88 of Directive 2001/83/EC in order to allow better information on certain prescription-only medicines. The strict ban of any kind of advertising for these products, however, is fully maintained.

(1) OJ L 311, 28.11.2001.

(2) OJ L 298, 17.10.1989.

(3) COM(2001) 404 final.