WRITTEN QUESTION E-2386/02

by Brice Hortefeux (PPE-DE) to the Commission

(2 August 2002)

Subject: Dangers of directly promoting certain medicines

The Commission plans to amend Community legislation to authorise the direct consumer advertising of certain medicines available only on prescription.

However, American experience is this area should serve as a warning as to what might happen in Europe. According to a recent study in the United States, direct advertising misleads consumers, generates large-scale use of expensive new products and doubles inflation for expenditure on medicines. An identical phenomenon has occurred in New Zealand, the only other country to authorise direct consumer advertising.

Under these circumstances, does the Commission not consider that, in authorising direct advertising, it is opening the way for escalating costs and excessive use of medicines in Europe, as has happened in the United States?

Answer given by Mr Liikanen on behalf of the Commission

(5 September 2002)

Medicinal products are distinct from most other products, in so far as from a public health point of view they should not be used as much as possible, but as little as necessary.

Consequently, the current legislation on advertising of medicinal products for human use provides in Article 88 paragraph 1 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) that Member States shall prohibit the advertising to the general public of medicinal products, which are available on medical prescription only.

The Commission's proposals to amend the existing pharmaceutical legislation(2) does not touch upon this strict ban of advertising of prescription-only medicines to the general public. The Commission is fully aware of experiences with direct-to-consumer advertising in other countries and does not have the intention to move into this direction.

The modifications that the Commission has proposed to Article 88 of Directive 2001/83/EC relate to information and not to advertising. This distinction is important since information is meant to serve the interest of the patients, whereas advertising shall promote the marketing of the product and serve the interest of pharmaceutical industry.

The proposals foresee a pilot phase where the dissemination of certain information to the public on some prescription-only medicines directly by the industry would be allowed under strict conditions. These conditions require compliance with principles of good information practice and a control by the European Medicines Evaluation Agency in London before the information is released to the public.

The focus of this proposal is exclusively the patients and their need for better information. This objective is clearly reflected by the choice of three specific disease groups (diabetes, acquired immune deficiency syndrome (AIDS) and asthma) to which the Commission's proposal is limited at present. All of them are diseases which are long-term and chronic, where there is specific patient demand for information. Over and above this, the patients suffering from these diseases are generally already taking specific medicines. So the improved information will have a positive impact for the patient, but is not expected to increase or create a need for these medicines.

(1) OJ L 311, 28.11.2001.

(2) OJ C 75 E, 26.3.2002.