WRITTEN QUESTION E-2427/02

by Erik Meijer (GUE/NGL) to the Commission

(26 August 2002)

Subject: Promoting sales of medication against nail fungus by means of advertising to the general public with the aim of bringing pressure to bear on general practitioners to prescribe it unnecessarily

1. Is the Commission aware that the pharmaceuticals company Novartis is seeking to increase sales of its product Lamisil in the Netherlands by means of TV advertising which causes viewers concern about the appearance of white and yellow patches in their nails, and in which, without mentioning any brand name, viewers are encouraged to ask their doctor to prescribe medication against fungal infections of the nails which can only be supplied by the company concerned?

2. Is the Commission aware that, as a result of this advertising campaign, unusually large numbers of people are contacting their doctors, even in cases where there is no obvious reason to undergo a strict course of treatment lasting three months which may have such side effects as anxiety neurosis, gastrointestinal complaints, loss of the sense of smell and/or taste and inflammation of the liver?

3. Is it acceptable that a pharmaceuticals company should within a short period of time gain 10 000 extra customers for its own product by means of indirect advertising while generating unnecessary work for general practitioners and unnecessary expense for health insurance funds and endangering the health of their potential customers?

4. Is this international corporation also carrying out similar campaigns in other EU Member States? How have the problems to which they give rise been tackled there?

5. Would it be possible to take measures at EU level to combat the type of action by pharmaceuticals companies referred to in paragraphs 1 and 2? If not, what means of preventing it are lacking?

6. Will the Commission take measures to prevent such customer-seeking campaigns in future?

7. If not, is it purely a matter for national legislatures to prohibit them? Why?

Answer given by Mr Liikanen on behalf of the Commission

(1 October 2002)

The overall policy objective is not to maximise the consumption of medical products, but to ensure a rational use. This means that advertising of medicinal products to the public could negatively affect public health, where it is excessive and ill-considered.

For these reasons, the Community legislation lays down strict provisions on the advertising of medicinal products for human use in Title VIII 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). They stipulate, for example, that all advertising shall encourage the rational use of the medicine. For certain categories of medicinal products, any kind of advertising to the general public is prohibited, in particular for medicines that are available on prescription only. In addition, Member States are entitled to prohibit the advertising for other categories such as medicines, the costs of which are reimbursed.

The provisions have been in place for about ten years now and have proven to provide a sound basis for the effective control of advertising activities by the pharmaceutical industry. It is important though to ensure that the legislative restrictions are actually enforced in practice.

This task lies within the responsibility of national authorities. Irrespective of whether the medicinal product has obtained a marketing authorisation by a Member State or by the Commission, its advertising has to be controlled and, where necessary, limited or even prohibited by the national authorities.

The Commission is fully aware of the potential conflict between public health objectives and commercial interests of the pharmaceutical industry. But as a consequence of the shared responsibilities, the Commission usually is not informed about particular advertising campaigns in the Member States. This is also true for the campaign by Novartis for Lamisil®.

(1) OJ L 311, 28.11.2001.