WRITTEN QUESTION E-2574/99

by Bill Miller (PSE) to the Commission

(11 January 2000)

Subject: Commercial communications rules in Italy

I believe the Italian Government's requirements for the advertising of NRT patches (Nicotine Replacement Therapy) exceed those in other Member States. As a consequence,

advertisements for NRT patches made for pan-European distribution and which aim to communicate smoking-cessation methods to smokers who wish to quit have to be re-made so as to meet Italian rules. However, advertisements that are distributed in Italy via satellite or cable and which originate from Member States other than Italy do not have to meet the same requirements. Consequently, advertisements in Italy for NRT patches (which promote public health) are restricted compared with advertisements for the same products in other Member States. This hinders the free flow of information to smokers in Italy about the health benefits of using NRT patches to stop smoking.

Does the Commission consider that the Italian advertising rules conflict with the objective they are seeking to attain the protection of public health? If so, will the Commission consider initiating infringement proceedings against Italy in respect of those rules?

Answer given by Mr Liikanen on behalf of the Commission

(11 February 2000)

Products that help people dependent on nicotine break their addiction are medicinal products. When it comes to classifying such products for the purposes of prescriptions and possible advertising to the general public, however, Member States have adopted different approaches. In some Member States, such products are available without a prescription while in others they are not. However, because they seek to improve public health by breaking nicotine addiction, such products have been granted a derogation where advertising is concerned, as medicinal products that are available only on prescription cannot usually be advertised to the general public. Advertising to the general public has therefore been authorised in most Member States.

Council Directive 92/28/EC of 31 March 1992 on the advertising of medicinal products for human use(1) provides for the advertising of medicinal products to the general public and harmonises requirements. Article 4b) of this Directive specifies that the following minimum information must be included: the name of the medicinal product, the information necessary for correct use of the product and an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging.

In order to protect public health, advertising medicinal products to the general public is very strictly regulated in all Member States. It is, of course, perfectly possible that advertisements in the different Member States comply with the regulations but at the same time vary as to content and length.

The Commission does not have the information necessary to verify whether Italian regulations on the advertisements in question conflict with the objectives of protecting public health and the free flow of information, and will therefore contact the Italian authorities for additional information.

(1) OJ L 113, 30.4.1992.