91997E3901

WRITTEN QUESTION P-3901/97 by Carlo Secchi (PPE) to the Commission (27 November 1997)

Subject: Ban on advertizing laxatives in Italy

Is the Commission aware that the Italian Health Ministry's Drugs Board has decided to reclassify laxatives, which are at present classed as OTC [over the counter] drugs, as so-called SOP (senza obbligo di prescrizione) or restricted non-prescription drugs which, unlike OTC drugs, cannot be advertized to the public?

Does the Commission take the view that this measure could constitute a barrier to the free movement of goods, in view of the fact that current European legislation, as well as the Member States' domestic legislation, allows drugs for self medication to be advertized to the public?

Answer given by Mr Bangemann on behalf of the Commission (22 December 1997)

The planned Italian measures which may have the consequence of prohibiting the advertising for all laxative products were brought to the attention of the Commission by an Italian pharmaceutical industry association on 20 November 1997.

Considering the clear wording of Article 3 of Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use ((OJ L 113, 30.4.1992. )) it seems that Member States are not allowed to have more restrictive rules on the advertising to the general public. Therefore, a national ban on the advertising of a certain category of medicinal products 'which by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary' and which is not covered by the explicit derogations laid down in Article 3 paragraphs 1 and 3, appears to be an infringement of Community law.

The Commission is closely monitoring the further development of this issue in Italy and will, if necessary, initiate the appropriate steps to ensure full compliance with Community law.

Directive 92/26/EC of 31 March 1992 concerning the classification for the supply of medicinal products for human use ((OJ L 113, 30.4.1992. )) gives to the Member States the possibility to re-classify the legal status of medicinal products so that advertisement requirements could be different, including the possibility of prohibiting such advertisement.