Judgment of the Court (Third Chamber) of 5 May 2011 (reference for a preliminary ruling from the Bundesgerichtshof (Germany)) — MSD Sharp & Dohme GmbH v Merckle GmbH

(Case C-316/09) (1)

(Medicinal products for human use - Directive 2001/83/EC - Prohibition on the advertising to the general public of medicinal products available only on prescription - Definition of ‘advertising’ - Information communicated to the competent authority - Information accessible on the internet)

2011/C 186/05

Language of the case: German

Referring court

Bundesgerichtshof

Parties to the main proceedings

Applicant: MSD Sharp & Dohme GmbH

Defendant: Merckle GmbH

Re:

Reference for a preliminary ruling — Bundesgerichtshof — Interpretation of the first indent of Article 88(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67) — Prohibition on advertising to the general public of medicinal products which are available on medical prescription only — Concept of ‘advertising’ — Advertising in relation to a medicinal product providing access to information only to persons who undertake an Internet search and which contains only those indications communicated to the competent authority in the context of the marketing authorisation procedure relating to the medicinal product and which is available to patients on purchasing the product

Operative part of the judgment

Article 88(1)(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, must be interpreted as meaning that it does not prohibit the dissemination on a website, by a pharmaceutical undertaking, of information relating to medicinal products available on medical prescription only, where that information is accessible on the website only to someone who seeks to obtain it and that dissemination consists solely in the faithful reproduction of the packaging of the medicinal product, in accordance with Article 62 of Directive 2001/83, as amended by Directive 2004/27, and in the literal and complete reproduction of the package leaflet or the summary of the product’s characteristics, which have been approved by the authorities with competence in relation to medicinal products. On the other hand, the dissemination, on such a website, of information relating to a medicinal product which has been selected or rewritten by the manufacturer, which can be explained only by an advertising purpose, is prohibited. It is for the referring court to determine whether and to what extent the activities at issue in the main proceedings constitute advertising within the meaning of Directive 2001/83, as amended by Directive 2004/27.

(1)  OJ C 267, 7.11.2009.