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    The Court of Justice of the European Union has made a decision regarding the interpretation of advertising medicinal products

    12.07.2011
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    The Court of Justice of the European Union (ECJ) has made a judgment concerning the reference for a preliminary ruling which concerns the question of interpreting Article 88 (1)(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6th of November 2001.

    The ECJ stated in its judgment that the concept of “advertising” should be regarded broadly and includes the dissemination of information relating to medicinal products on the internet. The ECJ points out that the purpose of the message is the decisive differentiating factor that separates advertising from merely presenting information.

    The ECJ stated that Article 88(1)(a) of Directive 2001/83/EC 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, 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. The ECJ added that 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.

    Furthermore, the ECJ explained the necessity to distinguish the following situations when presenting information:

    - the system of pull services which means that the information is simply available on the manufacturer’s website, so that consulting it requires active research;
    - the system of pop-up windows in which an internet user is confronted with the information without searching for it. From the last situation a strong presumption of advertising must be inferred.

    One of the main functions of the Court of Justice of the European Union is to ensure a unified implementation of EU legislation. The ECJ does not resolve the argument in its essence but only provides interpretations to EU legislation.

    The reference for a preliminary ruling by the German court and the Judgment of the European Court of Justice from the 5th of May 2011 with arguments and reasoning can be found on the home page of the Court of Justice of the European Union: http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=en.

    The number of the case is C-316/09.

    For further information please contact: info@ravimiamet.ee