A recent decision of the European Court of Justice suggests that the Court is beginning to adopt a strict interpretation as to what could constitute the "promotion" of medicinal products in the European Union.
The Court concluded that the absence of legal, commercial or other links between the manufacturer of a medicinal product and a third party disseminating information on the product does not exclude activities of the third party from the scope of the definition of "advertising" found in EU legislation.1 Furthermore, reference to the properties and/or availability of the product could qualify as "advertising;” provided that this could, potentially, influence consumers' behavior and encourage the consumption of the product. Finally, the Court concluded that it was for the EU Member States' authorities to assess the context on case by case basis and to apply strictly the rules on advertising of medicinal products in order to safeguard public health.
In the judgment the Court2 gave its response to a question from a Danish court regarding the interpretation of the EU definition of the advertising of medicinal products. The case concerned a Danish independent journalist who provided opinion and information on his website concerning a medicinal product, which had been banned in Denmark. The medicinal product, Hyben Total, was previously marketed in Denmark by its manufacturer, Natur-Drogeriet A/S (Natur-Drogeriet), as a product intended to relieve or treat gout, gallstones, kidney disorders, bladder disorders, sciatica, bladder bleeding, diarrhoea, stomach cramps, diabetes, and kidney stones. When the product was launched in Denmark, the information material on the product had been prepared by the journalist, Mr Damgaard. Sales of the product were halted in 1999, however, when marketing authorization was refused.
Mr. Damgaard subsequently posted information on his own website informing visitors of the therapeutic properties of the product and of its availability on neighboring countries' markets where it is classified as a food supplement. The Danish authorities considered that the dissemination of such information violated the country's national provisions implementing the EU ban on advertising of non-authorized medicinal products. Following criminal proceedings initiated against him, Mr. Damgaard was fined. Mr Damgaard appealed the judgment imposing the fine. He claimed that he had no connection with the manufacturer of the medicinal product, nor any commercial interest in the product. He considered his activities to be limited to communicating relevant information to professionals and to other interested parties and, thus, not covered by the definition of advertisement under EU law.
Court’s Analysis and Judgment
As a preliminary remark, the Court reiterated that the protection of public health is an essential aim of the EU legislation governing the promotion of medicinal products. The rules on advertising must be interpreted in a way that ensured that this aim was achieved.
When assessing the matter, the Court focused on the context in which dissemination of the information had taken place. It acknowledged the independence of the journalist and took into account the fact that the information provided by Mr. Damgaard referred to the availability of the product on the markets of neighboring countries.
The Court concluded, however, that the dissemination of information by independent third parties was not excluded from the EU definition of advertising. The absence of any links between the communicator and the manufacturer had no impact on this definition. This was because the dissemination of information on the properties and availability of a product could influence consumers' behavior and encourage its consumption. Even conducted outside any commercial or industrial activity such behavior could be considered advertising and be liable to impact public health. Thus, EU Member States should control and sanction such behavior when the safeguard of public health required it.
The Court considered that "dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, may be regarded as advertising [.], even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product".
The Ruling in Context
The approach of the Court in the present case appears to move away from its previous position concerning the provision of information about a medicinal product by an independent third party. In a judgment from 1992 regarding the presentation of a medicinal product, the Court had concluded that the dissemination of information about the therapeutic properties of a medicinal product by a third party acting on his own initiative and completely independently of the manufacturer or the seller did not constitute a presentation of the product, since it does not disclose an intention on the part of the manufacturer or the seller to market the product as a medicinal product.3
The present judgment is pronounced at a time when the European Union Institutions and stakeholders are discussing the revisions of the current rules on the provision of information to patients in the European Union. This revision may provide a clear and usable distinction between information and advertising of medicinal products. It is not expected, however, that the new legislation will be adopted before 2010.