2011/06 > What is the difference between advertisement and information?

As everyone knows, the advertising of medicines is highly regulated, and even prohibited for medicines that are issued on medical prescription. This results from Article 88 §1 a) of Community Directive 2001/83 (PDF), that has been implemented in German Law.

In the case presented before the ECJ (C-316/09), the company Merckle contested the diffusion, by its competitor MSD, of information related to medicines issued on prescription, on its website. Merckle considered that by acting in this way, MSD had breached German Law and adopted an unfair behaviour. Indeed, Merckle won.

However, MSD argued, in its last appeal before the Bundesgerichtshof, that the material in question was information that was available to any consumer, since it was limited to reproduction of: the packaging of the product, the therapeutical indication and the notice of use. MSD considered that this was not advertising.

This question led the Bundesgerichtshof to postpone its judgment and to ask the ECJ to answer the following question:
“Does Article 88(1)(a) of Directive 2001/83 also prohibit advertising to the general public of the type at issue in the present case, which contains only information communicated to the competent authority under the marketing authorisation procedure for the medicinal products concerned and which, in any event, is accessible to anyone who purchases them, where that information is not presented to the person concerned without his asking for it, but is accessible on the internet only by a person who takes steps to obtain it”.

In response, the ECJ states in the first place that the concept of advertising of medicinal products adopted by the European Union legislature is very broad and may include the dissemination on the internet of information relating to medicinal products. It is, in fact, the purpose of the message which constitutes the fundamental defining characteristic of advertising, and which is the decisive factor for distinguishing advertising from mere information. the decision also highlights that examination of this purpose, promotional or not, is determined by national Courts which will have to determine it by undertaking a detailed examination of all the relevant circumstances of the case and especially, based on its behaviour and its initiatives, the intentions of the producer to promote the medicine at issue.

The court recognised that communication from a producer can cause a patient to ask his doctor to prescribe one medicine rather than another one. However, the Court considers that this situation can be to the advantage of the patient – resulting in a fruitful discussion with his doctor (who has the final decision on what to prescribe), or reducing the risk of uninformed self-medication if the notice of use is lost – if the imparted information is objective.

In addition, information displayed on the packaging and the notice of use are de facto objective, since regulations prohibit any promotional element in these items and they are compulsory. Therefore, the Court concludes 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, […], 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 Court specifies nevertheless 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”.
(Case C-316/09, 5 May 2011, MSD Sharp & Dohme GmbH v/ Merckle GmbH).

This judgment completes the decision issued on the same day in Case C-249/09, which specifies that the elements of the advertising of a medicine authorised by Article 87 §2 of the same directive encompass “quotations taken from medical journals or other scientific works which are included in advertisements for medicinal products directed at persons qualified to prescribe or supply medicines” and that they can be completed by information which does not distort them, is not misleading and encourages the rational use of the medicinal product.
(Case C-249/09, 5 May 2011, Novo Nordisk AS v/ Ravimiamet.)