What is the difference between advertising and providing information?

This is the result of European legislation— Article 88 (1)(a) of Community Directive 2001/83—that has been implemented in national legislation.

In a German case (C-316/09) that eventually reached the Court of Justice for the EU (CJEU), pharmaceutical company Merckle contested the diffusion, by its competitor MSD Sharp & Dohme, of information about prescription medicines on its website. Merckle said that by acting in this way, MSD had breached the law prohibiting advertising for medicines, and in so doing, it displayed unfair behaviour. Indeed, Merckle won.

However, MSD argued—in its last appeal before the Bundesgerichtshof (the German Federal Supreme Court)—that the material in question was information that was commonly available to any consumer, as the material was limited to a reproduction of the packaging of the product, the therapeutic indication and the notice of use. MSD said that this was not advertising.

This argument led the Bundesgerichtshof to postpone its judgment and to ask the CJEU to answer the following question:

"THE CJEU RECOGNISED THAT COMMUNICATIONS FROM A PHARMACEUTICAL PRODUCER CAN CAUSE A PATIENT TO ASK A DOCTOR TO PROSCRIBE ONE MEDICINE OVER ANOTHER. HOWEVER, THE CJEU SAID THAT THIS SITUATION CAN BE TO THE ADVANTAGE OF THE PATIENT."

“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 CJEU stated that the concept of medicine advertising adopted by the EU legislature is very broad and may include the dissemination of information relating to medicinal products on the Internet. It is the purpose of the message that defines advertising, and so it is the decisive factor for distinguishing advertising from information. The CJEU’s response also highlighted that examination of this purpose—i.e. whether it is promotional or not—is determined by national courts.

They will have to undertake a detailed examination of all the relevant circumstances of the case and, especially, based on its behaviour and its initiatives, the intentions of the pharmaceutical producer to promote the medicine at issue.

The CJEU recognised that communications from a pharmaceutical producer can cause a patient to ask a doctor to prescribe one medicine over another. However, the CJEU said that this situation can be to the advantage of the patient. It can result in a fruitful discussion with a doctor (who has the final decision on what to prescribe), or reduce the risk of uninformed selfmedication if the notice of use is lost, as long as the imparted information is objective.

Additionally, the information displayed on the packaging and the notice of use are de facto objective, because regulations prohibit the presence of any promotional elements in these items.

Therefore, the CJEU concluded 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”.

Nevertheless, the CJEU specified 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”.

In France, the sale of medicines over the Internet, prescription or overthe- counter medicines, is prohibited. This situation is different to other countries. But discussions have started to open the market to the possibility of this. There is no doubt that the subtle distinction between information and advertising will feed these discussions and will open new possibilities and lines of arguments to be heard in the French courts.

Aurélia Marie is a partner at Cabinet Beau de Loménie. She can be contacted at: amarie@bdl-ip.com