On 2 April 2009 the ECJ interpreted Article 86 of Directive 2001/83/EC definition of advertising for medicinal products (Case C- 421/07 Frede Damgaard).

A Danish journalist was charged with the public dissemination, on his website, of information on the properties and availability of a medicinal product which was not authorised or marketed in Denmark.

The concept of advertising for medicinal products provided by Article 86(1) of Directive 2001/83/EC explicitly emphasises the purpose and the effect of the message conveyed (promotion of prescription, supply, sale or consumption), not the people who disseminate the information.

The Court therefore considered that a message issued by an independent third party may qualify as advertising if its effect is to “influence consumers’ behaviour and encourage them to purchase the medicinal product in question”, even though the information is disseminated outside any commercial or industrial activity and that the third party is acting on his own initiative.

It is for the national Courts to determine whether such public dissemination constitutes advertising or not. If so, the information provided must satisfy with legal provisions governing advertising for medicinal products.

Dissemination of information about a medicinal product by a third party, even if acting on his own name and independently, may be regarded as advertising within the meaning of Directive 2001/83/EC.

Drug manufacturers may not distance themselves from the communication made by their authorised distributors or by unapproved retailers; by the press, on the basis of press releases handed over to the journalists or on the basis of independent investigation; or by patient associations, medical societies, etc.

This decision was eagerly awaited as very few decisions had been given regarding third party advertising, in the face of a growing trend of indirect advertising to the public, for example via press releases, patient organisations and their magazines, and various medical websites.