Healthy Skepticism Library item: 15651

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Taylor L.
Media comment on medicines may constitute advertising, says EU Court
Pharma Times 2009 May 12
http://www.pharmatimes.com/WorldNews/article.aspx?id=15838

Full text:

Information about medicines produced by third parties such as journalists may constitute advertising, even though they have no connection with the product’s manufacturer or marketer, says a landmark European Court of Justice (ECoJ) ruling.

Article 86 of European Union (EU) Directive 2001/83/EC, which defines the concept of medicines advertising, “does not rule out the possibility that a message originating from an independent third party may constitute advertising, nor does [it] require a message to be disseminated in the context of commercial or industrial activity in order for it to be held to be advertising,” said the Court.

Moreover, such “advertising…is liable to harm public health,” even when it is carried out by “an independent third party outside any commercial or industrial activity,” added the Court, in a shock ruling which is raising concerns for the future of media reporting of health care issues.

The decision was given in a long-running case concerning Danish journalist Frede Damgaard, who in 2003 published information on his website about Hyben Total, a product licensed in Denmark as a treatment for a wide range of conditions – including gout, kidney and bladder disorders, sciatica, diarrhea and diabetes – until 1999, when the national regulator refused it a marketing authorisation. It is still sold as a medicine in Sweden and Norway.

Mr Damgaard’s positive description of Hyben Total’s effects on the symptoms of gout and arthritis led to his being prosecuted in the Danish courts, on the grounds that it constituted advertising of a medicinal product whose sale was not authorised in Denmark, thus contravening Directive 2001/83/EC.

Mr Dangaard appealed, claiming that his discussion of Hyben Total could not be held to constitute advertising as he had no interest in selling the product, and also that the court decision contravened EU protections of freedom of expression.

The Danish Regional Court of Appeal then referred the case to the ECoJ for a preliminary ruling, and last November an Opinion handed down by Advocate General (AG) Damaso Ruiz-Jarabo Colomer backed Mr Damgaard, noting that “a lack of connection between the author of the information and the sellers or manufacturers of the medicinal product and the non-commercial or non-industrial nature of the activity of that independent third party may…be strong indications that a message does not have promotional content.”

The AG added that this was not an isolated case; similar situations had arisen recently over statements about melatonin made in a widely-broadcast news programme in Spain, and also in the Czech Republic, where a collection of media features entitled “Yesterday Viagra, today Cialis” had been published.

AG Ruiz-Jarabo Colomer concluded that it is up to the individual EU states’ national authorities and courts “to ensure the correct balance between, on the one hand, the objectives of protecting health and promoting the rational use of medicinal products and, on the other, the right of the party concerned to freedom of expression, taking into account the special protection afforded to the party concerned, if it is established that he is a journalist.”

But in its recent ruling on the case, ECoJ said that Article 86 “is to be interpreted as meaning that dissemination by a third party of information about a medicinal product…may be regarded as advertising within the meaning of that article, even though the third party in question is acting on his own initiative and completely independently…of the manufacturer and the seller of such a medicinal product.”

However, the Court added that it is up to Denmark’s national court to determine whether “Mr Damgaard’s actions constitute a form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply sale or consumption of Hyben Total,” as is prohibited by the Directive, and for the national courts of all EU member states to make their own decisions in such cases.