Print“Where is the European media’s outrage on this ruling? And what will we hear from their American cousins?”
According to a new European Court of Justice ruling, 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. For those in the United States who believe in the First Amendment, this is quite startling news. For those who would seek to limit the pharmaceutical industry’s right to advertise, it might very well be a roadmap—and then some.
The European Court of Justice cited Article 86 of European Union Directive 2001/83/EC, which defines the concept of medicines advertising. And according to the wisdom of the court, it “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.”
Moreover, the court added, 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” (such as journalists, or patient groups, or doctors). It’s carte blanche for an almost complete gag order on anyone who wants to discuss anything to do with medicines.
According to a report in Pharma Times, the details of the case are as follows: In 2003, Danish journalist Frede Damgaard 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. The national regulator in 1999 refused it a marketing authorization. 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 authorized in Denmark, thus contravening Directive 2001/83/EC.
Mr. Damgaard 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 European Union protections of freedom of expression.
The Danish Regional Court of Appeal then referred the case to the European Court of Justice for a preliminary ruling. In November 2008, that court , in an opinion handed down by Advocate General 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 advocate general added that this was not an isolated case; similar situations had arisen recently over statements about melatonin made in a widely broadcast news program in Spain, and also in the Czech Republic, where a collection of media features entitled “Yesterday Viagra, today Cialis” had been published.
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, the European Court of Justice 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.”
It’s now back to the Danish courts to determine Damgaard’s fate based on the European Court of Justice’s ruling.
Where is the European media’s outrage on this ruling? And what will we hear from their American cousins?
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner. He is also Director of Global Healthcare for Porter Novelli.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner. He is also Director of Global Healthcare for Porter Novelli.
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