No free speech please, we’re European
According to a new European Court of Justice (ECoJ) 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 here in the US 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 ECoJ cited Article 86 of European Union (EU) 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 EcoJ 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.”
Like 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.
86? Shades of 1984.
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 - until 1999, when the national regulator 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.
When it comes to freedom of the press in Europe, it seems that the prime directive isn’t freedom of speech, but Directive 83 or Article 86. Talk about bureaucracy contravening basic human rights!
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 program in Spain, and also in the Czech Republic, where a collection of media features entitled “Yesterday Viagra, today Cialis” had been published.
Indeed, it seems that freedom of the press is breaking out all across Europe. And it must be stopped.
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.”
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 (ECoJ) 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 here in the US 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 ECoJ cited Article 86 of European Union (EU) 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 EcoJ 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.”
Like 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.
86? Shades of 1984.
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 - until 1999, when the national regulator 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.
When it comes to freedom of the press in Europe, it seems that the prime directive isn’t freedom of speech, but Directive 83 or Article 86. Talk about bureaucracy contravening basic human rights!
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 program in Spain, and also in the Czech Republic, where a collection of media features entitled “Yesterday Viagra, today Cialis” had been published.
Indeed, it seems that freedom of the press is breaking out all across Europe. And it must be stopped.
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.”
Where is the European media’s outrage on this ruling? And what will we hear from their American cousins?
