ECJ rules on marketing and medicinal claims

By Shane Starling

- Last updated on GMT

Related tags European union

Those writing about products on the frontier with pharmaceuticals risk having their articles interpreted as illegal marketing materials, according to a European Court of Justice (ECJ) ruling yesterday.

The ECJ found any information that promotes unauthorized medicinal claims can be construed as product marketing, after a Danish journalist, Frede Damgaard, was found to have illegally disseminated information about a banned rosehip powder-based, multi-benefit product called Hyben Total.

Blogger beware

The ruling could apply to independent articles written by journalists as well as content provided on online social networks and product review sites by the likes of consumers, bloggers and twitterers, said defense counsel in the case, Susie S. Ekstrand, of the Danish law firm, Lett.

“This ruling is significant because it means anything written about a product that maybe deemed medicinal in one member state, can be deemed inappropriate and consequences may follow for the author,”​ Ekstrand told CosmeticsDesign.com this morning.

“We were surprised by this ruling because we thought a commercial interest in the product in question would have to be demonstrated, but the ECJ has ruled otherwise,” ​she added. “It is a restriction of freedom of speech and journalists need to be careful now, especially those writing online across many member states.”

She made an example of a journalist writing about the joint benefits of glucosamine, which is classed as a drug in Denmark. Since such claims are forbidden in Denmark, a writer in that situation could find herself in legal hot water.

The verdict

The ECJ placed great emphasis on public health and noted that freedom of expression rights written in 1950 into the European Convention for the Protection of Human Rights and Fundamental Freedoms, was subject to “certain limitations justified by objectives in the public interest”.

It therefore found that statements about products could be construed as advertising under the 2001 Medicines Directive “even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product.”

The European Union’s highest court said it was for member state jurisdictions to interpret its ruling. It agreed with an earlier Danish court ruling against Damgaard, which saw the freelance journalist fined about €1500. That verdict is being appealed.

On your Gaard

Damgaard had previously written promotional material about Natur-Drogeriet-owned Hyben Total when it was approved for use by Danish medicinal products agency, Lægemiddelstyrelsen.

In 1999, Lægemiddelstyrelsen withdrew the medicinal license. It was marketed as a product that could relieve gout, gallstones, kidney disorders, bladder disorders, sciatica, bladder bleeding, diarrhea, stomach cramps, diabetes and kidney stones.

Damgaard’s problem arose some years later, in 2003, when he wrote about the arthritis and gout benefits Hyben Total on his website and noted it was legally available in Sweden and Norway. Lægemiddelstyrelsen took umbrage at this and informed Damgaard his statements “constituted advertising” in contravention of Danish law. He was found guilty in 2005.

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