This article is a follow-up to an article in our March 2012 update concerning the decision of the Swedish Medical Products Agency (the "MPA"), prohibiting Boehringer Ingelheim AB ("Boehringer") in September 2011 from advertising the prescription-based product Pradaxa to the public, in the form of a press release.
The decision by the MPA was appealed to the Administrative Court of Uppsala, which rendered its judgment on 18 February 2013, rejecting the appeal. Boehringer is thus prohibited from using the relevant press release or a similar statement, under the penalty of a fine amounting to SEK 750.000.
The press release at issue was released in Swedish and concerned the prescription drug “Pradaxa”. It was published on the website www.mynewsdesk.com/se/pressroom on 5 May 2011.
The decision of the MPA was based on the prohibition on advertising of prescription medicines in the Swedish Medicinal Products Act, which is based on EU Directive 2001/83:
“Member States shall prohibit the advertising to the general public of medicinal products which are available on medical prescription only.”
According to the MPA, the purpose of the message is decisive as to whether it is deemed to be advertising (i.e. falling within the scope of the prohibition) or pure information (i.e. falling outside the scope of the prohibition). The latter is usually limited to information on the product package and in the leaflet. According to the MPA the text in the press release clearly displayed advertising character, inter alia, mentioning only positive aspects of the product.
Boehringer rebutted that (i) the press release in itself was not to be considered as advertising, and (ii) it was not targeted to the general public. In addition, Boehringer claimed that the release was protected by the constitution, relying on the freedom of speech argument.
In respect of the substance of the press release, the Court found that it lacked objectivity, as it did not state any potential adverse effects of the product. It was neither a reproduction of the leaflet or the product summary of the MPA.
The release also coincided with the expected approval of a new indication for the product. The Court also considered that the press release was available to the general public (there were no technical obstacles to access the press release), albeit that it was stated in connection with the release that it was intended for journalists only. Overall, the Court found that the release was designed to promote the prescription, supply, sale or consumption of medicinal products, and thus that it was to be considered as constituting advertising.
In respect of the relevant public, the Court found that it was targeted to the general public, the other possible category being persons qualified to prescribe or supply medicinal products. As journalists cannot be deemed to fall within the latter category, they therefore belong to the "general public" category.
Finally, in respect of the freedom of speech arguments raised, the Court found that, on the basis that the press release constituted pure advertising, the prohibition was compatible with the constitution. Furthermore, the prohibition was deemed reasonable and proportional.
This is an interesting case, and appears to be the first of its kind in Sweden.
As for any potential implications, it may be that the circumstances of this particular case, such as the timing of the press release and the nature of the press release itself, tipped the scales. There is cause for prudence when communicating on a platform which is available to and accessible by everyone (the outcome may have been different had the press release only been made available to a limited number of people e.g. by means of a password).
In essence, the MPA wishes to limit information disseminated publicly concerning prescription-based pharmaceuticals to what is available on the packaging, the leaflet and in the product summary.
The judgment of the Court has been appealed to the Administrative Court of Appeal of Stockholm.