The Swedish Medical Products Agency (MPA) has upheld its decision to prevent Boehringer Ingelheim from using a press release about its oral anticoagulant Pradaxa (dabigatran).
The medicines regulator ruled that the press release constituted advertising a prescription-based product to the general public – which is prohibited under Swedish and European law.
The release publicised the company’s plans to lower the price for Pradaxa in Sweden and was published on the journalist website mynewsdesk.com in May 2011.
MPA’s assessment of the press release was that it had addressed the public with positive information about the product and therefore breached Swedish regulations.
Boehringer appealed the MPA’s initial September 2011 ruling, but the company’s bid has now failed.
In a written comment on the case, legal firm Bird & Bird said: “The Agency […] stated that the text in the press release has clear advertising character which only describes the advantages of the product with no mention of the disadvantages.”
However, the firm added: “The ‘public’ in this case comprised journalists, as the press release was explicitly targeted at journalists.”
Throughout its appeal, Boehringer contended the press release should not be construed as advertising, arguing that it “followed old established praxis regarding issuing press releases in Sweden,” and that such communications were protected as freedom of speech.
Following the verdict, the president of the Swedish pharmaceutical trade association LIF, Anders Blanck, expressed his disappointment at the decision.
He said the court has “chosen to completely ignore the clear and long-established practice” of providing journalists with press releases.
Blanck added: “We will now analyse the judgement in detail, and may later decide [if] LIF and the company concerned will proceed in the matter.”