Misleading and Comparative Advertising Directive, Article 5 Misleading and Comparative Advertising Directive, Article 7 Misleading and Comparative Advertising Directive, Article 7

Medical company A was prohibited from using a press release (again) and also required to rectify the claims in the press release. In the press release, A compared their product with another product in a way not sufficiently supported by science. Thus, the press release was contrary to the Danish Marketing Act.

A medical company sent out a press release and also presented a study at a conference. Both the press release and the information at the conference referred to a scientific study ordered by A with the aim of comparing their product with a product made by medical company B. In addition, the press release gave a short introduction to A’s product. The study was not conclusive on its primary endpoint, but A presented some other findings in the study. The use of the study in this way was contested by scientists.

The main legal issue was whether the press release was illegal according to the Act on medicinal products (both in regard to advertising medicinal products and to reporting results from the study) and whether the press release was against due diligence or/and misleading.

The Court stated that the two parties were in direct competition. There was no scientific justification for the communication of the secondary endpoints in the study when the primary endpoint was not conclusive. This conclusion was supported by guidelines from the EMA, FDA and a statistical expert. Thus, the press release was misleading and could potentially affect the behavior of buyers and users of the product in regard to the Marketing Act, §§ 5-6. Also, informing about a medicinal product in the press release was in violation of the ban against advertising medicinal products and therefore in violation of the Marketing Act, §§ 3,1 and 4,1.

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The three main claims from B were met. Company A had to rectify the misleading statement about the scientific study. In addition, A had to pay B for disturbance of the market to the detriment of B (500.000 Danish kroner). Lastly, A was fined for discrediting and harming B in a way suited for affecting the behaviour of buyers and users. Because A was a big company with deep knowledge of rules and standards of the area, the fine was set at 500.000 Danish kroner.