Hanseatic Higher Regional Court (OLG) sets the standard for pharmaceutical advertising

The marketing of pharmaceuticals is subject to strict legal requirements. Given the special function of medicines to cure, alleviate or prevent diseases, misconceptions among patients as well as physicians and other members of the healthcare professions must be avoided.

When is it permissible to refer to the gold standard in pharmaceutical advertising?

The underlying aspect of pharmaceutical safety, more precisely: safety in use, therefore precludes advertising that suggests particular therapeutic superiority if this is not demonstrably accurate. Thus, advertising using the frequently employed formulation that a preparation is the "gold standard" in the therapy of certain diseases is impermissible if this is (no longer) the case.

In this context, a recent judgment of the Hanseatic Higher Regional Court (OLG) Hamburg of 2 October 2024(Az. 3 U 21/24)is relevant. The Court had to examine the question of whether advertising for a pharmaceutical with the statement "The gold standard in the therapy of HCC" is permissible. The applicant, a pharmaceutical company that distributes a competing medication, applied for a preliminary injunction against the respondent, which had used this statement in an online banner on its website.

Facts and legal assessment

The advertising referred to the pharmaceutical T. in combination with A., which had previously been mentioned in S3 guidelines as the only recommended therapy for hepatocellular carcinoma (HCC). Following a revision of the guidelines in August 2023, however, another preparation, IMF. in combination with IMJ., was recommended on equal footing. The respondent nevertheless continued to advertise with the exclusive claim "The gold standard". However, there were no direct studies available that could demonstrate the superiority of T. + A. over the newly added therapy option.

The Court assessed this advertising as misleading pursuant to § 3 Heilmittelwerbegesetz (HWG) and § 3a Gesetzes gegen den unlauteren Wettbewerb (UWG). The formulation "The gold standard" suggested an exclusive position which was no longer justified following the update of the guidelines. The provision of a footnote referring to further information was insufficient to remedy the misleading nature, as this was only accessible via several intermediate steps. According to the case law of the Federal Court of Justice (BGH), mandatory information and explanatory notes must be directly accessible without substantial obstacles.

Decision

The Higher Regional Court (OLG) Hamburg prohibited the respondent from further using the statement "The gold standard in the therapy of HCC". The advertising was classified as an impermissible exclusive claim that violates the requirements for transparency and truthfulness in pharmaceutical advertising. Even the fact that therapy with T. + A. continues to be the most frequently used treatment did not justify the designation as "gold standard", as the guidelines now provide for two equivalent therapy options.

Recommendation

Pharmaceutical companies should exercise particular care incomparative or distinctive advertisingfor pharmaceuticals, in particular when guidelines or scientific assessments change. Advertising statements should always be based on current and scientifically verifiable grounds. References to further information must be accessible without substantial obstacles in order to meet the requirements of the Heilmittelwerbegesetz (HWG). It is recommended that such advertising statements be reviewed regularly from a legal and technical perspective in order to avoid litigation.