The marketing of medicinal products is subject to strict legal requirements. In view of the special function of medicines to cure, alleviate or prevent diseases, misconceptions among patients, but also among doctors and other healthcare professionals, must be avoided.
When may the following be used in pharmaceutical advertising gold standard?
The underlying aspect of drug safety, or more precisely: safety of use, therefore excludes advertising that suggests a particular therapeutic superiority if this is not demonstrably true. Advertising with the popular formulation that a preparation is the "gold standard" in the treatment of certain diseases is therefore inadmissible if this is (no longer) the case.
This is the context of a recent ruling by the Hanseatic Higher Regional Court of Hamburg on October 2, 2024 (Ref. 3 U 21/24). The court had to deal with the question of whether advertising for a drug with the statement "The gold standard in the treatment of HCC" is permissible. The applicant, a pharmaceutical company that markets a competing drug, applied for an interim injunction against the defendant, which used this statement in an online banner on its website.
Facts of the case and legal classification
The advertisement referred to the drug T. in combination with A., which had previously been named in S3 guidelines as the only recommended therapy for hepatocellular carcinoma (HCC). However, following a revision of the guidelines in August 2023, another drug, IMF. in combination with IMJ. was recommended with the same priority. Nevertheless, the defendant continued to advertise with the unique selling proposition "The gold standard". However, no direct studies were available that could prove the superiority of T. + A. over the newly added therapy option.
The court deemed this advertising to be misleading in accordance with Section 3 of the German Drug Advertising Act (HWG) and Section 3a of the German Act against Unfair Competition (UWG). The wording "The gold standard" suggested a unique position that was no longer justified following the updating of the guidelines. The indication of a footnote referring to further information was not sufficient to dispel the misleading effect, as this was only accessible via several intermediate steps. According to the case law of the Federal Court of Justice, mandatory information and explanatory notes must be accessible directly and without significant hurdles.
Decision
The Higher Regional Court of Hamburg prohibited the defendant from continuing to use the statement "The gold standard in the treatment of HCC". The advertising was deemed to be an inadmissible unique selling proposition that violated the requirements of transparency and truth in pharmaceutical advertising. The fact that therapy with T. + A. continues to be the most frequently used does not justify the designation as the "gold standard", as the guidelines now provide for two equivalent therapy options.
Recommendation
Pharmaceutical companies should comparative or prominent advertising special care for medicinal products, especially when guidelines or scientific evaluations change. Advertising claims should always be based on an up-to-date and scientifically verifiable basis. References to further information must be accessible without significant hurdles in order to meet the requirements of the Therapeutic Products Advertising Act (HWG). It is recommended that such advertising claims are regularly checked legally and professionally in order to avoid legal disputes.
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