Evidence when promoting medicinal products in Germany
April 2013
On 6 February 2013 the German Federal Court of Justice (BGH)1 rendered a decision in an unfair competition matter regarding the requirements of advertising medicinal products, setting out in particular the requirements in relation to scientific evidence.
The parties in this case are competitors in the business of marketing pharmaceuticals for the treatment of diabetes mellitus. The plaintiff’s product contains the active ingredient insulinglargin, and the defendant’s product contains the active ingredient insulindetemir. As the products are prescription-only, they can only be advertised to healthcare professionals. In a promotional campaign for his product the defendant stated that it led to a lower increase in weight than the product of his competitor. This advertising statement was in some instances made with reference to a clinical study alleged to support the claim, and in others, without reference to any study or other scientific evidence. The plaintiff claimed that the advertising was misleading.
The Court of First Instance (Regional Court of Berlin) dismissed the action. The appeal against this judgment was not successful. The Federal Court of Justice partly set aside the judgment on appeal and remitted the case to the lower court, to the extent that the advertising claim was based on the study.
The Federal Court of Justice found that the advertising claim made with reference to the study could be misleading. Results of studies which are quoted in an advertisement are only significant enough to justify the claim when they are carried out and evaluated according to recognised rules and principles of scientific research. In accordance with earlier judgments, the Federal Court of Justice stated that a randomised placebo-controlled, double blind study with an adequate statistical analysis that has been published and discussed by experts was usually necessary. The question arose as to whether, as here, study data in the context of a so-called sub group analysis or studies that are established by summary of several scientific analyses (meta-analysis), rather than original study data, can support an advertising message. This is a matter that would need to be further investigated by the Higher Regional Court depending on the circumstances of the individual case.
To the extent that the advertising message was made without reference to a study, the Federal Court of Justice stated that the company making the claim could generally refer to the content of the marketing authorisation and product information for health professionals (Fachinformation), which is examined by the regulatory authority within the authorisation procedure, in order to support the claim. In this context it is permissible to assert an advantage of the medicinal product without reference to a clinical study (provided that the marketing authorisation itself supports the claim). Referring to the content of the marketing authorisation can nevertheless be misleading if new scientific findings - which were not known at the date of product approval – suggest that the product claim made is no longer scientifically sound. A plaintiff may bring a misleading advertising claim on this basis.
In its recent decision, the Federal Court of Justice did not lower the standard for advertising medicinal products. Whenever health is the subject of an advertisement strict requirements need to be met in terms of accuracy and unambiguousness of the advertising message. The Federal Court of Justice confirmed that health related advertising claims had to be supported by reliable scientific data. Therefore, usually only the results of a randomised placebo-controlled double blind study could be quoted in an advertisement as support for a particular product claim.
For the first time, however, the Federal Court of Justice explicitly stated that – depending on the individual circumstances of the case - the content of the marketing authorisation and product information for health professionals could be considered as a sufficient scientific basis for an advertising claim for a medicinal product.
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