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Illegal advertisement of effect of a medicinal product

March 2019 - EU & Competition. Legal Developments by GRP Rainer LLP.

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It is illegal to advertise a specific effect attributed to a medicinal product if said effect is based merely on laboratory tests and has not been demonstrated in relation to humans.

The effect a medicinal product has on humans is, of course, critical information for consumers. That is why advertising statements regarding a specific effect of a product are deemed to be misleading if said effect is based merely on laboratory tests and has not been demonstrated in relation to humans. In these circumstances, no clinical relevance can be said to have been demonstrated with respect to humans. We at the commercial law firm GRP Rainer Rechtsanwälte note that this kind of misleading advertising is in breach of competition law.

This view was upheld by the Landgericht (LG) Frankfurt a.M., the Regional Court of Frankfurt am Main, in a ruling from August 17, 2018 (Az.: 3-10 O 22/18). In the instant case, a pharmaceutical company had promoted a cough syrup with the term “antiviral”, as well as with reference to antiviral properties having been demonstrated in a laboratory environment. An organization for the enforcement of competition law and against unfair competition filed injunction suits in response to this advertisement, claiming that it violated competition law. It argued that consumers would assume from the advertising statements that the medication or remedy has an antiviral effect. This meant that its application was being promoted for a field with respect to which it had not been approved.

The Landgericht Frankfurt ruled that the cough syrup manufacturer was in violation of the Heilmittelwerbegesetz (HWG), the German law on the advertising of medicinal products, according to which it is illegal to advertise medicinal products if the medication or remedy requires authorization but has not been authorized, or if the advertisement features applications that are not covered by the authorization. The LG Frankfurt took the view that the latter scenario applied to this case. It held that no clinical relevance had been demonstrated with respect to humans because the antiviral properties had only been established in a laboratory environment. Thus, the statements regarding the relevant effect had not been confirmed in relation to humans and the medicine or remedy’s application was being promoted for a field with respect to which it had not been approved. For this reason, the LG Frankfurt concluded that a violation of the HWG had occurred.

Given the ever-present possibility of violating competition law, advertising is often akin to tightrope walking for businesses. This is particularly true insofar as advertising and statements relate to medicinal products. Lawyers with experience in the field of competition law can offer advice as well as enforce or fend off claims arising from violations of competition law. 

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