Advertising for Medicinal Products in Germany Must Relate to Approved Fields of Application
Advertising for medicinal products must relate to approved fields of application. Failing this, the advertising may violate competition law as well as Germany’s Heilmittelwerbegesetz (HWG) [Advertising of Medicinal Products Act].
According to the HWG, it is not permissible to advertise medicinal products that require approval but have not yet been approved. [Some lawyers experienced in Competition Law] note that this also applies to advertising that relates to fields of application or pharmaceutical forms which are not covered by the approval.
A case that came before the Oberlandesgericht (OLG) Stuttgart [Higher Regional Court of Stuttgart] concerned advertising for a non-prescription pain medication. This had been approved for use in the case of “slight to moderate pain”, among other things, “in response to colds” as well as “fevers”. The pharmaceutical manufacturer also promoted the product with the phrase “Eine Extraportion Vitamin C unterstützt das Immunsystem” [An extra portion of vitamin C supports the immune system]. A competition association considered this statement to be unacceptable and sued for an injunction.
The OLG Stuttgart granted the lawsuit in its ruling of June 8, 2017 (Az.: 2 U 127/16). The Court considered the statement that the vitamin C contained in the pain medication supports the immune system to be a violation of the German Unfair Competition Act, Gesetz gegen den unlauteren Wettbewerb (UWG), as well as the Heilmittelwerbegesetz, because the promotional statement concerned a field of application in relation to which the medicinal product had not been approved. The OLG went on to say that consumers would assume from the statement that vitamin C supports the immune system that this is an additional application and not merely a reference to another one of the medication’s effects.
The Court noted that although a consumer who is not experiencing pain would not opt for this medication to bolster his immune system, consumers who are experiencing pain and have also been advised by a doctor to strengthen their immune system in another context might take the defendant’s medicinal product. However, it was said to be only permissible to make reference to additional effects if they relate to the approved field of application.
Violations of competition law can give rise to formal warnings, damages claims and injunction suits. Lawyers who are versed in the field of competition law can assist companies in fending off or enforcing claims arising from infringements of competition law.
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