Advertising for pharmaceuticals is impermissible if the content of a promotional statement is not based on sound scientific evidence. That was the verdict of the Oberlandesgericht Koblenz (OLG) [Higher Regional Court of Koblenz].
GRP Rainer Lawyers and Tax Advisors in Cologne, Berlin, Bonn, Düsseldorf, Frankfurt, Hamburg, Munich, Stuttgart and London conclude: In its ruling of January 27, 2016, the OLG Koblenz held that advertising for pharmaceutical products is impermissible if the content of a promotional statement is not based on solid scientific findings (9 U 895/15).
The case in question concerned a homeopathic medicinal product that had been approved as a treatment for “Entzündungen des Hals-Nasen-Rachenraums und der Nasennebenhöhlen” (inflammation of the ear, nose and throat as well as of the paranasal sinuses). The remedy was advertised in a magazine using statements such as that it provides “schnell und effektiv” (fast and effective) relief both in the case of an acute cold and chronic sinusitis, and that it has a “abschwellend, entzündungshemmend und regenerierend auf die Nasenschleimhaut” (decongestant, anti-inflammatory and regenerating effect on nasal mucosa). A second homeopathic medicinal product that had been approved as a treatment for “nervös bedingte Störungen wie Schlafstörungen und Unruhezustände” (disorders induced by nervousness such as insomnia and restlessness) was promoted using claims, among others, that it promotes calmness and composure as well as self-healing capacities and restores mental balance.
The OLG Koblenz broadly granted an action for an injunction against these advertising statements. In the case of the “Schnupfenmittel” (cold remedy), the statements were said to be impermissible due to the fact that the approval of the treatment by the Bundesamt für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices) did not give any indication of the product’s touted rapid effect. Furthermore, the Court ruled that the product’s “regenerating effect on nasal mucosa” did not fall within the scope of the approval. It was also impossible to adduce scientific evidence to conclusively support these claims. In the case of the second remedy, the OLG held that statements such as those pertaining to the promotion of calmness and composure or self-healing powers were similarly not covered by the approval and could not be conclusively substantiated with reference to scientific evidence.
When it comes to advertising, there is always a possibility of real or alleged violations of competition law occurring. This is especially true with respect to pharmaceuticals. Possible consequences include, e.g. injunction suits and damages claim. In order to fend off or enforce claims, one ought to consult a lawyer who is qualified in the field of competition law.