Is advertising with areas of application to specialist audiences permitted?

The advertising, packaging and distribution of medicinal products are subject to extensive legal regulation. The Higher Regional Court (OLG) Hamm had to decide whether § 5 Heilmittelwerbegesetz (HWG) also prohibits advertising with areas of application to specialist audiences, or whether this regulation should apply only to advertising measures to consumers.

The defendant pharmaceutical company advertised its registered homeopathic medicinal products in several brochures for doctors and alternative practitioners. On one page, the active ingredient of the preparations was listed, and alongside this, under the heading "Monographie", areas of application such as kidney and urinary tract diseases, calcification of cerebral blood vessels, etc. were stated.

The Wettbewerbszentrale (Advertising Standards Authority) issued a warning against this advertising and demanded cessation on grounds of unfair competition. The pharmaceutical company did not issue a legally binding declaration of discontinuance, as it was of the view that § 5 HWG did not apply to advertising directed at specialist audiences. Furthermore, the advertising did not name concrete areas of application, but rather made statements about which medicinal pictures the individual components of the preparation possessed.

Decision of the Court

The Higher Regional Court (OLG) Hamm ruled in its decision of 15.04.2010 – Az. I 4 U 218/09 in favour of the Wettbewerbszentrale. The wording of the regulation does not distinguish according to whether the advertising is directed at the consumer or at specialist audiences.

Homeopathic medicinal products do not require approval, but merely registration. In such an application, no information on the effect and area of application of the medicinal product needs to be submitted, because proof of efficacy for specific areas of application in homeopathic medicinal products is scarcely possible due to the high degree of dilution and the associated low content of active ingredients.

As a consequence of the waiver of proof of efficacy, § 5 HWG prohibits advertising with areas of application. The advertising prohibition is also not disproportionate, particularly as it remains open to the manufacturer to bring about scientific clarification and approval of the medicinal product in order to make corresponding statements.

Conclusion

Even in advertising directed at specialist audiences, homeopathic medicinal products may not be advertised with areas of application. If the manufacturer wishes to do so, it must obtain approval for the homeopathic remedy as a medicinal product. On approval, the pharmaceutical company must then provide proof of the effect and areas of application.