Advertising for homeopathic medicinal products misleading

The content of effect-related advertising statements for medicinal products must regularly correspond to established scientific knowledge. If this is not the case, the advertising for medicinal products is unlawful. According to the decision of the OLG Koblenz, this also applies to homeopathic medicinal products, provided that the advertising statements go beyond the scope of the approved therapeutic indication.

The subject matter of the legal dispute concerned advertising statements made by a manufacturer of two homeopathic preparations. The manufacturer advertised one preparation for "inflammation of the ears, nose, throat and sinuses" in a magazine, inter alia, by claiming that it works "quickly and effectively" for both acute rhinitis and chronic sinusitis and has "a decongestant, anti-inflammatory and regenerative effect on the nasal mucosa". It was claimed that stuck mucus would be loosened and accompanying symptoms such as general malaise, pressure in the head, sneezing and itching would be alleviated.

Furthermore, the manufacturer advertised another homeopathic preparation for "nervously-induced disorders such as sleep disturbances and states of unrest" also in a magazine, inter alia with the claim that the preparation promotes "composure and calm", helps one to face daily challenges again with renewed vigour, promotes the body's own healing powers, restores physical and mental equilibrium and offers effective support for unrest, nervousness and/or sleep disturbances.

The action for cessation of this advertising was dismissed by the LG Bad Kreuznach on the grounds that the pharmaceutical company did not advertise homeopathic medicinal products with a therapeutic effect that fell outside the approved therapeutic indications.

Court decision on advertising for homeopathic medicinal products

At the appellate level, the OLG Koblenz, by judgment of 27.01.2016 – 9 U 895/15(Press release of 20.04.2016) partially amended the first-instance judgment and largely prohibited advertising for both products with the disputed statements.

The advertising was partly misleading because the alleged therapeutic effect of the preparations was not covered by the approved therapeutic indication and had not been unequivocally demonstrated by a scientific treatise, the court held.

The reference in the advertising that the preparation for inflammation of the ears, nose, throat and sinuses works "quickly and effectively" for acute rhinitis and chronic sinusitis and has a "regenerative effect on the nasal mucosa" was misleading and therefore unlawful because the alleged rapid effect of the preparation could not be inferred from the approval of the medicinal product. Furthermore, a "regenerative effect of the product on the nasal mucosa" was not covered by the therapeutic indication of the approval. The pharmaceutical manufacturer had also failed to unequivocally demonstrate such mechanisms of action by submitting a scientific treatise.

Insofar as a preparation had been approved by the Federal Institute for Medicinal Products and Medical Devices, it could in principle be assumed that the effect-related statements referring to the approved therapeutic indication correspond to the established state of scientific knowledge at the time of approval, the court held. The manufacturer of the product could also advertise on this basis. Therefore, the court did not object to the advertising statement that the preparation helps for acute rhinitis, has a decongestant effect and alleviates accompanying symptoms such as general malaise, sneezing and itching and/or pressure in the head.

For the homeopathic medicinal product, which is approved as a medicament for "nervous disorders such as sleep disturbances and unrest as well as states of low mood", the court held that it must not be advertised with the claims that the preparation promotes composure, helps one to face daily challenges again with renewed vigour, promotes the body's own healing powers and restores physical and mental equilibrium. These advertising statements were likewise neither covered by the approved therapeutic indication of the medicament, nor had the pharmaceutical manufacturer been able to unequivocally demonstrate such efficacy of the medicament by other means.

Conclusion

Advertising for medicinal products is subject to strict requirements in Germany. In particular, statements concerning efficacy must be supported by scientific findings. Insofar as the homeopathic preparations in question were approved by the Federal Institute for Medicinal Products and Medical Devices for the respective therapeutic indications, the court did not, however, object to the corresponding advertising statements.