OLG Köln, Germany: Advertising Risks And Side Effects of Pharmaceuticals


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As demonstrated by a ruling of the Oberlandesgericht (OLG) Köln [Higher Regional Court of Cologne] from July 1, 2016, associated risks and side effects need to be taken into account not only in relation to medications but also advertising for pharmaceuticals (Az.: 6 U 151/15).

It is compulsory for the packaging of pharmaceutical products to include the statement “Zu Risiken und Nebenwirkungen lesen Sie die Packungsbeilage und fragen Sie Ihren Arzt oder Apotheker” (For information concerning risks and side effects, please read the package leaflet and consult your doctor or pharmacist), and this sentence is one which virtually every consumer ought to be aware of. Having said that, the high level of recognition which this notice has does not mean that the legal obligation to present it in a way that is clearly legible ceases to apply. To this end, the font size cannot be lower than 6pts. That was the verdict of the Oberlandesgericht Köln.

This obligatory notice must also be clearly legible in advertising for pharmaceutical products. This was not the case in relation to one pharmacist’s promotional flyer. The products promoted in the advertising brochure had little stars next to them, which referred to a text featuring the statement on risks and side effects that was not, however, displayed in the required font size. Moreover, the font was brighter than in the rest of the brochure and thus also more difficult to read. A legal action was brought against this by the Wettbewerbszentrale (Centre for Protection against Unfair Competition).

The OLG Köln granted the action for an injunction. The Court took the view that, pursuant to the Heilmittelwerbegesetz (HWG) [law on advertising in the healthcare sector], advertising outside expert circles needs to feature a notice on risks and side effects which is both very legible and clearly stands out from the rest of the advertising statements. It held that violations of the advertising rules of the HWG are generally deemed to be unfair because they are liable to appreciably harm the interests of consumers. The OLG also prohibited the promotion of a blood pressure monitor in connection with a voucher from an online retailer worth five to ten euros. These vouchers were said to be neither a permissible cash discount nor a triviality. The Court went on to say that the voucher was liable to prompt consumers to purchase the blood pressure monitor in question without comparing it to other devices, and thus risked being an unobjective influence.

Advertising, particularly in the case of medicinal products and other remedies, can prove to be something of a tightrope walk. Failure to observe legal regulations can give rise to infringements. Possible consequences include formal written warnings, injunctions suits as well as damages claims. Companies can seek legal advice from lawyers who are experienced in the field of competition law.

ABOUT THE AUTHOR: GRP Rainer LLP
GRP Rainer LLP is an international firm of lawyers and tax advisors who are specialists in commercial law. The firm counsels commercial and industrial companies and corporations, as well as associations, small- and mid-sized businesses, self-employed freelancers and private individuals worldwide from offices in Cologne, Berlin, Bonn, Dusseldorf, Frankfurt, Hamburg, Munich, Stuttgart and London UK.

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Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.

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