Last Updated February 20, 2019

Law and Practice

Contributed By Walder Wyss Ltd

Authors



Walder Wyss Ltd has 200 legal experts and office locations in Zurich, Geneva, Basel, Berne, Lausanne and Lugano. Walder Wyss Ltd has a team dedicated to life science and pharmaceutical regulatory law, including healthcare insurance law. The key areas of practice in relation to the pharmaceutical advertising sector are pharmaceutical regulatory law, healthcare insurance law and the law regarding research on humans and clinical trials, stem cells and blood components, genetic testing, transplantation, special nutrition, medical devices and reproductive medicine. The firm has established www.lifesciencelaw.ch, a website dedicated to all legal issues surrounding life sciences where case law is discussed and where interested people can find publications from the team.

As a general rule, all advertising is deemed unlawful if it is misleading or contrary to public order and morality, if it may incite an excessive, abusive or inappropriate use of medicines or if it is for medicines that may not be placed on the market in Switzerland (Article 32 paragraph 1 HMG).

All information given in advertising to professionals must be in accordance with the drug information most recently approved by Swissmedic. In particular, only indications and possible applications approved by Swissmedic may be advertised. If the drug information has not yet been published, the marketing authorisation-holder must include the complete content of the drug information last approved by Swissmedic in the advertisement. Advertising to professionals must be precise, well-balanced, factually accurate and provable. The statements must not be misleading and supporting documents must be made available to healthcare professionals upon request. Advertising must be recognisable as such and must be clearly distinguishable from editorial contributions.

The advertising statements must be based on and reflect the current state of scientific knowledge. They may only refer to clinical trials that were conducted in accordance with the rules of good clinical practice and that have been published or accepted for publication as well as to data collections, such as meta-analyses or reports on practical experience, that have been published in a scientifically recognised specialist medium. These publications must be quoted verbatim, completely and with their exact source. It must be indicated that the healthcare professionals can request a complete copy of the examination report and the corresponding references from the company.

A medicine, an indication, a dosage, a galenic form or a package may be advertised as “new” for 18 months after the first authorisation in Switzerland. The information must clearly indicate what this attribute refers to.

Advertising of complementary medicines must be based on scientifically recognised specialist media or recognised monographs of complementary medicine. Advertising statements in this regard must contain a reference to the respective therapy direction (Article 5 AWV).

Advertisements to healthcare professionals must contain certain information. It is mandatory to include the name of the product, the active ingredients with the short designations (DCI/INN or designation of the most recent edition of the Pharmacopoeia; in the absence thereof, other generally recognised short designations approved by Swissmedic), the name and address of the marketing authorisation holder and at least one indication or possible use as well as the dosage and the method of application. Furthermore, a summary of restrictions on use, adverse reactions and interactions must be added. The supply category is to be indicated along with a statement that detailed information is to be found in the published drug information, citing the list in Article 67 para. 3 or Article 95b HMG as a reference (Article 6 AWV).

Where the advertising of medicines does not make any statement as to its use, but merely provides information on the indications in the sense of a reference to the therapeutic category of the medicine (recall advertising), the information referred to in Article 6 lit. d (at least one indication or possible use as well as the dosage and the method of application) and lit. e AWV (summary of restrictions on use, adverse reactions and interactions) may be disregarded. If the advertisement is only intended to recall a brand (brand advertising), only the product name or additionally the name of the marketing authorisation holder as well as the active substances may be mentioned (Article 8 et seq. AWV).

Advertising to healthcare professionals must neither use the term “safe” unless the information provided clearly indicates what this attribute refers to, nor must it indicate that a medicine has no undesirable effects and that it is safe or harmless. Furthermore, it must not appear to be an editorial contribution or indicate that the medicine in question does not create habituation (Article 13 AWV).

Advertising may refer to clinical trials or data collections that are not included in the Summary of Product Characteristics. However, advertising statements must be based on and reflect the current state of scientific knowledge. They may only refer to clinical trials conducted in accordance with the rules of good clinical practice and published or accepted for publication as well as to data collections such as meta-analyses or reports on practical experience published in a scientifically recognised specialist medium. These publications must be quoted verbatim, completely and with the exact source. It must be indicated that the healthcare professionals can request a complete copy of the examination report and the corresponding references from the company (Article 5 para. 5 AWV).

If articles and contributions from other media about a company or its medicines are offered on the website of that company (press reviews), the content of these articles and contributions are attributed to that company in terms of advertising law. Therefore, the provisions of the AWV are fully applicable to such press reviews (Swissmedic Journal 8/2006, p. 796 et seqq.).

The same holds true for reprints of journal articles provided to healthcare professionals. Consequently, the restrictions that apply to advertising to healthcare professionals must be adhered to in connection with such reprints of journal articles. In particular, advertising must be recognisable as such. Therefore, advertising and editorial contributions must be clearly separated (Article 5 paragraph 4 AWV).

Walder Wyss Ltd

Walder Wyss Ltd.
Seefeldstrasse 123
P.O. Box
8034 Zurich
Switzerland

+41 58 658 58 58

+41 58 658 59 59

reception@walderwyss.com www.walderwyss.com/en/home
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Authors



Walder Wyss Ltd has 200 legal experts and office locations in Zurich, Geneva, Basel, Berne, Lausanne and Lugano. Walder Wyss Ltd has a team dedicated to life science and pharmaceutical regulatory law, including healthcare insurance law. The key areas of practice in relation to the pharmaceutical advertising sector are pharmaceutical regulatory law, healthcare insurance law and the law regarding research on humans and clinical trials, stem cells and blood components, genetic testing, transplantation, special nutrition, medical devices and reproductive medicine. The firm has established www.lifesciencelaw.ch, a website dedicated to all legal issues surrounding life sciences where case law is discussed and where interested people can find publications from the team.

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