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.

Advertising directed at the general public for prescription-only medicines is prohibited, whereas advertising for over-the-counter medicines is permitted. Advertising directed at the general public is deemed unlawful for medicines that contain narcotic or psychotropic substances and for medicines that may not, on account of their composition and their intended use, be used without the intervention of a doctor for the necessary diagnosis, prescription or treatment. This also applies to medicines that are frequently the object of abuse or that lead to an addiction or dependence. Furthermore, 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 31 paragraph 1 lit. b and Article 32 HMG; Article 14 AWV).

According to the KVV, medicines that are advertised to the public will not be included in the SL. Medicines included in the SL will be deleted if the marketing authorisation holder directly or indirectly advertises the medicine to the public (Article 65 paragraph 2 and Article 68 paragraph 1 lit. d KVV). A medicine that is not listed in the SL is not covered by compulsory healthcare insurance.

All advertisements directed at the public are further subject to the provisions regarding unfair competition. Any behaviour or business conduct that is deceptive or otherwise contrary to the principle of good faith and that affects the relationship between competitors or between suppliers and customers is deemed unlawful (Article 2 UWG). In particular, any company that disparages other companies, its goods or prices by making incorrect, misleading or unnecessarily offensive statements or who takes measures that are likely to cause confusion with their goods acts unfairly. It is further prohibited to compare a company or a company’s goods or prices in an incorrect, misleading or unnecessarily disparaging or similar manner with others, their goods or prices (Article 3 paragraph 1 lit. a, d and e UWG).

All information in advertising, especially indications and possible applications, must be in accordance with the drug information most recently approved by Swissmedic. The properties of the medicine as described in words, images and sound must be presented factually correctly and without exaggeration. The advertising must be recognisable as such and clearly distinguishable from editorial contributions. A medicine, an indication, a dosage, a galenic form or a package may be advertised as “new” for eighteen months after its first authorisation in Switzerland and it must be clearly indicated what this attribute refers to. Medicines in supply categories C and D must be clearly presented as such and any advertising for these medicines must include at least the name of the product, the authorisation-holder and at least one indication or possible use. It must further include the explicit and legible reference, in the case of a medicine with package leaflet, “This is an authorised medicine. Read the package leaflet.” or, in the case of a medicine without package leaflet, “This is an authorised medicine. Read the information on the package.” (Article 16 AWV).

There are certain special provisions for advertising of medicines of categories C and D in electronic media. For television commercials and cinema advertising, a note with the following message must be displayed at the end: “This is an authorised medicine. Read the package leaflet.” or, in the case of a medicine without package leaflet, “This is an authorised medicine. Ask a specialist for advice and read the information on the package.” This notice must be displayed legibly on a neutral background in a font block size of at least one third the size of the overall picture. In the case of cinema advertising it should be in at least the font size customary for subtitles – at the same time this notice must be clearly spoken. In the case of radio spots, a note with the following wording must be inserted at the end: “[product name] is an authorised medicine. Ask a specialist for advice and read the package leaflet” or, for medicines without a package leaflet: “[product name] is an approved medicine. Ask a specialist for advice and read the information on the package.” This notice must be spoken in a manner that is easily comprehensible. Advertising on electronic display boards must display the following message at the end: “This is an authorised medicine. Ask a specialist for advice and read the package leaflet” or, for medicines without a package leaflet: “This is an authorised medicine. Ask a specialist for advice and read the information on the package.” This notice must be displayed legibly on a neutral background in a text block at least one third the size of the advertisement and for at least five seconds (Article 17 AWV).

While medicines in supply categories C and D must use the reference to their authorisation status in any advertisements, medicines in supply category E may not use their authorisation status in advertising (Article 17a AWV). Advertising for medicines with a cantonal authorisation is subject to special provisions (Article 17b AWV).

In advertising that is only intended to recall a certain brand, only the product name or additionally the name of the marketing authorisation-holder may be mentioned. Brand advertising is not permitted in cinemas, on the radio and on television (Article 18 AWV).

Advertising on radio and television for medicines for human use containing alcohol and intended for oral use is only permitted if the maximum single dose of these products according to the recommended dosage contains less than 0.5 g pure alcohol (Article 20 AWV).

Advertising directed at the general public may not include indications or applications for which a medical diagnosis or treatment is required. It may not be obtrusive, blatant or appear to be an editorial contribution. Orders for medicines may not be accepted on the occasion of home visits, exhibitions, lectures or the likes. Furthermore, the direct distribution of medicines for the purpose of sales promotions as well as vouchers and competitions are prohibited. Finally, advertisements may also not include any invitation to contact the marketing authorisation-holder. Some of the mentioned prohibitions do not, however, apply to medicines in category E (Article 21 AWV).

Advertisements may not make a medical examination or surgical intervention appear superfluous, promise a guaranteed effect or claim that the product has no undesirable effects. In addition, advertising may not raise the expectation that the effect of a medicine corresponds to another treatment or to the effect of another medicine or that it is superior to them. It may further not give rise to the expectation that the condition of a healthy person will be improved with or that such a condition will deteriorate without the use of the medicine. Advertisements may never be aimed mainly or exclusively at children or adolescents or mention scientific publications, clinical studies, expert opinions, reports or recommendations by scientists, healthcare professionals, well-known personalities or medical–pharmaceutical laypersons. Furthermore, they may not show persons in the professional clothing of medical personnel, druggists or medical assistants or during medical activities specific to the profession.

The use of misleading, fictitious or not recognised titles or distinctions is prohibited as well as any phrases that may induce fear. The advertisement may not equate the medicine to food, feed, care products or other commodities or suggest that the safety or efficacy of the medicine is due to the fact that it is a “natural product” or the like. In no way may the advertisement lead to a false self-diagnosis through the presentation of a medical history nor may it use in an abusive, alarming or misleading manner visual representations of changes that the human body or parts thereof have undergone as a result of disease, injury or as a result of the effect of a medicine. Finally, the number of persons treated may not be disclosed (Article 22 AWV).

The Pharma Cooperation Code applies to, amongst others, the co-operation between pharmaceutical companies and patient organisations. It states that such co-operation and the pecuniary benefits granted in return must not constitute an inducement to recommend, prescribe, acquire, supply, sell or administer specific medicines. Pharmaceutical companies may not offer, promise or grant any inappropriate benefits to patient organisations including, in particular, any gifts (either in cash or non-cash considerations; rule 14 Pharma Cooperation Code).

The Pharma Cooperation Code contains various further provisions and principles in that regard in rule 3. An important principle is that of the independence of patient organisations. Pharmaceutical companies may not demand of patient organisations to be the sole pharmaceutical company to provide financial or other support for them, both for overall support and support for individual projects. Furthermore, pharmaceutical companies may neither require patient organisations to promote certain specific prescription-only medicines nor may they agree to requests in that regard made by patient organisations. In addition, the aims, scope and agreement on support and partnerships must be evidenced in writing and be transparent. Pharmaceutical companies must disclose the annual pecuniary benefits that they have granted to individual patient organisations and keep such information accessible to the public for at least three years after the date of disclosure.

The Pharma Cooperation Code further states that consultancy and services by patient organisations are permitted only if such consultancy tasks or services are provided to support healthcare or research. The need for the consultancy tasks or services must be justified and clearly designated and documented in the written agreement. The scope of the consultancy tasks or services must be no greater than is reasonably necessary to satisfy the specified requirement. Furthermore, the contractually retained pharmaceutical company must record the consultancy tasks and services provided and make expedient use thereof. The compensation for the consultancy tasks or services must be reasonable and may not exceed the normal market value of such consultancy tasks or services. In this connection, no sham contracts may be concluded to justify payments for patient organisations. The pharmaceutical companies must include provisions in their contracts with patient organisations stipulating that the patient organisation must disclose the fact that it has provided paid consultancy tasks or services for the pharmaceutical company whenever it writes or speaks in public on a topic that is the subject of the contract or on other matters that relate to the particular pharmaceutical company.

In connection with events and hospitality, the Pharma Cooperation Code specifies that events are to be held on premises that are appropriate and conducive to the main purpose of the event. Their choice should be guided primarily by the space and infrastructure availability with a view to the appropriate performance of the main purpose. Premises that are famous for their entertainment facilities or regarded as extravagant are to be avoided. Hospitality in connection with events must be confined to the journey, subsistence, accommodation and participation fees. In principle, hospitality may only be granted to persons who are entitled to it as participants. Hospitality must not include the support (sponsorship) or organisation of entertainment (eg sport or leisure activities). In principle, pharmaceutical companies may not organise or sponsor events that are held outside Switzerland.

Advertising to the public must not contain any recommendations or testimonials by healthcare professionals or references to expert opinions (Article 22 lit. g 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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