Switzerland: Pharmaceutical Advertising

The Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA) and the Ordinance on Advertising for Medicinal Products (OAM) provide the general legal framework for the advertising of medicines in Switzerland.

In addition to the legislation specifically relating to medicines, general legislation may restrict advertising activities, such as the Act against Unfair Competition.

There are two self-regulatory codes containing provisions that are relevant for the advertising of medicines:

• the Code of Conduct of the Pharmaceutical Industry in Switzerland of 4 December 2003, as last revised on 14 May 2020 (Pharma Code); and
• the Code of Conduct of the Pharmaceutical Industry in Switzerland on Cooperation with Healthcare Professional Circles and Patient Organizations of 6 September 2013, as last revised on 14 May 2020 (Pharma Cooperation Code).

Both codes were revised on 14 May 2020 against the background of the TPA revision, the entry into force of the Ordinance on Integrity and Transparency in the Therapeutic Products Sector, and the new requirements introduced by the  Code of the European Federation of Pharmaceutical Industries and Associations (EFPIA) of 2019. The revisions of 14 May 2020 entered into force on 1 January 2021 (see: https://www.scienceindustries.ch/en/article/15671/revision-2020-overview-of-the-changes-made).

The Pharma Code covers professional promotion, i.e. advertising activities directed specifically at healthcare professionals. It is not applicable to public promotion, i.e. advertising targeting the general public. The Pharma Cooperation Code contains provisions on pecuniary benefits.

Both codes, the Pharma Code and the Pharma Cooperation Code, only apply to pharmaceutical companies that have undertaken to comply with the respective code by signing a declaration. Scienceindustries (Swiss business association for chemistry, pharma and life sciences) regularly publishes the most recent list of the pharmaceutical companies that have signed the declaration (see: https://www.scienceindustries.ch/en/article/12556/pharma-code-signatories).

The provisions of the Pharma Code and the Pharma Cooperation Code are of contractual nature and do not have the status of statutory law. The Swiss Agency for Therapeutic Products (Swissmedic) is not bound by the codes, but considers them as an aid for interpretation of Swiss statutory laws.

Violations of the Pharma Code or the Pharma Cooperation Code are investigated by a Code Secretariat that can issue a written order to the member company to discontinue the conduct contrary to the respective code and to guarantee that it will desist from such conduct in the future. The Code Secretariats do not have any enforcement power in case of non-compliance with such order; but they may bring the case to the attention of Swissmedic.

Advertising is broadly defined in art. 2 lit. a OAM as “all information, marketing and incentive measures designed to promote the prescription, dispensing, sale, consumption or use of medicinal products”.

This broad definition covers all measures that are designated to promote medicinal products. Swiss jurisprudence has clarified that this requires that the measure is directed at a larger number of persons with the objective of influencing their behavior. From art. 1 OAM it follows that advertising does not include information on:

• information contained in a medicinal product’s package or package leaflet;
• trade catalogues and price lists provided that they don’t contain medical information on medicinal products; and
• information of a general nature on health or on diseases, provided that it does not relate directly or indirectly to specific medicinal products.

The definition of art. 2 lit. a OAM applies equally to all target audiences. However, the advertising activities which are allowed differ by target audience, namely public promotion, i.e. advertising activities targeting the general public (art. 2 lit. b OAM), is more strictly regulated than professional promotion, i.e. advertising activities directed specifically at healthcare professionals (art. 2 lit. c OAM).

Art. 4 and art. 15 OAM contain non-exhaustive lists of the advertising activities that are considered professional promotion and public promotion, respectively. According to this, professional promotion shall be deemed to include (art. 4 OAM):

• advertisements in professional journals and other printed materials for healthcare professionals;
• advertising on items;
• advertising by means of electronic media such as image, sound and data carriers and application software;
• advertising on the occasion of promotional events or scientific congresses;
• realisation and financial support of promotional events;
• mailings and promotional material;
• visits of drug representatives; and
• supply of drug samples.

Public promotion shall be deemed to include (art. 15 OAM):

• advertisements in newspapers, magazines and books, brochures, posters, newsletters, etc;
• advertising on items;
• advertising by means of electronic media such as image, sound and data carriers and application software;
• advertising on the occasion of home visits and presentations to non-professionals;
• advertising in medical and veterinary practices and at the points of sale (shop windows, containers for goods for sale, etc.); and

distribution of samples.

There are no specific rules on press releases, so that the general legislation on advertising of medicinal products applies. Hence, the crucial question is whether the press release qualifies as “advertising” in the sense of art. 2 lit. a OAM. In order to avoid that a press release qualifies as advertising, it should be ensured that the press release only contains information that is required by the target audience. For example, a press release that is directed at investors, should be strictly limited to scientific and financial information that is of interest for potential investors for their investment decision; any statement that is designed to promote the prescription, dispensing, sale, consumption or use of medicinal products must be avoided. Advertising and editorial contributions must be clearly separated (art. 5 para. 4 OAM).

Swiss statutory law does not require companies to implement an internal approval process. However, the holder of a marketing authorisation is obliged to designate a responsible person for advertising (art. 25 OAM). This responsible person must have a scientific, medical or other appropriate professional training or experience, and has to ensure compliance with applicable laws and the orders of Swissmedic. Furthermore, the responsible person has to store a copy of each advertisement for six months, including a directory of recipients, mode of distribution and date of first publication.

Art. 11 OITTP further requires any company manufacturing or selling medicinal products to designate a person that will: (i) upon request, provide to the Federal Office of Public Health all documents and information required by the Federal Office of Public Health, (ii) retain all agreements with healthcare professionals and organizations for a period of ten years, and (iii) maintain a list of all healthcare professionals and organizations that have received a due advantage within the meaning of the OITTP.

The Pharma Cooperation Code requires member companies to ensure that the activities regulated by the Pharma Cooperation Code, which includes professional promotion, i.e. advertising activities directed specifically at healthcare professionals, are approved prior to their practical implementation by a designated responsible person who is familiar and complies with the international codes, namely IFPMA and EFPIA as well as all relevant Swiss regulations (section 42 of Pharma Cooperation Code).

There is no general approval requirement under Swiss statutory law. However, two categories of advertisements have to be pre-approved by Swissmedic, namely: (i) radio, television or cinema advertising of over-the-counter products; and (ii) advertising targeting the general public in print media or via electronic media (e.g. online) for analgesics, sleeping pills and sedatives, laxatives and for appetite suppressants (art. 23 para. 1 OAM).

Furthermore, in case a marketing authorisation holder violates provisions on the advertising of medicines repeatedly or materially, Swissmedic may require such marketing authorisation holder to have all of its advertising materials pre-approved by Swissmedic for a reasonable period of time (art. 23 para. 2 OAM).

Comparative advertising is only allowed for professional promotion, i.e. advertising directed at healthcare professionals. According to Swiss statutory law, comparative advertising must be scientifically correct and based on Good Clinical Practice (GCP) compliant clinical trials that have been published or are accepted for publication (art. 7 para. 1 OAM). If the comparative advertising is based on an animal or in vitro study, or in case of a veterinary medicines product on another animal than the one targeted by such veterinary medicines product, this has to be disclosed (art. 7 para. 2 OAM).

For public promotion, i.e. advertising activities directed at the general public, comparative advertising is not allowed. According to art. 22 lit. c OAM, advertising shall not create the expectation that the treatment is equivalent to or better than another treatment or another medicinal product.

In addition to the specific provisions on comparative advertising of medicines, the general limitations of the Act against Unfair Competition have to be observed.

Swiss statutory law clearly states that advertising of an unauthorized medicine or indication is not permitted (art. 32 para. 1 lit. c TPA, art. 5 para. 1 OAM, art. 16 OAM). Hence, the possibility to provide information on unauthorised medicines or unauthorized indications is limited, and only allowed if the provision of such information does not qualify as advertising in the sense of art. 2 lit. a OAM. For example, information on an unauthorized medicine or unauthorized indication in an investor press release is permitted if such information is required by investors for their investment decision (e.g. information on successful completion of clinical studies), provided that the press release is not drafted in a way that promotes an unauthorized medicine or promotes the sale of an authorized medicine for an unauthorized indication.

The same applies to information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals. According to the Pharma Code, pharmaceutical companies may inform healthcare professionals about medicinal products that have not yet received marketing authorisation from Swissmedic; however, no promotion for these medicinal products is allowed. The same applies to new indications, possible applications, dosages, pharmaceutical forms and packaging of a medicinal product. The brand name may be used; however, it must always be accompanied by the official abbreviated designation of its active ingredients (DCI/INN12). With such information, it must always be clearly stated that this medicinal product, or the new indication, possible application, dosage, pharmaceutical form or packaging for the medicinal product has not yet received marketing authorisation from Swissmedic (section 26.2 and 26.3 of Pharma Code). Information materials that are handed out in response to a request at events with international participation may refer to medicinal products that are authorised in other countries but not in Switzerland, or are authorised in Switzerland under different conditions. However, such information materials must be accompanied by the following declarations: (i) reference to the countries where the medicinal products concerned are authorised, and to the fact that the medicinal products concerned are not authorised in Switzerland or are subject to different conditions in Switzerland; and (ii) reference to the possible differences in registration requirements and the government approved professional information (indications, warnings, etc.) in the country or countries where the medicinal products concerned are authorised (section 27 of Pharma Code).

Swiss statutory law differentiates between public promotion, i.e. advertising to the general public, and professional promotion, i.e. advertising that is directed at healthcare professionals (art. 31 para. 2 TPA; art. 2 lit. b and c OAM).

Public promotion is limited to over the counter medicines only, i.e. advertising activities for prescription medicines must not be directed at the general public (art. 31 para. 1 lit. b TPA). Furthermore, art. 32 para. 2 TPA clarifies that advertising to the general public is not permitted for medicines which:

• may only be dispensed on prescription;
• contain narcotics or psychotropic substances within the meaning of the Federal Law on Narcotics;
• due to their composition or intended use, cannot be used for the relevant diagnosis, prescription or treatment without involvement of a doctor;
• are frequently abused or may lead to habituation and dependence.

Section 3 (art. 14 through art. 22) of the Ordinance on Advertising for Medicinal Products lays down the details:

General requirements for public promotion:

According to art. 16 OAM, all information contained in public promotion must be in accordance with the most recent product information approved by Swissmedic, in particular, only indications or possible applications approved by Swissmedic may be advertised. All information on the characteristics of the medicine must be in a factually correct manner and without exaggeration. Furthermore, advertising must be recognizable as such, i.e. advertising and editorial content must be clearly separated. A medicinal product, an indication, a dosage, a galenical form or a package may be advertised as “new” for eighteen months after its initial authorisation in Switzerland. For specific categories of medicines (supply categories C and D), depending on the type of advertising, some further warnings and notices shall clearly be made, as well as a mention of their status of authorised medicines (art. 16 para. 5 to 17a OAM). This last mention is prohibited for supply category E medicines (art. 17a para. 2 OAM).

Prohibited public promotion:

According to art. 21 OAM the following advertising activities are prohibited (except for medicines of category E):

• advertising of indications or possible applications for which a medical or veterinary diagnosis or treatment is required;
• any intrusive, blatant advertising;
• advertising which gives the impression that it is an editorial contribution;
• the receipt of orders for medicinal products on the occasion of home visits, exhibitions, lectures, promotional trips and the like, and by means of addressed direct mail;
• the direct supply of medicinal products for the purpose of sales promotion;
• the handing over of goods vouchers for medicinal products;
• any invitation to contact the marketing authorisation holder; and
• the organisation of competitions.

Furthermore, according to art. 22 OAM advertising may not:

• make a medical or veterinary examination or surgical intervention appear unnecessary, in particular by offering a diagnosis or recommending treatment by correspondence;
• promise an impact of the medicinal product or claim that it has no undesirable effects;
• give rise to the expectation that the effect of the medicinal product is equivalent or superior to another treatment or to that of another medicinal product;
• give rise to the expectation that the condition of a healthy human being or a healthy animal will be improved by the use of the medicinal product;
• give rise to the fear that the condition of a healthy human being or healthy animal will deteriorate without the use of the medicinal product;
• be directed exclusively or mainly at children and adolescents;
• mention or refer to scientific publications, clinical studies, expert opinions, testimonials or recommendations by scientists, health care professionals, well-known personalities or medical-pharmaceutical laypersons;
• show persons in the professional clothing of medical personnel, druggists or medical assistants or in the exercise of profession-specific medical activities;
• use misleading, fictitious or unrecognised titles or awards;
• equate the medicinal product with food, feed, care product or other articles of daily use;
• state or imply that the safety or efficacy of the medicinal product is due to the fact that it is a “natural product” or similar;
• mislead the persons to make a false self-diagnosis or animal owners to make a false diagnosis by describing or presenting a medical history;
• use in an abusive, worrying or misleading manner pictorial representations of changes which have been made to the human or animal body or parts thereof as a result of disease or physical injury or as a result of the action of a medicinal product;
• indicate the number of persons or animals treated; or
• use phrases which may cause fear.

There are no specific restrictions in statutory law with respect to interactions between patients or patient organisations and industry.

The Pharma Cooperation Code provides some guidance on the interaction between pharmaceutical industry and patient organisations, for example:

• 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 (section 15.2 of Pharma Cooperation Code).
• Patient organisations may not be required by pharmaceutical companies to exclusively support such pharmaceutical company (section 15.7 of Pharma Cooperation Code).
• Pharmaceutical companies may not, in their own commercial interests, attempt to influence the texts in documents of patient organisations to whom they provide financial or other support. Pharmaceutical companies may only make a contribution to a text from a fair and balanced scientific perspective if specifically asked to do so by a patient organisation (section 23.2 of Pharma Cooperation Code).
• Pharmaceutical companies may neither require patient organisations to promote certain specific prescription-only medicinal products, nor may they consider corresponding requests made by patient organisations (section 31.3 of Pharma Cooperation Code).
• Specific requirements for pharmaceutical companies that wish to retain representatives of patient organisations for consultancy tasks or services (section 32.2 of Pharma Cooperation Code).

All information provided to health care professionals must be in accordance with the most recent medicinal product information approved by Swissmedic; in particular, only indications and possible applications authorised by Swissmedic may be advertised (art. 5 para. 1 OAM). The advertising must be accurate, balanced, factually correct and verifiable in its statements. The statements must not be misleading. Any supporting documents must be made available to the healthcare professionals upon request (art. 5 para. 3 OAM). Furthermore, advertising must be recognisable as such; advertising and editorial contributions must be clearly separated (art. 5 para. 4 OAM).

Advertising statements must be based on and reflect the current state of scientific knowledge. They may only refer to clinical trials that have been conducted and published or accepted for publication in accordance with the rules of good clinical practice, and 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, complete and with an accurate source. It should be pointed out that the experts can request a complete copy of the audit report and the corresponding references from the company (art. 5 para. 5 OAM).

Professional promotion, i.e. advertising directed at healthcare professionals must contain at least the following information (art. 6 OAM):

• the name of the preparation (trademark);
• the active substances with the abbreviated designation (DCI/INN or designation of the most recent edition of the Pharmacopoeia; in the absence of such designation, other generally recognised abbreviations approved by Swissmedic);
• the name and address of the holder of the authorisation;
• at least one indication or possible use, as well as the dosage and the type of application;
• a summary of any restrictions on use, adverse reactions and interactions;
• the delivery category;
• a statement that detailed information can be found in the published information on the medicinal product; the reference to the list in accordance with art. 67 para. 3 or art. 95b TPA must be given as the reference;
• the withdrawal periods for veterinary medicinal products for food-producing animals.

If, in the advertising of medicinal products, no statements are made about the use, but only information about the indications in the sense of a reference to the therapeutic category of the medicinal product is given or the advertising is only intended to recall a trademark, not all the above mentioned information must be contained (art. 8 et seq. OAM).

Professional promotion may not:

• use the term “safe” unless the information transmitted clearly indicates what this attribute refers to;
• state that a medicinal product has no undesirable effects and that it is safe or harmless;
• give the impression that it is an editorial contribution;
• indicate that the medicinal product for human use in question does not produce habituation (art. 13 OAM).

According to art. 55 para. 1 TPA, persons who prescribe, dispense, use or purchase prescription-only medicinal products or organisations employing such persons may not claim, be promised or accept an undue advantage, either for themselves or for the benefit of a third party. Similarly, it is forbidden to offer, promise or grant an undue advantage to such a person or organization for their own benefit or for the benefit of a third party.

Benefits of up to a maximum amount of 300 Swiss Francs per professional per year do not qualify as undue advantage and are therefore allowed provided that they are directly related to the professional practice of the respective healthcare professional or are directly for the benefit of the clientele of the respective healthcare professional (art. 55 para. 2 TPA, art. 3 , OITTP).

Yes, pharmaceutical companies are allowed to provide a limited amount of samples to healthcare professionals per medicine and per year, but only upon the written request of such healthcare professionals (art. 10 para. 1bis OAM). Furthermore, art. 10 para. 3 OAM requires inter alia that the sample package is clearly and permanently marked as “free sample” and contains all other required information, the sample contains an approved package leaflet, and the sample corresponds to the smallest approved package size. The authorization holder shall ensure that records are kept of all dispensed samples (art. 10 para. 5 OAM).

According to section 28.2 of the Pharma Code sample packages may not be dispensed as an inducement to recommend, prescribe, purchase, supply, sell, or administer a particular drug.

Yes, this is allowed in principle. However, financial support for the attendance by healthcare professionals to these events is restricted. Only sponsoring for participation in postgraduate or continuing education events for professionals is permitted provided that it has been agreed in writing and that the professionals participating (or the organisations employing the professionals) bear an appropriate share of the costs (art. 6 para. 1 OITTP).

Such personal contribution to the costs is not required if the participating professional provides a service in return of equivalent value at the event within the meaning of art. 7 OITTP, as well as if he or she is not required to make an overnight stay at the location, the event is no longer than half a working day and does not include any meals (art. 6 para. 3 OITTP).

In particular the following are not permitted:

• the full or partial refund of the personal contribution to the costs;
• any payment in respect of indirect participation costs such as lost working hours or lost income;
• any payment of the costs of fringe events that are not clearly of subordinate importance to the professional part of the event;
• any payment of the costs of travelling, accommodation, meals or fringe events for persons accompanying the participating professional, even if the accompanying persons are themselves professionals (art. 6 para. 4 OITTP).

The Pharma Code adds some details to the rules concerning sponsorship of such type of events (section 31 et seqq). For instance, events, which are organised or receive financial support from pharmaceutical companies with subsidiaries in Switzerland (sponsored) and which are aimed purely at participants from Switzerland, should fundamentally take place in Switzerland, unless the relevant information for the topic is only available abroad. Moreover, a Swiss subsidiary of an international company may invite Swiss participants abroad for an event organised by the headquarters or the company’s regional centre, provided that the participants pay for the main part of the fees.

According to section 34.6 of the Pharma Cooperation Code, pharmaceutical companies may not organize or sponsor events that take place outside of Switzerland, unless there are certain logistical reasons for hosting the event outside of Switzerland.

According to art. 6 para. 3 OITTP, a pharmaceutical company may not bear the costs for the framework program to conferences (e.g. part of program that is related to cultural, sports or other non-scientific activities).

On self-regulatory level, the Pharma Code and the Pharma Cooperation Code clearly prohibit pharmaceutical companies to offer or pay for any entertainment or other leisure or hospitality activities (section 32.5 of Pharma Code and section 34.5 of Pharma Cooperation Code).

Yes, it is possible to pay healthcare professionals for services, such as teaching, preparation of an expert opinion, consulting activities, implementation of scientific studies or clinical trials, participation in advisory boards etc. (see art. 7 para. 4 OITTP), provided that (i) the scope of services and the consideration have to be agreed in writing and (ii) the consideration must be appropriate (art. 7 para. 1 OITTP). The healthcare professional may not be paid for services that he/she is providing for him/herself, or in the performance of a legal obligation or that are reimbursed by other means (art. 7 para. 4 OITTP).

According to section 41.1 of the Pharma Code, contracts between pharmaceutical companies and healthcare professionals and healthcare organizations are only permissible if they are provided for the purpose of supporting healthcare, research, development or the promotion of medical education and at the same time they do not create an incentive to recommend certain drugs, to recommend, prescribe, buy, sell, supply or use certain medicinal products. In this context, section 41.5 of the Pharma Code determines that there must be a justified need for the intended service, which must be documented before the services are requested and any agreements are made. Furthermore, the selection criteria for said professionals must be directly related to the identified need, the professionals chosen for the assignment are suitable for its performance and no more professionals are contracted than are necessary.

Grants or donations may not be provided to healthcare professionals directly, but only to the organisation that employs the respective healthcare professional (art. 4 lit. a OITTP). The grant or donation must be based on a written agreement specifying the intended use of the grant or donation, and must only be used for such intended use (art. 4 lit. b and c OITTP). The grant or donation must be made to an account of the organisation over which the healthcare professional cannot dispose solely, and the amount of the grant or donation must be shown in the accounting of the organisation (art. 4 lit. e and f OITTP). Furthermore, the donation or grant may not be subject in any way to the prescription, supply, use or procurement of prescription medicines (art. 4 lit. d OITTP).

According to section 24 et seqq. of the Pharma Cooperation Code, pecuniary benefits granted by pharmaceutical companies must be disclosed to the public.

As from 1 January 2020, except from medicines belonging to the supply category E and medical devices belonging to the supply category I, anyone who grants or accepts discounts or rebates when purchasing therapeutic products shall indicate them in supporting documents and accounts, as well as in the books of accounting. Upon request, the company must report them to the Federal Office of Public Health (art. 56 TPA, art. 10 OITTP).

Donations or grants for research, postgraduate education or continuous education shall also be reported in the accounting of the respective organisation receiving such donation or grant (art. 4 and art. 5 OITTP). Moreover, all agreements with healthcare professionals or organisations concerning benefits shall be kept for ten years and a list of all the healthcare professionals and the organisations having benefited from benefits shall be established (art. 11 OITTP).

On self-regulatory level, the Pharma Cooperation Code provides several rules about disclosure of benefits (section 23 et seqq).

There is no general approval requirement under Swiss statutory law. However, two categories of advertisements have to be pre-approved by Swissmedic, namely: (i) radio, television or cinema advertising of over-the-counter products; and (ii) advertising targeting the general public in print media or via electronic media (e.g. online) for analgesics, sleeping pills and sedatives, laxatives and for appetite suppressants (art. 23 para. 1 OAM).

Furthermore, in case a marketing authorisation holder violates provisions on the advertising of medicines repeatedly or materially, Swissmedic may require such marketing authorisation holder to have all of its advertising materials pre-approved by Swissmedic for a reasonable period of time (art. 23 para. 2 OAM).

To advertising on the internet (including social media) the general rules apply, i.e. online advertising for prescription medicines may only be directed at healthcare professionals (art. 31 para. 1 TPA). Therefore, online professional promotion, i.e. online advertising activities that target healthcare professionals, has to be password restricted (art. 5a OAM).

The Swiss Criminal Code (SCC) prohibits active and passive bribery in the private sector (art. 322octies and 322novies SCC). In the case of healthcare professionals working in a public hospital (with public function), the prohibition of active and passive bribery of public officials is applicable (art. 322ter and 322quater SCC), as well as the prohibition of the acceptance and the granting of an advantage (without any relationship of exchange with the undue advantage) (art. 322quinquies and 322sexies SCC).

Under the TPA, the acceptance or the grant of unlawful benefits in favour of persons who prescribe, supply, use or purchase prescription medicines or in favour of organisations that employ such persons, qualifies a criminal offence (art. 86 TPA).

The provisions on the offering of benefits/inducement were revised with effect from 1 January 2020.

According to art. 55 TPA, persons who prescribe, dispense, use or purchase prescription-only medicines or organisations employing such persons may not claim, be promised or accept an undue advantage, either for themselves or for the benefit of a third party. Similarly, it is forbidden to offer, promise or grant an undue advantage to such a person or organisation for his own benefit or for the benefit of a third party. The details are laid down in the OITTP that entered into force on 1 January 2020.

As part of the revision of the medical device legislation, Parliament decided in March 2019 to extend the integrity provision to “benefits related to the prescription, dispensing and use of medical devices”. This requires a partial revision of the OITTP. A detailed timetable is not yet available; the revised art. 55 TPA and the partially revised OITTP are not expected to come into force before 2022.

Swissmedic is responsible for enforcing the rules on advertising. The Federal Office of Public Health in responsible for enforcing the rules on inducement. Decisions can be appealed to the Federal Administrative Court.

The Code Secretariats are responsible for the enforcement of the Pharma Code and the Pharma Cooperation Code, respectively (section 7 of Pharma Code, section 5 of Pharma Cooperation Code).

Companies can file a complaint with Swissmedic against competitors for advertising infringements. Furthermore, in case the conduct qualifies as an act of unfair competition, the company may also initiate a civil court proceeding based on a violation of the Act against Unfair Competition.

In case the complaining company and the infringing company are members to the Pharma Code, the complaining company may also initiate a proceeding before the Code Secretariat against the competitor.

There can be administrative measures or criminal penalties. Administrative measures include cease and desist orders, seizure or destruction of inadmissible advertising material or even the prohibition of advertising for a particular medicine in case of significant or repeated violations of law (art. 66 para. 1 and 2 TPA, art. 23 OAM).

Criminal penalties range from monetary fines of up to 50,000 Swiss Francs in case of a violation of advertising or transparency statutory rules (art. 87 TPA) to a monetary fine or custodial sentence not exceeding three years (up to ten years in case of profit making intention) in case of a violation of the statutory rules on the offering or acceptance of unlawful benefits (art. 86 TPA).

In addition, criminal sanctions under the Swiss Criminal Code can be imposed in case of bribery.

Procedures before or measures taken by self-regulatory authorities, namely the Code Secretariat under the Pharma Code and Code Secretariat under the Pharma Cooperation Code, are independent from procedures before or measures taken by courts/government competent authorities.

Members of the Pharma Code and the Pharma Cooperation Code, respectively, undertake not to refer a matter that is pending before the respective Code Secretariat to a state authority or to a court on grounds of breach of Swiss statutory law for as long as such proceeding is pending (section 14.2 of Pharma Code, section 14.2 of Pharma Cooperation Code).

If a pharmaceutical company refers conduct which it deems to be in breach of the scope of the Pharma Code or the Pharma Cooperation Code, respectively, to a state authority or to a court, the respective Code Secretariat will not suspend any proceeding that is pending before it for as long as none of the participating pharmaceutical companies asks for the proceeding to be terminated (section 77.1 of Pharma Code, section 57.1 of Pharma Cooperation Code).

Concerning advertising, recent case law was mainly about unlawful or misleading phrasing used for advertising or about the difficulty to distinguish general information from advertising.

According to the annual report on the Pharma Code and the Pharma Cooperation Code for 2021, published by the Code Secretariat, most proceedings concerning pharmaceutical advertising occur within the self-regulatory framework of the Code Secretariat, which dealt with 72 cases in 2021 (a significant decrease compared to last year’s 118 cases). As in 2020, no company reported itself. Following a complaint by a competitor, the Code Secretariat initiated a case against a pharmaceutical company that had not signed the Pharma Code. Despite several reminders, this company did not react and the case was referred to Swissmedic according to section 75.1 of Pharma Code, which then opened proceedings. No proceedings were classified as potentially hazardous to health.