In Switzerland, the regulation pertaining to the advertisement and promotion of medicines is spread over various statutes, ordinances and guidelines, and also includes self-regulatory codes. The Swiss regulatory environment is shaped by a ban on pre-approval promotion and direct-to-consumer (DTC) advertising of prescription medicines and provides for narrow limits for permissible pharmaceutical advertising that depend, in large part, on legal and regulatory expertise as well as extensive practical industry experience.

The legal terminology in Switzerland refers to “medicinal products” as the generic term for products of chemical or biological origin which are intended or claimed to have a medicinal effect on the human or animal organism.

The following key acts provide the principles of the national regulation of pharmaceutical advertising:

• the Therapeutic Products Act (TPA);
• the Ordinance on Advertising of Medicinal Products (OMPA);
• the Ordinance on Integrity and Transparency (TPITO); and
• the Unfair Competition Act (UCA).

In addition, provisions in the Health Insurance Act (HIA), the Ordinance on Health Insurance (OHI) and the Federal Act on the Medical Profession (MPA) may be of relevance.

The Swiss Agency for Therapeutic Products (Swissmedic) has issued several guidelines that further define the principles of pharmaceutical advertising.

For the pertinent self-regulatory instruments, see 1.2 Application and Influence of Self-Regulatory Codes on the Advertisement and Promotion of Medicines.

The advertising of medicinal products may also be subject to self-regulation, namely the Code of Conduct of the Pharmaceutical Industry in Switzerland (Pharma Code, PC)) and the Code of Conduct of the Pharmaceutical Industry in Switzerland on Cooperation with Healthcare Professional Circles and Patient Organisations (Pharma Cooperation Code, PCC).

The Codes are modelled in particular after the practice codes adopted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

The Codes cover the entire range of medicinal products – ie, both prescription and non-prescription medicines, patented originals as well as generics and biosimilars, but not medical devices. They have been adopted by the respective industry associations:

• scienceindustries (Wirtschaftsverband Chemie Pharma Life Sciences);
• Interpharma (Verband der forschenden pharmazeutischen Firmen der Schweiz);
• vips (Vereinigung Pharmafirmen in der Schweiz);
• ASSGP (Schweizerischer Fachverband für Selbstmedikation); and
• Intergenerika (Verband der Generikahersteller in der Schweiz).

EFPIA members are required to sign the respective country codes. Accordingly, a significant proportion of the pharmaceutical companies in Switzerland are bound by the Codes.

For healthcare professionals (HCPs), the Swiss Academy of Medical Sciences (SAMW) Guidelines on collaboration between the medical profession and industry contain guidance on the advertising of medicinal products. These Guidelines are applicable to all members of the professional association of doctors and medical organisations, the Foederatio Medicorum Helveticorum (FMH) (Article 18 FMH Code of Professional Conduct).

Advertising of medicinal products is defined as all information, marketing and incentivising measures aimed at promoting the prescription, administration, sale, usage or application of medicinal products (Article 2 lit a OMPA).

Information of a general nature on health or diseases does not constitute pharmaceutical advertising, provided that it does not refer directly or indirectly to specific medicinal products (Article 1 para 2 lit c OMPA). The distinction between information and advertising is not always easy to make in detail. However, it is of particular importance for the co-operation and communication strategies of pharmaceutical companies considering that DTC advertising of prescription medicines and pre-approval promotion are prohibited in Switzerland (Article 31 para 1 lit c TPA, Articles 3 and 14 OMPA, Sections 21 et seq PC).

Generally, an activity qualifies as pharmaceutical advertising if a multitude of people are influenced by certain measures or if incentives are created that are intended to lead these people to change their consumption behaviour. Even the mere provision of information on the possible uses of medicinal products constitutes advertising if it is intended and able to influence consumer behaviour (BVGer C-5490/2015, at 6.2 et seq, BGer 2C_93/2008, at 4.1). A subjective intention to promote sales is not a prerequisite for pharmaceutical advertising. Whether the advertising actually has the effect of promoting sales is irrelevant; what is primarily decisive is how the public is objectively addressed (BGer 2A_63/2006, at 3.7.1 et seq).

The link between a disease and a medicinal product is not the only possible way of advertising by making an indirect reference to a medicinal product. In this respect, the naming of active ingredients can also refer to a medicinal product without mentioning it by name. If, in this context, the information provider is recognisable as the supplier of a corresponding medicinal product, if the active ingredients are favourably compared to other effective active ingredients or if other active ingredients are neglected or undesirable side effects are concealed, this may constitute prohibited advertising to the public (BGer 2A_63/2006, at 3.6.4 et seq, 4.1).

However, not every piece of information that creates a link to a medicinal product always qualifies as advertising:

• General information on health or diseases (eg, disease awareness campaigns) that is neither directly nor indirectly related to specific medicinal products as well as the packaging material and medicinal product information is not considered advertising of medicinal products.
• The same applies to sales catalogues and price lists, provided that these do not contain any medical information on medicinal products (Article 1 para 2 OMPA).
• There are no special regulations for patient leaflets in Switzerland. Where an HCP gives the patient the leaflet as a source of information or the patient requests a leaflet from a pharmaceutical company or a patient organisation (PO) on their own initiative, factual information about a medicinal product does not constitute product-related advertising to the general public.

All of that said, the distinction between information and advertising cannot be made in the abstract; rather, it always depends on the entire circumstances of the individual case (BVGer C-2798/2020, at 6.1.6 et seq, BVGer C-5490/2015, at 6.4.1, BGer 2C_93/2008, at 4.1).

The dissemination of information by pharmaceutical companies to shareholders, investors, financial analysts or the media constitutes generally permissible public relations, even if it is accessible to the general public. The disclosure of such information may also be required by applicable securities laws. However, the information content must be strictly limited to the scientific, technical, organisational and financial aspects of the company’s activities (eg, annual reports, presentation of the company’s research activities) and must not be aimed at promoting a medicinal product.

In the context of any presentation of new medicinal products or products under development, or new active ingredients, as well as of the future prospects and focus of a pharmaceutical company’s research and development activities, only the name of the preparation and active ingredient (Denominatio Communis Internationalis) and the therapeutic area or area of application may be mentioned. The information addressed to investors and financial analysts may contain information and forecasts regarding sales, market share and sales volume, but no further statements on the therapeutic benefits of the medicinal products (cf Swissmedic Journal 08/2006, 797). All information must also comply with fair competition rules.

Comparative advertising for approved medicinal products to HCPs is generally permissible under Swiss law, provided that the promotion is scientifically correct and based on equivalent clinical trials or data analyses whereby:

• the clinical trials must have been carried out in accordance with Good Clinical Practice and must have been published or accepted for publication in a recognised scientific medium; and
• the data analyses, such as meta-analyses, pharmacoeconomic studies or field reports from practice, must have been published in a recognised scientific medium (Article 5 para 5 and Article 7 para 1 OMPA).

Moreover, the general principle that any promotion of medicinal products may not be misleading, eg, through distortion, inappropriate emphasis or omission or in any other way, must be complied with at all times (Article 5 para 3 OMPA, Article 3 para 1 lit e UCA).

In practice, therefore, robust comparative promotion will have to regularly rely on head-to-head studies in order to fulfil the requirement of equivalence and to comply with the prohibition of misleading advertising.

Promotional statements regarding medicinal products must be in accordance with the medicinal product information most recently approved by Swissmedic; in particular, only indications and possible uses approved by Swissmedic may be advertised (Article 32 para 1 lit c TPA, Article 5 para 1 OMPA).

The provision of pre-approval information to HCPs (eg, at a medical conference or through medical science liaisons) and the media is allowed in principle if the aim is to provide or obtain scientific input on unauthorised medicinal products or indications, thereby avoiding any promotional activities, and as long as it is clearly stated that the medicinal product, indication, possible application, dosage, pharmaceutical form or packaging has not yet received marketing authorisation from Swissmedic (Article 32 para 1 lit c TPA, Article 5, para 1 OMPA, Sections 26.2 and 26.3 PC; Swissmedic Journal 2006, p. 32 et seq; BGer 2C_93/2007, at 4.2).

Information about medicinal products must always be precise, balanced, fair, objective and complete. It must be based on and clearly present a current assessment of all relevant evidence (Section 26.1 PC).

The principles set out under 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medications or Indications apply to the provision of information concerning unauthorised medicines or indications during a scientific conference. In practice, this excludes the use of commercial sales representatives for such purposes.

With regard to international conferences, careful consideration should be given to conflict of laws questions. Any information disseminated at an international event should be structured so as to ensure that it meets the requirements of all applicable legal systems.

The principles set out under 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medications or Indications apply to the provision of information concerning unauthorised medicines or indications to HCPs. Care must be taken to ensure that the information is provided directly to the HCPs, and in particular not to patients, and that it is provided by medical science liaisons rather than commercial sales representatives of the pharmaceutical company as it may otherwise risk being qualified as unlawful promotion.

The principles set out under 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medications or Indications apply to the provision of information concerning unauthorised medicines or indications to healthcare organisations (HCOs). Care must be taken to ensure that the information is provided to the medical department, and not the marketing or sales department, of the HCO as it may otherwise risk being qualified as unlawful promotion.

Patients may be treated with an unproven investigational medicinal product outside of a clinical trial if it is identical to a medicinal product used in at least one clinical trial approved in Switzerland (Article 9b para 1 TPA, Articles 52 et seq Medicinal Products Licensing Ordinance). For this purpose, the sponsor of the clinical trial may apply to Swissmedic for a temporary authorisation to use the investigational medicinal product for a limited number of patients who do not qualify for inclusion in the clinical trial. The principles set out under 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medications or Indications apply to the provision of information about such compassionate use programmes or other forms of early access.

In Switzerland, advertising of prescription medicinal products to the general public is prohibited (Article 31 para 1 TPA, Article 3 OMPA, Sections 21 et seqq PC).

Advertising of over-the-counter (OTC) medicinal products is, in principle, permitted (Article 31 para 1 lit b TPA, Article 14 OMPA), with the exception of medicinal products that:

• contain narcotic or psychotropic substances as referred to in the Narcotics Act;
• may not, on account of their composition and their intended use, be used without the intervention of a physician for the necessary diagnosis, prescription or treatment; or
• are frequently the object of abuse or lead to addiction or dependence (Article 32 para 2 lit b to d TPA).

Medicinal products (prescription and OTC medicinal products) that are included in the list of specialities may not be advertised to the public as otherwise they will be deleted from the list of specialities and will therefore no longer be eligible for reimbursement by mandatory health insurance (Article 65 para 2, Article 68 para 1 lit d OHI).

For all promotional statements, it must be ensured that they are not misleading or contrary to public order and morality as well as that they do not incite an excessive, abusive or inappropriate use of medicinal products. Any advertising is furthermore deemed unlawful if it concerns medicinal products that may not be placed on the market in Switzerland (Article 32 para 1 TPA, Article 14 OMPA, Article 3 para 1 lit e UCA).

All promotional statements regarding indications and possible applications must comply with the principles set out under 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public and be in accordance with the medicinal product information most recently approved by Swissmedic; in particular, only indications and possible uses approved by Swissmedic may be advertised (Article 32 para 1 lit c TPA, Article 16 para 1 OMPA).

The properties of the medicinal product must be presented accurately and without exaggeration in words, images and sounds (Article 16 para 2 OMPA). Any advertising must be recognisable as such, and editorial contributions must be clearly separated (Article 16 para 3 OMPA). A medicinal product, an indication, a dosage, a galenic form or a pack may only be advertised as “new” for 18 months after the first authorisation in Switzerland and must clearly indicate what this attribute refers to (Article 16 para 4 OMPA). The statute also provides a list of impermissible forms and elements of pharmaceutical advertising to the general public (Articles 21 and 22 OMPA).

The promotion of medicinal products in supply category D (dispensing on specialist advice) must meet specific additional requirements regarding their content and where it is made through electronic media (eg, television commercials, cinema advertising, radio) (Article 16 para 5 lit c, Articles 17, 17a and 20 OMPA).

Patient engagement, such as disease awareness campaigns and similar patient communications that are limited to generic information about health, diseases, etc, is allowed in principle as long as it avoids any direct or indirect reference to individual medicinal products (Article 1 para 2 lit c OMPA).

As a matter of principle, pharmaceutical companies obliged to comply with the PC and the PCC have to safeguard the independence of POs with reference to their political attitude, their mode of action and their activity. Pharmaceutical companies may not require POs to promote certain specific prescription-only medicinal products, nor may they consider corresponding requests made by POs. The aims, scope and agreement on support and partnerships must be evidenced in writing and be transparent. In any case, the general goal is that POs are supported by more than one pharmaceutical company (Section 43 PC, Section 31 PCC).

All information in professional promotion must be in accordance with the medicinal product information most recently approved by Swissmedic; in particular, only indications and possible uses approved by Swissmedic may be advertised. As long as the medicinal product information has not been officially published, the version last approved by Swissmedic has to be appended to the promotion (Article 32 para 1 lit c TPA, Article 5 paras 1 and 2 OMPA).

Promotional statements must be exact, balanced, correct and verifiable, and evidence for promotional claims must be provided to the HCPs on request. All advertising claims must be based on and reflect the current state of scientific knowledge. Moreover, the general principle that any promotion of medicinal products may not be misleading, eg, through distortion, inappropriate emphasis or omission or in any other way, must be complied with at all times (Article 5 paras 3 and 5 OMPA, Article 3 para 1 lit e UCA). Any advertising must be recognisable as such, and editorial contributions must be clearly separated (Article 5 para 4 OMPA). A medicinal product, an indication, a dosage, a galenic form or a pack may only be advertised as “new” for 18 months after the first authorisation in Switzerland and must clearly indicate what this attribute refers to (Article 5 para 6 OMPA). The statute provides lists of mandatory and impermissible forms and elements of pharmaceutical advertising directed at HCPs (Articles 6 and 13 OMPA).

Advertising may refer to data on file, or data generated from other clinical studies, that are not included in the summary of product characteristics, provided that any such statements are based on and reflect the current state of scientific knowledge and only reference data:

• from clinical trials, whereby these trials must have been carried out in accordance with Good Clinical Practice and must have been published or accepted for publication in a recognised scientific medium; or
• from data analysis such as meta-analyses, pharmacoeconomic studies or field reports from practice provided that they have been published in a recognised scientific medium.

All publications must be cited verbatim and with the exact source. In the promotion, mention must be made of the fact that HCPs may request a copy of the full clinical trial report cited in the publication from the pharmaceutical company (Article 5 para 5 OMPA).

In the case of integrated combination products, their main effect determines whether they are qualified as medicinal products or as medical devices. If the pharmacological, immunological or metabolic effect of the integral component predominates, ie, if the medicinal product contained therein has the main function, the product is considered to be a medicinal product to which the corresponding advertising rules apply (eg, pre-filled syringes, nebulisers that are pre-filled with a medicinal product; Article 2 para 1 lit g Medical Devices Ordinance (MedDO)).

If, on the other hand, the effect of a medical device is merely supported by the medicinal product as an integral component, it is uniformly qualified as a medical device (eg, catheters coated with an antibiotic; Article 1 para 3 lit a MedDO). Medical devices intended solely for use by HCPs must not be advertised to the public. Claims for devices must only contain statements that correspond to the product information; and misleading statements, particularly concerning the intended purpose, safety and performance of a device, are prohibited (Article 69 MedDO).

If a combination product can be easily separated, the container is considered a medical device and the contents a medicinal product (eg, insulin pen with a separate insulin cartridge).

Companion diagnostic products, ie, medical devices which provide information that is essential for the safe and effective use of a corresponding medicinal product, are not separately regulated under Swiss law. Such companion diagnostic products are often in vitro diagnostic medical devices to which respective provisions apply. Accordingly, in vitro medical devices intended solely for use by HCPs must not be advertised to the public. Claims for devices must only contain statements that correspond to the product information; and misleading statements, particularly concerning the intended purpose, safety and performance of a device, are prohibited (Article 62 Ordinance on In Vitro Diagnostic Medical Devices).

If the website of a pharmaceutical company contains articles and contributions from other media about the company in question or about its own products, the company must accept the third-party statements as its own. The general advertising provisions of the legislation on therapeutic products therefore apply without restriction to press reviews. In particular, this means that articles and contributions that qualify as professional advertising must be provided with a suitable technical and password-protected access restriction and may only be made available to HCPs authorised to prescribe, dispense or apply medicinal products (Article 5a OMPA; Swissmedic Journal 8/2006, 800).

In principle, the advertising of all types of medicinal products is allowed if the advertising is directed exclusively at persons who prescribe or dispense them (Article 31 para 1 lit a TPA).

Scientific information on unauthorised medicinal products may be discussed with HCPs if the purpose of the discussion is to provide or obtain scientific input on unauthorised medicinal products or indications, thereby avoiding any promotional activities, and as long as it is clearly stated that the medicinal product, indication, possible application, dosage, pharmaceutical form or packaging has not yet received marketing authorisation from Swissmedic (Article 32 para 1 lit c TPA, Article 5, para 1 OMPA, Sections 26.2 and 26.3 PC; see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medications or Indications). It is therefore important to ensure that any such discussions are conducted with the HCP directly or with the medical department of an HCO, and not with its marketing or sales department.

Information about medicinal products must always be precise, balanced, fair, objective and complete. It must be based on and clearly present a current assessment of all relevant evidence (Section 26.1 PC).

In general, no additional steps or approvals are required before a medicinal product can be promoted after a marketing authorisation by Swissmedic has been received (Article 32 para 1 lit c TPA, Article 5 para 1 OMPA).

Advertising materials and statements for analgesics, sleeping medicinal products, sedatives, laxatives and appetite suppressants directed at the general public must be submitted to Swissmedic for approval prior to publication if the medicinal product information mentions a potential for abuse or dependence (Article 23 para 1 OMPA).

Furthermore, Swissmedic may for a reasonable period request a marketing authorisation holder that seriously or repeatedly violates the provisions on the advertising of medicinal products to submit all drafts of planned advertising in the form specified by Swissmedic for prior review and approval (Article 23 para 2 OMPA).

Marketing authorisation holders must designate a person who is responsible for the advertising of the medicinal products that they have placed on the market. The responsible person must have scientific, medical or other appropriate experience or professional training and must ensure that the promotion of the medicinal products adheres to the relevant regulations and that any directives of Swissmedic are immediately and fully complied with. They are also responsible for providing Swissmedic with all necessary documentation and information upon request. The responsible person must ensure that the company’s pharmaceutical representatives are adequately trained and adhere to the requirements outlined in the OMPA. They furthermore have the duty to maintain records of each advertisement distributed for a period of six months after its last intended use, including details of who received the advertisement, the method of distribution, and the date it was first distributed (Article 25 OMPA).

Pharmaceutical companies that are members of the PC or PCC have to ensure that their personnel who are responsible for the preparation, supervision and approval as well as for the performance of the activities governed by the Codes are familiar and comply with the international codes (IFPMA and EFPIA), the Codes and the relevant provisions of Swiss law (Section 61.2 PC, Section 41 PCC). Every pharmaceutical company must also appoint at least one senior employee who is responsible for supervising the pharmaceutical company and its associated group companies to ensure compliance with the PC and Swiss law (Section 61.2 PC).

Furthermore, pharmaceutical companies have to set up a scientific service which is inter alia responsible for the information about their medicinal products and their promotion (Section 62 PC).

Finally, pharmaceutical companies have to ensure that the activities regulated by the Codes are approved prior to their practical implementation by an expert (responsible person) employed by the pharmaceutical company or instructed by it, who is designated for this purpose (Clause 63 PC, Clause 42 PCC).

Electronic advertising of medicinal products without access restriction qualifies as advertising to the general public (Article 15 lit c OMPA), which is prohibited for prescription medicines (Article 32 para 2 lit a TPA).

When marketing OTC medicinal products on the internet, it is mandatory to include a statement confirming that the product is approved, and to advise consultation with an HCP or to refer to the packaging information (cf. Article 17 OMPA setting out further details).

Any public advertising in electronic media for analgesics, sleeping medicinal products, sedatives, laxatives and appetite suppressants requires pre-approval from Swissmedic, if the information on the medicinal product mentions a potential for abuse or dependence (Article 23 para 1 OMPA, see 6.1 Requirements for Prior Notification/Authorisation of Advertising Materials).

Professional advertising on the internet may not be made publicly available, but rather must be provided with a suitable technical and password-protected access restriction and may only be made available to HCPs authorised to prescribe, dispense or apply medicinal products (Article 5a OMPA). The same applies to media releases and press kits in which direct or indirect reference is made to specific prescription medicinal products. These may only be accessible to media professionals and must be password-protected (Swissmedic Guidelines for the advertising of medicinal products on the internet, 2007/09).

General information on health or diseases is not deemed as advertising as long as it does not directly or indirectly relate to particular medicinal products (Article 1 para 2 lit c OMPA). The distinction between information and advertising is not always easy to make in detail (see 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information).

Virtual scientific meetings are not explicitly regulated in Switzerland. Instead, the general rules on (electronic) pharmaceutical advertising in Switzerland apply (see 7.1 The Advertisement of Medicinal Products on the Internet and 7.2 Restrictions on Access to Websites Containing Material Intended for Healthcare Professionals).

As far as presentations by specialists at virtual scientific meetings include comments about the off-label use of medicinal products or therapies, the transmission of such presentations qualifies as continuing education, and not as pharmaceutical advertising, if the off-label comments are made by an independent speaker at the meeting. Presentations that are broadcast should have the same contents as those presented at a physical event; selective broadcasts would harbour the risk that such a measure becomes a tool for promoting sales of certain medicinal products or therapies and could thus qualify as professional promotion. If this should be the case, all comments about off-label use would have to be removed from the webinar (Code Secretariat, Recommendations for using digital channels, 9).

Virtual scientific meetings may raise complex conflict of laws questions. While the assessment depends on the facts of the individual case, the general recommendation is to structure electronic information or promotional measures to comply with the national regulations for the geographic areas that are the primary target of a virtual scientific meeting, which could mean that such measures have to meet the requirements of several legal systems. The established practice at present appears to be that the websites of country organisations focus on a national audience, while the websites of corporate groups address a wider, more international audience. Thereby, the information should in any case comply with the national law applicable at the pharmaceutical company’s headquarters (Code Secretariat, Recommendations for using digital channels, 3).

The use of social media is not explicitly regulated in Switzerland. Instead, the general rules on (electronic) pharmaceutical advertising in Switzerland apply (see 7.1 The Advertisement of Medicinal Products on the Internet). While it may be technically possible to apply access control to some social media channels, such limitations contradict the inherent nature of social media. Accordingly, particular challenges arise with the prohibition on DTC advertising of prescription medicines (see 7.2 Restrictions on Access to Websites Containing Material Intended for Healthcare Professionals). In context, it is to be noted in particular that DTC advertising must not include endorsements from scientists, HCPs, well-known persons or laypersons such as patients (Article 22 lit g OMPA).

Social media can be accessed from a transparently named business account as well as from the private accounts of employees. If employees are allowed to use their private accounts for business purposes, suitable measures should be implemented (eg, guidelines and training) to ensure that employees do not violate any statutory and self-regulation provisions, including through the use of posts as well as of ‘like’, ‘share’ and ‘comment’ functions. Otherwise, such violations could easily establish a liability on the part of the pharmaceutical company itself (Code Secretariat, Recommendations for using digital channels, 11 et seq).

The use of social media may raise complex conflict of laws questions (see 7.4 Virtual Scientific Meetings).

Switzerland does not have a comprehensive anti-bribery legislation that applies generally to all interactions between pharmaceutical companies and HCPs. Instead, the Swiss anti-bribery legislation consists of four key regulatory layers.

Bribery and Unlawful Inducement Under the TPA

The medicinal product-specific anti-bribery legislation in the TPA applies to undue advantages offered, promised or granted to, and/or claimed or accepted by, persons who prescribe, dispense, use, or purchase for the purpose of prescribing prescription medicinal products, and organisations employing such persons (Article 55 para 1 TPA, TPITO). Put simply, the TPA prohibits the extension of undue advantages to HCP or HCOs relating to the prescription medicinal products (ie, neither OTC products nor medical devices), irrespective of whether the HCP or HCO acts in a public or private capacity, whether the undue advantage qualifies as an act of bribery or merely as an unlawful inducement, and whether the undue advantage directly benefits the HCP or HCO or a third party.

Certain advantages are exempted from the prohibition, including (i) undue advantages of a modest value which are of relevance to medical or pharmaceutical practice, (ii) support for research, education and training (on certain conditions), (iii) consideration for equivalent services, in particular for services provided in connection with orders and deliveries of therapeutic products, and (iv) price discounts or refunds granted on medical purchases, provided they have no influence on the choice of treatment (Article 55 para 2 TPA). The conditions for these exemptions are detailed in the TPITO.

Bribery and Unlawful Inducement Under the SCC

The generally applicable anti-bribery legislation in the Swiss Criminal Code (SCC) is based on the distinction between bribery and unlawful inducement:

• Bribery requires a direct link between the undue advantage and an unlawful conduct or exercise of discretion by a public official or a private auxiliary.
• By contrast, to qualify as unlawful inducement, an undue advantage needs to be only loosely connected to the performance of public duties (ie, granted “in view of” a public office) and can consist of goodwill or “relationship care” payments.

In principle, sanctions under the SCC can relate to both the private and the public sectors. However, while provisions regarding the public sector prohibit both bribery and unlawful inducements (Articles 322 ter to 322 septies, Article 322 decies SCC), the provisions applicable to the private sector apply only to bribery (Article 322 octies to Article 322 decies SCC):

• Public sector provisions apply to public officials, ie, natural persons acting in a public capacity. Notably, public sector provisions under the SCC can apply to physicians acting on behalf of a public hospital or a hospital mandated by the Swiss public health insurance and eligible for public reimbursement (ie, hospitals listed on a cantonal list of hospitals).
• By contrast, HCPs in private practice can be subject to the private sector provisions. These provisions can apply to acts of bribery, but they do not sanction inducements.

Neither the private nor public sector provisions apply to advantages that:

• are permitted under public law or by the respective business principal (eg, the patient or company on whose behalf services are procured);
• represent the fair market value of an arm’s length consideration; or
• are of modest value and are considered socially acceptable, provided they are not offered, promised or granted in return for an unlawful conduct or the exercise of professional discretion. Socially acceptable benefits of modest value may, eg, consist of inexpensive wine or flowers given as a token of appreciation during the holiday season. According to literature, the threshold currently lies at about CHF100 to CHF300. Provided they are not offered, promised or granted in return for an unlawful conduct or the exercise of professional discretion within the meaning of bribery, permitted benefits can consist of customary discounts.

In principle, the sanctions under the SCC target the acting individuals. However, organisations (including HCOs) that fail to take all the reasonable organisational measures required to prevent acts of bribery and/or unlawful inducement can face fines of up to CHF5 million (Article 102 SCC).

Bribery Under the UCA

Mirroring the private sector anti-bribery provisions of the SCC, the UCA prohibits bribery committed by an auxiliary in a private-sector principal-agent relationship (Article 4a UCA). The provision can, eg, apply in case an HCP breaches their professional duty towards a patient by accepting undue advantages for the prescription, use or administration of a specific product from a pharmaceutical company. Violations may give rise in particular to damage claims.

Medical Professional Laws

Federal medical professional law stipulates that physicians, dentists, pharmacists, chiropractors and veterinarians practising under their own professional responsibility must act independently of financial gain and exclusively in the interests of patients when collaborating with members of other healthcare professions (Article 40 lit e MPA). Depending on the severity of a misconduct, violations can lead to disciplinary measures, including a temporary or indefinite ban on practising the profession under one’s own professional responsibility.

Industry Codes of Conduct

The PC sets out in particular the conditions under which pharmaceutical companies can (i) provide benefits to HCPs, HCOs and POs, (ii) support clinical trials, postgraduate medical training and continuing medical education, ensuring that such support does not compromise ethical standards or influence medical decisions, (iii) compensate HCPs, HCOs and POs for contributions of equal value, (iv) conclude consultancy and service contracts with HCPs, HCOs and POs, and (v) interact with POs, ensuring that these collaborations are transparent, are based on actual need, and do not constitute an inducement to use, prescribe or recommend specific medicinal products.

The PCC complements the broader PC by focusing specifically on the cooperation between pharmaceutical companies and HCPs, HCOs and POs, in particular concerning prescription-only medicinal products.

Like the PC, the PCC stipulates that where pharmaceutical companies co-operate with HCPs, HCOs and/or POs, such co-operation and the pecuniary benefits granted in return must not constitute an inducement to recommend, prescribe, acquire, supply, sell or administer specific medicinal products. In principle, the Codes prohibit pharmaceutical companies from offering, promising or granting any inappropriate benefits, including any gifts in cash or in kind, to HCPs, HCOs and POs. Inappropriate benefits do not include (Section 15 PC, Section 15 PCC):

• objects, information and training materials with a value of up to CHF300 per HCP and year provided for HCPs that are intended solely for the medical or pharmaceutical activity or are used for postgraduate or continuing education in medicine or pharmacy and which, in both cases, are also beneficial to patients;
• writing implements and pads of modest value, that are made available to participants at events and that do not bear any references to the pharmaceutical company or to particular medicinal products;
• financial contributions to support research, postgraduate medical training and continuing medical education, provided that the criteria specified in the Codes are met;
• appropriate compensation for contributions of equal value if it has no influence on the choice of treatment;
• delivery of free-of-charge samples of medicinal products to HCPs;
• payments for meals (including beverages) on a reasonable and modest scale, subject to a maximum of CHF100 per HCP per meal and only if it takes place in the context of a technical discussion or in direct relation to an event; or
• donations and grants offered to HCOs or POs (but not HCPs) that are documented and made in support of healthcare, research or medical education, provided they cannot be interpreted as an incentive to recommend, prescribe, acquire, deliver, sell or administer specific medicinal products.

Violations can lead to a resolution proceeding before the Code Secretariat. Depending on the severity of a breach, the Code Secretariat can issue a written summons against the pharmaceutical company. Should the pharmaceutical company fail to comply with the summons, following a warning letter, the Code Secretariat may refer the matter to the appropriate state authority (Section 7 PC, Section 5 PCC).

Medical Professional Codes of Conduct

Medical professional laws are complemented by self-regulatory professional codes of conduct that are adopted by medical associations and are binding upon association members.

For example, Articles 36 to 39 of the Code of Professional Conduct of the FMH regulate gifts, contributions towards training events, and reimbursement of expenses in case patients participate in scientific studies, as well as compensation or advantages for patient referrals. Violations of the Code can have disciplinary consequences for medical professionals, such as the public communication of a misconduct.

Similarly, the SAMW Guidelines for collaboration between medical professionals and industry define professional ethical standards for interactions between medical professionals and the pharmaceutical industry addressed to HCPs in Switzerland.

Gifts or hospitality offered, promised or granted to HCPs by pharmaceutical companies that market prescription-only medicinal products are regulated by the TPA and the TPITO. They may also fall within the scope of the general anti-bribery and inducement provisions of the SCC and of the self-regulation of the industry (PC and PCC; see 8.2 Controls on the Provision by Pharmaceutical Companies of Benefits and/or Inducements to Healthcare Professionals).

Gifts

In order to be permissible, benefits or advantages relating to prescription-only medicinal products must be of:

• modest value; and
• relevance to medical or pharmaceutical practice (Article 55 para 2 lit a TPA, Article 3 TPITO).

To be of modest value, such advantages or benefits must not exceed CHF300 per HCP per year. The cap is set to maintain the integrity of the professional relationship and to ensure that the gifts do not influence medical decision-making.

An advantage is relevant to medical or pharmaceutical practice if it is directly connected with the professional practice or of direct benefit to patients. Accordingly, unlike under the SCC, personal gifts such as inexpensive wines or chocolates are not permitted.

As examples of advantages benefiting professional practice or patients, the regulator lists the following:

• specialist literature and training via electronic media;
• equipment such as thermometers, computer software or mobile phones for emergency services; and
• water coolers or reading matter for the waiting room.

Hospitality and Reimbursement of Expenses

Costs of meals may be covered as compensation for the provision of commensurate services, such as in the context of a professional discussion. As a rule, such compensation must be based on a written agreement setting out the nature and extent of the service and the respective compensation. By way of an exception, no written agreement is required in the context of a specialist discussion, provided the costs covered by the pharmaceutical company do not exceed CHF100 (Article 7 paras 1 and 2 TPITO).

According to the self-regulation of the industry, pharmaceutical companies may not offer or pay for any entertainment or other leisure or hospitality activities (Section 32.5 PC). Furthermore, the self-regulation goes beyond the statute by stipulating that allowances for meals are only permissible in the context of expert discussions and events and are subject to a maximum limit to CHF100 per HCP per meal (see 9.3 Sponsorship of Scientific Meetings).

The provision of sample packs is in principle permitted, but only if the samples are distributed (Article 10 OMPA; cf also Section 28 PC):

• in small quantities per medicinal product, per year and HCP. Swissmedic defines “small quantities” as a limit of up to five sample packs for each HCP annually per medicinal product for a period of two years post-market introduction. From the third year post-market entry, the limit is reduced to a maximum of two sample packs per HCP annually per medicinal product;
• on the initiative of an HCP and at their written request;
• being clearly and permanently labelled as a “free sample”;
• containing the required information and text on the container and packaging material, as well as an approved package leaflet (unless the respective product can legally be placed on the market without a package leaflet);
• with the medicinal product information most recently approved by Swissmedic (alternatively, reference can be made to the public product information directory maintained under the TPA); and
• in the smallest authorised pack size.

The marketing authorisation holder must maintain records of the distribution of sample packs.

The dispensation of sample packs containing drugs classified as psychotropic or narcotic is governed by the specific regulations of the Narcotics Control Ordinance.

HCPs or HCOs may not sell free sample packs to third parties (Article 9 TPITO).

Sponsorships of scientific meetings, ie, contributions towards scientific events that (i) do not constitute a fair-market consideration for services provided by the HCP or HCO (eg, advertising services) (see 9.7 Payment for Services Provided by Healthcare Professionals) and (ii) exceed the threshold for gifts of modest value (see 9.1 Gifts to Healthcare Professionals) provided by pharmaceutical companies marketing prescription-only medicinal products may be made on the following conditions set out in Article 55 para 2 lit b TPA and Articles 4 et seqq TPITO.

Contributions to HCOs

Contributions in support of research, teaching, infrastructure, continuing education and training, and continuing professional development of HCPs (be it in the form of monetary donations or donations of equipment or services) are permitted if they are:

• not offered, promised or given to the HCPs personally, but to the HCO employing the HCPs;
• based on a written agreement which clearly states their intended purpose;
• used exclusively for that intended purpose;
• not subject to conditions or requirements that relate to the prescription, dispensing, use or purchase of certain prescription-only medicinal products;
• credited to a specific account held by the HCO to which HCPs do not have sole access; and
• shown in the HCO’s accounts.

HCOs must decide independently on the form and choice of the continuing education and training and continuing professional development events and on the professionals who participate (Article 5 para 2 TPITO).

Contributions to HCPs

Contributions made directly to HCPs in support of their participation in events for their continuing education and training and continuing professional development are permitted only if:

• they are agreed in writing; and
• the participating HCP or the HCO that employs them in principle makes an appropriate contribution to the costs of the event.

The personal contribution must in principle amount to at least:

• one-third per person attending a continuing professional development event; or
• one-fifth per person attending a continuing education and training event,

of the total (i) registration fees, (ii) travel costs to and from the event, (iii) accommodation and meals, and (iv) costs of activities that are not required to participate in the event (fringe events) and that are clearly of subordinate importance.

A personal contribution to the costs is not required if the participating HCP:

• provides a service in return of equivalent value at the event; or
• is not required to make an overnight stay at the location of the event and the event lasts for no more than half a working day, not including any meal served following the professional part of the event.

The following contributions 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; and
• 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.

According to the self-regulation of the industry, events hosted or supported by pharmaceutical companies in Switzerland and intended exclusively for Swiss attendees should generally be held within the country. Refreshments or meals (including drinks) can be provided only to event participants and should be modest and in line with local norms, with a spending limit of CHF100 per HCP for each meal. The chosen venues for these events should be suitable and focused on the primary objective of the event, avoiding any lavishness (cf Sections 15.4, 31.4 and 32.4 PC, Section 34 PCC, Section 4.3 SAMW Guidelines for collaboration between medical professionals and industry).

The organisation or sponsoring of cultural, sports or other non-scientific events for the benefit of HCPs by pharmaceutical companies that market prescription-only medicinal products is not permitted, unless they form part of an event with the primary purpose of imparting scientific or technical knowledge and unless the non-scientific event is clearly subordinate to the scientific or technical purpose of the main event. The law prohibits any contribution towards the costs of fringe events that are not clearly of subordinate importance to the professional part of the event in which HCPs participate (Article 6 para 4 lit c TPITO, Section 36.3 PC).

Grants or donations which exceed the threshold for gifts of modest value (see 9.1 Gifts to Healthcare Professionals) and which are provided by pharmaceutical companies that market prescription-only medicinal products may only be made as set out below (see also 9.3 Sponsorship of Scientific Meetings).

Grants or Donations to HCOs

Contributions to HCOs in support of research, teaching or infrastructure (be it in the form of monetary donations or donations of equipment or services) are only permitted if they are:

• based on a written agreement which clearly states their intended purpose;
• used exclusively for that intended purpose;
• not subject to conditions or requirements that relate to the prescription, dispensing, use or purchase of certain prescription-only medicinal products;
• credited to a specific account held by the HCO to which HCPs do not have sole access; and
• shown in the HCO’s accounts.

Grants or Donations to HCPs

Contributions in support of research, teaching or infrastructure that are paid directly to HCPs are only permitted in support of the HCPs’ participation in events for their continuing education and training and continuing professional development.

Price discounts or refunds granted on purchases of prescription-only medicinal products are permitted, provided they have no influence on the choice of treatment (Article 55 para 2 lit d TPA). To be considered as not having an influence on the choice of treatment, the discounts must be customary and documented in the pharmaceutical company’s books and records. Conversely, an undue influence is deemed to exist if it can lead to the following:

• an unsuitable prescription-only medicinal product is prescribed, dispensed, used or purchased for this purpose;
• a prescription-only medicinal product is prescribed, dispensed, used or purchased excessively; or
• a prescription-only medicinal product is prescribed, dispensed, used or purchased, although the use of a medicinal product is not indicated (Bundesamt für Gesundheit, Erläuternder Bericht VITH und KVV, 18).

A discount is defined as the difference between the standard price of a product and the price effectively paid in a purchasing transaction. For medicinal products included on the list of specialities, a discount is deemed to have been granted where the price effectively paid is less than the ex-factory price (Article 8 para 1 TPITO).

The delivery of a larger quantity than ordered and invoiced is not permitted (Article 8 para 2 TPITO).

In principle, HCPs must pass on direct or indirect financial advantages (including rebates and discounts) received in the purchase of medicinal products on behalf of patients to the payors (ie, patients or health insurers). With respect to medicinal products covered by statutory health insurance, failure to pass on such benefits can result in criminal sanctions (Article 92 para 1 lit d in conj. with Article 56 para 3 lit b HIA), unless certain conditions for retaining such benefits are met (Article 56 para 3 bis HIA).

Pharmaceutical companies which market prescription-only medicinal products can pay for services provided to them by HCPs or HCOs provided the compensation is:

• commensurate to the services provided by the HCP or HCO; and
• based on a written agreement setting out the nature and extent of the service and the compensation (unless in case of a specialist discussion where costs of meals can be covered up to a maximum of CHF100 without written agreement) (Article 7 paras 1 and 2 TPITO).

Such a compensation is in particular permitted for the following (Article 7 para 4 TPITO):

• costs assumed by HCPs or HCOs in connection with the purchase of prescription-only medicinal products, such as the payment of transport costs or storage costs, or the assumption of storage risks;
• teaching, expert and advisory activities or the conduct of scientific studies and clinical trials;
• reports on practical experiences that are published in a scientifically recognised specialist medium; and
• participation in advisory bodies, workshops or market research projects, provided they have no promotional purpose towards HCP.

By contrast, compensation is considered undue for services that:

• HCPs or HCOs provide for themselves;
• HCPs or HCOs provide in fulfilment of statutory obligations (eg, pharmacovigilance); or
• are otherwise remunerated (such as in case of reimbursement under health insurance) (Article 7 para 3 TPITO).

In principle, no prior authorisations or notifications (eg, employer consent or regulatory authority approval) are required to extend permitted benefits. However, where benefits fall within the scope of anti-bribery and unlawful inducement provisions under the SCC, public law approval (in case of public officials) or the principal’s permission (in case of private-sector bribery) can legalise a benefit that would otherwise be considered inadmissible.

All discounts and refunds provided to HCPs and HCOs that prescribe, dispense or administer therapeutic products (including medicinal products) or purchase such products for such purposes must in principle be accurately recorded in the financial statements of both the seller and buyer and must be disclosed to the Federal Office of Public Health (FOPH) upon request (Article 56 para 1 TPA, Article 10 TPITO). An exemption is provided for OTC medicinal products (ie, medicinal products classified as belonging to Distribution Category E) as well as Class I medical devices within the meaning of the EU Council Directive 93/42/EEC.

As per the self-regulation of the industry, pharmaceutical companies must publicly disclose all monetary benefits given to HCPs and HCOs in Switzerland on an annual basis, ensuring this information remains publicly accessible for a minimum of three years post-disclosure. As a rule, these disclosures should be made individually, clearly specifying the beneficiaries and the sums provided. The self-regulation also stipulates that the payment for agreed-upon services or consultancy work and the reimbursement for incurred costs by service providers should be disclosed distinctly and published on the pharmaceutical company’s website (Sections 24 et seq PCC).

The transparency obligations also apply to foreign companies to the extent that they market medicinal products in Switzerland.

While legislative transparency provisions relating to discounts and refunds do not apply to companies that have not yet placed products on the Swiss market, self-regulatory rules and legislative provisions regarding documentation of sponsorships and services have a broader scope and can apply to companies that have not yet sold but intend to sell (prescription-only) medicinal products.

Swissmedic is the regulatory agency charged with overseeing advertising regulations set forth in the TPA and OMPA. The FOPH is competent for supervising compliance with anti-bribery and unlawful inducement provisions in the TPA and TPITO. Orders issued by Swissmedic or the FOPH can in principle be appealed before the Federal Administrative Court and then further before the Federal Supreme Court.

Self-regulatory provisions of the PC and the PCC are enforced by the Code Secretariat (Section 7 PC, Section 5 PCC).

Competitors seeking enforcement of advertising, transparency and anti-corruption legislation have the following options:

• launching proceedings against competitors by notifying the Code Secretariat tasked with enforcing the PC and the PCC;
• initiating civil law proceedings should the competitor’s behaviour amount to unfair competition under the UCA; or
• notifying regulatory authorities in charge of enforcing the respective legislation of a suspected breach.

Administrative Sanctions

Swissmedic and the FOPH are competent to issue any administrative orders deemed necessary to ensure adherence to the TPA, OMPA and IPITO. Specifically, they may issue warnings, set deadlines to rectify a non-compliant situation, suspend or withdraw licences and marketing approvals, or shut down facilities. These authorities are also empowered to confiscate, securely store or destroy any medicinal products that pose a health risk or fail to meet TPA regulations. They may prohibit the sale, distribution, import, export and international trade of such medicinal products from Switzerland, demand their immediate removal from the market, or issue guidelines to prevent harm. Additionally, they can confiscate, securely store, destroy or ban the use of illegal advertising materials and announce the ban at the cost of the responsible parties. In cases of grave or recurrent violations of the TPA, they may temporarily or permanently halt the advertising of a particular medicine, announcing the ban at the expense of those responsible (Article 66 paras 1 and 2 TPA).

Swissmedic also has the authority to mandate that a marketer of medicines who seriously or repeatedly infringes advertising regulations submit all planned advertising drafts to Swissmedic for a specified period for review and approval before they are published (Article 23 OMPA).

Criminal Sanctions

Breaches of advertising, anti-bribery and transparency legislation can also lead to criminal charges.

Deliberate violations of the anti-bribery provisions set out in the TPA may be sanctioned with a custodial sentence of up to three years or fines (Article 86 para 1 lit h TPA). Unintentional (ie, negligent) breaches may lead to a monetary penalty (Article 86 para 4 TPA).

Additionally, any natural person who commits an offence against the general anti-bribery legislation (Article 322 ter et seq SCC) may face a custodial sentence of up to five years (public sector bribery) or three years (public sector unlawful inducement or private sector bribery).

In principle, penal sanctions apply to the natural persons responsible for the bribes or unlawful inducement. However, organisations (including HCOs) that have failed to take all the reasonable organisational measures required to prevent acts of bribery and/or unlawful inducement under the SCC may face fines of up to CHF5 million (Article 102 SCC). Similarly, a company can be held accountable for breaches of the TPA if a fine of no more than CHF20,000 can be imposed and the investigation of the persons liable to prosecution would require investigative measures that would be disproportionate to the penalty imposed.

A penalty of up to CHF50,000 may be levied on anyone who intentionally violates the transparency requirements set forth in Article 56 TPA or who purposefully disregards the Sections governing the advertising of medicines (Article 87 para 1 lit h and b TPA). Negligent violations may be sanctioned with a penalty of up to CHF20,000 (Article 87 para 3 TPA). A person who deliberately breaches the advertising legislation for commercial gain may face a monetary penalty (Article 87 para 1 lit b and para 2 TPA).

The PC and the PCC specify that pharmaceutical companies bound by these Codes also accept their enforcement provisions in proceedings before the Code Secretariat (Section 7 PC, Section 5 PCC). Generally, while such proceedings are in progress, the Code Secretariat and its signatories will refrain from simultaneously escalating the issue to a governmental body or judicial court based on violations of Swiss law, subject to measures taken to protect interests that could be compromised by adhering to these Codes (Sections 14.2 et seq PC, Section 14.2 et seq PCC).

Historically, Swissmedic has been the primary regulatory authority overseeing breaches in relation to pharmaceutical advertising.

With the entry into force of the TPITO on 1 January 2020, the FOPH has been endowed with authority to enforce the TPITO and respective anti-bribery and transparency provisions. Since the TPITO regime is still fairly new and given textual ambiguities of the new provisions, a comprehensive regulatory practice in enforcing the TPITO has yet to be established.

The Swiss regime for pharmaceutical advertising under the OMPA does not distinguish between medicinal products for human and veterinary use. Medicinal products for veterinary use thus fall under the general regime for medicinal products (Article 1 para 1 OMPA).