Pharmaceutical advertising regulation and medical device advertising in Switzerland

1.1 Medicines

The key statutes regulating advertising and promotion of medicinal products are:

• The Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, "TPA").
• The Federal Ordinance on Advertising for Medicinal Products (“OAMP”).
• The Federal Ordinance on Integrity and Transparency in the context of Therapeutic Products ("OITTP").

In addition, the Unfair Competition Act ("UCA") and the general anti-bribery offences set out in the Swiss Criminal Code may be relevant and restrict advertising activities.

1.2 Medical devices

The key statutes regulating advertising and promotion of medical devices are:

• The Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, "TPA").
• The Federal Medical Devices Ordinance (“MedDO”).

In addition, the Unfair Competition Act ("UCA") and the general anti-bribery offences set out in the Swiss Criminal Code may be relevant and restrict advertising activities.

2.1 Medicines

• Code of Conduct of the Pharmaceutical Industry in Switzerland (Pharma Code).
• Code of Conduct of the Pharmaceutical Industry in Switzerland on cooperation with Healthcare Professional Circles and Patient Organisations (Pharma Cooperation Code).

2.2 Medical devices

• Swiss Medtech Code of Ethical Business Practice.

3.1 The general public

Public advertising in print or electronic media for analgesics, sleeping drugs, sedatives, laxatives and appetite suppressants must be submitted to the Swiss Agency for Therapeutic Products ("Swissmedic") for approval prior to publication, if the information on the medicinal product mentions a potential for abuse or dependence (art. 23 (1) OAMP).

Furthermore, Swissmedic may require a marketing authorisation holder who seriously or repeatedly infringed the provisions on advertising of medicinal products to have all of its advertising materials pre-approved by Swissmedic for an appropriate period of time (art. 23 (2) OAMP).

3.2 Healthcare professionals

No licenses or approvals are required for professional promotion for therapeutic products.

However, in case of serious or repeated infringement(s) of the provisions on advertising of medicinal products, Swissmedic may require the marketing authorisation holder to submit future advertising material to the authority for prior approval (see answer to Q 3.1).

Yes. The distinction is important as different restrictions apply. In particular, advertising of prescription-only medicinal products/medical devices directed at the general public is prohibited, as opposed to OTC medicinal products and medical devices (see answer to Q 5 below).

5.1 Medicines

For both advertising of medicinal products and medical devices, advertising shall be deemed unlawful if it is misleading or contrary to public order and morality (art. 32 (1) (a) TPA). In addition, the Unfair Competition Act also provides relevant provisions on misleading advertising (in particular art. 3 (b), (e) and (i) UCA).

Advertising of medicinal products is only admissible once they have received marketing authorisation from Swissmedic or a cantonal authority (art. 32 (1) (c) TPA).

Advertising is unlawful if it may incite an excessive, abusive or inappropriate use of medicinal products (art. 32 (1) (b) TPA).

Also, advertising of prescription-only medicinal products (i.e. medicinal products in categories A and B) directed at the general public is prohibited (art. 32 (2) (a) TPA).

Advertising of OTC medicinal products (i.e. categories D and E) directed at the general public is regulated in great detail. It is allowed, provided that all information is in accordance with the latest drug information approved by Swissmedic; in particular, only indications and possible uses approved by Swissmedic may be advertised (art. 16 (1) OAMP). The properties of the medicinal product must be presented in a correct manner and without exaggeration (art. 16 (2) OAMP). Advertising must be recognisable as such (clearly separated from mere editorial contributions; art. 16 (3) OAMP).

In deviation of the EFPIA Code of Practice 2019, the use of the term "new" is admissible for a period of 18 months after initial approval of the medicinal product in Switzerland (art. 16 (4) OAMP).

The distribution of sample packs to the general public is also restricted: the samples must be provided free of charge and the sample pack must be marked as “free sample”. Furthermore, they must not contain more than a recommended daily dose. Samples of medicinal products in category D (dispensing after consultation by a specialist) must not be offered for self-service (art. 19 OAMP).

5.2 Medical devices

For both advertising of medicinal products and medical devices, advertising shall be deemed unlawful if it is misleading or contrary to public order and morality (art. 32 (1) (a) TPA). In addition, the Unfair Competition Act also provides relevant provisions on misleading advertising (in particular art. 3 (b), (e) and (i) UCA).

Advertising of medical devices for direct dispensing or for direct use by the general public is restricted to the claims contained in the product information (art. 21 (1) MedDO). This principle is also reflected in art. 69 (1) revised MedDO.

Misleading statements concerning the efficacy and performance of a medical device are prohibited (art. 21 (2) MedDO). Art. 69 (2) revised MedDO specifies that especially misleading statements on the intended purpose, safety and performance of a medical device, are prohibited.

With regard to prescription-only medical devices or medical devices that are placed on the market for exclusive use by professionals, advertising to the general public is prohibited (art. 21 (3) MedDO). Art. 69 (3) revised MedDO stipulates that public advertising is prohibited for medical devices that are intended exclusively for use by professionals.

Art. 69 revised MedDO will enter into force on May 26, 2021 (at the same time as the MDR in the EU).

6.1 Medicines

For both advertising of medicinal products and medical devices, advertising shall be deemed unlawful if it is misleading or contrary to public order and morality (art. 32 (1) (a) TPA). In addition, the Unfair Competition Act also provides relevant provisions on misleading advertising (in particular art. 3 (b), (e) and (i) UCA).

Advertising of medicinal products is only admissible once they have received marketing authorisation from Swissmedic or a cantonal authority (art. 32 (1) (c) TPA).

Advertising is unlawful if it may incite an excessive, abusive or inappropriate use of medicinal products (art. 32 (1) (b) TPA).

All information must be in accordance with the latest drug information approved by Swissmedic; in particular, only indications and possible uses approved by Swissmedic may be advertised (art. 5 (1) OAMP). The statements made must be exact, balanced, factually accurate and verifiable (art. 5 (3) OAMP). Advertising must be recognisable as such (clearly separated from mere editorial contributions; art. 5 (4) OAMP).

In deviation of the EFPIA Code of Practice 2019, the use of the term "new" is admissible for a period of 18 months after initial approval of the medicinal product in Switzerland (art. 5 (6) OAMP).

The distribution of sample packs is only allowed upon initiative and written request of an HCP and only in a small number per product, year and HCP. The sample pack must be marked as “free sample” (art. 10 OAMP).

In addition, Art. 55 TPA provides that persons who prescribe, dispense, use or purchase for such purposes prescription-only medicinal products, and organisations which employ such persons, must not be granted undue advantages. The provision contains a list of advantages that are not considered undue. These are: (i) benefits of modest value relevant to medical or pharmaceutical practice; (ii) support for research, education and training, provided that certain criteria are met; (iii) compensation for equivalent consideration, in particular for orders and deliveries of therapeutic products; (iv) price discounts or refunds granted on the purchase of therapeutic products, provided that they have no influence on the choice of treatment. The details are set down in the Ordinance on Integrity and Transparency in the context of Therapeutic Products.

6.2 Medical devices

For both advertising of medicinal products and medical devices, advertising shall be deemed unlawful if it is misleading or contrary to public order and morality (art. 32 (1) (a) TPA). In addition, the Unfair Competition Act also provides relevant provisions on misleading advertising (in particular art. 3 (b), (e) and (i) UCA).

Advertising of medical devices is restricted to the claims contained in the product information (Art. 69 (1) revised MedDO).

Misleading statements concerning the efficacy and performance of a medical device are prohibited (art. 21 (2) MedDO). Art. 69 (2) revised MedDO specifies that especially misleading statements on the intended purpose, safety and performance of a medical device, are prohibited.

Art. 69 revised MedDO will enter into force on May 26, 2021 (at the same time as the MDR in the EU).

Article 55 TPA (see answer to Q 6.1 above) does currently not apply in the context of OTC medicinal products and medical devices. However, de lege ferenda, advantages related to the prescription, dispensing, use or purchase for such purposes of medical devices will also be governed by Art. 55 TPA and the OITTP. The extent of the expansion of scope of Art. 55 TPA is unclear yet, as the Federal Council can exempt certain MD classes. The amended Art. 55 TPA is not expected to enter into force before 2022.

Moreover, the Swiss Medtech Code of Ethical Business Practice provides for specific rules regarding material benefits granted to HCPs. One of the most important principles is that grants or charitable donations shall no longer be provided to individual HCPs, but directly to the qualifying organisation or entity.

7.1 Medicines

According to art. 6 OAMP, the following information must be included:

• Name of the medicinal product (brand).
• Active ingredient(s) with the official abbreviated designation, should such exist.
• Name and address of the marketing authorisation holder.
• At least one indication or possible use, as well as dosage and method of use.
• Restrictions on use, adverse reactions and interactions.
• Category of the medicinal product determined by Swissmedic.
• Indication that detailed information is to be found in the published product information.
• Withdrawal periods for veterinary medicinal products for food-producing animals.

7.2 Medical devices

There is no obligation to provide any information on the use, performance, efficacy or other characteristics of the medical device. However, if such information is provided, the claims are restricted to those contained in the product information only (Art. 69 (1) revised MedDO).

8.1 Medicines

According to art. 16 (5) OAMP, advertising of medicinal products in categories C and D must contain the following information:

• Name of the medicinal product (brand).
• Name of the marketing authorisation holder.
• At least one indication or possible use.
• The explicit indication that the medicinal product is authorised and that the package leaflet/package information should be read.
• Withdrawal periods for veterinary medicinal products for food-producing animals.

8.2 Medical devices

There is no obligation to provide any information on the use, performance, efficacy or other characteristics of the medical device. However, if such information is provided, the claims are restricted to those contained in the product information only (art. 21 (1) MedDO and Art. 69 (1) revised MedDO).

9.1 Medicines

• Professional promotion: According to art. 5 (5) OAMP, the advertising statements of medicinal products must be based on and reflect the current state of scientific knowledge. They may only refer to clinical trials 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 recognised scientific medium. These publications must be quoted verbatim, in full and with the exact source.
• Promotion directed at the general public: According to art. 22 (g) OAMP, advertising must not mention or refer to scientific publications, clinical studies, expert opinions, certificates or recommendations made by scientists, HCPs, well-known personalities or medical-pharmaceutical laypersons.

9.2 Medical devices

It can be deduced from the prohibition of misleading advertising that promotional advertising claims must be in accordance with the clinical evaluation or testing of a medical device (if performed at all).

10.1 Medicines

• Professional promotion: Art. 7 OAMP provides that comparisons with other medicinal products are admissible if scientifically correct and based on equivalent clinical trials or data collection fulfilling the requirements of art. 5 (5) OAMP (for these requirements see answer to Q 9.1 above).
• Promotion directed at the general public: Comparative advertising is allowed within the limits of art. 22 (c) OAMP. According to this provision, advertising that creates the expectation that the effect of a medicinal product corresponds to, or is superior to, another treatment or to another medicinal product is prohibited.

10.2 Medical devices

The MedDO does not provide for specific rules. However, art. 3 (e) UCA applies, according to which comparisons of goods must be made in a correct manner.

11.1 Medicines

• Promotion directed at the general public: For advertising of medicinal products in categories C and D in electronic media, a special note stating that the product is an authorised product and that a specialist may be asked/the package information should be read must be displayed/inserted. Furthermore, specifications regarding the design and the font size must be observed (art. 17 OAMP). In addition, public advertising in print or electronic media for analgesics, sleeping drugs, sedatives, laxatives and appetite suppressants must be submitted to Swissmedic for approval prior to publication, if the information on the medicinal product mentions a potential for abuse or dependence (art. 23 (1) OAMP; see also answer to Q 3.1).
• Professional promotion: Such advertising may not be made publicly accessible on the Internet. It must be provided with suitable technical and password-protected access restrictions to ensure that it is only made available to HCPs (art. 5a OAMP).

11.2 Medical devices

There are no specific regulations for medical devices advertised on the Internet. The general rules apply.

The TPA provides for administrative measures as well as administrative criminal measures in case of an infringement.

Administrative measures: Among other measures, Swissmedic and the Federal Office of Public Health may confiscate inadmissible advertising media and hold in official storage, destroy or prohibit them. In the event of serious or repeated infringements of advertising regulations, advertising for a particular therapeutic product may be temporarily or permanently prohibited and the prohibition may be made public at the expense of those responsible (see art. 66 (2) (f) and (g) TPA).

Furthermore, Swissmedic may require a marketing authorisation holder who seriously or repeatedly infringed the provisions on advertising of medicinal products to have all of its advertising materials pre-approved by Swissmedic for an appropriate period of time (art. 23 (2) OAMP).

Administrative criminal measures: The Federal Office of Public Health is the authority in charge of prosecuting the rules on inducement (art. 55 TPA). Infringements against art. 55 TPA are punished with a custodial sentence of up to three years or a monetary penalty (art. 86 (1) (h) TPA).

Note that the Swiss Pharma Code and the Swiss Pharma Cooperation Code were revised on May 14, 2020. The revisions will come into effect on January 1, 2021.

Furthermore, the prohibition of promising and accepting undue advantages (Art. 55 TPA) will de lege ferenda also be relevant for medical devices companies (see answer to Q 6.2). The revised law and ordinance is not expected to enter into force before 2022.

Switzerland adapts it medical devices rules to the new EU regulations (the MDR and IVDR) by revision of the Medical Devices Ordinance (see answers to Q 5.2 and 6.2) and by issuing a new Ordinance on Clinical Trials with Medical Devices. The revised MedDO and the new Ordinance on Clinical Trials with Medical Devices will, in alignment with the MDR and IVDR, be applicable from May 26, 2021.