Pharmaceutical advertising regulation and medical device advertising in Switzerland

  1. 1. Which laws are applicable regarding advertising of medicines and medical devices?
  2. 2. Are there any other legal regimes such as self- regulatory codes of conduct that govern the advertising of medicines and medical devices?
  3. 3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?
  4. 4. Does the law in Switzerland regulate the advertising of prescription-only and over-the-counter medicines differently?
  5. 5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?
  6. 6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?
  7. 7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?
  8. 8. What information must appear in advertisements directed to the general public for medicines and medical devices?
  9. 9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?
  10. 10. Are there specific rules for comparative advertisement of medicines and medical devices?
  11. 11.Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?
  12. 12.Please describe the enforcement mechanism. Which bodies monitor compliance with the advertisement provisions and what are the legal consequences (e.g. penalties) for non-compliance?
  13. 13. Any future developments in Switzerland? 

1. Which laws are applicable regarding advertising of medicines and medical devices?

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. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?

3.1 The general public 

Public advertising for certain medicinal products such as 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 there is a potential for abuse or dependence. 

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. 

3.2 Healthcare professionals 

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

4. Does the law in Switzerland regulate the advertising of prescription-only and over-the-counter medicines differently?

Yes. In Switzerland, any advertising of prescription-only medicines to the general public is prohibited. By contrast, advertising of over-the-counter (OTC) medicines is permitted, subject to some further restrictions described below (see answer to Q 5.1) 

5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?

5.1 Medicines 

Advertising for medicines shall be deemed unlawful if it is misleading or contrary to public order and morality (art. 32 (1) (a) TPA).  Therefore, promotional claims must be based on sufficient and reliable scientific evidence, in particular if the claims relate to the therapeutic efficacy. The data/study that justifies the claim should be mentioned (e.g. in a footnote). The reference must be complete, correct and able to serve as scientific evidence. The statements must correspond to the currently valid version of the professional information approved by Swissmedic. 

Advertising  for medicines is only admissible once they have received marketing authorisation from Swissmedic or a cantonal authority. This applies also to new indications, applications, dosages, pharmaceutical forms and packaging of a medicine. 

Advertising is unlawful if it may incite an excessive, abusive or inappropriate use of medicinal products. 

Advertising of OTC medicines is permitted, provided that all information is in accordance with the latest product information approved by Swissmedic; in particular, only indications and possible uses approved by Swissmedic may be advertised. The properties of the medicinal product must be presented correctly and without exaggeration. Advertising must be recognisable as such (clearly separated from mere editorial contributions. On the other hand, any intrusive or blatant advertising or advertising that gives the impression of being editorial is prohibited. The same applies to the direct dispensing of medicinal products for the purpose of sales promotion or the distribution of vouchers or the organisation of competitions. 

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.. 

5.2 Medical devices 

For the advertising of medical devices only claims shall be made that correspond to the product information. Misleading statements, in particular about the intended purpose, safety and performance of a product are prohibited. 

Advertising to the public is prohibited for medicinal devices that are intended exclusively for use by healthcare professionals.

6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

6.1 Medicines 

Advertising for medicines shall be deemed unlawful if it is misleading or contrary to public order and morality. Statements in the professional promotion must be supported by evidence. They must not be misleading through inappropriate emphasis or omission. Statements about adverse reactions must reflect the current state of knowledge. 

6.2 Medical devices

Advertising medical devices is unlawful if it is misleading. Advertising of medical devices is restricted to the claims contained in the product information. It may not contain misleading or contradictory statements on the intended purpose, safety, efficacy or performance of a medical device. 

7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?

7.1 Medicines 

The following information must be included in advertisements for healthcare professionals, if the products are prescription only medicines:

  • 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 legal provision that regulates the content of an advertisement for medical devices. 

8. What information must appear in advertisements directed to the general public for medicines and medical devices?

8.1 Medicines 

The following information must be included in advertisements for the general public: 

  • 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 legal provision that regulates the content of an advertisement for medical devices. 

9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?

9.1 Medicines

  • Prescription medicines: the advertising for prescription medicines must reflect the current state of scientific knowledge. The statement 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.
  • OTC: 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 

The advertising claims for medical devices must be in accordance with the clinical evaluation or testing of a medical device. 

10. Are there specific rules for comparative advertisement of medicines and medical devices?

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.Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?

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).

13. Any future developments in Switzerland? 

In 2025 the Federal Council is expected to amend the Ordinance on Integrity and Transparency in relation to Therapeutic Products of 10 April 2019 (TPITO) so that its scope is no longer limited to prescription medicines, but applies also to medical devices. The parliament has empowered the Federal Council to exempt certain categories of medical devices from the prohibition of promising and accepting undue advantages (Art. 55 TPA).

Portrait ofPatrick Sommer
Dr Patrick Sommer, H.E.E.
Partner
Zurich
Christoph Willi