Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which laws apply when it comes to promoting medicines and medical devices?

1.1 Medicines

Therapeutic Products Act (TPA)
Ordinance on Advertising for Medicinal Products (OAMP)
Ordinance on Integrity and Transparency in the context of Therapeutic Products (OITTP)
Unfair Competition Act (UCA)
Swiss Criminal Code (anti-bribery provisions)

1.2 Medical Devices

Therapeutic Products Act (TPA)
Medical Devices Ordinance (MedDO)
Unfair Competition Act (UCA)
Swiss Criminal Code (anti-bribery provisions)

2. Are there any additional legislative frameworks, such as self-regulatory codes of conduct, that control the advertising of pharmaceuticals and medical devices?

2.1 Medicines

Pharma Code: Code of Conduct of the Pharmaceutical Industry in Switzerland
Pharma Cooperation Code: Code on cooperation with Healthcare Professional Circles and Patient Organizations

2.2 Medical Devices

Swiss Medtech Code of Ethical Business Practice

3. What licenses, approvals, or fees are required for advertising medications and medical devices to the general public and healthcare professionals?

3.1 General Public

Medicines: Public advertising for certain medicines (e.g., analgesics, sleeping drugs, sedatives, laxatives, and appetite suppressants) must be approved by Swissmedic. Repeat infringers may need pre-approval for all advertising materials.

3.2 Healthcare Professionals

Medicines: No licenses or approvals are required for professional promotion.

4. Does Swiss law govern the advertisement of prescription and over-the-counter medications differently?

Prescription-Only Medicines: Advertising to the general public is prohibited.
Over-the-Counter (OTC) Medicines: Advertising is permitted with restrictions.

5. What are the primary limits on promoting drugs and medical devices to the public?

5.1 Medicines

Lawfulness: Advertising is unlawful if misleading or contrary to public order and morality. Claims must be substantiated with reliable scientific evidence and align with Swissmedic-approved professional information.

Marketing Authorization: Medicines may only be advertised after receiving authorization from Swissmedic or a cantonal authority, including for new uses, dosages, or forms.

Prohibitions:

Encouraging excessive or inappropriate use
Disguised or intrusive advertising not clearly identifiable as advertising
Direct sales promotion through free samples or vouchers; sample packs must be marked “free sample” and limited to a daily dose

OTC Medicines: Advertising must reflect the latest approved product information without exaggeration. Only approved indications and uses may be promoted.

5.2 Medical Devices

Advertising must reflect accurate product information
Misleading statements regarding purpose, safety, or performance are prohibited
Devices intended solely for healthcare professionals must not be advertised to the general public

6. What are the primary limits on promoting drugs and medical devices to healthcare professionals?

6.1 Medicines

Advertising must not be misleading
Claims must be supported by evidence
Information must reflect the current state of scientific knowledge
Adverse reactions must be accurately represented

6.2 Medical Devices

Advertising must not be misleading
Claims must correspond to approved product information

7. What is the required information for advertisements directed only at healthcare professionals?

7.1 Medicines

Brand name
Active ingredient(s)
Marketing authorisation holder’s name and address
At least one indication or use, dosage, and method of administration
Restrictions, adverse reactions, and interactions
Product category
Reference to detailed product information
Withdrawal periods for veterinary medicines

7.2 Medical Devices

No specific legal provisions define mandatory content requirements.

8. What information must be included in public-facing advertisements for drugs and medical devices?

8.1 Medicines

Brand name
Marketing authorisation holder’s name
At least one indication or use
Indication that the product is authorised and that the package leaflet should be read
Withdrawal periods for veterinary medicines

8.2 Medical Devices

No specific legal provisions define mandatory content requirements.

9. Are there any constraints on the data used to support promotional claims?

9.1 Medicines

Prescription Medicines:

Advertising must reflect the latest scientific knowledge
Claims must reference clinical trials or data collections published or accepted for publication
Good Clinical Practice guidelines must be followed
References must be quoted verbatim and fully cited

OTC Medicines:

Advertising must not reference scientific publications, clinical studies, or endorsements
Endorsements by experts, healthcare professionals, celebrities, or laypersons are prohibited

9.2 Medical Devices

Advertising claims must align with the device’s clinical evaluation or testing results.

10. Are there any rules governing comparative advertising of drugs and medical devices?

10.1 Medicines

Professional Promotion:

Comparisons are permitted if scientifically accurate and based on equivalent clinical trials or data collections in accordance with Art. 7 and Art. 5(5) OAMP.

Promotion to the General Public:

Comparative advertising is permitted under Art. 22(c) OAMP but must not suggest equivalence or superiority over other medicines or treatments.

10.2 Medical Devices

The MedDO contains no specific comparative advertising rules. Comparisons must be accurate and fair in line with Art. 3(e) UCA.

11. Are there special guidelines for advertising drugs and medical devices on the internet or social media?

11.1 Medicines