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?

Medicines

Medicines and Related Substances Act, 1965 ("Medicines Act")
Medicines Act General Regulations, 2017 ("Medicines Act Regulations")
Guidelines for Advertisement of Medicines and Health Products ("SAHPRA Medicines Advertising Guidelines") by the South African Health Products Regulatory Authority ("SAHPRA")
Consumer Protection Act, 2008 ("CPA")

Medical Devices

Medicines Act
Medicines Act Regulations
SAHPRA Medicines Advertising Guidelines
Hazardous Substances Act, 1973 ("HSA")
Consumer Protection Act, 2008 ("CPA")

2. Are there any additional legislative frameworks or self-regulatory codes of conduct?

In addition to the Medicines Act, the HSA, the SAHPRA Medicines Advertising Guidelines, and the Medicines Act Regulations, there are nationally recognized codes of conduct governing the advertisement of medicines and medical devices.

2.1 Medicines

South African Code of Practice for the Marketing of Health Products by the Innovative Pharmaceutical Association of South Africa
South African Code of Marketing Practice for Health Products ("South African Marketing Code") by the Marketing Code Authority

2.2 Medical Devices

Medical Device Code of Ethical Marketing and Business Practice by the South African Medical Technology Industry Association

3. What licenses, approvals, or fees are required for advertising?

No express licenses, approvals, or fees are required specifically for advertising medicines and medical devices. However, certain regulations apply.

Medicines containing substances classified under schedules 2–6 may only be advertised to specific healthcare professionals.
Public information may include prices, names, pack sizes, and strengths, but not registered indications.
Distribution of medicines requires a license from SAHPRA.

4. Does South African law govern prescription and over-the-counter medicines differently?

According to regulation 42(1) of the Medicines Act Regulations, only over-the-counter or non-prescription medicines may be advertised to the public.

Medicines listed in schedule 1 of the Medicines Act Regulations, although available without a prescription, may only be dispensed by a pharmacist.

Under regulation 42(2), prescription-only medicines may only be advertised for informational purposes to pharmacists, medical practitioners, dentists, veterinarians, and other healthcare professionals, or in publications accessible exclusively to medical practitioners.

The sale of over-the-counter medicines to consumers is restricted to licensed pharmacists under the Pharmacy Act, 1974, and individuals licensed under section 22C or section 22A(15) of the Medicines Act.

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

5.1 Medicines

Medicines Act Regulations

Advertisements must not deviate from evidence submitted for registration regarding safety, quality, or efficacy.
Unregistered medicines must include the disclaimer: “This unregistered medicine has not been evaluated by SAHPRA for its quality, safety, or intended use.”
False or misleading advertisements are prohibited.

SAHPRA Medicines Advertising Guidelines

Scheduled medicines must be registered with SAHPRA.
No advertising of unapproved variations.
Advertisements must be accurate, complete, clear, and non-misleading.
Advertisements must not disparage competitors or undermine public trust.
Imitation of other advertisements in a misleading manner is prohibited.

Consumer Protection Act

Advertising must not falsely or misleadingly represent goods or services.
Misleading pricing claims are prohibited.

5.2 Medical Devices

Under the Medicines Act, no person may advertise any medical device or IVD unless the advertisement complies with prescribed requirements.

According to Advertising Codes published by the Advertising Regulatory Board of South Africa, advertisements for smoking deterrents must clearly state that the product provides assistance only and is not a cure.

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

6.1 Medicines

Only registered scheduled medicines may be advertised.
Advertisements must be accurate, complete, and clear.
Advertisements must not undermine confidence in the industry.
Comparative advertising that disparages competitors is prohibited.
Imitation of competitor advertising is prohibited.

6.2 Medical Devices

Medical devices must comply with registration requirements.
Unapproved variations may not be advertised.
Advertisements must not mislead or undermine public trust.
Comparative and imitative advertising is prohibited.

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

7.1 Medicines

Proprietary name of the medicine
Approved name and quantity of each active ingredient in legible lettering
Registration number or reference number with “Act 101/1965”
Any additional name must be in lettering half the size of the proprietary name

Additional Requirements

Veterinary medicines must state “for veterinary use only”
Complementary medicines must state the relevant discipline
Unregistered medicines must include the SAHPRA disclaimer
Printed professional information must be available after verbal advertising

7.2 Medical Devices

Proprietary name of the medical device
Technical specifications and intended use
Registration details
Applicable warnings and usage instructions

8. What information must be included in public-facing advertisements?

8.1 Medicines

The same requirements apply as for healthcare professional advertisements.

8.2 Medical Devices

The same requirements apply as for medicines.

9. Constraints on data supporting promotional claims

Data must be accurate, comprehensive, and clear.
Statements must not be misleading, directly or indirectly.

10. Rules governing comparative advertising

Comparative advertising must not be misleading or disparaging.
Comparisons must relate to similar products and purposes.
Comparisons must be based on relevant and verifiable features.
No confusion or unfair exploitation of brand reputation is allowed.

11. Internet and social media advertising

Health products may be advertised online subject to general advertising restrictions and only in appropriate electronic journals accessible to healthcare professionals.

12. Oversight bodies and legal consequences

SAHPRA oversees compliance with advertising provisions under the Medicines Act.

Contraventions may result in fines or imprisonment of up to 10 years.

Courts may order forfeiture and destruction of medicines or medical devices involved in violations.

13. Future developments in South Africa

Draft amendments published on 24 March 2023 aim to refine definitions of complementary medicine and address issues identified by the Supreme Court of Appeal.

How can OMC help?

Professional review of marketing and advertising materials with reports
Support in obtaining authority approvals where required
Translation of marketing materials by a professional translation agency certified with ISO 17100