Pharmaceutical advertising regulation and medical device advertising in South Africa

1.1 Medicines

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

1.2 Medical devices

• Medicines Act;
• Medicines Act Regulations;
• SAHPRA Medicines Advertising Guideline;
• Hazardous Substances Act, 1973 (“HSA”); and
• CPA. 

Yes, in addition to the Medicines Act, the HSA, the SAHPRA Medicines Advertising Guideline and Medicines Act Regulations, there are codes of conduct that are widely recognized nationally for purposes of the advertisement of medicines and medical devices such as:

2.1 Medicines 

• The 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; and 

2.2 Medical devices

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

There are no express licenses/approvals/fees required for advertisements of medicines and medical devices. However, in terms of the Medicines Act Regulations, medicines which contain a substance classified under schedules 2, 3, 4, 5 and 6 may only be advertised for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers (“Medical Practitioners”). However, the Medicines Act Regulations states that advertising to Medical Practitioners shall not be so construed as to prohibit informing the public of the prices, names, pack sizes and strengths of medicines which contain a substance appearing in schedule 2, schedule 3, schedule 4, schedule 5 or schedule 6 provided that no reference or inference is made to the registered indication. (see: Regulation 42)

Further, the distribution of medicine requires a licence that must be obtained from SAHPRA. SAHPRA issues licences to wholesalers, importers and retailers of medicines.     

Yes. In terms of regulation 42(1) of the Medicines Act Regulations, only over the counter medicines or non-prescriptive medicines may be advertised to the public. However, medicines in schedule 1 of the Medicines Act Regulations, although not obtained through a prescription, may only be dispensed by a pharmacist etc.

In terms of regulation 42 (2) of the Medicines Act Regulations, prescription-only medicines may only be advertised for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners and any other Medical Practitioners or in a publication only available to Medical Practitioners.

However, the sale of over-the-counter medicines to consumers is restricted to pharmacists who are licensed and registered under the provisions of the Pharmacy Act, 1974; and persons licensed under the provisions of section 22C of the Medicines Act or under section 22A(15), such as optometrists, paramedics and nursing professionals. 

5.1 Medicines

In terms of the Medicines Act Regulations:

• no advertisement for a medicine may contain a statement which deviates from, with or goes beyond the evidence submitted in the application for registration of such medicine with regard to its safety, quality or efficacy where such evidence has been accepted by SAHPRA in respect of such medicine and incorporated into the approved professional information of such medicine;
• where the medicine has not received registration with SAHPRA the following disclaimer should be included in the advertisement: "This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use."

In terms of the Medicines Act:

• no person shall advertise any medicine or scheduled substance, medical device or In Vitro Diagnostic Medical Devices (“IVD”) for sale unless such advertisement complies with the prescribed requirements; and
• prohibits the publication or distribution of any false or misleading advertisement relating to any medicine.

In terms of the SAHPRA Medicines Advertising Guidelines:

• no person or media shall advertise any scheduled medicines unless the product is registered with SAHPRA;
• no person or media shall advertise any registered product that has undergone some variation and the amendment has not been approved by SAHPRA;
• an advertisement shall be accurate, complete, clear and designed to promote credibility and trust by the general public and health practitioners. Statements or illustrations must not mislead directly or by implication;
• no advertisement shall bring the respective industry into disrepute, undermine confidence in advertising or prejudice public confidence in the product;
• no advertisement shall disparage any product of a competitor, either directly or by implication; and
• no advertisement shall imitate the general layout, text, slogans or visual presentation or devices of other advertisements from other companies in a way likely to mislead, deceive or confuse the consumer and / or health practitioners.

In terms of the CPA:

• a producer or service provider may not market, or rather advertise goods in such a way that may imply false or misleading representation or in a manner that is misleading, fraudulent or deceptive, including in respect of the nature, properties, advantages or uses of the goods or services; and
• a supplier of goods must not advertise goods as being available at a certain price in a way that may result in consumers being misled or deceived.        

5.2. Medical devices

• In terms of the Medicines Act, no person shall advertise any medicine or Scheduled substance, medical device or IVD for sale unless such advertisement complies with the prescribed requirements.
• In terms of the Code of Advertising Practice published by the Advertising Regulatory Board of South Africa (“Advertising Codes”), no advertisement will be accepted for any smoking deterrent unless the advertiser makes clear that the product offers only assistance and not a cure, and that its success will be dependent upon the willpower of the user.
• See response to 5.2 above on advertising of goods in terms of the CPA. 

6.1 Medicines

• In terms of the Medicines Act Regulations, medicines which contain a substance classified under schedules 2, 3, 4, 5 and 6 may only be advertised for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other Medical Practitioners. However, the Medicines Act Regulations state that advertising to Medical Practitioners shall not be so construed as to prohibit informing the public of the prices, names, pack sizes and strengths of medicines which contain a substance appearing in schedule 2, schedule 3, schedule 4, schedule 5 or schedule 6 provided that no reference or inference is made to the registered indication.
• In terms of the SAHPRA Medicines Advertising Guidelines:
  • no person or media shall advertise any scheduled medicines unless the product is registered with SAHPRA;
  • no person or media shall advertise any registered product that has undergone some variation and the amendment has not been approved by SAHPRA;
  • an advertisement shall be accurate, complete, clear and designed to promote credibility and trust by the general public and health practitioners. Statements or illustrations must not mislead directly or by implication;
  • no advertisement shall bring the respective industry into disrepute, undermine confidence in advertising or prejudice public confidence in the product;
  • no advertisement shall disparage any product of a competitor, either directly or by implication; and
  • no advertisement shall imitate the general layout, text, slogans or visual presentation or devices of other advertisements from other companies in a way likely to mislead, deceive or confuse the consumer and / or health practitioners.

6.2 Medical devices

• Same as medicines 

7.1  Medicines

In terms of the Medicines Act Regulations:

An advertisement for medicines shall contain:

• the proprietary name of such medicine;
• in the case of a written advertisement:
  • the approved name and quantity of each active ingredient of such medicine in lettering having minimum legibility. Provided that, in the case of a medicine containing only one active ingredient, such lettering shall be not less than one half the size of the largest lettering used for the said proprietary name;
  • registration number of the medicine;
  • in the case of old medicines, the reference number allocated to such medicine followed by the words "Act 101/1965"; and
  • where another name other than the proprietary name is also used, such other name shall be in lettering half the size of the largest type size in which the proprietary name appears in such advertisement; and 

for:

• veterinary medicine, the medicine must state that it is for veterinary use only;
• complementary medicine:
  • a statement providing the discipline whether the medicine is relevant;
  • an indication that the medicine must be used in accordance with the complementary discipline; and
  • the following disclaimer if the medicine is not registered "This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use".

When a medicine is advertised verbally for the first time, the printed professional information must be available and also provided for subsequent events. 

7.2 Medical devices

• Same as medicines mutatis mutandis
• In terms of the Advertising Codes, no advertisement will be accepted for any smoking deterrent unless the advertiser makes clear that the product offers only assistance and not a cure, and that its success will be dependent upon the willpower of the user. 

8.1 Medicines 

See response to Question 7.1

8.2 Medical devices 

See response to Question 7.1 

• The Medicines Act, Medicines Act Regulations and codes of conduct/practice do not contain express requirements in relation to the standard of evidence requirements for purposes of supporting any scientific claims which may be made on medicines and/or medical devices.
• However, in terms of the SAHPRA Medicines Advertising Guideline, an advertisement for medicine and/or medical devices "shall be accurate, complete, clear and designed to promote credibility and trust by the general public and heal practitioners. Statements or illustrations must not be misleading directly or by implication."

• Currently, national legislation does not regulate comparative advertising of medicines and medical devices.
• The South African Marketing Code provides that comparisons in advertisements for health products is only permissible in promotion material if:
  • it is not misleading or disparaging;
  • the comparison is against health products or services for the same needs or intended purpose;
  • one or more material, relevant and representative features which is capable of substantiation is compared;
  • no confusion is created from the comparison;
  • there is no unfair advantage taken of the reputation of a brand against which it is compared; and
  • the health care products are not represented as replicating or imitating good of another brand.
• However, open ended comparisons are prohibited. 

South African Marketing Code provides, inter alia, that health products can be advertised on the internet, subject to the same restrictions stated above, which generally apply to advertisements, as well as in a relevant independent electronic journal intended for Medical Practitioners or appropriate administrative staff which cannot be accessed by non-Medical Practitioners.

SAHPRA monitors compliance with the advertisement provisions contemplated in the Medicines Act.

Section 29 of the Medicines Act provides that any person who is contravention of the provisions of the Medicines Act or fails to comply with the provisions of the Medicines Act, make false or misleading statement about any health products or sell or dispense any medicine shall be guilty of an offence.

Section 30 provides that any person who is found to be guilty of an offence in terms of section 29 will be liable to either a fine or imprisonment of a period not exceeding 10 years. The court considering or convicting any person as referred to in section 29, may declare any medicine or medical device in respect of which the offence has been committed to be forfeited to the government. Any forfeited medicine or medical device may be destroyed as the Chief Executive Officer of the South African Health Products Regulatory (appointed in terms of section 3 of the Medicines Act) may direct and a magistrate's court shall be competent to enforce the penalties under section 30. 

On 24 March 2023, draft proposed amendments to the Medicines Act Regulations were published by the Minister of Health ("Proposed Amendments"). The Proposed Amendments are intended to substitute the current definition of complementary medicine to further include Category D medicine, which is defined to include discipline-specific medicines for humans, veterinary discipline-specific medicines for animals, health supplements for humans and veterinary health supplements for animals. Further, the Proposed Amendments provide that veterinary medicine needs to be specific in respect of the discipline of the medicine or that it is a veterinary health supplement and that it is a complementary medicine. These Proposed Amendments were made following the judgment made by the Supreme Court of Appeal in Minister of Health and Another v Alliance of Natural Health Products 256/2021 [2022] ZASCA 49, where the court held that certain provisions of the Medicines Act Regulations were unconstitutional as they are too wide/broad and included certain products, such as water, that are not medicine.