In addition to the laws that apply to the advertising of medicines, the Marketing Code Authority’s (“the MCA”) South African Code of Marketing Practice for Health Products Code and Guideline, July 2023 (“the MCA Code”) applies to members of the MCA.

The Advertising Regulatory Board’s (“the ARB”) Code of Advertising Practice (“the ARB Code”) applies to advertisers, advertising practitioners, media owners, government departments/agencies, non-commercial organisations, and to individuals who consent to its jurisdiction.

Gifts and monetary payments

The MCA Code provides that no gift may be offered to HCPs as a means of inducement.

Medical and educational goods and services intended for patient care and enhancement may be offered at a value to be determined by the MCA Board from time to time, but cannot be for personal benefit.

The value of scientific medical reference books/journals and periodicals given to HCPs or healthcare practices should not exceed ZAR3 000 (inclusive of VAT) per year.

The value of medical devices should not exceed ZAR300 (inclusive of VAT) per item and is capped at ZAR3 000 (inclusive of VAT) per practice per year.

Items of general utility/occasional items may be provided. They must be of modest value and enhance patient services and care. If branded, they must include the proprietary name of the product, an indication that the name of the product is a trademark, and the company name/logo and/or the product logo.

Anatomical models, medical textbooks, pens and diaries may be provided. The value of the item should not exceed ZAR300 (inclusive of VAT). These items may be offered only occasionally.

HCPs can accept items that form part of a package deal for patients. The transaction must be fair and reasonable. The items must be inexpensive and modest in value. Cash or cash equivalents are not permitted.

A single inexpensive gift per year, unrelated to the HCP’s practice in recognition of national, cultural or religious days, the value of which is determined by the MCA Board from time to time may be gifted.

Providing samples to HCPs

Section 18(B)(1) of the Medicines Act states that no person may sample any medicine.

“Sample”, means the free supply of medicines by a manufacturer or wholesaler or its agent to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974.

Free supply of medicines for clinical trials and donations of medicines to the State are permitted.

According to the draft Bonusing and Sampling Regulations incentive schemes are prohibited if achieved through providing samples.

Sponsored events and congresses

HCPs may be sponsored to attend local or international scientific meetings or congresses to facilitate better patient care and outcomes.

A written agreement must be concluded with the company. Sponsorship must not depend on the HCP prescribing, dispensing or administering the product.

Registration fees, travel, accommodation, and hospitality costs may be covered. Payment must be made to the professional associations/organisers/administrative staff organising the event, and not directly to the HCP unless proof of costs incurred is provided. Time spent is not paid for. Costs of spouses or guests attending are not covered.

Documented criteria must determine which HCPs should be sponsored and a final determination is made by the Company’s Code Compliance Officer. The rationale for attendance must be transparent, valid and cogent.

The programme must be the main attraction. Associated events must be subordinate to the sponsored event. Sponsorship of congress-organised events, other than recreational and sporting events, is permitted. The event must be appropriate to the area of the HCP’s expertise. HCPs must not be involved in direct promotion of products.

The program must be made available at least sixty days before the event. It must contain sufficient information to enable an evaluation of the scientific value of the sessions. HCPs must familiarise themselves with the products and must be aware of the obligation not to promote unapproved products.

Promotional events may only be attended by HCPs who have an interest in the information. Restraint must be exercised on the frequency and volume of promotional material distributed.

Payment for participation in events

Companies may engage HCPs to partake in events involving medical/scientific studies, training, advisory boards, clinical trials, market research, educational material/software/programs, and developing/managing patient compliance software/programs.

HCPs may be paid a fee-for-service/honorarium, reimbursed for travel, and provided with hospitality. Loss of income cannot be reimbursed. A written agreement must specify the services and payment details.

The HCP must provide a written undertaking, when consulting, speaking, advising and preparing written material on behalf of the company, to declare their relationship with the company. HCPs employed part time by companies but practising for their own account must declare their employment arrangements to the company.

The company must have a need for the services. Those selecting the HCPs must have the expertise to identify appropriate HCPs. The company must maintain records of the services provided.

If the HCP attends an event locally or internationally, the provisions of the MCA Code apply regarding payment of a fee-for-service/honorarium or reimbursement of costs. Payments may not be made to HCPs for rental of rooms or renting other services.

Grants and donations for healthcare research

According to the MCA Code, grants and donations can be made in monetary terms/in kind to healthcare institutions in support of healthcare research. Records containing all details must be kept as proof that it does not constitute inducement.

An agreement must be entered into. Companies are encouraged to make any information relating to donations or grants publicly known.

The donation must be made directly to the healthcare institute conducting the healthcare research and not to the HCP.

Anti-bribery rules and laws applicable to offering benefits or inducements

The Prevention and Combating of Corrupt Activities Act, 2004 (PRECCA) applies to organisations locally and internationally which carry on business in South Africa.

PRECCA provides that anyone who accepts or agrees to offer gratification for their own benefit or that of another to act or influence another to behave in an illegal manner by misusing or selling information, or exercising power amounting to abuse of a position of authority, a breach of trust, or the violation of rules designed to achieve an unjustified result or unauthorised or improper inducement to do or not do anything, amounts to corruption.

According to the MCA Code, companies must adhere to ethical business practices and socially responsible conduct. They should not use any form of compensation, payment, reward, benefit or inducement not legally due, or which is given to cause the recipient to engage or refrain from engaging in certain behaviour or in an illegal manner which is contrary to ethical or professional rules or norms to procure the sale, loan, lease or prescription of products, and which may adversely affect anyone’s interests.

There must be no personal or unjustifiable enrichment of HCPs or their staff. No gift, benefit in kind, rebate, discount, kickback, donation or pecuniary advantage is allowed as an inducement to prescribe, lease, borrow, supply, stock, dispense, administer, use or buy any product.

The Rules Relating to the Code of Conduct for Pharmacists prohibit pharmacists, interns and pharmacists’ assistants from accepting or paying any financial gain or valuable consideration in return for the sale or supply of goods, substances or materials used by the HCP. The definition of “sell” in the Pharmacy Act includes “advertise”.

The Health Professions Council of South Africa’s Guidelines prohibit a HCP from accepting payments from companies for services or facilities in the HCP’s working environment, for example, paying for patients’ parking, coffee and wi-fi usage, as well as providing cash equivalents or services that confer any benefit to the HCP or patients. The same applies to pharmacies and their customers.

Penalties and sanctions

Non-compliance with the Medicines Act may result in a fine or imprisonment of a period not exceeding ten years. A company may have its licence suspended or cancelled.

The ARB may order the withdrawal of an advertisement and publication of a summarised version of the ruling in the media.

The MCA may impose a sanction for contravention of the MCA Code in terms of its Sanction Policy Document.

The SAPC may take disciplinary action against the company and impose a reprimand, caution, suspension, removal from the register, or a fine.

If found guilty of improper or disgraceful conduct, a HCP may be handed a caution, suspension, removal of their name from the register, a fine, or a compulsory period of professional service by the HPCSA.

It is therefore imperative for pharmaceutical companies and healthcare practitioners to comply with the self-governing codes of practice and the laws that regulate the advertising of medicines in South Africa.

Natasha Naidoo
Director
Norton Rose Fulbright SA
March 2024

Click on the link to view the full South African Chapter of the 5th Edition of The Legal 500:  Pharmaceutical Advertising Comparative Guide