The regulation of complementary and alternative medicines in South Africa is a complex and evolving process, with a long history of legal battles and ongoing challenges. Dr. Andy Gray, a senior lecturer at the University of KwaZulu-Natal and co-director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence-based Practice, delves into this topic in his latest column for Spotlight. He explores the legal background, the current state of regulation, and the gaps that remain in the system.
One of the key issues is the concept of a 'call-up notice', which was introduced when South Africa's medicines legislation was first passed in 1965. This notice allows for the registration of medicines already on the market or those not yet marketed, with a stepwise approach to ensure safety, efficacy, and quality. However, an important exception was made in 1986 for homoeopathic medicines, which were exempt from full registration but had strict restrictions on medical claims and labeling.
The regulation of complementary medicines has been broadened to include a wider range of traditional health professions, such as homoeopaths, under the Allied Health Professions Council of South Africa. A separate regulatory body, the South African Health Products Regulatory Authority (Sahpra), is dedicated to Category D medicines, also known as complementary medicines. These medicines are defined as health supplements and medicines used in accordance with a 'discipline as determined by the Authority'.
Since 2013, there has been an intention to bring all complementary medicines under effective regulation, using a risk-based approach. However, no complementary medicines have yet been registered, and the initial 'call-up notices' have been repealed. This process has been affected by litigation, with the Supreme Court of Appeal ruling that Sahpra should not have regulatory power over substances and preparations that do not meet the definition of a medicine.
Despite the hiatus in finalising regulations, there is still some regulatory control over complementary medicines. The initial 'roadmap' has been replaced by a series of guidelines, and all manufacturers, wholesalers, or distributors of complementary medicines are required to be licensed by Sahpra. However, this process relies on an applicant's attestation of compliance rather than full inspections.
One of the gaps in the system is the regulation of African traditional medicines, which are not currently captured by the definition of Category D medicines. Dr. Gray argues that the 'let the buyer beware' dictum is no longer appropriate, and the Consumer Protection Act seeks to protect the public against unsafe products and unfair marketing. The remaining gaps in the medicines regulatory system need to be addressed to ensure effective oversight and protection for consumers.
