Accessing essential medicines in the South African public healthcare sector via section 21
Like all national medicines regulatory bodies, the South African Health Products Regulatory Authority (SAHPRA), previously the Medicines Control Council of South Africa, is responsible for ensuring that all South Africans access medicines that are safe, efficacious and of good quality.1 A basic tenet of medicines regulatory practice is to require that all medicines on the domestic market are registered and therefore that their marketing and sale is authorised. There are, however, circumstances where access to an unregistered medicine is needed, requiring an exceptional mechanism to be employed. In South Africa that exceptional mechanism, which allows for the sale of unregistered medicines, is provided by section 21 of the Medicines and Related Substances Act, 1965 (the Medicines Act).
This article describes the circumstances under which the South African public health sector would need to have recourse to section 21, and the required processes that would enable such access.