Accessing essential medicines in the South African public healthcare sector via section 21

  • T D Leong National Department of Health
  • T Ndlovu USAID Global Health Supply Chain
  • J Jugathpal National Department of Health
  • A Gray University of KwaZulu-Natal
  • B Mbongo University of KwaZulu-Natal
  • A Pillay National Department of Health
  • S Putter USAID Global Health Supply Chain

Abstract

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.

Author Biographies

T D Leong, National Department of Health

National Department of Health, Affordable Medicines Directorate, Essential Drugs Programme

T Ndlovu, USAID Global Health Supply Chain

USAID Global Health Supply Chain – Technical Assistance (South Africa)

J Jugathpal, National Department of Health

National Department of Health, Affordable Medicines Directorate, Essential Drugs Programme

A Gray, University of KwaZulu-Natal

Division of Pharmacology, Discipline of Pharmaceutical Sciences, University of KwaZulu-Natal

B Mbongo, University of KwaZulu-Natal

Division of Pharmacology, Discipline of Pharmaceutical Sciences, University of KwaZulu-Natal

A Pillay, National Department of Health

National Department of Health

S Putter, USAID Global Health Supply Chain

USAID Global Health Supply Chain – Technical Assistance (South Africa)

Published
2019-12-10
Section
News