oa South African Health Review - Health legislation and policy - review

Volume 2018 Number 1
  • ISSN : 1025-1715



South Africa is engaged in the complex task of advancing universal health coverage, in the form of a National Health Insurance (NHI) system. This will require the passage of new legislation and substantial changes to existing legislation. Two draft Bills have been published for comment, as well as provisional recommendations from the Competition Commission’s Health Market Inquiry which highlighted delays in implementation of the remaining components of the National Health Act. The Gauteng Mental Health Marathon Project tragedy has focused attention on the implementation, or lack thereof, of health policy and legislation, as well as measures to improve quality of care. It has served as a litmus test for the National Health Act, the Office of Health Standards Compliance (OHSC), and the Health Ombud, in that it tested the efficacy and fitness for purpose of these instruments and institutions. After 50 years, the Medicines Control Council (MCC) ceased to exist in 2018, and has been replaced by the South African Health Products Regulatory Authority (SAHPRA). This chapter provides a critical analysis of the process of reforming the regulator, and the challenges that lie ahead, with particular emphasis on the issue of transparency and the unfinished business of regulating health-product marketing. Medicine pricing has been identified as a key challenge to expanding universal health coverage. In this regard, there are ongoing debates about the medicine pricing model applied in South Africa, as well as the need for intellectual property policy reform.

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