oa South African Health Review - Health policy and legislation

Volume 2016, Issue 1
  • ISSN : 1025-1715



The health policy and legislation arena has been dominated in 2015/2016 by the release, after much delay, of the White Paper on National Health Insurance (NHI). Although a White Paper is expected to provide finality on a policy in a manner which is ready for implementation, including the development of any necessary legislation, the NHI document leaves many questions unanswered. The need for major changes to existing legislation is signalled in the White Paper, but few details are provided on exactly how those changes might be made. In addition to changes to the National Health Act and the Medical Schemes Act, and perhaps even the Constitution, the possibility of a new NHI Act is also flighted. Two small steps, in the form of drafts Bills to amend the National Health Laboratory Service Act and to create a new National Public Health Institute of South Africa, have been taken. However, neither Bill has yet been tabled in Parliament.

The Medicines and Related Substances Amendment Acts of 2008 and 2015 will need careful promulgation, once the necessary secondary (regulations) and tertiary (guidelines) legislation have been developed. The new South African Health Products Regulatory Authority is not expected to come into operation before 2017, and will have to face not only the backlog in registration applications for medicines that is the legacy of the Medicines Control Council, but also complete and entrench the effective regulation of complementary medicines and medical devices.
While there have been strident calls for a fundamental redesign of the Health Professions Council of South Africa in order to create an independent, self-regulatory council for the medical and dental professions, it is unclear whether these calls will be heeded.
The Medical Innovation Bill, one of the few Private Member's Bills to be tabled, still languishes in Parliament.

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