Courtesy of Elsabe Klinck and Associates

Preferential Procurement Regulations

At the start of 2022, the Preferential Procurement Regulations were declared invalid because there cannot be a “one size fits all” legislated criterion for the transformational elements in state procurement (tenders). The Constitutional Court clarified that the declaration of invalidity is suspended until 16 February 2023. Tenders have returned to requiring 20 (or 10) points allocated to a bidder’s BEE score until the finalisation of new regulations. It will become crucial to know how these transformational targets are to be set in the future, as it would affect all tenders after that date.

General Medicines Regulations

In April, the Supreme Court of Appeal declared parts of the General Medicines Regulations of 2017 invalid (suspended until 11 April 2023) for extending the regulatory control beyond just medicines, by including complementary products and health supplements of a non-therapeutic nature within its regulatory ambit. Non-medicinal products would have to be covered under the Foodstuffs, Cosmetics and Disinfectants (FCD) Act, and would necessitate sets of regulations under that law and members will need to be au fait with the FCD Act as well.

Certificate of Need

In June, the High Court declared the Certificate of Need in the National Health Act, 2003, unconstitutional. As these sections were not yet in effect, there was no need to suspend the order. The Constitutional Court, however, still has to confirm the order of unconstitutionality. Significantly, the application was unopposed (not the Minister of Health, the Director-General of Health or the President filed any notice to oppose). This will affect the implementation of a key NHI component and the findings of the Health Market Inquiry. Draft Regulations issued last year on the CON will also now not proceed.