The state’s regulations governing complementary medicines and health supplements are invalid, the Supreme Court of Appeal has ruled, dismissing with costs the application by the Minister of Health for leave to appeal against a Gauteng High Court (Pretoria) judgment passed in October 2020.
That judgment declared the regulations promulgated in August 2017 as unlawful to the extent that they apply to “complementary medicines” and “health supplements” that are not medicines or scheduled substances as defined in the Medicines and Related Substances Act.
There is a large market worldwide and in South Africa for complementary medicines and health supplements, and the regulations introduced a new category for these, such as herbal medicine, aromatherapy and vitamins, allocated to categories. The regulations require a number of obligations to these products: labelling of containers, furnishing of professional information in hard copy or electronically, providing a patient information leaflet, and advertising.
Compliance with these obligations requires significant effort and costs. The Alliance of Natural Health Products sought to review the regulations, contending that the minister was only empowered to regulate medicines and scheduled substances, which these products were not.
The High Court found for the Alliance and that the regulations were unlawful to the extent that they applied to complementary medicines and supplements that are not medicines or scheduled substances as defined in the Act.
In a unanimous judgment of the full Bench of the SCA, Justice Christiaan van der Merwe said section 35(1) of the Act provides for no less than 45 topics in respect of which the minister is empowered to make regulations. He said most relate directly to medicines, scheduled substances, medical devices and in vitro diagnostic devices. “In sum, the regulations purport to regulate substantial numbers of substances that are not medicines under the Act. The (High Court) correctly concluded that, to this extent, the regulations are ultra vires and invalid,” Van der Merwe said.
However, the SCA dismissed the cross-appeal by the Alliance of Natural Health Products against the suspension of the High Court order to give the minister 12 months to fix the defect. Van der Merwe said it was widely accepted there is a public interest need to regulate complementary medicines and health supplements that are not medicines under the Act. “Therefore it is in the public interest to regulate these substances under the regulations during the interim period of consideration of the appropriate regulation thereof. The cross-appeal must therefore fail,” he said.
Minister_of_Health_and_Another_v_Alliance_of_Natural_Health_Products_South_Africa
TimesLIVE article – Regulations governing complementary medicines are invalid: SCA rules (Open access)
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