Minister of Health and Another v Alliance of Natural Health Products (South Africa)

The Minister of Health, acting under s 35 of the Medicines and Related Substances Act 101 of 1965, promulgated General Regulations in August 2017 after a lengthy consultative process. These regulations introduced and regulated a new category of products called 'complementary medicines', including health supplements. The Alliance of Natural Health Products, representing manufacturers and retailers of such products, challenged the regulations in the Gauteng Division of the High Court. It contended that the Minister exceeded her powers by regulating substances that were not 'medicines' or 'scheduled substances' as defined in the Act. The High Court partially upheld the challenge, declared the regulations unlawful to that extent, and suspended the declaration of invalidity for 12 months. The Minister and the South African Health Products Regulatory Authority appealed, and the Alliance cross-appealed against the suspension.

The appeal was dismissed with costs. The cross-appeal against the suspension of the declaration of invalidity was dismissed. The order of the High Court was varied by deleting the declaratory paragraph interpreting the definition of 'medicine' and by substituting the Minister for the Authority as the functionary responsible during the suspension period.

The case clarifies the limits of ministerial regulation-making powers under the Medicines and Related Substances Act and affirms that regulations may not extend beyond the scope of the empowering statute. It is significant for the regulation of complementary medicines and health supplements in South Africa and reinforces the principle of legality and ultra vires review in administrative law.