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

The Minister of Health (First Appellant) and the South African Health Products Regulatory Authority (SAHPRA) (Second Appellant) published General Regulations on 25 August 2017 under GN 859, in GG 41064 after a consultative process. These regulations introduced a new category of "complementary medicines" (Category D), subcategorized into discipline-specific medicines and health supplements. The Alliance of Natural Health Products (South Africa) (Respondent), a voluntary association representing manufacturers and retailers, challenged the regulations in the Gauteng High Court seeking declaratory orders and review. The Alliance argued the regulations exceeded the Minister's rule-making powers under the Medicines and Related Substances Act 101 of 1965 (the Act) by purporting to regulate substances that were neither medicines nor scheduled substances as defined in the Act. The High Court (Kubushi J) partially upheld the challenge on the ultra vires ground.

• Whether the challenge to the regulations on the ultra vires ground was impermissibly abstract
• Whether the Alliance had standing to bring the challenge
• Whether the regulations made under section 35 of the Medicines and Related Substances Act 101 of 1965 were ultra vires to the extent they purported to regulate substances that were not 'medicines' as defined in the Act
• Whether the definition of 'complementary medicine' and 'health supplement' in the regulations fell within the definition of 'medicine' in the Act
• Whether the making of regulations by a Minister constitutes administrative action within the meaning of PAJA
• Whether the suspension of the declaration of invalidity was justified

1. The order of the court a quo was varied by deleting paragraph 2 thereof and by substituting the words 'South African Health Products Regulatory Authority' with the words 'Minister'. 2. The appeal was dismissed with costs, including the costs of two counsel. 3. The cross-appeal was dismissed with costs, including the costs of two counsel.

The binding legal principle established is that regulations made under section 35 of the Medicines and Related Substances Act 101 of 1965 are ultra vires and invalid to the extent that they purport to regulate substances that are not "medicines" as defined in the Act. A substance qualifies as a "medicine" under the Act only if it is used, purports to be suitable for use, or is manufactured or sold for use for a therapeutic or medicinal purpose, specifically: (i) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or (ii) restoring, correcting or modifying any somatic, psychic or organic function in humans. Substances used merely for maintaining, complementing or assisting normal physical or mental state, or for complementing health, supplementing diet, or providing nutritional effect, without a therapeutic purpose, do not fall within the statutory definition of "medicine" and therefore cannot be regulated under the Act's regulation-making powers.

The Court made several non-binding observations: (1) That there is a substantial market worldwide and in South Africa for complementary medicines and health supplements, and it was not disputed that this market should be regulated in the public interest - this was the main purpose of replacing the previous General Regulations; (2) That compliance with the obligations imposed by the regulations requires significant effort and costs; (3) That it is widely accepted that there is a public interest need to regulate complementary medicines and health supplements even if they are not medicines under the Act; (4) The Court expressed agreement with the principle from Esau that it should follow the approach in City of Tshwane that the making of regulations by a Minister constitutes administrative action within PAJA, and stated that the court is bound by such dicta unless convinced it is clearly wrong; (5) The Court noted that it is trite that a court should not issue a declarator in answer to a hypothetical or academic question; (6) The Court indicated that the High Court had exercised a true or strict discretion in suspending the declaration of invalidity, which may not lightly be interfered with, referring to the principles in Trencon Construction v IDC.

This case is significant in South African administrative and regulatory law for several reasons: (1) It clarifies the scope of ministerial regulation-making powers under the Medicines and Related Substances Act 101 of 1965, establishing that such powers are limited to substances that fall within the statutory definitions; (2) It provides important guidance on the interpretation of the definition of "medicine" in the Act, requiring a therapeutic or medicinal purpose; (3) It confirms the approach in Savoi regarding abstract constitutional challenges, establishing that while such challenges are permissible where the applicant has standing, they carry a heavy burden to show invalidity on the face of the provisions; (4) It reaffirms the principle from City of Tshwane v Cable City that the making of regulations by a Minister constitutes administrative action within the meaning of PAJA; (5) It demonstrates judicial willingness to strike down regulations as ultra vires while suspending such declarations to allow for appropriate corrective action, balancing legal principle with practical public interest considerations; (6) It has significant implications for the regulation of the complementary medicines and health supplements industry in South Africa, requiring alignment between regulatory definitions and statutory powers.