This blog was co-authored by Lisa Kriegler, Trainee Associate

The Supreme Court of Appeal dismissed an appeal by the Minister of Health and the South African Health Products Regulatory Authority (SAHPRA) in favour of the South African Alliance of Natural Health Products.  The Alliance brought an application to set aside the 25 August 2017 General Regulations published under the Medicines and Related Substances Act, 1965 on the basis that the scope and ambit of the Regulations exceeded the rule-making powers afforded to the Minister under the Act.

The Act defines “medicines” as any substance used or purported to be suitable for use or manufacture or sale in the diagnosis, treatment, mitigation, modification or prevention of disease, an abnormal physical or mental state or any such symptoms, or restoring, correcting or modifying any somatic or psychic or organic function.  In order to qualify as a medicine, a substance must accordingly either be used, purport to be suitable for use, or be manufactured or sold for use for therapeutic purposes.

The Minister and SAHPRA argued that the definition of “medicine” under the Act was wide enough to include complementary medicines, as defined in the Regulations.

The Regulations define a “complementary medicine” as any substance or mixture of substances originating from plants, minerals, animals or other substance, which is used or purports to be suitable for use or manufactured or sold for use in maintaining, complementing or assisting the physical or mental state, or to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or mental state of a human being or animal, and used as a health supplement or in accordance with those disciplines as determined by SAHPRA.

The court noted that the phrase “maintaining, complementing or assisting the physical or mental state” in the definition of “complementary medicine” departs from the definition of “medicines” set out in the Act, in that it does not restrict complementary medicines to substances that have, or claim to have, a therapeutic purpose.

The court held that the Act is aimed at regulating and controlling medicines and scheduled substances that fall within the ambit of the Act and not those that do not fall outside the definition of “medicine”. While some complementary medicines and health supplements as defined in the Regulations would be medicines under the Act, many would not be.

Therefore, the Regulations purport to regulate numerous substances that are not medicines under the Act, and were accordingly found to be beyond the powers of the Minister to regulate, to this extent.  The SCA dismissed the appeal on this basis.

The case is Minister of Health and Another v Alliance of Natural Health Products (South Africa) [2022] ZASCA 49 (11 April 2022)