Supreme Court of Appeal
On 11 April 2022, the Supreme Court of Appeal dismissed an appeal of a High Court judgment(1) filed by the minister of health and the South African Health Products Regulatory Authority (SAHPRA).(2) This article highlights the salient points of the judgment as well as its possible impact.
The purpose of the Medicines and Related Substances Act 101 1965 (the Medicines Act) is to regulate the following:
- scheduled substances;
- medical devices; and
- in vitro diagnostic devices (IVDs).
The Medicines Act provides comprehensive definitions for each of these terms. Under section 22A of the Medicines Act, the minister of health has the power to prescribe scheduled substances on the recommendation of the SAHPRA.
Section 14 of the Medicines Act provides that the SAHPRA may, from time to time, determine that a medicine, medical device, IVD or any class or category of any of them, shall be subject to registration in terms of section 16 of the Medicines Act.
The Alliance of Natural Health Products (South Africa) (the respondent) sought declaratory orders and a review of the General Regulations (Government Notice 859 of 25 August 2017) (the General Regulations).
The General Regulations, published in terms of the Medicines Act, introduced a new category of medicines – namely, "complementary medicines" – and set out a number of obligations with regard to the labelling and advertising of such medicines, among other things. The new category was further divided into "discipline-specific traditional claims" and "health supplements".
The respondent claimed that the scope and ambit of the General Regulations exceeded the rule-making powers of the minister of health in terms of the Medicines Act. It argued that the minister of health is empowered only to regulate medicines and scheduled substances, and that complementary medicines are neither, so the General Regulations were ultra vires.
The High Court stated as follows:
2. The definition of 'medicine' in section 1 of the Medicines and Related Substances Act, No. 101 of 1965 is declared to apply only to substances that are used or purport to be suitable for use or are manufactured or sold for use in the diagnosis, treatment, mitigation, modification or prevention of maladies, in order to achieve a medicinal or therapeutic purpose, in human beings and animals.
Therefore, the Court held that the General Regulations were unlawful. It suspended its declaration of invalidity for 12 months "to allow the South African Health Products Regulatory Authority an opportunity to correct the defect".
The minister of health and the SAHPRA (the appellants) appealed the Court's decision. The respondent cross-appealed the decision to suspend the declaration of invalidity for 12 months.
Are the General Regulations ultra vires?
The Court noted that section 35(1) of the Medicines Act empowers the minister of health to make regulations in respect of over 45 topics, the majority relating directly to medicines, scheduled substances, medical devices or IVDs. The Court was therefore required to determine whether the regulation of complementary medicines and health supplements in terms of the General Regulations fell within the minister of health's powers to regulate medicines as defined in the Medicines Act.
The Court held that to qualify as medicine,(3) a substance (or a mixture of substances) must be used, purport to be suitable for use, or be manufactured or sold for use for therapeutic or medicinal purposes. Van der Merwe JA thus held that: "On this interpretation, drinking water is clearly not a medicine under the Act, but water that is claimed to have the ability to cure a disease, would be one."
Next, the Court held that paragraph (b) of the definition of "complementary medicine" departs from the definition of "medicine" in the Medicines Act as the definition does not restrict complementary medicines to substances that have or claim to have a therapeutic purpose. The Court further held that while the definition of "health supplement" includes the phrase "restoring, correcting or modifying" as provided in in subparagraph (a)(ii) of the definition of "medicine", the definition proceeds to provide the additional requirement that the restoring, correcting or modifying must be achieved by:
- complementing health;
- supplementing a diet; or
- a nutritional effect.
The Court further emphasised that the reference to "health supplement" in the definition of "complementary medicine" further highlights that the definition excludes substances that claim to have a therapeutic purpose (which would fall within the definition of "medicine").
Ultimately, the Court found that the General Regulations purport to regulate substantial numbers of substances that are not medicines under the Medicines Act and, to this end, the General Regulations were ultra vires.
The Supreme Court of Appeal, however, set aside paragraph 2 of the High Court order (set out above) as there had been no dispute between the parties in respect of the definition of "medicine".
The Supreme Court of Appeal dismissed the respondent's cross-appeal and held that the High Court had "exercised a true or strict discretion that may not lightly be interfered with".
The Supreme Court of Appeal further reiterated that there is a public interest need to regulate complementary medicines and health supplements which are not medicines under the Medicines Act.
The Supreme Court of Appeal judgment confirms that complementary medicines and health supplements (which do not make any therapeutic claims) should not be required to comply with the noted onerous obligations provided in the General Regulations.
The General Regulations will therefore only apply to substances that make therapeutic claims, which would place them within the definition of "medicine" as provided in the Medicines Act.
On 7 May 2022, the SAHPRA issued a media release titled "SAHPRA Statement on the ANHP Judgement". Briefly, the media release confirms that the SAHPRA will join the minister of health in approaching the Constitutional Court for leave to appeal the Supreme Court of Appeal judgment.
An appeal of the Supreme Court of Appeal judgment will have the effect that the judgment (which confirmed the High Court's suspension of the declaration of invalidity for a period of 12 months) will be stayed, pending the outcome of the appeal to the Constitutional Court.
Accordingly, it is thought that the High Court's suspension of the declaration of invalidity for a period of 12 months will start running from the date of the outcome of the application for leave to appeal the Supreme Court of Appeal judgment.
For further information on this topic please contact Altair Richards or Thina Ntsaluba at ENSafrica by telephone (+27 21 410 2500) or email ([email protected] or [email protected]). The ENSafrica website can be accessed at www.ensafrica.com.
(1) Alliance for Natural Health Products (South Africa) v Minister of Health and the South African Health Products Regulatory Authority (Case No. 11203/2018).
(2) Minister of Health and Another v Alliance of Natural Health Products (South Africa) (Case No. 256/2021)  ZASCA 49 (11 April 2022).
(3) Section 1 of the Medicines Act defines "medicine" as follows:
"medicine" means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in -
(a) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or
(b) restoring, correcting or modifying any somatic or psychic or organic function in humans, and includes any veterinary medicine.