SOUTH AFRICA: THE REGULATION OF COMPLEMENTARY MEDICINES
The regulation of complementary medicines has been a hotly contested topic in the pharmaceutical realm for many years. Complementary medicines are those treatments and therapies that are used as an alternative to mainstream medicinal treatments and therapies, and comprise health supplements and discipline-specific traditional treatment (CAMS).
There is no doubt that there is a need for a regulatory regime for CAMS. In 2017 the general regulations (General Regulations) issued pursuant to the Medicines and Related Substances Act, 1965 (Act) were amended to, among other things, classify CAMS as a category of medicines (i.e., category D). With this change CAMS became subject, for the most part, to the same regulatory regime already established for medicines.
In 2018 the General Regulations were taken on review in the High Court by the Alliance of Natural Health Products South Africa on the basis that inter alia:
- they were too broad; and
- the Minister of Health (Minister) had acted beyond his legal scope by creating a new category of medicines (and thereby imposing various onerous obligations on producers and manufacturers of CAMS).
As a starting point, the Act empowers the Minister to make regulations in relation to medicines and scheduled substances, as defined in the Act. In this regard, the High Court found that CAMS, as defined, are neither medicines nor scheduled substances and accordingly the General Regulations are unlawful and invalid to the extent that they apply to CAMS.
The Court suspended the order of invalidity for 12 months (meaning that the General Regulations relating to CAMS would remain valid for the next 12 months, while the Minister puts in place a lawful and valid regulatory framework).
Recently, the Supreme Court of Appeal (SCA) upheld the High Court’s decision in so far as the declaration of unlawfulness and invalidity is concerned. However, the SCA overturned the High Court’s declaration that the definition of medicines in the Act only applies to substances used to achieve a medicinal or therapeutic result.
Following from the above, and within 12 months from the date of the order, namely 11 April 2022, the Minister must:
- amend the General Regulations so as to bring the definition of CAMS within the ambit of the definition of ‘medicines’ as set out in the Act; or
- to the extent that the definition of CAMS cannot be aligned with the definition of medicines, to amend the Act to cater for CAMS as they are currently defined (but this is more onerous and unlikely).
* This article was co-authored by Erin Hickey and Michael Gildenhuys