The Battle for Natural Health: Alliance vs Minister of Health in South Africa
In a landmark case that has gripped the nation, the Alliance of Natural Health Products (ANHP) took on the Minister of Health and the South African Health Products Regulatory Authority (SAHPRA) in a legal battle over the regulation of complementary medicines and health supplements.
The Controversial Regulations
The controversy began when the Minister of Health introduced the General Regulations under the Medicines and Related Substances Act, 1965. These regulations, published on 25 August 2017, introduced a new category of medicines – ‘complementary medicines’, which included health supplements and discipline-specific traditional claims. The ANHP argued that these regulations exceeded the rule-making powers of the Minister under the Act.
The ANHP, a partner of The Traditional & Natural Health Alliance (TNHA), contended that it was not the statutory duty of SAHPRA to regulate complementary medicines and health supplements as defined in the regulations, according to the original spirit and intention of the Medicines Act. The ANHP believed that these regulations would essentially shut down the entire natural health industry by classifying natural health and wellness products as pharmaceuticals, making them unavailable to the public unless they have prescriptions.
The Court Case
The ANHP initially filed for a declaratory order on the lawfulness of these regulations in the North Gauteng High Court on the 19th of February 2018. They won the High Court case on 1 October 2020, but the Minister of Health and SAHPRA filed an appeal against the judgment.
Then, on 11 April 2022, the Supreme Court of Appeal (SCA) in Bloemfontein ruled that these controversial regulations under the Medicines Act are indeed invalid and unlawful. The court held that the General Regulations were unlawful and suspended its declaration of invalidity for 12 months to allow the South African Health Products Regulatory Authority an opportunity to correct the defect.
The 11 April 2022 victory was not only a significant win for the natural health industry and its consumers but for South Africans in general. It meant that all these natural or complementary medicines have now been taken out of the clutches of Big Pharma, who want to expropriate and stifle the whole natural product industry.
However, until the Regulations are amended, complementary medicines must comply with the Regulation’s onerous and costly requirements in respect of labelling, provision of information, and advertising. For example, Regulation 12 requires complementary medicines to be accompanied by a patient information leaflet, containing various information in both English and another official South African language.
The Role of Natural Health Products in South Africa
The role of natural health products in South Africa is multifaceted, serving both local and international markets. This court case has highlighted the ongoing struggle between the need for regulation and the desire for freedom in the health and wellness sector. As the dust settles, all eyes will be on the Minister of Health as his Ministry works to correct the defects in the General Regulations. The outcome will undoubtedly have a significant impact on the future of the natural health products sector in South Africa.
The case of the Alliance for Natural Health vs Minister of Health in South Africa is a significant milestone in the fight for the rights of the natural health industry. It highlights the ongoing struggle between the need for regulation and the desire for freedom in the health and wellness sector. As the dust settles, all eyes will be on the South African Health Products Regulatory Authority as they work to correct the defects in the General Regulations.