A Balanced Discourse: Analysing the Controversy of ‘Category D’ Medicines Regulation in South Africa

The Controversy Surrounding the Regulation of Natural Health Products in South Africa

The Traditional and Natural Health Alliance (TNHA), a representative body for stakeholders in the natural health products sector, has raised concerns over both the Minister of Health and the South African Health Products Regulatory Authority (SAHPRA) recently publishing draft Amendments to its 2017 General Regulations and a Road Map Guideline for the continued regulation of ‘Category D’ medicines. The TNHA argues that the amendments and the guidelines are both invalid and unlawful for several reasons.

The Legal Battle Over Complementary Medicines

In 2017, regulations were introduced that for the first time referred to ‘category D medicines’ and ‘complementary medicines’. However, the Alliance for Natural Health Products in South Africa challenged this in court, arguing that SAHPRA and the Health Minister did not have the authority to introduce issues via regulations that were not dealt with in the primary Medicines Act legislation.

Both the High Court and Supreme Court of Appeal agreed with the Alliance, declaring references to complementary medicines in the regulations ultra vires (invalid).

The Minister was given a year to remedy this defect but failed to take any action for over 18 months. Subsequently the regulations were effectively struck down and became unenforceable in April 2023, a year after the judgement was passed down.

The Controversial Amended Regulations

In March 2023, the Minister published draft amendments to the invalidated regulations in the government gazette. However, this move was problematic.
On the 8th of October, the TNHA submitted comments on these draft amendments to the General Regulations for Medicines of 2017 under the Medicines and Related Substances Act.

The submission discusses two recent court judgments related to complementary medicines regulation. The Kubushi judgment found the regulations pertaining to complementary medicines to be unlawful and ultra vires. The Supreme Court of Appeal ordered the Minister of Health to remedy the defect identified by Kubushi J. However, the only attempt made by the Minister was publishing amended regulations on March 24, 2023, within the one-month comment period laid out in the Medicines Act. This did not comply with the three-month period or remedy the regulations before the 12-month suspension of invalidity lapsed on April 12, 2023.

As the situation continues to unfold, it will be crucial to monitor how these regulatory disputes are resolved and what impact they will have on the natural health products sector.

Public Perception and Trust in Natural health Products

The public perception and trust in category D medicines, which include complementary and traditional medicines, is a complex issue in South Africa. The Traditional and Natural Health Alliance (TNHA), a representative body for stakeholders in the natural health products sector, has been vocal in its criticism of the South African Health Products Regulatory Authority’s (SAHPRA) handling of these medicines. The TNHA has argued that the SAHPRA’s guidelines are invalid and unlawful, which has likely influenced public perception and trust.

The TNHA’s Advocacy for a Distinct Regulatory Framework

The TNHA has advocated for a distinct regulatory framework outside the scope of the Medicines Act to govern traditional and natural health products. They believe it is essential to establish a new, purpose-written statute (Act) that comprehensively encompasses all forms of traditional medicine while being regulated based on their demonstrated low-risk profile. This stance likely resonates with many stakeholders in the natural health products sector.

Concerns Over the Exclusion of African Traditional Medicine

The TNHA has also raised concerns over the continued exclusion of African Traditional Medicine from the regulations, arguing that this is unconstitutional in terms of Section 9 of the Bill of Rights, namely the Equality Clause. This exclusion could potentially erode public trust in the regulatory process and in natural health products.

Conclusion

In conclusion, the South African Health Products Regulatory Authority (SAHPRA) faces significant challenges in its regulation of category D medicines. These challenges include legal battles, criticism of regulatory guidelines, the exclusion of African Traditional Medicine, and advocacy for a distinct regulatory framework. Addressing these challenges will be crucial for SAHPRA to effectively regulate these medicines and maintain public trust. Failure by the Minister and SAHPRA to heed to TNHA warnings about their continued regulatory overreach could result in them being further challenged on a legal basis and key decision-makers being found to be in contempt of court.