HEALTH MINISTER & SAHPRA IN CONTEMPT OF SCA JUDGMENT – OPEN LETTER TO THE MINISTER

DETAILED ANALYSIS OF THE TRADITIONAL & NATURAL HEALTH ALLIANCE’S
OPEN LETTER SUBMISSION TO THE SOUTH AFRICAN MINISTER OF HEALTH

BACKGROUND

The Traditional & Natural Health Alliance (TNHA) has submitted a comprehensive letter to the Minister of Health in South Africa, outlining its concerns and recommendations following a Supreme Court of Appeal (SCA) judgment in April 2022 that invalidated certain 2017 regulations under the Medicines and Related Substances Act. The TNHA, as a representative of stakeholders in the natural health products sector, is advocating for a careful and inclusive approach to regulatory reform, emphasizing the importance of stakeholder consultation and legal compliance.

KEY ARGUMENTS OF THE TNHA

The TNHA bases its communication with the Minister on the principles of legality, procedural fairness, and non-discrimination. The Alliance argues that the SCA’s judgment, which was supported by a unanimous decision of five judges, clearly stated that the contested regulations exceeded the authority granted by the Medicines Act. It criticizes the South African Health Products Regulatory Authority (SAHPRA) for bypassing subsequent consultations with industry stakeholders, including the ANHP and the TNHA, and for not providing a clear interpretation of the SCA’s ruling to date, despite stating that it would do so in a media statement which they released shortly after the SCA judgment.

THE MINISTER’S NON-COMPLIANCE WITH LEGAL REQUIREMENTS

The letter highlights several instances of non-compliance by the Minister in terms of statutory legal requirements and the express judgment of the SCA. They point out that the Minister has failed to adhere to the mandatory steps outlined in the Medicines Act, such as a three-month public commentary period for draft regulations. The TNHA also accuses the Minister of not amending the regulations as required by the Act, and of not including Schedule 0 in the published regulations, as mandated by the Act, among other concerns.

IRREGULARITIES IN SAHPRA’S ACTIONS

The TNHA’s critique extends to the irregularities in SAHPRA’s approach to addressing the defects identified by the SCA. They question the authority’s disregard for public comments and the selective enforcement of regulations on CAMs imported through ports of entry. They also address the continued blind eye cast to Traditional African Medicines (TAMs). The TNHA also raises concerns about the potential misuse of enforcement and impounding powers by SAHPRA at ports of entry into South Africa, and the lack of transparency in their decision-making processes.

DISCRIMINATION AGAINST AFRICAN TRADITIONAL MEDICINES

The letter brings to light the discriminatory treatment of TAMs within South Africa’s regulatory framework. The TNHA argues that the South African Health Products Regulatory Authority (SAHPRA) has shown a bias by focusing on exclusively on regulating complementary and alternative medicines (CAMs), while neglecting the regulation of TAMs, which are deeply rooted in South African culture. This disparity in treatment is seen as a gross dereliction of duty and a violation of the principles of non-discrimination and equality under the South African Constitution.

CALL FOR INCLUSIVE CONSULTATIONS AND REGULATORY REFORM

In conclusion, the TNHA is urging the Minister to reconsider their submissions and to engage in a more inclusive and transparent process. They advocate for a new, separate regulatory framework, under a new and appropriate statute, that is equitable and addresses the concerns of all stakeholders, particularly in the context of CAMs and ATMs. The TNHA also calls for a review of the Medicines Act to ensure that it is aligned with the Constitution and promotes access to a diverse range of healthcare options.

IMPLICATIONS FOR COMPLEMENTARY AND ALTERNATIVE MEDICINES

The TNHA’s letter serves as a call to action for the Minister of Health to address the complex issues surrounding CAMs and TAMs. The implications of the SCA’s judgment and the subsequent regulatory changes could significantly impact the accessibility, affordability and availability of these natural health products in South Africa. The TNHA emphasizes the need for a balanced approach that respects the diversity of healthcare practices and the rights of consumers to choose their preferred forms of healthcare and to maintain wellness.

THE ROLE OF THE MINISTER IN REGULATORY COMPLIANCE

The Minister of Health plays a crucial role in ensuring that regulatory bodies like SAHPRA comply with legal requirements and uphold the principles of procedural fairness and non-discrimination. The TNHA’s letter underscores the importance of the Minister’s oversight in this regard and the potential consequences of non-compliance, such as the invalidation of regulations and the undermining of public trust in regulatory agencies.

THE FUTURE OF REGULATORY FRAMEWORKS IN SOUTH AFRICA

The TNHA’s submission to the Minister of Health is a significant contribution to the on-going debate about the regulation of healthcare products in South Africa. It highlights the need for a new purpose-orientated regulatory framework that is responsive to the diverse needs of the population and that promotes equity and access to a range of healthcare options. The TNHA’s call for inclusive consultations and regulatory reform is a step towards a more inclusive and effective healthcare system in South Africa.

We urge all stakeholders and members of the public to actively participate in the ongoing dialogue to ensure that traditional and natural health practices are recognized and integrated into our healthcare system. Your voice matters! — join us in advocating for health freedom and diversity in healthcare choices.

 

 

THE OPEN LETTER

 

Download the open letter (PDF).