Health minister and SAHPRA push for power

Author: Bruce Coetzee

The 11th of April 2022 will, for many, be heralded as a possible lifeline for what has become a lucrative industry that provides opportunity and income at a foundation level for South Africans. Complementary medicines and lifestyle supplements took the limelight as The Supreme Court of Appeal moved to reinforce The High Court’s declaration of invalidity, which focused on the ominous General regulations that form the nuts and bolts of the Medicines and Related substances act in relation to the control of complementary medicines and lifestyle supplements.

The appeal, filed by The South African Health Products Regulatory Authority and the Minister of health, aimed to usurp once again, what numerous stakeholders believe is a means to invest in local economic gain, and that the flexing of law to enforce control of this sector is beyond the jurisdiction of the Health Minister and SAHPRA.

A number of proudly South African-owned businesses have brought value through injecting capital and profits directly into communities, which combine efforts to help bolster the product chain values. International interest in complementary medicines sourced from Africa has helped affirm financial trust in the quality and appeal of locally produced products that fill a vital need for non-prescriptive treatment avenues.

The Medicines and Related substances act 101 of 1965 clearly defines its scope and influence regarding medicines, scheduled substances, medical devices, and in vitro diagnostic devices (IVDs). Whilst the General Regulations are supposed to represent the parameters of effective control. Both parties may exercise in construct with the principal wording and stipulations set out accordingly in the General Regulations.

However, according to the Supreme Court of Appeal, the interpretation of these parameters and just how far the might of SAHPRA and the Health Minister may reach fell short of including complementary medicines and supplements.

Several pertinent issues were raised as a clear indication of the invalidity set forth by the judgment. Section 35 (1) of The Medicines act, which essentially affords the Minister of Health power to make changes that encompass 45 varied topics, forms the basis of the act. The detailed argument that sighted the function and description of use and design in terms of complementary medicines and supplements highlighted not only the contradictions that arise from classifications but also the wording encompassed by the act that expressly, and without doubt, should exclude them from the influence of the Health Minister and SAHPRA.

The Alliance of Natural Health Products (respondent) brought many valid and pertinent points to the table, including the simple fact that complementary medicines and supplements cannot be defined as medicines in lei of the word's definition. Section 1 of the Medicines act provides a detailed analysis of the word, "medicines" as purposed in the act. Based on a multitude of contradictions sighting, among others, product advertising and labelling conditions, the Minister of Health cannot make such dramatic changes when the Medicines Act is designed to function in accordance with the president, and criteria set about in the wording and sections thereof.

For laymen and individuals desperately working towards repairing our failing economy, the news has brought a renewed hope for the future. Understanding the knock-on effect has become synonymous when SAHPRA, as confirmed by the track record set in the wake of what transpired in other similar sectors, is, by any indication, testament to the need for immediate change!

Whilst the onslaught has been stayed by the Supreme Court of Appeals, many pressing issues must now be addressed by lawmakers and community stakeholders.

If we are to repair the state of our economy and build towards a common goal, all parties of interest need to align with a more open dialogue and sense of inclusion. With impending changes to similar sectors still lobbying on the governments' table, it is with apprehension that variable interests within these sectors move forward.