CAM Regulations – A Bitter Pill for Emerging Businesses: Dissecting SAHPRA’s Regulation on Complementary Medicines

Analysis Report: SAHPRA’s Regulatory Overreach on Complementary Medicines
Issued by the TNHA

Introduction

Ladies and gentlemen, let’s talk about the South African Health Products Regulatory Authority (SAHPRA) and their latest move — a draft Road Map guideline for regulating what they call ‘category D medicines.’ Now, you won’t find this easily; it’s tucked away on their website, with a comment period open until October 17, 2023. But don’t be fooled, they’re not playing by the rules, and they didn’t even bother to announce this in the guideline itself. It’s a classic case of ‘hide and seek’ with public information.

The Legal Quagmire

The Traditional and Natural Health Alliance (TNHA) isn’t mincing words here. We’re calling out the guideline as invalid and unlawful. Why? Because SAHPRA’s trying to pull a fast one by slipping in ‘Category D medicines’ into the regulations without any backing from the primary legislation — that’s the Medicines and Related Substances Act of 1965. It’s like trying to fit a square peg in a round hole; it just doesn’t work.

Courtroom Drama

This isn’t just about bureaucracy—it’s about legality. The Alliance for Natural Health South Africa took SAHPRA to court, and guess what? The High Court and Supreme Court of Appeal agreed — twice — that SAHPRA’s actions were beyond their powers, ultra vires. All references to complementary medicines in the regulations were tossed out. But instead of fixing the problem within the twelve months the court gave the the Minister of Health – and by extension SAHPRA – to fix the unlawfulness declared and the they sat on their hands for over a year and now they are struck down permanently. Talk about dropping the ball!

A Defiant Stance

Despite clear court orders, the Minister of Health published so-called ‘amending’ regulations in late March 2023, blatantly ignoring the legal process and deadlines. It’s like they’re living in a parallel universe where court orders are mere suggestions. And to add insult to injury, they’re now pushing a guideline on how to implement these unamended, and let’s be honest, invalid regulations. It’s a reckless power play that disregards public input and the rule of law.

The Illusion of Compliance

SAHPRA even had the audacity to create a separate website for these ‘category D medicines,’ further obscuring the issue from the public eye. They continue to claim that complementary medicines fall under the Medicines Act, despite court rulings to the contrary. It’s a bold strategy. Let’s see if it pays off for them.

Industry Implications

The SAHPRA’s aggressive stance on regulating complementary medicines could spell trouble for the industry. With no natural health experts on the SAHPRA board with experience in the manufacturing and distribution sector and a history of regulating these products as if they were quazi-drugs, the industry faces a stifling environment. The absence of duly registered complementary medicines since SAHPRA’s inception in 2018 is a testament to the regulatory hurdles imposed on natural health products. This overreach not only hampers innovation but also threatens the livelihood of those businesses specializing in these products.

Consumer Choice at Risk

Consumers stand to lose as much as the industry. The over-regulation by SAHPRA limits the availability of complementary medicines, directly impacting consumer choice. With a track record of no recorded deaths or severe adverse reactions to these products to date, one has to question the necessity of such stringent oversight. The result? A potential decrease in the variety of natural health products available, forcing consumers to rely on more conventional — and often more expensive — medical treatments.

Potential for Legal Backlash

SAHPRA’s actions have already been met with legal challenges, and the courts have ruled against their regulatory overreach. This defiance of court orders not only undermines the rule of law but also sets the stage for further legal battles on the horizon. Such a contentious atmosphere could lead to a loss of confidence in the regulatory system, with consumers and industry players alike questioning the legitimacy of SAHPRA’s decisions.

Economic Consequences

The economic implications of SAHPRA’s overreach are significant. The complementary medicines industry contributes substantially to the economy, and excessive regulation could lead to job losses, decreased investment, and a slowdown in the sector’s growth. This, in turn, affects the broader health ecosystem, as complementary medicines often serve as affordable alternatives to pharmaceutical drugs.

Regulatory Cost Disparities

The financial burden of compliance with SAHPRA’s regulations presents a stark contrast between small businesses and large pharmaceutical corporations. Small businesses, often operating with razor-thin margins, are hit with regulatory costs that are proportionally higher than those absorbed by their larger counterparts. This disparity is not just a minor inconvenience; it’s a significant barrier to entry and sustainability in the health market. The costs for smaller businesses with fewer than 20 employees are nearly 20% higher than the average for all firms, creating an uneven playing field where the big fish have a clear advantage.

Resource Allocation Challenges

Unlike large corporations, small manufacturers, importers and distributors do not have the luxury of dedicated legal and compliance teams of full-time pharmacists who need to be responsible persons to waste their scarce skill sets on ticking boxes to navigate SAHPRA’s complex regulatory environment. This lack of resources means that small businesses are often playing catch-up, trying to understand and implement regulations without the necessary expertise. The result is not only lost productivity but also a potential stifling of innovation and growth, as small business owners are forced to allocate precious time and money to compliance rather than business development and serving health conscious consumers.

Impact on Market Dynamics

SAHPRA’s stringent oversight has a ripple effect on the market dynamics within the health sector. Small businesses, constrained by regulatory hurdles, are less able to diversify their product offerings and respond to consumer needs. This limitation will inevitably lead to a reduction in consumer choice and a shift in market share towards larger firms that can more easily absorb the costs and complexities of compliance. Firms that don’t necessarily produce the most innovative and true health benefiting products. The resulting concentration of market power can diminish competition, which is the lifeblood of a healthy economy. The pulbic’s choices in natural health products will significantly narrowed, along with their ability to discern which products will benefit them or not with traditional and time-honoured health claims stripped from product labels.

Potential for Policy Improvement

The evidence suggests that regulations tailored to assist small businesses often miss the mark in South Africa, either by inadvertently benefiting large businesses or by failing to achieve their intended goals. Policymakers might need to consider revising or even rescinding certain regulations if they prove to be ineffective or counterproductive. A more nuanced approach could involve monitoring the long-term effects of regulations and developing support programs specifically designed to help small businesses navigate the regulatory landscape.

A Call for Regulatory Balance

The need for a balanced regulatory approach is clearer than ever. SAHPRA’s current trajectory risks stifling an industry that has been safely serving the South African public for years. Up to 43% of South African adults use natural health products like health supplements, herbal remedies, sports supplements and homeopathic preparations. Moreover, between 60% and 70% of black South Africans utilize African Traditional Medicines in their self-help health regimes. It’s time for the Minister of Health to create a new regulatory framework under a separate regulator with both the law and the practical realities of complementary medicines and African Traditional Medicines, ensuring safety without compromising on consumer choice and industry innovation.

Conclusion

In conclusion, SAHPRA and the Minister of Health’s conduct is not what you’d expect from a body tasked with protecting public interest. It’s a regrettable situation that undermines trust in regulatory authorities. The right move? Amend the Medicines Act or draft a new one for complementary medicines and African Traditional Medicines. But let’s be clear, SAHPRA doesn’t have the authority to regulate complementary medicines as things stand now. It’s time for them to step back, to listen, and follow the law.