NATURAL HEALTH PRODUCT INDUSTRY SEEKS CHANGE AS REGULATORY LANDSCAPE SHIFTS

This came after a unanimous five-member bench of the Supreme Court of Appeal (“SCA”) ruled on April 11, 2022 that the regulations for complementary medicines were defective and ultra vires [beyond the scope of power allowed or granted by law]. Both the High Court and SCA came to the rightful conclusion that the complementary regulations were an unlawful overreach by both the Minister of Health and SAHPRA because they attempted to regulate natural health products or substances that were neither “medicines” defined in Section 1 of the Medicines and Related Substances Act, or contained scheduled substances.

medicine’ –

(a) means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in —

(i) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or

(ii) restoring, correcting or modifying any somatic or psychic or organic function in humans; and

(b) includes any veterinary medicine;

The courts determined that the definition of complementary medicine, which served as the foundation for the regulatory framework for natural health products in the 2017 regulations, was not legally consistent with the prescriptive definition of ‘medicine’ in section 1 of the Medicines Act (above).  As a result, the regulations could no longer be considered lawful or constitutional.  The High Court and the Supreme Court of Appeal both suspended the declaration of invalidity for a period of twelve months to give the Minister of Health time to consider the appropriate and lawful regulation of such products in the future.

However, because no lawfully gazetted final amendments to the regulations, or amendments to the Medicines Act to include complementary medicines were made within the twelve months following the SCA judgment, the regulations are now declared null and void.

THE DRAFT REGULATORY AMENDMENT NOTICE OF MARCH 24 IS UNLAWFUL

Draft amendments to the 2017 regulations were gazetted for public comment on March 24th, shortly before the twelve-month suspension ended. Sections 35(1) and 35(2) of the Medicines Act specify regulations must be gazetted for public comment three months before being considered by the Minister of Health in consultation with the South African Health Products Regulatory Authority (SAHPRA). The draft amendment was only gazetted 11 working days before the twelve-month suspension of invalidity expired, and it only allowed for 30 days (one month) for comment, renedring them ultra vires.

[Section 35(2)] The Minister shall, not less than three months before any regulation is made under subsection (1), cause the text of such regulation to be published in the Gazette, together with a notice declaring his or her intention to make that regulation and inviting interested persons to furnish him or her with any comments thereon or any representations they may wish to make in regard thereto.

In our opinion, the Minister cannot rely on Section 35(3)(b) to waive the three-month comment period in Section 35(2) because this provision is reserved for emergency situations where there is an imminent risk to the public if regulations are not imposed with haste.

[Section 35(3)] The provisions of section (2) shall not apply in respect of – (b) any regulation in respect of which the Minister is, after consultation with the Authority, of the opinion that the public interest requires it to be made without delay. 

The Minister had over two years to correct defects which rendered the regulations ultra vires and did nothing, except attempt to substitute a few words here and there, which in themselves correct nothing at the 11^th hour, and well beyond the prescribed three months prior to the regulations falling away. This is not only ultra vires, but also contempt of court.

The Alliance for Natural Health Products SA successfully demonstrated in the courts that there had been no verifiable, recorded deaths, nor severe adverse reactions relating to natural health products recorded by the SAHPRA or their predecessor Medicines Control Council since 2011 when official reporting systems first included complementary medicines and health supplements.

Furthermore, it has been demonstrated that in other countries, such as the United States, United Kingdom and European Union, where these products are widely popular and consumed by a large segment of the population they exhibit a de minimus risk base [sufficiently improbable risk], especially when compared to pharmaceutical medicines and even common foodstuffs.

Following the SCA judgment, there has been no meaningful broad-based consultation or transparency between the Minister and stakeholders. The only interactions we are aware of have been between the SAHPRA and a group of pharmaceutical industry representatives at highly secretive, behind-closed-doors meetings of an unofficial Industry Task Group (ITG) where they meet monthly to discuss SAHPRA’s regulatory policies.

Instead of holding the unconstitutional regulations in abeyance, pending the Minister’s decisions on how to appropriately regulate the industry in the year given by the court, the SAHPRA has continued to enforce the 2017 regulations and guidelines with increased vigour and even resorted to jackboot tactics by harassing manufacturers, importers, and distributors of natural health products in an arguably malevolent manner.

To regulate the natural health product sector constitutionally, the Minister should have consulted broadly with the natural health product sector and other stakeholders in a meaningful manner in order to address concerns and listen to alternative regulatory proposals. Additionally, the Minister should have gazetted draft regulatory amendments well before the 11th of January to amend the invalidated regulations within the twelve months given by the SCA to ensure that they were lawfully gazetted with adequate and lawful notice of three months for comments in terms of Section 35(2) of the Medicines Act.

The Minister cannot extend nor validate the 2017 complementary medicines regulations beyond April 11 by means of an amendment, which will miss the cut-off date of the twelve-month suspension of invalidity. Therefore, the draft amendments of the March 24 are ultra vires and will not stand in law if gazetted as finalized regulations, even if an extension for comment of three months is provided. The Minister’s actions in this regard are also in contempt of court.

Simply substituting the words “complementary medicine” and “health supplement” with the words “Category D medicine” does not make the draft amendment regulations lawful, as ‘Category D’ has no definition in law beyond that which was contained in the original text of the regulations, and which was found to be ultra vires. Therefore, the proposed amendments are fatally flawed for the same reason the regulations were invalidated.

THE ‘GENERAL INFORMATION GUIDELINE’ OF APRIL 17 IS UNLAWFUL

The General Information Guideline issued by SAHPRA on April 17th similarly lacks legal validity.
All previous ‘Guidelines’ that referred to “complementary medicine” have also been invalidated by the courts and cease to have relevance.

The definition of complementary medicine was found by the courts to be ultra vires, rendering references to “complementary medicines” in sections 1(1), 1(2), 3(6), 3(7), 4, 9(1)(3) of this new guideline to be invalid.

MOVING FORWARD

The Minister and SAHPRA must carefully consider the High Court and SCA rulings, and acknowledge that they can no longer legislate through regulation as they once did in a cavalier fashion and without consequences.

SAHPRA should exercise extreme caution when engaging with the natural health product industry going forward, it is no longer business as usual for them. Failure to do so could result in the Minister and Authority being found in contempt of court and facing punitive damages for the harms inflicted on the sector and running roughshod over the rights of members of the public to select the health and wellness options they prefer.

Going forward the TNHA will notify the Minister of Health that the latest draft regulatory amendment of March 24 is ultra vires and does not correct any of the defects found by the courts.
Additionally, we view his recent actions as nothing less than contempt of court. We demand that the notice be rescinded without delay.

The TNHA will notify the SAHPRA that the recently published ‘General Information Guideline’ of April 17, and all prior ‘Guidelines’ attributed to the fallen regulations published since 2017 are of no consequence, resulting from the regulations on which they rely having fallen away. They too must be formally withdrawn.

NEW SOLUTIONS NEED TO BE FOUND

The TNHA is willing to engage in meaningful discussions with the Minister of Health in order to find an appropriate and inclusive solution to regulate the natural health product industry, that recognizes natural health products are not pharmaceutical drugs that should be regulated as medicines under the Medicines Act.

The purpose of the Medicines Act has always been to regulate mostly synthetic substances which are new to man’s physiology, and in most cases, pose significant risks if not controlled.  The SAHPRA should therefore concentrate solely on its primary mandate which is to regulate pharmaceutical medicines and other related products, for which their legislation was specifically enacted.

The natural health product market has continued to expand and innovate in many countries where governments have been supportive of this sector, contributing to the fiscus in taxes, creating jobs, and greatly benefiting public health. As healthcare costs spiral, and as knowledge and attitudes evolve, greater numbers of people are interested in remaining healthy across their lifespan and desire active control over the decisions made in relation to their health. Pharmadynamics, in its “Hug Your Heart Campaign” survey conducted in South Africa in 2017, polled 1,837 adults, revealing that nearly half (46%) of the respondents take at least one nutritional supplement daily. The significant number is driven by the heightened interest of consumers in healthy living practices, and their desire to minimize the risk of illnesses.

In other counties with developed natural health product markets, these products are regulated as either foodstuffs or as a third distinct category wedged between foods and medicines. Each has its own autonomous regulatory authority or directorate, staffed by experts trained in complementary medicine and nutrition.

We would like to make recommendations for a new legislative and regulatory framework in South Africa which would regulate all traditional medicines [both indigenous and non-indigenous] and food supplements through either a new Directorate under the National Department of Health, similar to the Food Control Directorate, or a stand-alone Authority, similar to the SAHPRA. Our law-makers in Parliament have already given the public choices in the healthcare modalities they prefer, by allowing them to choose which types of practitioners and therapists they want to consult for their healthcare needs, whether they be modern medical [allopathic] practitioners, allied health practitioners [those who practice complementary medicine], or African Traditional Health Practitioners.

To this end, separate statutory Health Councils have been established under separate legislation, allowing the practitioners and therapists in each paradigm or branch to self-regulate and enforce codes of ethics to protect the public. We contend therefore that it is rational, reasonable and achievable to have separate statutory authorities, staffed by relevant experts, to regulate the affairs of pharmaceutical drugs (medicines) and natural health products accordingly. The one size fits all approach which the Minister and SAHPRA have relied on since 2017 has been nothing short of trying to repeatedly hammer a square peg through a round hole much to the frustration of all. To this end, not a single complementary medicine has been duly registered thus far.

Since the official establishment of the SAHPRA in February 2018, not a single natural health expert has been appointed to the SAHPRA’s Board, nor its administration, despite natural health products in their thousands making up a significant segment of those products the SAHPRA claimed to regulate. The systemic bias of the Authority regulating such products in a drug-like manner has been evident and hugely problematic for the industry.

We recognize the need to regulate such products in a responsible manner, which makes them ‘true to label’. The natural health product industry has become increasingly challenging to navigate for the average consumer, therefore an appropriate framework should be put in place to make certain that what information consumers see stated on natural health product labels and associated marketing materials are matched to what the product delivers.

We would support a new regulatory scheme intended to ensure that the natural health products that consumers use to support their health and well-being are safe, that the health claims made are scientifically or empirically valid, and that the products contain what the labels claim.

Natural health products for the most part are low-risk products and a light-handed regime will address any risks without imposing unreasonable costs on consumers or sellers of such products. We believe there are ample examples of regulatory regimes around the world which do not regulate natural health products as medicines’ and where the rights and needs of consumers and industry are appropriately balanced, safeguarded and promoted. Thus, targeted natural health substances and products should be promoted as a means to help control rising societal healthcare costs, and as a means for high-risk individuals to minimize the chance of having to deal with potentially costly events and to invest in increased quality of life.

CAN GOVERNMENT AFFORD TO RESTRICT THE PUBLIC’S ACCESS TO NATURAL HEALTH PRODUCTS?

It is time to turn a new leaf and make things right.