THNA STATEMENT ON THE DRAFT AMENDMENTS TO THE GENERAL REGULATIONS OF 2017

SUMMARY

During the course of yesterday (05 April) the natural health product industry was for the first time alerted to a draft amendment notice [Notice No. R. 3258] in the government gazette, which was signed by the Minister of Health on the 6^th of March and later officially gazetted on the 24^th of March.

The draft notice attempts to amend parts of the General Regulations of 2017, and more specifically the ultra-vires [unlawful] ‘complementary medicine’ provisions within them.

As of today, the said notice is not yet published on the website of the South African Health Products Regulatory Authority (the “SAHPRA”) or any other government website.

Furthermore, no emails were sent out to stakeholders in the industry after the notice was gazetted.

The notice specifies that interested parties have a period of just 30 days to comment on the draft amendments. However, this conflicts with Section 35(2) of the Medicines and Related Substances Act (Act No. 101 of 1965), which mandates a minimum comment period of three months for new regulations.

[Paragraph 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.

Following the North Gauteng High Court’s judgment on the 1^st of October 2020 in the matter of The Alliance for Natural Health South Africa vs. Minister of Health and SAHPRA, and the consequent unanimous judgment of the Supreme Court of Appeal (the “SCA”) on the 9^th of April 2022 affirming the lower court’s decision, the Minister of Health was granted a period of 12 months by the SCA to address the unconstitutionality and unlawfulness of his overreach in attempting to regulate complementary medicine and health supplements beyond the scope permitted by the primary legislation. This is commonly referred to as a ‘suspension of the declaration of invalidity’. This suspension period expires on the 9^th of April 2023.

As of today, the Minister has not applied for an extension of the suspension before the expiration of the 12 months ends. Additionally, there has been no significant engagement with the broad base of stakeholders relating to the future of complementary medicine by either the Minister or the SAHPRA to date. The only official communications issued to the sector since the SCA judgment was a media release on the 27^th of May 2022, stating that the Minister and SAHPRA had reversed their decision to appeal the SCA judgment in the Constitutional Court and that certain limited policies would remain in place during the 12-month suspension period.

We are of the view that the Minister should have adhered to Section 35(2) of the Act and gazetted draft amendments to the General Regulations of 2017 prior to the 9th of January 2023, in order to facilitate adequate and lawful stakeholder engagement.

Moreover, he should have carefully considered the apex arguments ventilated in court, which resulted in the declaration of invalidity of complementary medicine regulations.

It appears that the Minister has not given due consideration to the reasons for the adverse judgments against him in the High Court and SCA, or taken steps to resolve the serious constitutional issues that were presented and adjudicated in the courts. In our opinion, the proposed piecemeal regulatory amendment, which has been gazetted at this late stage, is ultra vires and therefore unlawful.

This is just another demonstration of ill-considered policy, in a litany of adverse court judgments and internal appeal rulings spanning over decades, where our Ministry of Health and Medicines Regulatory Authority have failed to understand their limitations in terms of defining what are, and what are not medicines in terms of the definition of a medicine in the Medicines Act.

This draft amendment notice, even if it is subsequently gazetted into law, will not serve to extend, validate or resurrect the complementary medicine regulations as they stood in 2017, as various provisions have been invalidated by the courts and will soon cease to exist.  At this point, we feel there is no need for the TNHA to comment on the subject matter of the fatally flawed draft notice, as it does not make the complementary medicine regulations in toto [in all or completely] constitutional or lawfully enforceable beyond the 9^th of April.

According to the High Court and SCA judgments the Medicines Act will now only apply to bona fide ‘medicines’ and scheduled substances on the 9^th of April.

Below are key paragraphs from the Judge Elizabeth Kubushi’s judgment in the Gauteng North High Court which highlight this.

[Paragraph 145] “Section 35 of the Medicines Act, as it has been said, empowers the Minister, in consultation with the Authority, to make Regulations. The Minister may make different Regulations in relation to different medicines or scheduled substances, or different categories of medicines or scheduled substances. The upshot is that the regulatory scheme only permits the regulation of substances that are ‘medicines’ or contain ‘scheduled substances’.  Any regulation promulgated under the Act that purports to regulate substances that are neither ‘medicines’ nor contain ‘scheduled substances should not be permitted.”

[Paragraph 150] “I would rather grant the third suggestion proposed by the applicant, that of striking down the impugned Regulations only to the extent that they apply to complementary medicines and health supplements that are not medicines as defined in section 1 of the Medicines Act, or do not contain scheduled substances. This would have the benefit of leaving the rest of the Regulations in place and give the respondents an opportunity to come up with the best way of regulating complementary medicines and the appropriate altemative categorization thereof. The relief is just and eqoitable under the circumstances.”

The full bench of the SCA concurred with the previous judgment.

[Paragraph 26] “In sum, the regulations purport to regulate substantial numbers of substances that are not medicines under the Act. The court a quo correctly concluded that, to this extent, the regulations are ultra vires and invalid. Paragraph 3 of its order cannot be faulted. It follows that the appeal must fail on the ultra vires ground and that it is unnecessary to make a final determination of the other review grounds.”

Therefore, some natural health products may be deemed to be ‘medicines’ if they are marketed with health claims to either diagnose, treat, mitigate, modify or prevent diseases or symptoms or if they claim to restore, correct or modify somatic (physical biology) or psychic (psychiatric) or organ function. This is in accordance with the broad definition of medicine in Section 1 of the Medicines Act (below).

“‘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;

Additionally, if any products contain previously scheduled substances such as vitamins, minerals & electrolytes, proteins & amino acids, probiotics & prebiotics, enzymes, animal extracts, carotenoids, saccharides & monosaccharides, polyphenols (and bioflavonoids) and certain listed botanicals and botanical isolates (e.g Cannabidiol), they are subject to maximum daily upper dosages in schedule 0. If these dosages are exceeded such products will need to be registered as medicines.

You can view the relevant natural health substances within the schedules here. [note Annexures C to O]

If natural health products don’t make medicinal health claims, then they are not considered medicines.

It is okay to make certain general health and wellness supporting claims and structure-function claims listed in Annexures C to O.
However, it’s best to get expert advice from trade associations or regulatory consultants before making changes to your labelling and marketing materials.

Remember to keep the ingredients in your product formulations within the Schedule 0 maximum daily dosage ranges.

The TNHA will update our members on further developments.

If you are not yet a TNHA member, you can sign up here.

Anthony Rees
National Chairman
TNHA