A monumental victory for ANHP in the South African High Court
The Issue
The South African Health Products Regulatory Authority (SAHPRA) has been attempting to bridle, through a series of regulations for complementary medicines published in 2017, the natural health industry. These regulations would essentially shut down the entire natural health industry by classifying natural health and wellness products as pharmaceuticals and making them unavailable to the public unless they have prescriptions.
The impact of this would be to take away the public’s right to choose and use natural remedies by redefining them as pharmaceutical products. So, if we consider the covid pandemic, for example, it will mean that vitamin C, vitamin D, zinc and all the other natural remedies that have been so essential for people’s immune systems to remain strong and healthy throughout this time would become unavailable.
The Case
Enter: The Alliance of Natural Health Products South Africa (ANHP), a partner of The Traditional & Natural Health Alliance (TNHA). According to ANHP, it is not the statutory duty of SAHPRA in terms of the Medicines and Related Substances Act (Act 101) of 1965 to regulate complementary medicines and health supplements as defined in the regulations, according to the original spirit and intention of the Medicines Act. Complementary medicines include products such as vitamins, minerals, amino acids, enzymes, pro-biotics, pre-biotics, herbal remedies, homeopathic medicines, sports supplements and so forth.
The ANHP initially filed for a declaratory order on the lawfulness of these regulations in the North Gauteng High Court on the 19th of February 2018. They won the High Court case on 1 October 2020 but the Minister of Health and SAHPRA filed an appeal against the judgment.
Then, on 11 April 2022, the Supreme Court of Appeal (SCA) in Bloemfontein ruled that these controversial regulations under the Medicines Act are indeed invalid and unlawful.
The unanimous judgement of the five presiding judges of the SCA was to uphold the judgement of the High Court in favour of the ANHP, which meant the SCA unanimously agreed with the High Court case won previously, in October 2020, where it was determined that these substances are not medicines and therefore cannot be regulated as drugs.
Another point to note is that the ANHP argued that the Minister of Health (and this would then also mean SAHPRA – as it was established as an organ of state by the Medicines Act) is only authorized to regulate medicines and scheduled substances within the definition of a medicine in the Medicines Act, and that attempting to regulate substances which do not purport to be medicines (like natural remedies, for example) was a regulatory overreach.
Furthermore, both the High Court and the SCA unanimously agreed that SAHPRA has no legal jurisdiction to regulate substances that are not medicines or scheduled substances, and to that extent, the 2017 regulations are unlawful.
Fast forward to 27 May 2022 and we find out that SAHPRA had considered approaching the Constitutional Court for leave to appeal the SCA judgement together with the Minister of Health (in fact, it seems they were determined to do so and had published a statement to that effect on 7 May 2022 stating exactly that). Only it turns out the Minister is not willing to apply to the Constitutional Court for leave to appeal. So it seems they have backed down and the SCA judgment stands uncontested. The fact that they would even consider going to the Concourt on this, beggars belief. Fortunately for the time being it appears good science, good law and basic common sense have prevailed.
The Impact
Let us, for a moment, contemplate what could have happened if this case had been lost and SAHPRA was left to regulate the industry in their usual fashion. Specifically, let’s evaluate the ivermectin matter and the way SAHPRA dealt with that. Here was a safe, decades-old treatment that would have saved thousands of lives in this country if it had been distributed when Covid was at its peak in South Africa. We knew of ivermectin’s efficacy in treating the so-called virus since June 2020 when countries like Peru, Argentina, Brazil, Bangladesh and India were distributing ivermectin with notable success. For example, India’s most densely populated province, Uttar Pradesh, is a living testament that ivermectin could have been used to wipe Covid-19 off the map, because their Covid cases fell dramatically at the time. Sadly, SAHPRA had to be taken to court before it was legal from January 2021, for doctors in South Africa to prescribe ivermectin through a compassionate use programme via a section 14 script (read more).
But lo and behold, on 30 May 2022, SAHPRA announces that they have decided to terminate the compassionate use citing no credible evidence to support the therapeutic role for ivermectin in Covid-19. Now, the only way patients can get ivermectin is if a doctor follows section 21 of the Health Act to prescribe it — a lengthy and laborious process used for unscheduled medication – which is by no means a guarantee to obtaining it anyway since importation is banned, bulk stock holding is banned and the section 21 script may not even be approved in any case.
It certainly seems that SAHPRA is not so much interested in a medical solution to save lives than it is in a politically driven solution that would help government retain the control it had established over the population during the pandemic.
Would it be far-fetched to presume that SAHPRA’s attempt to regulate complementary medicines is more of the same?
Similarly, let us review the consequence of not being able to easily access natural medicines. Many natural medicines, plant remedies, vitamins and minerals are safe and time-tested dietary supplements. Take zinc, for example. It’s often recommended that zinc be included in everyone’s nutritional supplementation program as it decreases the inflammatory process and boosts the body’s natural ability to fight infection by strengthening the immune system. That’s a good thing, right? Especially with Covid-19 around, right?
Now, something like ivermectin is designed to go together with zinc, to be taken together. Ivermectin is a zinc ionophore (which just means that it helps to transport zinc across biological cell membranes. Since zinc regulates adaptive immune cell function, these compounds can help maintain higher levels of intracellular zinc and decrease the replication of RNA viruses like influenza, SARS, and Covid-19.) So, assuming we can get ivermectin easily, it would be a good thing to get a zinc supplement easily and cheaply too, right?
If we can’t, then we are worse off. This is perhaps one reason why countries like India handed out free Covid kits that contained zinc and ivermectin along with doxycycline (and announced that these kits had been “miraculously” effective in reducing their number of Covid cases). And there were other cases of natural remedies that helped to prevent Covid-19 fatalities. Madagascar recommended herbal drinks made from African wormwood (Artemisia annua) — with its long history of treating common colds, cough, sore throat, flu’ and asthma — to their citizens, which they claimed helped with the nation’s case and fatality rates.
The Bigger Picture
Why then would SAHPRA and the Minister of Health want to regulate these products. What’s in it for them? Could it be more than mere “governmental overreach”? Could it possibly be that they are hell-bent on the “vaccine” even though everyone now agrees the vaccines do not stop transmission. Could there be a bigger link with Big Pharma than they are letting on? If we consider the fact that the above mentioned Covid Kits cost 150 Indian Rupees (roughly R30) each, then why would our government not have considered this treatment protocol? It was effective in so many countries and would have cost very little. If our government was as concerned about the health of South Africans as they say they are, why are they still not doing so? Why didn’t they use the R500-billion in funding to provide these simple remedies?
The Outcome
The 11 April 2022 victory was not only a significant win for the natural health industry and its consumers but for South Africans in general. On the one hand, it does, of course, mean that all these natural or complementary medicines have now been taken out of the clutches of Big Pharma, who want to expropriate and stifle the whole natural product industry.
On the other hand, however — and more importantly, we believe – it means that the freedom and rights of all South Africans have been upheld in a court of law. What could easily have happened, is that this case could have gone the same way as the ivermectin debacle. Fortunately, for now, we continue to have freedom of choice with regards to complementary medicine, whether traditional, homeopathic, herbal remedies or vitamins and minerals. Big Pharma has not been able to take away our choice by turning these into pharmaceutical products. And we continue to have health freedom in a time where it has become increasingly challenging to hold onto. The government and its agencies – the Minister of Health and SAHPRA in this case – have been called to account.
What we do need is to remain vigilant and guard against SAHPRA continuing to regulate the industry in a business-as-usual fashion. To do so would be to undermine the legislative reform ordered by the Supreme Court of Appeal and we, the people need be aware of this and hold SAHPRA and the government accountable should they attempt to amend the 2017 complementary medicines regulations or gazette new regulations – something that they may well attempt to do, considering their track record and how they tend to operate.
