Posted 01 June 2020
28th May 2020 Tendai Mafuma and Julia Chaskalson
Those who manufacture or sell complementary medicines often make claims about what these medicines contain and all the diseases they prevent or cure. As the public, we might assume that the claims must be true since some authority would stop the sale of these products if the claims were untrue. Unfortunately that is not something we can take for granted.
A set of regulations published in 2017 tasked the South African Health Products Regulatory Authority (SAHPRA) with regulating complementary medicines – essentially so that the public can have confidence that these products contain what they are claimed to contain and that they do what they are claimed to do. This was an important step forward for the public’s right to know and right not to be misled by quacks.
But yesterday (27 May 2020) the Pretoria High Court heard a matter in which these regulations are being challenged. Judgement in the case has been reserved.
As far back as in 1973, government sought to find ways of regulating complementary medicines. Developing regulations on complementary medicines intensified in the early 2000s to ensure that health products that are placed on the markets are not only effective but also that they are not harmful. These efforts became legally complicated and progress was stalled for a while.
According to the Constitution regulating medicines is essential for the realisation of the right to access health care services. With this in mind, government went through a long process over the last decade of developing a regulatory mechanism for complementary medicines.
In 2017 the Minister of Health published the General Regulations in terms of the Medicines and Related Substances Act (Medicines Act). The Regulations meant that complementary medicines must be registered by the South African Health Products Regulatory Authority (SAHPRA) if it complied with SAHPRA requirements. Registration requirements ensure that health supplements and complementary medicines comply with the Medicines Act and do what they purport to do. The Medicines Act also prohibits the sale of unregistered medicines precisely for this reason.
In 2018 the Association of Natural Health Products (ANHP), an association of manufacturers of complementary medicines, brought a court case against the Minister of Health and SAHPRA challenging the regulation of complementary medicines. Their case is based on two claims; one relating to the Minister’s power to regulate complementary medicines, and another challenging procedural fairness. The ANHP wants the Court to review and set the Regulations aside, or alternatively, to interpret the definition of “medicines” in a way that excludes complementary medicines from regulation.
According to the ANHP, the Medicines Act does not empower the Minister to regulate complementary medicines. This argument revolves around interpretations of the definition of “medicine”.
The Medicines Act empowers the Minister of Health to regulate medicines as defined by the Act as: “any substance or mixture of substance used or purporting to be suitable for use or manufactured or sold for use in – The diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms there of in humans; or Restoring, correcting or modifying any somatic or psychic or organic function in humans…”
The ANHP argues the correct interpretation of the definition of medicine is one that does not include complementary medicines and this makes any attempts by the Minister, to regulate complementary medicines in terms of the Medicines Act, unlawful.
It also argues that the definition of “complementary medicines” and “health supplements” in the Regulations is too broad. It includes substances such as nutritional supplements, vitamins, minerals and food supplements that do not fall within the definition of medicine. According to the ANHP, including these substances, which are not supposed to be regulated by the Medicines Act, makes the Regulations unlawful.
The effect of the Regulations, the ANHP claims, will mean that many health supplements and complementary medicines manufacturers will needlessly have to go through the SAHPRA registration process. This they say is likely to make manufacturing such products more costly and time consuming, resulting in more expensive products for consumers. These additional bureaucratic requirements have financial implications for many businesses that can possibly lead to closing down of companies and loss of jobs.
This expedient argument is based on the relative inconvenience of the manufacturers of complementary medicines, and not on protecting consumers. Ultimately, the ANHP wants to save a buck or two by sidestepping the regulatory process.
This is not acceptable.
The respondents in the case are the Minister of Health and SAHPRA. Both oppose the application and argue that the Regulations are lawful because the definition of “medicine” is wide enough to include complementary medicines. They also argue that the Regulations were passed following a fair and constitutionally compliant process.
They emphasise that the government’s efforts to regulate complementary medicines are in the public interest and meant to ensure that members of the public who buy complementary medicines off the shelves are fully informed of their safety, efficacy and quality. They have also published registration guidelines intended to guide the industry towards compliance with standards of manufacture, packaging, labelling supply, advertising and sale of the products required by the Medicines Act.
The Treatment Action Campaign (TAC), represented by SECTION27 was admitted as amicus curiae (friend of the court) in the case because they believe that if the application succeeds, the health of many health care users will be placed in jeopardy. Relying on its past experience dealing with false claims, the TAC provided evidence on government’s duty to take reasonable legislative and other measures to ensure the progressive realisation of the right to have access to healthcare services. The TAC argued that a key part of that right is the right to have access to medicines of proven quality, safety and efficacy and the State has an obligation to protect the health of the population by requiring that all types of medicines and health products meet acceptable standards for consumption.
Why the case is important
Failure to regulate complementary medicines creates a gap for untested and unproven products to be sold to the public, often with detrimental effects to individual health and on public health systems. South Africa has a history with such opportunists, most notably in the early years of the HIV/AIDS pandemic.
In the early 2000s, the official government position denied the relationship between HIV and AIDS, with the then President Thabo Mbeki and Health Minister Dr Manto Tshabalala-Msimang rejecting proven treatments and denying healthcare and dignity to millions.
Fake cures blossomed in this environment.
Matthias Rath, a renowned AIDS denialist claimed to be able to cure and prevent HIV with his multivitamins. Many of his followers were HIV positive and stopped taking their antiretroviral therapy (ART) in favour of his supplements. By the time Rath was eventually stopped by the court in 2008, a number of patients with HIV had stopped taking ART at the expense of their own health. It is quite possible that some who died may have lived had Rath not convinced them to stop taking ART.
In recent months Kim Cools, an AIDS denialist based in KwaZulu-Natal, has been advertising his “miracle juice” that he claims to be effective against a wide range of diseases, including COVID-19.
When health products are subjected to scrutiny by SAHPRA, one characteristic that is verified is whether the product does what it is claimed to do. For example, if a product claims that it is effective for treating TB or COVID-19, there must be scientific evidence that it indeed treats TB or COVID-19. This is becoming increasingly important for several reasons including that there are many products on the market that claim to assist with a wide range of health issues but most of these have not been put to the test.
Whilst some of these claims may very well be true, others are false – and there is no way for consumers to tell between true and false claims.
The risks are real.
As was witnessed during the early years of the HIV/AIDS pandemic, many patients shunned medically proven medicines in favour of unproven products. The reasons for this are varied. These products are often less expensive, are available over the counter so there is no need for a prescription; and more-often than not, offer the promise of no-side effects.
There are also economic implications for consumers as sick and desperate people can be convinced by quacks to spend their hard earned money on products that do not have any therapeutic effect. For SAHPRA to verify claims about complementary medicines is therefore critically important as it can prevent quacks like Rath and Cools from getting away with selling unproven cures.
Another concern is that in the absence of the Regulations, manufacturers and distributors of complementary medicines do not have to comply with the stringent requirements for labelling, packaging and marketing of medicines. Without such information being provided to consumers, they remain in the dark about the ingredients used to manufacture the products.
The regulations provide that all medicines, including complementary medicines, are subjected to the same standard as conventional medicines when providing information to consumers. The Regulations will ensure that complementary medicines are labelled accurately to reflect potentially scheduled substances in their ingredients. Ultimately, the Regulations protect the consumer who is, in this case, a person or patient who wants to exercise their right to access healthcare and his or her right to information.
The case ultimately hinges around technical legal concepts of ‘standing’ and fair procedural processes, but why the case matters is not just academic. Government has an obligation to take reasonable legislative and other measures to ensure the progressive realisation of the right to access to healthcare services. A fundamental component of that right is the right to have access to medicines of proven quality, safety and efficacy.
Government accordingly has an obligation to protect the health of the population by requiring that all types of medicines and health products meet acceptable standards for human consumption. Government’s 2017 regulations was both in line with this obligation and the public interest.
*Mafuma is a legal researcher and Chaskalson a communications officer at Section27
Note: SECTION27 and the TAC are mentioned in this article. Spotlight is published by SECTION27 and the TAC, but is editorially independent, an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.