STATEMENT: TAC and SECTION27 push back against the return of the quacks
Johannesburg, 26 May 2020 – As scientists around the world search for viable vaccines for COVID-19, a virus that has infected over 5,4 million people and caused the deaths of about 345 000 people, a case about the regulation of complementary medicines will be heard, virtually, in the Pretoria High Court (Court) on 26 and 27 May 2020.
Following a lengthy process of public consultations, government finalised and published General Regulations in terms of in terms of section 35 of the Medicines and Related Substances Act (“the Medicines Act”) in 2017. The purpose of these Regulations is to protect consumers by requiring that all medicines, including complementary medicines, are subjected to the same standard as conventional medicines when providing information to consumers. The key focus is on the information provided in the labelling, marketing and the sale of such health products so that efficacy, safety and quality control measures are met for all medicines.
In 2018, the Association for Natural Health Products (ANHP) approached the Court to challenge the Regulations, in its own interest and in the public interest. The basis for this challenge is two-fold. First, the ANHP argues that the Medicines Act does not empower the Minister to regulate complementary medicines because complementary and alternative medicines do not fall within the definition of a “medicine”, as contained in the Medicines Act. For the ANHP, any attempts to regulate complementary medicines under the Medicines Act are unlawful, as that Act does not authorise the Minister to do so unless they contain scheduled substances or make therapeutic claims. Secondly, it argues that the procedure followed in finalising these regulations was unfair. The ANHP seeks to have the Regulations set aside. Alternatively, they seek an interpretation of the definition of “medicine” that excludes complementary medicines, thereby excluding them from regulation by SAHPRA.
The Minister of Health (the Minister) and the South African Health Products Regulatory Authority (SAHPRA) are the respondents in this case. They oppose the application and argue that there is a need to regulate complementary medicines and ensure that the public is protected from false claims. According to them complementary medicines, in the form of health products, herbal medicines and supplements are widely available over the counter and the numbers and variety of available “health products” have grown over the years. In some instances, these products make claims about quality, safety, efficacy and contents. However, because there is no requirement for complementary medicines to be registered or regulated by the SAHPRA, manufacturers and distributors cannot be held accountable. The Minister and SAHPRA also dispute that an unfair procedure was followed, and they challenge the ANHP’s standing.
The Treatment Action Campaign has been admitted as a friend of the court (amicus curiae). Public interest law organisation, SECTION27 is acting as TAC’s attorneys of record. The TAC and SECTION27 have worked on the issue of access to medicines for more than a decade because it is a critical component of the right to access health care as defined by section 27 of the Constitution.
The TAC will argue that the Minister has a constitutional obligation to regulate medicines to protect consumers: an obligation that he is seeking to meet through the Regulations. The TAC has particular insights into the effect of false claims made in respect of complementary medicines, most notably in respect of Dr Rath. Rath claimed that a programme of nutritional supplements, including formulations that he sells, could treat or cure diabetes, cardiovascular disease, cancer, and HIV/AIDS. The high court sanctioned Rath in 2008 and the Department of Health and Minister of Health were required to take reasonable steps to prevent Rath conducting clinical trials and advertising his fake claims.
Sibongile Tshabalala, the organisation’s National Chairperson said, “this case comes at a critical time, with the COVID-19 pandemic affording quacks a chance to resurface, among other things. We have fought this battle with some of these foes such as Kim Cools and won before and we firmly believe that quacks should not be allowed a chance to beguile genuine people seeking access to quality and affordable medicines.”
Anele Yawa, the organisation’s General Secretary said, “We have lost many comrades due to quacks purporting that they have miracle treatments. Many people have lost money while barely eking out an existence, while many others have suffered side effects as a result of these medicines. This case will go a long way into protecting health care users living in the country.”
An important aspect of this obligation is the right for people to have access to medicines of proven quality, safety and efficacy. 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.
For more information, please contact:
Ngqabutho Mpofu (TAC): 061 807 6443 or via email: firstname.lastname@example.org
Nontsikelelo Mpulo (SECTION27): 082 782 7143 or via email: email@example.com