Pretoria - Health supplements and complementary medicines - which are not scheduled medicines as defined by the Medicine’s Act - will soon no longer be regulated by the South African Health Products Regulatory Authority, which regulates all medicines, including scheduled medicines.
But, while the Gauteng High Court, Pretoria, did strike down the current regulations over these substances, it made it clear that alternative medicines still had to be regulated.
Judge Elizabeth Kubushi gave the minister of health and the regulatory authority 12 months to determine how best to regulate these alternative medicines.
“I am loath to leave the regulation of complementary medicines without a time frame.”
She said 12 months should give the health authorities ample time to decide how best to regulate this popular industry.
The order was sparked by the Alliance of Natural Health Products in South Africa saying the minister of health did not have the power to add alternative and supplementary medications to the same regulations as that of scheduled medicines.
It said the definition of alternative medicines was too wide and included products that did not fall under the definition of medicine at all.
The court looked into how the international world regulated health supplements or alternative medicines.
In Australia, for example, these substances, including dietary supplements, fall within the medicines directorate, but it has a separate listing system.
In Canada, natural health products are regulated under medicines, but have their own regulations, while in the US, dietary supplements are regulated by the Federal Food and Drug Administration, under the food legislation.
The judge said that from this, it was clear that health supplements were regulated differently in the various countries.
The applicant argued that the vast majority of health and alternative medicines promote health and well-being, and they are vastly different from normal medicines.
It said the regulations, as they stood, treated and regulated all these products as if they were conventional medicines.
The minister and the regulatory body, on the other hand, said they had an obligation to safeguard the public.
They said the definition of medicine in the Medicines Act applied to all products which treated, mitigated or prevented illnesses.
Thus, those products which purported to do so, whether conventional medicines or alternative or traditional medicines, should fall under the medicine act regulations, the minister said.
The judge said the correct interpretation of the concept of medicines as defined in the Medicines Act, was in dispute here.
She concluded that only those complementary medicines and health supplements which purported to be used or manufactured for use or sale to treat or prevent physical or mental diseases should be regulated under the act.
She agreed that the minister was not allowed to regulate all complementary medicines under the act, but ordered that the government had to come up with ways within a year to best and separately regulate these substances.
Until that time, these alternative medicines would remain under the Medicines Act, so that pending suitable regulations and categorising of these products, they could be regulated to ensure the public’s safety, the judge said.