Pending the result of an appeal, health supplements and complementary medicines – not scheduled medicines as defined by the Medicine’s Act – may soon no longer be regulated by the South African Health Products Regulatory Authority, which regulates all medicines, including scheduled medicines. But, notes a Cape Times report, 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.
The Minister of Health and SAHPRA have filed an application for leave to appeal the Gauteng High Court ruling. Therefore, the General Regulations under GG 41064 relating to the regulation of complementary medicines remain in force, SAHPRA noted in a statement on 12 November.
Judge Elizabeth Kubushi gave the Minister of Health and the regulatory authority 12 months to determine how best to regulate these alternative medicines. The order was sparked by the Alliance of Natural Health Products in South Africa saying the Minister 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 Minister and the regulatory body, on the other hand, 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 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, concluding that only those complementary medicines and 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.
On 12 November, SAHPRA issued a correction to the Cape Times report:
Whilst the Hight Court ruled in favour of ANHP, it must be noted that the Minister of Health and SAHPRA have since filed an application for leave to appeal as it is their intention to appeal this judgment. Since the Minister and SAHPRA are appealing the judgement, this means that the judgment is stayed, pending the outcome of the appeal.
Therefore, the General Regulations under GG 41064 relating to the regulation of complementary medicines remain in force.
Thus, the statement in the article: “Health supplements and complementary medicines – 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.” is therefore misleading and incorrect.
Dr Boitumelo Semete
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