Health Minister Aaron Motsoaledi recently implemented various changes to Schedules 4, 6 and 7 of the Medicines Act in relation to cannabis and its related components. Although amendments to the Drugs and Drug Trafficking Act remain to be seen, the recent changes to the Medicines Act are a step in the right direction and a significant contribution to the rights of adults to cultivate, possess and use cannabis in private.
On the recommendation of the South African Health Products Authority, the minister of health recently issued Government Gazette 43346, which essentially exempts, under Section 36(1) of the Medicines and Related Substances Act, the free supply of medicines, medical devices and in vitro diagnostics to the state for three years. This exemption also extends to the supply of samples to the state as part of a tender published by the state.
The National Health Insurance (NHI) scheme, which is set to come into force on 1 January 2026, will centralise the purchasing of healthcare services in a single body established by the government: the National Health Insurance Fund. The proposed link between the NHI scheme's full implementation and the arbitrary date of 1 January 2026 may be irrational considering the risk of the requisite infrastructure not being sufficiently in place by such date.
Cannabis has enjoyed heightened attention following a recent ruling decriminalising the private possession, consumption and cultivation of the plant for recreational purposes. While there have been several positive developments in the promotion of the medical cannabis market in South Africa, the overarching regulatory framework and authorities' current practice remain barriers to entry for prospective local players in the medical cannabis product manufacturing market.
The South African minister of health has called for public comment on the recently published Draft General Regulations Relating to Bonusing. The draft regulations aim to flesh out Section 18A of the Medicines Act, which prohibits the supply of any medicine, medical device or in vitro diagnostic medical device that is subject to a bonus system, rebate system or any other incentive scheme.