Professional Indemnity Law
Scheduling Amendments to the Medicines Act
Posted 25 June 2020
Hanneke Verwey
On 22 May, 2020, the Minister of Health published an amendment to the Schedules of the Medicines and Related Substances Act (101 of 1965) (the Medicines Act) in Government Gazette No 43347, notice number R586. The Schedules were amended to comply with the Constitutional Court’s order in Minister of Justice and Constitutional Development and Others v Prince; National Director of Public Prosecutions and Others v Rubin; National Director of Public Prosecutions and Others v Acton and Others 2018 (6) SA 393 (CC).
In the aforementioned case, the Constitutional Court declared that the provisions of the Drugs and Drug Trafficking Act (140 of 1992) and the Medicines Act are inconsistent with section 14 of the Constitution to the extent that they criminalise the use or possession in private or cultivation in a private place of cannabis by an adult for his or her own personal consumption in private. The order was suspended for 24 months in order to enable Parliament to rectify the constitutional defects. The amendments to the Medicines Act have now been finalised.
Section 22A of the Medicines Act provides for a graduated system of control over the sale and supply of scheduled substances. This ranges from minimal control, where consumers are able to purchase the substance from an open shop, on the one end of the spectrum, to the complete prohibition of certain addictive substances, on the other end. Prior to the amendment, Cannabidiol (CBD) was classified as a Schedule 4 substance in terms of the Medicines Act. Schedule 4 substances can only be obtained with a prescription from an authorised prescriber, and are indicated for use in disease or conditions which require professional medical, dental or veterinary diagnoses and management. In terms of the amendment, certain preparations and mixtures containing CBD will now be regulated as Schedule 0 substances. The amendment provides that CBD is listed as a Schedule 4 substance, except –
- In complementary medicines containing no more than 600mg CBD per sales pack, providing a maximum daily dose of 20mg of CBD, and making a general health enhancement, health maintenance or relief of minor symptoms (low-risk) claim;
or - In processed products made from cannabis raw plant material intended for ingestion, containing 0.0075% or less of CBD, where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product.
CBD-containing products that meet the listed conditions will thus be regulated as Schedule 0 substances. Schedule 0 substances are generally accepted to be substantially safe and may be consumed without prior medical advice. In terms of section 22A(3) of the Medicines Act, Schedule 0 substances may be sold in an open shop. Schedule 0 products include substances such as aspirin and vitamins that are sold without a prescription and off-shelf in pharmacies, health shops and supermarkets.
CBD remains a Schedule 4 substance unless it meets the exception criteria listed in the amendment. Schedule 4 substances are subject to the provisions of section 22A(5) of the Medicines Act, and may only be sold by the persons listed in section 22A(5) of the Act, including pharmacists, medical practitioners and other persons registered under the Health Professions Act (56 of 1974) and on prescription by an authorised prescriber. Furthermore, Schedule 4 substances have to be registered by the South African Health Products Regulatory Authority (SAHPRA). Insofar as Schedule 0 CBD-containing products qualify as complementary medicines, they will also still have to comply with the requirements for registration if and when called upon to do so by SAHPRA.
Prior to the amendment both cannabis and tetrahydrocannabinol (THC) were regulated as Schedule 7 substances in terms of the Medicines Act. Schedule 7 substances are not recognised for therapeutic use. They are considered to have a very high risk for abuse or dependency in users and the use of such substances is considered unjustifiable and undesirable, except for limited scientific purposes. Schedule 7 substances are subject to section 22A(9) of the Medicines Act, and a permit from the Director General of the National Department of Health is required to acquire, use, possess, manufacture or supply such substances. In terms of the amendment, THC (the main psycho-active constituent to cannabis) is now listed as a schedule 6 substance, with certain limited exceptions. In this regard, the amendment provides that THC is listed in Schedule 6, except -
- In raw plant material and processed products manufactured from such material, intended for industrial purposes and not for human or animal ingestion, containing 0,2% or less of tetrahydrocannabinol;
- In processed products made from cannabis containing 0,001% or less of tetrahydrocannabinol; or
- When raw plant material is cultivated, possessed, and consumed by an adult, in private for personal consumption.
The effect of the amendment is that the cannabis plant has been removed from Schedule 7. THC is now listed in Schedule 6, subject to limited exceptions. Like Schedule 4 substances, Schedule 6 substances are prescription medicines that may be sold by the persons identified in section 22A(5) of the Medicines Act. Schedule 6 substances are also subject to the provisions of section 22A(6)(i) of the Medicines Act and may not be repeated unless a new prescription has been issued. Insofar as THC-containing products meet the listed exception requirements, they will not be subject to the Medicines Act. The third exception, in particular, represents Parliament’s attempt to comply with the judgment of the Constitutional Court, to the extent that the Court required Parliament to make amendments to the Medicines Act in order to enable adults to use or be in possession of cannabis for personal consumption in private.
Access to cannabis-related products for medicinal purposes remains subject to the requirements of the Medicines and Related Substances Act, the Regulations and Schedules issued in terms of the Act, and the guidelines issued by the authority. In terms of section 21 of the Medicines Act SAHPRA may authorize the use of unregistered medicines in limited circ*mstances. Medicines that are subject to the Medicines Act otherwise have to be registered with SAHPRA in order to be lawfully sold. To date, no CBD- or THC-containing medicines have been registered with SAHPRA.
Should you require advice or assistance concerning your compliance obligations with regard to CBD or related cannabis products, you may contact MacRobert Inc for assistance.
