Legislation regulating cannabis in South Africa
There are currently two acts that govern the use, cultivation, possession and dealing in cannabis (locally known as “dagga”) in South Africa.
The Drugs and Drugs Trafficking Act 140 of 1992 (the Drugs Act)
The Drugs Act categorizes cannabis as an “undesirable dependence-producing substance.”
In terms of the Drugs Act, it is a criminal offence to use, possess, deal in and/or cultivate cannabis or any part of the cannabis plant, with a few specific exceptions provided for in the Medicines Act below. ‘Deal’ is defined very broadly in the Drugs Act.
The Medicines and Related Substances Act 101 of 1965 (the Medicines Act)
The Medicines Act makes a distinction between THC, CBD, the cannabis plant in its entirety and the components thereof. The Medicines Act regulates cannabis and its components as follows:
The cannabis plant and THC
The cannabis plant, any portion thereof and THC are classified in Schedule 7 of the Medicines Act, with specific exceptions. Schedule 7 substances are those that are deemed to have no legitimate medical use2.
The cannabis plant, the whole plant, or any portion or product thereof falls into Schedule 7, except:
- When separately specified in the Schedules
- Processed hemp fiber containing 0.1 percent or less of THC and products manufactured from such fiber, provided that the product does not contain whole cannabis seeds and is in a form not suitable for ingestion, smoking or inhaling purposes
- Processed product made from cannabis seeds containing not more than 10mg/kg (0.001 percent) of THC and does not contain whole cannabis seeds
THC also falls into Schedule 7, except:
- When separately specified in the Schedules
- When intended for therapeutic purposes
- In hemp seed oil, containing 10mg/kg or less of THC, when labelled “Not to be taken” or “Not for internal human use”
- In products for purposes other than internal human use containing 10mg/kg or less of THC
This means that processed hemp fiber products (e.g. textiles, bricks, ceiling boards) and processed cannabis seed products (e.g. hemp seed oil, cosmetics containing hemp seed oil) are specifically excluded.
In summary, Schedule 7 substances are regulated as follows:
|Acquisition, use, possession, manufacturing and supply
||According to section 22A(9)(a), the Director-General of the National Department of Health (the “Director-General”) may authorize the acquisition, use, possession, manufacturing or supply of a Schedule 7 substance in order to provide such substance to a medical practitioner, analyst, researcher or veterinarian. Provided that the substance is used for the medical treatment or prevention of a medical condition of a specific patient, or for the purposes of education, analysis or research.
|Import and export
||According to section 22A(11)(a), only persons in possession of a permit issued by the Director-General may import or export a Schedule 7 substance.
THC for therapeutic purposes
THC is classified as a Schedule 7 substance unless it is intended for therapeutic use. In these circumstances, THC falls under Schedule 6 and is regulated as follows:
|Persons who may sell for medicinal use
|According to section 22A(5), only pharmacists, medical practitioners and dentists with the requisite authority to prescribe and dispense such substances may sell. According to section 22A(6), the particulars of each sale must be recorded and kept in the prescribed manner.
|Persons who may sell for other uses
||According to section 22A(7)(a), only a pharmacist, pharmacist’s intern or person in possession of a permit issued by the Director-General may sell such substances for analytical purposes, manufacture of foods, cosmetics, educational or scientific purposes.
|Manufacturing, import and export
||Only persons in possession of a permit issued by the Director-General may manufacture, import or export such substances for medicinal or other uses.
CBD for medicinal use
According to the South African Health Products Regulatory Authority (SAHPRA), products containing CBD (except for those products discussed under the next heading) fall into Schedule 4 of the Medicines Act. Schedule 4 substances are regulated much in the same way as Schedule 6 substances with the exception that a special permit from the Director-General is not necessary to import or export such substances.
Any person who imports or manufactures a CBD-containing medicine must be in possession of a license issued in terms of the Medicines Act, must comply with the Good Manufacturing Standards Practices standards and must have their products tested by an accredited laboratory indicating the concentrations of THC and CBD.
SAHPRA is responsible for the registration and regulation of cannabis-containing medicines in South Africa. According to SAHPRA it is currently considering the entries for cannabis and related substances in the Schedules.
Exempted CBD containing products
On May 23, 2019, the Minister of Health published a notice in the government gazette which effectively excluded the operation of the Medicines Act in as far as it related to certain CBD products for medical use for a period of 12 months. The exemption applied to those products which:
- Contain a maximum daily dose of 20mg CBD with an accepted low risk claim or health claim
- Consist of processed products made from cannabis raw plant material, where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product, and which contain no more than 0.001 percent of THC and no more than 0.0075 percent of total CBD.
The effect of the Notice is that the above CBD products may be sold, exported and/or imported without a license or permit from the Director-General and may be purchased at any retailer without a prescription. The sellers of such products may not make any medicinal claims about the product unless these products fall within the definition of health supplements in terms of the Medicines Act. Hemp foodstuffs containing the exempted levels of CBD also have to comply with the requirements of the Foodstuffs, Cosmetics and Disinfectants Act, 1972. This regulates labeling, claims, advertising and content of foodstuffs. According to SAHPRA, CBD should not be included as an additive in foodstuffs; however, this is an untested interpretation.
The exemption is in place until May 23, 2020 unless extended.
In terms of sections 21 and 22A(9)(a)(i) of the Medicines Act, medical practitioners may apply to SAHPRA for permission to access and prescribe unregistered medicines, including medicines containing cannabis, to treat patients in exceptional circumstances.
Section 22C(1) provides that the Director-General may issue licenses to registered medical practitioners, dentists, veterinarians and other practitioners registered under the Health Professions Act 56 of 1974 to compound and dispense medicines.
Licenses to cultivate cannabis for industrial purposes may be undertaken by persons who hold a permit issued by the Director-General in terms of section 22A(9)(a). To date, only a handful of permits have been issued by SAHPRA. The cultivation of cannabis for medicinal purposes on a commercial basis requires a license issued in terms of section 22C(1)(b) from SAHPRA and a permit in terms of section 22A(9)(a)(i) from the Director-General.
A license can be issued for any or all of the following activities, including to:
- Grow and produce cannabis and cannabis resin
- Extract and test cannabis, cannabis resin and/ or cannabinoids
- Manufacture a cannabis-containing or cannabinoid-containing medicine
- Import a cannabis-containing medicine or cannabinoid-containing medicine
- Export a cannabis-containing medicine or cannabinoid-containing medicine
- Distribute a cannabis-containing medicine or cannabinoid-containing medicine
SAHPRA has, in January 2020, approved cannabis related clinical trials to be run by a consortium of parties, including government entities and a university.
To date, there are no registered cannabis-containing medicines in South Africa and any access to these medicines must be done in terms of the special circumstances exemption contained in section 22 of the Medicines Act.
The Constitutional Court judgment on personal use in private
According to the landmark judgment handed down in September 2018 by the Constitutional Court, South Africans are now permitted to use, possess and cultivate cannabis for personal consumption in private.
The basis of the court’s decision was that the prohibition on the use of cannabis by an individual in private, and the cultivation of cannabis in private and for private use, was inconsistent with the Constitutional right to privacy. The court also considered that there was no evidence to suggest that cannabis could be any more harmful than alcohol.
The South African legislature was given 24 months to amend the Drugs Act and the Medicines Act to allow for the possession and cultivation of cannabis for personal use. Until such time that the legislation is amended, South Africans will not know the exact allowable quantity or composition of cannabis or cannabis products.