By Andy Gray
Division of Pharmacology, Discipline of Pharmaceutical Sciences, University of KwaZulu-Natal
After many years of simple prohibition, the world is in the process of re-evaluating its attitude to and regulation of cannabis and products made from the plant. Cannabis is widely grown, in almost all countries, and has been used for various reasons for millennia.1 In September 2018, the Constitutional Court found provisions of both the Medicines and Related Substances Act (Act 101 of 1965) and the Drugs and Drug Trafficking Act (Act 140 of 1992) to be unconstitutional, insofar as they apply to cannabis.2 Parliament has been given 24 months to amend the necessary legislation.
Despite a paucity of evidence, prescribers, patients and their carers may approach pharmacists seeking access to cannabis- or cannabinoid-containing medicinal products. Among the indications for which access is sought, and for which some evidence is available, are spasticity, pain, nausea and vomiting and epilepsy.3 However, new evidence is rapidly being generated for an even wider range of applications.
The South African Health Products Regulatory Authority (SAHPRA) has already taken a number of steps to enable regulated access to quality-assured medicines containing cannabis and cannabinoids. Firstly, access to products that are legally marketed in other countries is possible in terms of section 21 of the Medicines Act.4 Secondly, SAHPRA has initiated the process to issue cultivation licences for medicinal cannabis.5 Thirdly, the Minister of Health has exempted certain cannabidiol (CBD) preparations from the operation of the Schedules for a 12-month period from May 2019.6 Exemptions were made for those preparations that: (1) contain a maximum daily dose of 20 mg CBD with an accepted low risk claim or health claim which only refers to: (a) general health enhancement without any reference to specific diseases; (b) health maintenance; or (c) relief of minor symptoms (not related to a disease or disorder); or (2) consist of processed products made from cannabis raw plant material and processed products, where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product, and which contain not more than 0,001 % of tetrahydrocannabinol (THC) and not more than 0,0075 % total cannabidiol (CBD). CBD has already been listed in Schedule 4, whereas THC is listed in Schedule 6 when intended for therapeutic purposes. Further changes to the Schedules are currently under consideration.
At the time of writing, there were no registered cannabis-containing medicines on the South African market. Access to such products can therefore only be via section 21 approval, or in terms of the May 2019 exclusion notice. Medicinal products that comply with the exclusion notice will still need to be manufactured in accordance with current Good Manufacturing Practice standards by a SAHPRA-licensed manufacturer (in terms of section 22C(1)(b)).
In November 2019, SAHPRA and the South African Police Service issued a joint statement, warning that “dealing in cannabis is still illegal”.7
Pharmacists need to be ready to respond to these changes, but also offer clear, upto-date, evidence-informed advice to the public now, and very cautiously and judiciously decide which, if any, cannabis-related products to place on their shelves.
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1 Ren M et al. The origins of cannabis smoking: chemical residue evidence from the first millennium BCE in the Pamirs. Science Advances 2019: 5(6): eaaw1391. DOI: 10.1126/sciadv.aaw1391
2 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] ZACC 30. URL: https://collections.concourt.org.za/handle/20.500.12144/34547
3 Whiting PF et al. Cannabinoids for medical use: a systematic review and meta-analysis JAMA 2015; 313(24):2456-73. DOI: 10.1001/jama.2015.6358
4 SAHPRA Section 21 guidance document. URL: https://www.sahpra.org.za/documents/06b69aa69.113_Section_21_Authorisation_Oct18_v2.pdf; applications need to be made electronically via https://goo.gl/forms/RcM1Kbh6Q9tEUy5Z2
5 SAHPRA to issue cultivation licences for medicinal cannabis. 16 April 2019. URL: https://www.sahpra.org.za/documents/773202cd10.23_Media_Release_Cultivation_Licences_for_Medicinal_Cannabis_Apr19_v1.pdf
6 Minister of Health. Exclusion of certain preparations containing cannabidiol (CBD) from operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965). Government Notice No. 756, Government Gazette No. 42477, 23 May 2019. URL: https://www.gov.za/sites/default/files/gcis_document/201905/42477rg10949gon756.pdf
7 Joint SAHPRA/SAPS media release: Warning: SAPS warns that dealing in cannabis is still illegal. URL: https://www.sahpra.org.za/documents/7a39fccbMediaRelease-SAPSandSAHPRA.pdf
