The only way South Africans can legally buy cannabis is by having a prescription issued in terms of Section 21 of the Medicines Act. This is an exemption that allows a medical practitioner to prescribe a drug for which there is no effective registered alternative.

Although patients have to be registered with SAHPRA, what is unclear is the actual source of supply offered by many ‘Section 21 service providers’.

Because of the Kafkauesque legal situation in which SAHPRA-licensed cultivators are not allowed to sell their product in South Africa, much of the ‘medical cannabis’ being consumed locally is imported (with SAHPRA approval). This is an expensive irony for legal and illicit growers who are sitting on stockpiles of biomass. It is an open secret that many SAHPRA-licensed cultivators are supplying the local ‘black market’ in desperation because of difficulty in meeting export quality standards.

Many of the ‘grey zone’ cannabis retail outlets that have sprung up in the metros in the past offer a ‘Section 21 service’, whereby an in-house doctor will prescribe cannabis after a consultation with the patient and support his or her application to SAHPRA to become a registered medical cannabis user.

SAHPRA is concerned about the number of applications it has received for Section 21 exemptions. Cannabiz Africa  sources say there has already been an administrative review of applications and that a physical clampdown is imminent on how medical cannabis patients are being supplied.

Cannabiz Africa contacted SAHPRA a week ago for official comment on the Section 21 issue and how many registered medical cannabis patients there are in South Africa, but to date has received no response.

According to SAHPRA’s guidelines to Section 21 access, released in January 2024,:

“The main purpose of any authorisation granted in terms of section 21 of the Act is to provide access to medicines on an exceptional basis, where conventional therapies have been ruled out, have failed or are unavailable. This must always have regard to the safety, efficacy and quality of medicines accessed through section 21 which are set out in regulation 29. Affordability on its own is not generally a significant reason to grant a section 21 authorisation, however, applications will be considered on a case-by-case basis.

Internationally-backed Cannabis Clinics South Africa is probably the biggest issuer of medical cannabis prescriptions in the country, and enjoys the brand exposure of ‘trusted partners’ like Clicks and Wellness Warehouse. It offers to “assist South African patients seeking access to legal, (their italics) local and imported pharma-grade medicinal cannabis through either using text, voice, online video or in-person consultations. It was established in 2016 and has prided itself on compliance.

The same cannot be said of many other ‘informal’ cannabis outlets that have sprung up, offering a ‘Section 21 service’ and selling illegal flower to customers as their 'prescription'.

One doctor, who wished to remain anonymous, said: “Section 21, as its being used, is giving cannabis a bad name; it’s not a ‘cure-all’ solution and its legitimate medicinal use should not be confused with non-medical use. The whole system needs to be relooked at because it is open to abuse”.

Lawyer Paul Michael Keichel of Cullinan and Associates says there is no doubt that Section 21 is being abused. He told Cannabiz Africa that one had to look closely at the purpose behind Act, particularly the phrase “exceptional basis”, to see the problem.

The SAHPRA Guidelines state that:

“This scenario considers access to unregistered medicines for the treatment, diagnosis, or prevention of conditions, diseases or disorders for an individually named patient when conventional therapies have been considered and ruled out, have failed, are unsuitable or unavailable as marketed products. Section 21 access should be an exception and, where possible, post-trial, open-label or compassionate access provisions should be incorporated into medicine development plans to meet the needs of patients not eligible for enrolment in clinical trials.

Keichel said that it was hard to apply ‘exceptional basis’ to the way medical cannabis was currently being prescribed for ailments such chronic pain, inflammation and insomnia.

Afriplex CEO Danie Nel said Impilovest had considered offering a Section 21 service as part of its cannabis health assets but had pulled the plug on the project because of the controversy over medical cannabis prescriptions.

READ SAHPRA’s 'Section 21 Access to Unregistered Medicines Guidelines' HERE

Schindlers Attorneys take on Cannabis and Section 21:

Cannabis, intended for medicinal uses, certainly, meets the definition of “Medicine” in section 1 of the Medicines Act, as it purports to be suitable in the terms listed therein. At present, no cannabis-containing medicines have been registered in South Arica.

In practice, applications in terms of section 21(1) can only be made on behalf of individual patients by their attendant medical practitioners. The medicine, which forms the subject matter of an application in terms of section 21(1), must be registered in another jurisdiction which is recognised by SAHPRA, but must not be registered in South Africa.

The section 21(1) procedure, therefore, allows medical practitioners to import an unregistered medicine to administer to specific patient, subject to a strict dosage regime. However, if that medicine contains a schedule 7 substance, such as cannabis, the relevant doctor must also apply for a s22A(9) Permit, as detailed above, and for a further permit in terms of section 22A(11)(a) of the Medicines Act, which must be obtained when anyone intends to import or export a substance which is categorised in is in schedules 5 to 8 of the Medicines Act (“s22A(11) Permit”).

Statistics on medical cannabis use in South Africa are not readily available.

It is estimated that the number of South African medical cannabis patients are in the thousands as there is no public record available. Statistics from elsewhere show an explosion of medical cannabis patients in those jurisdictions that have a clear regulatory framework, such as Germany, the UK, Australia, Canada and Israel.