SAHPRA has reportedly closed the only legal pathway to medical cannabis. The regulator appears to have stopped approving Section 21 applications under the Medicines Act, prompting an outcry from service providers and putting patients’ health at risk.
Section 21 allows doctors to prescribe an unregistered medicine where no registered alternative is available. It needs SAHPRA approval and is widely used across the pharmaceutical industry.
For medical cannabis, it is currently the only legal route.
It now appears SAHPRA has halted approvals of all Section 21 applications and reapplications for medical cannabis. SAHPRA has not confirmed whether Section 21 has been closed, or what the alternatives are. SAHPRA did not consult anyone in the sector before taking this unilateral decision. Repeated requests for comment since 15 September 2026 have had no official response.
Patients and service providers are paying the price for SAHPRA’s incompetence
AKOS BIO CEO Anton Ofield-Kerr says patients are already being hurt.
“Our records show that SAHPRA stopped approving applications on 18 July 2026. The only approval I knows of since then was for a three-year-old with Dravet syndrome, a rare form of epilepsy, and only after a lawyer’s letter threatened court action” he told Cannabiz Africa on 9 October 2026.
He says the sector has invested heavily in doing things properly. That includes GMP manufacturing with batch testing and certification, prescribing within clinical guidelines, and dispensing through licensed pharmacies.
Each Section 21 application is a detailed clinical submission compiled by the treating specialist. It covers the patient’s history, previous treatments, clinical motivation, dosing plan and the product’s quality documentation.
“AKOS BIO built its model on regulatory compliance,” says Ofield-Kerr. “Specialists and their staff put hours into every application, and we have invested years developing a regularity compliant model which SAHPRA themselves endorsed before its launch in September 2024. Doctors who followed every rule can no longer get approval for patients with serious conditions who benefit from high-quality cannabis medicine. The sector wants to work with the regulator. We need clarity and a workable pathway now.”
AKOS BIO’s Responsible Pharmacist, Courtney Yip, says: “As a pharmacist, my first concern is continuity of care. These patients have conditions like severe epilepsy, and their specialists have prescribed a GMP-certified medicine that is working. Interrupting treatment suddenly puts them at risk, and families are being left without answers.”
The clearest example is Mathew Kendall, 28, from Kommetjie in the Western Cape. He has refractory epilepsy and had been receiving treatment as an approved Section 21 patient. His reapplication was first rejected over an incorrect code. When his specialist corrected it and resubmitted, it was rejected again with no reason given.
“It drives me crazy when I look around and see how freely available illegal cannabis is for social use,” says his mother, Ursula Kendall. “But here I am, trying to go the legal, ethical path for my boy, whose quality of life has been made so much better. And it’s being disallowed. How is this right?”
Taariq Mohamed, founder of Curated, a health technology platform designed to connect prescribing, pharmacy dispensing and patient follow-up to build evidence on medical cannabis treatment, says the sector wants to work with SAHPRA on sustainable pathways, but the regulator is non-collaborative.
“One of the grey areas in medical cannabis is compounding,” says Mohamed. “This is where a pharmacist prepares medicine for an individual patient on prescription. We have engaged directly with SAHPRA, but questions about how existing rules apply to cannabinoid ingredients remain unresolved.
“We have built Curated to make care more traceable. SAHPRA should provide clear, practical guidance so patients are not left to carry the consequences of regulatory uncertainty.”
Lack of regulations encourages ‘lie to get high’
Myrtle Clarke, CEO of Fields of Green for ALL, says one problem is that Section 21 is being misused by some operators.
“With the granting of our constitutional right to use, possess and cultivate cannabis in private places, came changes to the Medicines Act and some nefarious operators used the Section 21 permits for access to unregistered medicines from SAHPRA to muddy the waters between medical and adult use” she says.
“We have termed this the “lie to get high” situation and is the direct result of a lack of clear, enforceable regulations in both sectors and the unfair economic advantage enjoyed by the corporations who used this loophole to the ultimate detriment of the entire sector, including patients who genuinely, desperately need the medicine.”
As a consequence of the chaos triggered by SAHPRA, a Cannabis Crisis Committee has been formed by key stakeholders and will host a Section 21 Crisis webinar for interested parties on Thursday 29 October 2029 at 12h00.
The interim Cannabis Crisis Committee consists of Anton Ofield-Kerr, pharmacist Courtney Yip and Ed Justice of AKOS-BIO , Taariq Mohamed of Curated, Myrtle Clarke of Fields of Green for ALL (FGFA), Jacqui Farage of the South African Cannabis Association of Professionals (SANCAP), consultant Adrian Coutts, policy specialist Shawn Shelley and Cannabiz Africa publisher Brett Hilton-Barber.
For more information about the Cannabis Crisis Committee and for more details contact Ed Justice at ed@equalinternational.org.
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