What on earth is going on at the South African Health Products Regulatory Authority (SAHPRA)?
The regulator said earlier this year that it would be overhauling its systems in the face of technical inefficiencies and widespread abuse of Section 21 of the Medicines Act, but has since retreated behind a wall of silence.
No Section 21’s appear to have been approved by SAHPRA since 18 July 2026
Cannabiz Africa has emailed the regulator requesting clarification on the issue but to date has not received any response . We will publish SAHPRA’s response and/or any media statement the regulator may send out if and when received.
Anton Ofield-Kerr is CEO of AKOS BIO Pharmacy, which is likely the only fully regulatory compliance pharmacy in South Africa that enables clinicians to access South African GMP cannabinoid medicines which is otherwise all exported. He tells Cannabiz Africa that SAHPRA appears to have authorised its last Section 21 approval on or around 18 July 2026. Ofield-Kerr says that as far as he is aware, no other medical cannabis service provider has had a request approved since then.
“We want to be really clear about this: AKOS BIO Pharmacy supports SAHPRA’s crackdown on the grey-market abuse of Section 21 — providers using it to supply recreational demand under a medical label was never going to be sustainable, and SAHPRA is right to close that down”.
Ofield-Kerr: Blanket suspension is not the answer
But, he says, a blanket suspension of all Section 21 applications is not the answer as genuine medical cannabis patients are being unfairly treated. He says SAHPRA should have used a more targeted approach around compliance.
“AKOS BIO Pharmacy is a fully regulatory compliant registered pharmacy dispensing NAPPI-coded oral cannabinoid medicines working with registered prescribers treating patients with complex drug resistant conditions under systematic clinical monitoring, and we’ve had zero approvals — for genuine, documented patients with epilepsy and a range of refractory neurological conditions since 18 July” he says.
“That’s over 30 patients in our care alone left without a route to treatment, through no fault of their own. We’d welcome the chance to work with SAHPRA to ensure South African patients do not lose their constitutional right to access treatment for complex health condition.”
SACHIDA: If Section 21 is to be replaced, what’s replacing it?
The South African Cannabis and Hemp Association (SACHIDA) has confirmed that its members are struggling to get information from SAHPRA. Deputy chair Cian McClelland told Cannabiz Africa on 16 September 2026 that he was still trying to obtain further details, but was deeply concerned about the negative impact this will have on medical users, particularly those living with chronic pain.
He noted that the lack of information, combined with continued uncertainty over what will replace Section 21, is making the situation far worse than it needs to be.
A source in the sector, who wishes to remain anonymous, tells Cannabiz Africa that Section 21 appears to have hit the ceiling as a pathway to medical cannabis access.
“Section 21 of the Medicines Act was never intended to be for prescribing cannabis, and was designed for approving medicines for which there were no alternatives available on the local market,” says the source.
“SAHPRA historically found Section 21 a useful control mechanism, but I think they’ve worked out that it’s not fit for purpose. Not only are they very worried about the widespread abuse by operators who are misusing Section 21 to supply the non-medical market, but they must be concerned about their own compliance.”
“I mean, cannabis is being prescribed for anxiety and sleep under Section 21, but there are hundreds of alternative non-cannabis products available for these maladies. So how can SAHPRA authorise cannabis prescriptions using Section 21 without breaking its own rules? It’s a joke.”
Actually, it’s not a joke. SAHPRA’s concern about Section 21 misuse is having seriously negative consequences for genuine medical cannabis patients.
Negative impact is not hypothetical
Ofield-Kerr tells Cannabiz Africa that AKOS BIO Pharmacy is the dispensing pharmacy for a number of neurologists and paediatricians treating patients with refractory conditions such as multi-drug-resistant epilepsy and severe neurological conditions with very positive results.
Far from a pilot programme just getting off the ground, these are established, clinically monitored prescribing relationships — patients enrolling at a rate of several a week, with outcomes systematically tracked by treating clinicians as well as AKOS BIO Pharmacy’s responsible pharmacist.
“This isn’t a hypothetical. AKOS BIO Pharmacy dispenses for prescribers who’ve been treating children with drug-resistant epilepsy and severe neurological conditions for the best part of a year now, with results good enough that we’re seeing steady referrals from other clinicians.
“Our patients have seen seizure frequency of up to 120 a day reduce by over 95% once established on our hight dose cannabinoids. We presented our model and results to the Neurological Association of South Africa congress in May this year – many neurologist welcome the ability to access hight dose GNP manufactured CBD medicines for their most challenging patients.
‘Every week of rejection is a week for a patient who can’t be helped’
“Every week that goes by that SAHPRA routinely rejects every application is a week a patient who could be helped isn’t being helped. We understand SAHPRA needs to protect Section 21 from abuse, and we’re not asking for a return to a system with no oversight.
“What we need is a route — whether that’s individual approvals resuming, or a cohort-based authorisation for monitored programmes like these — that lets clinical decision-making happen again for the patients already in treatment and the ones waiting to start.”
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