Eastern Cape lawyer Ricky Stone, of Cullinan and Associates, is the only person who appears to have squeezed a Section 21 approval out of the South African Health Products Regulatory Authority (SAHPRA) in the past few months.
That’s because he was acting on behalf of a medical services provider to get specialist cannabis medicine for epilepsy reinstated to a child, and threatened to take the regulator to court.
Speaking on Cape Talk Radio on 4 November 2026, Stone said that doctors prescribing medical cannabis to patients should not be put off by SAHPRA’s refusal to approve any new applications or re-applictions for treatment under Section 21 of the Medicines Act. Stone said it was clear the system was being abused, but that SAHPRA could have come up with an alternative to the blanket halting of all applications.
Stone said SAHPRA was on questionable legal grounds by preventing patients with legitimate clinical needs from accessing unregistered medicines through the legal mechanism provided for in the Medicines Act.
Patients and their doctors may have grounds to challenge rejected applications through the courts, he said.
“The regulator cannot simply refuse applications without properly considering them”.
Stone said SAHPRA had been refusing every new application since July 2026, without publicly communicating a reason for the decision.
He argued that this did not mean doctors should stop submitting applications. Instead, he suggested that they continue submitting applications and consider further legal steps if they were rejected.
“The law requires SAHPRA to consider them, to apply their minds and to make a rational decision,” he said.
He acknowledged that the system had become problematic, with large numbers of people obtaining access to cannabis through a provision intended for exceptional circumstances.
He said hundreds, if not thousands, of applications had been submitted, with the process becoming remarkably easy to navigate.
“You could probably get one on this call by sending an SMS and saying you’ve got an old sports injury, or you can’t sleep at night, and you would have got your application,” he told talk show host Jon Maytham.
Stone said this undermined the original purpose of Section 21, which was to provide access to unregistered medicines in exceptional circumstances.
He argued that many adults had been using the provision to obtain cannabis legally, rather than because they were seriously ill and needed access to an otherwise unavailable treatment.
“It’s been largely abused, to put it bluntly,” he said.
He highlighted the importance of distinguishing between applications made for genuine medical reasons and those exploiting the system.
SAHPRA has so far chosen not to respond to emails from media outlets requesting clarity on medical cannabis access.
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