Anri Hornsveld of the Pharmaceutical Association of South Africa (PASA) says the pharmaceutical supply chain is going through a severe disruption and there has been a shortage of certain medicines nationwide. The conflict in the Middle East has created delivery backlogs, especially in medicines being imported from India.
She says this has put all the more pressure on alternative access pathways, such as Section 21. Cannabz Africa understands that SAHPRA has not approved any medical cannabis applications since mid-July 2026, but cannot establish whether Section 21’s are being processed for alternative medicines other than cannabis.
SAHPRA has not issued any clarification on the issue and has not responded to numerous emails in the past 10 days.
Speaking to Rapport on 20 September 2026, Hornsveld said that in general there were ongoing and serious problems with SAHPRA’s Section 21 online application system and this was placing unnecessary pressure on medical service providers.
“Pharmacists report delays, unexplained refusals and difficulties with the portal”, she said. “and the inability to communicate directly with the application reviewer when an application is rejected or queried is not a viable or sustainable process”.
Although the pharmaceutical industry is seeking an urgent meeting with SAHPRA and the Department of Health, cannabis access is not a priority. Pharmacists are more concerned with the availability of mainstream medicines, and of particular concern is the SEP, the regulated price at which medicines above Schedule 2 must be sold.
The Section 21 crisis has also highlighted the lack of a single body that represents South Africa’s medical cannabis sector. Cannabiz Africa contacted the main cannabis medical service providers for comment, but there was an almost unanimous response of not wanting to go on the record until SAHPRA provided more clarity on the situation.
“Look we don’t really know what’s going on” said one CEO. “We don’t know if SAHPRA has deliberately halted approving Section 21’s for medical cannabis, or whether they’re just not coping. We don’t know whether this is applying just to medical cannabis or other medicines and we don’t know what alternative pathways they’re proposing. All we do know is that this is turning into a crisis that will be to the financial detriment of service providers and that ultimately the patient will bear the brunt of a broken system”.
“One thing I’ll tell you is that they are becoming very arrogant and hard to get hold of” said another services provider who did not want to be identified. “The frustrating thing is that the sector is desperate to develop legitimate pathways for medical cannabis access, and instead of welcoming our input, we are treated like children”.
The source said: “SAHPRA’s handling of its mandate is actually a disgrace. We’ve been saying for years that Section 21 (of the Medicines Act) is not an appropriate mechanism and that it is being widely abused. Now it seems like SAHPRA has suddenly woken up to the fact that Section 21 is legally unsound and is making a mockery of medical cannabis access. But instead of coming up with an alternative solution or working with the private sector, they’ve simply closed it down. It’s actually unbelievable! You’ve got to ask, how are they benefitting from being obstructive. It’s almost like they want to drive the cannabis back underground – medical and all”.
A source close to the regulator says SAHPRA’s has a motivation in shutting down Section 21 because abuse has been so widespread. “They can’t keep up with the applications, very few of which are for genuine medical concerns. Up to now they’ve been quite happy to take their R400 cut from every application processed as they need the money. But now I think they’re overwhelmed” she says.
“To be fair, cannabis is pretty far down on SAHPRA’s priority list, they are not policy makers but regulatory enforcers, and if the regulations don’t make sense, there’s a limit to which SAHPRA can be held accountable. Having said that, their professional standards are slipping, and they are going to have to do something to reverse the slide”.
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