By Rodney Africa, Partner, Adriano Esterhuizen, Partner & Daveraj Sauls, Associate at Webber Wentzel
The Minister of Health (the Minister) in terms of section 22A(2) of the Medicines and Related Substances Act 101 of 1965 (the Medicines Act), and on the recommendation of the South African Health Products Regulatory Authority, has invited interested persons to submit substantiated comments or representations on the proposed update of Schedule 6 to the Medicines Act.
The proposed update to Schedule 6 of the Medicines Act intends to exclude certain cannabis products containing Tetrahydrocannabinol (THC), the psychoactive compound in cannabis, from the operation of the Schedules to the Medicines Act and will, inter alia, permit the manufacturing of cannabis consumer items and products, with no limitation on the percentage of THC content, provided that the items and products have no pharmacological action or medicinal purpose. This will also allow adults to cultivate and possess cannabis in private for personal consumption, with no limitation on the percentage of THC content.
This proposed update appears to be a move away from utilising THC content as a threshold to distinguish between consumable and industrial cannabis. This shift seemingly comes in response to the growing South African market for cannabis products and aims to augment the Cannabis for Private Purposes Bill 2023 [B19 – 2020] recently passed by the National Council of Provinces and submitted to the President for his assent and signature.
For the management of children’s cancer symptoms, cannabis products have increased in popularity, but questions remain over their efficacy and safety. A recent review of published studies to date shows a lack of evidence to determine the dosing, safety, and efficacy of medical marijuana or cannabis-containing products for managing symptoms experienced by children with cancer. The analysis is published online in CANCER, a peer-reviewed journal of the American Cancer Society.
Although great strides have been made in treatments for childhood cancer, even leading to cures for many patients, many children still suffer from symptoms such as pain, anxiety, and weight loss related to cancer and its treatment. Over the last decade, cannabis products, both synthetic cannabinoids and natural phytocannabinoids, have gained popularity with patients and families for managing such symptoms, but paediatric oncologists are cautious to authorise cannabis for their patients given the limited data to inform dosing, product selection, and safety monitoring.
To provide insights for clinicians and parents, and to inform an upcoming clinical trial, a team led by Lauren E. Kelly, PhD, associate professor of pharmacology and therapeutics in the Rady Faculty of Health Sciences at the University of Manitoba, searched the medical literature to summarise existing knowledge about the potential benefits and harms of cannabis products in children with cancer.
The investigators identified 19 unique studies with a total of 1927 participants with cancer: eight retrospective chart reviews, seven randomised controlled trials, two open‐label studies, and two case reports. The products studied included medical-grade cannabinoids (such as the prescription drug nabilone), synthetic cannabinoids, and unspecified cannabis herbal extracts. Products were most commonly used to manage chemotherapy‐induced nausea and vomiting.
In the randomised controlled trials, patients who used cannabinoids were more likely to experience drowsiness, feeling high, dizziness, and dry mouth. Also, trial participants who received cannabinoids were almost four times more likely to drop from the study due to adverse events, compared with the control group who received placebo. Across all included studies, no serious cannabis‐related adverse events were reported.
Dr Kelly and her colleagues noted that most studies did not adequately describe the types, dosing, frequencies, and routes of administration of cannabis products, and outcomes were mixed and were reported in different ways. Therefore, researchers should develop standards for reporting cannabis exposures, cannabis‐related effects, and patient outcomes.
“It was difficult to measure benefit across studies, given a range of different outcomes and study designs; however, in interventional studies with active control groups, cannabinoids performed better in managing nausea and vomiting. Data are lacking on cannabinoids’ effects on pain, mood, sleep, and health-related quality of life,” said Dr Kelly. “Given that some children report benefits and some children experience adverse events, it is critical that more rigorous studies evaluating the effects of cannabinoids on children with cancer are conducted and shared with parents, patients, and the health care community.”
This literature review informed the design of a three-arm tolerability trial later this year.
I walked into a store in Cape Town and I bought a gram of cannabis for R100. With GroundUp’s money. I had my editor’s consent.
The store was small, dimly lit, and lined with a variety of cannabis products in glass jars.
On the table was a stack of medical forms used by a doctor to prescribe cannabis to people for health reasons.
I did not have a doctor’s note. So I complimented the salesman on his luscious black curls. I think it worked because he became very chatty. Let’s call him Bob.
We discussed how the store works and the current laws. He said they’re working in a “grey area”.
There are two ways the store sells cannabis to people, Bob explained.
Method one: the membership system. Bob said that members pay a monthly fee and receive a certain amount of cannabis over a month. He says this gets around the legal problem, which is, he says, that “buying and selling” are not allowed. With the membership system, Bob said, you’re not doing either.
Method two: the medical method. The store uses section 21 of the Medicines Act to facilitate medical sales.
Bob said he was keen for the store to use the medical route for customers during the day and to run a club in the evenings where members come and smoke in a chilled environment.
I explained to Bob that I get quite anxious when I smoke. I can hear myself think with an echo of my thoughts swirling in my brain. (Boring truth be told, I haven’t smoked cannabis in years, and I didn’t smoke what I bought either. I won’t reveal who did.) Bob recommended a specific cannabis for me.
I asked him if he could recommend a doctor so I could get a prescription. Laughing, he said that he was a doctor. I think he was only half-joking, because it seemed like we then used method two: the medical route. He took out a scale and some bright green cannabis. He weighed it, and sold me 1 gram of OG Kush for R100.
Nope, that’s not how the law works
Was Ashraf’s transaction legal? No, according to a lawyer with expertise in the cannabis industry whom we spoke to.
First, the lawyer explained, cannabis can only be produced in a facility licensed by the South African Health Products Regulatory Authority (SAHPRA). It’s unlikely that the store obtained its cannabis from such a licensed facility. In fact there is a view that even weighing out a small amount of weed from a bag obtained from a licensed cultivator, and then packaging it, is manufacturing.
Second, if Section 21 of the Medicines Act is to be used, the sale of the cannabis can only take place after the doctor has prescribed it and SAHPRA has authorised the sale of weed to that particular patient. (Ashraf didn’t even give Bob his name.)
Even if these two conditions are met, no sale of cannabis to a patient can take place outside of a retail or community pharmacy.
There’s nothing unique about Ashraf’s experience. Dozens of stores across the country are selling cannabis using the same approach. We got the impression that in Durban there isn’t even a pretence of trying to be legal as there is in some of the Cape Town and Johannesburg stores. Our experience in Durban is that you can pretty much walk into stores and simply buy cannabis over the counter without any fuss.
How it got this way
South Africa’s cannabis sector is in limbo five years after the Constitutional Court ruled that cultivation and possession of the plant for private use is legal.
In 1997, Gareth Prince, a practising Rastafarian, applied to the Law Society of the Cape of Good Hope to be admitted as an attorney. The Society rejected his application because he had two criminal convictions for possession of cannabis and he continued to smoke cannabis. Prince argued that the use of cannabis was part of his religion, and that the Law Society’s decision violated his right to religious freedom.
Prince took the decision to court in 1998. But the High Court, Supreme Court of Appeal and Constitutional Court ruled in favour of the Law Society. The Constitutional Court’s 2002 decision was close: five versus four.
After the Constitutional Court’s judgment, Prince and two cannabis activists – Jeremy Acton and Jonathan Ruben – approached the courts again. Instead of focussing solely on religious freedom, their applications challenged provisions of the Drugs Act and Medicines Act that criminalised the use of cannabis on the basis that these provisions violated the right to privacy in section 14 of the Constitution. As these challenges were related, the High Court consolidated the cases.
In 2017, the Western Cape High Court declared the provisions in the Drugs Act and Medicines Act that criminalise private adult use of cannabis unconstitutional. This decision was upheld by the Constitutional Court in 2018. This judgment has become known as Prince 3. But the Constitutional Court did not confirm the High Court order that decriminalised the dealing of cannabis. Parliament was given 24 months to deal with the offending legislation.
In the event that Parliament didn’t fix things within the two-year deadline, the court ruled that its reading-in remedy (which permits the narrow exception for personal use) would become permanent, at least until Parliament amended the law.
Five years later, the slow pace of drafting legislation following the Prince 3 judgment has resulted in a proliferation of businesses using “grey areas” in the wording.
“People are looking for gaps, so these so-called dispensaries are stepping into the market claiming to sell something legal,” explained Andy Gray, chair of the Cannabis Working Group at SAHPRA and a pharmacy lecturer at the University of KwaZulu Natal (UKZN).
Substances that you can ingest are scheduled by SAHPRA from 0 to 8. A schedule 0 substance has very few controls; anyone can sell it without any licence required. At the other end of the scale, a schedule 8 substance is very strictly controlled, it may have some medicinal benefits but also has extremely high potential for abuse. Medical practitioners have to get special permission from SAHRPA for use and prescription of any of these substances.
After the Constitutional Court ruling, SAHPRA lowered the schedules of some of the substances found in cannabis. Low doses of Cannabidiol (CBD), a component of cannabis that isn’t psychoactive, were lowered to schedule 0 in complementary medicine products. But it is unclear if CBD in products such as drinks and gummies, with their varying dosages, manufacturing processes and contents – found in nearly every major shopping outlet – qualify as “complementary medicines”.
Tetrahydrocannabinol (THC), the key psychoactive component of cannabis, was lowered from schedule 7 to schedule 6. But schedule 6 substances are still highly restricted: According to SAHPRA these are medical substances that have “a moderate to high potential for abuse” which necessitates strict control and management of supply, including restrictions on repeat prescriptions and a supply limit of 30 days’ worth.
Danmari Duguid is head of the cannabis department at Schindlers Attorneys who represented Julian Stobbs and Myrtle Clarke, intervening parties in the 2018 Constitutional Court case, Prince 3. She says that the only way you can legally buy cannabis containing THC is through the medical route. This is done using section 21 of the Medicines Act.
Why section 21 of the Medicines Act is important
In a nutshell, this clause is a way for people with particular needs to legally obtain medicines that have not been registered by SAHPRA, but contain scheduled substances. For example, patients with serious cases of lung or skin cancer use Section 21 authorisation to access a medication called nivolumab (branded as Opdivo). SAHPRA has registered a lung and skin cancer medicine called pembrolizumab (branded as Keytruda) but this may not work with every patient.
In the 2000s, the Treatment Action Campaign (TAC) famously imported a generic version of a drug called fluconazole to treat an illness that particularly affects people with advanced HIV disease. A patented version of the medicine was available in the country but it was extremely expensive. The much more affordable version of the medicine that the TAC imported was not registered in South Africa, so the then Medicines Control Council allowed a doctor working with the TAC to import the medicine for patients using section 21 of the Medicines Act.
But section 21 authorisations are far from a straightforward legal route to using cannabis as explained above.
Hardly any of the cannabis retailers that claim to use the section 21 process are adhering to what’s legally required. It is in theory possible but in practice very hard for small cannabis retailers to do so.
Also, the Cannabis for Private Purposes Bill, currently before Parliament, does not provide for a recreational or adult market.
Gray told GroundUp that he fears people who want to buy and sell recreational cannabis in private will continue to abuse the medical route.
This happened in California in the United States, where the state legalised cannabis through the medicinal route and this led to extensive abuse of the process by patients, doctors and retailers.
The most direct way to combat this abuse is through the introduction of an adult use market, said Gray. This would mean cannabis products would be highly regulated and taxed, similar to alcohol and tobacco. This model could include the “legacy” or “peasant cultivators” who grow cannabis in rural parts of the country, and cannot meet the strict conditions for growing medical grade cannabis, said Gray.
Duguid agrees that the adult use model would work best for the legalisation of recreational cannabis sale and use in the future.
“At the moment you are allowed to brew beer for your own consumption, similar to how you are now allowed to grow cannabis for your own consumption after the 2018 judgement; but the moment you want to retail the product you should need a licence like you do to sell alcohol. This would ensure you meet certain safety standards,” said Duguid.
The Department of Agriculture and Land Reform and the Presidency recently hosted the Phakisa Action Lab in June 2023, which brought together 130 representatives of government and business, religious leaders and legal experts to discuss the legalisation of cannabis and hemp.
The final report from Phakisa emphasised that the government is taking a “science-based and human rights approach” approach to creating and regulating an adult use market, but that the “supply and trade of cannabis to consumers remains illegal”.
The report suggests adding a clause to the Cannabis for Private Purposes Bill which would remove cannabis from the Drugs Act “subject to parliamentary process and approval”.
The report highlights that adult use legalisation must include “the existing historical cultivation of cannabis by indigenous communities and black rural farmers”.
But it does not provide a timeline for doing this.
In JAMA Network, researchers have published the first robust clinical study proving that medicinal cannabis effectively treats the debilitating effects of Tourette syndrome. Their findings show a statistically and clinically significant reduction in motor and vocal tics in as little as six weeks.
The researchers’ analysis found a significant association between levels of cannabis in the bloodstream and the response to active treatment.
THC (tetrahydrocannabinol) is the psychoactive compound in cannabis that produces a ‘high’ effect, while CBD (cannabidiol) is a non-psychoactive compound. Both are used medicinally in Australia.
Study co-author Professor Iain McGregor, the Academic Director of the Lambert Initiative, said: “We were delighted to be able to work with Professor Mosley and this team to deliver this important clinical trial showing the efficacy of oral THC and CBD in treating Tourette syndrome.
“This is such a difficult syndrome to treat. It severely impacts the quality of life of 1 in 100 young Australians. It is gratifying to know that our result provides strong evidence of an alternative treatment method for these patients in need.
“While there are well-known concerns about the side effects of THC on cognition and mental health, this trial demonstrates that careful dosing with THC in an oral formulation is very well tolerated in a relatively young patient group.”
The study involved testing 22 adult patients with severe Tourette symptoms. In the double-blind study, participants received both medicinal cannabis oil and a placebo over two six-week blocks.
“This is the first rigorous and methodical trial of medicinal cannabis to be undertaken in a sufficiently large group of people to make definitive conclusions about its effectiveness,” said neuropsychiatrist Dr Philip Mosley, who led the clinical trial.
“It shows that medicinal cannabis can reduce tics by a level that makes a life-changing difference for people with Tourette syndrome and their families.
“In addition, we found that other symptoms associated with Tourette syndrome in our participants also reduced, particularly symptoms of obsessive compulsive disorder and anxiety.”
Tourette syndrome affects about 1% of the population and is four times more common in men than women. The neurological disorder often begins in childhood and is characterised by involuntary movements and vocalisations, or tics.
“Cannabis interacts with specific receptors on nerve cells in the brain that are part of the body’s own ‘endocannabinoid’ system,” Dr Mosley said.
“Effectively, stimulation of these receptors tightens a leaky filter that now stops the involuntary movements and vocalisations from getting out and being expressed by our participants.”
