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Medical Cannabis SA: Here’s What You Need to Know
There has been a huge upsurge of Section 21 medical cannabis patients in the last year, with SAHPRA expressing concern that many ‘dispensaries’ offering this service are actually just a front for ‘recreational’ sales. Just what is the current legal landscape in terms of medical cannabis in South Africa? Bassani Medical Cannabis CEO Mike Stringer lays down the line.
Mike Stringer, CEO Bassani Medical Cannabis
8 October 2024 at 09:00:00
This article was first published by Bassani Medical Cannabis on 6 August 2024.
Under the Medicines Act, and in line with the Single Convention, the use, cultivation and harvesting of cannabis and the manufacture of cannabis-containing products for medicinal use may only occur through a licence issued by the SAHPRA and a permit in case of manufacturing, issued by the Department of Health.
The sale of medical cannabis and cannabis intended for recreational use was ambiguous in South Africa and many businesses were created on the back of the Constitutional Court ruling and were deemed as illegal operators. The 2024 legislation provides a comprehensive framework that addresses these ambiguities.
The Cannabis for Private Purposes Act outlines the following key provisions:
1. Personal Use and Cultivation: Adults aged 18 and over are allowed to possess up to 600 grams of dried cannabis per person and cultivate up to eight plants per household for personal use. Sales of this product is strictly forbidden.
2. Public Consumption: Public consumption of cannabis remains prohibited, similar to the regulations governing alcohol use. This measure aims to balance personal freedom with public health and safety concerns.
3. Commercialisation: While personal use is decriminalised, the commercial sale of cannabis requires stringent licensing. This regulatory approach seeks to ensure quality control, prevent underage access, and curb the illegal market.
4. Medical Cannabis: The act expands access to medical cannabis, allowing healthcare professionals to prescribe cannabis-based treatments for various conditions. It also promotes research into the therapeutic benefits of cannabis.
5. Social Equity Programs: Recognising the historical injustices of cannabis criminalisation, the legislation includes provisions for social equity programs.
To date, there are no registered cannabis-containing medicines in South Africa, though under the Medicines Act, people can acquire, use, and possess cannabis for medical use if they have a permit from a medical practitioner.
Unpacking Section 21 of the Medicines Act
The Medicines Act also allows medical practitioners to apply for a license to import and distribute cannabis-containing medicines. Under Section 22A(5)(f) of the Act, medical practitioners may prescribe and supply Dronabinol which is a registered in most parts of the world but not South Africa.
The Medicines Act enables patients to access unregistered, medical cannabis products for therapeutic purposes through the provisions of section 21 of the Medicines Act. For patients to access these unregistered medicines, a registered medical practitioner or authorised prescriber needs to apply to the SAHPRA on the patient’s behalf, to allow for the purchase and use of unregistered medicine as a treatment regime.
Verified by Cliffe Dekker Hofmeyr, once the section 21 application is complete, patients can access medical cannabis products through a variety of online and, more recently, physical pharmacies that are authorised to acquire and distribute medical cannabis products.
“However, the section 21 procedure highlighted above may be considered a stop-gap measure until registered cannabis medicines become more prevalent locally and are available for prescription by pharmacies across the country”.
THC was amended to Schedule 6, except for private adult use of the plant or its derivatives and if they have/claim no pharmacological action or medicinal purpose. Schedule 6 and Schedule 7 are narcotics and other controlled substances and products like morphine and heroin. These are not easy to access and, according to South Africa’s Medical Society, “are only used in extreme cases”.
It is important to note that if cannabis products claim any medicinal benefits, they face regulatory conditions which have to be substantiated with clinical trials. There is no such data available for any cannabis product in South Africa. Going the Section 21 route is thus the only way one can transact with cannabis for medicinal use.
'Current dispenseares are 'trading on a fine legal edge'
The current “dispensaries “selling Cannabis for medical use are mostly trading on a fine legal edge and many may be breaking the law. It is, however, a business which should be allowed to operate, as long they comply with the guidelines.
These businesses will pave the way and the direction for legislation drafting and the inclusive manner in which it should be written. This is the approach in which the German traders operated and they paved the way for their authorities to adapt the legislation to meet their demands.
THC is a mind-altering cannabinoid which has significant medicinal benefits but it cannot be expected to use medication that can influence our ability to operate effectively in the workplace. This is where the medicinal use needs control and this can be done with proper scientific manipulation, without compromising the effectivity of the cannabinoids.
Blending certain cannabinoids like THC and CBD is certainly a start as this combination reduces the psychoactive effect and it can even be eliminated.
Low-potency varieties would also be less harmful because of their lower amount of THC and potential compresence of another cannabinoid (CBD), which seems to mitigate THC detrimental effects. A growing body of studies begins to suggest that CBD may not only provide protective effects against the psychotomimetic effects of THC but even therapeutic properties on its own, opening new prospects for the treatment of psychosis.
Future research will need to optimize the pharmacological manipulation of the endocannabinoid signalling before any cannabis-related medical product for the treatment of psychosis and cognitive impairment might actually make it to the market.
So, in reality, cannabis for medical use is in its infancy and the current international markets have thus adapted their legislation to meet the growing demand despite clinical trials lagging behind this demand. In the interim, patients are smoking highly potent THC-laden flower as means to find a natural alternative to anxiety, stress, pain, sleeplessness and many other diseases. This is not sustainable as the psychoactive impact is detrimental to normal productivity.
Use after hours is key but impossible to control in the working environment. Let’s see how Germany deals with this process as I am of the opinion that we will have some exciting challenges when patients use highly potent THC-laden medical cannabis during working hours.
To control this is going to be challenging as each person reacts differently to THC.
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