Medical Cannabis: South Africa’s highest court has made the decision to decriminalize cannabis for private use. This makes SA the third country in Africa to do so after Lesotho and Zimbabwe and includes the right to possess, consume and cultivate the cannabis plant. So, we will now begin to see a whole host of cannabis-related products appear in the South African market place.
Already, one of South Africa’s major beverage groups has started to advertise and market a hemp oil-infused beer. There are no products containing the psychoactive THC (tetrahydrocannabinol) available on the mainstream public. Even though SA has now taken the right step into the cannabis industry, the legal aspect regarding medical use remains undeveloped and still somewhat misunderstood.
New Cultivation Guidelines for Medical Cannabis
Cultivate or obtain medical cannabis require certain guidelines to be followed. In November 2017, the South African Health Products Regulatory Authority (SAHPRA) along with the department of agriculture and Forestry and Fisheries published this guideline.
This was done in order to promote local cultivation of cannabis for medical use. This seemed like a practical idea at the time, however, this guide contains impractical and strict requirements. In order for someone to cultivate cannabis for medical and research purposes they will need to meet requirements regarding these aspects of cultivation:
- Storage and Distribution
- Buildings and Infrastructure
- Record Keeping
The main drawback with the growing requirements is that some of these are aimed at traditional allopathic medicines. These guidelines are not all suited to the cultivation of medical cannabis.
In terms of obtaining growing licenses from SAHPRA under the medicines control act, this will allow you to:
- Distribute medicine containing cannabis
- Import medicine containing cannabis
- Export medicine containing cannabis
- Manufacture a cannabinoid or cannabis-containing medicine
- Produce and cultivate cannabis and cannabis resin
- Test and extract cannabinoids, cannabis or cannabis resin
Schedule 7 substance
Anyone looking to produce therapeutic products containing THC or Dronibinol not only needs a license from SAHPRA but also need to apply for a permit from the director general of health. Only products containing CBD have been rescheduled from 7 to 4.
It is important to note that the medicines act still classifies the following as schedule 7 substances: This means that a license under the medicines act is required in order to obtain, possess, use, manufacture or distribute:
- Cannabis (the whole plant or any portion thereof), except:
- When separated and specified in another schedule.
- Hemp containing less than 0.1% THC.
- Products that don’t contain whole cannabis seeds.
- Products made from cannabis seeds that contain less than 0.001% THC.
- Cannabidiol that is not used for therapeutic purposes.
- THC that is not used for therapeutic purposes.
- THC and alkyl homologues, except:
- When separated and specified in the schedules.
- Cases involving THC that is intended for therapeutic purposes.
- Cases involving hemp seed oil that contains 10mg per Kg or less of THC and is labeled “Not to be taken” or “Not for internal human use”.
- In cases involving products that are not intended for human use that contain 10mg per Kg or less of THC.
Medicines and Related Substances act.
Medical cannabis is any cannabis-containing product intended solely for medical use. This is regulated by the Medicines and Related Substances act.
Up to now, patients are only able to gain access to medical cannabis under section 21 of the medicines act. Healthcare practitioners can only prescribe cannabis under exceptional circumstances and will need to apply for permission to do so from SAHPRA. This application from your doctor, if you wish to obtain medical cannabis, will be dependent on:
- Submitting an effective and appropriate dosage regiment.
- Acceptable justification
- Reporting regularly to SAHPRA
SAHPRA will also need to be fully satisfied by the quality of the product that is intended for medical use.
In conclusion, the constitutional court found that:
- The production of cannabis by an adult in a private place for their personal consumption is no longer a criminal act.
- The use of cannabis in a public place (including smoking) or in the presence of children is still illegal.
- Any adult may use or be in possession of cannabis for their personal consumption in private.
- The use or possession of cannabis by anyone other than an adult in a private place for their personal consumption remains prohibited.
Even though cannabis remains highly controlled and regulated under the Medicines Act, the rescheduling of THC and cannabinoids for therapeutic use is certainly a step in the right direction. This definitely will help stimulate the medical cannabis market in South Africa and has already initiated the development of a regulatory framework for the cultivation of cannabis and cannabis-related products. Now that South Africa’s constitutional court has made their ruling, parliament has been given 24 months to apply the new legislation.
So after all this, where does it leave the regular South African that wishes to obtain a license to grow cannabis for medical use? Currently, unless you hold a pre-existing product it is very unlikely that SAHPRA will issue an applicant a manufacturing license. This sounds like a downer. It seems like a pre-existing registered product may not be needed for a cultivation license.
Most newbie’s to cultivation are not likely to already have registered products. How are we supposed to enter the market? The best way around this roadblock is to simply join with established manufacturers and act as a supplier of raw materials or as a contract manufacturer.
Even though the medical cannabis industry in South Africa has taken the right steps in the right direction. The over-complicated guidelines and regulations make entry into the market by regular growers almost impossible.
Written, January 2019
~ Medical Cannabis Seed Bank