Clarification comes on cannabis scheduling in the Medicines Act
Kudos to the health department for clarifying this at such a time, as cannabis can become an SA industry with exponential growth potential
On May 23 2019, the minister of health published a notice in the Government Gazette that excluded certain preparations containing cannabidiol (CBD) from the operation of certain provisions of the Medicines and Related Substances Act, No 101 of 1965 (Medicines Act).
This exemption provided that CBD-containing products could be sold in the market without full registration as a medicine if it contains a maximum dose of 20mg of CBD, with an accepted low risk claim, or health claim only referring to things such as general health enhancement, without any reference to specific diseases, health maintenance or relief of minor symptoms not related to a disease or disorder.
It also exempted preparations containing CBD, which consisted of processed products made from cannabis raw plant material and processed products, in which only the naturally occurring quantity of cannabinoids found in the source material are contained in the product, and which contain no more than 0.001% of tetrahydrocannabinol (THC) and not more than 0.0075% total CBD. This exemption was valid for 12 months and lapsed on May 15 2020.
However, on Friday, the department of health published an update to the Schedules of Medicines in Government Gazette No 43347, notice number R 586.
In terms of the amendments made to the schedules of the Medicines Act, CBD remains a schedule 4 substance, except in two circumstances:
- In complementary medicines containing no more than 600mg CBD per sales pack, providing a maximum daily dose of 20mg of CBD, and making a general health enhancement, health maintenance or relief of minor symptoms (low-risk) claim (schedule 0); or
- Where the processed products made from cannabis raw plant material intended for ingestion, containing 0.0075% or less of CBD, where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product (also Schedule 0).
From this update, and with the inclusion of this information on CBD in schedule 4, it would appear that the minister of health and the SA Health Products Regulatory Authority (SAHPRA) have attempted to address the matter of control over what goes into the local market by including some information from the previous exemption in the actual schedules, providing a more concrete and long-term solution to the many questions surrounding this specific aspect of CBD.
As expected, cannabis (or dagga or marijuana), the whole plant or any portion or product thereof remains included under schedule 7 with specific reference to the exceptions where different schedules apply to different types and applications of cannabis. Exclusions to this include:
- When cannabis is separately specified in the schedules, for example in schedule 4 and/or schedule 6; or
- In the case of processed hemp fibre containing 0.1% or less of THC and products manufactured from such fibre, provided that the product does not contain whole cannabis seeds and is in a form not suitable for ingestion, smoking or inhaling purposes; or
- Where the processed product made from cannabis seeds containing not more than 10mg per kg (0.001%) of THC and does not contain whole cannabis seeds.
This is a welcome addition to the information available until now, with the specific references to hemp fibre and cannabis seeds being addressed at last. Hemp fibre is a potentially huge source of income for many, with it being used for manufacturing of things such as pulp, paper, fabric and many other marketable products.
With SA moving forward to regulate medicinal cannabis and CBD, we can be a leader for other countries to do the same
Cannabis seeds remaining schedule 7 — though one can grow and use cannabis in one’s own home — means the seeds, their purchase and sale, remain illegal.
With these changes to the schedules, the department of health and SAHPRA has provided a clear path to understanding the do’s and don’ts surrounding CBD, and kudos to them for releasing these new regulations amid the current health crisis.
Though some companies may have been in limbo for the past week due to the expiry of the exemption, it is still a ripe time for these new regulations, and companies may now continue to sell their CBD products if their products are in line with the exemption that has now been legislated. The Medicines Act now also provides further clarity on how the different parts of the cannabis plant are to be regulated, which includes cannabis and hemp, THC and CBD.
Hemp, for a long time now, has also been lumped together with marijuana or cannabis, and therefore treated as being illegal, though it does not contain enough THC to cause psychoactive effects. We now see that the government recognises the difference between the plants and has considered this in the amendment to the Medicines Act.
SA’s cannabis industry is growing and it’s admirable that the government notices the potential of this robust and versatile plant — President Cyril Ramaphosa’s reference to the cannabis industry during his state of the nation address is proof of this.
With the industry taking off, it has the potential to create jobs in a desperate economy and has so much to give to our communities, especially to our subsistence farmers, as well as small and medium enterprises that have been trying to get their businesses off the ground. With SA moving forward to regulate medicinal cannabis and CBD, we can be a leader for other countries to do the same. It will stimulate economies in developing countries and assist with job creation on different levels within the socio-economies.
Taking Canada as an example, when medicinal cannabis became properly regulated there was a steady climb and growth in its capital market. The same can be expected in SA because we have the market for it as well as the necessary resources to grow this industry exponentially.
Market entry has traditionally been exclusive due to cost and regulatory red tape — hopefully with these positive steps in the right direction we can start breaking down all these barriers.
• Smit is Fasken partner in the life sciences group and Gilbert is a Fasken candidate attorney.