The ongoing development of South African law related to cannabis
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12 Mar 2020
For those following the ongoing developments surrounding cannabis legalisation in South Africa, the publication of Government Notices R755 and R756 in May last year was met with considerable interest. These notices made use of the Minister’s powers under the Medicines and Related Substances Control Act to both lower the Schedule of cannabidiol (CBD) to Schedule 4, and to specifically exclude certain formulations of CBD from the Schedule. Previously CBD had been treated as a high-schedule drug due to its status as a component of cannabis, but the lowering to Schedule 4 allows CBD to be prescribed by medical professionals when intended for therapeutic purposes.
The exclusion from the schedules entirely was limited, however, to preparations containing “a maximum daily dose of 20mg” of CBD, with a restriction on the claims which may be made as to the health benefits of the product. A further exclusion was also made for processed products made from cannabis which contain “not more than 0,001 % of tetrahydrocannabinol (THC) and not more than 0,0075 % total cannabidiol (CBD)”. No definitions or guidance are provided in either the Act or the Regulations as to what these percentages mean, but on the assumption that they refer to weight percentage it can be assumed that this latter category is aimed at either processed hemp (as the same percentage of THC is specified in government releases regarding industrial hemp cultivation and processing), or hemp oil.
As a result, it is now possible to both get a prescription for CBD, as well as to buy and sell CBD products which meet the terms of the exclusion over the counter (assuming that they also conform to the other requirements specified by the Act). Or, at least, to do so until the terms of the exclusion expire on 23 May 2020.
Here our understanding is that these exclusions were provided principally in order to allow the current CBD import market to operate, with the predictable result being a boom in pop-up stores and stands selling CBD vape products, rubbing oils, supplements and the like. With local licences for cannabis cultivation being both new and rather thin on the ground, the import sector also looks to be where most of the regulatory action will be for the time being.
All of which leads to the question: what next for cannabis and hemp in South Africa? As is so often the case, the waters of government intent are murky and spotting ongoing trends is difficult. Were the author to hazard a guess, it may be assumed that the exclusion will be renewed sometime in mid-2020 (perhaps with more or less restrictions as feedback continues to filter in to the Minister).
Here the South African Health Products Regulatory Authority (SAHPRA) has also indicated an intent to resolve the current grey area that commercial hemp production fell into – where growers wishing to make hemp for industrial fibre purposes (normally a sphere of activity which falls under the remit of the Department of Agriculture, Forestry and Fisheries) are still required to get a permit from them to do so under terms closer to a drug manufacturing facility than a farm.
Here it would be optimistic to expect rapid movement, but incremental news on this front may be forthcoming over the course of the year as SAHPRA and DAFF continue to engage. The stated intention of the President (voiced at the recent State of the Nation Address) to open up and regulate commercial hemp production in the country will also presumably bring the fruit of any such engagement out into the open.
With regard to the market for medical cannabis and CBD, the general trend in other countries has been towards a steady progression of legalisation once decriminalisation and medical use has been allowed. With pressure on government to raise additional revenue and lower costs, the twin promise of taxes on (legal) cannabis sales and less police resources spent raiding cannabis growing operations must seem very tempting. The relatively low levels of mechanisation present in both cannabis and hemp production may also appeal to a government in need of good news on the jobs front.
Overall, although the situation is still fluid, there is reason to expect good news for CBD customers, cannabis growers, and hemp farmers in the near future.
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Thomas Schmidt is an Associate at KISCH IP with experience in patent and design prosecution, as well as in regulatory compliance. With a strong technical background in plant and crop... Read more about Thomas Schmidt