Scheduling change for cannabis

Introduction
Scheduling status
Implications

Introduction

In 2018 the Constitutional Court – South Africa's highest court – legalised the private cultivation, possession and use of cannabis (the ConCourt Judgment).(1) As such, the court:

• invalidated provisions of the Drugs and Drug Trafficking Act 140 of 1992 and the Medicines and Related Substance Act 101 of 1965 (the Medicines Act) that prohibit or criminalise such activities; and
• suspended its order for 24 months from the date on which the judgment was delivered to allow Parliament to rectify the constitutional defects.

At the time of the ConCourt Judgment, the cannabis plant was one of the substances listed in Schedule 7 of the Medicines Act, without qualification, and various components of the cannabis plant were given alternative scheduling, including in Schedules 4 and 6.

Schedule 7 substances are deemed to have no legitimate medicinal use and can be accessed only by means of a permit issued by the director general of the National Department of Health. Medicines and substances listed in Schedules 4 or 6 are available only on the prescription of an authorised prescriber and can be obtained only from a pharmacy or the holder of a dispensing licence issued under the Medicines Act. Accordingly, without any such permit, persons could not use, possess or supply cannabis for private purposes. It was this broad prohibition that the Constitutional Court found problematic.

Scheduling status

Some months after the ConCourt Judgment, Health Minister Aaron Motsoaledi, on the recommendation of the South African Health Products Authority (SAHPRA), issued a notice in the Government Gazette 42477 to exempt certain preparations containing cannabidiol (CBD) from the Medicines Act schedules. This exemption subsequently lapsed on 15 May 2020. Those CBD preparations which were not exempt from the Medicines Act schedules remained subject to their respective schedule, as noted below.

Pursuant to this exemption being issued, the scheduling status of cannabis-related substances was as follows:

• cannabis (the whole plant or parts or products thereof) and delta-9 tetrahydrocannabinol (THC) were listed as Schedule 7 substances, except when:
  • present in processed hemp fibre and products thereof, in a form not suitable for ingestion, smoking or inhaling purposes, and containing not more than 0.1% THC;
  • present in processed products from cannabis seed containing not more than 0.001% THC; or
  • separately specified in Schedule 6 for therapeutic use;
• synthetic cannabinoid substances were listed separately in Schedule 7;
• THC (also known as the synthetic variant, dronabinol) was listed in Schedule 6 when intended for therapeutic purposes; and
• CBD was listed as a Schedule 4 substance, subject to those exempted preparations noted above.

Subsequently, and in recognition of the ConCourt Judgment, Motsoaledi published the Government Gazette 43347 and, as of 22 May 2020, implemented various changes to Schedules 4, 6 and 7 of the Medicines Act in relation to cannabis and its related components. In particular, the following amendments were made:

• CBD constitutes a Schedule 4 substance (when intended for therapeutic purposes) except:
  • in complementary medicines containing no more than 600mg cannabidiol per sales pack, providing a maximum daily dose of 20mg of cannabidiol and making a general health enhancement, health maintenance or relief of minor symptoms (ie, low risk) claim (Schedule 0); or
  • processed products made from cannabis raw plant material intended for ingestion containing 0,0075% or less cannabidiol where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product (Schedule 0).
• THC constitutes a Schedule 6 substance, except:
  • in raw plant material and processed products manufactured from such material, intended for industrial purposes and not for human or animal ingestion, containing 0.2% or less THC;
  • processed products made from cannabis containing 0.001% or less THC; or
  • when raw plant material is cultivated, processed and consumed by an adult in private and for personal use.

Cannabis (dagga) and THC no longer constitute Schedule 7 substances under any circumstances.

Implications

These changes to the schedules have several implications. First, the exclusion of certain products containing CBD from Schedule 4 has been confirmed, but with important differences from the 2019 exclusion notice. However, many of these excluded products containing CBD, although being Schedule 0, when used for therapeutic purposes, must still be registered with SAHPRA prior to sale. Second, cannabis as a plant and THC have been removed from Schedule 7. THC is now listed in Schedule 6, with specific exemptions made for industrial applications of low-THC cannabis. Most significantly, considering these scheduling changes, personal use of the cannabis plant by an adult, in private, is legal under the Medicines Act in accordance with the ConCourt Judgment.

Notably, in light of the fact that the exemption has expired and that there are a number of CBD products on the market that were subject to this exemption and which have not been excluded from Schedule 4 and/or are now considered Schedule 0 medicines, the minister of health would have been expected to extend the exemption period to allow for these products to be registered with SAHPRA and still be traded in the interim. However, at the time of writing, no extension has been granted, which means that many CBD products will need to be pulled from the shelves until they have been registered with SAHPRA. This is perhaps an oversight, but one that could be costly to persons dealing in this market. However, where the CBD products are considered complimentary medicines, as contemplated in Paragraph 1.5.1.1, the argument would be that persons trading in these products need not register them with SAHPRA until the authority issues a call-up notice.

Notwithstanding the above oversight and although amendments to the Drugs and Drug Trafficking Act remain to be seen, the recent changes to the Medicines Act are a step in the right direction and a significant contribution to the rights of adults to cultivate, possess and use cannabis in private.

For further information on this topic please contact Altair Richards or Alexandra Wood at ENSafrica by telephone (+27 11 269 7600) or email (arichards@ensafrica.com or awood@ensafrica.com). The ENSafrica website can be accessed at www.ensafrica.com.

Endnotes

(1) The Minister of Justice and Constitutional Development v Prince; National Director of Public Prosecutions v Rubin; National Director of Public Prosecutions v Acton [2018] ZACC 30.