Altair Richards Pieter Erasmus December 5 2018 Medical cannabis: growing pot-ential ENSafrica | Healthcare & Life Sciences - South Africa Altair Richards, Pieter Erasmus Healthcare & Life Sciences IntroductionFactsNew guidelineImplicationsCommentIntroductionCannabis has enjoyed heightened attention since the Constitutional Court (South Africa's highest court) recently issued a unanimous ruling decriminalising the private possession, consumption and cultivation of cannabis for recreational purposes. This appears to have emboldened the industry to bring cannabis-related products into the South African mainstream, albeit not products containing tetrahydrocannabinol (THC). For example, one of South Africa's major beverage groups, RCL Foods, has begun to distribute and market hemp oil-infused beer (the somewhat salaciously named Durban Poison Cannabis Lager). Despite this, the South African legal landscape pertaining to medical cannabis remains relatively undeveloped and somewhat disjointed.Facts In Minister of Justice and Constitutional Development v Prince; National Director of Public Prosecutions v Rubin; National Director of Public Prosecutions v Acton,(1) the Constitutional Court found that the ban on the use of cannabis for recreational purposes infringed Section 14 of the Constitution 1996, which enshrines the right to privacy. In sum, the court found that:an adult may use or be in possession of cannabis in private for their personal consumption in private;the use, including the smoking of cannabis in public or in the presence of children or non-consenting adult persons remains a criminal offence;the use or possession of cannabis in private other than by an adult for their personal consumption is prohibited; andthe cultivation of cannabis by an adult in a private place for their personal consumption in private is no longer a criminal offence.South Africa is the third country in Africa to decriminalise cannabis for recreational use, after Lesotho and Zimbabwe.'Medical cannabis' (ie, cannabis-containing products intended solely for medicinal use) continues to be regulated by the Medicines and Related Substances Act 1965 and is administered by the South African Health Products Regulatory Authority (SAHPRA) (the successor body to the old Medicines Control Council), which falls under the scope of the Department of Health. To date, patients can gain access to medical cannabis only under Section 21 of the Medicines Act (and Section 22A in the case of Schedule 7 cannabinoids), which provides that authorised healthcare practitioners can, under exceptional circumstances, apply to SAHPRA for permission to access and prescribe unregistered medicines (including cannabis-containing medicines that are not currently registered in South Africa) when intended to treat individual, identified patients under medical supervision. This authorisation is dependent on:the submission of an appropriate dosage regimen;acceptable justification; andregular reporting to SAHPRA.In addition, SAHPRA must be satisfied by the quality of the product. Understandably, this is a time-consuming and tedious process.New guidelineIn November 2017, SAPHRA, in collaboration with the Department of Agriculture, Forestry and Fisheries (DAFF), published a guideline in an attempt to promote the local cultivation and manufacture of cannabis for medicinal and research purposes. The guideline contains several strict and often impractical requirements applicants must fulfil in order to cultivate or manufacture medical cannabis products in South Africa. Some of these requirements concern:personnel;security;buildings and infrastructure;equipment;storage and distribution;manufacturing;record keeping; andreporting.Some of these requirements and processes are couched in terms that are usually associated with conventional allopathic medicines, which may not be appropriate for cultivation activities.The new guideline also addresses the process of obtaining the necessary licence under Section 22C(1)(b) of the Medicines Act in order to:cultivate and produce cannabis and cannabis resin;extract and test cannabis, cannabis resin or cannabinoids;manufacture a cannabis-containing or cannabinoid-containing medicine;import a cannabis-containing medicine;export a cannabis-containing medicine; ordistribute a cannabis-containing medicine.In addition to the licence application to SAHPRA, applicants that wish to manufacture products for therapeutic purposes containing THC (delta-9-tetrahydrocannabinol or dronabinol), which has recently been re-scheduled from Schedule 7 to Schedule 6, must also apply to the director general of health for a permit under Section 22A(9)(a)(i) of the Medicines Act in order to manufacture this substance. Products that contain only cannabidiol (when intended for therapeutic purposes) have recently been rescheduled from Schedule 7 to Schedule 4. Notably, the Medicines Act still classifies the following as Schedule 7 substances, for which a licence must be obtained under Section 22A(9)(a)(i) of the Medicines Act in order to acquire, use, possess, manufacture or supply:cannabidiol not used for therapeutic purposes;cannabis (whole plant or any portion thereof), except:when separately specified in another schedule;in cases involving 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 that is unsuitable for ingestion, smoking or inhaling; orin cases involving processed product that has been made from cannabis seeds which contain no more than 10 milligram per kilogram (0.001%) of THC and no whole cannabis seeds;THC not used for therapeutic purposes; andTHC and alkyl homologues, except:when separately specified in the schedules;in cases involving THC intended for therapeutic purposes;in cases involving hemp seed oil that contains 10 milligram per kilogram or less of THC, when labelled "Not to be taken" or "Not for internal human use"; orin cases involving products for purposes other than internal human use containing 10 milligram per kilogram or less of THC.ImplicationsAlthough cannabis remains highly regulated under the Medicines Act, the downgrading of the scheduling of THC and cannabinoids for therapeutic use bodes well for the medical cannabis market in South Africa and is indicative of initial steps to stimulate this growing market. In addition, the DAFF, since the landmark court ruling referred to above has also issued a formal statement which articulates its commitment to leading an inter-departmental taskforce to develop a new regulatory framework concerning the cultivation of cannabis and the manufacture of cannabis-containing products. Following the Constitutional Court's ruling, Parliament has been provided 24 months to implement legislation that will concretise the ruling.CommentDespite the positive developments mentioned above, where does this leave prospective South African applicants that wish to apply for a licence to cultivate or manufacture medical cannabis products? In terms of SAHPRA's current practice, it is unlikely that an applicant will be granted a manufacturing licence if it does not also hold a pre-existing registered product. All medicines, medical devices and in vitro diagnostic devices subject to registration must be registered under Sections 14 and 15 of the Medicines Act. However, it appears that a pre-existing registered product may not be required to apply for a cultivation licence. Local start-ups and cultivators in this market will rarely already have registered products, so how should they go about entering the manufacturing market? One of the current options to overcome this potential barrier is for cultivation licence holders to join forces with established manufacturers with pre-existing product registrations and act as suppliers of raw material or contract manufacturers.While there have been several positive developments in the promotion of the medical cannabis market in South Africa, the overarching regulatory framework and current practice remain barriers to entry for prospective local players in the medical cannabis product manufacturing market. As mentioned above, one potential solution to this would be the pursuit of collaborative efforts between newcomer cultivators and established manufacturers.For further information on this topic please contact Altair Richards or Pieter Erasmus at Edward Nathan Sonnenbergs Inc by telephone (+27 11 269 7600) or email ([email protected] or [email protected]). The Edward Nathan Sonnenbergs Inc website can be accessed at www.ensafrica.com.Endnotes(1)  ZACC 30, available here.