Medicinal cannabis: keeping up with the changes Andy Gray Division of Pharmacology Discipline of Pharmaceutical Sciences 1 SAAPI Conference May 2019
Disclaimer ◼ I am the chair of SAHPRA’s Names and Scheduling Advisory Committee, and a member of its Legal Advisory Committee and Regulatory Advisory Committee. ◼ I am the chair of SAHPRA’s Cannabis Working Group. ◼ I am speaking here as an academic, and not on behalf of the Authority or any of its advisory committees or task teams. 2 SAAPI Conference May 2019
Outline ◼ Legal and policy background – fitting in with the global regulatory system (as that changes) ◼ Implementing the ConCourt decision ◼ Current and envisaged provisions for legal access in South Africa for medicinal purposes ◼ Evidence for the therapeutic value of cannabinoids 3 SAAPI Conference May 2019
Cannabis as a medicine Royal Pharmaceutical Society Museum exhibits SAAPI Conference May 2019 4
A racialised past “ Dr. White replied that in western countries it might be assumed that the use of a drug was legitimate if it was prescribed by a doctor, but in such a country as India it was necessary to define, not merely legitimate use, but also the doctor. He had known native practitioners in India who used opium. very skilfully in the treatment of disease, but according to western standards their use of the drug would be regarded as illegitimate. He agreed that there was much greater tolerance for narcotic drugs amongst the Indian native population than amongst Europeans .” 5 SAAPI Conference May 2019
International regulation International Narcotic Control Board United Nations Commission on WHO Expert Committee on Narcotic Drugs Drug Dependence UN Organization on Drugs and Crime 6 SAAPI Conference May 2019
Current status ◼ Cannabis and cannabis resin are currently listed in Schedules I and IV in terms of the Single Convention on Narcotic Drugs (1961), so are prohibited substances, considered to have no therapeutic uses . ◼ This status was “inherited” from the 1923 Opium Commission, which specifically included cannabis on the request of the South African government. 7 SAAPI Conference May 2019
A slow review process ◼ The 38 th ECDD in November 2016 considered a “pre - review” document on cannabis and cannabis resin. ◼ The 39 th ECDD in November 2017 considered a “pre - review” on cannabidiol. ◼ The 40 th ECDD in June 2018 was a special session looking only at cannabis and cannabis resin, extracts and tinctures of cannabis, THC and isomers of THC. ◼ The 41 st ECDD in November 2018 made a series of recommendations, which were to be considered by the 62nd Session of the CND in March 2019, but were deferred to December 2019. 8 SAAPI Conference May 2019
Overlapping jurisdictions • Drugs and Drug Trafficking Act Minister of (Act 140 of Justice/ 1992) • Medicines and National Prosecuting Related Authority/ Substances Act Police (Act 101 of 1965) Minister of Social Development / Central Drug Authority Minister of Health/SAHPRA/ • Prevention of and Names and Scheduling Treatment for Substance Advisory Abuse Act (Act 70 of 2008) Committee 9 SAAPI Conference May 2019
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South African Constitutional Court judgment 2018 ◼ In a unanimous judgment written by Zondo ACJ, as he then was, the Constitutional Court declared that — (a) section 4(b) of the Drugs Act was unconstitutional and, therefore, invalid to the extent that it prohibits the use or possession of cannabis by an adult in private for that adult’s personal consumption in private; (b) section 5(b) of the Drugs Act was constitutionally invalid to the extent that it prohibits the cultivation of cannabis by an adult in a private place for that adult’s personal consumption in private; and (c) section 22A(9)(a)(i) of the Medicines Act was constitutionally invalid to the extent that it renders the use or possession of cannabis by an adult in private for that adult’s personal consumption in private a criminal offence. 11 SAAPI Conference May 2019
Consequences ◼ Parliament has 24 months to revise the 2 Acts, BUT in the interim, the following is “read in” “(c)the following words and commas are to be read into the provisions of section 22A(9)(a)(i) of the Medicines and Related Substances Control Act 101 of 1965 after the word “unless”: “, in the case of cannabis, he or she, being an adult, uses it or is in possession thereof in private for his or her personal consumption in private or, in any other case,” 12 SAAPI Conference May 2019
In draft form, but not yet published 13 SAAPI Conference May 2019
Current scheduling (about to change) ◼ S4 Cannabidiol, when intended for therapeutic purposes. (S7) ◼ S6 Dronabinol ((-)-transdelta-9-tetrahydrocannabinol), when intended for therapeutic purposes. (S7) ◼ S7 Cannabidiol, except when intended for therapeutic purposes. (S4) Cannabis (dagga), the whole plant or any portion or product thereof, except: a. when separately specified in the Schedules; (S6) or b. processed hemp fibre containing 0,1 percent or less of tetrahydrocannabinol 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 c. processed product made from cannabis seeds containing not more than 10 milligrams per kilogram (0,001 percent) of tetrahydrocannabinol and does not contain whole cannabis seeds. ["Processed" means treated by mechanical, chemical or other artificial means but does not include - (a) harvesting; or (b) the natural process of decay"]. 14 SAAPI Conference May 2019
The preamble to S4 (somewhat contested) 15 SAAPI Conference May 2019
Legal? 16 SAAPI Conference May 2019
Cannabinoid receptors ◼ Cannabinoid receptors are widely distributed, not only in the CNS, but also in the GIT, liver, adipocytes, skeletal muscle, macrophages, osteoclasts and osteoblasts. They also have complex and poorly understood immunological effects. ◼ Cannabinoid receptors bind both to endogenous endocannabinoids (neurotransmitters) and, variably, to exogenous cannabinoids. 17 SAAPI Conference May 2019
Exogenous cannabinoids ◼ Herbal cannabis has at least 489 chemical constituents, at least 70 of which are cannabinoids. ◼ The main psychoactive ingredient is delta ‐ 9 ‐ tetrahydrocannabinol (THC), which interacts with a number of cannabinoid receptors (CBRs). THC has also been named as dronabinol, when registered as a medicine. A synthetic variant, nabilone, has also been available in the past. They are basically equivalent. ◼ The other major cannabinoid of interest is cannabidiol (CBD), which is not psychoactive. ◼ A 50:50 THC:CBD mixture has been registered by GW Pharmaceuticals as nabiximols in some jurisdictions. 18 SAAPI Conference May 2019
https://www.na p.edu/resourc e/24625/Cann abis_committe e_conclusions .pdf 19 SAAPI Conference May 2019
Local stance - evolving The Minister of Social Development has failed to issue an updated National Drug Master Plan (though the Cabinet has accepted a report on the 2013-2018 version and indicated that the next version should be called the “Anti - Drug Master Plan“) 20 SAAPI Conference May 2019
Local “right -to- try” legislation 21 SAAPI Conference May 2019
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Legal basis - Medicines Act ◼ Section 22C(1)(b): “the Council may - on application in the prescribed manner and on payment of the prescribed fee, issue to a manufacturer....of a medicine, ...or scheduled substance a licence to manufacture....such medicine, .....or scheduled substance, upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the council may determine.” ◼ Section 22A(9)(a)(i): “No person shall - acquire, use, possess, manufacture, or supply any Schedule 7....substance, or manufacture any .....Schedule 6 substance unless he or she has been issued with a permit by the Director-General for such acquisition, use, possession, manufacture, or supply.....” 23 SAAPI Conference May 2019
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Key developments to date ◼ By February 2019, there had been 56 section 21 approvals, for importation from Canada and The Netherlands ◼ On 16 April 2019, SAHPRA announced that 3 licence to cultivate medicinal cannabis would be issued – evidence of a “developmental approach” ◼ NO legal, locally-produced medicinal products as yet ◼ BUT …. 26 SAAPI Conference May 2019
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e.g. 19 placebo-controlled clinical trials of oromucosal nabiximols for spasticity, pain, nausea and vomiting 28 SAAPI Conference May 2019
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• Started with 726 abstracts • Selected 65 papers for full text review • Eliminated all but 7 , but could only do a qualitative review, as disparate outcomes did not allow meta- analysis 31 SAAPI Conference May 2019
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