Access to Cannabis for Medicinal and Research Purposes Update to the Portfolio Committee 15 November 2017

Medical Innovation Bill, 2014 11/6/2019 Medical Innovation Bill, 2014 The Bill provides for: Legalising the use of cannabinoids for medical purposes Legalising commercial and industrial use of cannabis Allowing innovation in medical treatment – medical practitioners may depart from existing evidence-based treatments where patients are no longer deriving benefit Prevent reckless, illogical and unreasonable departure from standard practice Regulating the use of cannabis for medicinal and research purposes Regulating cannabis for commercial and industrial use

Medical Innovation Bill Medicines and Related Substances Act Provisions of the Bill vs. Medicines Act Medical Innovation Bill Medicines and Related Substances Act Innovation in medical treatment Regulation 30: Conduct of clinical Trials for humans and animals Any person desiring to initiate or conduct a clinical trial shall apply, on an application form obtainable from the office of the Chief Executive Officer, to the Authority for authorisation to conduct such a clinical trial. 3

Medical Innovation Bill Medicines and Related Substances Act Provisions of the Bill vs. Medicines Act Medical Innovation Bill Medicines and Related Substances Act Legalising the use of cannabinoids for medical purposes Section 21 The Authority may in writing authorise any person to sell during a specified period to any specified person or institution a specified quantity of any particular medicine which is not registered. 4

Medical Innovation Bill Medicines and Related Substances Act Provisions of the Bill vs. Medicines Act Medical Innovation Bill Medicines and Related Substances Act Legalising the use of cannabinoids for medical purposes Regulation 29: Subject to the provision of information, requirements and conditions as determined by the Authority, a person desiring to sell an unregistered medicine subject to registration in terms of Section 14 of the Act, for purposes other than clinical trial, shall apply to the Authority, on an application form obtainable from the Chief Executive Officer, for authorisation in terms of Section 21 of the Act to sell such a medicine. 5

Medical Innovation Bill Medicines and Related Substances Act Provisions of the Bill vs. Medicines Act Medical Innovation Bill Medicines and Related Substances Act Legalising commercial and industrial use of cannabis Hemp Hemp trials started in 1999: collaboration between DAFF, DoH, SAPS Purpose – to explore suitability of growing hemp in RSA Outcome THC levels below 0.1% Agricultural Research Council developed RSA genetically modified seeds. DAFF to develop guidelines on growing hemp Hemp for medicinal use to follow guideline document published recently by MCC 6

Medicines and Related Substances Act, 1965 11/6/2019 Medicines and Related Substances Act, 1965 Schedule 7 – Cannabis The whole plant or any portion or product thereof, except: When separately specified in the Schedules; (S6) or Processed hemp fibre containing 0,1% 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 Processed products made from cannabis seeds containing not more than 10mg per kilogram (0,001%) of tetrahydrocannabinol and does not contain the whole cannabis seeds.

Scheduling Status of Cannabidiol (CBD) Rescheduling of cannabidiol (CBD) as a Schedule 4 substance recommended by the MCC (27-28 July meeting). Submission to the Minister. Signed on 24/10/2017. Gazette to be published by week ending 17/11/2017. Schedule 4 All substances referred to in Schedules are excluded when specifically packed, labeled, sold and used for – Industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose; …… Cannabidiol, when intended for therapeutic purposes, (S7) 8

Rescheduling of Cannabidiol - Implications Section 22A(9)(i) (9)(a) No person shall- (i) acquire, use, possess, manufacture, or supply any Schedule 7 or Schedule 8 substance, or manufacture any specified Schedule 5 or 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: Provided that the Director-General may, subject to such conditions as he or she may determine, acquire or authorise the use of any Schedule 7 or Schedule 8 substance in order to provide a medical practitioner, analyst, researcher or veterinarian therewith on the prescribed conditions for the treatment or prevention of a medical condition in a particular patient, or for the purposes of education, analysis or research; 9

Guidelines for growing Cannabis for Medicinal and Research Purposes Purpose of the guidelines To provide for minimum operating procedures relating to the cultivation of cannabis and the manufacture of cannabis-related pharmaceutical products; To regulate the availability of quality cannabis for medicinal purposes; 10

Guidelines for growing Cannabis for Medicinal and Research Purposes 11/6/2019 Guidelines for growing Cannabis for Medicinal and Research Purposes Requirements: Quality products to be grown; Consistency in growing conditions; Security requirements to be adhered to; Police clearance of growers/applicants Remove 11

Requirements for Growing Cannabis for Medicinal Purposes Application Forms Section 22C(1)(b) Application: the Council/SAHPRA 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. 12

Requirements for Growing Cannabis for Medicinal Purposes - cont Section 22C(1)(b) - Purpose Cultivation/growing of cannabis Extraction and testing of cannabis, cannabis resins and/or cannabinoids; Manufacturing of cannabis-containing medicines; Importation of cannabis-containing medicines; Exportation of cannabis-containing medicines; Distribution of cannabis-containing medicines; 13

Way Forward Applications from growers to be evaluated Open door policy with stakeholders Inspection and evaluation of growers’ sites Seed bank and importation of seed varieties to be controlled by DAFF Establishment of a DoH and DAFF working Group Collaborative decision making between DoH and DAFF on evaluation of applications Ongoing review of applications for research and medicinal use. 14

Thank you Website: www.mccza.com 15