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

2. 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

3. 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

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
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

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 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

6. 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

7. 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.

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. Thank you
Website: 15