National Cannabis Master Plan Framework for Economic Growth

 
SAHPRA Presentation on Cannabis
PC on Small Business
06 March 2024
 
Cannabis and the Cannabis Master Plan
 
Cabinet took a decision in July 2019 that South Africa needs a national strategy
for industrialisation and commercialisation of Cannabis in order to increase
economic growth, create jobs and poverty alleviation. The Minister of
Agriculture, Land Reform and Rural Development was appointed as the convener
of this process.
The Inter-departmental Committee was established to guide the development of
the National Cannabis Master Plan. This committee is composed of
representatives from departments like Health, Justice, DALRRD, Small Business
Development; Science and Innovation; DTIC;  Presidency; and SAPS.
Representatives of state owned entities like SAHPRA, ARC, CSIR, and some
universities were also co-opted into the committee.
The scope of the master plan includes both low-THC and High-THC Cannabis.
NATIONAL CANNABIS MASTER PLAN FRAMEWORK
 
3
The Master Plan is aimed at providing a framework for the establishment,
growth and development of the Cannabis industry in South Africa in order to
contribute to economic growth, poverty alleviation and job creation
 
OBJECTIVES
Increase the volumes and variety of Cannabis products destined for both local and export markets.
Establish and increase the capacity of South African farmers to produce dagga and hemp
Create opportunities for creation of small and medium size enterprises across the Cannabis value chain.
Replace imported Cannabis products with locally produced products.
Increase investments in research and technology development to support increased production, productivity and competitiveness of the Cannabis industry.
Establish and increase the manufacturing capacity of the South African Cannabis industry.
Development and maintenance of an effective regulatory system by strengthening law enforcement measures to deter the production, manufacturing and sale of Cannabis outside the legal framework.
1. EFFECTIVE
REGULATORY
SYSTEMS
2. SUSTAINABLE
SEED SUPPLY
SYSTEMS
3. RESEARCH
AND
TECHNOLOGY
DEVELOPMENT
4. SUSTAINABLE
PRODUCER
SUPPORT SYSTEMS
5. MARKET
DEVELOPMENT
6. SUPPLIER
DELOPMENT
SYSTEMS
7.
MANUFACTURING
AND PRODUCT
DEVELOPMENT
8. EDUCATION AND TRAINING
9. COMMUNICATION AND AWARENESS
 
Authorities regulating the Cannabis Plant
 
DALRRD
Low THC Cannabis for industrial purposes (less than 0.2%
THC)
SAHPRA (DOH)
THC for medicinal purposes (including the cannabis plant
material that exceeds the 0.2% THC Limit)
 
Current Cannabis Regulation
 
Section 22C(1)(b) requires that manufacturers of scheduled
substances are required to be licensed by SAHPRA.
THC and CBD and the cannabinoids implicated by the schedules
require a licence to manufacture (includes cultivation).
Inspections are conducted by SAHPRA according to GMP, which
includes plants cultivated for medicinal purposes (hence
inclusion of GACP – See Annexure 7 of the PIC/S GMP guide)
Section 22A(9) permits are required for possessing THC during
the cultivation / manufacturing process
Section 22A(11) permits are required for exporting THC
containing product
Licences are for export by default, unless demonstrated
otherwise.
 
Current SAHPRA Regulation of Cannabis for Medicinal Purposes
 
 
Current Scheduling of Cannabinoids
 
Cannabidiol (CBD)
 is listed in Schedule 4, except:
a)
in 
complementary medicines 
containing no more
than 600 mg cannabidiol per sales pack, providing a
maximum daily dose of 20 mg of cannabidiol, and
making a general health enhancement, health
maintenance or relief of minor symptoms (low-risk)
claim; or [S0]
b)
processed products made from cannabis raw plant
material intended for ingestion containing 0,0075
percent or less of cannabidiol where only the
naturally occurring quantity of cannabinoids found
in the source material are contained in the product.
 
 
Current Scheduling of Cannabinoids
 
(-)-transdelta-9-tetrahydrocannabinol (THC
) is listed in
Schedule 6, except
a)
A. 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 % percent or less of
tetrahydrocannabinol;
b)
processed products made from cannabis containing
0,001 percent or less of tetrahydrocannabinol; or
c)
when raw plant material is cultivated, possessed,
and consumed by an adult, in private for personal
consumption.
 
Cannabis Phakisa Action Lab
 
SAHPRA participated in the Cannabis Phakisa Action Lab hosted
by DALRRD and Operation Vulindlela, held 19 to 23 June 2023.
Attendees: Government, social partners, traditional leaders,
faithbased organisations, industry experts/scientists and legal
experts
3 workstreams in the programme:
Enabling legislative and regulatory reform
Enabling innovation for investment
Enabling inclusive business growth
Important outcomes were actions identified by responsible
departments and agreed Foundational Policy principles for
Cannabis.
 
Cannabis Phakisa Action Lab
 
Schedule amendment to enable DALRRD to
regulate cultivation of all Cannabis
Enable the 
limit for THC to be determined by the
Minister of Agriculture
Enable SAHPRA to have oversight over cannabis
cultivated for medicinal purposes only (including
cultivation for the purposes of APIs)
NB: Schedule amendment is subject to DOJ legislation overcoming cannabis
in the Drugs and Drugs Trafficking Act schedule
 
Actions identified for SAHPRA
 
Revision of licensing framework based on DALRRD
development of Good Agricultural Practice standard
Enable farmers to cultivate under GAP which is the
minimum requirement for plants for medicinal purposes.
Enable SAHPRA to licence activities of cutting, drying,
extraction etc under GMP requirements (see annexure 7 of
PIC/S GMP Guide)
 
Actions identified for SAHPRA
 
Update on Actions Identified
 
SAHPRA has proposed amendments to the
Schedule 6 in the Medicines Act with respect
to THC.
Schedules are currently out for comment as
per the Minister of Health, published 15 Jan
2024 for a 2-month comment period.
 
Schedule 6 amendment  of THC
 
 
Schedule 6 amendment  of THC – comparison of changes
 
 
Schedule 6 amendment  of THC – comparison of changes
 
To ensure public health and safety and to ensure
South Africa fulfils its obligations in terms of the
1961 Single Convention on Narcotic Drugs,
SAHPRA advised that the proposed amendments
to THC inscription in Schedules is subject to 7
contingencies.
The contingencies were communicated to:
Minister of Health
DG of DALRRD
DG of DOJCD
 
Schedule 6 amendment  of THC – Contingencies for amendment
 
DALRRD must develop and implement Good Agricultural
Cultivation Practice standards, applicable to all holders of a
permit to cultivate cannabis
The designation, in terms of the Plant Improvement Act of
appropriate limits for raw cannabis plant material to be
considered “low-THC”, and thus appropriate for industrial
purposes.
The designation in permits issued by DALRRD in terms of the
Plant Improvement Act, of appropriate measures to prevent the
diversion of raw cannabis plant material cultivated specifically
for its THC content, and to designate how and to which channels
such material would be distributed. This would include mention
of the requirement to obtain a manufacturing license from
SAHPRA for any facility engaging in the production of plant or
processed material for medicinal purposes.
 
Schedule 6 amendment  of THC – Contingencies for amendment
 
The development of reporting procedures to enable the DALRRD to
report on the quantities of cannabis with THC content in excess of the
limit set for “low-THC cannabis” cultivated in South Africa to the
International Narcotics Control Board.
Passage of the Cannabis for Private Purposes Bill, with a clear indication
of how non-medicinal (“adult use”) cannabis with higher THC content
than that provided for “low-THC cannabis” would be regulated. This step
would also entail the subsequent removal of mention of cannabis in the
Schedules to the Drugs and Drug Trafficking Act.
Appropriate measures being taken by the National Department of
Health, in terms of the Foodstuffs, Cosmetics and Disinfectants Act, to
regulate cannabis-derived products intended for human ingestion or
other human use, other than for medicinal purposes.
Appropriate measures being taken by DALRRD, in terms of the Fertilizers,
Farm Feeds, Agricultural Remedies and Stock Remedies Act, to regulate
cannabis-derived products intended for animal ingestion or other animal
use, other than for medicinal purposes.
 
Schedule 6 amendment  of THC – Contingencies for amendment
 
Way forward
 
After public and stakeholder comments on
proposed schedule amendments, work
towards finalization of amendments
Engage with stakeholders identified in the
contingencies to ensure implementation of
items identified.
 
Way forward
 
SAHPRA implemented a licence application status
letter for medical cannabis licence applicants
SAHPRA provides leniency in terms of time for
applicants to meet requirements
Challenges in medicinal cannabis space:
Diversion of product into the illicit market
Applicants meeting requirements for medicinal cannabis
Registration of medicines containing THC and CBD
South African licence holders have and still are
exporting bulk medicinal cannabis legally to importing
countries
 
Support, Challenges and Successes
 
THANK YOU
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South Africa initiated the National Cannabis Master Plan to industrialize and commercialize the cannabis industry, aiming to boost economic growth, create jobs, and alleviate poverty. The plan encompasses low-THC and high-THC cannabis, with objectives such as increasing product variety, supporting local farmers, promoting small businesses, and enhancing research and technology development. Regulatory systems, seed supply, producer support, market development, manufacturing, education, and communication are key focus areas in this strategic framework.


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  1. SAHPRA Presentation on Cannabis PC on Small Business 06 March 2024

  2. Cannabis and the Cannabis Master Plan Cabinet took a decision in July 2019 that South Africa needs a national strategy for industrialisation and commercialisation of Cannabis in order to increase economic growth, create jobs and poverty alleviation. The Minister of Agriculture, Land Reform and Rural Development was appointed as the convener of this process. The Inter-departmental Committee was established to guide the development of the National Cannabis Master Plan. This committee is composed of representatives from departments like Health, Justice, DALRRD, Small Business Development; Science and Innovation; DTIC; Presidency; and SAPS. Representatives of state owned entities like SAHPRA, ARC, CSIR, and some universities were also co-opted into the committee. The scope of the master plan includes both low-THC and High-THC Cannabis.

  3. NATIONAL CANNABIS MASTER PLAN FRAMEWORK The Master Plan is aimed at providing a framework for the establishment, growth and development of the Cannabis industry in South Africa in order to contribute to economic growth, poverty alleviation and job creation OBJECTIVES Increase the volumes and variety of Cannabis products destined for both local and export markets. Establish and increase the capacity of South African farmers to produce dagga and hemp Create opportunities for creation of small and medium size enterprises across the Cannabis value chain. Replace imported Cannabis products with locally produced products. Increase investments in research and technology development to support increased production, productivity and competitiveness of the Cannabis industry. Establish and increase the manufacturing capacity of the South African Cannabis industry. Development and maintenance of an effective regulatory system by strengthening law enforcement measures to deter the production, manufacturing and sale of Cannabis outside the legal framework. 3. RESEARCH AND TECHNOLOGY DEVELOPMENT 7. 1. EFFECTIVE REGULATORY SYSTEMS 2. SUSTAINABLE SEED SUPPLY SYSTEMS 4. SUSTAINABLE PRODUCER SUPPORT SYSTEMS 6. SUPPLIER DELOPMENT SYSTEMS 5. MARKET DEVELOPMENT MANUFACTURING AND PRODUCT DEVELOPMENT 8. EDUCATION AND TRAINING 9. COMMUNICATION AND AWARENESS

  4. Authorities regulating the Cannabis Plant DALRRD Low THC Cannabis for industrial purposes (less than 0.2% THC) SAHPRA (DOH) THC for medicinal purposes (including the cannabis plant material that exceeds the 0.2% THC Limit)

  5. Current Cannabis Regulation

  6. Current SAHPRA Regulation of Cannabis for Medicinal Purposes Section 22C(1)(b) requires that manufacturers of scheduled substances are required to be licensed by SAHPRA. THC and CBD and the cannabinoids implicated by the schedules require a licence to manufacture (includes cultivation). Inspections are conducted by SAHPRA according to GMP, which includes plants cultivated for medicinal purposes (hence inclusion of GACP See Annexure 7 of the PIC/S GMP guide) Section 22A(9) permits are required for possessing THC during the cultivation / manufacturing process Section 22A(11) permits are required for exporting THC containing product Licences are for export by default, unless demonstrated otherwise.

  7. Current Scheduling of Cannabinoids Cannabidiol (CBD) is listed in Schedule 4, except: a) in complementary medicines containing no more than 600 mg cannabidiol per sales pack, providing a maximum daily dose of 20 mg of cannabidiol, and making a general health enhancement, health maintenance or relief of minor symptoms (low-risk) claim; or [S0] b) processed products made from cannabis raw plant material intended for ingestion containing 0,0075 percent or less of cannabidiol where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product.

  8. Current Scheduling of Cannabinoids (-)-transdelta-9-tetrahydrocannabinol (THC) is listed in Schedule 6, except a) A. 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 % percent or less of tetrahydrocannabinol; b) processed products made from cannabis containing 0,001 percent or less of tetrahydrocannabinol; or c) when raw plant material is cultivated, possessed, and consumed by an adult, in private for personal consumption.

  9. Cannabis Phakisa Action Lab

  10. Cannabis Phakisa Action Lab SAHPRA participated in the Cannabis Phakisa Action Lab hosted by DALRRD and Operation Vulindlela, held 19 to 23 June 2023. Attendees: Government, social partners, traditional leaders, faithbased organisations, industry experts/scientists and legal experts 3 workstreams in the programme: Enabling legislative and regulatory reform Enabling innovation for investment Enabling inclusive business growth Important outcomes were actions identified by responsible departments and agreed Foundational Policy principles for Cannabis.

  11. Actions identified for SAHPRA Schedule amendment to enable DALRRD to regulate cultivation of all Cannabis Enable the limit for THC to be determined by the Minister of Agriculture Enable SAHPRA to have oversight over cannabis cultivated for medicinal purposes only (including cultivation for the purposes of APIs) NB: Schedule amendment is subject to DOJ legislation overcoming cannabis in the Drugs and Drugs Trafficking Act schedule

  12. Actions identified for SAHPRA Revision of licensing framework based on DALRRD development of Good Agricultural Practice standard Enable farmers to cultivate under GAP which is the minimum requirement for plants for medicinal purposes. Enable SAHPRA to licence activities of cutting, drying, extraction etc under GMP requirements (see annexure 7 of PIC/S GMP Guide)

  13. Update on Actions Identified

  14. Schedule 6 amendment of THC SAHPRA has proposed amendments to the Schedule 6 in the Medicines Act with respect to THC. Schedules are currently out for comment as per the Minister of Health, published 15 Jan 2024 for a 2-month comment period.

  15. Schedule 6 amendment of THC comparison of changes Current Schedule Proposed schedule Amendments Comment Brackets deletion/omission Underlined - addition Tetrahydrocannabinol [(-)-transdelta-9- tetrahydrocannabinol)], except (-)-transdelta-9-tetrahydrocannabinol (THC), except Adjustment of name a. in raw cannabis plant material cultivated and possessed in accordance with a permit issued in terms of the Plant Improvement Act (Act 11 of 2018) and processed products manufactured from such material, intended for agricultural or industrial purposes, [and not for human or animal ingestion, containing 0,2 % percent or less of tetrahydrocannabinol;] including the manufacture of consumer items or products which have no pharmacological action or medicinal purpose, or a. 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 % percent or less of tetrahydrocannabinol; Exemption from S6 applies to all cannabis plant material cultivated under Plant Improvement Act Exemption includes agricultural purposes Expansion on what industrial purposes means in line with Schedule 0 to 4 preamble

  16. Schedule 6 amendment of THC comparison of changes Current Schedule Proposed schedule Amendments Comment Brackets deletion/omission Underlined - addition b. [processed products made from cannabis containing 0,001 percent or less of tetrahydrocannabinol; or] b. processed products made from cannabis containing 0,001 percent or less of tetrahydrocannabinol; or Deletion of limit for processed products - Allow other product regulators to impose regulations and limits e.g. foodstuffs, cosmetics, agricultural feeds Aligning description to point a. c. when raw cannabis plant material is cultivated, possessed and consumed by an adult, in private for personal consumption. c. when raw plant material is cultivated, possessed, and consumed by an adult, in private for personal consumption.

  17. Schedule 6 amendment of THC Contingencies for amendment To ensure public health and safety and to ensure South Africa fulfils its obligations in terms of the 1961 Single Convention on Narcotic Drugs, SAHPRA advised that the proposed amendments to THC inscription in Schedules is subject to 7 contingencies. The contingencies were communicated to: Minister of Health DG of DALRRD DG of DOJCD

  18. Schedule 6 amendment of THC Contingencies for amendment DALRRD must develop and implement Good Agricultural Cultivation Practice standards, applicable to all holders of a permit to cultivate cannabis The designation, in terms of the Plant Improvement Act of appropriate limits for raw cannabis plant material to be considered low-THC , and thus appropriate for industrial purposes. The designation in permits issued by DALRRD in terms of the Plant Improvement Act, of appropriate measures to prevent the diversion of raw cannabis plant material cultivated specifically for its THC content, and to designate how and to which channels such material would be distributed. This would include mention of the requirement to obtain a manufacturing license from SAHPRA for any facility engaging in the production of plant or processed material for medicinal purposes.

  19. Schedule 6 amendment of THC Contingencies for amendment The development of reporting procedures to enable the DALRRD to report on the quantities of cannabis with THC content in excess of the limit set for low-THC cannabis cultivated in South Africa to the International Narcotics Control Board. Passage of the Cannabis for Private Purposes Bill, with a clear indication of how non-medicinal ( adult use ) cannabis with higher THC content than that provided for low-THC cannabis would be regulated. This step would also entail the subsequent removal of mention of cannabis in the Schedules to the Drugs and Drug Trafficking Act. Appropriate measures being taken by the National Department of Health, in terms of the Foodstuffs, Cosmetics and Disinfectants Act, to regulate cannabis-derived products intended for human ingestion or other human use, other than for medicinal purposes. Appropriate measures being taken by DALRRD, in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, to regulate cannabis-derived products intended for animal ingestion or other animal use, other than for medicinal purposes.

  20. Way forward

  21. Way forward After public and stakeholder comments on proposed schedule amendments, work towards finalization of amendments Engage with stakeholders identified in the contingencies to ensure implementation of items identified.

  22. Support, Challenges and Successes SAHPRA implemented a licence application status letter for medical cannabis licence applicants SAHPRA provides leniency in terms of time for applicants to meet requirements Challenges in medicinal cannabis space: Diversion of product into the illicit market Applicants meeting requirements for medicinal cannabis Registration of medicines containing THC and CBD South African licence holders have and still are exporting bulk medicinal cannabis legally to importing countries

  23. THANK YOU

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