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A Proposal Submitted to Medicines Control Council (MCC) Department of Health (DOH)

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A Proposal Submitted to Medicines Control Council (MCC) Department of Health (DOH) RESEARCH PROJECT PROPOSAL 7 Year (2015 to 2022) Commercial Trial Determining key factors for commercializing medicinal cannabis A proposal submitted to Medicines Control Council (MCC) Department of Health (DOH) A joint Proposal submitted by House of Hemp Holdings (Pty) Ltd in partnership with IKS Research Unit, Dept. of Pharmacology, University of Free State (UFS). AUTHORISING SIGNATURES Prepared by House of Hemp: Checked by University of Free State: Name and Designation: Dr. Thandeka R. Kunene Dr. Motlalepula G. Matsabisa Signature: Name and Designation Ms. Leanne Blumenthal Ms. Miranda Javu Signature: 1 This 7 Year (2015 to 2022) Commercial Research project is supported by the following Government departments and agencies: 1. Department of Science and Technology. 2. Department of Trade and Industry. Please see the Appendix D for copies of the two letters of support. 3. Department of Agriculture, Forestry and Fisheries 4. C.D.A. – Central Drug Authority 5. C.S.I.R. ( Council for Scientific and Industrial Research) 6. N.A.M.C (National Agricultural Marketing Council) 7. A.R.C ( Agricultural Research Council) 8. Ingquza Municipality Lusikisiki (Eastern Cape) 9. EThekwini Municipality Durban (Kwa Zulu Natal) 10. Industrial Development Cooperation Letters of support and MOAs describing professional relationships are available upon request. The following universities have agreed to collaborate, supervise and assist with research objectives: University of Free State University of the Witwatersrand University of Cape Town University of Natal Fort Cox Agricultural College 2 Table of contents ACRONYMS: 4 SECTION 1: INTRODUCTION TO CANNABIS 5 Cannabis used for medical purposes 5 Cannabis in Africa 7 Cannabis in Asia, Europe, Middle East and America 8 SECTION 2: BACKGROUND OF THE SA MEDICAL CANNABIS STUDY 9 SECTION 3: THE APPLICATION 12 The proposal 13 Problem Statement 13 Research Objectives 13 Activities to be undertaken 14 Activity 1: Literature Research 14 Activity 2: Geographic indicators research 14 Activity 3: Seed breeding pilot 15 Activity 4: Cultivating Pilot 15 Activity 5: Pharmacology compounds 15 Activity 6: Extraction of compounds 17 Activity 7: Conversion into end products 17 Activity 9: Clinical Studies 18 Activity 9: Marketing 21 Activity 10: National Medical Cannabis Access Program 22 SECTION 4: PERMITS NEEDED 23 DETAILS OF THE PROPOSED PROCESSES 23 Operational plan 23 Cultivar names 24 Area expected to be planted 24 Materials to be harvested and transported 25 Security Measures 26 Notification of local security officials 28 Security Tracking System 28 Analysis and Record Keeping 28 Reporting 29 SECTION 5: IMPLEMENTING TEAM 30 APPENDICES Appendix A: Reference list Appendix B: 4 Application forms for 4 Coordinators and 4 site managers Appendix C: Exact Geographical location – Dube Port; GPS coordinates and Site Map Appendix D: Exact Geographic location – Lusikisiki: GPS coordinates and Site Map Appendix E: Letters of support from the DTI and the DST. 3 ACRONYMS: - ARC: Agricultural research council - CBD: Cannobidiol - CDA: Central Drug Authority - CSC: Cannabis Steering Committee - CSIR: Council for Scientific and Industrial Research - DAFF: Department of Agriculture, Forestry and Fisheries - DEA: Department of Environmental Affairs - DOH: Department of Health - DST: Department of Science and Technology - DTI: Department of Trade and industry - EC: Eastern Cape - EDD: Department of Economic Development - GAP: Good Agricultural Practises - HOH: House of Hemp - HRD: Human Resource Development - IKS: Indigenous Knowledge systems - KZN: KwaZulu Natal - MCC: Medical Control Council - NAMC: National Agricultural Marketing Council - NHCF : National Hemp and Cannabis Foundation - NMCAP: National Medical Cannabis Access Program - NMCRI: National Medical Cannabis Research Institute - RDI: Research, develop and innovate - SAPS: South African Police Services - THC: 9 Delta Tetra HydroCannabinoids - UFS: University of the Free State - WC: Western Cape - WHO: World Health Organisation 4 INTRODUCTION This proposed research study is as a result of a Medical Cannabis Research program set up by the Department of Science and Technology on request by the Parliamentary Science and Technology Portfolio Committee that recommended a detailed research, development and innovative study of how South Africa can increase its access to medicinal cannabis for sick people in-line with global trends. This is to be done in a manner, which will ensure quality, safety, efficacy and more importantly control of the (currently) illegal substance to be effectively regulated within a framework of strict legal controls. This request by the Parliamentary committee was a response to the late IFP M.P. Ambrosini proposed Medical Innovation Bill of 2014. At the same time, the Department of Trade and Industry has partnered with the Department of Science and Technology to ensure that this study leads to the commercialization of the research results. Thus the study aims includes determining the factors/variables that will influence the commercialization of cannabis cultivation and processing in South Africa for improved quality of life and sustainable livelihood. Activities of the study include the investigation of how the emerging legal Medical Cannabis industry will benefit poor rural areas and ensure substantial involvement of indigenous Knowledge holders/practitioners that have traditional claims to Cannabis. Furthermore this study is in line with one of the key recommendations of the 2015 National Hemp Foundation Report (NHF) that concluded that the NHF should also include research for medicinal cannabis applications due to the presence of Cannabinoids (CBD) in the hemp crops. Thus, this proposal further serves to extend into Phase 3 the research study commissioned by the government driven NHF that started with Phase 1 (agronomic feasibility) that was conducted from 1999 to 2005 and entered into phase 2 (commercial feasibility study) that was conducted from 2009 to 2015. This proposal is divided into five sections, namely: 1. Introduction to cannabis; 2. Background to the South African Medical Cannabis Research Study; 3. The application including the proposed research study objectives aims, objectives and activities to be undertaken; 4. Requirements from the permit based on activities to be undertaken as well as arrangements to ensure adherence and compliance to permit conditions; and 5. Implementing team and partnerships SECTION 1: INTRODUCTION TO CANNABIS The Cannabis Sativa L plant family has been used for many centuries as a source of fibres, seed-oils and medicines. Despite its many uses, the cannabis family was banned in 1928 due to high THC content of Cannabis Sativa plants (commonly known as dagga in South Africa). However, the early 1990’s saw renewed global interest in cannabis as ecological regulatory policies and tax incentives increasingly favoured natural and environmentally friendly produce and with most EU governments researching and cultivating cannabis for medical and industrial/commercial purposes. More than 30 countries have adopted industrial hemp as an established agricultural commodity. More than 27 countries have decriminalized the medical uses of cannabis. This proposed research study is focused on the medicinal uses of cannabis. Cannabis used for medical purposes There have been many claims internationally as to what diseases medical cannabis can be used as cure. In putting together this proposal the research team conducted a limited pre-study literature search to get a glimpse of the existing research and potential new research related to cannabis for medicinal uses. This limited literature search 5 indicated that there is a vast amount of credible scientific journals that published papers, conferences proceedings, books and references which document clinical research that reveals numerous pre-clinical and clinical studies demonstrating cannabinoid’s ability to be effectively used in the many diseases listed below. First a brief discussion on the 10 priority diseases of South Africa that were cited in the limited literature as being positively affected by cannabis: Priority disease as identified SA government Notes on the disease and research interest Cancer (breast; colorectal; brain; leukemia; lung; Literature demonstrates ca combination of cannabinoids have the ability to act as melanoma; oral; pancreatic; prostate; Skin; antineoplastic agents on gliomas cells (an especially aggressive malignant form of cancer). Testicular) and oncology Cannabinoids have also been reported to inhibit growth of gliomas cell lines and of gliomas tumor in humans. Some experts now believe that cannabinoids may represent a new class of anticancer drugs that have antitumor properties and thus retard cancer growth, inhibit cell proliferation, invasion, angiogenesis and metastatic spreading/migration of cancer cells in tumors that highly resistant to current treatments. Gastrointestinal system disorders Many experts believe that cannabis and its compounds represent a novel therapeutic approach (irritable bowel syndrome, inflammatory bowel for treatment of numerous gastrointestinal (GI) disorders. Cannabis suppresses gastrointestinal disease, Crohn’s disease, ulcerative colitis, metabolic motility, inhibits intestinal secretion, reduces acid reflux, and protects from inflammation, and syndrome). promotes epithelial wound healing in human tissue. Hepatitis and other diseases of the Hepatitis C is a viral disease associated with fatigue, depression,
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