The concept of Medicalization of Cannabis is based on the following principles:
1. Regulated supply chain, standardization of medical grade cannabis products and quality assurance
In order to insure high quality standardized medical grade products, all components of practice and workers in the “supply chain” of medical grade cannabis products, from the stage of plant reproductive material to the final “cannabis product” that is dispensed at the pharmacy, will be controlled by stringent criteria and quality control in accordance with the IMC – Good Practices Procedures of the Ministry of Health – IMCA.
Medical cannabis products that are approved for marketing in Israel will be at a level of quality that is suitable for medical use, and will be marked “IMC – Medical Grade”.
In order to reach a high level of standardization and to ensure a high level of reproducibility and uniformity, as appropriate for a medicinal product, the entire process will be closely controlled and supervised in the form of good practices, in accordance with the IMCA good quality practice procedures – IMC-GAP, IMC-GMP, IMC-GDP, IMC-GSP. These include respectively, growing, manufacturing, distribution and security under appropriate conditions, standardizing all aspects of the supply chain.
Accordingly, throughout the process, from the breeding material stage to the final medical grade cannabis product, optimal and uniform environmental conditions must be adhered to, as well as defined, uniform work processes that are based on standard operating procedures (SOPS).
Throughout the process, regular and periodical analytic checks will be required to be performed ensuring and documenting the compliance of the stem lines, reproduction batches, growing plants, growing batches and production batches of cannabis with the required analytic standards and quality level, as prescribed for each stage of the process. The generic medical grade cannabis products that will be available at pharmacies will be defined by constant concentration margins of the selected API.
2. Methodology for indication based clinical practice and training of physicians
The use of medical grade cannabis should be comparable to the use of any registered medicine or medicinal product, as far as possible. A fundamental clinical methodology for treatment with medical grade cannabis products is required in order to administer the appropriate treatment based on the medical indication.
The attending physician is required to determine the appropriate product type and adjust the potency, administration route, monthly quantity, daily dosage and consumption.
The increasing number of potential patients necessitates the need for a clinical guideline in order to provide existing relevant information and scientific background, authorized indications for treatment and a clinical method for the administration of treatment with cannabis products.
There is also a necessity for a training program of physicians based on such guidelines, in order to provide tools required to build a treatment plan using medical grade cannabis products and create an ongoing, constantly improving medical cannabis ecosystem.
3. Research and Development
Currently scientific knowledge regarding the mechanism of action of cannabis and its constituents in the human body is lacking. There is little evidence based medicine in the field as the research of cannabis is forbidden in many countries around the world due to its legal status.
The Ministry of Health of Israel acknowledges the necessity for more research and for evidence based medicine in the field of cannabis. Therefore the Ministry is in favor of promoting research and advancing scientific knowledge at all levels from plant science to clinical trials.
4. Supervision and Compliance with the Legal Status of Cannabis
The State of Israel is bound by the provisions of The International Single Convention on Narcotic Drugs, 1961, and exacting observance of the provisions of the ordinance and regulations in the Dangerous Drugs Ordinance [New Version] 1973.
The state is responsible for and committed to protecting public safety and health and is entrusted with the prevention of misuse and criminal use related to narcotic drugs, including cannabis.
The Ministry of Health target is to make treatment with medical grade cannabis accessible, while ensuring safety and quality.
The “medicalization” process is intended to ensure correct medical practice and to ensure that the quality of the supply chain of medical grade cannabis, including growing, production, distribution and dispensing of medical grade cannabis products, will be of the highest quality.
The IMCA has prepared, (with assistance of Prof. Rafael Mechoulam, – a world renowned expert in cannabis research who pioneered the characterization of the endocannabinoid pathway, for his invaluable scientific contribution) , "The Medical Grade Cannabis Cannacopeia" -Israeli Medical Cannabis – Good Clinical Practices, guidelines to all the cannabis chain the in order to provide the initial information base :
• IMC-GAP (for Medical Grade cannabis growers)
• IMC-GMP (for Medical Grade cannabis products manufacturers)
• IMC-GDP (for distributers and pharmacies)
• IMC-GSP (security) for all the chains.
And the most important :
• IMC-GCP : Good Clinical Practices [clinical guide “Medical Grade Cannabis – A Clinical Guide” (“The Green Book”)]
The clinical guide covers information that has been accumulated and published in scientific literature as well as the accumulated experience of professionals practicing in the field. The guide covers information regarding the cannabis plant and its constituents, the endocannabinoid system, pharmacology, side effects, main drug interactions and more.
The Cannabis research covers a comprehensive meta-analysis of multiple sources dealing with cannabis in the fields of botany, pharmacology, chemistry and biochemistry.
This has enabled the determination of a “therapeutic methodology”. The guide also shows the approved indications for receiving a cannabis usage license, the guidelines and recommendations for developing an effective treatment plan.
The combination of the clinical guide (“The Green Book”) and the quality procedures IMC-GAP, IMC-GMP, IMC-GDP, IMC-GSP for the supply chain of medical grade cannabis products, constitute the Israeli pharmacopeia for medical grade cannabis. Accordingly, combining coherent, well defined medical practice with Medical Grade Cannabis Products that fulfill quality standards, constitute the first step to regulated, research based medical use.
There is the paucity of EBM in the field of medical grade cannabis. With this guide we hope to encourage the creation of an expert community that will be part of the ongoing research effort.
In order to expand the evidence based knowledge, an effort must be made to advance research. In the future, as more studies and knowledge based on empiric facts and medical opinions evolve, modifications may be made to this clinical guide , improving and upgrading the medical guidelines for treatment with medical grade cannabis, benefiting the wellbeing and health of the public.