מבזק לקוחות | פברואר 2017
רפורמת הקנאביס הרפואי בישראל (אנגלית):
Medical Cannabis Reform in Israel
• More than 50 Israeli Start Ups engaged in the field of cannabis.
• Israel is one of a few countries that proactively support the research and development of cannabis based products.
• The Israeli Ministry of Health recently issued regulations which standardized the medical cannabis market, which include:
– Unlimited number of the licensed growers and suppliers
– More physicians will be allowed to prescribe medical cannabis
– Pharmacies throughout the country will be authorized to distribute medical cannabis
• The new regulations are aimed to balance between the constant supply of quality medical cannabis on the one hand, and a tight control of a product that is considered a dangerous drug, on the other hand.
Israeli law defines cannabis as a dangerous drug, but authorizes the Ministry of Health to issue permits related to the use of cannabis. The Ministry of Health receives over 300 daily applications for permits to use medical cannabis by patients. The Israeli government set forth rules for the use of cannabis for medicinal purposes.
The Israeli Ministry of Health generally acknowledged the fact that cannabis based products may assist patients with certain medical conditions, and a specialized unit has been established at the Ministry of Health – the Medicinal Cannabis Department (Yakar).
Government Resolution No. 1587 – The Cannabis Reform
Israel, like other countries in the world, has been experiencing a substantial increase in the use of medical cannabis, both in research and for treatment purposes.
As a result of such increase and the lack of international standards on the one hand, and in line with the policies previously adopted by the Israeli Ministry of Health in June 2016, on the other hand, the Israeli Government decided to lead a new paradigm in the field of medical cannabis by creating a practice as similar as possible to that of other pharmaceutical drugs, starting with its cultivation, through its production, packaging and distribution and ending with the prescription and supply of medical cannabis.
Only 9 growers of medical cannabis are currently licensed in Israel and only approximately 30 physicians are authorized to administer medical cannabis. However, approximately 23,000 patients hold permits to consume medical cannabis. Among others, the new regulations are also meant to deal with this discrepancy.
Israeli Government Resolution number 1587 approved and established a new medicalization model, which outlines the regulation on the use and research of medical cannabis.
The new medicalization model evolves around four main aspects:
- Medicalization of the use of cannabis for medical purposes, not legalization nor decriminalization. Cannabis for medical purposes will be treated like any other pharmaceutical narcotic drug.
- Medical indications for prescribing Cannabishave been, and will continue to be, established by the professional authorities within the Israeli Ministry of Health.
- Training of medical practitioners has been established by written guidelines and oral courses. Once successfully completing the necessary medical training, MD practitioners will be permitted to prescribe medical cannabis according to the applicable prescription guidelines.
- Standardization of medicinal cannabis products – the concentration levels of the medical cannabis will be constant and controlled and will thus enable both the safe prescription by MD practitioners on the one hand and the safe consumption by patients on the other hand.Following this Government Resolution, the Israeli Ministry of Health published 5 new directives, as follows:
Directive 150/2016 – Securing the Medical Cannabis Supply Chain– sets the standards for the security and protection measures that must be undertaken throughout the entire supply chain of medical cannabis. The directive also sets forth the security measures for the transportation of the products between the various parts of the supply chain.
Directive 151/2016 – IMC – GAP- Growing Cannabis for Medical Purposes – sets the standards for growing medical cannabis. These standards are based on the WHO Guidelines on good agricultural & collection practices (GACP) for medical plants – Geneva 2003; the Guidelines for cultivating cannabis for medicinal purposes – Netherland December 2002; and the GLOBAL G.A.P IFA 4.0 (FV) March 2013. Furthermore, under the directive each person growing medical cannabis will need to be licensed by entities approved by the Ministry of Health. The directive sets forth the process for the approval of such entities.
Directive 152/2016 – IMC – GMP – provides the good manufacturing procedures for medical cannabis.
Directive 153/2016 – IMC GDP – Storing and Delivering Cannabis Products for Medical Use – sets the conditions for the proper storing and delivery of medical cannabis products.
Directive 154/2016 – IMC GCP – Medical Cannabis – Medical Guidance Booklet This unique booklet is the first of its kind in the world and is also referred to as the 'Green Book'. It incorporates all information currently known in the field of using cannabis for medical purposes. This guidance booklet is intended as a reference tool for physicians when establishing a treatment program, setting the dosage, the type and quantity of cannabis products, etc. and the intent is for it to be updated from time as more clinical information is gathered.
The anticipated effects of the new reform:
The new reform will separate the production chain to five separate elements, namely the growing, production, packing, review and distribution of medical cannabis to patients.
The number of the licensed growers of medical cannabis will increase. Each such person will, subject to compliance with the necessary standards, receive a license to grow medical cannabis.
Pharmacies throughout the country will distribute medical cannabis. Pharmacists in such pharmacies will be required to undergo a special training program, covering the issues of medical cannabis maintenance, prescription issuance, distribution and patient instruction.
Resources will be allocated for research and development to create alternatives for smoking of medical cannabis.
The feasibility of export will be handled at a later stage in an inter‐ministerial forum headed by Directors General of the Ministries of Health and Finance and attended by representative of the Ministries of Agriculture, Defense, Justice and Economy. The inter‐ministerial forum will submit its Recommendations to the Government for further discussions and final resolutions.
For additional information please contact your GKH attorney or one of the following Adv. Hili Cohen, partner and head of the Life Sciences department [Hili@gkh-law.com], or Adv. Tami Fishman, an associate in the Life Sciences department [Tamif@gkh-law.com].