Cannabis is a substance that is defined as a “dangerous drug”. Medical Cannabis is not a medicine, it is not registered as a medicine, and its efficacy and safety when used for medical purposes has not yet been established. Nevertheless, there is evidence that cannabis could help patients suffering from certain medical conditions, and alleviate their suffering. In any arrangement regarding the use of cannabis for medical purposes, the State is obligated to strictly uphold the provisions of the Dangerous Drugs Ordinance [New Version] 1973
and the Regulations made under this Ordinance, as well as the provisions of the Single Convention on Narcotic Drugs 1961, including the amendments of 1972.
In accordance with Government Resolution number 3609, it was determined that the Ministry of Health shall maintain a “government agency” pursuant to the provisions of the said Convention. For this purpose, the Medical Cannabis Unit was established.
According to Government Resolution No. 1050, the principles for examining indications, improving dispensation proceedings, appointing “directors” and improving patient access to service were laid down. The Medical Cannabis Unit is in charge of regulating the field of cannabis for medical and research use.
According to a resolution of the Government of Israel dated June 26, 2016 (Resolution No. 1587), an outline was laid down, led by the Minister of Health Yaakov Litzman, for “medicalization
” of cannabis products, which outline is to ensure on the one hand an appropriate indication for patients, access to care and supply of good quality cannabis products, and on the other hand appropriate oversight of a product that is defined as a “dangerous drug”.
The cannabis products that the caring physician will prescribe are to be of a good quality level like that required of drugs. Each link in the supply chain of cannabis products must fulfill a very high level of quality, in accordance with the IMC good practices of the Ministry of Health – the Medical Cannabis Unit, from the plant reproduction material to the finished “cannabis product” dispensed at the pharmacy.
This will allow patients a decent source of cannabis supply for use for medical purposes, produced under the highest quality conditions, thus ensuring the health, wellbeing and safety of the public and preventing the unregulated use of the drug.
The Medical Cannabis Unit is the authorized body in the Ministry of Health to issue patients with permits to use cannabis for medical purposes, in accordance with the Procedures that have been set (link to Procedure 106), to assess authorization and to issue appropriate permits to those engaged in the field of cannabis and to investigators and various research bodies that wish to carry out studies of cannabis and cannabinoids.
Principles of Operation
The Medical Cannabis Unit operates according to the following principles:
- Cannabis should be considered, so far as possible, in the same manner as any other medicinal product, requiring supervision and regulation in order to protect public health and welfare, even when taking into account its special characteristics - being a plant rather than a product manufactured in a laboratory or factory.
- In view of the fact that cannabis is classified as a dangerous drug, an arrangement regarding the use of medical cannabis in Israel must approximate as closely as possible the arrangements regulating the use of narcotic medicines.
- The Ministry of Health’s commitment to all that pertains to the supply of cannabis is no different - neither greater nor less - from its commitment regarding any other medicinal product that is not essential in emergencies and is not included in the health basket.
- The Ministry of Health wishes to remove obstacles to the supply of this drug to patients who could benefit from it medically and who wish to purchase it at their own expense.
- The State is responsible for and committed to protecting public welfare and health, and is tasked with preventing deleterious use and criminality associated with dangerous drugs, including cannabis.
- It is the State’s obligation to supervise the cannabis market through the various governmental organizations (Health, Police, Customs, Agriculture), to grant permits when needed and to take all actions needed to protect public welfare and health, or to prevent deleterious use and criminality associated with the drug.
The Unit operates vis-à-vis the following parties:
- Persons being treated or applying to be treated with cannabis
- Recommending physicians
- “Administrators” - Physicians qualified to approve recommendations for the use of cannabis
- Cannabis growers, authorized laboratories, companies that transport and produce cannabis
- Pharmacies that dispense cannabis
- Cannabis suppliers
- Government ministries and bodies: The Ministry of Agriculture and Rural Development, the Ministry of Public Security, the Ministry of Justice, the Ministry of Finance, the Israel Tax Authority- Customs, Israel Police, the Israel Anti-Drug Authority
- Counterpart government agencies in countries that are signatories to the Convention on Narcotic Drugs 1961
- Professional consultants
- Organizations and associations: the Israeli Medical Association, the Pharmacists’ Association, professional medical associations (in fields relevant for indications), public associations, and more
Committees that operate in the Medical Cannabis Unit, and their objectives:
- Inter-Ministerial Steering Committee: For monitoring and coordinating the subject, constituting a “Board of Directors” for recommending operating strategies. The Committee includes representatives of the following ministries and bodies: the Ministry of Health, the Ministry of Finance, the Ministry of Justice, the Ministry of Public Security, the Ministry of Agriculture, Israel Police, the Israel Tax Authority- Customs, the Israel Anti-Drug Authority.
- Indications Committee: Broadening/narrowing the range of indications, clinical recommendations, consideration of ethical and pharmaco-legal rules.
- Appeals / Exceptions Committee: Urgent treatment, compassionate use, appeals against decisions.
- Growing Committee: Issues of growing, distinction between varieties, quality, pests.
- Security Committee: Security standards for growing, for growers/workers, transportation, production, supply, registration.
- R&D Committee: (Medicine, academia, agriculture) Advancement of research, assessment of professional standards, international conference.