Obtaining Permits for Use of Medical Cannabis in Israel
Israel is considered a global leader in research, development and use of cannabis for medical purposes with its unwavering commitment to patients and clinical trials. The medicalization of Cannabis in Israel did not spring up overnight. Over the past few years, there have been various reforms and amendments to provisions, which we shall further elaborate in our article.
The advantages of conducting study trials with medical cannabis in Israel are broad. Primarily, the strict regulations surrounding the supply chain and the involvement of law enforcement (The Israel Police), ensure judicial action for criminal activities if misuse of the cannabis product is detected. In addition, the warm climate and costs of crop cultivation are favourable for breeding the plant. Consequently, to date, nearly every medical center in Israel is running numerous clinical trials with medical cannabis.
IMP – Clinical Supply Services has recently obtained the “IMC-GDP License”. This exclusive license is issued by the Ministry of Health-The Israeli Medical Cannabis Unit and states that the importation, distribution and storage of cannabis for medical use are permitted only if the designated facility holds an “IMC-GDP License”.
There are mainly various interfaces in connection with the supply chain of medical cannabis for clinical trials: cultivation farms, production facilities, pharmacies, certified warehouses for storage and distribution of medical cannabis to clinical sites and more. Each interface, part of the supply chain of cannabis products, must meet the highest of quality standards, under the following IMC Good Practices:
- IMC-GAP (Good Agricultural Practices)
- IMC-GMP (Good Manufacturing Practices)
- IMC-GDP (Good Distribution Practices)
- IMC-GSP standards (Good Security Practices).
1) Cultivation farms adhere to IMC-GAP standards and IMC-GSP.
2) Production facilities adhere to IMC-GMP standards and IMC-GSP.
3) Facilities handling transport, distribution adhere to IMC-GDP and IMC-GSP
In accordance with an Israeli government decision in 2016, it was determined that the Ministry of Health maintain a “government agency” to administrate the medical cannabis topic.
According to the provisions of said Convention, the Israeli Medical Cannabis Unit (IMC) was established. Thus it was decided that the Medical Cannabis Unit and the Director will be authorized to provide the license for import, export or diversion of a dangerous drug, provided that these services have been sanctioned.
Over the past few years, the presence of the Israeli Police Department has become more dominant, as the exclusive enforcement authority dealing with the security aspect for the medical cannabis supply chain. Meaning, the Israeli Police Department, is exclusively in charge of overseeing the enforcement of the GSP (security authorization) throughout the intricate process of obtaining a license for handling medical cannabis.
Without this approval, a breeder, supplier or any other party from the supply chain may not proceed to handle, import, export, distribute or breed cannabis for medical use.
In January 2019, the Ministry of Internal Affairs requested an amendment to the Dangerous Drugs Ordinance, providing the Israeli Police with two primary responsibilities:
- The Israeli Police Department will provide all security guidelines, to all companies handling medical cannabis.
- An extensive background security check will be conducted by the Israeli Police Department to ensure the safety and security of the medical cannabis supply chain, thus reducing risks for criminal activity.
Given the above, the recommendations to qualify an institution for a license is enforced by the Israeli Police Department. The Director of the Unit for Medical Cannabis may/may not accept the police recommendations, thus qualifying/disqualifying the company requesting the permit.
The security authorization requires each facility to align their security processes with the recommendations from the IMC-GSP guidelines, prior to submitting request for the permit. Security guidelines are varied, but are not limited to: safe installation, camera and security surveillance, facility entrance control with security tags and intercom system, alarm system for protection against theft and prohibited entry into the facility, security clearance for all new and hired employees, secured distribution plathform and much more. Click here for the full list of guidelines for the IMC-GSP requirements.
In general, cannabis remains a prohibited substance worldwide; therefore, the medicalization process established in Israel requires compliance to rigid standards for production, storage and distribution.
This unique plant is proving to alleviate pain and help cope with intolerable side-effects for millions of patients worldwide. More studies need to be conducted to master the mechanism and strive to understand the in-depth value of the drug for treating various medical conditions. The extensive scientific evidence of the beneficial effects deriving from the use of cannabis should be the primary focus when applying for the permit.
The Health Care Providers in Israel offer several services in many domains – beginning with the occasional doctor visit or routine blood tests, up to prolonged treatment for which nursing services are required.
Home-care treatment can be challenging and complicated in terms of the logistics. The coordination of the medical care as well as the supply of the required medicines direct to patient home requires a qualified sub-contractor with suitable licenses and logistics capabilities.
The benefits of home care are obvious. Researches supports the fact that a familiar environment for the patient improves the patient recovery. When a doctor provides home-care treatment, the exclusive attention given to that patient in addition to the accuracy of the diagnose/treatment concerning the time frame the doctor has, is immeasurably greater than the attention, patience or time the doctor has in the hospital or clinic.
Another benefit is that non-hospitalization reduces the number of infections in which the patient risks under hospitalization, saving excessive costs (hospital beds) and maintaining the continuity of the treatment.
In addition, home care services for clinical trials have many advantages for pharma companies who have implemented this model in the study. For example, side effects are immediately reported, patient compliance significantly rise as there is a beneficent influence on adherence to the doctor’s instructions.
Israel is considered a suitable choice for conducting clinical trials for many reasons. One reasons being is the small geographical size, which is very convenient for managing the required logistic operation. In addition, Israel has a high level of health care services with a suitable technological platform to perform studies.
A conceptual change of mind is required in order to encourage more companies to conduct their clinical studies with this influential model , this fact is as opposed to what is actually requires for including this service in clinical trials design: to submit it for approval to the Ethics Committee.
The Ethics Committee approval should include in the request form an approval to perform part of the treatment, including the delivery of the drug, to the patient’s home. After gaining the approval a contract needs to be signed between the parties (sponsor, medical center & service provider) defining the responsibilities of each party and assuring the compliance to the study protocol to GCP requirements.
When choosing the adequate clinical supply chain supplier and distribution partner for home care services, one should ensure that the suppliers are in compliance with GCP/GDP and local regulations, flexible and of course have a service-oriented approach. IMP has built a suitable supply chain platform to provide solutions for clinical trial logistics in the fundamental trend of Direct-to-Patient Models.
The platform for providing drug products in adequate conditions to patients home is accessible. It is clear today that all medical services are moving forward and implementing this important service and it is only a matter of time before it will become the common practice.