Inside Israel’s New Medical Cannabis Reform

Inside Israel’s New Medical Cannabis Reform

*Editor’s Note: What follows is the most current information we have about Israel’s new reform and the changes it may bring. As with any new piece of legislature – there are still a many kinks to work out and language whose meaning will only be understood in time. Much of the information in this document was inspired from an article that originally appeared in קנאביס magazine, a big thank you to them for their reporting. We invite you to share your insights and thoughts in the comments below, by all means, call us out if you notice any glaring mistakes. Change is a living breathing thing…we’re counting on all of you to weigh in and “breathe through this” with us.

Inside Israel’s New Medical Cannabis Reform.

Big news for business owners interested in stepping in on the ground floor of the emerging medical cannabis industry in Israel. True, medical cannabis has been legal in Israel since the early 90’s, but its commercial reach has been limited until now. The passing of the recent reform in the Knesset this past June 2016 is poised to disrupt the market in a big way. Companies interested in opening a farm, becoming a distributor, a packager or even selling cannabis in their pharmacy will soon have an inroad to the future of this industry. To be sure, the Ministry of Health has outlined a detailed approval process, but they have opened a lot of doors to what could lead to huge opportunity. This new reform allows new businesses to step into the seed to sale chain.

The main impact of the reform is focused on formalizing and standardizing medical cannabis across Israel and establishing good practice across every sector of the product chain.This includes modifying production processes and standardizing the distribution process to patients. Currently, there are nine companies that are solely responsible for producing, packing, processing and distributing medical cannabis to the estimated 22,000 licensed patients in Israel. The new model cracks that process chain wide open and makes way for business opportunity in a way it never has. It will be interesting to watch who fills those spaces and see what they do with it.

The new medical cannabis reform will include the establishment of  five separate units, each of which could contain several dozen companies. Where as now, one “grow company” controls all sectors of the production chain, the reform serves to separate each unit and allow for different business leaders and companies to run different aspects of the chain. The Ministry of Health laid out the following requirements for all companies vying to enter the Israeli medical cannabis supply chain.

The Medical Cannabis Production Chain

The top of the chain will be headed by the  “National Center for Cannabis” which was recently opened in the  Volcani Center, the Ministry of Agriculture and Rural Development’s Agricultural Research Center (ARO) in conjunction with the special cannabis unit (The Yakar) of the Ministry of Health. They will be responsible for all genetics of medical cannabis strains, monitoring and providing the products for growers. Think “ground zero” for strain development.

A sign outside the building says: “This is the National Center for Research of Medical Cannabis.  This center promotes agricultural and scientific research and development for application in the in the field of medical cannabis. The center focuses its research activities and innovation towards advancing [this field of study], directing and guiding the agricultural production and related product manufacturing of medical cannabis plants.”

volcani-center-cannabis2-
photo credit קנאביס magazine

 

Breeding Farms

The breeding farm (or nursery) is the body responsible for growth, genetics and cultivation of cannabis strains and will supply other farms with marking and identification labels.

In order to obtain a license for a breeding farm there are a few conditions:

1) The applicant must be an Israeli citizen or Israeli company.

2) They must own agricultural land and have the ability to grow with proper, government approved water allocation.

3) They must receive approval of the Agricultural Society.

4) Additionally, authorization is required by the Israel Police Department.

5) Security standards and compliance with good manufacturing practice (IMC-GAP standard – will soon be published by the Ministry of Health, based on a standard GACP WHO).

Grow Farms

“Farms” are the agricultural body that will be responsible exclusively for the cultivation of cannabis. The farm will receive the young seedlings from the breeding farm, grow the plants and deliver the product at the end of the growth process to a processing plant (next step). There is no plan to provide any licensing for applicants looking to grow for personal consumption.

The steps to apply for this license are:

1) The applicant must be an Israeli citizen or Israeli company.

2) They must own agricultural land and have the ability to grow with proper, government approved water allocation.

3)  They must receive approval of the Agricultural Society.

4) Additionally, authorization is required by the Israel Police Department and compliance with security standards (IMC -GSP) is required.

5) In addition, they must meet the criteria of agricultural appropriate standards of IMC-GAP (soon to be published soon by the Ministry of Health. This criteria will be primarily based on the guidelines of the World Health Organization herbs and International Standard growing conditions for fruits and vegetables).

Processing Plants

The processing plants will be responsible for collecting the harvested cannabis from the grow farms and processing the products into oils, creams, extracts, and other related products.

In order to apply for a processing plant license, these are the steps:

1) The applicant must be an Israeli citizen or an Israeli company.

2) All applicants need to own property to house the plant and receive approval for an urban building plan or an exemption on the surface which the plant will be built.

3) They will need authorization by the Israel Police Department and meet compliance with security standards IMC-GSP and standards for good manufacturing practice GMP.

Since the production plant is one of the most complex parts to operate and requires special control, the Health Ministry published an entire appendix concerning the conditions which must be met in order to manage this business. These are the complete document details in Hebrew (Appendix B).

Distribution House

“The Distribution House” will be responsible for the storage and distribution of all medical cannabis products to the pharmacy (next step).In order to obtain a license for the establishment and management of the “Distribution House” the following is required:

1) The applicant must be an Israeli citizen or an Israeli company.

2) All applicants need to own property to house the distribution facility and receive approval for an urban building plan or an exemption on the surface which the plant will be built.

3)They will need authorization by the Israel Police Department and meet compliance with security standards IMC-GSP and production standards adequate (standard GDP).

Pharmacy

The final link in the production chain is the advent of the pharmacy to the medical cannabis landscape. Pharmacies will be responsible for the distribution of all medical cannabis products. Only patients who hold licenses and/or have a prescription for cannabis treatment will be able to receive cannabis from the pharmacy.  It’s important to note that for the foreseeable future medical cannabis patients will still be using their licenses to receive their medicine.

The steps to obtain a license for the establishment and management of a pharmacy are:

1) The applicant must be an Israeli citizen or an Israeli company.

2) The applicant must hold a business license to operate a pharmacy.

3) Additionally, authorization is required by the Israel Police Department and compliance with security standards (IMC -GSP) is required.

4) Every pharmacist needs to be approved and confirmed by the “Yakar” (the medical cannabis unit at the Health Ministry).

If you are interested in applying for a license to any of the above, and you meet the criteria and conditions above, you can contact the Ministry of Health.

Details Mailing Address: Ministry of Health, medical cannabis only (Ik”r), 39 Jeremiah Street, PO Box 1176 Jerusalem, zip code 9101002

Email: Imca@moh.health.gov.il

In summary…iCAN would like to offer three cheers for democracy, celebrate the opportunity to use business as a force to do good and say: Game on.

 

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