The Israeli Cannabis industry – export and regulation status

The Israeli Cannabis industry – export and regulation status

Cannabis in Israel – a Historical Review

A pioneering country in the field of cannabis science, Israel is considered a global leader in clinical and scientific research, product development, patient care, regulation and quality. THC and CBD, the predominant Cannabinoids found in the cannabis plant, were discovered, isolated, and studied for the first time by Prof.  Raphael Mechoulam and his research colleagues at the Hebrew University of Jerusalem in the 1960s. Back In the 50s, Hemp was grown in the north of Israel for industrial applications. Following a 70-year period during which cannabis was banned for use or research, the ban was finally lifted in countries such as the Netherlands, Israel and Uruguay, and other countries began to reexamine the controversial plant. Cannabis has been approved for treatment of Israeli patients in 2006, mostly for palliative care. Since then, more and more medical conditions of lesser severity have been prescribed  medical cannabis treatment . Since Prof. Mechoulam’s breakthrough, scientific research, novel discoveries and innovative technology in agriculture and medicine have thrived and are continuing to do so. Israel is well known for its academic freedom and encouragement for cannabis-related research, and is keen to examine the medicinal potential of the Cannabis plant and its derived products. Israeli cannabis research is a highly active domain which gives birth to abundant academic studies and clinical trials. Extraordinary medical and scientific discoveries are published regularly, bearing tremendous social, economic and business potential.

Cannabis business activity in Israel

The field of cannabis has been developing rapidly in recent years, in Israel and worldwide. More and more countries are permitting the use of cannabis for medical and recreational purposes. In Israel, medical Cannabis is available as a prescription drug for patients who’ve consulted an authorized physician and have met certain criteria. It is still illegal for recreational use. Several steps are being taken towards partial decriminalization which will be finally approved by the Israeli government soon. Under the proposed law, growing a single plant at home without using specialized equipment will be permitted as long as it’s done for recreational, and not commercial purposes. Moreover, the future decriminalization policy for recreational cannabis will include fines as initial corrective measures prior to arrest, giving users a chance to avoid criminal records. In recent years, we’ve witnessed significant progress in cannabis production and regulation in Israel. Most notable is the establishment of the YAKAR (the medical cannabis governmental unit) in 2013, which acts under the Israeli Ministry of Health, and are responsible for the management and supervision of the activities in this field, including regulatory and legal aspects regarding patient health, research, quality, GAP (Good Agriculture Practice), GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), safety and security. Until 6 months ago, only few physicians were allowed to prescribe Cannabis for Israeli patients. Today there are more than a 100 authorized physicians who’ve been given specific training on the health benefits of cannabis, contemporary clinical results, and relevant medical conditions in order to increase the licensing rate for  Israeli patients’ medical needs. To illustrate, in 2013, medical cannabis prescriptions in Israel were provided by just 6 physicians and were handed out to approximately 9,000 licensed patients, by 2015 the number rose to about 22,000 licensees, and by 2018 to about 40,000. The clinical data being accumulated in Israel about specific cannabis strain and product efficacies, per medical indication is analyzed constantly, proposing an advanced clinical methodology to be used all over the world.

Cannabis product Quality & GxP

In recent years, the cannabis sector in Israel has been undergoing a series of preparations in which the Ministry of Health, the Ministry of Agriculture and the YAKAR are all taking part, mostly in updating regulation. We are witnessing extensive efforts and welcome activity by all relevant government ministries improving the safety, efficacy and quality of cannabis products. In addition, new information is published regularly regarding cannabis breeding and growing, innovative production techniques, clinical trials, academic research, transportation, distribution, security and more.Israel was the first country to publish formal Cannabis Quality Assurance (QA) and good practices (GXP) regulatory guidelines which are relevant for Cannabis cultivation (GAP), manufacture (GMP), Laboratory (GLP) and distribution (GDP). Companies in the growing, manufacturing, and distribution chain are obligated to work based on the current guidelines and are audited and inspected by the Israeli Ministry of Health before they can distribute their products locally or export them globally. The main target of these new regulations is to assure that the Cannabis products be safe and meet the accepted quality standards in terms of purity, consistency and efficacy.

Cannabis products Israeli regulation and export

To date, the cannabis market in Israel has been held by 8 companies only. As part of the new regulations, the various parts of the cannabis supply chain are separated: cloning, growing, production and distribution. The YAKAR have opened the market  by supplying  licenses to new players from Israel and abroad –  farmers and companies that wish to enter the Israeli Cannabis industry.  Towards the soon to be approved Cannabis export, more than a 100 new Cannabis cultivation, manufacturing and distribution companies have entered the marked, among which are several Canadian, American, and other international players.  Estimates are growing that the monthly price per patient (currently 370 ILS~100$) will be converted to price per gram, so that each patient  pays based on the amount they actually need, as listed in the medical prescription they  hold. This is likely to increase the profits of growers and manufacturers alike. The updated quality and quality control requirements require laboratory testing for the dry flowers and products, so this extra cost will probably be rolled over to the end consumer and prices will rise accordingly (quality costs money). As the new export law is approved, the Israeli Cannabis industry is about to flourish due to higher product prices coupled with favorable climate conditions which are sure to keep operation costs low and the Israeli branded products competitive. In addition, GMP certification, along with the use of Israeli clinical methodology, will guarantee that Israeli Cannabis products be classified and labeled “premium” easily. It is safe to assume that these moves will yield the Israeli economy billions of shekels a year.

About Cannabis GxP consultancy

Cannabis GXP is proud to stand at the forefront of the Cannabis industry in Israel and worldwide thanks to many years of experience in these areas.

Our team is compelled to spread the message of the importance of cannabis science, regulation and standardization as the world enters a new era of cannabis legislation.

We aim to position our clients with their best foot forward when it comes to anything and everything cannabis related.

Our vast expertise allows us to assist companies in a wide range of services and needs: Anything from Cannabis R&D, growing and manufacturing, new products development, facility design, technology, Quality Assurance, Good Practices (GAP/GMP/GLP/GDP/GCP), staff training, local and global regulations.

Cannabis GxP is a subsidiary company of Bio-Chem Ltd. (2007), a consultancy firm for the Pharmaceutical field, Medical devices, Cosmetics and food supplements industry based in Israel.

Our cannabis consultancy services include:

  • Product development, delivery system & clinical trials
  • Growing, Manufacturing and Lab Facilities Design
  • Quality Assurance and Good Practices (GxP)
  • Cultivation & Product Manufacturing Technology
  • New product Regulations and Submissions
  • Qualification & Validation
  • Risk Assessment
  • Staff training

If you need one or several of our services, we will be more than happy to assist.

Please do not hesitate to contact us for further information.

2019-05-19T08:34:20+00:00

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