Medicinal Cannabis—An Update

Written by: Flora Koch Davidovich | Approved by: Shelly Levy, Senior Team Leader Date: 21 May 2020

Comparative Review

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The following document, which was written in response to a request by the ECPRD (European Centre for Parliamentary Research and Documentation),1 provides a brief overview of the procedures and circulars that regulate the field of medicinal cannabis in Israel. Although the vast majority of Government resolutions and Ministry of Health procedures that regulate this field (including all those cited in this document, unless otherwise noted) are published in Hebrew, a brief summary of the key regulations is available in English on the Ministry of Health website. Background Cannabis is not registered as a pharmaceutical (medication), and it is currently defined as a “dangerous drug” according to both the Dangerous Drugs Ordinance [New Version], 5733—1973 and the 1961 UN Single Convention on Narcotic Drugs, to which Israel is a signatory. However, both the Dangerous Drugs Ordinance and the Single Convention on Narcotic Drugs allow the use of cannabis for medical or research purposes, and, according to the Ministry of Health, there is evidence that cannabis may help patients in specific cases and alleviate their suffering.2 In matters related to medicinal cannabis, the Ministry of Health operates in accordance with medical principles listed on its website, a practice that is similar to the accepted norm regarding registered pharmaceuticals:3

 The Ministry of Health does not believe that a medication should be approved for use without an appropriate scientific basis as to its safety and effectiveness, and the same is true of cannabis use;  The Ministry of Health does not allow the registration of a pharmaceutical for treating a particular condition without proof that the pharmaceutical is safe and effective in treating that condition, and the same is true of cannabis;  Cannabis, too, is approved for indications where there is sufficient and reasonably convincing evidence that it is safe and effective;  The Ministry of Health does not allow for the production of medications under unsuitable conditions, and the same is true of cannabis.

Currently, the use of medicinal cannabis is regulated not by legislation but rather by guidelines, procedures, and circulars issued by the relevant Government ministries.

1 This document is an update to a response by the Knesset Research and Information Center to a similar request from the ECPRD in June 2019. 2 Ministry of Health, "Cannabis for Medicinal and Research Applications," accessed: May 18th 2020. 3 Ibid.

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As part of Government Resolution 3609 of August 7th 2011, the Government tasked the Ministry of Health with regularizing a supervised source for a supply of cannabis for medical and research purposes.4 The Medicinal Cannabis Unit (MCU), which has been part of the Health Ministry's Pharmaceutical Division since 2013, is the unit responsible for issuing permits for patients to use cannabis for medical purposes, in accordance with Procedure 106—Permits for Cannabis Use. It is also the unit authorized to assess, approve, and issue the appropriate permits for all those who work on cannabis and research it. According to the Ministry of Health, the regulation is intended to ensure that the quality of the medicinal cannabis supply chain will adhere to the highest possible standards and will be as similar as possible to the quality of the supply chain for medications and pharmaceuticals. Additionally, the regulation aims to create a basic pharmacological–regulatory common ground, which is the foundation of a regularized branch of medicine that includes medically effective, research- and evidence-based practices and medical products.5

In accordance with the aforementioned Government resolution, and based on Government Resolution 1050 of December 15th 2013 on the use of cannabis for medicinal purposes and Resolution 1587 of 26 June 2016 on the use of cannabis for medicinal purposes and research, the Ministry of Health has drawn up an outline for regulating cannabis that addresses the following issues, among others: the medicalization of cannabis products for medical purposes, indications for prescribing cannabis, the standardization of cannabis products, and the cannabis supply chain. An English- language summary of the general outline is available at the following link: Policy Principles of Cannabis for Medicinal Use. Note that it is impossible to learn from this publication about the manner in which the outline is implemented in practice.

4 Resolution 3609 of the 32nd Government, "Supervision and Regulation of the Supply of Cannabis for Medicinal Purposes and Research," August 7th 2011. 5 Ministry of Health, Associate Director General's Circular, IMC-G.A.P. Medicinal Cannabis Cultivation (Update 3—October 2017), October 2nd 2017; idem, Associate Director General's Circular, IMC-GMP Production of Cannabis for Medical Use (update 3—December 2017), December 13th 2017. www.knesset.gov.il/mmm The Knesset Research and Information Center | Abstract Medicinal Cannabis—An Update

1. Production of Medicinal Cannabis 1.1. Regulating the cultivation and production of medicinal cannabis Israeli law prohibits the cultivation of cannabis for private use. Indeed, according to the aforementioned Government Resolution No. 1587, any action involving the cannabis plant and its by-products—including cultivation, distribution, possession, transport, laboratory testing, dispensing, or research involving the cannabis plant—must adhere to all laws, which includes obtaining the appropriate permits in accordance with the Dangerous Drugs Ordinance and complying with the terms of the permit. Specific permits for each action are to be issued only by the MCU, in accordance with a recommendation from the Israel Police regarding the identity requirements for permit applicants. Conditions for obtaining a permit include compliance with obligatory quality and safety requirements, among others, as well as additional conditions that vary by permit type and situation, as they have been formulated and as they are periodically redefined.6

The aforementioned Government resolution stipulated that no limit would be placed on the number of places for cultivating medicinal cannabis, but that no permits would be issued for the cultivation of cannabis for personal use. Cannabis, and cannabis propagating agents, are to be cultivated in suitable greenhouses, which will comply with proper agricultural standards, among other requirements.

The Ministry of Health regulates the cultivation of medicinal cannabis through a detailed procedure on the subject: IMC-G.A.P. Medicinal Cannabis Cultivation (Update 4— September 2019). The procedure is designed to ensure that the quality of the medicinal cannabis supply chain—which includes cultivation, production, distribution and dispensing of medicinal cannabis products—adheres to the highest possible standards, as similar as possible to those governing the supply chain for medications and pharmaceuticals. The aforementioned procedure defines quality requirements and necessary standards for cultivating medicinal cannabis in suitable conditions. It addresses threshold requirements for applicants to cultivate medical cannabis, required knowledge and experience, cultivation conditions and greenhouses, propagating materials, cultivation regimens, farm waste management, care for the

6 Idem, "Work in the Cannabis Field," accessed: May 19th 2020.

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product after harvesting, packaging guidelines and growth batch validation, laboratory tests, and issuing of batch certificates, as well as other areas.7 Among other things, the aforementioned procedure states that:8

 Applicants to cultivate medicinal cannabis must be Israeli citizens over age 25 or a corporation registered in Israel, either with rights to agricultural land where the desired plants can be grown and which has a water allocation that permits cultivation or that acts in partnership with those who hold rights to agricultural land of the aforementioned type and have received a non-conforming use permit in accordance with the Agricultural Settlement Law;  The entrepreneur/applicant or his or her appointed agricultural manager possesses experience in greenhouse farming (e.g., vegetables, herbs and spices, mushrooms, flowers, and similar crops) for at least the five years prior to cultivating cannabis, proven professional experience in intensive agricultural cultivation, and a contract with an agronomist who is an expert in greenhouse cultivation and production. The procedure also stipulated that cultivation and propagation farms must follow proper agricultural practice and have valid IMC- G.A.P. (Israel Medical Cannabis Unit—Good Agricultural Practice) certification at all times;  In addition to the permit for the farm or cultivation farm, each farmworker or laborer who comes into direct contact with the cannabis—or may do so— requires an individual permit from the MCU. The MCU will issue the permits after receiving recommendations from the Israel Police regarding identification requirements, among other steps. Everyone employed and working on the premises must maintain high levels of personal hygiene and adhere to health and safety standards. In addition, employees will receive professional training and obtain professional qualifications suitable to their role, and they will be provided with proper clothing and equipment;  Medicinal cannabis and its propagation materials are to be cultivated only on cannabis cultivation farms with valid permits under the Dangerous Drugs Ordinance. Cannabis is to be cultivated in suitable greenhouses or structures. No cannabis cultivation will be permitted in open fields or the open air;  The cultivation of propagation material and of cannabis varieties will be carried out only on separate propagation farms (“nurseries”) distinct from the cultivation farms (even if located in close proximity within the same compound),

7 The aforementioned procedure is based mainly upon the general good agricultural practices (GAP) for plants; the WHO Guidelines on Good Agricultural & Collection Practices (GACP) for Medicinal Plants; the Dutch Government's "Guidelines for Cultivating Cannabis for Medical Purposes," Netherlands, December 2002; and the international standard for proper growing of fruit and vegetables Global G.A.P. IFA 4.0 (FV), March 2013. (Note that these documents are available in English; the Dutch guidelines are available in translation from the original Dutch.) 8 Ministry of Health, IMC-G.A.P. Cultivating Medicinal Cannabis (Update 4—September 2019), September 19th 2019. www.knesset.gov.il/mmm The Knesset Research and Information Center | Abstract Medicinal Cannabis—An Update

with valid permits under the Dangerous Drugs Ordinance. The farms will cultivate and supply cannabis seedlings bearing a unique label and identification to farms holding valid permits;  The government agency (MCU) will take possession of the cannabis plants (or plant parts intended for destruction outside the farm itself) at the cultivation farm, no later than four months after the harvest (i.e., pruning the flos) and released, barring a cause that prevents doing so, without conditions or qualifications, only to another licensed entity or to a disposal site licensed by the Ministry of Health in coordination with Israel Police, as appropriate;9  Any transportation of cannabis will be done by an entity possessing a valid transport permit from the MCU. Transport will take place in a closed vehicle that is equipped with a functioning air conditioner and a temperature-monitoring system, as required in Section 4.9 of the Associate Director General's Circular IMC-DGP Storage, Distribution and Delivery of Cannabis and Cannabis Products, which was originally published in July 2016 and which is periodically updated;  The importation of propagation material in the form of plant matter (e.g., seeds, cuttings, parts of plants, etc.) will be carried out in accordance with MCU regulations and with the laws and guidelines applicable to imports.

According to the data from the Ministry of Health on the number of permit holders for working with cannabis for medical and research applications, which are displayed on the Ministry’s website, on 19 May 2020, Israel had 17 cannabis propagation sites, 15 cannabis cultivation sites, and seven factories for producing cannabis products.10 As noted, these entities all hold permits from the MCU to operate in this field.

1.2. The medicinal cannabis supply chain Government Resolution 1587 on the use of cannabis for medical and research purposes, which was mentioned above, states that cannabis products may only be produced in factories for cannabis products—similar to pharmaceutical factories—which will conduct themselves according to appropriate professional standards, among other requirements. These factories will produce generic cannabis products in forms and concentrations approved by the MCU. The cannabis products will be transported from the factories to distribution facilities similar to those for pharmaceuticals, that will be

9 For details, see the Ministry of Health procedure on the subject: IMC-GWDP Procedures for Handling Cannabis Waste Disposal (March 2018), April 29th 2018. 10 Ministry of Health, "Parties Licensed to Work with Cannabis," accessed: May 19th 2020. Note that the list is updated periodically. www.knesset.gov.il/mmm The Knesset Research and Information Center | Abstract Medicinal Cannabis—An Update

managed according to appropriate professional standards, among other requirements. From there, the products will be distributed to pharmacies. The cannabis products will be dispensed to patients by pharmacies that wish to do so, and that meet the requirements. (See Section 3.4 for information on the purchase of cannabis products by patients.) Cannabis products are to be dispensed and managed similarly to narcotic drugs, with only the necessary changes, and according to the instructions of the Ministry of Health. The aforementioned Government resolution also states that corporate separation must be maintained between the cultivation, production, and dispensing links (i.e., farms, factories, distribution facilities, pharmacies) just as exists in the pharmaceuticals market between production and dispensing. However, the various companies may be owned in common or subsidiaries of a single entity.

The Ministry of Health issued procedures and circulars on the various aspects of the supply chain. These include a circular entitled "Securing the Medicinal Cannabis Supply Chain (Update 4—April 2020)" from March 31st 2020, which addresses quality requirements and necessary standards for supply chain security, as well as a circular entitled "MC-DGP Storage, Distribution and Delivery of Cannabis and Cannabis Products (Update 1—December 2017)" from December 7th 2017, which sets out quality requirements and necessary standards for storing, distributing, and dispensing cannabis and cannabis products for medicinal purposes.

1.3. Concentration of active ingredients Section 7.4 of the Ministry of Health circular "Cannabis Production for Medical Use (Update 3—2017)" from July 2016, which was updated for the third time on December 13th 2017, addresses the concentration range of active ingredients in cannabis products for production and distribution. According to the paragraph, the range of active ingredients permitted for each product, as presented in the table below, refers to the total concentration of cannabinoids and their acidic forms. For instance, THC refers to the total concentration of THC and with THC acid (THCA). In cannabis products, the permitted deviation must fall within the range specified in parentheses, and no additional deviation is allowed. In the following tables, we present the concentrations allowed in medicinal cannabis flos and medical cannabis oils.

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Table 1: Concentration in Medicinal Cannabis Flos—IMC Medical Grade11

Type Item THC CBD CBN Exp.

Medical cannabis 0% (0.0%–0.5%) 24% (20%–28%) 0% (Up to 1.5%) Min. 6 months CBD T0/C24 Medical cannabis 1% (0.0%–2.5%) 20% (16%–24%) 0% (Up to 1.5%) Min. 6 months CBD T1/C20 CBD-Rich Medical cannabis 3% (0.5%–5.5%) 15% (11%–19%) 0% (Up to 1.5%) Min. 6 months CBD T3/C15 Medical cannabis 5% (2.5%–7.5%) 10% (6%–14%) 0% (Up to 1.5%) Min. 6 months CBD T5/C10 Medical cannabis 10% (6%–4%) 10% (6%–14%) 0% (Up to 1.5%) Min. 6 months T10/C10 Sativa Medical Cannabis T10/C2— 10% (6%–14%) 2% (0.2%–3.8%) 0% (Up to 1.5%) Min. 6 months origin/type of Sativa variety Indica Medical Cannabis T10/C2— 10% (6%–14%) 2% (0.2%–3.8%) 0% (Up to 1.5%) Min. 6 months origin/type of Indica variety Sativa Medical Cannabis T15/C3— 15% (11%–19%) 3% (0.5%–5.5%) 0% (Up to 1.5%) Min. 6 months origin/type of Sativa variety THC-Rich Indica Medical Cannabis T15/C3— 15% (11%–19%) 3% (0.5%–5.5%) 0% (Up to 1.5%) Min. 6 months origin/type of Indica variety Indica Medical Cannabis T20/C4— 20% (16%–24%) 4% (1%–7%) 0% (Up to 1.5%) Min. 6 months origin/type of Indica variety Indica Medical Cannabis T20/C4— 20% (16%–24%) 4% (1%–7%) 0% (Up to 1.5%) Min. 6 months origin/type of Indica variety

11 Ministry of Health, Associate Director General's Circular, Cannabis Production for Medical Use (Update 3—2017), December 13th 2017, accessed: June 16th 2019 and May 19th 2020.

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Table 2: Medicinal Cannabis Oil—IMC Medical Grade12

Type Item THC CBD CBN Exp. Medical cannabis 0% (0.0%–0.5%) 24% (20%–28%) Min. 6 months oil CBD T0/C24 0% (Up to 1.5%) Medical cannabis 1% (0.0%–2.5%) 20% (16%–24%) Min. 6 months oil CBD T1/C20 0% (Up to 1.5%) CBD-Rich Medical cannabis 3% (0.5%–5.5%) 15% (11%–19%) Min. 6 months oil CBD T3/C15 0% (Up to 1.5%) Medical cannabis 5% (2.5%–7.5%) 10% (6%–14%) Min. 6 months oil CBD T5/C10 0% (Up to 1.5%) Medical cannabis 10% (6%–4%) 10% (6%–14%) Min. 6 months oil T10/C10 0% (Up to 1.5%) Medical cannabis 10% (6%–14%) 2% (0.2%–3.8%) Min. 6 months oil—T10/C2 0% (Up to 1.5%) Medical cannabis 15% (11%–19%) 3% (0.5%–5.5%) 0% (Up to 1.5%) Min. 6 months THC-Rich oil—T15/C3 Medical cannabis 20% (16%–24%) 4% (1%–7%) 0% (Up to 1.5%) Min. 6 months oil—T15/C3 .1 1.4. Cannabis export Government Resolution 4490 from December 27th 2019, on the adoption of the recommendations of the medicinal cannabis export feasibility study team, determined, among other things, that the holders of permits to work in the cannabis field in accordance with the Dangerous Drugs Ordinance [new version], 5733—1973 would be allowed to export medical cannabis products that adhere to the quality standards set and published by the Ministry of Health, subject to tight oversight by the State authorities. Work and export permits will have a limited period of validity that is subject to change. On May 13th 2020, the Government signed Free Export Order (Amendment No. 2), 5780—2020 to regulate the export from Israel of specific medicinal cannabis products, including cannabis seeds (including personal export); bulk cannabis flos (including personal export); packaged cannabis products in measured doses, including those packaged in kits or packaged for retail (including personal export); and other products. This order will take effect 30 days after publication in Reshumot [the official gazette],13 i.e., in mid-June 2020.

12 Ibid. 13 Ministry of Economy and Industry, "A Free Export Order has been Signed for Regulating the Export of Medical Cannabis," May 13th 2020, accessed: May 18th 2020; Reshumot, Kovets Hatakanot, Free Export Order (Amendment No. 2), 2020, May 13th 2020. www.knesset.gov.il/mmm The Knesset Research and Information Center | Abstract Medicinal Cannabis—An Update

2. Recreational Cannabis Use Israeli law does not permit the recreational use of cannabis. In Israel, the cannabis plant—along with all its components and derivatives—is defined as a "dangerous drug" according to the Dangerous Drugs Ordinance [new version], 5733—1973. Section 7 of the ordinance prohibits possession or use of a dangerous drug unless that use was permitted by the ordinance or its regulations or by a permit issued by the Associate Director General of the Ministry of Health or any party he appointed for this purpose. In addition, Section 12 of the ordinance states that “the use of a dangerous drug is permitted if it is for medical needs and the drug was issued to the user by a pharmacist, physician, or veterinarian under conditions detailed in Section 11(3), or was dispensed with a permit.”

On July 19th 2018, the Knesset passed the Dangerous Drugs Ordinance (Special Penalty Offense Ordinance), 5778—2018, which amended the Dangerous Drugs Ordinance [new version], 5733—1973 and the Criminal Procedure Law [new version], 5742—1982 regarding the possession or personal use of cannabis. This law was defined as a temporary order for three years beginning April 1st 2019, and it applies to adults (18 years or older). The law states that if the use of a dangerous drug of the cannabis type (or its resin) or its possession for self-consumption is a first offense—or a second offense committed within five years of the first—it will be considered a special penalty offense. This offense will be enforced by fines (NIS 1,000 for the first offense and NIS 2,000 for a second offense) and will be subject to special legal procedures. Persons using cannabis or possessing it for self-consumption for the third time will be referred for a procedure closing the case under a conditional order if the offender meets the criminal procedure requirements and is found to be fit. Persons possessing or using cannabis for the fourth time will be referred for normal criminal proceedings.14 Additionally, Section 230J of the law states that the Israel Police will manage a database that includes entries on adults who committed special penalty offenses, not including cases that were closed due to lack of guilt.15

14 Israel Police, "Information on the Law on Possession/Use of Cannabis for Self-Consumption," updated April 11th 2020, accessed: May 20th 2020. 15 Section 230 of the Dangerous Drugs Ordinance (Special Penalty Offense—Temporary Order), 2018, July 19th 2018. www.knesset.gov.il/mmm The Knesset Research and Information Center | Abstract Medicinal Cannabis—An Update

The orders presented above do not apply to minors. Section 230J(c)(1) of the Criminal Procedure Law [new version], 5742—1982 states that the special database mentioned above will include data on minors who committed offenses of use and possession for self-consumption under Section 7(c1) of the Dangerous Drugs Ordinance, pursuant to conditions to be determined by the Israel Police, the Ministry of Public Security, and the Ministry of Justice in a procedure to be published on the Israel Police website. According to the guidelines published on July 9th 2019, the police database will include information on minors, subject to the following conditions and circumstances, unless the case was closed due to lack of guilt: a first or second offense16 of cannabis use or possession for self-consumption; the minor has no convictions for one or more offenses detailed in the procedure during the three years preceding the offense; there is no fear that the minor committed another offense during the offense in question or in connection to it, except for an offense pursuant to the end of Section 10 that accompanies the offense of cannabis use or possession for self-consumption; and the minor is not a prisoner when the offense is committed. According to the Israel Police website, the guideline is in effect as of July 9th 2019.17

3. Medical Cannabis Use 3.1. Indications As of May 2020, permits could only be obtained in accordance with the medical indications defined in the aforementioned Health Ministry Procedure 106, Permits for Cannabis Use from March 2013, which was last updated in May 2019.18 These indications include the following fields: oncology—for patients with an active oncological disease, or undergoing active antineoplastic treatment, to alleviate the symptoms of an active disease or the side effects of an active treatment (e.g., chemotherapy); gastroenterology—for patients suffering from an active

16 I.e., an additional offense committed within three years of the date of the first offense. If a minor committed a second offense three years after the first offense and while still a minor, the second offense shall be viewed as a first offense. If a minor committed a first and second offense and then committed a third offense three years after the second offenses and while still a minor, it shall be viewed as a second offense. Israel Police, "Procedure for Registering a Minor Committing Offenses of Possession or Use of Cannabis for Self-Consumption in the Special Police Database," July 9th 2019, accessed: May 21st 2020. 17 Ibid. 18 Information on the work of the Indications Committee is available from the Ministry of Health website, see "Work of the Committee on Indications for Cannabis Use," March 2013, updated May 2019, accessed: May 19th 2020.

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inflammatory bowel disease (Crohn’s or colitis) and who meet the criteria determined in the aforementioned procedure; pain—for patients suffering from organic neuropathic pain from a well-defined source; infectious diseases—for patients with HIV/AIDS; neurology—for patients with multiple sclerosis, Parkinson’s disease, Tourette’s syndrome, epilepsy; palliative care—for terminal patients; and psychiatry—for patients with Post-Traumatic Stress Disorder (PTSD). We emphasize that these indications also include qualifications; for example, in some cases, cannabis can only be prescribed after traditional treatment options have been exhausted.19

As of the beginning of December 2019, there were some 61,000 permit holders for medicinal cannabis use in Israel.20 We do not possess current information on the breakdown of permit holders by indication. According to data from 2018 (through October 31st 2018) when there were 30,464 permit holders for medicinal cannabis use in Israel, the distribution of permit holders by indication was as follows:

Table 3: Breakdown of Permit Holders by Reason for Permit Request, October 201821

Indication Number of Permits Percentage Chronic neuropathic pain unrelated to 17,963 58.93% cancer, with a clear cause, after the exhausting of traditional treatments Psychiatry—PTSD 3,131 10.27% Oncology (various) 2,861 9.39% Neurology (various) 1,680 5.51% Gastroenterology (various) 1,210 3.97% Palliative care (end-of-life care) 276 0.91% Infectious diseases—HIV/AIDS 137 0.45% accompanied by cachexia a CD4 count under 400 cells/mm3 Glaucoma 1 -

19 Ministry of Health, "Permits for Cannabis Use," March 2013, updated May 2019, accessed: May 19th 2020. 20 Ministry of Finance, "Summary of the Price Committee Discussion on Medicinal Cannabis," January 9th 2020. 21 The data from the Ministry of Health were provided to the Knesset Research and Information Center by Or Sadan, the Freedom of Information Movement, email, June 5th 2019. www.knesset.gov.il/mmm The Knesset Research and Information Center | Abstract Medicinal Cannabis—An Update

Other 3,225 10.58% Total 30,484 100%

3.2. Forms of medicinal cannabis Paragraph 7 of the Ministry of Health circular Manufacturing Medicinal Cannabis (Update 3—December 2017) from December 13th 2017 states that medicinal cannabis can be supplied in four forms: dried and packaged medicinal cannabis flos in packages with a net weight of 10g of cannabis per package, rolled medicinal cannabis flos in tube form in cigarettes with a filter or holder, medicinal cannabis oil, and medicinal cannabis cookies. It further states that other products, whether in different forms or different dosages, may only be distributed if they are approved by the MCU at the Ministry of Health.22

3.3. Prescription There are two ways for patients who fit the criteria detailed in Procedure 106, Permits for Cannabis Use to obtain a permit for possession and use of medicinal cannabis. 1. Through an MCU-authorized physician: Patients may visit one of the physicians authorized and licensed by the MCU to issue cannabis permits; the fee for such an appointment is the same as a visit to an outpatient clinic. If the physician decides to approve treatment with medicinal cannabis, he or she will issue a permit during the visit and provide a “dispensing order” (prescription) for the pharmacy. From the moment they receive the permit, patients may purchase medicinal cannabis in one of the licensed pharmacies. Patients who use private healthcare may submit a request to the MCU via an online form. Cancer patients can receive the service in the oncological wards of the hospitals where it is available.23 According to the Ministry of Health data, on May 19th 2020, some 94 physicians had been authorized by the MCU.24 2. An online request to the MCU by a specialist: Patients can see a specialist in the field of the relevant medical indication. If the physician decides to recommend treatment with medicinal cannabis, he or she fills out an online request form and attaches the required documents. If necessary, patients

22 Ministry of Health, Associate Director General's Circular, "ICP-GMP Manufacturing Cannabis for Medicinal Uses (Update 3—December 2017)," December 13th 2017; idem, Medicinal Cannabis— Information Brochure and Medical Guide: Draft update No. 3—May 2019, accessed: May 19th 2020. 23 Idem, Treatment with Medicinal Cannabis, accessed: May 19th 2020. 24 Idem, Physicians authorized to issue permits for medicinal cannabis, accessed: May 19th 2020.

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can also submit documentation into the system directly through a dedicated link. After the MCU receives all the required materials, the request will be forwarded for review and decision to an MCU physician with “manager” authorizations under the Dangerous Drugs Ordinance. The permit and/or a letter referencing the request will be sent by email directly to the patient and the treating physician.25

We note that it is possible to submit a request for a decision to be reviewed. This request will be submitted online by the treating physician and will be reviewed by two specialists at the MCU.26

3.4. Purchasing medicinal cannabis As stated above, Government Resolution 1587 defined a new arrangement, according to which cannabis will be dispensed to patients in pharmacies that request to do so and that meet the requirements. Cannabis products are to be dispensed and managed in accordance with the regulations for narcotic medications, with necessary changes only, and in accordance with instructions from the Ministry of Health. From the moment patients receive a permit, they may purchase medicinal cannabis in one of the licensed pharmacies.

However, in March 2019, the High Court of Justice received a petition from the Medical Cannabis Association against the Ministry of Health and the Ministry of Agriculture.27 During the hearing on the petition, the court ruled on October 6th 2019 that the timeline set out by the Ministry of Health for converting all permits for cannabis use to the new arrangement could disturb the treatment regimen for a large number of patients. The High Court therefore decided to issue an interim order extending the validity of cannabis permits that had been issued under the old arrangement, had expired between February 2nd and July 31st 2019, and had been extended by the Ministry of Health until December 31st 2019. According to the court, the validity of these permits would be further extended until the earlier of March 31st

25 Idem, Medical Treatment with Cannabis, accessed: May 19th 2020. 26 Ibid. 27 Documents related to HCJ 2335/19, Medicinal Cannabis Association v. Ministry of Health and Ministry of Agriculture, petition, accessed: May 20th 2020.

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2020 or ten days after a decision by the Price Committee on the subject—or until a different decision would be reached.28

On March 8th 2020, the High Court of Justice extended the validity of the aforementioned interim order, in light of the fact that the proceedings before the joint Health Ministry–Finance Ministry Price Committee—including topics involving the aforementioned petition and orders that had been issued in its wake—had dragged out. According to this order, cannabis use permits—whose validity the court had previously extended—would continue to be valid until May 15th 2020 or until ten days after the decision of the Price Committee, whichever occurred first. Moreover, the High Court of Justice ruled that during this period, cannabis would be dispensed to the people who held permits under the old arrangement according to the conditions and prices that were in effect under that arrangement.29

On May 13th, 2020, the High Court of Justice granted the respondents an extension through June 2nd, 2020 to submit additional information, as per the aforementioned court decision from March 8th. As a result, the validity of the interim order was extended until June 15th 2020.30

Currently, patients whose permit was granted on or after April 29th 2019 receive permits that are valid for purchasing from pharmacies licensed to sell medicinal cannabis.31 According to Ministry of Health data, there were 73 such pharmacies as of May 19th 2020.32 Patients with old permits that list the provider's name can use their permit to make purchases in pharmacies even without presenting a new permit, but only if they requested a new permit from the pharmacy and its details have already been entered into the system.33

28 HCJ 2335/19, Decision, October 6th 2019. 29 HCJ 2335/19, Decision, March 8th 2020. 30 HCJ 2335/19, Decision, May 13th 2020. 31 Ministry of Health, Medical Treatment with Cannabis, accessed: May 19th 2020. 32 Idem, Pharmacies Authorized to Sell Medicinal Cannabis, accessed: May 19th 2020. 33 Idem, Additional Information on Cannabis and its Effects, accessed: May 19th 2020.

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In addition, patients with a valid permit may purchase products directly from the vendor whose name appears in the permit (in contrast to pharmacies, where one may purchase a variety of products from different vendors). These permits are intended for procuring cannabis from a specific grower.34

34 Ibid. www.knesset.gov.il/mmm The Knesset Research and Information Center