Medical Cannabis – Regulatory Updates
(i) Removal of CBD from the Israeli Dangerous Drugs Ordinance:
Earlier this month, the Director General of the Israeli Ministry of Health announced the appointment of a committee intended to examine the possibility of excluding CBD from the Israeli Dangerous Drugs Ordinance [New Version], 5737-1973 (the “Committee” and the “Ordinance”, respectively). As of this date, cannabis, including all parts of the plant and the roots (but excluding oil extracted from its seeds) is defined, under the Ordinance, as a “dangerous drug” such that the sale and use of cannabis are prohibited unless a permit has been granted by the Israeli Ministry of Health (“MOH”).
The appointment of the Committee is a step by the MOH, which is in the process of examining the removal of CBD (extracted from the cannabis plant) from the definition of “dangerous drug” under the Ordinance, so that products containing CBD (including food and cosmetics) could be marketed in Israel, without the need for a specific permit.
The Committee’s role will be, inter alia, to map the existing legislation and policies in the world regarding CBD products; determine the required conditions (e.g. quality, concentrations levels); examine existing information on the safety of CBD products; examine benefits and necessity of the use of CBD products. The Committee’s recommendations will be submitted to the Director General of the MOH by January 15, 2022.
(ii) Importation of Medical Cannabis – Procedure 109 Update:
The Israeli Medical Cannabis Agency (“IMCA”), updated Procedure 109, titled “Guidelines for the Approval Process of Applications for the Importation of Cannabis for Medical Use and Research” (“Procedure 109”). According to the update, laboratory tests performed on raw materials and imported products for the examination of pesticide residues, will also be performed in relation to additional pesticide (as specified in Procedure 109). Such requirements are to enter into effect in May 2022.
(iii) IMCA’s Guidelines Regarding “Former Regime” for Medical Cannabis Licenses:
On November 28, 2021, the IMCA published guidelines for companies that provide patients with medical cannabis products (the “Medical Cannabis Providers”), based on the regime that preceded the MOH’s medical reform that took place in 2011 (the “Reform“; and the “Guidelines”, respectively). The Guidelines were published due to a ruling of the Israeli Supreme Court (HCJ 2335/19), with respect to a petition filed in 2019 against the Reform.
The Supreme Court dismissed the petition, and effectively ruled that as of March 1, 2022, all patients’ licenses for cannabis use that have been granted under the “former regime” (i.e. prior to the Reform) will expire.
Pursuant to the Guidelines, Medical Cannabis Providers are instructed to assist patients in converting their “former regime” licenses to the “Reform regime” licenses. Medical Cannabis Providers are instructed to contact their patients and to inform them that they need to apply for a change of license, and to deliver to the Medical Cannabis Provider their original “former regime” license, for the purpose of submitting the license to the IMCA for the conversion into a new license.
We note that the above is merely a short summary of the subject matter, and does not cover all relevant provisions of the guidelines. For additional information please contact your Gross & Co. attorney or one of the following Adv. Hili Cohen, partner and head of life sciences department (Hili@gkh-law.com) Adv. Tami Fishman, partner (Tamif@gkh-law.com), or Adv. Ofir Goldstein (Ofirg@Gkh-Law.com).
