Israeli Healthcare and Life Sciences Legal Update | Medical Cannabis – Regulatory Updates

Medical Cannabis – Regulatory Updates

Cannabis Reform – Proposed Transition from Licenses to Prescriptions:

Medical cannabis is listed in the Dangerous Drags Ordinance [New Version], 5737-1973, (the “Dangerous Drugs Ordinance”) as a dangerous drug, the use of which in Israel requires a license. Presently, licenses to use medical cannabis in Israel are granted by the Director General of the Israeli Ministry of Health (the “Director General” and the “MOH”, respectively) or by those to whom the Director General delegated the authority to grant such licenses. Currently, there are about 400 physicians authorized to issue licenses for use of medical cannabis, but only about 110 of them are active. The regulation and responsibility for the subject is centralized and carried out by the Medical Cannabis Unit in the Economy, Regulation and Innovation Division of the Ministry of Health (the “IMCA”).

Attempting to promote the exclusion of CBD from the Dangerous Drugs Ordinance (see our update from March 2022; link https://www.gkh-law.com/israeli-healthcare-update-march-2022/) the Director General appointed, at the end of October 2021, a committee for the examination of the professional and regulatory framework that will allow the transition from a licensing regime to a prescriptions regime with respect to the use of medical cannabis (the “Committee”).

In July 2022, the Committee published its recommendations. These recommendations include an outline, which the Committee believes will allow an improvement in accessibility and a significant bureaucratic relief for patients whose illnesses can be helped by medical cannabis (the “Proposed Outline”).

The Committee’s report emphasized the need to formulate a model that would be acceptable to professionals, that would be practical to implement from an operational perspective and that will address relevant financial aspects. . The Committee concluded that the best answer to the issues raised will be to transit from the grant of personal patient licenses to the issuance of prescriptions available through public healthcare services (the “Reform“). The new regulations adapting this Reform (the “Reform Regulations“) have been presented for the public comments.

The Reform Regulations propose to amend the Dangerous Drugs Ordinance to allow medical cannabis to be prescribed by physicians, trained certified as stipulated in the Reform Regulations, and to be held and distributed by pharmacies. Under the Reform Regulations it is also proposed toto; (i) state that physicians will not be allowed to hold medical cannabis at their clinics; (ii) establish that medical cannabis prescriptions will be filled by a licensed pharmacist – in order to prevent medical cannabis from being supplied in places other than a pharmacy; (iii) determine that medical cannabis prescriptions will be issued only under the authority public healthcare services, in public health institutes or public hospitals.

In the event that the prescription will be provided by a party other than the respective Healthcare Maintenance Organization (“HMO”), the party who issued the prescription will have an obligation to update the patient’s HMO, and the HMO will add the information to the patient’s medical file.

Additionally, it is proposed under the Reform Regulations, to limit the prescription dose to 60 grams per month, where a higher dose will only be provided with the approval of an authorized healthcare provider. Furthermore, it is suggested to state that physicians will be allowed to prescribe medical cannabis for a period of up to a year in the case of renewing a prescription, and for a period of up to six months when a prescription is being issued to a patient for the first time.

As part of its report the Committee recommended to encourage all of the HMOs to act in order to reduce the prices of medical cannabis for its insured.

The Reform Regulations will enter into in effect 180 days following the adoption by the Israeli Parliament of the HMOs collection plan.

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), Adv. Ofir Goldstein (Ofirg@gkh-Law.Com), or Adv. Shira Shick (Shirashi@gkh-law.com).

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This alert is prepared as an informational service to clients and colleagues of Gross & Co. and the information presented is not intended to provide legal opinions or advice. Readers should seek professional legal advice regarding the matters about which they are particularly concerned.