On September 13, 2022, the Israeli Ministry of Health (“MOH”) published a notification concerning research in plant-based psychoactive substances (the “Notification”).
In its Notification the MOH recognized that there is a wide variety of psychoactive substances that originate from plants (mainly from mushrooms), such as Psilocin, Psilocybin, Mescaline, Ibogaine or DMT. Each of these is listed in the Israeli Dangerous Drags Ordinance [New Version]-1973, as a dangerous drug. Therefore, the possession and use of such substances require a license from the MOH. There is hope that these substances will be able to, after proper research provide medical benefit, to patients. Hence, the MOH acknowledged in its Notification the importance of conducting such research on these substances for the purposes of asserting their therapeutic benefits, proper methods of growth, substance extraction etc.
Over the past year, various parties within the MOH, examined the matter of research on plant-based psychoactive substances. Such examination was followed by a recommended plan of action of the Chief Scientist of the MOH, to promote research in this field. Following such recommendations, the MOH notified as follows:
- Non-clinical research (e.g., research of cultivation, extraction or formulation) of plant-based psychoactive substances as well as import and export of materials for research purposes, will be supervised in a similar manner to the supervision of cannabis research. Such research, export and import will be handled and supervised by Israeli Medical Cannabis Unit of the MOH (the “IMCA”), and in accordance with IMCA’s existing regulations and guidelines for conducting research on cannabis.
- Approvals for clinical studies on humans, granting GMP approvals for studies (from phase 3 only), including approval to use raw materials or active substances (APIs) for the production of preparations – shall be under the responsibility of the MOH’s Pharmaceutical Division, all in accordance with existing regulations.
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).
