Company: INCR
Filing Date: 2025-05-01
Form Type: 20-F
Source: 0001641172-25-007971
Chunk: 85

Company: Intercure Ltd.
Filing Date: 2025-05-01
Form: 20-F
Item: Item 4
Chunk 85
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 established an inter-ministerial safety committee, composed of representatives of government ministries, government authorities and other government bodies, for intergovernmental cooperation regarding the regulation of cannabis. The IMCA examines medical recommendations for the use of cannabis for medical purposes and in accordance with established procedures (the “IMCA Procedures”). The IMCA is also authorized to examine applications and issue permits to hold, use and research cannabis.
Regulations Governing the Use of Cannabis for Medical Purposes
 
Under the Israeli DDO, cannabis is defined as a “dangerous drug” and the use of cannabis is prohibited unless a license is duly issued by the IMCA or a competent government agency.
 
Pursuant to the Israeli DDO, the use of cannabis was allowed for patients and for medical purposes, in respect of certain medical conditions, under a special approval of the MOH.
 
In June 2016, the Israeli government published Resolution No. 1587, which established a new regulatory framework for the “medicalization” of cannabis. Pursuant to Resolution No. 1587, the IMCA adopted regulations expanding the number of qualifying medical conditions for treatment with medical-use cannabis to include such conditions as cancer, pain, nausea, seizures, muscle spasms, epilepsy, Tourette syndrome, multiple sclerosis, amyotrophic lateral sclerosis, post-traumatic stress disorder (“PTSD”), autism, migraines, arthritis, Parkinson’s disease, residual limb pain, spinal cord injuries, HIV/AIDS, Crohn’s disease, colitis, inflammatory bowel disease and terminal illnesses (“Medical Indications”).
 
With the intent to expand the access to cannabis and to simplify the bureaucratic process, in January 2024, the MOH published an update to the IMCA Procedures (the “Enabling Reform”) pursuant to which, inter alia, broader discretion in the administration of medical cannabis is granted to the family physician or to the physician in the physician’s area of expertise, and for a larger number of Medical Indications at a wider spectrum of severity and the administration of cannabis as “last resort treatment” was eliminated. However, we believe that the implementation of the Enabling Reform has been subject to significant challenges, including bureaucratic hurdles and practical difficulties in full execution.
 
Regulations Governing the Production, Manufacturing and Distribution of Cannabis for Medical Purposes
 
In March 2016, the IMCA published New Regulations (the “New Regulations”) that introduced strict pharmaceutical-grade standards for the production, manufacturing and distribution of cannabis for medical use pursuant to Israel Medical Cannabis-certified