In the intricate landscape of medical cannabis, Belgium has established a regulated framework to govern the use of cannabis for medicinal purposes. Our insights stem from the comprehensive book “Principles of Clinical Cannabinology“ authored by Viola Brugnatelli and Fabio Turco, in collaboration with Cannabiscientia and Prohibition Partners.
This excerpt sheds light on the intricacies of medical cannabis regulation in Belgium, offering a glimpse into the thorough analysis and extensive information available in the book.
1. The Legal Framework: Royal Decree and Circular 648
Belgium’s foray into medical cannabis began with the Royal Decree of 11 June 2015, marking a significant step in regulating its usage.
Subsequently, Circular No. 648 was issued by the Federal Agency for Medicines and Health Products (FAMHP) on 16 July 2019, providing essential supplements to the original decree.
Circular 648 allows the use of medical cannabis and derivatives with CBD and minute traces of THC, setting specific limits to THC exposure based on the patient’s body weight.
2. Products and Routes: Options for Medical Usage
Belgium offers several approved medical cannabis products and routes of administration. Sativex® and Epidiolex® (not yet marketed as of 2022) are among the approved products.
Additionally, magistral preparations based on CBD powder with acceptable THC levels are allowed. These can be administered orally (as oil or capsules) or topically (as ointments), providing versatility in treatment options.
3. Medical Prescriptions: Who Can Prescribe?
In principle, a neurologist should prescribe medical cannabis in Belgium. However, given doctors’ therapeutic freedom, any licensed doctor can prescribe approved cannabis-based medicines. The prescribing physician assesses the patient’s need and provides information on risks, and, with the patient’s consent, initiates the treatment.
4. Eligible Pathologies and Reimbursement
Belgium permits medical cannabis for moderate to severe spasticity resulting from multiple sclerosis (MS). Reimbursement for cannabis-based medicines is limited in the private healthcare system.
However, specific conditions, such as severe spasticity due to MS and prescription by a neurologist, allow reimbursement in the public system, albeit with stringent conditions.
5. Obtaining Medicinal Cannabis: Process and Costs
To access medicinal cannabis, patients need a prescription from their physician, which they can fill at a pharmacy. Sativex® is available at public pharmacies but is reimbursable only when dispensed by a hospital pharmacy. The average cost of cannabinoid preparations varies, with Sativex® priced at approximately 400-500 € /100ml and magisterial preparations at 110-120 € for a 10% oil.
This excerpt offers a glimpse into the extensive regulatory framework that governs medical cannabis in Belgium. For a deeper understanding of the subject and comprehensive insights into the global landscape of medical cannabis, we invite you to explore the book “Principles of Clinical Cannabinology.” Discover a wealth of knowledge and expertise to navigate the intricate world of medical cannabis with clarity and confidence.