In the realm of medical cannabis, Italy has been progressively establishing its regulatory framework to facilitate access and enable the use of cannabis-based treatments.
This guide, based on insights from “Principles of Clinical Cannabinology” by Viola Brugnatelli and Fabio Turco, in collaboration with Cannabiscientia and Prohibition Partners, offers a detailed understanding of the intricate world of medical cannabis regulation in Italy.
1. Law References and Regulation
The journey of medical cannabis regulation in Italy commenced in 2007 with Decree No 98. This decree recognised THC and its derivatives for therapeutic use, positioning them in Table 2, section B, of narcotic drugs. Subsequently, the Ministerial Decree of 2015 refined the regulation, governing cultivation, production, possession, and usage of medical cannabis. However, implementation responsibilities were decentralised to individual Regional Health Systems, leading to regulatory variations across regions.
2. Differences in Healthcare System and Reimbursement
In Italy, the reimbursement policy for medical cannabis hinges on the prescription’s origin. Private prescriptions do not warrant reimbursement, contrasting with prescriptions originating from the public healthcare system. Reimbursement is extended for specific pathologies, yet discrepancies persist concerning the eligible conditions for reimbursement across various regions.
3. Prescribing Authorities
Prescribing medical cannabis in Italy is an option available to any registered doctor licensed to practice. However, each region has the autonomy to designate eligible doctors authorized to prescribe reimbursable medical cannabis, leading to variations across the country.
4. Approved Pathologies for Prescription
The Italian Ministry of Health has outlined various pathologies eligible for reimbursed cannabis treatments, ranging from chronic pain to conditions like glaucoma and Gilles de la Tourette syndrome. The list is subject to regional variations, allowing regions to customize the approved pathologies based on local considerations.
5. Available Medical Products and Routes of Administration
In Italy, compounded cannabis preparations predominantly rely on raw inflorescences imported from authorised sources. Notable varieties available include Bedrocan, Bediol, Bedrobinol, and more. Patients have the flexibility to opt for oral, inhalation, or topical administration routes based on their specific medical requirements.
6. Prescription Format and Patient Access
The format of medical cannabis prescriptions varies across regions in Italy. However, the common thread is the necessity for informed consent from patients. Patients, in turn, must personally collect their prescribed therapy from authorised dispensaries, which could be hospital pharmacies or designated public and private pharmacies.
7. Medical Cannabis Treatment Costs
In Italy, the cost of medical cannabis inflorescences is legislatively set at €9/gram plus VAT. For compounded preparations, additional costs include production and container expenses. Reimbursements typically cover a significant portion of the total treatment cost, ensuring medical cannabis remains accessible to those in need.
8. Decree CBD: The Vanishing Science?
Recently, Minister of Health Orazio Schillaci signed a decree concerning CBD, a component of cannabis known for its non-psychotropic properties. Cannabiscientia, a scientific education company focusing on Medical Cannabis and the Endocannabinoid System, has expressed concerns regarding this decree. The decree’s scientific foundation and alignment with existing research and global regulations have been questioned.
The Ordine dei Medici Chirurghi ed Odontoiatri (OMCeO) of Rome highlighted the use of CBD as a means to introduce psychoactive cannabinoids, a claim contradicted by the absence of scientific evidence supporting this assertion. The OMCeO further referenced an increase in psychiatric disorders allegedly linked to unrestricted cannabis use, failing to differentiate between THC-induced psychoses and the therapeutic potential of CBD, which is extensively studied for its antipsychotic properties.
Cannabiscientia emphasised the importance of evidence-based decision-making, highlighting that CBD is not considered a narcotic substance by reputable global health organisations. The dissonance between the decree and established scientific understanding raises concerns about the potential misclassification of CBD in Italy.
Understanding the nuances of medical cannabis regulation in Italy is crucial for both healthcare professionals and patients. The evolving landscape signifies a progressive approach, striving to integrate medical cannabis as a legitimate and viable therapeutic option. However, the recent CBD decree has brought to light the importance of ensuring regulatory decisions align with established scientific evidence.
Disclaimer: The information provided is derived from “Principles of Clinical Cannabinology” by Viola Brugnatelli and Fabio Turco, in collaboration with Cannabiscientia, Prohibition Partners and a consortium of clinicians.