Italy

Italy legalised the prescription of medical cannabis in 2015 through ministerial decree. Products must be prepared by a pharmacist through a magistral process.

Implementation responsibilities rest at the individual regional health system level, leading to significant variation between regions — some regions do not implement frameworks in practice at all.

Medical cannabis is available through both public and private healthcare. The key difference: reimbursement is only available under the public system.

The regulatory framework theoretically permits broader imports, but the government has in practice restricted approved suppliers to Bedrocan (Netherlands) for flower imports, citing the goal of eventually supplying the market through domestic production.

Paid prescription (private healthcare): Any doctor can prescribe for any condition supported by scientific evidence, when traditional treatments are ineffective or require dosages that could harm the patient.

Reimbursed prescription (public healthcare): Requires a therapeutic plan by a specialist. Each region sets its own limitations on pathologies, authorised prescribers, and available products. General practitioners may provide prescription renewals.

Commonly covered conditions under the public system: chronic pain, spasticity, chemotherapy-induced nausea and vomiting, muscle spasms, anorexia, glaucoma, and Tourette's syndrome.

Reimbursement: Available under public healthcare only, subject to regional approval.

Six flower strains are currently available for patient treatment in Italy:

• Bedrocan
• Bediol
• Bedica
• Bedrolite
• Bedrobinol (authorised but not currently available)
• FM2 (grown by the Italian military — approximately 100 kg of one proprietary strain annually)
• Hindu Kush (from Linneo Health)

All flower products are sold at a fixed price of €9 per gram + VAT.

Ten extract products are available, produced by Farmalabor, Avextra, and Tilray. Pharmacies must sell at cost price with zero markup. Extract products include THC-dominant, CBD-dominant, and balanced formulations from Farmalabor, Avextra/Fargon, and Tilray.

Bedrocan (Netherlands) remains the dominant supplier, representing approximately 90% of all products used in patient treatment by volume.

Other suppliers have historically competed for limited tender contracts, with each tender winner supplying the market for a limited period and in restricted quantities.

Domestic production is government-controlled: the Italian military cultivates approximately 100 kg of FM2 annually. Annual cultivation targets have never been met, while imports have continued to increase.