🇮🇹 Italy Overview
The Italian government maintains tight control of the country’s medical cannabis market, controlling supply and distribution. The government itself imports from one supplier under a supply agreement, renewing the agreement or changing the supplier every few years. Direct imports of flower products by hospitals in the country are only permitted from Bedrocan in the Netherlands, while a small number of extract products are also permitted to be imported from other suppliers.
The only production which takes place in the country is cultivation, and is also government controlled. This is undertaken by the military, which grows approximately 100kg of one proprietary strain, FM2.
Tight governmental control combined with a lack of regulatory development in the medical cannabis industry over the last number of years has resulted in a lack of market development in Italy. The situation in terms of patient access, prescribing procedures, treatment variety, resources available for doctors etc. has not changed over this time.
🇮🇹 Regulations
Italy legalised the prescription of medical cannabis in 2015 through ministerial decree, stipulating that the medical cannabis product used in treatment must be prepared in a magistral process by a pharmacist.
Implementation responsibilities for medical cannabis frameworks are at the level of individual regional health systems, leading to some variation in how medical cannabis treatment functions between regions in Italy. Some regions do not implement frameworks in a practical sense at all.
Medical cannabis is prescribed under the private health system as well as the public health system in Italy, with the significant difference between the two systems being reimbursement of treatment costs, which only takes place in medical cannabis treatment under public healthcare.
The regulatory framework, as it currently exists, would allow Italy to import more medical cannabis from various suppliers. The government has, in practice, denied permission for most imports aside from Bedrocan, however, with the long-term intention of supplying the market adequately with domestically produced cannabis.
🇮🇹 Patient Access
Who Can Prescribe?
It depends on the prescription:
- Paid prescription: accessible through private healthcare. Any doctor may prescribe for any condition supported by scientific evidence, when traditional treatments are ineffective or require increased dosages that could harm the patient.
- Reimbursed prescription: accessible through public healthcare. Each region has specific limitations on treatable pathologies, authorised prescribers, and available products. A therapeutic plan by a specialist is always necessary. General practitioners are authorised to provide prescription renewals.
What are the Treatable Pathologies?
- Paid prescription: all pathologies supported by scientific evidence.
- Reimbursed prescription: each region has limitations on covered pathologies. Generally, there is coverage for chronic pain, spasticity, chemotherapy-induced nausea and vomiting, muscle spasms, anorexia, glaucoma, and Tourette syndrome.
🇮🇹 Products & Prices
There are currently six flower strains available to patients in Italy for treatment, these are:
- Bedrocan
- Bedrolite
- Bediol
- Bedica
- Bedrobinol (authorised but not available)
- FM2 strain grown by the Italian military
- Hindu Kush strain from Linneo Health
All of the flower products are sold for treatment at a fixed price of €9 per gram + VAT.
There are 10 extract products available in Italy, produced by Farmalabour, Avextra and Tilray. There is no price cap on extract products, but pharmacies are forced to sell at the cost price with 0% gain. The extract products available in Italy are:
- FARMALABOR CANNABIS EXTRACT 15% THC
- FARMALABOR CANNABIS EXTRACT 1% THC and 1% CBD
- FARMALABOR CANNABIS EXTRACT 2,5% THC
- FARMALABOR CANNABIS EXTRACT 2% THC
- FARMALABOR CANNABIS EXTRACT 1% THC
- FARMALABOR CANNABIS EXTRACT 5% CBD
- Avextra/Fagron Cannabis Extract 1% THC and 1% CBD
- Tilray T25 - 25 milligrams/millilitres THC
- Tilray T10C10 - 10 milligrams/millilitres THC and 10 milligrams/millilitres CBD
- Tilray T5C20 - 5 milligrams/millilitres THC and 20 milligrams/millilitres CBD
🇮🇹 Imports & Exports
A variety of players have been active in importing medical cannabis into the Italian market over the last number of years, however only Bedrocan has done so on a consistent basis. Other suppliers have had to compete for limited tender contracts, with the winner of each tender supplying the market via imports for a short time, and in limited quantities.
🇮🇹 Domestic Production
The Italian medical cannabis market has always been supplied primarily via imports, despite the stated intention of the government to establish sufficient domestic supply to cover market demand. Annual cultivation targets set by officials have never been reached, with volumes produced remaining relatively stable since 2018, while imports have steadily increased over the same period.
Bedrocan remains the major supplier of the Italian market, with their products representing approximately 90% of those used in patient treatment, by volume
Patient Access
What are the treatable pathologies?
Conditions for which doctors prescribe medical cannabis include but not limited too (doctors judgment):
- Chronic Pain
- Depression or anxiety disorders
- Multiple Sclerosis
- AIDS symptoms
- ADHD
- Cancer patients undergoing chemotherapy
- Epilepsy
- Insomnia
Reimbursement
As medical cannabis is classified as an ordinary prescription medicine it has significantly eased patient access allowing patients to receive medical cannabis consultations and prescriptions through telemedicine platforms. This has dramatically fuelled the increased use of cannabis-specific telemedicine platforms with Prohibition Partners identifying over 20 telemedicine clinics operating in the German medical cannabis market. When assessing the monthly visitor count of the leading telemedicine providers of medical cannabis in Germany, the numbers provide a clear picture of how frequently they are used. The leading six providers have a monthly visitor count of over 150,000. Although the visitor count does not provide a 100% accurate representation and translation of prescription and patient numbers, it does highlight the extremely high use of these platforms which is fuelling the dramatic demand for medical cannabis in the market.
- Specialist and specialisation designations
- Specialists in general medicine
- Specialists in internal medicine
- Specialist and specialisation designations
- Specialists in anaesthesiology
- etc.
Doctors outside the designated specialist groups can prescribe reimbursed medical cannabis if they meet certain qualifications. Under the new framework, statutory insurance covers medical cannabis for serious illnesses when no recognized alternative treatment is available and it benefits the patient.
- Geriatrics
- Palliative medicine
- Specialised pain therapy
- Drug tumour therapy
- Sleep medicine