© 2022 KOMAND Consulting
ITALY
Population: 59,035,584
GDP/Capita: USD$35,551.30
Wholesale Medical Flower Price/Gram: €6.88 (excl VAT)
Pharmacy purchase price from SCFM (Military Chemical Pharmaceutical Plant of Florence)
Current Med/Rec Usage (15-64yrs): 10.2% (2017 Prevalence)
Prescription Count 2022 EST
>50,000
Patient Count 2020 EST
>20,000
Prescription & Patient Count
c
Sources : World Population Review, World Bank, EMCDDA, istat.it , Bedrocan, IMF
STATUS
• In January 2013, Italy legalized the medical use of cannabis
• Cannabis products can only be used as a raw material as an
ingredient for prescribed masterful preparations in pharmacies
• The country is facing a severe shortage of 1000kg per year,
and home cultivation of up to 4 plants is being considered as
one possible solution
• Patients are covered by public insurance for some indications
NEWS
• Tilray wins approval to import and distribute THC25 in Italy
• Italian start-up becomes the first to support pharma companies in every
aspect of medical cannabis development and distribution
Status Quo & Recent News
PatientsProducts
Product
THC/CBD
per gram of flower
Country of Origin
FM1
(Italian Military)
130-200mg / 0
Italy
FM2
(Italian Military)
50-80mg / 0
Italy
Bedrocan flos
220mg / 0
Netherlands
Bedrobinol flos
135mg / 0
Netherlands
Bediol flos (granulated)
63mg / 80mg
Netherlands
Bedica flos (granulated)
140mg / 0
Netherlands
Bedrolite flos (granulated)
0 / 90mg
Netherlands
Pedanios 22/1
(Aurora)
220-260mg / 0
Canada
Pedanios 8/8
(Aurora)
80mg / 80mg
Canada
Pedanios 1/9
(Aurora)
0 / 90mg
Canada
List of Available Products – Dried Flower
a
a
Retail Pharmacy Price Per Gram = Max chargeable is €9/gram
Wholesale cost from SCFM to Pharmacies = €6.88/gram
Italian compounding pharmacists are the only professional authorized to
manufacture and dispense medicinal cannabis products. Dried flower is sold as an
active pharmaceutical ingredient to the pharmacies
Back to Europe
Pharmacy Magistral Preparation Prices
d
d
Source : www.farmagalenica.it
In mid 2019, the Ministry of Health mandated the reduction ( by decree)
of the retail pharmacy price per gram of dried flower to €9/gram. This
significantly drove down the price of what the pharmacy can charge for
their preparations, as the dried flower API has to be shown to be
€9/gram and the pharmacy can only charge certain labour and
packaging costs beyond that.
Ministry for Health Indication Guidance
Updated Jan 2022
e
1. Analgesia in pathologies involving pain-associated
spasticity (multiple sclerosis, spinal cord injury) resistant to
conventional therapies
2. analgesia in chronic pain (with particular reference to
neurogenic pain) in which treatment with non-steroidal
anti-inflammatory drugs or with cortisone or opioid drugs
has proved ineffective
3. The anticinetotic and antiemetic effect in nausea and
vomiting, caused by chemotherapy, radiotherapy, HIV
therapies, which cannot be obtained with traditional
treatments
4. The appetite stimulating effect in cachexia, anorexia,
loss of appetite in cancer patients or AIDS patients and in
anorexia nervosa, which cannot be obtained with standard
treatments
5. the hypotensive effect in glaucoma resistant to
conventional therapies
6. The reduction of involuntary body and facial movements
in Gilles de la Tourette syndrome which cannot be
achieved with standard treatments
e
Ministry for Health - Information for doctors and pharmacists
4.1 Medical use of cannabis
c
KOMAND estimates
Medical Cannabis Sales to Pharmacies in Italy
b
2017 2018 2019 2020 2021
162kg
284kg
451kg
665kg
743kg
129kg
147kg
252kg
215kg
251kg
60kg
147kg
157kg
243kg
278kg
From Bedrocan (Holland)
To Hospital Pharmacies
(Ministry of Health)
From Bedrocan (Holland)
To Private Wholesalers
To Pharmacies
From SCFM
(Domestic)
To Pharmacies
b
SCFM (Stabilimento Chimico Farmaceutico Militare) is the only LP in Italy, with
distribution capability. In 2019 they imported a nominal amount of cannabis from
Aurora Canada as part of their inventory.
The wholesale price (for dried flower) charged by the SCFM to pharmacies is set at
€6.88/gram before VAT.
The private wholesalers charge the pharmacies €8-10/gram for the foreign product.
Italian Medicinal Cannabis Import and Distribution
j
Product Channels
Producer Importing/Distribution Company End Buyer
Tilray Brands FL Group (Nuuvera) Retail Pharmacies
SCFM
(Stabilimento Chimico Farmaceutico Militare)
SCFM
(Stabilimento Chimico Farmaceutico Militare)
Retail Pharmacies
Aurora Canada
Little Green Pharma
Bedrocan International B.V. Ministry of Health/Hospital Pharmacies Hospital Pharmacies
FL Group (Nuuvera) Retail Pharmacies
ACEF
Galeno
Farmalabor
Fagron
351 kg
578 kg
861 kg
Pharmacy Preparation
Grams €/g or mL €/Package
30 sachets of 100mg 3g 22.0 65
30 sachets of 200mg 6g 16.0 95
30 sachets of 300mg 9g 13.9 125
30 sachets of 500mg 15g 12.3 185
100ml cannabis Olive Oil
(10g Cannabis)
10g 17-19 170-190
50ml cannabis Olive Oil
(5g Cannabis)
5g 22-24 110-120
25ml cannabis Olive Oil
(2.5g Cannabis)
2.5g 28-36 70-90
j
Aurora were awarded a contract in 2018 to supply 100kg of medical cannabis to the SCFM
Little Green Pharma were awarded a contract in Feb 2022
In September 2022, Tilray Brands secured approval for THC25
Last Updated – Oct 2022
Ministry of Health (Ministero della Salute)
Authority for the cultivation, manufacturing, import, export and
distribution of medical cannabis in Italy
The European Medicines Agency
Compliance guidelines for EU GMP, EU GDP & EU GACP,
inspection procedures and forms agreed by all EU Member States
Italian Drug Agency (Agenzia Italiana del Farmaco)
Regulates of the marketing, use and supervision of
pharmaceutical products, including cannabinoid-based drugs
Regulatory Agencies
Cannabis
Pharma
1,123 kg
1,272 kg