© 2020 KOMAND Consulting
ITALY
Population: 60,317,116
GDP/Capita: USD$40,470
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 2019 (Jan)
26,042
Patient Count 2019 (Jan)
12,998
Prescription & Patient Count
c
Sources : European Monitoring Centre for Drugs & Drug Addiction (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
Italian supplier Bedrocan is the primary source for Italy
Patients are covered by public insurance for some indications
NEWS
The path towards cannabis legalization in parliament begins again
Italian need for cannabis is 3 tonnes per annum
Italy court rules home-growing cannabis is legal, reigniting dispute
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 bi-annually
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 anticetetoxic 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
“Use and Safety of Cannabis for Medical Use in Italy” - Roberto Da Cas
Medical Cannabis Sales to Pharmacies in Italy
b
2017 2018 2019 2020
162kg
284kg
451kg
665kg
129kg
147kg
252kg
215kg
60kg
147kg
157kg
243kg
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
SCFM
(Stabilimento Chimico Farmaceutico Militare)
SCFM
(Stabilimento Chimico Farmaceutico Militare)
Retail Pharmacies
Aurora Canada
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, followed by a contract in 2019 to supply 400kg to the SCFM. Less than
150kg of Aurora supplied cannabis had been delivered by 2019YE
Last Updated – Apr 2021
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