© 2022 KOMAND Consulting
Patient Count 2022
All pilot participants: 1900
Current patient numbers :1272
Patient Count
b
FRANCE
Population:64,628,119
GDP/Capita: USD$43,518
Cannabis Flower Price/Gram: €9.3
Current Med/Rec Usage (15-64yrs): 11% (2017 Prevalence)
ANSM # (see above)
International Cannabis Company French Pharma Partner
Lot 1.1
Main supplier
Alternative supplier
AURORA EUROPE GmbH
TILRAY
LABORATOIRES ETHYPHARM SAS
MEDIPHA SANTE
Lot 1.2
TILRAY
PANAXIA PHARMACEUTICAL INDUSTRIES
MEDIPHA SANTE
NEURAXPHARM FRANCE
Lot 1.3
PANAXIA PHARMACEUTICAL INDUSTRIES
EMMAC LIFE SCIENCES
NEURAXPHARM FRANCE
LABORATOIRES BOIRON
Lot 2.1
AURORA EUROPE GmbH
TILRAY
LABORATOIRES ETHYPHARM SAS
MEDIPHA SANTE
Lot 2.2
TILRAY
LITTLE GREEN PHARMA Ltd
MEDIPHA SANTE
INTSEL CHIMOS SAS
Lot 2.3
PANAXIA PHARMACEUTICAL INDUSTRIES
EMMAC LIFE SCIENCES
NEURAXPHARM FRANCE
LABORATOIRES BOIRON
Lot 3.2
LITTLE GREEN PHARMA Ltd
ALTHEA COMPANY PTY Ltd
INTSEL CHIMOS SAS
LABORATOIRES BOUCHARA RECORDATI
Lot 3.4
AURORA EUROPE GmbH
No alternative supplier
LABORATOIRES ETHYPHARM SAS
No alternative supplier
Lot 3.5
LITTLE GREEN PHARMA Ltd
PANAXIA PHARMACEUTICAL INDUSTRIES
INTSEL CHIMOS SAS
NEURAXPHARM FRANCE
ANSM Pilot Program Products– 2022
Allowable products, forms & potencies
a
a
ANSM questions dedicated to the supply and distribution of medical cannabis
Distribution of indications among patients
currently participating in the trial
c
c
ANSM, Indications among current participants in the pilot programme (Aug 2022)
Sources : World Population Review, World Bank, UNODC, EMCDDA
Companies providing cannabis-based medicines free of charge
e
e
ANSM
Cannabis Flower
CATEGORY POTENCY RANGES ANSM #
THC Dominant (20/1 target) THC> 8%, CBD <1% Lot 1.1
Balanced Ratio (1/1 target) THC and CBD> 5% Lot 2.1
CBD Dominant (1/20 target)
THC <1% CBD> 5%
THC <5% CBD> 5%
Lot 3.1
Lot 3.4
Form:
Flower must be prepared in a form for inhalation by vaporization (such as
dried flowering tops or granules)
Back to Europe
STATUS
• Afterdelayscausedbythepandemic,Francelauncheda2-year
pilotprograminMarch2021.Theaccessschemesetsoutto
treat3,000patientsandwillendMarch2023
• Thepilotmade9specificmedicines(from6suppliers)available
freeofchargetopatients.AsofFebruary2022,1,218patients
hadreceivedinitialtreatment.Morethan200hospitalsand
1,100doctorssigneduptoparticipateinthetrial.
NEWS
• Frenchlawsnowpermitmanufacture,importanddistributionofmedical
cannabis
• SantéFrancesupportsextensiontomedicalcannabispilotprogramme
• ANSMaskscurrentsuppliersforpricelisttoestimatecostof2nd
experiment
Status Quo & Recent News
Patients
b
Pilot programme participation rates
Products
Product Channels
L’Agence nationale de sécurité du médicament (ANSM)
ANSMhasfullcontroloversupplyanddistributionofcannabis-based
drugsforapilotprogram,andisresponsibleforselectingthe
suppliersthemselves.Allmedicalcannabiswillbeimported
The European Medicines Agency
ComplianceguidelinesforEUGMP,EUGDP&EUGACP,
inspectionproceduresandformsagreedbyallEUMemberStates
Regulatory Agencies
Cannabis
Pharma
Last Updated – Oct 2022
Cannabis Extracts
THC Dominant (20/1 target) THC 5mg/ml, CBD<1 mg/ml Lot 1.2
Balanced Ratio (1/1 target) THC and CBD oil> 5 mg/ml Lot 2.2
CBD Dominant (1/20 target)
THC<1mg/ml, CBD>5 mg/ml
THC<5mg/ml, CBD>5 mg/ml
Lot 3.2
Lot 3.5
Form:
An oral form based on extracts solubilized in an oily matrix
Cannabis Capsules
THC Dominant (20/1 target) THC 5mg/ml, CBD<1 mg/ml Lot 1.3
Balanced Ratio (1/1 target) THC & CBD ingest>5 mg/ml Lot 2.3
CBD Dominant (1/20 target)
THC<1mg/ml, CBD>5 mg/ml
THC<5mg/ml, CBD>5 mg/ml
Lot 3.3
Lot 3.6
Form:
An oral form based on extracts dissolved in oily matrix in form of capsules
PainfulspasticiyinotherCNS
pathologies,4.0%
Cancer,7.0%
Palliativecare,
8.0%
Drug-resistant
epilepsies,14.0%
PainfulspasticiyinMS,
15.0%
Refactory
Neuropathic
pain,52.0%
1538 Health professionals trained
d
Health Professionals
CEIP-A/CRPV referents
Community relay doctors
PUI pharmacists
Healthcare professionals from
Reference structure
Community pharmacists
69
111
372
470
516
d
ANSM, Indications among current participants in the pilot programme (Aug 2022)