French pilot programme for medical cannabis

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

The French temporary specialized committee on cannabis (Comité scientifique spécialisé temporaire, CSST), which has been established in 2018, held its last meeting on 26 June 2019. The committee presented its final recommendations regarding the feasibility of implementing a French medical cannabis pilot programme to the National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé, ANSM).

The main objective of the programme is to evaluate cannabis prescribing and dispensing and to assess the adherence of health professionals and patients. In addition, safety and efficacy data for medical cannabis will be collected.

Amongst others, the CSST has issued the following framework for the pilot:

Investigation objects

• Active component: Cannabis preparations, or full ingredient spectrum extracts.
  
• Dosage forms: Immediate release forms (sublingual and inhaled forms) as well as extended release forms (oral solutions or capsules).
  
• THC / CBD ratio: Five different Tetrahydrocannabinol / Cannabidiol ratios (1/1, 1/20, 1/50, 5/20 and 20/1).
  
• Dose: The dose should be adjusted until the minimum effective dose is reached (with adverse reactions considered to be tolerable by the patient and the doctor).

Timelines

The pilot project will be divided into four 6-month phases:

• 6 months for implementation,
  
• 6 months for patient inclusion,
  
• 6 months for patient monitoring with issuance of an interim report, and
  
• 6 months of data analysis and submission of a final report by the CSST to the ANSM.

In parallel, a multidisciplinary Scientific Committee will be created in order to develop a guide with recommendations for prescribers, analyze registry data, monitor safety data and write study reports.

The pilot programme will start as soon as the French Public Health Ministry has given green light and provided the necessary funding. Thus, medical cannabis is not expected to be "legalized" in France prior to the end of 2021.

For more information please see the framework Cannabis à visée thérapeutique: Projet d’expérimentation.