Details of medical cannabis trials in France

From approval of medical cannabis experimentation in France by the ANSM, the CSST is actively working on its implementation. A final hearing is scheduled for June 26 to present the Committee's conclusions on the trial, due to start in 2020, and to gather patient feedback.

«The main objective of the experimental phase is to evaluate, in real-life situations, the Committee's recommendations on prescribing and dispensing conditions, and the compliance of healthcare professionals and patients with these conditions», explains the ANSM. «Its secondary objective is to collect the first French data on efficacy and safety».

What kind of medical cannabis?

As expected, it is the cannabis plant itself that is being tested, rather than pharmaceutical products per se. Available will be cannabis preparations and full-spectrum extracts, oils, sublingual tablets, syrups and capsules. The CSST has refused to make smoking cannabis available. Flowers will be available, however, but will have to be vaporized.

In terms of active ingredient content, the CSST has established five THC/CBD ratios :

• THC 1 : 1 CBD,
• THC 1 : 20 CBD,
• THC 1 : 50 CBD,
• THC 5 : 20 CBD
• THC 20 : 1 CBD.

Dosage to be determined by the doctor.

For and by whom?

5 indications have been selected to justify the use of medical cannabis: neuropathic pain refractory to accessible therapies (drug or non-drug), certain forms of severe and drug-resistant epilepsy, as part of supportive care in oncology, in palliative situations, in painful spasticity in multiple sclerosis or other central nervous system pathologies. Access to cannabis is available to anyone who needs it, including children, particularly in cases of epilepsy resistant to conventional treatments.

Initially, only specialist doctors will be able to prescribe medical cannabis. They will also have to be affiliated to multidisciplinary reference centers or structures. These centers' pharmacies - known as pharmacies for internal use (PUI) - will be responsible for dispensing medical cannabis. Participation in the experiment by centers and doctors will be on a voluntary basis.

Once treatment has been stabilized, i.e. the dosage and duration of treatment have been established, GPs can take over medical monitoring and prescribing. Dialogue between specialist and general practitioner is essential. As a general rule, doctors are required to undergo prior training (in e-learning) to be authorized to prescribe cannabis. In a second phase, community pharmacies will also be able to take over from the PUI and distribute cannabis to «stabilized» patients.

The calendar

Following publication of the terms and conditions of the trial, a 6-month implementation phase will follow. Once the system is ready, another 6-month phase will be devoted to patient inclusion, followed by another phase of the same duration for patient follow-up. Finally, there will be 6 months of data analysis by the CSST, which will submit a final report to the ANSM. The agency will then have to take a position on legalization.

The trial will therefore last a total of two years. Patient enrolment is scheduled for early 2020. Patients with a favorable benefit/risk profile will have access to the treatment for the duration of the trial. Throughout the trial, doctors will be required to enter treatment progress and observations on a national electronic register provided by ANSM. This will enable information on dosage and adverse effects to be pooled.

In terms of supply, no French production chain has yet been established. Medical cannabis will therefore have to be imported. The CSST has already auditioned foreign producers.