Therapeutic cannabis: the first experiments can begin

The trial is scheduled to run for two years from the prescription to the first patient and at the latest from 31 March 2021. It concerns the following therapeutic indications or clinical situations:

• neuropathic pain refractory to therapies (drug or non-drug);
• certain forms of drug-resistant epilepsy;
• certain reluctant symptoms in oncology related to cancer or cancer treatment;
• palliative (end-of-life) situations;
• painful spasticity (exaggerated reflex muscle contraction) due to multiple sclerosis or other central nervous system disorders.

The cannabis-based drugs used during the experiment are finished products, containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). They may come in different pharmaceutical forms:

• a spray inhalation form such as dried flowery tops or granules, containing THC and CBD;
• an oral form based on extracts solubilized in an oily matrix in the form of capsules or in an equivalent pharmaceutical form containing THC and CBD;
• an oral or sublingual form based on extracts solubilized in an oily matrix containing THC and CBD.

This experiment involves a maximum number of 3,000 patients, divided according to the therapeutic indications for which the medical use of cannabis is authorized. The Director General of the National Agency for the Safety of Medicines and Health Products (ANSM) defines this distribution according to medical needs. This authority may also carry out random checks before the experiment is carried out and throughout its duration.

Patients should be informed about special precautions for use of these medicinal products, possible adverse reactions and contraindications.

The medicinal products shall be supplied free of charge by the companies participating in the experiment. They are initially prescribed by voluntary and trained doctors practicing in the structures chosen for the experiment and may be dispensed by pharmacists who are also voluntary and trained.

The texts shall also specify the arrangements for importing, transporting, storing, holding and offering medicinal products used during the experiment.