It was also confirmed that up to 3,000 patients will be able to participate in the experiment.
Participating companies will have to supply the medical cannabis products to patients free of charge, and the products will have to comply with pharmaceutical standards, including Good Manufacturing Practice.
The first prescriptions are now expected to occur in March 2021.
The experiment will be limited in time – two years starting with the first prescription or March 31, 2021, whichever comes first.
The decree also determined that the Ministry of Health and Solidarity is responsible for the execution of the project.
The minister, with the opinion of the general director of the French Agency for the Safety of Medicines and Health Products (ANSM), will decide:
- The characteristics, composition, pharmaceutical form and technical specifications of the cannabis-based medical products.
- The list of conditions for which doctors will be able to prescribe medical marijuana within the experiment.
- The specific procedures for importing, storing, distributing and controlling the cannabis.
Nicolas Authier, a university professor and chair of the ANSM scientific committee on medical cannabis, told Marijuana Business Daily that “an invitation to tender for the selection of cannabis-based products” will be proposed in the coming days.
Because cultivation of high-THC cannabis is still illegal in France, Authier believes the suppliers “will probably be foreign … in collaboration with pharmaceutical laboratories established in France and licensed for narcotics.”
“Five more months of work before the first prescriptions,” he added, “but France is now officially committed to access to medical cannabis.”
The ANSM will be responsible for implementing a patient registry that will be updated, with the consent of patients, by doctors and pharmacies.
The registry will serve several pharmacovigilance-related purposes.
As is typical in Europe, medical cannabis will be prescribed only as last resort.
Doctors and pharmacies will have to complete a mandatory training program, but their participation in the trial will be voluntary.
The budget necessary for authorities to be able to carry out the experiment still needs to be approved by the French parliament.
Alfredo Pascual can be reached at firstname.lastname@example.org