A temporary scientific committee launched by the French National Agency for the Safety of Medicines and Health Products (ANSM) has recommended that medical marijuana be authorized – five years after the country passed legislation to allow cannabis-based medicines.
The initial rules allowed only for specific MJ medicines with licenses, also known as marketing authorization. The new recommendations expand the classification.
Currently, the only form of cannabis available to French patients is Marinol, but it is rarely prescribed. Sativex has marketing authorization but has yet to be sold.
The ANSM committee, created to assess the feasibility of a national medical marijuana market, recommended that MMJ be authorized for use in addition to or as a replacement for existing medicines – but only for certain conditions when those existing medicines don’t provide adequate relief.
- Chronic pain that’s untreatable with already existing therapies.
- Some forms of severe and refractory epilepsy.
- Supportive care in oncology.
- Palliative care.
- Multiple sclerosis spasticity.
Smoking was discouraged as a route of administration.
The committee received input to form the recommendation from health professionals, patient associations and experiences reported by Canada, certain Latin American countries, Germany and Switzerland.
Nicolas Authier, head of the committee, told le Quotidien du Medicin, a French medical publication, that cannabis should be available in the form of “magistral preparations” instead of waiting for full marketing authorizations of medicines that have had clinical trials.
Helene Moore, corporate development for Aurora Europe and CEO of PharmBD, told Marijuana Business Daily that “after a positive first recommendation of the committee, the ANSM must now conduct a diligence process to answer a second set of questions pertaining to the mechanics of making these medications accessible to patients.
“In their communication from (last week) the committee already provided some basic guidelines, defining therapeutic cannabis as going beyond the classic pharmaceutical products, probably including full spectrum products,” Moore added.
The committee’s final recommendation is expected by September 2019, according to French newspaper Le Figaro.
The committee expects a legislative change to follow its recommendations.
Antonin Cohen, director of compliance at ACTIVE, a European trade association, and CEO of Harmony CBD, emphasized the importance of this first step to MJBizDaily.
“Because this committee includes reputable doctors and scientists, we expect policymakers to follow their recommendations,” he said.
“It’s the beginning of a long process that will lay the (groundwork) for forward-looking and efficient regulations for a better accessibility of cannabis-based medicines in France.”
Alfredo Pascual can be reached at [email protected]