France has moved closer to allowing medical marijuana by sending two key proposals to the European Commission that would set rules for its production and distribution.
This notification, submitted on March 19 through the Technical Regulation Information System (TRIS) procedure, is a required step before the country can fully incorporate medical marijuana into its legal system.
These decrees, finalized nearly two years ago, had been awaiting government approval for submission to Brussels. Now, a three-month standstill period allows the European Commission and member states to review and comment on the regulations. If a detailed opinion is issued, the review period could extend by another three months, requiring France to justify its proposed measures.
If no major objections arise over the course of a three-month period, the regulations could move forward, but further steps remain. Individual marijuana-based medications must receive separate authorization from French health authorities before they can be prescribed. Health Minister Frédéric Valletoux recently stated that the decision on medical marijuana’s integration into the healthcare system will be left to the Haute Autorité de Santé (HAS), though this responsibility traditionally falls under the Agence nationale de sécurité du médicament et des produits de santé (ANSM).
Even if the European Commission clears the regulations, access to medical marijuana in France may still be limited due to pricing and reimbursement challenges, bur advocates are hopeful the system can be reformed to be more patient-friendly after its implemented. Estimates suggest that between 300,000 and 800,000 patients in France could qualify for a prescription under the proposed framework.