French Secretary of State proposed to discuss the legalization of cannabis

Статс-секретарь Франции предложил обсудить легализацию каннабиса: A New Dawn for Medical Cannabis in France

Introduction

In a significant turn of events, the uncertainty surrounding the fate of medical cannabis patients in France has finally been lifted. The government's recent amendment to the Social Security Financing Bill (PLFSS) marks a pivotal moment, bringing medical cannabis under the umbrella of France's general medical framework. This groundbreaking decision opens new avenues for patients and signals the potential growth of the medical cannabis industry in the country.

The Journey So Far

France initiated its medical cannabis experiment in 2021, providing free cannabis products to around 3,000 patients for an initially planned two-year duration. The experiment aimed to assess the recommendations for prescribing and dispensing conditions, with safety and efficacy data as secondary objectives. However, as the trial approached its scheduled end in March 2024, the absence of any mention of its continuation in the PLFSS raised concerns among patients and industry stakeholders.

Government's Response: The Amendment

Responding to industry pushback and concerns about the future of the medical cannabis program, France's Minister of Health confirmed in mid-October the government's commitment to address the issue. The subsequent amendment introduced key provisions:

Temporary Authorization

Medical cannabis products will now receive a 'temporary authorization' for five years, extendable by the French authorities in subsequent five-year periods. This establishes a crucial legal framework for medical cannabis within general law.

Case-by-Case Authorization

Products will be authorized on a case-by-case basis, ensuring a careful evaluation of each medicinal product containing cannabis.

Timeline for Generalization

Generalization is not expected before January 2025, pending approval from European authorities. A maximum 'transition period' of nine months, post the experiment's end in April 2024, has been allocated for generalization.

Budget Allocation

The government has earmarked €10 million for this transition period, a significant increase from the current experiment's budget. This aims to facilitate patient access and reimbursement during the transition.

Restrictions and Criteria

Even after generalization, access to medical cannabis will remain restricted to a last-resort treatment, prescribed only in hospitals. The criteria for prescription will be defined in subsequent decrees based on proposals from the ANSM.

Price Determination

Prices for medical cannabis products are yet to be determined, but will consider prices in comparable European markets. Flowers and other inhaled forms will be excluded.

Remaining Questions and Concerns

While the industry welcomes the amendment, questions linger:

Patient Access

Campaigners question the continued restrictiveness of patient access, emphasizing the need for exhausting all other treatment avenues before considering medical cannabis.

Budget for Generalization

Uncertainty looms regarding the lack of a specified budget for generalization, raising concerns about the continuity of reimbursement.

Data Protection

Groups such as L360 express concerns about data protection, as companies supplying medical cannabis must collect data on patient consumption and reactions to treatment.