Frances’ incoming medical hashish framework is predicted to take the ultimate step earlier than it may be signed into regulation within the ‘coming weeks’.
In keeping with a brand new report from Paris-based market consultancy Augur Associates, citing ‘a number of sources near the method’, the excellent reimbursement decree has reached the Conseil d’État and is now underneath evaluate.
The brand new white paper, printed earlier this month (October 2026) and titled France Medical Hashish: Regulatory Progress & Market Entry Outlook, means that the closing consideration for this long-awaited last piece of the regulatory puzzle is predicted imminently, although Augur stresses that this newest procedural standing has not been publicly confirmed and needs to be handled as knowledgeable market intelligence.
The reimbursement decree is the second of two regulatory packages which might be set to finish France’s transition from an prolonged pilot to a everlasting medical hashish framework.
In July this yr, the core ANSM authorisation decree and two accompanying orders on product specs and cultivation cleared Conseil d’État evaluate and the EU’s technical notification process.
This adopted affirmation by the French authorities on January 21, 2026, that the primary decree had acquired the Council’s approval and that its publication would enable the ANSM to start processing purposes however tied the timing to the still-outstanding reimbursement textual content.
“The decree has progressed considerably throughout 2026, however its route via the ultimate administrative levels has taken longer than the timetable introduced by the federal government in June advised,” the report finds.
On June 30, the federal government instructed the Senate that the textual content had been finalised in mid-June, validated by the Ministry of Financial system and Finance, and can be transmitted to the Conseil d’État that day, with publication anticipated after the summer season recess.
Augur’s sources point out the draft finally went via the CNAM (la Caisse nationale de l’Assurance Maladie) earlier than reaching the Conseil d’État, in line with the statutory session framework for social-security measures. The extra time additionally coincided with the recess and the appointment of Mickaël Benzaqui as the brand new well being adviser to the prime minister on July 06.
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HAS hearings deliberate for October 20 and 21 have been postponed in September as a result of the regulatory decree required for the following stage had not been printed, Augur notes, including {that a} Q1 2027 begin for first prescriptions underneath the everlasting framework stays believable.
As soon as once more, that is contingent on Conseil d’État evaluate, signature, publication and the following HAS analysis timetable. The report advises operators to plan in opposition to a timetable vary moderately than a single launch date.
The therapeutic scope is unchanged from the draft offered at Hashish Europa Paris in February 2026, which incorporates refractory neuropathic ache, pharmacoresistant epilepsy, painful spasticity related to a number of sclerosis or different central nervous system issues, refractory oncology signs, and superior palliative conditions involving refractory signs.
Three cannabinoid profiles are recognised (delta-9-THC dominant, balanced THC/CBD, CBD dominant), uncooked dried flower just isn’t meant to be admitted, and fast-acting codecs are thought of solely in safe, tamper-proof, non-refillable single-dose cartridges, with inhaled administration anticipated to depend on a devoted CE-marked medical system. With this in thoughts, Augur recommends treating France as a product-by-product regulatory mapping train moderately than a generic market-access operation.
Whereas the variety of individuals nonetheless concerned within the multi-year pilot has continued to say no, dropping from 1,849 sufferers in September 2024 to an estimated 700, the addressable market nonetheless represents a substantial alternative for operators with a product vary appropriate for its pharmaceutically-minded framework.
Affected person organisations have cited roughly 100,000 individuals doubtlessly eligible for therapy, whereas parliamentary dialogue has referred to a spread of 150,000 to 300,000 sufferers in therapeutic deadlock. Augur’s personal 2025 report, projected roughly 100,000 reimbursed sufferers by 2030, with the potential to develop three to 4 instances by 2035.
“Publication won’t mark the start of the market-entry course of. It is going to mark the purpose at which corporations can transfer from preparation to formal regulatory submissions,” the report concludes.
