Medical Cannabis: Augur Associates’ latest report provides an update ahead of the publication of the decrees

Augur Associates has published «France Medical Cannabis – Regulatory Progress & Market Entry Outlook,» a 20-page report that provides an update on the progress of France’s future medical cannabis regulatory framework and outlines what operators can do to prepare now.

Three documents, a decree still pending

The legal basis has been in place since December 2023, with the’Section 78 of the Social Security Funding Act for 2024. The pilot program, launched in March 2021, ended on December 31, 2024. The future system is based on three legal documents: a decree establishing the operational framework (submission of applications, evaluation by the ANSM, pharmacovigilance, and supply), an order on the specifications and indications of medicines, and an interministerial order on cultivation, import, export, transport, and storage.

All three were notified to the European Commission on March 19, 2025, and the main decree has been approved by the Council of State. However, the government has linked its publication to that of the decree on evaluation by the HAS and reimbursement. According to information gathered by Augur from sources close to the matter—which has not been publicly confirmed—this second decree is reportedly under review by the Council of State. It would then need to be signed and published. Hence the delay we mentioned earlier, when Medical cannabis was stalled at the Ministry of Health and 14 organizations called for the law to be enforced.

A calendar to read from end to end

The January 2027 target for the first products is no longer a firm date. The report identifies the first quarter of 2027 as a plausible planning scenario, but one that is contingent on the Council of State’s decision, the signing and publication of the relevant documents, and the HAS’s schedule.

A Deliberately Restrictive Framework

Five indications have been approved: refractory neuropathic pain, drug-resistant epilepsy, painful spasticity, refractory symptoms in oncology, and advanced palliative care, with an initial hospital prescription as a last resort. According to the proposed regulations, raw flowers would not be permitted in their natural state, and smoking would be prohibited. The ANSM’s Scientific Committee has also issued favorable opinions for other conditions (Crohn’s disease, autism, Tourette syndrome), though without formal extension of the authorization.

When it comes to the numbers, caution is advised. Patient advocacy groups cite approximately 100,000 people affected, while parliamentary debates mention 150,000 to 300,000: these are estimates of the potential population, not projections of the number of patients who will receive reimbursement. As for patients in the transitional phase, their number is said to have fallen from 1,650 in July 2025 to about 700, but this apparent decline should not be interpreted as an actual loss, as the method of counting has changed.

What Operators Must Do

The report emphasizes that a product sold in another European country does not automatically comply with French requirements. It recommends five key areas of focus: a product-by-product gap analysis, regulatory structuring (with applicants required to be established in the EU or the EEA), dossier preparation, a market access strategy, and establishing a local presence with pharmaceutical companies, importers, and distributors. This is because the ANSM decides on market entry, the HAS assesses therapeutic value, and ministers decide on reimbursement. The report also identifies two paths: operating as a product and pharmaceutical player, or positioning France within a longer-term European production strategy.

His conclusion: The preparation phase has already begun, and waiting for the regulations to be published before getting started means waiting until regulatory, pharmaceutical, and local capacities are under the greatest strain.

Download the report

Disclosure: The founder of Newsweed is a co-founder of Augur Associates.