Just months ago, France’s long battle to establish a permanent generalised medical cannabis framework was on the brink of failure.
Despite other major European countries looking to France’s 2019 pilot scheme for inspiration, COVID-19, waning political will, operational hurdles, and the dissolution of the National Assembly in 2024 posed an existential crisis to the project.
However, in a dramatic about-turn from the government, which had only just emerged from months of political chaos, three separate documents detailing its proposed medical cannabis system were submitted to the EU for approval in March 2025.
Augur Associates and Newsweed, two organisations at the forefront of the ongoing developments in the region, believe that the incoming system not only sidesteps many of the issues other countries have faced in the implementation phase, but that it could reestablish the country’s standing as a model of inspiration for neighbouring states and prospective forthcoming EU supra-regulation.
A recently published report from the two French industry experts argues that while the incoming framework will be tough for many businesses to break into, its rigorous pharmaceutical approach will not only protect the industry and patients but also encourage innovation.
Its authors, Benjamin-Alexandre Jeanroy and Aurélien Bernard, told Business of Cannabis: “Overall, the system is serious, pharmaceutical, and designed to reduce stigma and improve access. It might not be the fastest rollout, but it’s likely to be a durable and exportable framework for other countries to follow. It fully integrates cannabis into the healthcare system, avoiding future arbitrary decisions which would single out regulatory processes or medical uses of the plant.”
Following the submission to the EU in March, two distinct processes are now at play. First, Jeanroy explained, is the regulatory process. These draft texts have now cleared the three-month TRIS period. In parallel, the texts have been submitted to the Conseil d’État (State Council) to check for potential legal contentions, a process which still ongoing and expected to be rolled out in the upcoming weeks.
“From what we’ve heard, the Council was asked to expedite their review, so we’re hopeful something could happen in September. After that, the texts need to be signed by the Ministries of Health and Economy – both have reportedly agreed – and then they’ll be published in the Journal Officiel.
“The second process is being led by the Haute Autorité de Santé (HAS), which will be responsible for setting price and reimbursement structures, determining prescriber training requirements, and potentially issuing broader recommendations as per stakeholder input.
“HAS is currently gathering public input – mostly from patient associations, but there is a way for the industry to formally participate in collaboration with a local pharmaceutical exploitant partner. Their process, especially in regard to reimbursement, should conclude at the end of T1 2026 as recently announced in July. So, assuming no major delays, things could start to move by Q1 2026.”
On July 29, 2025, HAS published a roadmap detailing its evaluation process for cannabis-based medicines, following a formal request from the Ministry of Health.
The evaluation, led by the Transparency Committee, will focus exclusively on cannabis-based medicines that do not already hold a marketing authorisation (AMM) and that meet specific criteria outlined in a forthcoming decree. It will assess products for five strictly last-line indications, aligned with those defined during the pilot programme:
The process will include stakeholder hearings, ranging from the national medicines agency (ANSM) and scientific experts to patient associations and user groups, and is expected to conclude with a final reimbursement recommendation by the end of Q1 2026.
Unlike other markets, which have essentially established a standalone framework for medical cannabis, France is planning to integrate its incoming industry into its existing pharmaceutical regulatory structure.
According to the authors, this was an intentional effort to avoid many of the growing pains other markets have experienced when establishing a new market.
“French authorities didn’t want to simply copy the German model or any others. They’ve built something more streamlined – more ‘French’ – but it also makes business and regulatory sense,” they explained.
“For example, by excluding raw flower (outside of sealed-vape formats), they avoid a lot of stigma and public confusion. Capsules, oils, and vaporisers are easier for doctors to prescribe and for pharmacists to dispense. Although we believe the ban won’t hold forever, it’s an initial and practical compromise that increases comfort for cannabis-naive healthcare professionals.”
As suggested in the report, generalist doctors in France still have reservations due to a lack of training, clear protocols and robust clinical trials. Acceptance, therefore, remains largely conditional on a more structured regulatory and scientific framework.
With the integration of cannabis into existing healthcare pathways, it is understood that the prescribing regime will largely be transferred from the pilot programme, namely, initial prescriptions of medical cannabis are issued by a hospital-based specialist or a physician working in a specialised centre, before being handed over to a general practitioner for follow-up.
While conceding that it’s ‘not a huge’ cohort, Jeanroy argues that the existing base of 2000-3000 trained healthcare professionals, including specialists, GPs, pharmacists and hospital staff, is far more than many countries had a launch.
He added: “Prescriptions currently must be initiated by a specialist, but in practice, those patients are usually handed over to GPs right after this first prescription for ongoing care. That’s essential for scaling access. HAS has also made prescriber training more accessible – it’s modular, short, and designed to get more professionals on board quickly.”
Based on growth trajectories in Germany and Poland, both of which initially followed regulatory models similar to France’s, Prohibition Partners (who contributed to the report) projects the French medical cannabis market could grow to €806 million in annual turnover by 2035.
As the market comes online, initial opportunities will centre around importing products for the newly expanded patient base.
A key component of the system’s integration into the national pharmaceutical framework is that cultivators, importers, and processors of medical cannabis must either be registered pharmaceutical entities or work in partnership with one, i.e an “exploitant pharmaceutique”.
The authors reiterate that ‘there is no cannabis specific path’ for international businesses to enter the market, but they must comply with general narcotics and pharmaceutical regulations.
As establishing a French pharmaceutical entity requires setting up a local facility, hiring licensed pharmacists and security, alongside filing with the ANSM, they suggest that the most realistic and cost-effective option is to ‘partner with an existing licensed importer or pharma company’.
“For European companies with EU-registered products, much of the documentation will already meet French requirements. They might need to adapt to local formats or supply extra data, like product stability timelines, but it’s manageable. Where things could get tricky is with non-standard formats, which may require further validation,” they continued.
This, however, will ‘open the door to innovation’ in the small, likely competitive market.
“Companies will need to create patient-focused, differentiated products to stand out. France could become a testing ground for innovation in formulation and delivery.”
As the industry matures and more domestic cultivators come online, the report argues that legal regulation of medical cannabis and active support from the State will also allow France to position itself as a European exporter, supplying other countries with high-quality GMP-compliant cannabis medicines under innovative forms.
The post Why France’s Strict Medical Cannabis Plans Could be its Secret Weapon appeared first on Business of Cannabis.
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Despite other major European countries looking to France’s 2019 pilot scheme for inspiration, COVID-19, waning political will, operational hurdles, and the dissolution of the National Assembly in 2024 posed an existential crisis to the project.
However, in a dramatic about-turn from the government, which had only just emerged from months of political chaos, three separate documents detailing its proposed medical cannabis system were submitted to the EU for approval in March 2025.
Augur Associates and Newsweed, two organisations at the forefront of the ongoing developments in the region, believe that the incoming system not only sidesteps many of the issues other countries have faced in the implementation phase, but that it could reestablish the country’s standing as a model of inspiration for neighbouring states and prospective forthcoming EU supra-regulation.
‘State of the Medical Cannabis Industry in France – 2025’
A recently published report from the two French industry experts argues that while the incoming framework will be tough for many businesses to break into, its rigorous pharmaceutical approach will not only protect the industry and patients but also encourage innovation.
Its authors, Benjamin-Alexandre Jeanroy and Aurélien Bernard, told Business of Cannabis: “Overall, the system is serious, pharmaceutical, and designed to reduce stigma and improve access. It might not be the fastest rollout, but it’s likely to be a durable and exportable framework for other countries to follow. It fully integrates cannabis into the healthcare system, avoiding future arbitrary decisions which would single out regulatory processes or medical uses of the plant.”
Following the submission to the EU in March, two distinct processes are now at play. First, Jeanroy explained, is the regulatory process. These draft texts have now cleared the three-month TRIS period. In parallel, the texts have been submitted to the Conseil d’État (State Council) to check for potential legal contentions, a process which still ongoing and expected to be rolled out in the upcoming weeks.
“From what we’ve heard, the Council was asked to expedite their review, so we’re hopeful something could happen in September. After that, the texts need to be signed by the Ministries of Health and Economy – both have reportedly agreed – and then they’ll be published in the Journal Officiel.
“The second process is being led by the Haute Autorité de Santé (HAS), which will be responsible for setting price and reimbursement structures, determining prescriber training requirements, and potentially issuing broader recommendations as per stakeholder input.
“HAS is currently gathering public input – mostly from patient associations, but there is a way for the industry to formally participate in collaboration with a local pharmaceutical exploitant partner. Their process, especially in regard to reimbursement, should conclude at the end of T1 2026 as recently announced in July. So, assuming no major delays, things could start to move by Q1 2026.”
On July 29, 2025, HAS published a roadmap detailing its evaluation process for cannabis-based medicines, following a formal request from the Ministry of Health.
Cannabis médical : la HAS précise sa méthode d’évaluation !
Le 23 juillet 2025, la Haute Autorité de Santé (HAS) a adopté un cadre méthodologique rigoureux pour évaluer les médicaments à base de cannabis. pic.twitter.com/qHRmasiaYP
— Nicolas Authier (@NicolasAuthier_) August 1, 2025
The evaluation, led by the Transparency Committee, will focus exclusively on cannabis-based medicines that do not already hold a marketing authorisation (AMM) and that meet specific criteria outlined in a forthcoming decree. It will assess products for five strictly last-line indications, aligned with those defined during the pilot programme:
Refractory neuropathic pain
Drug-resistant epilepsy (adults and children)
Painful spasticity in multiple sclerosis or CNS disorders
Cancer-related treatment-resistant symptoms
Advanced palliative care with persistent symptoms
The process will include stakeholder hearings, ranging from the national medicines agency (ANSM) and scientific experts to patient associations and user groups, and is expected to conclude with a final reimbursement recommendation by the end of Q1 2026.
The public consultation is open from 28 July 2025 to 16 September 2025:
Contribute to the assessment of medicines for reimbursement or early access authorisation
A pharmaceutical framework
Unlike other markets, which have essentially established a standalone framework for medical cannabis, France is planning to integrate its incoming industry into its existing pharmaceutical regulatory structure.
According to the authors, this was an intentional effort to avoid many of the growing pains other markets have experienced when establishing a new market.
“French authorities didn’t want to simply copy the German model or any others. They’ve built something more streamlined – more ‘French’ – but it also makes business and regulatory sense,” they explained.
“For example, by excluding raw flower (outside of sealed-vape formats), they avoid a lot of stigma and public confusion. Capsules, oils, and vaporisers are easier for doctors to prescribe and for pharmacists to dispense. Although we believe the ban won’t hold forever, it’s an initial and practical compromise that increases comfort for cannabis-naive healthcare professionals.”
As suggested in the report, generalist doctors in France still have reservations due to a lack of training, clear protocols and robust clinical trials. Acceptance, therefore, remains largely conditional on a more structured regulatory and scientific framework.
With the integration of cannabis into existing healthcare pathways, it is understood that the prescribing regime will largely be transferred from the pilot programme, namely, initial prescriptions of medical cannabis are issued by a hospital-based specialist or a physician working in a specialised centre, before being handed over to a general practitioner for follow-up.
While conceding that it’s ‘not a huge’ cohort, Jeanroy argues that the existing base of 2000-3000 trained healthcare professionals, including specialists, GPs, pharmacists and hospital staff, is far more than many countries had a launch.
He added: “Prescriptions currently must be initiated by a specialist, but in practice, those patients are usually handed over to GPs right after this first prescription for ongoing care. That’s essential for scaling access. HAS has also made prescriber training more accessible – it’s modular, short, and designed to get more professionals on board quickly.”
Business opportunities
Based on growth trajectories in Germany and Poland, both of which initially followed regulatory models similar to France’s, Prohibition Partners (who contributed to the report) projects the French medical cannabis market could grow to €806 million in annual turnover by 2035.
As the market comes online, initial opportunities will centre around importing products for the newly expanded patient base.
A key component of the system’s integration into the national pharmaceutical framework is that cultivators, importers, and processors of medical cannabis must either be registered pharmaceutical entities or work in partnership with one, i.e an “exploitant pharmaceutique”.
The authors reiterate that ‘there is no cannabis specific path’ for international businesses to enter the market, but they must comply with general narcotics and pharmaceutical regulations.
As establishing a French pharmaceutical entity requires setting up a local facility, hiring licensed pharmacists and security, alongside filing with the ANSM, they suggest that the most realistic and cost-effective option is to ‘partner with an existing licensed importer or pharma company’.
“For European companies with EU-registered products, much of the documentation will already meet French requirements. They might need to adapt to local formats or supply extra data, like product stability timelines, but it’s manageable. Where things could get tricky is with non-standard formats, which may require further validation,” they continued.
This, however, will ‘open the door to innovation’ in the small, likely competitive market.
“Companies will need to create patient-focused, differentiated products to stand out. France could become a testing ground for innovation in formulation and delivery.”
As the industry matures and more domestic cultivators come online, the report argues that legal regulation of medical cannabis and active support from the State will also allow France to position itself as a European exporter, supplying other countries with high-quality GMP-compliant cannabis medicines under innovative forms.
The post Why France’s Strict Medical Cannabis Plans Could be its Secret Weapon appeared first on Business of Cannabis.
Continue reading...
