A proposal has been tabled in France aimed at further extending the country’s long-running medical cannabis ‘experiment’ to ensure patients are able to keep receiving their medication amid government inaction.
France’s medical cannabis programme has found itself in an eerily similar position to this time last year, having once again been left out of the draft Social Security Financing Bill (PLFSS).
This annual document lays out the budget for the coming year, and with no mention of medical cannabis, which is currently in a ‘transition’ phase ahead of a full rollout, the future of the programme has once again been thrown into uncertainty.
In a last-ditch effort to secure funding to keep the process moving forward, an amendment to the PLFSS has now been proposed by Ensemble pour la République MPs Michel Lauzzana and Jean-François Rousset with help from Santé France Cannabis.
Yesterday, Newsweed reported that an amendment had been tabled seeking to extend the timeline of the medical cannabis experiment, which has now been running since 2021.
Currently the programme, which includes thousands of patients, is in a so-called ‘transition’ period. This means that while no new patients can sign up to take part in the trial, those currently taking part will continue to receive their medication and be reimbursed until a fully fledged medical cannabis programme has been established.
This time last year, the government set aside €10m for this transition period, (five times the previous budget for the experiment).
As the trial officially ended in April 2024, the transition period was given a maximum timeline of nine months, with expectations medical cannabis would be brought into the national health system by January 2025.
The amendment proposes that the PLFSS is modified to extend the deadline of the transition period by another year, taking the end date to December 31, 2025.
Furthermore, it seeks to add language to keep it running ‘until a medication is authorized under Article L. 5121-15 of the Public Health Code and available, and no later than December 31, 2025’.
It proposes that the extension should be funded by ‘an increase in excise duties on tobacco’, a key factor given the much tighter budget this year.
The proposal also highlights the messy development of the programme so far, and the reasons behind its ongoing delays.
Citing the experiment’s initial end date of March 2023, it references the one-year extension granted for relatively unclear reasons, allowing for the ‘collection of additional data, which has been positive,’ showing positive results for patients and no missuse of products.
“During the review of the 2024 Social Security Financing Law, the government proposed creating a temporary status for medical cannabis, with the aim of integrating it into common law by January 1, 2025.
“Meanwhile, efforts to establish a French supply chain for the cultivation and production of medical cannabis were halted last spring. Two decrees, highly anticipated by patients and industry stakeholders, were meant to supplement the February 17, 2022 decree to specify the requirements for medical cannabis-based medicines and set production conditions.
“However, political circumstances following the dissolution delayed the necessary decisions, which were originally expected to be published by early summer, at the latest.”
Whether the amendment will be included in the PLFSS will become clear during its first reading on Monday, October 28.
This latest development follows a long and frustrating battle for patients who have repeatedly been promised secure access to medical cannabis treatment.
The post France Proposes Budget Amendment in Last-Ditch Effort to Keep Medical Cannabis Programme Alive appeared first on Business of Cannabis.
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France’s medical cannabis programme has found itself in an eerily similar position to this time last year, having once again been left out of the draft Social Security Financing Bill (PLFSS).
This annual document lays out the budget for the coming year, and with no mention of medical cannabis, which is currently in a ‘transition’ phase ahead of a full rollout, the future of the programme has once again been thrown into uncertainty.
In a last-ditch effort to secure funding to keep the process moving forward, an amendment to the PLFSS has now been proposed by Ensemble pour la République MPs Michel Lauzzana and Jean-François Rousset with help from Santé France Cannabis.
The proposed amendment
Yesterday, Newsweed reported that an amendment had been tabled seeking to extend the timeline of the medical cannabis experiment, which has now been running since 2021.
Currently the programme, which includes thousands of patients, is in a so-called ‘transition’ period. This means that while no new patients can sign up to take part in the trial, those currently taking part will continue to receive their medication and be reimbursed until a fully fledged medical cannabis programme has been established.
This time last year, the government set aside €10m for this transition period, (five times the previous budget for the experiment).
As the trial officially ended in April 2024, the transition period was given a maximum timeline of nine months, with expectations medical cannabis would be brought into the national health system by January 2025.
The amendment proposes that the PLFSS is modified to extend the deadline of the transition period by another year, taking the end date to December 31, 2025.
Madame la ministre de la santé @gdarrieussecqnous demandons que les inclusions de nouveaux patients dans l’expérimentation du cannabis médical puissent reprendre le plus tôt possible jusqu’au seuil prédéfini de 3000 patients en file active
. #sante #santé #douleur pic.twitter.com/4xRb1QCMlX
— Nicolas Authier (@NicolasAuthier_) October 4, 2024
Furthermore, it seeks to add language to keep it running ‘until a medication is authorized under Article L. 5121-15 of the Public Health Code and available, and no later than December 31, 2025’.
It proposes that the extension should be funded by ‘an increase in excise duties on tobacco’, a key factor given the much tighter budget this year.
The proposal also highlights the messy development of the programme so far, and the reasons behind its ongoing delays.
Citing the experiment’s initial end date of March 2023, it references the one-year extension granted for relatively unclear reasons, allowing for the ‘collection of additional data, which has been positive,’ showing positive results for patients and no missuse of products.
“During the review of the 2024 Social Security Financing Law, the government proposed creating a temporary status for medical cannabis, with the aim of integrating it into common law by January 1, 2025.
“Meanwhile, efforts to establish a French supply chain for the cultivation and production of medical cannabis were halted last spring. Two decrees, highly anticipated by patients and industry stakeholders, were meant to supplement the February 17, 2022 decree to specify the requirements for medical cannabis-based medicines and set production conditions.
“However, political circumstances following the dissolution delayed the necessary decisions, which were originally expected to be published by early summer, at the latest.”
Whether the amendment will be included in the PLFSS will become clear during its first reading on Monday, October 28.
A frustrating battle for patients
This latest development follows a long and frustrating battle for patients who have repeatedly been promised secure access to medical cannabis treatment.
- September 2022: With France’s medical cannabis pilot project approaching its March 2023 deadline, over 2,000 patients had been receiving free treatment since March 2021. The project was expected to integrate medical cannabis into the national health system, but the government extended the pilot for another year due to insufficient clinical results, raising concerns about its generalization and patient access.
- February 2023: The first clinical data from the trial showed positive responses, with 91% of patients supporting medical cannabis legalization. However, these findings had little impact on the uncertain plans for full integration. Suppliers had to prepare for another tender process, raising cost concerns.
- April 2023: The tender process failed, with companies like Aurora Cannabis, Tilray, and Little Green Pharma initially offering products for free, but later pulling back due to unsustainable costs. This resulted in supply shortages, leaving many patients without access to treatment. The lack of a budget or regulatory framework exacerbated the crisis.
- July 2023: Australian firm Little Green Pharma (LGP), already a key supplier, won a second call for tenders, agreeing to supply $1.6 million worth of CBD50 medical cannabis oil, despite initial reluctance due to low compensation offers.
- September 2023: France’s 2024 Social Security Financing Bill (PLFSS) made no mention of medical cannabis, causing frustration among patients and stakeholders. Activist groups launched petitions to pressure parliamentarians to include cannabis-based medicines in the bill.
- October 2023: Health Minister Aurélien Rousseau confirmed the continuation of the medical cannabis experiment, but no commitment was made for full integration into France’s healthcare system. He cited the need for European marketing authorization, expected by 2025, and hinted at a “compassionate access” scheme if authorization was delayed.
- November 2023: The government introduced an amendment to the PLFSS, bringing medical cannabis into France’s general medical framework for the first time. The amendment provided a five-year temporary authorization for cannabis products, marking significant progress towards legalization.
- December 2023: The National Assembly approved the PLFSS, including the medical cannabis amendment. Although not yet full-scale generalization, a nine-month transition period was set following the pilot’s end in April 2024. A €10 million budget was allocated, ensuring continued patient access and reimbursement, five times the current budget.
The post France Proposes Budget Amendment in Last-Ditch Effort to Keep Medical Cannabis Programme Alive appeared first on Business of Cannabis.
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