Via Newsweed
In order to meet the deadline imposed by law, i.e. authorisations for medicinal products to be issued before 31 December 2024, France should have notified the European Commission (EC) in the first half of 2024 that it was bringing the production and distribution of cannabis-based medicinal products into line with common law.
According to our information, everything was ready before the summer recess, even though the dissolution of the National Assembly had been confirmed, we were told this would not disrupt the process.
Now that the recess is over, Newsweed has learned that new arbitrations have taken place on the project, even though it had already been validated, notably on the part of Mildeca. In addition, the Direction Générale de la Santé (DGS) explained that ‘in the context of the management of current affairs’, it had not been possible to make the notification.
Our various sources tell us that it is the fear, legitimate or otherwise, that the project will not meet with the approval of the future government, which has blocked the project in certain political strata.
However, this notification is the prerequisite for the widespread use of medical cannabis in France. Following notification, the EC has 3 months to study the proposal and a further 3 months if it wishes to make any comments.
The texts must then be incorporated into French law by decree and/or order. The ANSM then has to collect and process the drug applications before they can be made available to the few patients who will be able to make do with flower-free oils and other formulas.
At a meeting held last Thursday between the ANSM and manufacturers, the Agency explained that it had done as much work as it could and was now awaiting political decisions that were outside its remit.
The possibilities of having flowers in secure cartridges for patients to vaporise and for manufacturers to export are still being studied.
As the DGS has told us that the project will have to wait until there is a new government willing to look into the matter, the generalisation of medical cannabis will not take place on 1 January 2025 as announced and will be postponed, in view of the time needed for each stage and according to our calculations, to the vote in the next PLFSS, with a transition to real life in 2026.
2025 remains unclear. The transitional period between experimentation and generalisation could be extended to 2025, still without cannabis flowers and with a major unknown both in terms of funding and the possibility of including new patients.
The patients we contacted who were included in the trial, and who already felt sidelined by the absence of cannabis flowers in the generalised system, told us that their only solution would be to go back either to growing their own cannabis or to the black market to obtain supplies, with the risk of coming across flowers containing bacteria harmful to their immune systems, which have been damaged by their various illnesses.
There are currently two manufacturers ready for 2025 in France, which will also have to wait and finance the year 2025 out of their own pockets, with no possibility of producing oils outside the R&D framework or exporting their flower production for the time being, to Germany for example.
This article was originally published by Newsweed and is reprinted here with permission.
The post France’s medical cannabis launch likely to be delayed until 2026 appeared first on Cannabis Health News.
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While the French National Agency for the Safety of Medicines (ANSM) assured at the beginning of the year that cannabis-based treatments would be available by 2025, it will be difficult to achieve widespread use of medical cannabis in France before 2026.
In order to meet the deadline imposed by law, i.e. authorisations for medicinal products to be issued before 31 December 2024, France should have notified the European Commission (EC) in the first half of 2024 that it was bringing the production and distribution of cannabis-based medicinal products into line with common law.
According to our information, everything was ready before the summer recess, even though the dissolution of the National Assembly had been confirmed, we were told this would not disrupt the process.
Is a 2025 launch still realistic?
Now that the recess is over, Newsweed has learned that new arbitrations have taken place on the project, even though it had already been validated, notably on the part of Mildeca. In addition, the Direction Générale de la Santé (DGS) explained that ‘in the context of the management of current affairs’, it had not been possible to make the notification.
Our various sources tell us that it is the fear, legitimate or otherwise, that the project will not meet with the approval of the future government, which has blocked the project in certain political strata.
However, this notification is the prerequisite for the widespread use of medical cannabis in France. Following notification, the EC has 3 months to study the proposal and a further 3 months if it wishes to make any comments.
The texts must then be incorporated into French law by decree and/or order. The ANSM then has to collect and process the drug applications before they can be made available to the few patients who will be able to make do with flower-free oils and other formulas.
At a meeting held last Thursday between the ANSM and manufacturers, the Agency explained that it had done as much work as it could and was now awaiting political decisions that were outside its remit.
The possibilities of having flowers in secure cartridges for patients to vaporise and for manufacturers to export are still being studied.
As the DGS has told us that the project will have to wait until there is a new government willing to look into the matter, the generalisation of medical cannabis will not take place on 1 January 2025 as announced and will be postponed, in view of the time needed for each stage and according to our calculations, to the vote in the next PLFSS, with a transition to real life in 2026.
What happens now?
2025 remains unclear. The transitional period between experimentation and generalisation could be extended to 2025, still without cannabis flowers and with a major unknown both in terms of funding and the possibility of including new patients.
The patients we contacted who were included in the trial, and who already felt sidelined by the absence of cannabis flowers in the generalised system, told us that their only solution would be to go back either to growing their own cannabis or to the black market to obtain supplies, with the risk of coming across flowers containing bacteria harmful to their immune systems, which have been damaged by their various illnesses.
There are currently two manufacturers ready for 2025 in France, which will also have to wait and finance the year 2025 out of their own pockets, with no possibility of producing oils outside the R&D framework or exporting their flower production for the time being, to Germany for example.
This article was originally published by Newsweed and is reprinted here with permission.
The post France’s medical cannabis launch likely to be delayed until 2026 appeared first on Cannabis Health News.
Continue reading...
