Via Newsweed
New information suggests that the Macron government will not support the general legalisation of medical cannabis in France when the ongoing trial ends in 2024.
French media outlet Newsweed reports that the future Social Security Financing Bill (PLFSS) will not include a budget for the general legalisation of cannabis for medicinal use, the dispensing of which is currently limited to those taking part in an ongoing trial.
Last year the National Agency for the Safety of Medicines and Health Products (ANSM) announced an extension to its medical cannabis experiment. The trial allows 2,000 patients to access medicinal cannabis through select pharmacies – for five approved conditions – in order to evaluate how products could be prescribed and dispensed legally in France.
A government report, submitted to parliament at the end of September 2022, was in favour of the widespread provision of medical cannabis, but found that GPs had too little involvement in the treatment process. No issues of cannabis abuse or diversion were reported.
According to reports, 91% of patients have indicated that they are in favour of general legalisation. The majority have reported positive outcomes in terms of symptom management, particularly for pain relief and palliative care.
When questioned by Newsweed about the reasons for the absence of medical cannabis legalisation in the budget, the General Directorate of Health did not respond. However, other sources have suggested it is due to opposition from The Interministerial Mission for Combating Drugs and Addictive Behaviors ( MILDECA ).
Franck Milone, founder of the medical cannabis manufacturing company, LaFleur, told Newsweed that they had ‘mobilised with the authorities’ in recent months in order to participate in the various working groups for the integration of medical cannabis into common law.
He said: “The legislative texts are ready, patients and healthcare professionals are waiting for a clear framework, allowing secure access to medical cannabis. The situation for patients is critical, many have already been impacted last year with product shortages. The government needs to get more involved in this public health issue! France should not be a submarket.”
For Mado Gilanton, president of Association Apaiser, ‘it’s a political decision’.
“The people who made the decision were not able to read the various reports of the experiment, were not confronted with the positive feedback from patients and their extremely difficult situation when products were out of stock,” she said.
“After five years of work and extremely positive feedback, it is incomprehensible. There may still be amendments that will allow compassionate access for people who can afford it, but it is very disappointing for those involved and the patients.”
Professor Nicolas Authier, chair of the Scientific Committee on Medical Cannabis also highlighted the opposition.
“After five years of serious work on this question, contrary forces are waking up,” he said.
“They will do everything to restrict access to these drugs as much as possible, even though they are intended for patients in therapeutic impasse and in severe suffering. We must be convincing in the coming weeks and contrast their ideology with the relevance and rigour of the approach undertaken during these five years of work and experimentation.”
According to Frantz Deschamps, president of Santé France Cannabis, said: “The discussions around the PLFSS were decisive for the sector and for patients. Our main fear is that there will be an extension or an entry into common law, with a status which does not offer real accessibility to patients. The DGS has, however, done substantial work on the ad hoc status for these drugs and patients in therapeutic impasse. Contrary to what some may say, the French industry is ready to provide its first batches to patients. The fight today remains an entry into common law and real accessibility.”
Frédéric Prat, president of Principes Actifs, commented: “After five years, the experience of medical cannabis in France gives us undeniable facts: a glimmer of hope for 70% of patients in therapeutic impasse. Their quality of life improves significantly, with a reduction or even complete elimination of their suffering. The simple observation that individuals are enduring unnecessary pain, all in the name of purely political considerations, is unbearable. The integration of the legalisation of medical cannabis into the PLFSS 2024 represents the only and best way forward to ensure access to this new beneficial therapy for our patients.”
Pascal Douek, a doctor and patient involved in the experiment since April 2021, added: “I can only be worried about the government’s inertia. The issue is not only the 2,000 patients who are part of the experiment but also and above all the tens of thousands of chronically ill people who are waiting for relief. It is incomprehensible that the excellent results of the experiment are not taken into account for wider access to medical cannabis.”
What chance remains for medical cannabis in France?
The inclusion of the generalisation of medical cannabis in the PLFSS 2024 was the royal road to moving away from experimentation and leading to delivery for patients suffering from at least one of the five eligible conditions (epilepsy, oncology, neuropathic pain, palliative care and painful spasticity).
The legalisation of medical cannabis could still be proposed by an amendment during the debates around the PLFSS, Professor Authier confirms: “In the absence of arbitration, there will therefore be an amendment from the government at least to bring it into common law – because it seems established that the experiment ends in March 2024 – or even a transpartisan amendment in preparation with Caroline Janvier [Deputy in the National Assembly of France], as a counter-proposal if the first does not seem suitable and above all too restrictive.”
What does the future hold for the medical cannabis experiment?
There are two possible scenarios:
The experiment could be extended to continue to support current patients and provide them with the medications they need. In this case, it would not be able to enrol any additional patients.
It could end completely, without any access to cannabis-based medicines for patients, unless a solution is found elsewhere via the amendments.
The article was originally published by Newsweed and is reprinted here with permission.
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Author: Aurélien Bernard