As reported in NewsWeed.fr
LAST month France’s Directorate General of Health (DGS) pushed ahead with plans to extend the country’s medical cannabis trial by a minimum of one year without waiting for the results of the trial to be submitted to parliament.
This move was widely condemned by patient groups, who were only informed of the decision after a press release was leaked from representatives of the agro-industrial sector, who were initially consulted.
The decision also left two points to be clarified – the pharmaceutical status of these products and whether or not they will be reimbursed by health insurance.
It also left many questions around budgetary indications for the postponement of the experiment. Since the 3,000 patient target for the experiment had not been reached, the current suppliers of medical cannabis could be offered to continue to supply their products free of charge. A “lightening” of the device was also mentioned, without further details.
Social Security Financing Bill
The extension of medical cannabis trials, although desired by the Ministry of Health, is now being played out within the framework of the Social Security Financing Bill (PLFSS), which is understood to determine how the country’s social security income is allocated.
Several amendments were tabled by the various parliamentary groups making up the committee.
- The Europe Ecologie Les Verts (EELV) party proposed four separate amendments. The legalisation of recreational cannabis, an experiment in the legalisation of recreational cannabis, the generalisation of medical cannabis or the extension of the experiment for one year. The first three were deemed inadmissible, the last was rejected.
- A cross-partisan group led by Caroline Janvier proposed the extension of the experimentation of medical cannabis for one year with the obligation for the Ministry of Health to work on “the conditions of production and distribution of medical cannabis as well as on the advisability of its reimbursement. The amendment was rejected.
- Horizons proposed extending the experiment for 3 years. The amendment was adopted.
- Loiret MEP Stéphanie Rist, rapporteur for the Commission, tabled a sub-amendment proposing a one-year extension. The sub-amendment was carried .
The amendment, which will be debated in France’s parliament, will therefore propose extending the experiment for a year.
To our knowledge, no budget has been allocated for this extension. There are also no obligations for the government to generalise medical cannabis at the end of the possible extension.
Furthermore, the ministry does not commit to the construction of the conditions for the production and distribution of medical cannabis in France in the meantime, or to consider the reimbursement issue.
If the proposed amendment was not voted on during its study in the assembly, from our understanding, the trial would stop without generalisation.
The statement of the adopted sub-amendment explains that the experiment “has not yet been able to produce sufficient clinical results for us to be able to decide on its generalisation.
It is worth noting that the purpose of the medical cannabis trial was not to produce clinical results but “to evaluate, in a real situation, the recommendations of the committee in terms of prescribing and dispensing conditions and the adherence of health professionals and patients to these conditions” according to the National Agency for the Safety of Medicines (ANSM).