One year ago, the first medical cannabis prescription was handed out in France, commencing a multi-year study of over 1500 patients representing the first step in the process of legalizing cannabis in the country for general availability on prescription. But now that a year has passed, how has the study panned out? While no conclusive findings are available, there are a few points worth noting.
On March 26, 2021, the first medical cannabis prescription took place in France in the presence of the Minister of Health, Olivier Véran, at the University Hospital of Clermont-Ferrand. This moment was the realization of two and a half years of reflection carried out by two successive scientific committees, created by the national agency for the safety of medicines and health products (ANSM).
The relevance of this legalization of cannabis for medical use had previously been recognized not only by the health authorities based on the available international scientific data, but also by the political authorities. The latter expressed their position during the vote in the National Assembly on Article 43 of Law No. 2019-1446 on the financing of Social Security for 2020, carried by Olivier Véran – then deputy. In application of this law, decree 2020-1230 of October 7, 2020, authorized experimentation relating to the medical use of cannabis in the form of drugs, on an experimental basis and for a period of two years from the prescription to the first patient.
Now, one year on from the first medical cannabis prescription, where are we with this national public policy experiment, the main objective of which is to determine the conditions for legalizing access to cannabis-based medicines? But before we get to answering the question, take a moment to download our free cannabis news app.
1500 Patients Have Already Received a Medical Cannabis Prescription
Before France handed out its first medical cannabis prescription, several countries authorized access to cannabis-based medicines, sometimes for a long time. This is notably the case in Canada (2001), Israel (2004), Italy (2013), and Germany (2017).
The experiment in progress in our country prepares for the next legalization of access to medical cannabis and makes it possible to adapt the latter to the French specifications for access to care. It also makes it possible to treat the first patients without waiting in complete safety (“relieve without harming”), pending decision-making on the legalization of these treatments.
Patients who wish to obtain a medical cannabis prescription must make the request to their doctor. The latter can then help them to medically justify their inclusion with regard to their pathology and the treatments already prescribed. However, not all requests will probably be able to be accepted, because the current experiment, which is due to end in March 2023, concerns only a limited number of patients: it has been calibrated to treat up to 3,000 patients. Halfway through, 1,500 patients have already been able to benefit from these treatments, despite a difficult health situation linked to Covid, which is strongly mobilizing hospital and private health professionals. Community pharmacists have also been heavily involved in dispensing these treatments,
The relay of these medical cannabis prescriptions to the doctors treating the patients remains limited, for two main reasons. On the one hand, because of a certain caution towards these new treatments, and on the other hand, because of the constraints imposed by the experimental nature of these prescriptions, which requires compulsory training as well as the completion of a register at each consultation. Nevertheless, hundreds of doctors working in more than 240 hospital structures, in mainland France and overseas, are already involved in the introduction of these treatments: in total, more than 1,000 health professionals have already been trained in the prescription and dispensing of these drugs.
It is recommended that patients who would like to include a potential medical cannabis prescription in their usual care pathway speak about it beforehand with their general practitioner and their community pharmacist, who can refer them to one of the 280 participating hospital structures. All the answers to questions about this experiment can be consulted on the ANSM website (in particular to find out if one of the hospital services near you is part of it).
Medical Cannabis Prescription — Who and How?
On the occasion of the first medical cannabis prescription in France, on March 26, 2021, Olivier Véran, Minister of Solidarity and Health, declared: “It is the role of medicine to fight diseases and relieve the pain. […] I am proud that France can experiment with the use of cannabis for medical purposes, and thus better support thousands of patients who face serious pathologies.”
These treatments are intended for patients for whom medicine has failed therapeutically in the following five clinical situations: neuropathic pain, epilepsy, painful spasticity (abnormal muscle contraction), palliative situations, and complications related to cancer and its treatments. Indeed, a modest level of scientific evidence on their effectiveness does not allow them to be considered first-line treatments.
Patients may obtain a medical cannabis prescription for oils to take orally containing cannabis flower extracts. This form represents the basic treatment prescribed in the first intention. Dried cannabis flowers associated with a vaporization device for inhalation are sometimes associated with these oils, in particular, to relieve acute painful episodes that are poorly controlled by the background treatment.
All these drugs are characterized by their content of two phytocannabinoids, the most frequently present in cannabis flowers: CBD or cannabidiol (slightly psychoactive substance, without proven risk of dependence, not classified as narcotics) and THC or tetrahydrocannabinol (substance the most psychoactive, at the origin of the euphoric and disinhibiting effects, but also of the risks of dependence of cannabis. It is classified as a narcotic). The levels of these two substances vary according to the varieties of cannabis.
As expected, and as with all medications, some patients did not show significant improvement in their symptoms. In others, the treatment sometimes had to be stopped due to the appearance of well-known adverse effects, mainly neurological (drowsiness), psychiatric (anxiety), cardiovascular (palpitations), or digestive (diarrhea). In the end, a quarter of the patients treated stopped their treatment for one of these two reasons.
“Certain experimental methods are regularly reviewed in order to meet the needs of patients and healthcare professionals as closely as possible, in consultation with them,” underlines Nathalie Richard, director of the medical cannabis project at the ANSM.
It should be noted that a medical cannabis prescription is not always aimed explicitly at a cannabis-using patient. Patients treated with these cannabis-based drugs have, in their vast majority, never used cannabis.
A French sector for the production of these drugs
The ongoing experiment will make it possible to assess the best conditions for prescribing and dispensing these drugs. This should not pose any particular difficulties. Indeed, prescribing narcotic drugs in the first hospital prescription is already well known and mastered by health professionals. Adaptations have already been proposed by the ANSM to optimize patient access to these drugs.
An important point will consist in establishing a French sector for the production of these drugs. In France, decree 2022-194 of February 17, 2022, which entered into force on March 1, now authorizes the cultivation of cannabis for medical use. In practice, a first decree will be published to specify the legal conditions of this culture. It will fall under different rules from that of hemp in the open field, due to the presence in the varieties concerned of THC, a substance classified as a narcotic.
At the same time, the ANSM has also set up a new temporary scientific committee, called “Culture in France of cannabis for medical use – technical specifications of the production chain from the plant to drug.” It will define the expected specifications for cannabis-based drugs that will be produced by a future French production chain, from seed to drug.
This committee is made up of representatives of the various ministries concerned (agriculture, health, economy, interior), representatives of the National Research Institute for Agriculture, Food and the Environment (INRAE), and the National Council of the Order of Pharmacists. The first meetings on medical cannabis have already taken place at the Ministry of Health.
“The conditions of the experiment have been defined in such a way as to best secure the use of cannabis-based medicines for patients receiving a medical cannabis prescription. From supply to rigorous monitoring of adverse effects. “, explains Nathalie Richard.
In the years to come, the research work will have to continue: these cannabis-based therapies, although available in certain countries on a medical cannabis prescription for more than twenty years, are still experimental and will therefore require additional knowledge to better specify their indications, the profiles of patients concerned and the compositions of the products. The training of health professionals will also be one of the major challenges.
Finally, the reimbursement of a medical cannabis prescription by Health Insurance will also be one of the crucial questions to be addressed before any generalization, because this will obviously condition their accessibility. Public opinion seems ready for the arrival of these new treatments: a survey carried out in January 2022 by the IFOP reported that more than two-thirds of French people (70%) are in favor of the legalization of the use of cannabis for therapeutic purposes.
(Featured image by Nataliya Vaitkevich via Pexels)
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