As part of the French experimentation with cannabis for medical use, drugs will be provided in the form of oil, dried flowers to spray or tablets to the 3,000 selected participants.

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Charles Rex Arbogast / AP / SIPA

  • Postponed due to the coronavirus health crisis, the French experimentation with cannabis for medical use will be launched on March 31.

  • It will include 3,000 patients and will last 24 months.

  • At the end of this full-scale trial, parliamentarians could decide to generalize the use of cannabis for medical use in France.

Launch imminent.

Approved by the National Assembly in 2019, long awaited, several times postponed because of the coronavirus crisis, the experimentation in France of cannabis for medical use will finally begin on March 31.

An experiment piloted and controlled by the National Medicines Safety Agency (ANSM), which will include 3,000 patients and will last 24 months.

“The objective is not to define the benefit / risk balance of cannabis for medical use [already established].

The aim is to assess the feasibility of the circuit and to collect the first French data in real life on the efficacy and safety of cannabis in a medical setting ”.

And to lay the foundations "of the patient journey" and, ultimately, "to determine if and how the use of cannabis in a medical setting could be generalized", explained Christelle Ratinier Carbonneil, Director General of the ANSM, during the meeting. 'a press point this Thursday.

Medical cannabis “is something new”, she stressed, insisting on the “supervised and secure” nature of this experiment with a narcotic product which is also illegal in France.

Who will be able to participate in this experiment?

How will it be supervised and what types of cannabis products will be prescribed to participants? 

20 Minutes

 reveals the outlines of this essay.

How will the experiment be framed?

It will be carried out under the control of the ANSM.

The first consultations to include patients in the experiment will take place in the coming days, and will take place in one of the 200 selected reference centers, the list of which will be published shortly.

This will involve including patients already followed in these specialized hospital services, or referred by their attending physician to one of these centers.

The ANSM has developed training for participating physicians and pharmacists, "with the help of foreign physicians and pharmacists accustomed to prescribing medical cannabis," explained Christelle Ratignier-Carbonneil.

It is a two-and-a-half-hour distance training course, with compulsory validation ”.

Thereafter, the doctor will be able to issue a prescription, of 28 days maximum, which can be renewed by a general practitioner appointed by his patient, on the condition that he is trained and voluntary to participate in the project.

Who can be included?

Patients will be eligible if they suffer from serious illnesses.

"We have identified five therapeutic indications: neuropathic pain refractory to accessible therapies, certain forms of severe epilepsy and drug resistance, certain rebellious symptoms in oncology linked to cancer or its treatments, certain paliative situations, and in the painful spasticity of sclerosis. in plaques or other pathologies of the central nervous system ”, enumerated Nathalie Richard, director of the project at the ANSM.

And only "in case of insufficient relief or poor tolerance" with existing treatments.

Another clarification: "there is no age criterion, the children will possibly be included in this experiment," added Nathalie Richard.

In certain clinical situations, and always weighing the benefits and risks, the use of medical cannabis may be useful "in minors, she said, citing the example of" children with drug-resistant epilepsy. treatments ”.

The objective is to collect complete data on 3,000 participants who have tested cannabis for medical use over at least six months, "if one of them stops treatment, due to poor tolerance or poor efficacy. , it can be replaced by another, explained the director of the project.

He will not be able to stop his treatment on his own, but will be free at any time to withdraw from the experiment.

In addition, from the moment the patient is included, that he tolerates his treatment well and that it is effective, he will be able to receive cannabis for medical use for the duration of the trial ”.

In what form will medical cannabis be prescribed?

“The treatments will come from the Sativa variety of cannabis, listed in the pharmacopoeia, and delivered in the form of oils, dried flowers to inhale with a vaporization device and, as a last resort, tablets”, detailed Françoise Duperray , director of the controls department at ANSM.

Regarding the composition of these treatments, “the THC / CBD ratio [tetrahydrocannabinol and cannabidiol] - the two active ingredients of the cannabis plant - will be established according to the therapeutic indications by the prescribing physician.

For example, for heavier pathologies, the THC ratio will be higher ”.

“The dosage schedules are well detailed in the training of healthcare professionals participating in this experiment,” added Nathalie Richard.

We have three types of products: balanced ratio of THC and CBD, dominant THC or dominant CBD.

For epilepsy: the treatment will be predominantly based on CBD ”.

Who will supply the medical cannabis products?

"We are importing the drugs" provided free of charge by the manufacturers selected in January by the ANSM, "without any compensation promised to suppliers if the experiment was generalized", insisted Christelle Ratignier-Carbonneil.

"These are foreign suppliers, since the production of cannabis is currently prohibited in France," said Nathalie Richard.

The priority was to have access to drugs that were directly usable and as safe as possible ”.

"These treatments will be delivered free of charge to participants, according to the principle of national solidarity," said the director of the ANSM.

And a register which will allow the follow-up of patients is being put in place ”.

At the end of this full-scale clinical trial of two years, a summary report will be submitted to parliamentarians, with a view to possible generalization in France.

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  • Drug

  • Therapeutic trial

  • Health

  • Cannabis