Paris (AFP)
Only certain specialist medical specialists should be able to prescribe therapeutic cannabis as part of the experiment that will begin in early 2020, according to the conclusions of a group of experts unveiled Wednesday.
These recommendations, still provisional, were immediately hailed as an "important advance" by several associations, even if they consider the proposed framework too restrictive.
"While they are fully trained and competent, some general practitioners are in fact excluded from the experimentation," said Bertrand Rambaud, co-chair of the Alternative for Cannabis for Therapeutic Use (ACT) collective, which groups together three patient and physician associations.
The expert committee set up by the National Agency for Drug Safety (ANSM) will discuss this project next Wednesday with health professionals and patient associations, before delivering its final opinion.
The ANSM will then decide, before a phase of "setting up" the practical details of the experiment, which could last six months, for an effective start of the inclusion of patients in early 2020.
The committee of thirteen specialists, chaired by psychiatrist and pharmacologist Nicolas Authier, then recommends another six months of "patient follow-up" and "six months of data analysis" by a scientific committee created for the occasion.
The framework that will be chosen for the experiment does not prejudge the rules that will be decided in case of generalization of the therapeutic cannabis, underlined the ANSM.
For this test "in real life", the committee recommends that the "initial prescription" of cannabis products can only be made by certain doctors: those who are specialists in the five indications concerned by the experiment and who practice in referral centers (pain centers, multiple sclerosis expert centers, etc.).
- "Possible for all ages" -
The indications concerned are neuropathic pain (resulting from nerve damage) not relieved by other therapies, epilepsies resistant to treatment, the side effects of chemotherapy or for palliative care and uncontrolled muscular contractions of multiple sclerosis.
The "participation in experimentation, centers and doctors" should be done "on a voluntary basis" and after a "compulsory prior training", also recommends the committee.
"Once the patient's treatment is stabilized" (in particular to obtain the "minimum effective dose"), the patient's treating physician can then take over.
Experts also believe that it will be necessary to make available products containing different dosages of the two active ingredients of cannabis, THC and CBD, which do not have the same effects.
They also suggest making therapeutic cannabis available both in forms that have an "immediate effect" (oil and flowers dried for inhalation) and in "long-acting forms" (oral solutions and oil capsules), to best meet the different needs of patients.
The smoke form (joint) was not considered from the outset because of the harmful effects of combustion on health.
"We had the fear that flower heads (flowers, ed) are not allowed." Today the (committee) signs a report that promotes them, it's good news, "said Bertrand Lebeau, doctor addictologist who supports ACT's collective approach.
All participating patients will have to be listed in a "national electronic follow-up register", suggest the experts, who believe that the prescription can be "possible whatever the age" but exclude pregnant women from the device.
The data collected (prescribed doses, possible side effects or discontinuation of treatment, etc.) will be used to assess whether the framework is suitable or needs to be modified.
They will also be able to feed a study on the risk / benefit ratio of therapeutic cannabis, a field in which we still lack solid data, the committee emphasized during its work.
? 2019 AFP