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Therapeutic cannabis: towards legalization in France?

Therapeutic cannabis: towards legalization in France?

Therapeutic cannabis: towards an experimentation of use in 5 indications

In this video Agnès Buzyn Minister of Health, recognizes the possible benefits of Therapeutic Cannabis and supports the usefulness of an assessment for the use of cannabis for certain pathologies.

Cannabis, a narcotic whose therapeutic use is contemplated by law
In France, cannabis is considered a narcotic whose possession and use are prohibited (Law No. 70-1320 of December 31, 1970). Nevertheless, in 2013, a decree amended the Public Health Code to allow drugs based on cannabis and its derivatives to be placed on the market (decree no. 2013-473 of June 5, 2013 amending the provisions of Article R. 5132-86 of the Public Health Code relating to the prohibition of operations relating to cannabis or its derivatives).

Today, two cannabis-based specialties exist, but are little or not used
In France, two cannabis-based specialties are available:
  • SATIVEX (nabiximols) which comes in the form of a mouth spray and delivers 2 plant extracts of cannabis (delta-9-tetrahydrocannabinol and cannabidiol). It obtained a marketing authorization (AMM) in January 2014 in the treatment of symptoms related to moderate to severe spasticity related to multiple sclerosis, in second intention in adult patients. In the absence of an agreement on the price between the Economic Committee for Health Products (CEPS) and the Almirall laboratory, which owns this product, this specialty is not currently marketed in France. MARINOL (dronabinol) which has been available since 2003 on hospital prescription under a nominative temporary authorization for use (ATU) in three indications: neuropathic pain after failure of all treatments, nausea and vomiting in the context of cancer chemotherapy, and anorexia in the HIV (human immunodeficiency virus) patient. This synthetic analogue of a cannabis extract is little used (over the period 2006-2013, 508 nominative ATUs were granted, 70% of which were for neuropathic pain).
A favorable opinion from the Ethics & Cancer Committee
In November 2018, the Ethics & Cancer Committee, contacted by a patient, issued an opinion in which he says " cannot identify any reason to oppose the use of cannabis by patients who say they derive benefit from it, even if this benefit is not demonstrated according to the most rigorous scientific methodologies " .
In addition, this Committee recommends that " for these patients, access to cannabis or its active substances can be in a form allowing them to avoid smoking it, so as not to be exposed to the deleterious effects of this mode of consumption. It (should) also be that this access can be supervised by the health authorities ".

The creation of an ad hoc evaluation committee within the ANSM
Because the question of the use of cannabis for therapeutic purposes arises for health authorities, the National Agency for the Safety of Medicines and Health Products (ANSM) created, in September 2018, a temporary Specialized Scientific Committee ( CSST) called "Assessment of the relevance and feasibility of the provision of therapeutic cannabis in France" ( our article of December 20, 2018 ).
In this context, by "therapeutic cannabis", the ANSM means "the cannabis plant excluding pharmaceutical specialties with an MA or an ATU". SATIVEX and MARINOL are therefore not concerned.
Initially, this committee assessed the relevance and feasibility of making therapeutic cannabis available in France in the treatment of certain pathologies or certain symptoms of pathologies, analyzed the experiences of other countries that had already implemented it. and makes an inventory of national and international regulations on the subject.

The conclusions of the ANSM ad hoc committee
In December 2018, the CSST issued its conclusions and it considers, " that it is relevant to authorize the use of cannabis for therapeutic purposes for patients in certain clinical situations and in the event of insufficient relief or poor tolerance. therapeutics, medicinal or not, accessible (and in particular specialties based on cannabis or available cannabinoids) ".
The therapeutic indications retained by the experts for the use of cannabis for medical purposes are as follows:
  • in pain refractory to accessible therapies (medicated or not);
  • in certain forms of severe and drug-resistant epilepsy;
  • in the context of supportive care in oncology;
  • in the painful spasticity of multiple sclerosis;
  • in palliative situations.
Considering the health risks, the CSST excluded the "smoke" route of administration for cannabis for therapeutic purposes. The Committee also wanted the monitoring of patients treated to be set up in the form of a national register to ensure an assessment of its benefit/risk, and that an assessment of adverse effects be regularly carried out by the pharmacovigilance networks and of addictovigilance.

Conclusions accepted by the ANSM, which wants prior experimentation
At the end of December 2018, the ANSM subscribed to the first conclusions of the CSST and therefore ruled favorably on the use of cannabis for therapeutic purposes in certain indications. In addition, as a first step, it proposed that access to this use be subject to experimentation.
The CSST therefore met again to study the terms of the experiment and hear the stakeholders (representatives of health professionals and patients). On July 11, 2019, the ANSM accepted the recommendations of the CSST on the experimental phase of making therapeutic cannabis available.

The conditions of experimentation on therapeutic cannabis
The main objective of this experimental phase is to evaluate, in a real situation, the recommendations of the Committee in terms of prescribing and dispensing conditions, and the adherence of healthcare professionals and patients to these conditions.
To do so, the CSST recommends making available:
  • medicines based on dried cannabis flowers and full-spectrum extracts;
  • immediate effect forms (sublingual and inhaled based on oil and dried flowers for vaporization) and long-acting forms (oral forms of the oral solution type or oil capsules).
In addition, the CSST recommends the provision of 5 different TetraHydroCannabinol (THC)/CannaBiDiol (CBD) ratios and dose adjustment by titration carried out by the doctor until the minimum effective dose and/or effects are obtained. side effects acceptable to the patient.

Who can participate in this experiment?
According to the CSST, the initiation of treatment should be reserved for doctors practicing in reference centers covering the 5 indications retained by the CSST in their opinion of December 2018, throughout the country, until the patient has stabilized.
These referring physicians would be recruited on a voluntary basis and trained using an e -learning platform . Once the patient has stabilized, the city doctor can take over after prior agreement with the referring doctor.
Patient follow-up must be entered in a national electronic follow-up register set up by the ANSM (adverse effects and efficacy). The products will be dispensed both in pharmacies "for internal use" (PUI) and in pharmacies, only if the prescriber has been trained and the follow-up register filled in.
For patients with a favorable risk/benefit, continued access to the drugs used will be ensured throughout the experimental phase.

A protocol carried out over two years and evaluated by a multidisciplinary committee

The framework-and-implementation-of-medical-cannabis-experimentation will include 6 months of implementation, 6 months of patient inclusion, 6 months of patient follow-up with submission of an interim report and 6 months of data analysis.
This evaluation will be carried out by a multidisciplinary scientific committee composed in particular of patient representatives. This committee will be responsible for analyzing the data in the registry, regularly monitoring safety data and writing study reports.
In addition, he will work on the development of specifications for the suppliers of drugs used for experimentation, the development of training (prescriber, dispenser and patient modules), the definition of the content of the register, and the drafting a guide of recommendations for prescribers.

The ANSM has undertaken to prepare the technical procedures for implementing the experiment as of now, with the various State services concerned.

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