Green light for therapeutic cannabis experiment in France

The French legislator has always placed strict restrictions on the use of therapeutic cannabis. But the situation and legislation are evolving in France.

In September 2018, the French Health Authority (Agence nationale de sécurité du médicament et des produits de santé, ANSM) set up, for one year, a Temporary Specialised Scientific Committee (CSST) to assess the relevance and feasibility of making therapeutic cannabis available in France. During several meetings, the experts of the CSST examined the French and international legislation on therapeutic cannabis, studied data from the scientific literature on various therapeutic indications and feedback from other countries which authorise the use of medicinal cannabis.

The CSST released its first conclusions in December 2018. The Committee recommended that the use of cannabis for therapeutic purposes be authorised in France under certain conditions.

The French Health Authority endorsed the conclusions of the CSST on 27 December 2018 but concluded that an experimental phase should be set up to allow access to therapeutic cannabis use to patient in specific therapeutic situations within a determined framework for prescription and delivery conditions.

Since then, the CSST reconvened on several occasions and met one last time on 26 June 2019. The Experts released a framework for the therapeutic use of cannabis in an experimental phase. The main objective of the experimental phase is to evaluate, in real-life situations, the CSST's recommendations regarding the conditions of prescription and delivery and the adherence of health professionals and patients to these conditions. Its secondary objective is to collect the first French efficacy and safety data.

In this framework, the CSST set the modalities for the provision of cannabis for therapeutic purposes during this experimental phase, e.g. the methods of administration, the conditions of prescription and issuance, contraindications and precautions for use, and patient follow-up and evaluation of adverse reactions.

The CSST recommended that therapeutic cannabis be used for patients in certain therapeutic situations and in cases of insufficient relief or poor tolerance of accessible therapies, i.e.:

  • in chronic pain refractory to therapies (medicinal or not) available;
  • in certain severe and drug-resistant forms of epilepsy;
  • in certain rebellious symptoms in oncology (such as nausea, vomiting, anorexia);
  • in palliative situations;
  • in the painful spasticity of multiple sclerosis or other pathologies of the central nervous system.

The CSST advised that a national registry of treated patients be created to monitor them and evaluate the benefit/risk ratio of therapeutic cannabis. The experts also recommended the collection and analysis of data including adverse effects and data on the efficacy of therapeutic cannabis, as well as the creation of a multidisciplinary scientific committee to set up and evaluate the experiment.

On 11 July 2019, the French Health Authority endorsed the CSST's recommendations and suggested framework for the experimental phase. In its communication published on its website, the French Health Authority announced that it "undertakes from now on to prepare, with the various State services concerned, the technical arrangements for implementing the experiment".

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