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France: National Medication Safety Agency to Consider Experimenting with Legalized Medical Cannabis

(Jan. 8, 2019) The French agency in charge of evaluating the efficacy and safety of pharmaceutical products, L’Agence nationale de sécurité du médicament (ANSM) (National Agency for the Safety of Medication), announced on December 27, 2018, that it would consider experimenting with cannabis-based preparations for medical purposes. (L’ANSM souscrit aux premières conclusions du CSST sur la pertinence de l’usage du cannabis à visée thérapeutique [The ANSM Endorses Preliminary Conclusions of CSST on Appropriateness of Use of Cannabis for Therapeutic Purposes], ANSM (Dec. 27, 2018).)

On September 10, 2018, the ANSM created the Comité Scientifique Spécialisé Temporaire (CSST) (Temporary Specialized Scientific Committee) to assess the appropriateness and feasibility of allowing medical cannabis in France. (Cannabis thérapeutique en France : l’ANSM publie les premières conclusions du CSST – Point d’Information [Information Point – Medical Cannabis in France: ANSM Publishes CSST’s Preliminary Conclusions], ANSM (Dec. 13, 2018).) The Committee’s preliminary conclusions, which the ANSM endorsed, are that it would be appropriate to authorize the use of cannabis for (1) patients suffering from pain that is not alleviated by currently accessible therapies, (2) certain forms of epilepsy, (3) certain cancer patients, (4) palliative care, and (5) painful spasms related to multiple sclerosis. (Id.) The Committee recommended that patients who are prescribed medical cannabis be monitored to study and evaluate its risks and benefits. (Id.)

The Committee is scheduled to meet again five times between January and June 2019 to consider the practicalities of experimenting with cannabis, including modes of supply and distribution, doses and concentration levels, and modes of administration. (L’ANSM souscrit aux premières conclusions du CSST sur la pertinence de l’usage du cannabis à visée thérapeutique, supra). The Committee has already recommended against smoking cannabis as a means of administration due to related health risks, but other methods will be considered, such as capsules or sprays. (L’agence du médicament souhaite expérimenter le cannabis thérapeutique d’ici fin 2019 [The Medication Agency Wishes to Experiment with Medical Cannabis by the End of 2019], LE FIGARO (Dec. 28, 2018).)