16 October 2019 - Authored by:Eveline Van Keymeulen
On 15 October 2019, The General Director of the French National Agency for Medical and Health Products (ANSM) issued two Decisions (Decision DG n°2019-365 and 2019-381) in order to pursue the necessary work to set up the medical cannabis pilot programme in France. The decisions (i) create a new French specialised scientific committee (CSST) responsible for the implementation of the medical cannabis pilot programme and define its attributed tasks, and (ii) nominate the members thereof.
The two decisions seem to mark the official start of the medical cannabis pilot programme in France which is expected to last two years, and in particular of the first 6 month implementation period.
The main missions of the newly created CSST are based on the previous CSST’s recommendations, as endorsed by the ANSM (see our previous post: “French cannabis committee unveils recommendations for medical cannabis pilot programme in France” and “Big day for legal cannabis in France: ANSM endorses medical cannabis pilot and launch of cannabis Parliamentary Mission“). The new CSST will in particular need to draft:
- Recommendations on the scope of work (“cahier des charges“) of the pilot programme, in particular regarding (i) the type of medical cannabis (formulations, dosage forms…) to be used, (ii) the necessary training (content of prescriber modules, dispenser and patient information) and (iii) the content of the patient monitoring register;
- Recommendations for prescribers.
The ANSM’s press release specifies that the work of this CSST will continue during the pilot programme in order to monitor and analyse the data of the patient register (including efficacy and safety data) and to prepare an analysis and final report. The CSST is composed of 18 experts, including health care professionals and patient représentatives, and met for the first time on 16 October 2019.
If you are interested in a broader overview of EU and national developments with respect to cannabis regulations, please have a look at our latest Cannabis Legal & Regulatory Updates here.
This article was co-authored by Alexis Vaujany.