09 October 2020 - Authored by:Eveline Van Keymeulen
Today, the long-awaited decree regarding the French medical cannabis pilot programme was published in the Official Journal. The pilot programme, discussions on which were initiated in 2018, was officially authorised by law in December 2019, but publication of the necessary implementing decree incurred significant delay because of the COVID-19 health crisis.
Today’s decree proclaims that the medical cannabis pilot programme should start by 31 March 2021 at the latest (but possibly earlier) for a duration of two years starting from the first prescription for the first patient. In June 2020, the French National Agency for Medicines and Health Products Safety (ANSM) had already announced that the pilot, originally due to start in September 2020, had been postponed to January 2021 (see our previous blog post “Start of French medical cannabis pilot programme postponed to January 2021”).
The decree further confirms some elements that had already been communicated by the ANSM and its specialised scientific committees (CSST and CST) at an earlier stage (see our previous blog post “French medical cannabis programme: CSST provides further guidance and statement of works to be published in February”), in particular:
- The medical cannabis pilot programme will include a maximum of 3000 patients;
- The relevant medical cannabis products must be manufactured according to EU Good Manufacturing Practices (GMP) or equivalent standards recognised at international level;
- The products must be provided on a free-of-charge basis by the selected suppliers;
- Participation by health care professionals (physicians and pharmacists) in the pilot is voluntary and subject to prior mandatory training;
- Initial prescriptions must be issued by participating physicians practicing in selected multidisciplinary reference centres, but can be renewed by any physicians who have followed the mandatory training;
- Products may be dispensed by hospital and other pharmacies (provided they are participating in the pilot);
- An electronic registry will be put in place (for patient monitoring, pharmacovigilance/addictovigilance, and scientific/study purposes).
In order to allow the implementation of the pilot programme, the decree provides the necessary derogations from the current provisions of the French Public Health Code which stipulate a very broad prohibition on the use of cannabis in France. Consequently, patients (and their family members) as well as participating health care professionals and selected pharmaceutical establishments will be able to legally use, prescribe, supply and distribute medical cannabis under the pilot programme.
However, the decree remains silent on a number of important requirements that have been eagerly awaited by suppliers and distributors of cannabis-based medicines, which will need to be set out in future ministerial orders (arrêtés du ministre chargé de la santé). This concerns in particular the required specifications/statement of works allowing the selection of future suppliers and distributors of cannabis-based medicines to be used in the pilot programme.
In sum, the following elements still need to be defined by ministerial order(s) of the Health Minister in the coming months:
- The specifications/statement of works defining the characteristics, composition, pharmaceutical form and technical specifications of the medicinal products to be used in the pilot programme;
- The list of therapeutic indications and clinical conditions for which the use of medical cannabis is authorised (we note that the CSST had already defined these indications/conditions, see here);
- The list of medical cannabis suppliers and partnering pharmaceutical establishments which have been selected for the pilot programme;
- The specific modalities with respect to import, storage, distribution and control of medical cannabis (including traceability, monitoring and possible withdrawal);
- The modalities for health care professionals (physicians and pharmacists) to participate in the programme on a voluntary basis;
- The practical aspects and implementation of the obligatory training and the body responsible for providing such training; and
- The technical conditions allowing the establishment and implementation of the national electronic registry.
In addition, the decree specifies that the Director of the ANSM is responsible for:
- Defining the respective number of patients for the relevant therapeutic indications or clinical situations;
- Establishing the content of the mandatory patient information form that must be provided to patients (including information on specific precautions, adverse events, contra-indications, etc.); and
- Providing a list of selected multidisciplinary reference centres (where initial prescriptions can take place).
Consequently, while the publication of today’s decree is only one small step forward for medical cannabis suppliers (which will need to exercise some more patience until the publication of the ministerial order containing the statement of works), it is a giant leap for French patients who can now look forward to medical cannabis becoming available – under the strict conditions of the pilot programme – in the next six months.
If the pilot programme is indeed to start on 31 March 2021, for a duration of two years, that also means that medical cannabis – in a best case scenario – should not be expected to be officially legalised in France before end of 2023.