27 June 2019 - Authored by:Eveline Van Keymeulen
Yesterday, the French specialised committee on cannabis (CSST), which was established in mid-2018, held its last meeting and presented its final recommendations for the implementation of a medical cannabis pilot programme to the French National Agency for Medicines and Health Products Safety (ANSM). Last week, on 19 June 2019, the CSST had already published the basic framework for such pilot programme.
These recommendations follow the CSST’s prior advice (issued in December 2018) that the use of cannabis for therapeutic purposes is appropriate in certain clinical situations and if the available therapies provide insufficient relief or are poorly tolerated by patients, which was later endorsed by the ANSM. (See our previous blog post: “French ANSM recommends medical use of cannabis under certain conditions“). Since then, the CSST met three times in order to discuss the modalities of the experimental pilot phase and define, inter alia, the types of products that would be proposed to patients and physicians, appropriate modes of administration, competent prescribers and their obligations, the distribution and dispensing circuit, and the follow-up procedure for patients undergoing treatment.
The main objective of the experimental pilot project, which is expected to last for a two-year period (until 2021) is to evaluate, in real life situations, the recommendations of the CSST with respect to the prescribing and dispensing conditions and the adherence of health care professionals and patients to such conditions. Its second purpose is to collect the first French safety and efficacy data related to medical cannabis (in order to assess the relevance thereof).
The CSST issued the following recommendations for the pilot phase:
- Available products, modes of administration, ratios and dosages: Cannabis preparations or full spectrum extracts, in immediate release forms (sublingual and inhaled forms, i.e., oil and dried flowers for inhalation) as well as prolonged effect forms (oral solutions or oil capsules), in five different THC:CBD ratios (1:1, 1:20, 1:50, 5:20 and 20:1). The dosage should be adjusted by means of titration until the minimum effective dose is reached (with adverse reactions considered tolerable by the patient and the physician).
- Prescribing and dispensing conditions:
- The initial prescription – until stabilisation of the patient – should be reserved to physicians (working in multidisciplinary reference centres) which are specialised in the five indications for which treatment with medical cannabis will be allowed (i.e., refractory neuropathic pain that cannot be treated with available medicines; certain serious and pharmaco-resistant forms of epilepsy; as part of supportive care in oncology; in palliative situations; or for painful spasticity related to multiple sclerosis). Once the patient is stabilised, the patient’s general physician should be able to ensure the follow-up (upon agreement of both the specialist and the general physician). Participation in the pilot project is voluntary. All prescribers will have to follow mandatory training.
- The dispensing of medical cannabis should initially occur in hospital pharmacies – until stabilisation of the patient – but can later take place in retail pharmacies (once the patient has been stabilised).
- Contraindications and precautions for use: Medical cannabis should not be prescribed to pregnant women. In addition, effective contraception for women of childbearing age should be implemented. Warnings about the ability to drive vehicles and use machines should be given.
- Patient follow-up and evaluation of adverse reactions: The establishment of a national electronic registry to track patients treated with medical cannabis will allow the collection and analysis of registry data, including adverse reactions and data on the effectiveness of medical cannabis.
- Timetable for the implementation and evaluation of the pilot phase: The pilot project will be divided into four 6-month phases (6 months for implementation, 6 months for patient inclusion, 6 months for patient monitoring with issuance of an interim report, and 6 months of data analysis and the submission of a final report by the CSST to the ANSM). In parallel, a multidisciplinary Scientific Committee will be created in order to develop a guide with recommendations for prescribers, analyse registry data, monitor safety data and write study reports.
- Communication and information: Communication actions towards health care professionals and the general public will be implemented.
These recommendations were followed by the last meeting of the CSST on 26 June 2019 which focused in particular on stakeholders’ views on the proposed pilot project and national (French) perspectives on the cultivation and supply of medical cannabis.
On the one hand, the different stakeholders, including Olivier Veran (French Deputy of Isère), Alain Milon (French Senator of Vaucluse) and patient associations welcomed the pilot project. They underlined that the availability of full spectrum extracts and different THC:CBD ratios were a necessity to satisfy the different needs of patients. In addition, they insisted on the fact that the pilot project had to be a success and argued that its modalities should be specified and strictly applied.
On the other hand, three projects were presented in order to highlight the French capabilities and knowledge with respect to the cultivation and supply of the plant in France. Stakeholders repeatedly underlined that France is the leading country in Europe for (industrial) hemp production (and the third largest producer of hemp in the world) and therefore has the necessary skills and expertise to ensure proper and sufficient production of cannabis for medical purposes as well.
As indicated in our previous blog post (“Medical cannabis in France: Latest state of play“), the experimental pilot programme will be able to commence as soon as the French Public Health Ministry has given green light and provided the necessary funding, and is expected to start sometime later this year (until mid/end 2021). Consequently, medical cannabis is not expected to be officially legalised in France before the end of 2021.
This article was co-authored by Alexis Vaujany.