French medical cannabis programme: CSST provides further guidance and statement of works to be published in February
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The first phase of the programme, which is the implementation phase, officially kicked off in October 2019 (see our latest blog post “First phase of French medical cannabis pilot programme officially started“). While the CSST confirmed some of the main requirements that will apply, the full statement of works (“cahier des charges”) will be published in February on the website of the ANSM. It appears that the CSST intends to publish a separate statement of works for (i) suppliers and (ii) distributors.
For companies that would like to become suppliers for the French medical cannabis programme, the main takeaways with respect to product quality measures are:
- The CSST confirms that the cannabis used for the pilot programme should be presented in the form of finished products (which will not require preparation or processing);
- The application files to be submitted by suppliers in due course will need to provide specifications on (i) the plant (e.g. cultivation method, selection method, compliance with good agricultural practices, THC/CBD content, terpenes), (ii) the finished products used by patients and (iii) the analytical procedures of the control methods and the results of these controls;
- The selected products will have to be manufactured according to Good Manufacturing Practices (GMP). For countries outside the EU, the GMP or equivalent status of the production sites may be audited by the Inspection Department of the ANSM based on the mutual recognition agreements (MRA) that France has entered into with the various countries that host the production sites. The ANSM may also carry out on-site inspections if necessary, after informing the local competent authority.
The CSST also provides the following guidance as to the further implementation of the programme:
- Distribution security measures: Only a limited number of distributors, located in France, will be authorised for the storage and distribution of narcotic medicines. They will centralise the importation of medical cannabis and distribute the products to pharmacies, and need to apply for the relevant narcotics (import) licenses in this respect. These distributors will have to comply with a specific statement of works (“cahier des charges”).
- Patient monitoring and evaluation of adverse reaction measures: The electronic registry (covering all patients) will include different modules to assess the feasibility of the envisaged supply chain and its acceptability by patients (e.g. time to obtain an appointment, dispensing time after presentation of the prescription, ease of finding a pharmacy). The data included in the registry will mainly be data on dispensed dosages, efficacy, adverse effects and impact on quality of life. The registry will be filled out by prescribers, pharmacists and patients (with the possibility of including nurses). In addition to the registry, a complementary study involving a smaller number of patients (included in the registry) will be set up and carried out by a research team.
- Healthcare professionals’ training: Healthcare professionals (physicians and pharmacists) will have to follow a prior mandatory training in order to prescribe and dispense medical cannabis. A specific training for the French pilot programme will be developed in coordination with teachers, clinicians and patients. This should guarantee the independence of healthcare professionals vis-à-vis the companies supplying the products and allow supervision of the messages that will be delivered. This programme will evolve according to the scientific and medical knowledge on the subject. The CSST considers that the best training format would be a 3h30 e-learning course.
- Prescription security measures: Learned societies have been requested to organise the pre-selection of the multidisciplinary reference centres where volunteer physicians will prescribe the products. The validation of this list by the ANSM is pending. The entire national territory will have to be covered and the CSST confirms that once the patient is stabilized, the patient’s general physician should be able to ensure the follow-up.
- Dispensing security measures: As cannabis and derived products are considered narcotics, they will need to be prescribed by means of a secured prescription and will need to be stored in locked safes.
More information on the French medical cannabis programme can be found on the website of the ANSM here.