French ANSM recommends medical use of cannabis under certain conditions
07 January 2019
Just before the end of 2018, the French National Agency for Medicines and Health Products Safety (ANSM) recommended allowing the use of medical cannabis under certain conditions, thus following the recommendations of a Temporary Specialised Scientific Committee (CSST) that was created earlier in 2018. An official opinion from the CSST is expected before summer 2019. This opinion is expected to provide recommendations on the type of medical care that should be given to patients (e.g. the type of prescribers, the distribution and dispensing system, methods of administration etc.). Medical cannabis will then be made accessible to patients by means of pilot project first.
On 13 December 2018, the CSST had published its first conclusions on the pertinence and feasibility of medical cannabis in France. The CSST considers that authorising the use of cannabis for therapeutic purposes is appropriate in certain clinical situations and if the available (medical or non-medical) therapies provide insufficient relief or are poorly tolerated by patients (in particular, where those available therapies are cannabis or cannabinoid-based medicinal products). The medical use of cannabis could be considered as an addition or replacement for some of those therapies.
The experts selected several therapeutic situations in which the use of therapeutic cannabis should be permitted:
- For treatment of refractory pain that cannot be treated with available medicines.
- For treatment of certain severe forms of epilepsy.
- As part of supportive care in oncology.
- In palliative situations.
- For painful spasticity related to multiple sclerosis.
The CSST recommends:
- Implementing a patient monitoring regime in the form of a national register to ensure evaluation of the benefit-risk ratio of medical cannabis.
- Regularly evaluating adverse reactions related to medical cannabis through pharmacovigilance and addictovigilance networks.
- Promoting research in this field.
- Excluding the smoking of medical cannabis as a route of administration. The CSST will provide detailed advice on the various possible routes of administration.
These conclusions follow several meetings during which the CSST: (i) assessed the therapeutic value of cannabis in the treatment of certain pathologies; (ii) analysed the experiences of other countries that have already authorised such use; and (iii) reviewed the relevant regulatory frameworks in France and internationally.