Medicinal cannabis in France – a work in progress

Medicinal cannabis in France – a work in progress
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Discover how France has taken its first steps towards the legalisation of medicinal cannabis, are we seeing a shift in the French cannabis market?

In France, the laws surrounding cannabis have consistently remained strict, including the restriction of the use of cannabis for medicinal purposes. However, since 2014, France’s relationship with the legislation and administration of medicinal cannabis has started to change. This attitude shift was first demonstrated at the beginning of 2014 when the Ministry of Health amended France’s Code of Public Health to allow the use of the cannabis-based medicine Sativex.

The only cannabis-based medicine approved by the French Ministry of Health, Sativex is a spray that has equal parts of tetrahydrocannabinol (THC) and cannabidiol (CBD) and is applied directly under the tongue. However, despite this amendment to allow to use of Sativex in France, this is strictly limited to the treatment of patients with multiple sclerosis (MS).

As well as having MS, the patient must also suffer from severe muscle spasms and intractable spasticity before the spray can be prescribed. The patient must also not have found any success previously with other types of MS treatment.

Additionally, the patient has to be prescribed the treatment of Sativex by either a neurologist or a physician specialised in MS. Patients are only permitted to be given a prescription for Sativex every six months and each prescription is to last the patient the course of one month.

The French National Agency for Medicines and Health Products Safety

Since then, France has progressed even further with the legalisation of cannabis for medical use with the development of a committee specifically developed for the investigation into introducing medical cannabis into France.

During September 2018, the French National Agency for Medicines and Health Products Safety (ANSM) launched the ‘Temporary Specialised Scientific Committee’ (CSST). Running for only a year, the CSST aims to evaluate, according to their website, ‘the relevance and the feasibility of the provision of therapeutic cannabis in France’.

The CSST was established with the key aims of evaluating, analysing and reviewing therapeutic interest surrounding cannabis, including the treatment of specific pathologies and any national and international regulations. Following several meetings surrounding the discussion of the aforementioned key elements of the CSST, the committee recommended four main strategies for the implementation of medical cannabis in France.

Firstly, it recommended that a patient monitoring regime is implemented. The CSST suggested that this should be in the form of a national register to ensure the evaluation of the benefit to risk ratio of medicinal cannabis. The second recommendation was for pharmacovigilance and addictovigilance networks to regularly evaluate any adverse reactions patients have to the treatment. Thirdly, the CSST recommended the promotion of research in France for the use of cannabis for medicinal purposes. And, lastly, the committee recommended the exclusion of administrating medicinal cannabis by smoking; however, other methods of administration are still to be further investigated by the CSST.

Medical cannabis and therapeutic situations

At the end of 2018, CSST officially published their first conclusions on the relevance and practicality of cannabis being used for medicinal purposes in France, alongside the release of the following statement: “It is relevant to authorise the use of cannabis for therapeutic purposes for patients in certain clinical situations and in case of insufficient relief or poor tolerance of therapeutics … This use can be considered in addition to or as a replacement for certain therapies.”

The committee concluded that the authorisation of cannabis is relevant for therapeutic purposes for patients in specific clinical situations. CSST has deemed the following therapeutic situations appropriate for the use of medicinal cannabis:

  • Chronic pain
  • Some forms of severe and drug-resistant epilepsy
  • Part of supportive care in oncology
  • Palliative situations
  • Multiple sclerosis (particularly painful spasticity).

The head of the CSST, Nicolas Authier, suggested that research will be done into medical cannabis and magistral preparations. In an interview with the French publication Le Quotidien Du médecin, he said: “It must be possible to propose [cannabis medicines] in the form of magistral preparations, which raises the questions of care, prescription and delivery. These are issues that our committee will be looking at if we get a mandate for that.”

The future for medical cannabis in France

Interestingly, a month after the CSST published its first recommendations on the use of medical cannabis in France, a poll demonstrated that it wasn’t only the industry’s view that was starting to change. 82% of those surveyed were in fact in favour of medical cannabis.

In terms of industry, Belgian pharmacist Igna Huyghe told legal medicinal cannabis producer Bedrocan that the move for medicinal cannabis had “been a long time coming, but now there is real movement and it is clear that signals about the potential of medicinal cannabis are taken seriously at the highest level. Over a short period of time, the CSST committee interviewed a large number of stakeholders in France and beyond and appears to be following the lead of many other European countries. Although the committee quite rightfully acknowledges that large amounts of scientific research are required, it also recognises that cannabis provision for medicinal purposes meets a major need.”

As views towards the use and legalisation of medicinal cannabis begin to change, it will be interesting to see how countries such as France that have previously placed strict restrictions on its use will evolve their laws, expand their research efforts, and grow their industries.

Please note, this article will appear in issue 9 of Health Europa Quarterly, which will be available to read in April 2019.

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