France is taking steps towards medicinal cannabis

Scientific Committee gives green light to medicinal cannabis

Like most other European countries, France is considering a programme for medicinal cannabis, to ensure patients have legal access to a product that can improve their quality of life. On Thursday the 13th of December, the temporary scientific Committee CSST submitted its advice and findings to the ANSM, the French National Agency for Medicines and Health Products Safety. The preliminary conclusion is that ‘It would be “appropriate to authorise the use of therapeutic cannabis […] in certain clinical situations and in cases where [existing] therapies provide insufficient relief or are not well tolerated”.

CSST

According to the French media, that means the temporary Committee gives the ‘green light’ for medicinal cannabis in France, even though this Comité Scientifique Spécialisé Temporaire (CSST) – which started under the Chairmanship of the psychiatrist Dr Nicolas Authier on the 10th of September 2018 – does impose some prerequisites. Next, the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) will take a decision about the Committee’s advice. This decision is expected shortly.

Important steps

The Belgian pharmacist and adviser Igna Huyghe has been closely tracking the process in France and she believes that important steps have been taken over the past few months. Certainly since June this year. “It has 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.”

French patients

France has an estimated 300,000 to 1 million patients that could benefit from medicinal cannabis. The country has permitted use of two products based on cannabinoids, but one is only prescribed to patients with neuropathic pain in extremely specific conditions (Marinol®), whilst the other (Sativex®) is still not available in pharmacies due to discussions about the price.

It is a well-known fact that a large number of French patients has discovered cannabis as medication, but need to enter the illegal circuit and are not guaranteed a consistent or safe product. There is an urgent need to regulate cannabis for medicinal use in France, and the Minister for Public Health Agnès Buzyn has said that she will not exclude cannabis as a legal medicinal product for patients.

Medicinal cannabis

As in many other countries, the concept of ‘medicinal cannabis’ leaves plenty of room for discussion. “The problem is that the concept of ‘medicinal cannabis’ is not clear to many people, including patients, healthcare professionals or politicians”, concludes Ms Huyghe. “There is a demand for a standardised full-spectrum product that is produced in accordance with pharmaceutical standards, i.e. that is GMP compliant. A product that is of consistent quality, guaranteed safe as much as possible, affordable and still available in the future. A product that is tested carefully and ends up with patients through the healthcare systems – doctors and pharmacists – and where there are options to monitor the patients and consequently the product. Such a standardised product is also the only basis for scientific research.”

Round table in Paris

Ms Huyghe, who provides information about medicinal cannabis to patients in Belgium and France was in Paris on the 5th of December, when the temporary CSST Committee shared the first findings of its study with the public during a round table. “On that day we actually heard the recommendations from the report”, she said. “They want to make medicinal cannabis available for chronic pain, certain types of epilepsy, palliative care, supportive care in oncology and for multiple sclerosis. Smoking cannabis is not an option, but the Committee sees possibilities for vaporizing or oral administration.”
The Committee also recommends that patients are monitored to ensure that the effectiveness and any side effects of medicinal cannabis are charted. There will be special attention for the assessment of the benefits of treatment and any risk of addiction. The Committee also aims to promote scientific and other research. When the ANSM adopts the Committee’s recommendations, the second phase of the research starts. That will determine the most appropriate administration method, how the distribution of medicinal cannabis can be organised and whether there can be any reimbursement. The final advice from the temporary Committee is expected in September 2019 and it would seem logical that the French programme for medicinal cannabis will not start before 2020.

Agricultural country

Aside from the discussion about the contribution that medicinal cannabis makes to public health, France also has a discussion about the economic impulse promised by the cultivation of medicinal cannabis. Traditionally, France is an agricultural country and in some départements and régions farmers are struggling to keep their heads above water. It is not surprising that the agricultural sector is considering the opportunities provided by medicinal cannabis with interest and espoir (hope). Hemp is grown in many parts of France and the country is already able to deal with cultivating controlled substances; France harvests more than 100 tonnes of opium poppies, which accounts for 21% of total global production, per year. Ms Huyghe continued “It is logical that the French wish to study how they can control the production of medicinal cannabis themselves, but for patients we hope that the economic interests will not undermine the medicinal importance. I have the distinct impression that they are well aware of this in France.”