Medical cannabis in France: Latest state of play
12 June 2019
Following the penultimate meeting of the specialised committee on cannabis (CSST) established by the French National Agency of Medicine and Health Products Safety (ANSM) (see our previous blog posts "French ANSM temporary scientific committee pursues activities on modalities of medical cannabis availability" and "French ANSM recommends medical use of cannabis under certain conditions"), the French Senate held a hearing on 28 May 2019 entitled "Cannabis, a major public health issue" during which the senators present at the hearing came (despite existing concerns) to a quasi-consensus regarding the need of legally permitting medical cannabis in France. In the days and weeks following the debate, both politicians and experts, amongst others Nicolas AUTHIER, the chairman of the CSST, provided some further insights on the future of medical cannabis in France.
We list below some of the key takeaways from these recent developments.
- The next and last meeting of the CSST is scheduled to take place on 26 June 2019. According to the meeting agenda, this session will focus on the national (French) perspectives on cultivation and supply (foreign stakeholders were heard during the last meeting of the CSST on 15 May).
- It has been reported that the CSST will also release its final report on 26 June (which seems rather improbable if the report should take due account of the findings of the last CSST meeting). This report is expected to provide recommendations on the regulatory framework that should govern the supply of medical cannabis, such as the type of prescribers, the distribution and dispensing system, and the permitted methods of administration.
- The experimentation (pilot) phase with therapeutic cannabis is expected to last for about two years, and will be able to commence as soon as the French Public Health Ministry has given green light and provided the necessary funding. The French Minister of Health Agnes BUZYN has previously indicated to be in favour of such pilot programme (based on the ANSM’s scientific recommendations). While there are rumours that the pilot could start within weeks from the final report being delivered, other sources suggest that it is unlikely to start before Q4 2019 (until mid/end 2021). Consequently, medical cannabis is not expected to be officially legalised in France (which requires a change in the relevant regulations) before the end of 2021.
- Several senators and deputies, amongst which Jean-Baptiste MOREAU, strongly advocate for ensuring a French supply chain for the production of medical cannabis, in particular in the French department of La Creuse (this department is the largest hemp producer in France, with France being the third largest hemp producer in the world, and elected officials already requested in 2018 for a permit to cultivate and produce medical-grade cannabis to boost the local economy). A report of the Senate mission on medicinal plants in this respect also recommended "removing regulatory obstacles to the development of a French hemp production sector for therapeutic use." However, to date, medical cannabis production is not authorised in France. Nicolas AUTHIER indicated that, during the pilot programme, medical cannabis will most likely have to be imported (from countries where medical cannabis is legal) until a French supply chain is set up. He underlined that, in the future, French producers will in any event need to comply with the EU rules for producing medicines of consistent quality (probably referring to compliance with, amongst others, Good Manufacturing Practices).
- The use of medical cannabis during the pilot programme will be strictly controlled: physicians will be permitted to prescribe it only for the indications identified by the ANSM in December 2018: cancer, certain types of epilepsy, multiple sclerosis, palliative care, and pain that does not respond to usual treatments; and “a last resort, after trying other available therapeutic treatments.” Senator Esther BENBASSA, who opened the Senate debate on 28 May, indicated that the scope of eligible illnesses may have to be widened in the future. During the debate she insisted on the fact that between 300,000 and one million French people could benefit from medical cannabis, and recalled that more than 82% of French citizens are allegedly in favour of using cannabis in a medical setting (according to a 2018 survey)
- In particular Republican senators warned during the Senate hearing that the authorisation of medical cannabis should not be a “Trojan horse” for the legalisation of recreational cannabis. In this respect, it is worth noting that while France has one of the most repressive cannabis laws in Europe, it also has one of the highest levels of recreational cannabis consumption: cannabis is smoked regularly by 11% of French people aged 18 to 64, according to the French Observatory for Drugs and Drug Addiction. In response to such concerns, CSST President Nicolas AUTHIER underlined that the risk that medical cannabis will be abused for recreational purposes is very limited given that it has different users with different objectives and that medical-grade cannabis (which often has lower THC concentrations than recreational cannabis) will not satisfy those looking for psychoactive effects.
- Meanwhile, other senators and stakeholders have also drawn attention to the fact that France will similarly and additionally have to consider adequately regulating well-being cannabis (e.g. food supplements, cosmetics with very low levels of THC). In that respect, Deputy MOREAU indicated that he has plans to propose an investigation into other uses of cannabis in France. However, legal/regulatory change with respect to well-being cannabis is unlikely to take place before the Court of Justice of the European Union takes a decision in the pending referral (Case C-663/18) and the French Supreme Court recently stayed proceedings pending the judgment of the CJEU in this respect.