What is the current legal framework of medical cannabis in France?

loi française sur le cannabis-marco legal cannabis medicinal en Francia

Should cannabis be legalized? The issue has never been more topical. In April 2019, the French Observatory for Drugs and Drug Addiction published a survey conducted at the end of 2018: 45% of French people “agree for the legalization of cannabis” and 91% believe that “cannabis consumption could be prescribed by doctors for certain serious or chronic diseases”.[1]

The current legislation on the consumption, possession, purchase or sale of cannabis is in any case not simple. Many texts are to be considered and it is difficult to understand what is legal from what is not. Let’s make a review.

French law prohibits cannabis, its extracts and resins

The decree of 22 February 1990 classifies cannabis, cannabis resin and tetrahydrocannabinol (THC) as narcotic drugs.[2]

According to article L. 3421-1 of the French Public Health Code (FPHC), “The illicit use of any of the substances or plants classified as narcotic drugs is punishable by one year’s imprisonment and a fine of 3750 euros. Persons guilty of this offence shall also be required, as an additional penalty, to complete a training course to raise awareness of the dangers of the use of narcotic substances.[3]

In practice, a circular on the fight against drug addiction and dependences published in April 2005 recommends an “adapted and diversified judicial response towards users” depending on the case. Age, personality, use, and consumption habits are taken into account. “The implementation of criminal proceedings shall be exceptional and shall be reserved for repeat offenders and users who refuse to comply with alternative measures ordered by the public prosecutor’s office”. Closings without action, if they are not followed by a warning or a reminder to the law, must be excluded.[4]

French law does not yet distinguish therapeutic from recreational use of cannabinoids. Consuming cannabis for therapeutic purposes is therefore punished in the same way as recreational use.

In accordance with Article R. 5132-86 FPHC, the production, manufacture, transport, import, possession, offer, transfer, acquisition or use of cannabis, its plant, resin and their derivatives is also prohibited. The same applies to tetrahydrocannabinols, except for delta-9-tetrahydrocannabinol (THC) and some of its derivatives.

Since 2018, questions about cannabis use have been regularly asked in the National Assembly. A bill on the controlled legalization of the production, sale and consumption of cannabis (therapeutic or recreational) was even tabled on July 2, 2019 by environmentalist MP François-Michel Lambert.[5]

Yet, some derogations authorices cannabis in some cases

The article R. 5132-86 FHPC also allows the Agence nationale de sécurité du médicament et des produits de santé (ANSM) [editor’s note: Medication and Health Products Safety National Agency] to grant exemptions in the context of research, control and manufacture of derivatives.

In addition, “The cultivation, import, export and industrial and commercial use of cannabis varieties without stunning properties or products containing such varieties may be authorized, on the proposal of the Director General of the Agency, by order of the Departments responsible for agriculture, customs, industry and health. »[6]

Article 1 of the decree of 22 August 1990 implementing Article R. 5132-86 FHPC for cannabis provides details of these authorisations:

“the cultivation, import, export and industrial and commercial use (fibre and seed) of Cannabis sativa L [editor’s note: hemp] varieties are authorised meeting the following criteria:

  • the delta-9-tetrahydrocannabinol content of these varieties is not more than 0,20 %;
  • the determination of the delta-9-tetrahydrocannabinol content and the taking of samples for this determination shall be carried out in accordance with the Community method provided for in the Annex.»

Article 2 lists authorised hemp varieties.[7]

In other words:

– only the varieties listed in Article 2 of the above-mentioned Order may be used;

– only the fibres (located on the stem) and seeds of the plant can be used: the use of the flower and leaves is prohibited;

– the THC content of the seeds or fibres used must be less than 0.2%;

– the derogation does not apply to finished products: any finished product containing THC, even with a content of less than 0.2%, is prohibited by law.

In practice, only CBD and its derivatives (oils, food products, creams, cosmetics, etc.) are authorised in France, and only if the above-mentioned conditions are met.

Learn more about the current European legal framework concerning the use of medical cannabis

The case of therapeutic cannabis in France

What the law says

In accordance with Article R. 5132-77 FPHC, the ANSM sets the conditions for the derogations mentioned above. They may only be granted to a natural person who has never been convicted of a drug offence.[8] In the case of pharmaceutical products, Article L. 5138-1 FPHC stipulates that the manufacture, import and distribution of active substances may only be carried out in establishments authorised by the ANSM.[9]

It should be noted that some organizations (ANSM, the French Anti-Doping Agency, the National Agency for Food, Environmental and Occupational Health Security and many others) do not require this authorization. Conversely, authorisation is automatically granted to certain health professionals such as certain pharmacists or veterinarians.[10]

In what other cases can an authorization be obtained?

Article R. 5132-86 CSP makes it possible to obtain two types of authorisation.

The first is a marketing authorization (in French: Autorisation de Mise sur le Marché or AMM). According to the ANSM, the AMM is “a mandatory prerequisite for any possibility of marketing a pharmaceutical specialty, as well as for reimbursement by the French health insurance”. Only SATIVEX, which contains CBD and THC, has benefited from it to date since 2014. However, it is still not available in pharmacies in France.[11]

The second is a temporary use authorization (in French: Autorisation Temporaire d’Utilisation or ATU). This is an “exceptional use of a pharmaceutical speciality that does not have an AMM and is not the subject of a clinical trial”. It can be issued by the ANSM under certain conditions.

In the case of a person suffering from a pathology, he/she may request a nominative ATU. Cannabinoids eligible for a nominative ATU request are EPIDYOLEX (CBD) and MARINOL (Dronabinol).

The nominative ATU is subject to many conditions and is often difficult to obtain. However, it is possible to make a request to the ANSM. It is valid for a maximum of one year and can be renewed.[12]

In addition, drugs with an ATU are fully reimbursed by the French health insurance.[13]

The ANSM experiment: towards the legalization of therapeutic cannabis?

In June 2018, the ANSM created a temporary specialized scientific committee (CSST) to “assess the relevance and feasibility of making therapeutic cannabis available in France”.

As a first step, the SSTC interviewed patients and health professionals, studied the interest of medical cannabis and analysed the experience and legislation of countries already using it. The CSST concluded in September 2018 that, in some cases, it was indeed appropriate to use therapeutic cannabis, through patient follow-up and regular assessment of adverse reactions.

In December, the ANSM agreed with these conclusions and supported the use of cannabis for therapeutic purposes in the following cases:

  • Pain refractory to therapies (drug or not) available;
  • Some severe and drug-resistant forms of epilepsy;
  • The framework for supportive care in oncology;
  • Palliative situations;
  • The painful spasticity of multiple sclerosis.[14]

In a second step, the ANSM proposed that an experiment be conducted to “evaluate, in real situations, the prescription and dispensing circuit as well as the adherence of health professionals and patients to these conditions”. It is also about obtaining French data on the effectiveness and safety of medicinal cannabis treatments.

The CSST has been asked to study the modalities. In June 2019, the CSST published its proposals for experimentation. In particular, the document specifies which preparations will be used, the conditions of prescription and delivery.

In July 2019, the ANSM accepted these proposals and committed itself to prepare the implementation of the experiment.[15]

In parallel, following the conference about hemp and welfare in France, organised on 11 July 2019, deputies announced the creation of a parliamentary information mission on cannabis use. The latter should start in September and last for a year. It would be conducted jointly by four committees of the National Assembly: the Law Committee, the Sustainable Development Committee, the Social Affairs Committee and the Economic Affairs Committee.

In conclusion, the current legal framework of medical cannabis in France is not simple, especially as things are changing: with the experimentation carried out by the ANSM and the launch of the parliamentary mission, France seems to be taking a step towards the legalization of cannabis, at least therapeutic. But as things stand at present, it will still be at least another year before it takes the next step.

Did you like the post? Give us some feedback! This post has been done based on existent research to the date of publication of the article. Due to the increase in studies based on medical cannabis, the information provided can vary over time and we’ll keep informing in further writings.

[1] Observatoire français des drogues et des toxicomanies. Tendances n°131, avril 2019. Enquête sur les représentations, opinions et perceptions sur les psychotropes. Figure 3 : Opinions sur des modifications de la législation sur le cannabis selon le fait de l’avoir expérimenté ou non.

[2] Arrêté du 22 février 1990 fixant la liste des substances classées comme stupéfiants (Version consolidée du 14 aout 2018)

[3] Code de la santé publique, art. L. 3421-1

[4] Circulaire relative à la lutte contre la toxicomanie et les dépendances.

[5] Proposition de loi relative à la légalisation contrôlée de la production, de la vente et de la consommation de cannabis. Enregistrée à la Présidence de l’Assemblée nationale le 02/07/2019.

[6] Code de la santé publique, art. R. 5132-86

[7] Arrêté du 22 août 1990 portant application de l’article R. 5132-86 du code de la santé publique pour le cannabis (Version consolidée au 06 août 2019)

[8] Code de la santé publique, art. R. 5132-77

[9] Code de la santé publique, art. L. 5138-1

[10] Code de la santé publique, art. R. 5132-76

[11] Agence nationale de sécurité du médicament et des produits de santé. Autorisations – AMM.

[12] Agence nationale de sécurité du médicament et des produits de santé. Autorisations temporaires d’utilisation (ATU).

[13] Ministère des Solidarités et de la Santé. Autorisations temporaires d’utilisation (ATU).

[14] Agence nationale de sécurité du médicament et des produits de santé. (13/12/2018) Cannabis thérapeutique en France : l’ANSM publie les premières conclusions du CSST – Point d’information.

[15] Agence nationale de sécurité du médicament et des produits de santé. (11/07/2019). Cannabis à visée thérapeutique en France : l’ANSM souscrit au cadre de la phase expérimentale de mise à disposition proposé par le comité d’experts – Point d’information.

About Pauline

Author of articles dealing with cannabinoids and their uses. Monitoring the latest scientific publications and news on therapeutic cannabis

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