Medical Cannabis & Cannabinoid Regulation 2023 Comparisons

In France, cannabis and cannabinoids are regulated by a complex set of rules composed notably of laws, decrees and ministerial orders setting forth a general prohibition of cannabis, which is classified as a narcotic substance.

General Prohibition of Cannabis Under French Law

According to the French public health code, the production, manufacturing, transportation, importation, exportation, possession, sale, purchase and use of plants, substances or preparations classified as poisonous, including narcotic substances and psychotropic substances, are governed by regulatory provisions defined by ministerial orders. For the sake of clarity, ministerial orders (Arrêté in French) are administrative acts published by ministers and set forth certain rules regulating (for instance) specific sectors, products or activities.

The French ministerial order of 22 February 1990 (Appendix I) classifies cannabis and cannabis resin as narcotic substances. More specifically, French law strictly prohibits the production, manufacturing, transportation, importation, exportation, storage, supply, distribution, purchase or use of:

• cannabis, and its plant and resin, as well as products that contain it or are produced from cannabis, its plant or its resin; and
• tetrahydrocannabinols, their esters, ethers and salts, and the products containing them.

Exceptions to the General Prohibition Rule

Nevertheless, French law provides for several exceptions.

• The manufacturing, transportation, importation, exportation, possession, sale, purchase or use of medicinal products containing cannabis or one of the cannabis plant components is allowed if the product has been granted a marketing authorisation either from the French Medicines Agency (Agence nationale de sécurité du médicament et des produits de santé (ANSM)) or from the European Medicines Agency (EMA).

• Other cannabis-based medicinal products that satisfy specific criteria (notably characteristics, composition, pharmaceutical forms, therapeutic indications) but do not hold a marketing authorisation are accessible to a limited number of patients through a pilot programme (as described below).

• The ANSM can grant specific authorisations for the production, manufacturing, transportation, importation, exportation, storage, supply, distribution, purchase or use of cannabis and/or its components for research and development purposes.
• Cultivation, importation, exportation and industrial and commercial use of hemp plants that do not have any narcotic properties or of products containing or made out of such hemp strains can be allowed by ministerial order upon proposition from the General Director of the ANSM.

To date, cannabis regulation remains a work in progress since there is no fully established legal framework in France. Adult-use cannabis is not legal, and legalisation thereof is unlikely to happen any time soon. Medical cannabis (other than medicinal products holding a marketing authorisation) is currently only authorised and therefore accessible through a pilot programme. Regulation on wellness hemp is the most developed framework, but remains subject to grey areas that could benefit from numerous clarifications for the sake of a safe market both for consumers and for operators.

Medical Cannabis

Medical cannabis is only allowed in France if the product is a medicinal product that holds a marketing authorisation or is accessible through early access programmes (eg, Sativex, Epidyolex, Marinol) issued by the French or the European competent health authority, or if the cannabis product is supplied, prescribed and administered to patients as part of a pilot programme that started in March 2021.

In other words, any activities related to the cultivation, production, manufacture, transportation, importation, exportation, detention, supply, transfer, acquisition or use of cannabis for exclusively therapeutic purposes outside one of the above-mentioned frameworks are considered criminal offences related to drug trafficking and are therefore prohibited in France.

The ongoing pilot programme on therapeutic cannabis, which began in March 2021, was designed to enroll up to 3,000 patients over a two-year period to assess the feasibility of the supply, prescription and delivery of medical cannabis to patients for whom no other therapeutic alternative is available. Because there is no domestic production line in France, supply is performed exclusively by foreign companies who were selected through a tender, and who were initially required to supply the products free of charge and at their own costs for the entire duration of the pilot programme.

The requirements related to the products, the supply chain, physician training, prescription and delivery as part of the pilot programme were set out in a statement of work published on 19 October 2020, as summarised below.

• Medical cannabis is allowed for five therapeutic indications:
1. neuropathic pain that cannot be treated with available therapies (medicines and non-medicines);
2. certain serious and pharmaco-resistant forms of epilepsy;
3. as part of supportive care in oncology (eg, nausea, vomiting, anorexia);
4. palliative situations; and
5. painful spasticity related to multiple sclerosis or other central-nervous-system-related diseases.
• The products must be supplied as finished products only in their final packaging ready to be delivered to the patient.
• The authorised forms of medical cannabis are dried flowers for inhalation by vaporisation (smoking use has been excluded from the allowed uses) and oil and capsules for oral use.
• The products use different ratios – the THC dominant ratio, CBD (cannabidiol) dominant ratio or balanced THC and CBD ratio.
• The production of medical cannabis must comply with a certain number of industry standards, such as good agricultural and collection practices (GACP) for starting materials of herbal origin (EMEA/HMPC/246816/2005) and good manufacturing practices (GMP) set forth in the French public health code or any equivalent guidelines recognised at the international level, in addition to several other guidelines, including:
1. the Guidelines on Quality of HMPs/THMPs (CPMP/QWP/2819/00 Rev 2);
2. the Reflection Paper on Microbiological Aspects of HMPs and THMPs (EMA/HMPC/95714/2013); and
3. the ICH Q2 Guidelines for Validation.
• The plants used to make the products must meet the specifications of the monograph “Plant Drugs” (1433) of the European Pharmacopoeia. 
• Suppliers need to obtain both an importation authorisation for narcotic substances from the ANSM and an exportation authorisation for narcotic substances from the country of origin.
• Selected suppliers are required to enter into a partnership agreement with a pharmaceutical establishment located in France for the distribution of medical cannabis to pharmacies and hospital pharmacies that participate in the pilot programme.
• The pharmaceutical establishment located in France in charge of the distribution of the medical cannabis on the territory must have the status of operator and importer, if applicable, and hold a narcotics authorisation relating to medical cannabis in the context of the pilot programme.
• The initial prescription of the products is reserved to physicians working at multidisciplinary reference centres specialised in the five indications for which treatment with medical cannabis is allowed. However, once the patient is stabilised, general practitioners are allowed to prescribe medical cannabis to them, upon agreement of both the specialist and the general physician.
• All prescribers involved in the pilot programme must have followed mandatory training (e-learning).
• The dispensing of medical cannabis occurs initially in hospital pharmacies and can later be carried out by retail pharmacies once the stabilisation of the patient has been reached.

While legalisation of medical cannabis was expected at the end of the two-year programme, the French authorities decided to extend the pilot programme by one year (Decree No 2023-202 of 25 March 2023). As part of the extension of the programme, the products are no longer supplied for free by the selected suppliers and some clarification was provided as to the requirements and modalities related to physicians’ and pharmacists’ participation in the pilot programme, training, remuneration and product specifications by three ministerial orders dated 25 March 2023. This point is detailed further in 1.4 Key Challenges.

Industrial Hemp and Cannabinoid-Based Consumer Products

Industrial hemp and hemp extracts are governed by the French ministerial order of 30 December 2021, authorising the cultivation, importation, exportation, and industrial and commercial use of hemp plants that contain up to 0.3% of THC and that are duly registered on the Common Catalogue of Varieties of Agricultural Plant Species or the French Catalogue of Plant Varieties and Species.

Hemp extracts and hemp-derived finished products containing extracts can be legally marketed in France if they meet the following requirements:

• hemp extracts (including CBD) must be obtained by using the entire hemp plant (including the flowers and leaves) and finished products containing CBD are extracted from the entire hemp plant; and
• the THC level contained in the hemp extracts and the products containing such extracts must not be more than 0.3%, without prejudice to the provisions of Articles 14 and 15 of Regulation (EC) 178/2002 related to the general safety of goods requirements or any other more restrictive specific regulation.

In addition, specific rules apply depending on the category of the finished products concerned, as follows.

• CBD in foodstuffs – CBD is considered a novel food and must therefore be authorised prior to it being placed on the market as such or used in a food product as per Regulation (EU) 2015/2283 (the “Novel Food Regulation”). This point is explained in more detail in 3.2 Use of Non-controlled Cannabinoids in Food.
• Animal food products – CBD used as an isolated substance or enriched extracts obtained from extraction processes are considered food additives and as such must be authorised prior to being placed on the market. To date, CBD, regardless of its processing method, has not been authorised at the EU level as a pet food additive.
• CBD-based cosmetic products can be legally placed on the market if they comply with the provisions of Regulation (EC) 1223/2009 on cosmetic products (the “Cosmetics Regulation”), and assuming that they do not make any health claim. The use of hemp extracts in cosmetic products is strictly regulated. CBD alone or other hemp extracts must not fall under one of the prohibitions set out in Annex II of the Cosmetic Regulation, notably entry No 306 “Narcotics, natural and synthetic: All substances listed in Tables I and II of the Single Convention on Narcotic Drugs signed in New York on 30 March 1961”. Cannabis extracts that can be used in the manufacturing of cosmetic products without restrictions are listed in the European Commission database for information on cosmetic substances and ingredients (COSING). Even though the COSING is not legally binding, it is used as a reference by competent authorities, notably in the control of cosmetic products. E-liquids and vaping products can be marketed on the French market if:
1. the maximum THC level they contain remains below 0.3%;
2. they comply with Regulation (EC) 1272/2008 (the “CLP Regulation”) and Regulation (EC) 1907/2006 (REACH); and
3. they are not sold to minors.

It should be noted that the ministerial order of 30 December 2021 initially set forth a prohibition on the retail sale to consumers and possession, use and/or consumption by consumers of raw hemp flowers and leaves, regardless of their form (eg, smoking products, potpourri, tea), whether alone or mixed with other ingredients (such as tea preparations), hence limiting the authorised use of the entire hemp flower to industrial use only.

Several legal actions were commenced in order to challenge this prohibition before the French Council of State (Conseil d’Etat), which repealed the litigious provision in a ruling of 29 December 2022, notably judging that the French government had failed to bring sufficient proof of an actual risk to public health or public order such as they were using as grounds for the prohibition (please see 1.5 Level of Regulation for more detail).

The cannabis sector is controlled by several competent authorities, each charged with specific missions.

• The ANSM is charged with the control of health products governed by the French public health code. It is the control authority for cannabis-based medicines and medical cannabis, as well as for cosmetic products. Among its powers, it can:
1. provide marketing authorisations;
2. authorise pharmaceutical establishments;
3. issue importation/exportation authorisations;
4. control regulatory compliance of products; and
5. allow clinical trials.
• The DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes) is charged with the control of several types of products, in particular consumer products such as food and cosmetics. It ensures that these products are compliant in terms of quality, composition and labelling, and that they are not associated with misleading commercial practices related to their origin or quality. The DGCCRF also controls the claims that may be made by distributors on their products.
• The DGAL (Direction générale de l’Alimentation) is charged with the control of food safety. It is competent to control supply chains of vegetal and animal food stuffs. Food safety control was under the DGCCRF’s power until 2023; this power has now been transferred to the DGAL.
• The ANMV (Agence nationale du médicament vétérinaire) is the competent authority for veterinary drugs and is competent to:
1. assess marketing authorisation applications;
2. control the risk of side effects;
3. control the quality of veterinary medicines and advertising thereof; and
4. authorise veterinary medicines, clinical trials and pharmaceutical establishments, and the importation/exportation of products.

There are several trade bodies and organisations in France in charge of medical cannabis or industrial hemp-related activities, including:

• Santé France Cannabis;
• Le Syndicat du Chanvre (SPC);
• L’Union des Industriels pour la Valorisation des Extraits de Chanvre (UIVEC); and
• La Fédération Nationale des Producteurs de Chanvre (FNPC).

These organisations represent players in the industry and participate in the setting of legal frameworks related to medical cannabis or industrial hemp.

Medical Cannabis

As medical cannabis is only authorised as part of the pilot programme or as a licensed medicinal product, market opportunities in France are currently limited to foreign suppliers who were selected for the implementation of the pilot programme or to the marketing authorisation holders of cannabis-based medicines, as the case may be.

The lack of clarity on the exact timing of legalisation of medical cannabis in France, as further discussed in 3.1 Legal Elements Affecting Access to Medical Cannabis, creates a lot of uncertainty for other players seeking to enter the French market.

Wellness Hemp

Companies producing and distributing cannabinoid-based consumer products, including CBD products, also face a certain number of challenges.

Until the recent decision by the French Council of State, the distribution of raw hemp flowers and leaves to consumers in France was made at risk. Numerous controls were run by law enforcement, resulting in stores being shut down and store owners brought to criminal courts for drug trafficking. While the decision of the Council of State has allowed distribution and sale of these products to resume, it should be noted that the French government is expected to modify the ministerial order of 30 December 2021. However, it remains unclear what modifications will be made and if any new restrictions will be set out.

Another major challenge for operators in the French market relates to novel food. The quite limited controls run by the French competent authorities on the market in past years, combined with the absence of a clarified position being taken by such authorities, creates uncertainty and generates risk for market players, who are still likely to face controls and sanctions.

Finally, litigation has also arisen between economic players, with some companies engaging in lawsuits against competitors on the grounds of unfair competition for selling CBD foodstuffs before the CBD has been given the requested marketing authorisation from the European Food Safety Authority (EFSA).

Medical Cannabis

As medical cannabis is not legal yet, the legal framework remains quite undeveloped as the existing rules have only been set out for the purpose of the ongoing pilot programme.

Following the extension of the programme, legalisation of medical cannabis in France is now expected in 2024. The legal framework is currently being developed, but to date there is still a lack of visibility as to certain fundamental questions, such as regarding:

• rules on cultivation;
• status of medical cannabis products and authorisation thereof; and
• determination of applicable criteria for price fixing and reimbursement.

Consumer Products

The regulation of CBD-based consumer products has been subject to many changes over the past three years. Case law has notably played a major role in the evolution of the applicable regulation. Currently, even if recent case law repealed the provisions prohibiting retail sale to consumers of raw hemp flowers and leaves, the government is expected to modify the ministerial order of 30 December 2021.

However, there is still some lack of clarity as to what the new provisions will be, and whether regulation allows retail sale to consumers of raw hemp flowers and leaves, whatever their form, or whether some restrictions still apply regarding certain categories of products.

Conducting business in an emerging sector, for which the legal and regulatory framework is not entirely developed, necessarily involves risks.

The most common identified risk is that related to THC levels contained in products. Any product containing more than 0.3% of THC, and which is not a cannabis-based medicine holding a marketing authorisation or a cannabis product supplied as part of the pilot programme on therapeutic cannabis, or which has not been authorised for research and development purposes, is considered a narcotic, and any activity related to such product is therefore considered a drug trafficking offence.

In addition, companies distributing hemp-derived products including CBD products to consumers must be aware of the following risks.

• The prohibition of therapeutic claims and the risk of qualification of foodstuffs/food supplements as medicinal products – Therapeutic claims are strictly prohibited for food/dietary supplements as set out in Regulation (EU) 1169/2011 of 25 October 2011 on the provision of food information to consumers. As the line between some product categories (ie, medicinal products, food supplements and foodstuffs) is very slim, making unauthorised health and therapeutic claims in relation to foodstuffs is likely to result in the requalification of the products as medicinal products and entail criminal sanctions.
• The prohibition of sale of a medicinal product without a prior marketing authorisation – A medicinal product (including a medicine by presentation and a functional medicine) can only be placed on the market if it has been granted a marketing authorisation from the French competent health authority, the ANSM or the EMA for human medicines and from the ANMV for veterinary medicines. In the event a food product may be requalified as a medicinal product due to the prohibited therapeutic claims that were made in relation thereto, the selling of a medicinal product without prior marketing authorisation would constitute an offence.
• The illegal practice of pharmacy – Under French law, only pharmacists are allowed to sell medicines. Consequently, operators using therapeutic claims to sell consumer products may face charges for illegal practice of pharmacy should their products be requalified as a medicinal product.
• Incitement to use narcotics – CBD products must not be presented or advertised in a way that could be interpreted as an incitement to use narcotics. In other words, any presentation and/or advertising of a CBD product that is likely to create confusion with recreational cannabis and hence be considered as inciting the consumer to use recreational cannabis is strictly prohibited.
• Breach of the Novel Food Regulation – applicable enforcement and sanctions are discussed in 3.2 Use of Non-controlled Cannabinoids in Food.

Various authorities oversee compliance depending on the category of products concerned. Controls and administrative sanctions are applied by the ANSM for medicines, other health products and cosmetics, while the ANMV is the enforcement authority for veterinary products.

For consumer products, the DGCCRF runs frequent controls to verify compliance with the requirements on claims, presentation and labelling of products as well as to identify any misleading commercial practices in relation to food products, food supplements and even cosmetic products. The DGAL oversees enforcement in the case of any breaches of food safety requirements.

The competent authorities can apply administrative sanctions, such as:

• issuing warnings;
• requiring corrective actions; and
• ordering the withdrawal of non-compliant products from the market.

They can also apply administrative fines to infringing companies.

In addition, several types of criminal penalties can apply. For criminal offences, enforcement is the responsibility of the public prosecutor who can decide to prosecute either following police investigation or upon transfer of a report from the competent authorities mentioned above.

Among the common criminal sanctions that can apply in relation to the cannabis industry, it is worth noting the following:

• drug trafficking can result in sanctions between five years and life in prison (generally subject to a determined period of unconditional imprisonment) and a fine of between EUR75,000 and EUR7.5 million;
• the placing on the market of a medicinal product without having obtained the requested prior marketing authorisation is a criminal offence punishable by up to five years imprisonment and a fine of up to EUR375,000;
• the illegal practice of pharmacy is punishable by up to two years in prison and a fine of up to EUR30,000;
• incitement to use narcotics is punishable by up to five years in prison and a fine of up to EUR75,000, even if the incitement does not result in actual use of recreational cannabis by a consumer; and
• the placing on the market and the distribution of non-compliant products (eg, in breach of requirements relating to product composition, labelling and safety) can result in a fine of up to EUR1,500 multiplied by the number of non-compliant products.

Under French law, the amount of the fine applied to an individual is multiplied by five when applied to companies.

The main cross-border issues concern THC levels. The maximum THC level allowed in France is 0.3%.

Consequently, any product containing THC above this maximum level is considered a narcotic and falls under drug trafficking regulation, except where the product is:

• a cannabis-based medicine holding a marketing authorisation;
• a medical cannabis product duly authorised as part of the pilot programme; or
• a product holding an importation authorisation from the ANSM.

Issues are likely to happen in the case of importation of products manufactured in other EU member states where allowed THC levels are higher than in France (eg, Italy, the Czech Republic), or of those manufactured in non-EU countries such as Switzerland, where consumer products can contain up to 1% of THC.

Other issues may arise in relation to importation of finished products manufactured in non-EU countries where the applicable regulation is different from French and/or EU regulation. In practice, issues have been observed in the market in relation to the composition of some products (eg, cosmetic products containing unauthorised ingredients or ingredients subject to limitations on levels above the maximum authorised levels) or in relation to the labelling of products (eg, those missing mandatory information).

Finally, the use of the wrong tariff codes as part of importation/exportation activities would likely constitute tax fraud.

Operators should therefore be extremely cautious when engaging in importation/exportation activities, in particular between EU and non-EU countries.

Access to medical cannabis remains very limited in France. Indeed, very few cannabis-based medicines holding marketing authorisations are available on the market, and they are only prescribed to a limited number of patients for very specific therapeutic indications.

Medical cannabis (other than cannabis-based medicines holding a marketing authorisation) is only authorised as part of the pilot programme, which has been designed for 3,000 patients. To date, the pilot programme involves approximatively 1,500 patients (ie, half the number initially planned).

In addition, following the decision in March 2023 to extend the pilot programme by one year, some product shortage situations have been reported.

Nevertheless, with legalisation expected to happen in 2024, the legal and regulatory framework is currently being set up. In particular, the following aspects need to be defined and regulated:

• the requirements related to medical cannabis cultivation and processing;
• the definition of medical cannabis product characteristics, including the status of products, pharmaceutical forms, etc;
• product pricing and reimbursement;
• conditions and modalities of prescription and dispensing to patients; and
• distribution channels.

Many questions remain as to what the exact scope of the legal framework related to medical cannabis will be.

France is therefore being watched closely by market players anxious to enter the market once medical cannabis is legalised. In the meantime, most players are trying to navigate the practical and legal uncertainties around expected legalisation.

Broadly speaking, food products can be placed on the market provided they meet the general safety requirements set out by applicable laws and regulations, notably Articles 14 and 15 of Regulation (EC) 178/2002.

The Novel Food Regulation

However, as in other EU member states, cannabinoids (including CBD) and food products containing cannabinoids are considered a novel food as per Regulation (EC) 2015/2283 of 25 November 2015 related to novel food (the “Novel Food Regulation”), and are registered as such in the Novel Food Catalogue.

Novel foods are products for which the history of safe consumption before 1997 has not been demonstrated. These products must therefore obtain an authorisation from the EFSA prior to being placed on the market. The prior authorisation requirement applies both to cannabinoid extracts and to finished products containing cannabinoid extracts as an ingredient, regardless of whether the extract is natural or synthetic.

Consequently, some food products that are derived from the hemp plant (eg, hemp seed oils, hemp seed flour and hemp seeds) are not considered novel food and can legally be placed on the market.

However, hemp extracts and any products to which hemp extracts have been added as an ingredient (eg, hemp seed oil, drinks, waters and chewing gum enriched with CBD) are considered novel food and as such may not be placed on the market until a risk assessment has proved that they are safe for consumption and a novel food authorisation has been granted for CBD or another cannabinoid, as the case may be.

In addition, it should be noted that French Decree No 2006-352 of 20 March 2006 on food supplements expressly prohibits the use of novel food in the manufacturing of food supplements. Consequently, according to this regulation, only hemp seeds can be used in the manufacturing of food supplements (eg, cold-pressed hemp seed oil, grounded hemp seeds).

Enforcement of the Novel Food Regulation in France

In recent years, the enforcement of the Novel Food Regulation regarding CBD has apparently been handled very differently from one member state to another.

More specifically, while some countries’ competent authorities have adopted a clear position on the implementation of the Novel Food Regulation and are taking restrictive measures accordingly, it appears that enforcement in France has remained quite limited, with frequency of controls varying depending on region.

This has resulted in a very large number of CBD food products being placed on the French market. These products can be found at CBD stores, pharmacies and supermarkets.

The quite limited actual enforcement by the competent authorities, combined with the lack of a clear and official position regarding the placing on the market of CBD food products and dietary supplements, has created an insecure environment where operators distribute their products while still being exposed to controls and potential sanctions, notably including:

• products’ withdrawal from the market;
• destruction of products at the cost of a non-compliant company; and
• a fine of up to EUR1,500 per non-compliant product.

Several novel food authorisations have been applied for before the EFSA. However, to date no authorisation has been given for CBD.

Another issue resulting from the lack of regulatory clarity relates to the CBD levels contained in products. While some medicinal products containing high doses of CBD have obtained marketing authorisation, other consumer products available on the French market (and in particular at pharmacies) are also marketed with a very high CBD content, often along with therapeutic claims, and are largely used by consumers for self-medication, which is not without risk for the consumers. To date, there is no legal provision or official position from the competent authorities establishing a maximum level of CBD permitted to be used in consumer products.

With medical cannabis legalisation still under discussion and the regulatory framework still being put in place, further clarifications may be expected as to what threshold should determine qualifying a CBD product as a consumer product or as a medicinal product requiring an authorisation to be placed on the market, hence providing clearer definitions for both categories of product.

While France is often described as Europe’s biggest consumer of cannabis, it also has some of the toughest laws against drugs. Although the conversation regarding whether cannabis should be legalised has arisen several times over the past few years, with lobbying actions being engaged or public consultation launched, cannabis remains a major stigma in France.

To date, there has been no discussion as to whether or not cannabis for recreational purposes should be legalised, and based on the current government’s firm position on narcotics (particularly cannabis), it is very unlikely that any change should be expected until at least the next presidential elections, which will take place in 2027.