Legalization of cannabis is a recurrent topic in France, which has reached a new milestone under the pressure of the changes underway in other European countries. Many of them, starting with Belgium, the Netherlands, the United Kingdom and Germany, have actually authorized therapeutic cannabis in recent years.
European deputies have also sought to grab hold of the issue. On February 13, 2019 a resolution requested that the European Commission and member states (i) remove the regulatory, financial and cultural barriers which weigh on scientific research into the use of cannabis for medicinal purposes and on research into cannabis in general, (ii) determine the priority areas for research into cannabis for medicinal purposes and (iii) revise their legislation on the use of cannabis-based medicines when scientific research proves that the same positive effect cannot be achieved by using ordinary medicines that do not have addictive effects1.
To date, use of cannabis, or its derivatives, in France remains largely prohibited by the provisions of the Code of Public Health even though rare exceptions exist. The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products, (the ANSM) has, however, recently open the door toward legalization of therapeutic cannabis.
This is an update on the regulations of what is authorized and what is not and what potential changes there will be in the future.
Legislative prohibition of the use of cannabis
For recreational purposes
Pursuant to Article L. 32421-1 of the Code of Public Health, the illicit use of a plant or substance classified as narcotic is punishable by a year’s imprisonment and a fine of EUR 3750. This general provision applies to the use of cannabis which is classified as narcotic. In addition, narcotic users may be sentenced to the completion of a sensitization training related to the danger of narcotics use.
In practice, the consumption of cannabis is rarely punished by a term in prison and a fine whose levels vary between EUR 150 and EUR 450 is generally imposed.
The use of cannabis for recreational purposes is a sensitive debate in France and its legalization does not seem to be on the political agenda of the current government. A parliamentary mission on the subject was announced last July but has not yet been set up.
For therapeutic purposes
The Code of Public Health regulates the use of “poisonous substances and preparations”, including “narcotic substances” such as cannabis2.
To this effect, Article R. 5132-86, I of the Code of Public Health specifically prohibits the: (i) production, (ii) manufacture, (iii) transport, (iv) importation, (v) exportation, (vi) detention, (vii) sale, (viii) transfer, (ix) purchase, or (x) use:
- “of cannabis, plant and resin, products containing it, or those obtained from cannabis, plant or resin.”
- “tetrahydrocannabinols, except for delta 9-tetrahydrocannabinol, and its esters and ethers, salts and the salts of the aforecited derivatives, and products containing them."
Limited exceptions established by legislation
Article R. 5132-86-1 of the Code of Public Health lists the limited exceptions to the prohibition of cannabis and tetrahydrocannabinol principles (THC).
The aforesaid terms of Article R. 5132-86-1 I of the Code of Public Health specify that the use of THC is prohibited except for delta 9-tetrahydrocannabinol (delta 9-THC). This derogation only concerns synthesized delta 9-THC3 to allow the supply of medicines, specifically Marinol®, used to relieve central and peripheral pain or after the failure of first line tricyclic antidepressant, antiepileptic or opioid treatments.
However, the supply of Marinol® is only authorized as part of a Temporary Use Exemption by name (ATUn) . This mechanism allows exceptional use of a pharmaceutical specialty (i) only meant for a single patient and (ii) that is supplied under the responsibility of the prescribing physician who must, in the case of Marinol®, obligatorily practice in a pain center. Supply of Marinol® is therefore very limited.
Research and control
Article R. 5132-86, II subsection 1 of the Code of Public Health establishes that the ANSM Director General can derogate from the prohibition set by Article R. 5132-86, I of the Code of Public Health for purposes of (i) research or control or (ii) manufacture of derivatives.
These derogations issued by the ANSM Director General are not, however, published.
Cannabis without narcotic properties
Article R. 5132-86, II subsection 2 of the Code of Public Health establishes that the (i) culture, (ii) importation, (iii) exportation and, (iv) industrial, and commercial use of cannabis free of narcotic properties may be authorized by Ministerial Decree.
The Decree dated August 22, 1990 (NOR: SPSM9001750A) therefore authorizes the use of various cannabis varieties under the condition that:
- Said varieties be specifically tested, among which are Carmagnola, C.S. or Delta-Llosa4.
- The delta 9 THC assay of cannabis varieties must be less than 0.2 percent and tested as per a specific method based on quantitative determination by gas chromatography after extraction with a suitable solvent.
- Only the seeds and fibers are used. Use of the flowers is therefore prohibited.
This derogation is to allow the use of hemp for industrial and commercial purposes. It specifically allows commercialization of products containing cannabidiol (CBD) used for the manufacture of liquids for electronic cigarettes, cosmetic products, or capsules.
Regularly authorized cannabis-based medicines
Article R. 5132-86, III of the Code of Public Health authorizes the (i) manufacture, (ii) transport, (iii) importation, (iv) exportation, (v) detention, (vi) sale, (vii) purchase or (viii) use of pharmaceutical specialties containing cannabis or THC are authorized as long as these specialties have been granted with a valid marketing authorization (MA).
To date, only Sativex® has held an MA since January 8, 2014 for the treatment of multiple sclerosis in adult patients. Sativex® is not, however, marketed in France due to a lack of agreement between Almirral Pharmaceuticals and the government on the level of reimbursement. The Transparency Commission of the Haute Autorité de la Santé [High Authority on Healthcare] deemed that the medical service was low and that the lack of an improvement of the medical service given by Sativex® could only justify a reimbursement rate of 15 percent of the sales price5.
Resurgence of the debate on therapeutic cannabis
On September 10, 2018, the ANSM implemented a temporary specialized scientific Committee to assess the relevance and feasibility on making therapeutic cannabis available in France (the Committee).
The Committee met several times and progressively defined the ways to authorize the use of therapeutic cannabis. It was thus recommended to put in place a trial phase of cannabis for therapeutic purposes.
The methods of this trial phase were established by the Committee to define:
- The medicines made available, methods of administration, ratios and posology:
- Preparations of cannabis or full spectrum extracts
- Medicines with prolonged effect (in the form of a drinkable solution and oil capsules) or immediate effect (in the form of oil and dried flower for vaporization)
- Five ratios of THC/CBD: THC 1: 1 CBD, THC 1: 20 CBD, THC 1: 50 CBD, THC 5: 20 CBD and THC 20: 1 CBD
- The conditions for prescription and supply:
- Prescriptions only by specialized doctors for: (i) the treatment of pain refractory to accessible therapy (medical or otherwise), (ii) the treatment of some forms of severe and drug-resistant epilepsy, (iii) oncology support care, (iv) palliative situations, and (v) the treatment of multiple sclerosis
- Voluntary participation in a trial
- Obligatory registration in an electronic national register for patient follow-up
- Prior compulsory training for prescribing doctors
- The contraindications and precautions for use: (i) contraindication for pregnant women and (ii) warning for all patients on the ability to drive vehicles and operate machines
- Ways for following-up treated patients: (i) implementation of an electronic national register for patient follow-up and (i) creation of a multidisciplinary scientific committee for evaluating the trial. This trial phase is set up to begin in 2020 and will last two years: (i) six months to initiate it, (ii) six months for patient screening, (iii) six months of patient follow-ups with the issuance of an intermediate report, and (iv) six months of data analysis and the issuance of a report by a multidisciplinary scientific committee
On June 26, 2019, the Committee noted that the issue of reimbursement by the social security department during and after the trial phase was still pending. This will be a central issue for the promotion of therapeutic cannabis.
As a consequence, the draft Social Security Financing Law for 2020 contains a new provision to authorize such experimentation for a period of two years. The implementing provisions regarding: (i) the reimbursement by the State, (ii) the number of patients involved, (iii) the import or supply conditions of the products, (iv) the conditions of prescription by the pharmacist, (v) the follow up of the patients and (vi) the conditions of training of health professionals will be established by subsequent regulatory measures that have not been disclosed yet.
Finally, a report shall be sent to Parliament six months before the end of the trial phase to examine whether the generalization of this experimentation is appropriate and to determine the appropriate reimbursement scheme by the social security department.
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