The French government has issued a long-awaited decree detailing how a limited medical cannabis experiment will be conducted.
The first prescriptions should now take place in March 2021.
It has also been confirmed that up to 3,000 patients have been selected and 700 of them suffer from chronic pain. It is important to know that chronic pain affects 5% of the population. This clinical trial is important to them. If the results are conclusive, these new drugs mixing THC and CBD will relieve them on a daily basis.
The experience will be time-limited - two years from the first prescription.
The first results of the clinical trial expected after 6 months
The decree also determined that the Ministry of Health and Solidarity is responsible for the execution of the project. The Minister, with the advice of the Director General of the French Agency for the Safety of Medicines and Health Products (ANSM), will decide:
The characteristics, composition, pharmaceutical form and technical specifications of medicinal cannabis products.
the pharmaceutical form
the medical cannabis during the experimentation will be presented either in the form of flowers, oils and capsules, full spectrum extracts
Flowers for vaporization inhalation will be part of the experience, as well as extracts - capsules or oils - with different THC and CBD ratios.
- - forms with immediate effect: provision of sublingual and inhaled forms (oil and dried flowers for vaporization, etc.)
- - long-acting forms: provision of oral forms (oral solution and oil capsules, etc.)
Spraying is the only acceptable route of administration for flowers.
CBD/THC ratio
provision of the following 5 THC/CBD ratios: THC 1: 1 CBD, THC 1: 20 CBD, THC 1: 50 CBD, THC 5: 20 CBD and THC 20: 1 CBD
dose adjustment by titration by the doctor until the minimum effective dose is obtained and/or undesirable effects tolerable by the patient.
Only patients with the following qualifying conditions will be eligible to participate in the trial
- Refractory neuropathic pain.
- Some forms of drug-resistant epilepsy
- Certain intractable oncology symptoms related to cancer or cancer treatment. (such as nausea, vomiting, anorexia…)
- Palliative situations.
- Painful spasticity due to multiple sclerosis or other pathologies of the central nervous system.
Contraindications and precautions for use
- Contraindication in pregnant and breastfeeding women
- effective contraception for women of childbearing age
- a warning about fitness to drive and use machines
- Prescription possible regardless of age if the benefit is considered favorable given the severity of the disease.
Patient Monitoring and Adverse Reaction Assessment
- Creation of the national electronic register for the follow-up of patients treated with cannabis for therapeutic purposes
- Collection and analysis of registry data, including adverse effects and initial medical cannabis efficacy data
- The primary purpose of the patient follow-up register will be to assess the experience.
Frequently Asked Questions About Experimenting With Medical Cannabis
How to be included in the experience? who should I contact?
Inclusion is only carried out by the hospital services (reference structures) which supervise one of the 5 indications selected for the experiment. The list of these structures is being finalized and published by the ANSM.
If you are not followed in one of these structures, you will have to contact your general practitioner or the specialist following you so that he can direct you to a listed reference structure.
Can I be monitored by my doctor during the experience?
After being involved in the experimentation through a referral structure, your doctor can take charge of your follow-up care, provided that he has completed the preparatory and compulsory training for the prescription of medical cannabis.
How do I get my medical cannabis prescription?
Like all narcotics, medical cannabis is prescribed on a secure prescription that does not need to be refilled for more than 28 days.
The prescription must be presented to the pharmacy of the hospital where the prescription was issued or to the pharmacy of the city of your choice. The pharmacist must also be trained in the distribution of cannabis for medical use.
What data is collected during the experiment?
Inclusion in the experiment involves the collection of personal data in a national electronic surveillance registry. The purpose of this register is to evaluate the prescription and dispensing cycle and to collect the first French data on the efficacy and safety of the use of cannabis in a medical environment.
Your personal information is protected and will not be published.
It is currently being drafted by the ANSM and its implementation is subject to the approval of the CNIL (Commission Nationale de l'Informatique et des Libertés).
What are the precautions for use?
Cannabis and THC, one of its active ingredients, are narcotics.
Cannabis can significantly affect alertness. It is also potentially addictive and can lead to addiction (a physiological phenomenon that requires increasing the dose regularly to achieve the same effect).
In addition, cannabis is contraindicated for medicinal purposes as a precautionary measure for pregnant and breastfeeding women. The prescribing doctor will require effective contraception for women of childbearing age during the first consultation.
A collection and analysis of adverse events for all patients followed in the experiment is planned. Adverse effects are analyzed by the networks of CRPV (Regional Centers for Pharmacovigilance) and CEIP (Centres for Evaluation and Information on Pharmacodependence - Addictovigilance - Centers for Evaluation and Information on Pharmacodependence - Addictovigilance ).
source :
https://www.ansm.sante.fr/Dossiers/Cannabis-a-usage-medical/Appel-a-candidatures-fourniture-et-distribution-de-medicaments-a-base-de-cannabis-pour-l- experiment/(offset)/0
