By, Aurelien Bernard
France has created a governmental scientific committee comprising experts in neurology, sociology, pain management, HIV/AIDS, and public drug policies to evaluate whether medical cannabis should be available.
This panel, the Temporary Scientific Specialist Committee (CSST), is charged with determining whether to approve medical cannabis, and if approved, to draft a regulatory framework.
France legalized medical cannabis in 2013, but has not released any cannabis-based drug yet. Sativex, an oral spray composed of a 1-to-1 ratio of THC-to-CBD and recommended for spasticity in multiple sclerosis (MS) patients, has been blocked from pharmacies’ shelves because of a cost dispute between the French health minister and Almirall, the pharmaceutical laboratory that makes Sativex.
According to what has been done in existing medical cannabis markets in Canada, Germany, and Uruguay, various models are possible, but not so many if the peculiarities of the French mindset are taken into consideration.
Options on the Table
The most restrictive option would be to allow the sole pharmaceutical groups to use and distribute cannabis under galenical, or natural, medicinal forms. The medical cannabis would be grown by producers under licenses, and the manufacturing of drugs would be done by pharmaceutical laboratories. THC and CBD would be equally controlled substances, and cannabis-based drugs would be distributed by pharmacies with a prescription from a specialist.
For many socioeconomic issues, France follows Germany as an example. Concerning its model of regulation of medical cannabis, France could authorize the prescription of dried cannabis flowers, as well as pharmaceutical drugs. Initially, flower could be imported from Germany, the Netherlands, or Canada, until the country adopts a national medical cannabis production system.
The cannabis producers would ask for licenses from a regulation bureau to be determined, as would manufacturers and authorized distributors. The retailers would still be pharmacies, which will deliver cannabis by prescription. As it is the case in Germany, medical cannabis could be reimbursed through national health insurance.
Self-Cultivation, Private Companies and Pharmacies
The least restrictive regulation would allow access for medical cannabis in pharmacies and private shops, as is the case in some Canadian provinces such as British Columbia. Patients would also be allowed to grow their own cannabis, with a limited number of plants.
The access to medical cannabis would still require a doctor’s prescription, to limit black-market cannabis or bogus prescriptions — as had plagued California before the November 2016 passage of Proposition 64.
Use of medical cannabis would be possible only at private facilities or in authorized public places such as schools, universities, or workplaces, as long as they are in the form of a spray, pill, or oil.
For France’s Consideration
Whatever the conclusions of the CSST will be, some guidelines can be drawn from other models in use outside of France:
- A national regulatory agency should be created to regulate the distribution of licenses at each step of the supply chain — production, manufacturing, distribution, and retail — as well as how medical cannabis is prescribed.
- The interests of the patients should be held above all else. The price of a medication could be restrictive, as some forms of medical cannabis like Sativex have proven to be.
- The process of prescribing should be as clear and simple for doctors and patients to avoid pitfalls that Germany has experienced, such as the difficulty of obtaining prescriptions or finding stock available in pharmacies.
- Access should be immediate, as patients should not have to bear the burden of waiting.
- A national-level production regime, for French consumption or the international export market, could diminish the cost of the medication and create jobs.
- Patients should be allowed to cultivate their own plants to ease access to medicine without resorting to the black market.
Observers won’t know if France will follow the best practices of various pre-existing models or create its own regulatory structure until the CSST releases its conclusions before the end of 2018.