Like many states in the United States that have struggled to set up a medical cannabis program, France is in an ambiguous situation: medical cannabis has been legal since 2013, but no cannabinoid-based drugs are available to patients thanks to inaction by the French National Agency for Drug Safety..
The 2013-473 Decree signed on June 5, 2013 authorizes the issuing of a retail license for medicinal products containing cannabis or cannabis derivatives, in accordance with the directives of the European Parliament.
This law has been enacted to allow the sale of Sativex to patients with MS. Sativex is an oral spray containing natural THC and CBD, produced by GW Pharmaceuticals. It is prescribed to ease the pain commonly associated with Multiple Sclerosis, and is distributed in more than 30 countries, including Germany, the Netherlands, the United Kingdom and Spain for Europe.
In 2014, Sativex received authorization to be sold to patients, but is still not available. Two reasons cited by the French National Agency for Drug Safety are the low number of patients it serves and the drug’s high price tag.
According to the official figures from the High Authority of Health, between 8,000 and 10,000 patients could have been helped with the Sativex, representing only 10 percent of the MS patients in France. Because of this, the Authority recommended a medical reimbursement of 15 percent, leaving the remaining 85 percent of the cost at the expense of the patients, though such drugs are usually reimbursed at least at 80 percent in France.
In addition these recommendations, the National Agency for Drugs, dependent on the Ministry of Health, wanted to negotiate a low price with the distributor of Sativex in France, Almirall.
For comparison, in Germany Sativex is sold around € 330 for a 20-day treatment. For the French market, the French Economic Committee for Health Products asked for a price of € 60, which Almirall did not accept. Since then, negotiations have been deadlocked.
For five years, French patients suffering from multiple sclerosis have been waiting for the arrival of Sativex. The lucky ones manage to acquire Sativex abroad, while those who can not move or can not afford to purchase the drug without a healthcare reimbursement fall back on more traditional medicines, which are not always effective, or to cannabis, which is illegal in France.
Sativex is the only cannabis-based medicine that received authorization to be sold in France. For example, Bedrocan, another European medical cannabis producer, has never had contact with the French government to ship its products to France.
As for CBD, the non-psychoactive cannabis molecule, it is legal in France. CBD shops have been growing strongly since the General Board for Health confirmed CBD e-liquids were legal.
CBD now comes in different forms: oils, balms, sweets, crystals — and most of it is imported. French law prohibits hemp flower production, which significantly reduces the possibility for local CBD extraction.
In addition, doctors are not trained to prescribe CBD. Self-medicating and the exchange of information between patients and associations are the only ways to learn how to use it to alleviate ailments. Some French families have created bridges with individuals in Colorado to learn how to use CBD oil to treat severe epilepsies in children such as Dravet syndrome.
Without the appropriate regulatory framework for CBD and THC-based medicines, French patients are left with few options to treat their approved conditions with medical cannabis.