Cannabis. Where are we and where are we going ?, Edison, 30 april 2019

Where are we and where are we going ?

Bilan sur les statuts du cannabis dans le monde
Le groupe Edison a publié une revue sur le statut du cannabis dans le monde. Où sommes-nous et où allons-nous?


EDISON Healthcare, 30 April 2019

The cannabis sector is relatively broad, spanning FDA-approved drugs toconsumer products. Both markets are still at a fraction of their potential peak sizes due to laws forbidding the use of cannabis and also regulatory hesitance to approve drugs with related active ingredients. Worldwide sales for all regulator-approved cannabinoid therapeutics were only $53m in 2018 while the total legal cannabis market in the United States was only around $8bn in 2017 compared to $234bn in sales for the alcoholic beverage industry. However, things are changing, mainly due to two reasons: legalization is popular with voters and politicians recognize that the tax revenue that could be extracted through sales taxes/VAT could fill budgetary holes.

The tide has turned in North America
Despite a relatively benign safety profile even compared to alcohol, cannabis use has been broadly banned historically, even for medical use. This is all changing. Canada became the first major western country to legalize medical and recreational cannabis in 2018. In the United States, 10 states have legalized recreational cannabis and 33 states have legalized medical cannabis (though it remains illegal on a federal level). Additional states, such as New Jersey and New York, are expected to follow shortly. More importantly, several prominent Democratic presidential candidates have endorsed removing cannabis from the Schedule of Controlled Substances.

Epidiolex leading the way
Prior to 2018, the FDA had only approved three cannabinoid products (with two of them based on the same active ingredient, dronabinol) with all of them being synthetic compounds. Then in June 2018, the FDA approved Epidiolex (cannabidiol, CBD) from GW Pharma for the treatment of certain rare epilepsies. Consensus estimates expect sales of $1.7bn in 2024, which would make it the largest cannabis-related FDA approved drug in history (it is also the first plantbased cannabinoid to gain approval).

Europe moving toward liberalization, slowly
Europe has been slower than North America to reform its cannabis laws, as no European countries have fully legalized recreational cannabis. The Netherlands and Spain are the most liberal, with personal recreational use allowed in some areas (though the Netherlands has legalized medical cannabis while Spain has only legalized cannabis-derived drugs). The other large economies in Europe have been
moving in that direction as well. Since 2017, medical use in seriously ill patients is legal in Germany. Medical cannabis was allowed in France in 2013 and penalties for possession were reduced to a €200 fine in 2018. In Italy, the medicinal use of cannabis was legalized in 2013, while possession of small amounts has effectively been decriminalized. The UK legalized the medical use of cannabis in November
2018, though recreational legalization efforts are stymied by the fact that the Liberal Democrats are the only major party coming out in support of it.

It’s not just hype, it’s real
Cannabis is thought to be one of the oldest plants cultivated by humans with multiple medicinal uses (including problems with the eyes, gynecological disorders as well as to fight inflammation) documented in Ancient Egyptian texts. In all, cannabis was used to treat a wide variety of different indications, including pain, spasticity, cancer, epilepsy, nausea, anorexia and infectious disease.1 In the 1800s and early 1900s, cannabis was included in certain patent medicines and elixirs for a variety of indications though with little evidence to back up claims. Regulation in the US started with the Pure Food and Drug Act of 1906 (which also led to the creation of the FDA) and continued with numerous state laws until the possession and transfer of cannabis, outside of medical and industrial use, was made illegal by the Marihuana Tax Act of 1937. The modern regime for the regulation of cannabis was born in 1970 with the passage of the Controlled Substances Act, which assigned cannabis a Schedule I classification and prohibited all uses, even medical ones. Regulation outside of the United States had a similar progression with generally broad illegality by the early 1970s.