Medicinal cannabis: what next for Brazil?

The medicinal use of Cannabis has been reported since 2,900 BC, originally in China, and was introduced into western medicine around 1840 (Grieco, M. Protection and Regulation of the Legal Use of Cannabis—Impact and Opportunities in relation to IP. In: XXXIX International Congress of Intellectual Property of the Brazilian Intellectual Property Association (ABPI). Rio de Janeiro, 2019).

Recently, the increased popularity of Cannabis and the emergence of its therapeutic uses raised concerns regarding the safety of uncontrolled and sometimes unknown use and the potential for abuse.

Three different species of Cannabis have been explored so far: Cannabis sativa, Cannabis indica and Cannabis ruderalis. The difference from one to another relies on their phytocannabinoids content, particularly, to the most known, tetrahydrocannabinol (THC), which is known to be psychoactive, and cannabidiol (CBD), a nonpsychoactive component. Cannabis sativa and Cannabis indica have high grades of THC and low grades of CBD while Cannabis ruderalis has the opposite.

Both phytocannabinoids can mimic human endocannabinoids activity on CB1 and CB2 receptors of human endocannabinoids system and, thus, have potential therapeutic use (Bridgeman, M B, & Abazia, D T (2017). Medicinal Cannabis: History, Pharmacology, And Implications for the Acute Care Setting. P & T: a peer-reviewed journal for formulary management, 42(3), 180–188). Cannabis and cannabinoids are indicated to alleviate symptoms or treat diseases. They are often used as adjunctive treatments to other therapies, as well as on their own only after a patient has failed to respond to traditional treatments.

The effectiveness of cannabinoids has been evidenced from controlled clinical trials for some conditions or diseases, such as, as anti-emetics, for stimulating appetite, for neuropathic pain and spasticity in multiple sclerosis, for palliative cancer care and for intractable childhood epilepsy.

“Currently, in Brazil, there is no regulation in force for the approval of medicinal use of Cannabis”

Other indications are still under evaluation, including, anxiety disorders; such as post-traumatic stress disorder; depressive disorders; sleep disorders; types of chronic pain not included in the clinical trials to date; degenerative neurological conditions; and inflammatory bowel diseases such as Crohn’s disease (European Monitoring Centre for Drugs and Drug Addiction (2018), Medical use of Cannabis and cannabinoids: questions and answers for policymaking, Publications Office of the European Union, Luxembourg).

Medicines combining CBD and THC have received regulatory approvals in Europe and in the US. Currently, in Brazil, there is no regulation in force for the approval of medicinal use of Cannabis. According to the Brazilian Anti-drugs Law, drugs, as well as, planting, cultivating, harvesting and exploiting plants and substrates from which drugs can be extracted and produced, are prohibited within national territory.

However, the planting, cultivation and harvest of said plants in Brazil can be authorised exclusively for medical or scientific use (Fidalgo, CB Protection and Regulation of the Legal Use of Cannabis—Impact and Opportunities in relation to IP. In: XXXIX International Congress of Intellectual Property of ABPI. Rio de Janeiro, 2019).

Nevertheless, despite the lack of regulatory instruments in favour of Cannabis-related medicines, small steps were taken towards regulating the medicinal use of Cannabis in Brazil: