06
2019
Regulation approved for products derived from Cannabis sativa. And now?
This last Tuesday (03), Anvisa - National Health Surveillance Agency - approved regulation for products derived from sativa cannabis, which is the active ingredient of marijuana, excluding the possibility of plant cultivation in Brazil. The standard also provides that the sale of the product can only be made by means of a prescription.
In the composition of Cannabis sativa there are two most relevant substances: cannabidiol (CBD) and THC (tetrahydrocannabinol). CBD has been associated with an anticonvulsant therapeutic effect, for certain types of epilepsy, according to Resolution No. 2,113/14, of the Federal Council of Medicine. However, other therapeutic indications for the substance still require more in-depth scientific studies to prove them.
The case of THC is different. The substance is mainly responsible for the psychoactive effects of marijuana, and its power to cause chemical dependency, schizophrenia, anxiety attacks and depression has been proven. Impairment of memory and cognitive capacity is also observed.
In Brazil, products derived from Cannabis sativa, as a rule, may contain up to 0.2% THC, according to ANVISA regulations. In this context, effective supervision is essential for patient safety. There are cases like the one in the United Kingdom, where 39% of products were found to contain less than 50% of the amount of CBD described on their labels. Something similar also occurred in the United States, where THC concentrations in such products reached up to 5%, an amount much higher than that allowed in the country, which is also up to 0.3%.
Pursuant to Law No. 9,782/1999, in addition to standardization, it is up to Anvisa to the continuous and effective supervision of these products, in view of the protection of the health of the Brazilian population.
Adriana da Fontoura Alves
Neurologist and Lawyer, she completed a master's degree in Constitutional Law at the Brasiliense Institute of Public Law (IDP), where she teaches the disciplines of Forensic Medicine and Law and Bioethics.