In the 1970s, drug consumption in Brazil became more visible; cannabis, cocaine, and hallucinogens were the main drugs circulating at the time. In 1976 the law 6368, also known as the Narcotics Law, was approved. The law not only prohibited, but also criminalized the recreational and medicinal use of cannabis products.
In 2006 the drug legislation changed, giving birth to the current regulations concerning drugs in Brazil. Law 11343/06 still prohibits transporting, selling, and trafficking cannabis; Article 33 of the Law imposes a penalty of 5 to 15 years of imprisonment for the import, export, transport, production, purchase, sale, storage, or prescription of drugs or their raw materials. The same punishment applies to anyone who sows, cultivates, or harvests plants that constitute raw material, input, or chemical used for the preparation of drugs.
One of the main changes in the 2006 law was that it decriminalized personal consumption. It provides that whoever “acquires, keeps, stores, transports, or carries for personal use drugs without authorization” will receive only socio-educational measures. Furthermore, the legislation created exceptions for medical and scientific cultivation of cannabis, as is seen in Article 2, Sole Paragraph, and in Article 31 respectively:
The Federal Government may authorize the planting, cultivation, and harvesting of the plants referred to in the main clause herein only for medical or scientific purposes, in a predetermined place and time, by means of inspection, subject to the above-mentioned provisos,” and
- one must obtain prior authorization by the competent authority to produce, extract, manufacture, process, prepare, hold, store, import, export, re-export, ship, transport, display, offer, sell, buy, exchange, assign or acquire, for any purpose, drugs or raw material intended for preparation thereof.
In other words, the legislation created exceptions for the use and cultivation of cannabis on a case-by-case basis. Since then, other regulations were written to clarify and guide the population regarding the use of the plant. For example, the therapeutic medicinal use of cannabis was first approved by Brazil’s National Sanitary Vigilance Agency (ANVISA) in 2015; ANVISA allowed the prescription of medicines having CBD and THC to be imported by means of exceptional authorization. Metavyl, which is the same as Sativex, a medicine compromised of both THC and CBD, was approved by the agency in 2017.
Cannabis, however, remains listed as a plant that cannot be cultivated, harvested, exploited, imported, exported, traded, extracted, handled, or used in Brazil. Because of that, patients have to go through a long and expensive process to obtain medicine. In addition to a doctor’s prescription, patients must meet certain regulatory requirements, set out by ANVISA. They also must complete a medical report, justifying their use of the drug. Once authorized, the patient is allowed to purchase the medicine.
To facilitate and lower the costs for those patients, ANVISA published Resolution RDC No. 327 on 9 December 2019 (‘RDC 327 of 2019’) to regulate the manufacturing, importation, commercialization, prescription, dispensation, monitoring, and inspection of a new category of products named ‘Cannabis Products’. Brazilian companies, now, are allowed to produce ‘Cannabis Products’, if they follow the agency's new regulation for clearance. The products that are allowed to be commercialized must be predominantly CBD, containing less than 0.2% of THC. Yet, products with more than 0.2% of THC can be commercialized only for patients that have no other therapeutic alternatives and are in irreversible or terminal clinical situations. Since, the Resolution did not legalize the cultivation of cannabis, companies must import the pharmaceutical input in the form of plant derivative, phytopharmaceutical, in bulk, or industrialized product, prohibiting the import of the plant or parts of it.
Attorneys, on the other hand, have found another solution to minimize the costs for patients and to allow them to cultivate the plant. They are using habeas corpus (HC), a constitutional action which goal is to guarantee the individuals' right of freedom when threatened or in any way restricted. In this case, people are filing HC to domestically cultivate cannabis for medical use. HC guarantees freedom of the patient to plant and guarantees the preservation of its cultivation in case of any police action. Courts are slowly being more accepting and granting HC for patients, however, it is still analyzed on a case-by-case basis.
Brazil has a long way to go for cannabis legalization, but it is walking toward the 21st century of medical cannabis regulations. In June of 2021, a special committee of the Brazilian Chamber of Deputies passed a bill that would enable cannabis cultivation for medicinal, veterinary, scientific, and industrial use. If approved the bill will legalize cannabis cultivation only by companies, patient associations, and NGOs; individual cultivation would still be illegal. The bill must still be approved by the upper house to take effect; nonetheless, it was great a step towards cannabis legalization.