Brasil se une à Colômbia e Uruguai na regulamentação da Cannabis Medicinal
The Brazilian Health Regulatory Agency, Anvisa, has approved the sale of THC and CBD products at drugstores, enabling consumers to obtain cannabis-derived products.
Brazil has become the third country in Latin America to regulate medical marijuana, joining Uruguay and Colombia (https://www.npr.org/2019/09/07/757292830/colombia-is-turning-into-a-majormedical-marijuana-producer) to allow more consumers to obtain cannabisderived products. The Brazilian Health Regulatory Agency, Anvisa, on Tuesday unanimously approved the sale of THC and CBD products at drugstores across the country of 210 million inhabitants. The decree is to take effect in about 90 days, with products expected to hit store shelves in early 2020.
The Anvisa ruling does not authorize commercial cultivation of cannabis. Within hours of the announcement, however, a Brazilian judge granted Schoenmaker Humako Agri-Floriculture, part of the Terra Viva group, the right to import and grow industrial hemp seeds with THC concentration below 0.3%. Denver-based Hoban Law Group advised Schoenmaker Humako on its petition. The 60-year-old company, which was founded by a Dutch couple in the city of Holambra, in the state of São Paulo, is a major Brazilian flower and potato producer. Now it wants to plant hemp to produce fiber, food and especially medicines.
Bob Hoban, founding partner at Hoban Law Group, called Brazil’s steps toward domestic cannabis distribution “extremely significant,” saying this week’s approval by the national health care agency represents a major advancement in the early stages of Latin American cannabis policy. Latin American nations have been at the forefront of the movement to enact legislation, regulation and policies aimed at providing pieces of the international supply chain for cannabis, Hoban noted. Mexico is also in the midst of drafting legislation for legal cannabis. (https://www.law.com/legalweek/2019/09/09/mexico-moves-toward-the-legalization-of-cannabis/) Yet Hoban says countries like Brazil could go further. “With so much competition in this nascent industry, it is essential that new markets also supply cannabis domestically. This is not something that we have seen by way of policy in many of the Latin American nations,” Hoban said.
The conservative government of Brazilian President Jair Bolsonaro worries that greater flexibility for cannabis, and in particular facilities for planting, could lead to an increase in recreational use of the plant.
This week’s regulatory ruling represents “part of a slow change of mind-set” for the conservative government, said Isabela Amorim Diniz Ferreira, a corporate lawyer with expertise in regulatory matters at Farroco Abreu Advogados in the city of São Paulo. Farroco Abreu Advogados is one of a handful of Brazilian law firms that has taken a deep dive into the burgeoning cannabis sector to advise Brazilian entrepreneurs on regulatory and other matters related to the business. According to Amorim Diniz Ferreira, the law firm has also been fielding calls from international cannabis companies that are looking to do business in Brazil.
Market intelligence firm New Frontier Data (https://blog.newfrontierdata.com/topic/brazil) puts the annual value of the medicinal cannabis market in Brazil at $1.4 billion, based on estimates that millions of Brazilians suffer from chronic pain. Still, the stipulation that Brazilian companies import expensive raw materials to produce these medicines could put the remedies out of reach for many in Brazil, where the per-capita annual income is $8,920. (https://data.worldbank.org/indicator/NY.GDP.PCAP.CD?locations=BR)
A bill is currently being discussed in the Brazilian Congress to amend the country’s anti-drug law. Amorim Diniz Ferreira expects this bill to now include the possibility of planting, cultivating and harvesting cannabis domestically. Brazil has the potential to become a cannabis-producing powerhouse, she says, as it’s already a major supplier of agricultural goods on the world stage. Anvisa has gradually eased restrictions on cannabis. In 2015, the regulator allowed imports of Cannabidiol-based products for health care. Two years later, it included cannabis sativa in its list of medicinal plants. According to agency data, more than 9,000 authorizations were granted to import medicines made from cannabis extract between 2015 and 2019.
This week’s Anvisa decision to regulate cannabis followed a host of recent court rulings in Brazil favoring medical marijuana use. A Brazilian court authorized the parents of an autistic child with severe epileptic seizures to grow cannabis, while in another case, a stomach cancer patient was also granted an exemption. More than 50 Brazilians have been authorized by local courts to produce their own cannabis oil for medicinal use.
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