Brazil: Market and legal data analysis of the cannabis sector

13th December 2024: Brazil: The Attorney General’s Office (AGU) has filed an appeal with the Superior Court of Justice with a request to extend the deadline of six months for the regulation of the import of seeds, cultivation, industrialisation and commercialisation of cannabis plants of up to 0.3% THC for medical, pharmaceutical or industrial purposes. In November 2024, the Superior Court of Justice gave the National Health Surveillance Agency (Anvisa) and the federal government six months to issue regulations on the matter. According to the AGU, the regulations are a significant regulatory challenge that requires coordination and political-administrative alignment between several government agencies, which require a longer period to ensure a cohesive, comprehensive and technical approach.
29th November 2024: Brazil: The National Public Health Surveillance Agency (Anvisa) has updated its 2024-2025 regulatory agenda. The agenda includes, among other items, a review of the regulation of cannabis products for medical purposes (RDC 327/2019). According to the document, the aim is to “enable safe access to essential products and services for the health of the population”. No more details of the update were provided.
14th November 2024: Brazil: The Superior Court of Justice has unanimously decided to authorise the import of seeds, cultivation, industrialisation and commercialisation of cannabis plants of up to 0.3% THC for medical, pharmaceutical or industrial purposes, press reports. The decision is binding, and the National Health Surveillance Agency (Anvisa) and the federal government have six months to issue regulations. Hemp is currently prohibited in Brazil.
12th November 2024: Brazil: The Supreme Court will decide whether the National Health Surveillance Agency (Anvisa) exceeded its powers when it banned the sale of medical cannabis-based products in compounding pharmacies by creating a distinction between compounding and non-compounding pharmacies not provided by law. An Anvisa decision stipulated that sales could only take place in non-compounding pharmacies and drugstores, as it is a psychotropic substance subjected to special control. The process has yet to be defined.
31st October 2024: Brazil: The National Health Surveillance Agency (Anvisa) board of directors has approved the prescription of cannabis-based products for veterinary use. Qualified veterinarians can prescribe registered products, products with an Anvisa health authorisation and products for exclusive animal use regulated by the Ministry of Agriculture. Products will require a special prescription.
27th June 2024: Brazil: Following the Federal Supreme Court's decision to decriminalise cannabis possession, the judges have decided that a person possessing or storing 40 g of cannabis or six female plants will be presumed to be a cannabis user until the National Congress legislates on the matter. The decision states that the presumption of possession or storage is relative, meaning that, depending on the situation, it will be up to the police to decide whether the situation qualifies as drug trafficking.
26th June 2024: Brazil: The Federal Supreme Court has resumed its deliberations on the decriminalisation of cannabis possession. One judge, who was undecided last week, added to his vote by saying that his vote was “clear that no user of any drug can be criminalised”, forming a majority for decriminalisation of possession. The judges will now have to define the criteria for distinguishing users from dealers. The president of the court signalled that there could be a consensus among the judges at an average of 40 g.
21st June 2024: Brazil: The Federal Supreme Court has resumed its deliberations on the decriminalisation of cannabis possession. One more judge has voted, but his vote was not decisive. He did not give his opinion on the decriminalisation of possession and said the sanctions foreseen in the law are not criminal but administrative. The result, therefore, is still 5 judges in favour and 3 against, out of a total of 11 judges. The hearing is scheduled to resume on 25th June. The case has been before the court since 2011.
13th June 2024: Brazil: Following the Senate’s approval, the Chamber of Deputies’ Constitution and Justice Committee approved a constitutional amendment that would make possession of cannabis and other drugs a crime, regardless of the amount. The amendment will now go through another commission before going to the Chamber of Deputies’ plenary.
3rd June 2024: Brazil: João Paulo Perfeito, manager of medicines and herbal medicines at the National Health Surveillance Agency (Anvisa), said during an event that the review of resolution 327 – which allows the marketing, prescription and selling of cannabis products for medical purposes – will maintain the same regulatory scenario as in 2019. This means the expansion of the pathologies and the variety of available medicines with a THC limit of more than 0.2% will not happen. “Despite the progress made in recent years, the 2019 scenario remains, indicating a situation of scientific evidence confirming limited efficacy for a large number of clinical conditions,” Perfeito said.
16th May 2024: Brazil: The National Health Surveillance Agency (Anvisa) has approved the Regulatory Impact Analysis Report on medical cannabis products. The report supports the maintenance of the current authorisation method set in Resolution of the Collective Board (RDC) 327/2019 for medical products and identifies improvements to the regulation. These improvements include the development of measures to expand access to medical products in terms of cost, quality and availability. The next steps in the review of RDC 327/2019 are yet to be determined, but at this stage there are no proposed changes to the regulation.
17th April 2024: Brazil: The Senate’s plenary has approved an amendment to the Constitution that would declare possession of cannabis and other drugs a crime, regardless of the amount. In the first round of voting, the score was 53 votes in favour and 9 against, and in the second, 52 votes in favour and 9 against. The amendment will now go to the Chamber of Deputies for discussion.

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