BRAZIL Trends and Developments Contributed by: Eduardo Hallak, Juliana Neves, Isabella Bonisolo and Juliana Castelo Branco, Licks Attorneys
corresponds to the act of processing the appli - cation prohibited by the RDPL, leading to unfair advantage on the part of the applicant and vio - lating the principle of equality. In a fair competi - tive environment, third parties would not be in a privileged position compared to others who wait for the expiration of the regulatory data protec - tion period before submitting their applications. Accepting the early submission of applications gives those applicants an advantage, which is unfair competition practice. In a similar case, in 2024, the Seventh Federal Court of the Federal District rendered a pre - liminary injunction on the same grounds and with reference to the above TRF-1 decision. The trial court decision ordered MAPA, Anvisa and IBAMA to refrain from processing, analys - ing and/or approving any formulated and/or equivalent technical product applications that referred to the regulatory data of the reference molecule under regulatory data protection. The order applies to registration requests pending in the analysis queues, as well as those submit - ted before the expiration of the regulatory data protection. The final decisions on the merits of these cases are expected in 2025. Superior Court of Justice Validates Medicinal Cultivation of Cannabis by Companies In November 2024, the First Section of the STJ ruled it legally possible to grant sanitary authori - sation for the planting, cultivation and commer - cialisation of industrial hemp – a type of Can - nabis sativa with a tetrahydrocannabinol (THC) content of less than 0.3% – by legal entities, for exclusively medicinal and pharmaceutical pur - poses (Case REsp # 2024250/PR). The STJ highlighted that the cultivation must follow regulations – to be written in six months, by Anvisa and the federal government. With this
ruling, the court issued a precedent that must be observed by all Brazilian trial courts and appel - late courts. As industrial hemp has a low THC content, there are no psychoactive effects, making it different from marijuana and other variations of cannabis used for drug production. As a result, industrial hemp is not subject to the prohibitions in the Law # 11.343/2006 and can be cultivated in Bra - zil, as ruled by the STJ. The rapporteur also explained that this ruling does not encompass the possibility of importa - tion or cultivation of industrial hemp by individu - als, nor does it discuss uses of the product other than medicinal and pharmaceutical applications. Although Brazil currently authorises the use and commercialisation of cannabis-based medi - cines, the national production of the elements necessary for their preparation is prohibited. Decisions Regarding the Supply of High-Cost Medicines by the Government In 2024, the STF ruled on new guidelines for the judicial provision of drugs by the government, editing Topic # 6 and Topic # 1,234. Topic # 6 (RE # 566,471) This has been under discussion since 2020. The STF decided that the government is not obliged to provide high-cost medicines requested in court, when they are not provided for in the list of the SUS Exceptional Drug Dispensation Pro - gramme, nor registered with Anvisa. Currently, the criteria for exceptions are under discussion before the STF, for circumstances in which the state may be required to provide high-cost medicines not available in the system, provided that the following are verified:
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