BRAZIL Trends and Developments Contributed by: Eduardo Hallak, Juliana Neves, Isabella Bonisolo and Juliana Castelo Branco, Licks Attorneys
• the scarcity of resources and efficiency of public policies; • the equal access to health and respect for technical and technical expertise; and
ing the performance of the judiciary in this mat - ter. This topic is relevant to the life sciences and pharma industry in relation to market dynamics, strategic planning of pharmaceutical companies, pricing strategies, reimbursement policies and potential alterations to the regulatory landscape. Battling Counterfeit Seeds in Brazil: an Ongoing Struggle in the Agricultural Sector As Brazilian agribusiness exports break records every year, the country faces a serious problem regarding seed counterfeiting. The agribusiness sector estimates that 30% of the seeds on the market are of unknown and illegal origin, putting the economy at significant risk. This is particu - larly concerning for those investing in cultivars and genetic improvement of seeds, protected by patents. As there are no criminal provisions in the Plant Varieties Law (Law # 9,456/1997), all actions against counterfeiters related to cultivars have only civil implications. As an example of actions in this area, CropLife Brazil, a non-profit civil association that repre - sents R&D companies in the sectors of germ - plasm, biotechnology, agrichemical and bio inputs, has been leading an investigation and litigation project against soybean seed coun - terfeiters, which has resulted in significant out - comes. For example, in 2024, CropLife was able to seize over 1.488 million kilograms of illegal seeds, thereby preventing the return of what is estimated to be more than BRL8 million’s worth of illegal seeds to the Brazilian market. Class Action Filed by ABPI Regarding the BPTO’s Funds and Efficiency The Class Action filed by the Brazilian Associa - tion of Intellectual Property ( Associação Bra- sileira da Propriedade Intelectual , or ABPI) that
• the evidence-based medicine. Topic # 1,234 (RE # 1,366,243)
The STF decided that claims related to drugs not incorporated into SUS public policy are within the jurisdiction of the federal courts, when the value of the specific annual treatment of the drug or active ingredient is equal to or greater than the value of 210 minimum wages (currently approxi - mately BRL300,000 or USD50,000). Non-incorporated drugs are those that are: • not included in SUS lists; • provided for in official clinical protocols for other purposes; • not registered with Anvisa; and • used off-label without a clinical protocol, or not part of lists of the basic component. A special commission was created for debates with representatives of federative entities and civil society, culminating in the ratification by the STF of agreements signed between the federal government, the states, the federal district and the municipalities. These agreements include the competence of the federal courts to judge cases that deal with the supply of medicines not incor - porated by the SUS, as well as the reimburse - ment to be made by the federal government to satisfy such demands. The STF also determined the need to create a national platform to gather data on every lawsuit in which plaintiffs seek the supply of drugs, and to facilitate the management and monitoring of responsibilities between the federal government, states and municipalities, in addition to improv -
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