IN FOCUS
Regulatory
AI in medicine
CFM establishes a new governance framework
On February 27, 2026, the Federal Council of Medicine (CFM) published Resolution No. 2,454/2026, establishing unprecedented guidelines for the use of artificial intelligence (AI) tools in medical practice.
Scheduled to enter into force on August 26, 2026, the resolution consolidates ethical standards, reinforces the centrality of physicians’ clinical decision-making, and requires transparency toward patients whenever AI is used as a relevant support tool.
In practice, the regulation raises governance standards for AI use, driving adjustments in care workflows, patient communication, and internal adoption criteria, while reducing regulatory grey areas and increasing predictability for responsible digital health innovation.
Fertilizers
Decree aligns inspection with the Self-Control Law
On February 25, 2026, Decree No. 12,858/2026 was published, updating the regulations under the Fertilizers Law (Law No. 6,894/1980) and redefining inspection and oversight rules across the fertilizers and agricultural inputs supply chain.
The decree aligns the regulatory framework with the Self-Control Law (Law No. 14,515/2022) and details administrative sanctions enforced by the Agricultural Defense Secretariat of MAPA, including precautionary measures, classification of violations, and penalties.
Operationally, the decree reorganizes inspection procedures, increasing compliance and documentation requirements for manufacturers, importers, and other market participants, while providing authorities with clearer tools for rapid response to risks and irregularities.
Supplementary healthcare
ANS updates Health Regions
On February 27, 2026, ANS issued Normative Resolution No. 665/2026, redefining the Health Regions used as references for mandatory coverage under private health plans.
The resolution revokes and replaces Normative Instruction No. 16/2022 and updates territorial criteria to reflect regionalization models adopted by the Ministry of Health and state authorities.
The changes affect how coverage compliance is assessed and how provider networks are structured, with impacts on planning, credentialing, and service availability management by insurers.
Clinical research
Ministry of Health opens consultation on new national platform
The Ministry of Health launched an electronic form to collect contributions for the development of a new national platform for research involving human subjects, which will replace the Plataforma Brasil.
The initiative seeks to expand social participation and modernize submission, monitoring, and ethical review workflows, in alignment with the Human Research Law (Law No. 14,874/2024), recently regulated by Decree No. 12,651/2025.
The contributions will support a modular, collaborative platform design, representing a relevant opportunity to influence operational aspects and mitigate transition risks.
Intellectual Property
INPI
Federal Court recognizes structural deficiencies
The 1st Panel of the Federal Regional Court of the 2nd Region (TRF-2) upheld a lower court decision recognizing structural deficiencies at the Brazilian Patent and Trademark Office (INPI), including excessive backlog, limited budget, and insufficient staffing.
The court ordered INPI to prepare a detailed reorganization plan, after which the Federal Government must allocate the necessary resources. A request to automatically allocate all INPI revenues to the agency was denied. Appeals remain possible.
“Pipeline” patents
Supreme Court closes abstract review
Before the current Industrial Property Law (Law No. 9,279/1996), Brazil did not grant patents for certain chemical and pharmaceutical inventions. A transitional regime allowed so-called “pipeline patents” to be filed until 1997, based on corresponding foreign patents.
The constitutionality of this mechanism was challenged before the Supreme Federal Court (STF), arguing lack of substantive examination and exceptions to the novelty requirement. The Court ultimately declined to rule on the merits, closing the discussion under abstract judicial review.
Seventeen years after the action was filed, Brazil’s Supreme Federal Court (STF) unanimously dismissed the case as moot. According to the reporting justice, Justice Cármen Lúcia, the maximum 20‑year term for these patents, as provided under the Industrial Property Law, expired in 2017, thereby rendering the claim devoid of subject matter. Any remaining practical effects or financial impacts must be addressed in specific proceedings, rather than through abstract constitutional review.
Litigation
Oncology medicines
Supreme Court approves agreement and sets reimbursement and jurisdiction rules
The approval by Brazil’s Supreme Federal Court (STF) of the agreement entered into by the Federal Government, states, and municipalities marks a turning point in the debate over reimbursement of the costs of oncology medicines. By endorsing the agreement, the Court maintained the 80% reimbursement rate by the Federal Government for amounts incurred by states and municipalities in litigation involving cancer treatments and updated the precedent established under Topic No. 1,234, which governs the judicialization of access to medicines under Brazil’s public healthcare system (SUS). The objective is to reduce administrative bottlenecks and enhance legal certainty for federative entities amid the growing volume of such claims.
The agreement also reorganizes jurisdiction for adjudicating these cases, based on which entity is responsible for procuring the medicine within the SUS. When procurement is centralized by the Federal Government (Group 1A), cases must be heard by the Federal Courts. When procurement results from national negotiations or decentralized purchases by states and municipalities (Group 1B), cases fall under the jurisdiction of the State Courts. For oncology medicines not incorporated into the SUS, the value-based criterion remains applicable: cases involving treatments exceeding 210 minimum wages per year are subject to Federal Court jurisdiction.
To avoid abrupt changes affecting thousands of ongoing cases, the STF determined that these new rules apply only to actions filed as of October 22, 2025, the date on which the ordinance reorganizing Brazil’s oncology policy was published. The decision strengthens federative governance by making both reimbursement mechanisms and jurisdictional allocation more predictable. For public authorities, healthcare institutions, and other sector stakeholders, the new framework provides a more stable basis for planning, interinstitutional coordination, and continuity of care.
PRESS
_Rubens Granja commented on Law No. 14,874/2024, highlighting it as a watershed moment for the Life Sciences sector.
Read the publication in the AASP bulletin. (Available in Portuguese)
RADAR ALERT
_Brazil’s Chamber of Deputies approves bill allowing the sale of medicines in supermarkets. (Available in Portuguese)
This material is for informational purposes only. Our Life Sciences & Healthcare team is available to provide specific legal advice.
