Life Sciences & Healthcare Newsletter | February 2026

The Life Sciences and Healthcare Newsletter gathers monthly updated information on the main topics, laws, and regulations related to the life sciences and healthcare sector in Brazil and is an opportunity to access legal information and comments on relevant market issues.

Enjoy reading!

Demarest’s Life Sciences and Healthcare Team

This material is for informative purposes only, and should not be used for decision-making. Specific legal advice can be provided by one of our lawyers.

MAIN NEWS

Brazil’s Supreme Court updates framework for reimbursement and jurisdiction over oncology therapies

On February 19, 2026, Brazil’s Federal Supreme Court (“STF”) ratified an agreement establishing new reimbursement guidelines and defining jurisdiction for lawsuits involving access to cancer therapies in the Brazilian Unified Health System (“SUS”).

The agreement – signed between the federal government, states, and municipalities within the context of the Tripartite Interagency Committee (CIT) – was unanimously approved during the Court’s review of Ordinance GM/MS No. 8,477/2025, which established the Oncology Pharmaceutical Assistance component within the SUS (“AF‑ONCO”) and reorganized the Brazilian model of pharmaceutical care in oncology.

Below are the key issues addressed by the STF: 

Reimbursement rules: Federal government maintains 80% coverage

The agreement preserves the existing cost-sharing mechanism for oncology medicines, maintaining the federal government’s 80% reimbursement of amounts spent by states and municipalities to comply with court orders requiring the supply of oncology therapies.

This percentage remains valid both for lawsuits filed up to June 10, 2024, and, provisionally, for those filed after that date. This extension is temporary and will remain in force until a new inter-federative agreement is reached and subsequently approved by the STF.

STF justices emphasized this rule during the review, especially given the financial constraints faced by many municipalities, which often lack the budget to fund high-cost cancer medicines.

Medicines incorporated into the SUS: updated precedent in Subject 1234

Another central development was the update to the STF’s precedent under Subject 1234, aligning it with Ordinance GM/MS No. 8,477/2025 – particularly regarding jurisdiction over cases involving oncology medicines already incorporated into SUS.

The previous precedent assigned jurisdiction to the Federal Courts when a claim involved access to medicines costing the equivalent of 210 minimum wages or more per year. The new ordinance, however, aligns jurisdiction with the level of pharmaceutical management, as follows:

• Oncology medicines centrally procured by the Ministry of Health: Treated as equivalent to Group 1A medicines under the SUS Specialized Pharmaceutical Component. Lawsuits seeking access to these products fall under Federal Court jurisdiction.
• Oncology medicines purchased through national or decentralized negotiations: Treated as equivalent to Group 1B medicines under the Specialized Pharmaceutical Component. Claims involving these medicines fall under State Court jurisdiction.

Updating the precedent required special attention to the transition between models. To prevent mass redistribution of ongoing cases, the STF applied a transitional rule: the change in jurisdiction applies only to lawsuits filed from October 22, 2025, onward (the publication date of Ordinance GM/MS No. 8,477/2025).

Collaborative judicial governance framework

The STF also reaffirmed collaborative judicial governance as a structural pillar of Theme 1234, emphasizing that the management of health-related litigation requires continuous coordination among federal, state, and municipal authorities.

According to Justice Gilmar Mendes’ vote, this governance model enables complex public policies, such as oncological pharmaceutical care, to be adjusted through formally constructed inter-federative consensus and subsequently approved by the STF to ensure full legal effectiveness.

The Court further noted that any future changes in reimbursement rules or judicial competence will also require judicial approval, ensuring regulatory continuity and national uniformity.

PUBLISHED REGULATIONS

MEDICINES

ANVISA RDC No. 1,011/26: Provides for the update of Annex I (Lists of Narcotics, Psychotropic Drugs, Drug Precursors and Others under Special Control) of SVS/MS Ordinance No. 344, dated May 12, 1998.

MEDICAL DEVICES

ANVISA Normative Instruction No. 426/2026: Establishes the requirements for the sharing and management of the database on Unique Device Identification (“UDI”) in compliance with ANVISA RDC No. 591/21 (which provides for the identification of medical devices regulated by ANVISA, through the UDI system).

FOODS

RDC ANVISA No. 427/26: Updates ANVISA Normative Instruction No. 162, dated July 1, 2022, which establishes the acceptable daily intake (ADI), the acute reference dose (ARfD), and the maximum residue limits (MRL) for active pharmaceutical ingredients (API) of veterinary medicinal products in foods of animal origin.

CANNABIS PRODUCTS

ANVISA RDC No. 1,015/2026 Provides for the marketing and importing authorization for cannabis products for human medicinal use and establishes requirements for its sale.

SUPPLEMENTARY HEALTH

ANS Normative Resolution No. 665/26: Regulates the concept of “Health Region” provided for in item V, paragraph 1, Article 1, and amends paragraph 2, Article 1 of ANS Normative Resolution No. 566/22 (or any rule that may succeed it), which provides for the guarantee of care for beneficiaries of private healthcare plans.

ANS Normative Resolution No. 664/26: Amends ANS Normative Resolution No. 565/22 to exclude the regular submission of information to the Product Information System (“SIP”) as a requirement for authorizing adjustments to monetary considerations in individual or family supplementary medical and hospital healthcare plans, with or without dental coverage, contracted after January 1, 1999, or adapted to Law No. 9,656/98.

MS-ANS Normative Instruction No. 60/26: Amends ANS Normative Instruction No. 30/22, in order to exclude the regular submission of information to the SIP as a requirement for authorizing adjustments to monetary considerations in individual or family supplementary medical and hospital healthcare plans.

PROFESSIONAL BOARDS

CFM Resolution No. 2,454/26: Regulates the use of artificial intelligence in medicine.

CFM Resolution No. 2,453/26: Establishes the CFM’s Safe Medicine platform within the scope of the Medical Council System, among other measures.

CFBM Ordinance No. 66/2026: Implements guidelines and establishes policies on behavior in virtual environments.

ANVISA – ADMINISTRATIVE STRUCTURE

ANVISA RDC No. 1,016/26: Defines directors responsible for ANVISA boards.

MS-ANVISA Ordinance No. 124/26: establishes the Regulatory Oversight Committee for Innovation in Health within the scope of ANVISA.

PERSONNEL OF THE NATIONAL COMMITTEE FOR HEALTH TECHNOLOGY INCORPORATION IN SUS (“Conitec”)

MS-GM Ordinance No. 172/26: Amends GM/MS Personnel Ordinance No. 1,310, dated December 8, 2025, with regard to the appointment of members nominated by the respective bodies and entities that will compose the Conitec Committees.

SOCIAL PARTICIPATION

ANVISA Public Consultation No. 1,384/26: Proposal to revise the collegiate board resolution establishing the Brazilian pharmacopoeia collegiate bodies and approving their internal regulations.

Contribution deadline: April 10, 2026