Life Sciences and Healthcare Newsletter | November 2025

The Life Sciences and Healthcare Bulletin offers monthly updated information on the main topics, laws and standards related to the life sciences and health 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.

CFM publishes new resolution on medical auditing and reinforces ethical, technical, and contractual limits

On October 23, 2025, Brazil’s Federal Council of Medicine issued CFM Resolution No. 2,448/2025, which establishes new ethical guidelines for conducting medical audits in Brazil, with significant implications for the supplementary health sector.

The regulation repeals Resolution No. 1,614/2001 and consolidates the rights, duties, and prohibitions applicable to the practice of medical auditors, assistants, and technical directors. The new rules aim to establish medical auditing as an activity exclusive to physicians, safeguard clinical autonomy, and impose ethical limits for claim denials.

The regulations emphasize that only physicians can:

• conduct audits;
• establish ethical criteria for claim denials;
• limit administrative interference in medical decisions; and
• expand the responsibilities of technical officers overseeing healthcare facilities.

Below is a summary of the key aspects established in the new resolution.

Medical auditing

CFM Resolution No. 2,448/2025 defines medical auditing as a qualified technical analysis of medical actions and procedures involving patient care. The resolution clarifies that it can only be conducted by certified physicians and must be supported by scientific evidence, clinical guidelines, and existing therapeutic protocols. Medical audits must observe the autonomy of attending physicians in determining the best therapeutic plan for their patients.

Medical auditors have been assigned specific rights, duties, and prohibitions regarding their professional practice, as outlined below.

Rights:

• Accessing all clarifications and documents required to perform their duties. Removing medical records or copies from institutions is prohibited.
• Examining patients upon their consent or that of a legal representative.
• Conducting medical audits of patients in hospital.

Duties:

• Practicing with ethics, impartiality, autonomy, and technical competence.
• Reporting any inconsistent or irregular practices to the attending physician in charge.
• Reporting any evidence of ethical violations to the institution’s technical officer.

Prohibitions:

• Interfering with therapeutic approaches that comply with recognized clinical guidelines, scientific evidence, and coverage under the Brazilian Supplementary Health Agency (“ANS”) or the Brazilian Unified Health System (“SUS”).
• Sharing medical opinions with patients or referring them to other physicians.
• Transferring their responsibilities to other professionals.
• Disclosing confidential information obtained during the medical auditing process.
• Denying claims regarding previously authorized procedures that have been performed by the attending physician in charge.

Attending physicians have been assigned the following rights and duties.

Rights:

• Establishing the best course of treatment for patients, provided it is scientifically based, recognized by SUS, or included in the list of health procedures and events of the ANS.
• Being informed if a medical auditor evaluates a patient under their care, and observing the procedure.

Duties:

• Responding promptly and responsibly to requests and inquiries from medical auditors, while complying with all ethical, technical, and legal principles in medicine.

Technical officers:

The regulation revises duties previously established in CFM Resolution No. 2,147/2016, primarily to reinforce the obligation to observe the attending physician’s autonomy, ensure that claim denials are justified and duly notified in writing to the attending physician, and ensure that medical audits are conducted exclusively by physicians, without sharing information with non-medical third parties.

New obligations assigned to technical officers include:

• Ensuring that medical auditors practice with technical autonomy, without outside interference.
• Preventing claim denials for previously authorized and performed procedures.
• Voiding any link between the auditor’s compensation and the number of claim denials they issued.
• Prohibiting requests for additional reports or forms beyond the clinical indication provided by the attending physician for authorizing complementary exams.
• Ensuring that the coding provided in the ANS Unified Supplementary Health Terminology is recognized, preventing rules set by healthcare plan operators from interfering with these standards.
• Preventing healthcare plan operators from grouping procedure codes without complying with the individual ANS coding.
• Refraining from changing or replacing therapies, orthoses, prostheses, and special materials duly prescribed by the attending physician and already authorized by healthcare plan operators, medical cooperatives, self-managed entities, or SUS administrators.

Decree modernizes inspection of plant-based products and consolidates agriculture and livestock regulations

On October 31, 2025, Decree No. 12,709 was published, consolidating the regulation on plant-based products based on numerous sectoral laws, including the law that established self-monitoring as the central pillar of food and agricultural defense.

The decree represents a regulatory advancement by consolidating regulations and aligning Brazil with international standards. The primary details of the new decree are summarized as follows:

Identity, quality, and self-monitoring standards

The decree establishes the technical criteria to ensure compliance of plant-based products with applicable standards, including:

• Normal sensory perception, quality, and quantity of components;
• Absence of harmful substances, contaminants, and deterioration;
• Compliance with microbiological and physicochemical limits;
• Adoption of good manufacturing practices and appropriate technological procedures; and
• Conservation and presentation compatible with safe consumption.

Product quality and identity standards will be established in further normative acts. In the absence of such standards, the Codex Alimentarius may be used as a reference.

The decree also outlines the primary criteria for developing and adopting self-monitoring programs, which must be implemented to monitor, verify, and correct the plant-based product manufacturing and distribution procedures. Such criteria include:

• Physical, chemical, and biological risks assessment;
• Control of suppliers and inputs;
• Compliance of facilities and equipment with applicable requirements;
• Hygiene and anti-fraud procedures;
• Proper transportation and logistics management.

Those agents involved in primary agricultural and livestock production, as well as family farming, can voluntarily participate in these programs through private production protocols.

Compliance Incentive Program in Agricultural and Livestock Defense

Decree No. 12,709 establishes the Compliance Incentive Program in Agricultural and Livestock Defense as one of the pillars of the self-monitoring system, offering benefits and incentives to establishments that adhere to the program voluntarily. These advantages include the possibility of remedying any irregularities before a fine is issued, and no fine being issued if measures specified in the notice are implemented within the deadline set by the inspector to remedy health violations.

The primary purpose of the program is to encourage companies to bring their operation into good standing preventively, establishing cooperation between the production sector and the Ministry of Agriculture and Livestock (“MAPA”). Key targets include promoting transparency, stimulating the improvement of quality assurance systems, and optimizing the flow of administrative procedures, in which decision-making must comply with risk analysis and risk-based management principles.

To remain in the program, agents must share all operational and quality data updates in compliance with regulatory specifications, in addition to achieving the minimum performance standards established in a supplementary regulation to be published by MAPA. Failure to comply with these obligations may result in a warning, suspension, or exclusion from the program.

Traceability and collection

Decree No. 12,709 established that all agents in the plant-based production chain, including producers, distributors, traders, and importers, must implement traceability mechanisms for each product batch. These mechanisms must be supported by systematized and auditable records that enable the identification of the origin and tracking of products throughout the entire chain. Additionally, the data must remain available for inspection for 18 months after the product’s expiration date or shipment.

The decree also established that recalls must occur in the event of deficiencies or irregularities that pose a risk to consumers, plant health, or animal health. In such cases, the product manager or importer must immediately withdraw the product from the market at their own expense. This obligation includes suspending sales, segregating the corresponding batch, and enforcing corrective measures. These measures may be taken voluntarily, mandated by the competent inspection authority, or determined by an administrative decision. Mapa will also issue a risk warning regarding the recall, and the measures agents should execute.

Finally, the decree defines violations and severe penalties for non-compliance with these obligations. Failing to keep auditable records for traceability, for instance, is a serious violation, whereas failing to execute the mandatory recall, whether partially or entirely, is deemed a very serious violation. Additionally, the maximum fine threshold may increase by up to 20% if the recall is not executed.

Inspection and inspecting agents

Decree No. 12,709 provides for a risk assessment-based system that encompasses all stages of the production chain for plant-based products, including production, processing, manufacturing, transportation, sale, and export, as well as e-commerce, port, airport, and cross-border operations.

The inspection authority may record images, audio, and videos of the operation to document irregularities, provided that it complies with confidentiality rules. Simplified procedures are also an option if the violation can be promptly remedied.

Federal agribusiness tax auditors are responsible for these inspections, supported by a technical staff and accredited companies. These professionals issue deficiency notices, enforce precautionary measures, audit self-monitoring programs, conduct national and international inspections, and issue health certificates. The inspection authority should have free access to information and premises, and may request police support, when necessary, while always protecting data confidentiality and trade secrets.

The decree also establishes the Brazilian System for the Inspection of Plant-Based Products (“Sisbi-POV”) to ensure the identification, quality, and health safety of plant-based products. Implementation will be voluntary, with equivalent systems across the federal government, states, municipalities, and public consortia. Mapa will be responsible for coordinating Sisbi-POV, conducting compliance audits, licensing establishments, and products, inspecting self-monitoring actions, issuing import and export certifications, and managing compliance programs, among other measures aimed at mitigating risks against agricultural defense.

Violations and penalties

Decree No. 12,709 addresses violations that may result from various actions by agents involved in the production, sale, import, or export of plant-based products, including those related to e-commerce, digital platforms, or social networks. The seriousness of such conduct can vary depending on how seriously it affects the safety and compliance of these products according to health standards.

• Minor violations refer to irregularities that do not significantly impact product safety or quality, such as documentation failures, the use of non-standard packaging, unreported changes in the industrial plant, and issues with classification services.
• Moderate, serious, or very serious violations, on the other hand, involve significant regulatory and health risks. Examples include omitting information, operating without authorization, misusing labels, making unauthorized changes to product composition, failing to implement self-monitoring programs, selling contaminated products, committing fraud, obstructing inspections, and not complying with penalties.

Applicable penalties include warnings, fines, condemnation of products, suspension or revocation of marketing authorizations and accreditations, and revocation of professional licenses. According to Law No. 14,515/2022, citations can be prevented in the case of minor violations if they are remedied in advance. Fines range from BRL 100 to BRL 150,000, with a 10% surcharge for repeat offenses. Suspensions or revocations may be converted into fines through a settlement agreement. If Mapa approves such agreement, it will have the force of an out-of-court enforcement order.

Sanctions will be graded based on the risk associated with the violation, the agent’s background, and any mitigating or aggravating circumstances, ensuring that agents are held accountable proportionally and effectively.

Transition rules

Decree No. 12,709 came into force on its date of publication and will take effect immediately, with the exception of:

• Identification guidelines for facility and product authorization records, and the mandatory labeling description in e-commerce, which will come into force 90 days after the publication of the decree, but still require supplementary regulation; and
• Adjustments to the marketing authorization data of beverages whose name has changed, which will come into force 730 days after the publication of the

According to Mapa, any clarifications regarding Decree No. 12,709/2025 can be resolved by the Department for the Inspection of Plant-Based Products.

New decree updates CONITEC’s decision-making process and revokes changes made in 2022

On November 12, 2025, Decree No. 12,716/2025was published in the Federal Official Gazette, amending the decree that regulated the operation of the National Committee for Health Technology Incorporation (CONITEC) and the administrative process for incorporating, excluding, and altering health technologies within the scope of SUS (Decree No. 7,646/2011).

The standard updates CONITEC’s decision-making process and structure, expanding public participation in healthy technology decisions, with emphasis on:

• Increased number of voting members

The new decree incorporates representatives from society and specialized medical entities into CONITEC’s structure. Participation was previously restricted to government agencies and experts appointed by the Ministry of Health. The regulatory update now expressly provides for public organizations operating for at least two years within the scope of the specialty or pathology in question, in addition to representatives from the Brazilian Medical Association.

• Committee meeting

The decree establishes a minimum meeting frequency and emphasizes that the agenda must be publicized in advance to ensure transparency.

• Ministry of Health’s Department of Science, Technology, and Innovation in Health

Decree No. 12,716/2025 replaced all references to the former Department of Science, Technology, Innovation, and Strategic Health Supplies with references to the Department of Science, Technology, and Innovation in Health.

For more information, see Decree No. 12,716/2025 in full. (PT only)

• BRAZILIAN HEALTH REGULATORY AGENCY (“ANVISA”)

RDC No. 996/25: Provides for the classification as medical devices, for health regulation purposes, of sodium chloride-based products in powder form for preparing solutions, and 0.9% sodium chloride solutions for nasal irrigation.

RDC No. 997/25: Provides for exceptional and temporary measures to optimize the queue for analyzing clinical research approvals and applications regarding marketing authorizations and post-authorization of medicines and biological products, seeking to mitigate regulatory liabilities, among other provisions.

RDC No. 998/25: Establishes guidelines for assessing the exposure risk of operators, workers, residents, and passersby to pesticides, environmental control products, related products, and bio-inputs for phytosanitary use. 

RDC No. 999/25: 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.

IN No. 402/25: Publicizes the updated Reference Listed Drugs (““LMR”) in Brazil.

IN No. 403/25: Updates Normative Instruction No. 289, dated March 20, 2024, to include entities and expand the scope of the Equivalent Foreign Regulatory Authority (“AREE”).

IN No. 404/25:: Updates the official list of over-the-counter medicines.

IN No. 405/25: Provides for the inclusion of the monograph of active ingredient T85 – TETRANILIPROLE in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in Normative Instruction No. 103, dated October 19, 2021.

IN No. 406/25: Provides for the inclusion of the monograph of active ingredient A73 – 2,3,5-TRIIODOBENZOIC ACID in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in Normative Instruction No. 103, dated October 19, 2021.

IN No. 407/25: amends Normative Instruction No. 211, dated March 01, 2023, which establishes the technological functions, limits, and conditions of use for authorized food additives and processing co-formulants.

IN No. 408/25: Provides for the composition of seasonal COVID-19 vaccines to be used in Brazil.

IN No. 409/25: Approves the list of administration routes (conventional-release pharmaceutical dosage forms) and analytes to be quantified in relative bioavailability/bioequivalence (BA/BE) studies and pharmacokinetic studies.

• NATIONAL SUPPLEMENTARY HEALTHCARE AGENCY (“ANS”):

RN No. 649/25: amends ANS Normative Resolution No. 137, dated November 14, 2006, and repeals Normative Instruction No. 20, dated April 29, 2022.

RN No. 650/25: Updates Normative Resolution (RN) No. 465, dated February 24, 2021, which provides for the list of mandatory health events and procedures in supplementary healthcare, to regulate the compulsory coverage of the oral antineoplastic medicine alectinib, used in the adjuvant treatment of stage IB (tumors = 4cm) to IIIA non-small cell lung cancer (NSCLC) following tumor resection, in cases positive for anaplastic lymphoma kinase (ALK), in compliance with paragraphs 4, 7 and 8 of Article 10 of Law No. 9,656/1998.

• DEPARTMENT OF SCIENCE, TECHNOLOGY, AND INNOVATION AND OF THE ECONOMIC-INDUSTRIAL HEALTHCARE COMPLEX (SECTICS)

SECTICS Ordinance No. 87/25: Publicizes the decision not to incorporate carbetocin into SUS for preventing postpartum hemorrhage. Ref: 25000.022265/2025-56

SECTICS Ordinance No. 88/25: Publicizes the decision to incorporate abemaciclib into SUS for treating early-stage breast cancer that is hormone receptor-positive, human epidermal growth factor receptor 2 (“HER2”)-negative, lymph node-positive, and at high risk of recurrence, in accordance with the Ministry of Health’s Clinical Protocol. Ref: 25000.197048/2024-38

SECTICS Ordinance No. 89/25: Publicizes the decision to incorporate bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg into SUS for treating people living with HIV, in compliance with the Clinical Protocol of the Ministry of Health. Ref: 25000.037936/2024-01

SECTICS CP No. 90/25: Public consultation to obtain contributions from society regarding the CONITEC Medicines Committee’s proposed use of ezetimibe in the treatment for reducing cardiovascular risk in individuals with high and very high cardiovascular risk, as presented by SECTICS in case NUP 25000.019792/2025-83.

SECTICS CP No. 91/25: Public consultation to obtain contributions from society regarding the CONITEC Medicines Committee’s proposed use of tranexamic acid and levonorgestrel-releasing intrauterine devices (LNG-IUDs) for patients with uterine leiomyoma with heavy uterine bleeding, as presented by the Department of Science, Technology, and Innovation and of the Health Economic-Industrial Complex (SECTICS/MS) in case NUP 25000.046842/2025-03.

SECTICS CP No. 92/25: Public consultation to obtain contributions from society regarding the CONITEC Medicines Committee’s proposed use of rosuvastatin in the treatment of individuals with high and very high cardiovascular risk, as presented by SECTICS/MS in case NUP 25000.019750/2025-42.

SECTICS CP No. 93/25: Public consultation to obtain contributions from society regarding the CONITEC Products and Procedures Committee’s proposed use of ELISA tests for myeloperoxidase (MPO)-ANCA and proteinase (PR3)-ANCA for diagnosing patients with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (“ANCA”), as presented by SECTICS in case NUP 25000.111904/2025-57.

SECTICS CP No. 94/25:  Public consultation to obtain contributions from society regarding the CONITEC Medicines Committee’s proposed use of dimethicone 92% for treating tungiasis, as presented by the Department of Indigenous Health (“SESAI/MS”) in the records of case NUP 25000.127948/2024-18.

SECTICS CP No. 95/25: Public consultation to obtain contributions from society regarding the CONITEC Medicines Committee’s proposed use of sofosbuvir/velpatasvir for treating chronic hepatitis C in children aged 3 to 11, as presented by the Secretariat for Health and Environmental Oversight (“SVSA/MS”), in the records of case NUP 25000.164956/2024-45.

SECTICS CP No. 96/25: Public consultation to obtain contributions from society regarding the CONITEC Medicines Committee’s proposed exclusion of medicines ledipasvir 90 mg/sofosbuvir 400 mg and elbasvir 50 mg/grazoprevir 100 mg for treating hepatitis C, as presented by the SVSA/MS in the case NUP 25000.126877/2024-36.

SECTICS CP No. 98/25: Public consultation to obtain contributions from society regarding the CONITEC Medicines Committee’s proposed use of pertuzumab in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of patients with early HER2-positive breast cancer, as presented by Produtos Roche Químicos e Farmacêuticos S.A. in the records of case NUP 25000.075272/2025-51.

• BRAZILIAN FEDERAL MEDICINE COUNCIL (“CFM”):

CFM Resolution No. 2448/25: Provides for medical auditing practices, among other measures.

ANVISA CP No. 1354/25: Proposed normative instruction that includes the active ingredient O24 – Eucalyptus Globulus in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

Contribution deadline: January 02, 2026

ANVISA CP No. 1355/25: Proposed normative instruction that includes the active ingredient T59 – Tannin, in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

Contribution deadline: January 02, 2026

ANVISA CP No. 1356/25: Proposed normative instruction that includes the active ingredient E35 – Eucalyptus Globulus in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

Contribution deadline: January 02, 2026

ANVISA CP No. 1357/25:  Proposed review of general food package labeling regulations.

Contribution deadline: March 09, 2026

ANVISA CP No. 1358/25: Proposed review of packaged foods nutrition facts labeling regulations.

Contribution deadline: March 09, 2026

ANVISA CP No. 1359/25:  Proposed normative instruction that includes the agronomic class “resistance inducer” (“Fungicide”) and the crops of sweet potato, bell pepper, and tomato in monograph A72 – Nonanoic Aid, in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in Normative Instruction No. 103, dated October 19, 2021.

Contribution deadline: January 23, 2026