The Life Sciences and Healthcare Newsletter provides monthly updates on the main topics, laws, and standards related to the life sciences and healthcare sector in Brazil, and offers 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.

KEY UPDATES

Regulation of discount cards in healthcare advances with public call

The National Supplementary Health Agency (ANS) announced two measures aimed at regulating the market for discount cards, prepaid cards, and related services in the healthcare sector:

• Public Call for Contributions No. 4/2026, to gather contributions on the operation of companies and entities in the market to supplement a potential regulation of the sector.
• An internal committee to study the market and provide input for decision-making on this matter by the ANS Board of Directors (Presidential Ordinance No. 8/2026).

This marks a step forward in regulating the sector, particularly given that the Superior Court of Justice (STJ) has recognized the ANS’s authority to regulate this segment.

According to the ANS, the lack of consolidated information on business models, operational structures, and the practices adopted by companies in the sector justifies obtaining this data directly from the market before issuing specific regulations.

The call for contributions seeks to gather information on the structure and operation of the services offered, contract terms, terms of use, payment mechanisms, customer service network models, consumer profiles, and the economic and financial data of companies operating in the sector.

Legal entities that provide these services may submit contributions by August 3, 2026, using the online form available on the ANS website.

See our Client Alert for more details.

Medicine pricing rules in brazil are updated, but regulatory uncertainties persist

CM-CMED Resolution No. 3/2025 took effect in June, amending the new regulatory framework for medicine pricing in Brazil (CM-CMED Resolution No. 3/2025).

With the new resolution, Brazil’s Drug Market Regulation Chamber (CMED) clarified concepts, updated documentation requirements, and improved the medicine pricing procedure. Among the key changes are:

• a specific definition for “additional benefit”;
• a revised set of criteria for grouping dosage forms;
• An updated concept of incremental innovation;
• reworked requirements applicable to the Price Information Document (DIP); and
• Price-setting criteria adjusted based on international prices.

Despite these advances, certain aspects of the new regulatory model still concern the regulated sector:

• Off-label comparators: their use is conditioned upon a therapeutic indication “preferably” based on the package insert or on robust evidence (Art. 12, paragraph 1). This wording could enable the use of comparators whose therapeutic indication was not properly approved in Anvisa’s marketing authorization.
• Sharing of sensitive information: it remains a concern regarding risk-sharing agreements executed in other markets, including those involving data potentially subject to confidentiality obligations.

See our Client Alert for more details

Bill No. 5,875/2013: health data interoperability moves forward with public hearing

In May 2026, the Brazilian House of Representatives’ Health Committee (CSAUDE) held a public hearing on Bill No. 5,875/2013, which proposes a legal framework for health data interoperability in Brazil. The proposal seeks to provide comprehensive regulation for the national health data ecosystem, establishing rules for the National Health Data Network (RNDS), information sharing between public and private entities, interoperability governance, and the protection of personal data in the sector.

If approved, Bill No. 5,875/2013 could directly impact service providers, health insurance operators, healthtechs, and other industry stakeholders in Brazil, as they would need to adapt internal systems and procedures to newly established technical standards and interoperability requirements.

In this context, the public hearing received contributions from industry stakeholders, who suggested adjustments to the proposal, particularly regarding interoperability governance, information security, and the definition of responsibilities.

See our Client Alert for more details.

PUBLISHED REGULATORY ACTS

MEDICINES

• ANVISA Technical Note 60/2026 – Updates the interpretation of the interchangeability of products registered through the comparability pathway (biosimilars) and the comparator biologic.
• Normative Instruction 451/2026 – Amends Normative Instruction 292/2024, which outlines the specific criteria and procedures for defining Equivalent Foreign Regulatory Authorities in the health inspection process involving manufacturers of active pharmaceutical ingredients, cannabis products for medicinal purposes, medicines, and biological products. It also establishes the optimized review process for obtaining Good Manufacturing Practice (GMP) certification.
• ANVISA Collegiate Board Resolution (RDC) No. 1,028/26 – Amends RDC No. 1,000, dated December 11, 2025, which provides for control requirements for notifications of prescriptions, special-control prescriptions, and prescriptions subject to retention issued electronically.
• Law No. 15,440/26 – Amends Law No. 6,360/1976 (Law on Health Oversight of Pharmaceutical Products) to require proof of Good Manufacturing Practices (GMP) certification for the marketing authorization of domestically or foreign-manufactured medicines and pharmaceutical ingredients.

PROFESSIONAL COUNCILS

• CFBio Normative Instruction No. 11/2026 – Establishes the eligibility requirements for biologists and ecologists to serve as technical officers in activities involving the production of seeds, vegetative propagation material, and seedlings of forest species or species of environmental or medicinal interest, whether native or exotic.
• CFM Resolution No. 2,461/26 – Bans the use of polymethyl methacrylate (PMMA) as a filler and establishes an exception for the treatment of lipodystrophy in patients living with HIV/AIDS, within the framework of the Brazilian Unified Health System’s public health policies.
• CFM Opinion No. 19/2026 – Reaffirms that medical records may be discarded 20 years after the last entry, provided that the appropriate requirements for security, confidentiality, and traceability of the procedure are met, even if they have not been digitized. The regulation establishes that there is no obligation to give prior notice to patients, family members, or the Medical Councils regarding the disposal of documents; however, as a precautionary measure, prior contact with the patient or their relatives is recommended.

HEALTH OVERSIGHT

• ANVISA Normative Instruction No. 448/26 – Amends Normative Instruction No. 389, dated July 29, 2025, which provides for temporary health measures to be adopted at ports and airports in light of the current epidemiological scenario, pursuant to Articles 12 and 19 of Collegiate Board Resolution No. 932/2024.

CLINICAL RESEARCH

• INAEP GUIDANCE ORDER No. 3/2026 – Addresses, within the context of research involving human subjects:
  • the single-ethics-review system and jurisdiction;
  • collaborative governance and interaction among committees;
  • the separation between ethical and administrative review;
  • residual competencies and local monitoring;
  • transparency and the Informed Consent Form (ICF);
  • accountability; and
  • the Brazil Platform.

HEALTH SERVICES

• GM/MS Ordinance No. 11,527/26 – Establishes the National Policy on Quality and Patient Safety to promote safe, high-quality, and person-centered care throughout the Health Care Network.
• GM/MS Ordinance No. 11,694/26—Provides for the planning and guidelines for the procurement of equipment intended for diagnostic or therapeutic procedures within the SUS.

FOOD

• MS-ANVISA Normative Instruction No. 450/26 – Amends Normative Instruction No. 28, dated July 26, 2018, which establishes the lists of ingredients, usage limits, claims, and supplemental labeling for dietary supplements.
• MS-ANVISA Normative Instruction No. 452/26 – Amends Normative Instruction No. 211, dated March 1, 2023, which establishes the technological functions, maximum limits, and conditions of use for food additives and processing aids authorized for use in food.

MEDICINAL CANNABIS

• MS-ANVISA Normative Instruction No. 451/26 – Amends Normative Instruction No. 292, dated May 2, 2024, which sets forth the specific criteria and procedures for defining Equivalent Foreign Regulatory Authorities in the health inspection process of manufacturers of active pharmaceutical ingredients, cannabis products for medicinal purposes, drugs, and biological products. It also establishes the optimized review procedure for Good Manufacturing Practice (GMP) Certification.

PUBLIC CONTRIBUTIONS

• Ministry of Health Public Consultation No. 7/2026 – Evaluation and submission of recommendations from the general public and a proposed text for Draft Resolution No. 04/21 “Requirements for Good Practices in Health Technology Assessment.”
  Deadline for submissions: July 9, 2026
• ANVISA Call for Contributions No. 4/2026 – Collection of contributions for the revision of the regulatory framework for technovigilance, from the perspective of registration and notification holders of medical devices in Brazil.
  Deadline for submissions: July 16, 2026

• ANVISA Public Consultation No. 1,398/26 – Proposal to establish the National Pharmacovigilance System (Sinaf) and to define the guidelines and procedures for monitoring and managing pharmacovigilance activities related to adverse drug events.
  Deadline for submissions: July 23, 2026

• Targeted Consultations 5/2026: Discussion on the adequacy of packaging and logistics for the physical package insert (RDC 885/2024), to collect data on the physical and industrial compatibility of the QR code and the logistics strategy for providing the physical package insert on demand for drugs included in Brazil’s digital package insert pilot project.
  Deadline for submissions: July 31, 2026

• ANS Public Consultation No. 173/26 – Collection of contributions on proposals to update the list of mandatory health procedures and events to expand mandatory coverage for digital mammography.
  Deadline for submissions: July 11, 2026.