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.

NEWS

The challenge of balancing access to healthcare and budgetary control in HTA policy

Access to healthcare in Brazil has long been balanced between the constitutional ideal and budgetary constraints within the public system. The Brazilian Federal Supreme Court (STF) has ruled on Topics 6 and 1234, which, in brief, redefined the boundaries of healthcare judicialization by reinforcing the fundamental administrative role of the Health Technology Assessment (HTA), conducted by the National Committee for the Incorporation of Technologies into the Brazilian Unified Healthcare System (CONITEC).

Based on these precedents, judicial review of the provision of technologies not incorporated into SUS must be limited to verifying the legality of the HTA administrative process and the cumulative fulfilment of the exceptions established by the STF; courts are not allowed to replace the technical merits assessed by CONITEC with their own judgment.

The HTA is a fundamental process for enabling access to healthcare. It has become increasingly important in the institutional design of public policies. It must take into account Brazil’s current reality to balance the interests of patients, public authorities, and regulated agents. As a result, access to healthcare has become even more dependent on the HTA’s quality, regularity, and efficiency.

Find more details in our article published at JOTA (BR-PT).

Brazil’s Patient Bill of Rights comes into force

The Patients’ Bill of Rights has entered into force to establish the principles, rights, and responsibilities applicable to patients in Brazil. Enacted by Law No. 15,378/26, the statute establishes mechanisms to promote patient autonomy, dignity, and safety across all stages of public and private healthcare services.

Law No. 15,378/26 entered into force on its date of publication, April 07, 2026, establishing a new legal framework for the protection of patients’ rights.

See our Client Alert for more details.

ANS opens public consultation to update rules governing contracts between healthcare plan operators and service providers

The Brazilian National Supplementary Health Agency (ANS) published Public Consultation No. 170/2026, proposing a draft normative resolution that consolidates and updates rules on contracts executed between private healthcare plan operators and healthcare service providers.

The proposed regulation stems from the Regulatory Outcome Evaluation Report (RARR), developed by ANS’s Innovation Incentives and Providers’ Quality Assessment Unit (GEIQP). According to the report, although formal contractual execution no longer represents the main regulatory challenge in the sector, significant asymmetries remain in the performance of contractual clauses, particularly regarding prices, increases, disallowances (glosas), and default.

If approved, the new resolution will repeal Normative Resolutions No. 503/2022 and No. 512/2022, consolidating rules that are currently dispersed regarding contracting arrangements and the price increase index.

See our Client Alert for more details.

PUBLISHED REGULATIONS

MEDICINES

• ANVISA Collegiate Board Resolution No. 1,021/2026: 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.
• ANVISA Ordinance No. 488/2026 – Establishes a working group for technical discussions on GLP-1 receptor agonist medicines.
• ANVISA Ordinance No. 489/2026 – Establishes a working group to monitor and evaluate the action plan related to GLP-1 receptor agonist medicines.
• ANVISA Normative Instruction No. 433/2026 – Approves the lists of radiopharmaceuticals for therapeutic and diagnostic use that may rely on literature data to demonstrate safety and efficacy, pursuant to RDC No. 738/2022.
• ANVISA RDC No. 1.019/2026 – Amends RDC No. 768/2022, which establishes rules for the labeling of medicine.

PROFESSIONAL COUNCILS

• CFN Resolution No. 856/2026 – Approves the Code of Ethics and Conduct for Nutritionists, among other measures.
• CFO Resolution No. 286/2026 – Recognizes Orofacial Aesthetic Surgery as a dental specialty, defines its scope of practice, competencies, and training parameters, among other measures.
• CFO Resolution No. 285/2026 – Amends Article 1 and revokes Article 3 of CFO Resolution No. 230/2020 to establish that dentists without specialization in Orofacial Aesthetic Surgery must not perform the following surgical procedures on the face: alectomy, blepharoplasty, brow surgery or eyebrow lifting, otoplasty, rhinoplasty, rhytidoplasty, or face lifting.
• COFEN Resolution No. 806/2026 – Establishes guidelines for the practice of Perfusionist Nurses within healthcare institutions, defining competencies, duties, and responsibilities.
• Decree No. 12.921/2026 – Regulates Law No. 14,725/2023, which governs the profession of public health specialists (sanitaristas).
• Law No. 15.381/2026 – Provides for the practice of the doula.

PERSONAL HYGIENE PRODUCTS, COSMETICS, AND PERFUMES

• Portaria n° 471/2026 – Institui a Câmara Técnica de Cosmetovigilância (CTEC), nos termos da Portaria nº 693/2020.

HEALTHCARE

• Law No. 15.379/2026 – Amends Law No. 8,080/1990 to include immunotherapy in clinical protocols and therapeutic guidelines for cancer.
• Law 15.390/26 Amends Law No. 8,080/1990 (Brazilian Organic Health Law) to establish a financial allowance for users of the Brazilian Unified Healthcare System (SUS) who must undergo treatment outside the municipality where they reside.

FOODS

• ANVISA Normative Instruction No. 431/2026 and ANVISA Normative Instruction No.º 438/2026 – Amend Normative Instruction No. 28/2018, which establishes the lists of ingredients, limits of use, alleged benefits, and supplementary labeling of food supplements.
• ANVISA Normative Instruction No. 432/2026 – Amends IN No. 211/2023, which establishes technological functions, maximum limits, and conditions of use for authorized food additives and processing aids.
• ANVISA Normative Instruction No. 435/2026 – Establishes definitions, authorized substance lists, and analytical methods applicable to silicones used in materials, packaging, coatings, and equipment intended to come into contact with food.
• ANVISA Collegiate Board Resolution No. 1.020/2026 – Provides for sanitary requirements applicable to silicones used in materials, packaging, coatings, and equipment intended to come into contact with food.
• ANVISA Normative Instruction No. 438/2026 – Amends Normative Instruction No. 28/2018, which establishes the lists of ingredients, limits of use, alleged benefits, and supplementary labeling of food supplements.

PESTICIDES, DISINFESTING SANITIZERS, AND WOOD PRESERVERS

• ANVISA Normative Instruction No. 437/2026– Provides for the update of monographs of active ingredients in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103/2021.

SOCIAL CONTRIBUTIONS

• MS/ANVISA PUBLIC CONSULTATION No. 1.393/26 – Contributions on the proposed amendment to RDC No. 359/2020, which establishes the Active Pharmaceutical Ingredient Dossier (CADIFA), aimed at optimizing the process.
  Contribution deadline: June 15, 2026

• MS/ANVISA PUBLIC CONSULTATION No. 1.392/2026 – Contributions on the draft RDC regarding the coordination, structuring, organization, and execution of health oversight actions carried out by the Federal Government, states, the Federal District, and municipalities.
  Contribution deadline: July 04, 2026