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.

MAIN UPDATES

New ordinance amends rules and establishes a working group for Brazil’s Farmácia Popular Program

Brazil’s Ministry of Health has updated the rules for the Farmácia Popular Program, a government initiative that provides free or heavily discounted essential medicines to the public. The new rule covers drugstores’ participation, oversight, risk management, document retention, and the application of penalties.

Key changes introduced by GM/MS Ordinance No. 12.091/2026 include:

• Renewal of drugstore participation every two years
• Reduction of the document and recordkeeping period to five years
• A 60-day period to request a review of payment discrepancies

The ordinance also imposes fines in proportion to the severity of the irregularities. Additionally, it authorizes the creation of a working group within the program’s Monitoring Committee to propose innovation, modernization, expansion, and improvement measures, such as:

• Services, procedures, and diagnostic tests and therapeutic monitoring;
• Telehealth and telecare initiatives, including teleconsultations;
• Advanced healthcare service units and other service delivery models; and
• Strategies to expand access to the program’s benefits, particularly in vulnerable, remote, or underserved areas.

These initiatives have not been directly incorporated into the program under the new regulation; they depend on the establishment of the working group and the development and evaluation of the corresponding proposals.

CFM resolution on artificial intelligence in medicine enters into force

The Federal Council of Medicine has published a resolution outlining guidelines for the research, development, governance, auditing, monitoring, training, and responsible use of AI systems in medical practice, with a focus on safety, transparency, ethics, and the protection of patients’ fundamental rights.

The rule stipulates that artificial intelligence tools must only support medical practice and defines the rights and duties of physicians in this regard, emphasizing that AI does not replace clinical judgment and must be used in accordance with ethical principles, the protection of health data, and patients’ rights.

Physicians have the right to access clear information about the systems used, to decline tools lacking proper validation, and to disregard AI-generated recommendations when they deem it necessary. Medical professionals must use these technologies critically, document their use in patient records, protect patient data, and report any relevant failures or risks.

The regulation also protects the doctor-patient relationship: doctors must disclose the use of AI in care and cannot delegate sensitive communications, such as diagnoses and prognoses, solely to the technology.

The resolution also mandates the classification of AI systems based on risk and the implementation of governance, supervision, auditing, and monitoring mechanisms appropriate to each category.

The implementation of the resolution has prompted questions from the regulated sector regarding the responsibilities of physicians, healthcare institutions, developers, and suppliers, including in cases of system failures. There are also questions about the practical application of concepts and requirements, such as risk classification, monitoring frequency, and the scope of governance obligations.

See further details in our Client Alert: CFM publishes resolution on the use of AI in medicine

ANVISA makes progress in regulating digital medicine delivery platforms

The Brazilian Health Regulatory Agency (ANVISA) has approved the launch of a regulatory process to establish rules for contracting digital platforms and e-commerce channels for the logistics and delivery of medicines to consumers. The initiative should address oversight and governance mechanisms and define the responsibilities of pharmacies, drugstores, and digital platforms.

The measure stems from Law No. 15.357/2026, which authorized pharmacies and drugstores to contract these services.

ANVISA will also launch a public consultation to discuss the issue with representatives from the regulated sector, professional organizations, consumers, and members of the National Health Regulatory System. The Agency, however, waived the regulatory impact assessment (RIA) as this is considered a low-impact regulation.

The current health standards governing the sale and delivery of medicines will remain in effect until the regulation is concluded.

PUBLISHED REGULATORY ACTS

MEDICINES

• MS-ANVISA-RDC Resolution No. 1.037/26 – Amends Collegiate Board Resolution (RDC) No. 957/2024, which addresses the criteria for designating a medicinal product as a reference drug and the procedures for adding medicinal products to and removing them from the Reference Listed Drugs.
• Joint MS-SCTIE-SAES Ordinance No. 3/26 – Provides for the national negotiation system for the procurement of pharmaceuticals within the scope of the Pharmaceutical Care Component in Oncology – AF-Onco.
• GM/MS Ordinance No. 12.085/26 – Establishes criteria for registration in Brazil’s National Registry of Healthcare Establishments (CNES) and the minimum requirements, structure, organization, and responsibilities for implementing Dilution Centers for very high-cost medicines within the scope of the Pharmaceutical Care Component in Oncology (AF-Onco); amends Annex XV of GM/MS Consolidation Ordinance No. 1, dated September 28, 2017, and the Table of Specialized Services of the National Registry of Healthcare Establishments.
• MS-SCTIE Ordinance No. 54/26 – Provides for the composition, coordination, and operation of the working group referred to in Article 65 of GM/MS Ordinance No. 12,091/2026, which amends GM/MS Consolidation Ordinance No. 5/2017 to address the Brazilian Popular Pharmacy Program – PFPB.
• Resolution MS-ANVISA-RDC No. 1.041/26 – Amends Article 63 of Collegiate Board Resolution RDC No. 870, dated May 17, 2024, which addresses notification, marketing authorization, and post-authorization changes for medicinal gases classified as medicinal products.

GLP-1 RECEPTOR AGONISTS

• MS-ANVISA Ordinance No. 943/26  – Amends Ordinance No. 488/2026, which establishes a Working Group for technical discussion on GLP-1 receptor agonist medicines.
• MS-ANVISA Ordinance No. 944/26 – Amends Ordinance No. 489/2026, which establishes a Working Group to monitor and evaluate the action plan related to GLP-1 receptor agonist medicines.

PROFESSIONAL COUNCILS

• CFF Resolution No. 14, dated August 20, 2026 – Regulates the role of pharmacists in clinical research centers and other institutions conducting clinical research.
• COFFITO Resolution No. 660/26 – Addresses the role of the physiotherapist in palliative care and palliative rehabilitation, among other provisions.
• COFFITO Resolution No. 661/26 – Addresses the role of occupational therapists in palliative care and palliative rehabilitation, among other provisions.
• CFBM Resolution No. 427/26 – Addresses the regulation, competencies, and responsibilities of biomedical professionals in the production, analysis, research, and clinical-laboratory monitoring of cannabis for medicinal and scientific purposes, among other provisions.

HEALTH OVERSIGHT

• Anvisa RDC No. 1.039/26 – Establishes criteria, requirements, and procedures for analytical laboratories that perform quality control tests on products and services subject to health oversight, and provides for good practices for analytical laboratories and accreditation within the Brazilian Network of Analytical Laboratories in Health.

FOOD

• Normative Instruction No. 466/2026 – Amends Normative Instruction No. 211, dated 2023, which establishes authorized technological functions, maximum limits, and conditions of use for food additives and processing aids.

SANITIZERS

• RDC Anvisa No. 1.040/2026 – Amends Anvisa Collegiate Board Resolution No. 989/2025, which addresses the regulation and classification of sanitizing products based on their health risk.
• Anvisa Normative Instruction No. 468/2026 – Amends Anvisa Normative Instruction No. 394/2025, which addresses general requirements, analytical tolerances, label distribution, the list of categories, and proof of the expiration date for sanitizing products, pursuant to Anvisa Collegiate Board Resolution No. 989, dated August 15, 2025.

PORTS, AIRPORTS, AND BORDERS

• ANVISA RDC No. 1.038/26 – Establishes health and safety requirements for airports and aircraft and establishes obligations for airport administrators, airlines, and companies providing services to third parties.

PUBLIC CONTRIBUTIONS

• ANVISA Public Consultation No. 1,415 – Draft normative instruction amending Normative Instruction No. 211/2023, which establishes authorized technological functions, maximum limits, and conditions of use for food additives and processing aids.
  Contribution deadline: October 19, 2026
• ANVISA Public Consultation No. 1,417 – Draft normative instruction updating information on toxicological characteristics regarding precautionary statements and including sub-item P67.1 – Metabolic Extract and Lysed Cell of Pseudomonas fluorescens, in monograph P67 – Pseudomonas fluorescens, in the List of Active Ingredients of Pesticides, Sanitizers, Disinfectants, and Wood Preservatives, published through Normative Instruction No. 103, dated October 19, 2021.
  Contribution deadline: October 29, 2026
• Public consultation by the Ministry of Agriculture and Livestock – Draft ordinance establishing control procedures for the import and export of agricultural inputs.
  Contribution deadline: October 23, 2026