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

LAW NO. 15.471/2026: BRAZIL ENACTS HEALTH ECONOMIC-INDUSTRIAL COMPLEX LEGAL FRAMEWORK

The bill establishing the National Health Strategy for the Health Economic-Industrial Complex (ENSCEIS) has been signed into law. Law No. 15.471/2026 establishes a new legal framework for policies on productive development, innovation, and technology transfer in the health sector. Accordingly, the law seeks to strengthen the Health Economic-Industrial Complex (CEIS) and provide greater legal certainty for instruments that, until now, were primarily regulated by non-statutory rules.

Key innovations introduced by Law No. 15.741/2026 include:

• Creation of the CEIS National Health Strategy, which establishes a unified legal framework for instruments concerning productive development, technology, and innovation in healthcare.
• Creation of the Strategic Health Products (PES) category, which encompasses goods, services, and technologies deemed essential for health safety, national production autonomy, and the sustainability of the Brazilian Unified Health System (SUS).
•  Creation of Strategic Health Companies (EES), which are public or private legal entities accredited to engage in the development, innovation, and production of PES, enabling development partnerships exclusively between private entities.
•  Restructuring of Productive Development Partnerships (PDPs) with a new contractual and economic framework focused on economic predictability, technology transfer, and public procurement.
• Specific provisions for Indirect Benefits and Expenses (BDI), requiring PDP contracts to distinguish the PES price and the costs related to technology transfer — a mechanism not provided for in the previous PDP regulations.
• Strengthening technological internalization and production verticalization, with a focus on active pharmaceutical ingredients (APIs), strategic components, and critical technologies for the healthcare supply chain.
• Exclusion of the Executive Branch’s liability for intellectual property violations committed by third parties within the scope of PDPs.

Several aspects of the new regime still require regulation by the Executive Branch, including the accreditation criteria for the EES, the definition of the PES, and the operational rules applicable to PDPs and other instruments created or amended by the legislation.

See our Client Alert for more details.

Radical Innovation in Health: New program aims to overcome research “Valley of Death”

The Ministry of Health has launched the National Program for Radical Innovation in Health (PNIRS). The initiative aims to strengthen Brazil’s capacity to develop strategic health technologies, stimulate high-impact innovation, and expand its technological autonomy.

The ordinance that established the program defines radical innovation as “the development or introduction of products, processes, services, or technology platforms that are new to the national or international market, marked by high technological risk, high potential for impact, and the ability to transform scientific, production, care, or regulatory competencies in healthcare.”

The program will operate through partnerships with “Radical Innovation Anchor Centers,” which will provide specialized scientific and technological infrastructure, deliver technological services, and carry out research, development, and innovation projects within the program.

The program aims to overcome the innovation “Valley of Death” — a research stage in which projects struggle to advance beyond the laboratory and find concrete market applications. To achieve this goal, the program will prioritize strategic and emerging technologies, such as new molecules, advanced therapies, biotechnologies, medical devices, radiopharmaceuticals, and digital healthcare solutions.

While the PNIRS is structured around anchor centers, the initiative expands opportunities for participation by private companies, startups, and other stakeholders engaged in developing innovative healthcare technologies. The program aims to strengthen the connection between scientific research and its practical application, fostering collaborative environments that can accelerate the validation, scaling, and transfer of strategic technologies.

In this context, the PNIRS can bridge research institutions, investors, and innovative companies, helping transform high-technology-risk projects into solutions that can be incorporated into the healthcare system and introduced to the market.

Ministry of Health establishes committee to negotiate economic terms for health technologies

The Ministry of Health has established a Committee for Negotiating Prices and Economic Terms for Health Technologies. This permanent committee will focus on negotiations related to medicines, medical devices, and other technologies under analysis for integration into SUS or in the process of being procured by the government.

The committee will be responsible for:

• Negotiating prices and economic terms for health technologies, particularly in cases involving exclusive suppliers, concentrated markets, or significant budgetary impact, within the scope of the Ministry of Health’s procurement and SUS incorporation processes.
• Proposing strategies to expand access and promote the financial sustainability of public health policies.
• Negotiating economic and operational conditions for managed access and risk-sharing models, conditional discounts, and other economic mechanisms applicable to health technologies.
• Recommending, when appropriate, measures to ensure the confidentiality of information obtained during negotiations.

The law also allows companies that hold health authorizations or are responsible for marketing the technologies to participate in the Committee’s negotiations, where they may submit commercial proposals and provide information on prices and conditions in other markets.

The measure reinforces the use of negotiation tools in the incorporation and acquisition of health technologies by SUS and could impact the pricing and negotiation strategies of companies in the pharmaceutical and medical device sectors.

In the same context, the Ministry of Health also established a process to monitor and control the availability of health technologies incorporated into SUS with federal funding.

PUBLISHED REGULATORY ACTS

TECHNOLOGIES, INNOVATION, AND PARTNERSHIPS IN HEALTH

• Law No. 15,471/2026 – Establishes the National Health Strategy for the Health Economic-Industrial Complex (ENSCEIS) and amends Law No. 6,360 of September 23, 1976, Law No. 14,133 of April 1, 2021 (Administrative Bidding and Contracts Law), and Law No. 8,080 of September 19, 1990 (Organic Health Law).
• GM/MS Ordinance No. 12.011/2026 – Establishes, within the scope of the Ministry of Health, the Committee for Negotiating Prices and Economic Conditions for Health Technologies, and provides for its organization, operation, and the negotiation of economic conditions applicable to such technologies.
• GM/MS Ordinance No. 11.921/2026 – Amends GM/MS Consolidation Ordinance No. 5, dated September 28, 2017, to establish the National Program for Radical Innovation in Health (PNIRS) within the scope of the Ministry of Health.
• GM/MS Ordinance No. 11.981/2026 – Amends GM/MS Consolidation Ordinance No. 1, dated September 28, 2017, to provide for the monitoring and control process for the availability of health technologies incorporated into SUS, funded by the Federal Government.
• Ordinance GM/MS No. 12.015/2026 – Establishes the Technical Committee of Experts (CTE) for the Ministry of Health’s proposed Technology Order (ETEC) to develop a Portable Integrated Molecular Diagnostic System for Tuberculosis.
• GM/MS Ordinance No. 12.021/2026 – Establishes governance guidelines for the proposal, analysis, formalization, execution, and termination of Technical Cooperation Agreements (ACT) and Cooperation Agreements (AC), as well as their respective amendments, within the scope of the Ministry of Health.
• MS-SCTIE Ordinance No. 15/2026 – Designates the members of the Technical Committee of Experts within the scope of the CEIS.
• MS-GM Ordinance No. 659/2026 – Amends GM/MS Personnel Ordinance No. 1.310/2025 regarding the appointment of members nominated by the respective bodies and entities to serve on the Conitec committees.
• Joint MS-SCTIE-SAES Ordinance No. 2/2026 – Establishes the Ministry of Health’s list of ultra-high-cost oncology drugs, as provided for in Article 10, Paragraph 6, of GM/MS Ordinance No. 8.477, dated October 20, 2025.

MEDICINES

• Joint SCTIE/SAES/MS Ordinance No. 2/2026 – Establishes the Ministry of Health’s list of ultra-high-cost oncology drugs, as provided for in Article 10, paragraph 6, of GM/MS Ordinance No. 8.477, dated October 20, 2025. Ref.: 25000.042060/2026-78.
• Informative Note 1/2026/GGBIO/ANVISA – Evaluation of Comparative Pharmacokinetic Studies of Biosimilars submitted as supporting documentation for the registration and approval of the Drug Clinical Development Dossier (DDCMs) — documentation required for the approval of clinical research with biosimilars in Brazil. 
• MS-ANVISA Normative Instruction No. 455/26 – Updates the Reference Listed Drugs (LMR) in Brazil.
• MS-ANVISA-RDC Collegiate Board Resolution (RDC) No. 1,036/26: 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.
• RDC MS-ANVISA No. 1.031/2026 – Amends Annexes I and III of Collegiate Board Resolution No. 870, dated May 17, 2024, which addresses the notification, marketing authorization, and post-authorization changes for medicinal gases classified as medicinal products.

SUPPLEMENTARY HEALTH

• ANS Normative Resolution No. 677/2026 – Amends ANS Normative Resolution No. 585, dated August 18, 2023, which provides for the criteria for changes to the hospital care network regarding the replacement of a hospital entity and network resizing through reduction.

• ANS Normative Instruction No. 38/2026 – Amends ANS Normative Instruction No. 28, dated December 16, 2022, which provides for the procedures for registering products marketed by health plan operators.

PROFESSIONAL BOARDS

• Law 15.456/26 – Regulates the profession of orthopedic prosthetist and orthotist. The law outlines the responsibilities and requirements for practicing the profession.
• CFM Resolution No. 2.464/2026 – Regulates the use of platelet-rich plasma as an adjuvant medical procedure in the treatment of specific musculoskeletal conditions, among other provisions.
• CFM Resolution No. 2.463/2026 – Amends CFM Resolution No. 2.386/2024 to expand the duties of transparency and declaration of conflicts of interest applicable to medical entities.
• CFFa Resolution No. 836/2026 – Provides for the regulation of the use of electrostimulation by speech-language pathologists.
• CFFa Resolution No. 835/2026 – Provides for the regulation of speech-language pathologists’ practice in the field of orofacial aesthetics.
• CFF Resolution No. 6/2026 – Provides for the responsibilities of pharmacists in the context of palliative care and end-of-life care.
• CFO Resolution No. 297/2026 – Provides for the prohibition of the use of polymethylmethacrylate (PMMA) as an injectable filler substance for exclusively aesthetic purposes within the scope of the practice of dentistry.

GOOD PRACTICES

• RDC No. 1.032/2026 – Amends Article 5 of RDC No. 497, dated May 20, 2021, which provides for the administrative procedures for granting the Certification of Good Manufacturing Practices and the Certification of Good Distribution and/or Storage Practices.

RESEARCH INVOLVING HUMAN SUBJECTS

• MS-ANVISA Normative Instruction No. 457/2026 – provides, pursuant to RDC No. 945, dated November 29, 2024, for the criteria for filing the documents that make up the Investigational Medicinal Product Dossier (IMPD) for the Clinical Development Dossier (DDCM) process, or for the request for a substantial modification to the investigational product.
• Ordinance MS-GM No. 625/2026 – designates the full and alternate members to serve on the National Research Ethics Authority (INAEP).
• MS-CNS Resolution No. 803/2026 – provides for the creation of the Working Group to establish the Intersectoral Research Ethics Committee (Conep) of the National Health Council (CNS).

PUBLIC CONTRIBUTIONS

• ANVISA Public Consultation No. 1,399/2026 – Proposed public consultation on updating the list of substances that personal hygiene products, cosmetics, and perfumes must not contain, except under the conditions and with the restrictions established.
  Contribution deadline:  September 8, 2026.
• ANVISA Public Consultation No. 1.400/2026 – Proposed RDC amending RDC No. 727/2022 to address requirements regarding the quantitative declaration of ingredients, the use of technology for transmitting information on labeling, and the labeling of irradiated foods.
  Contribution deadline: October 19, 2026