National Program for Radical Innovation in Health (“PNIRS”)

1. Introduction

The National Program for Radical Innovation in Health (Programa Nacional de Inovação Radical em Saúde – PNIRS) was established within the Ministry of Health through Ordinance GM/MS No. 11,921, dated July 3, 2026, which amends Consolidation Ordinance GM/MS No. 5/2017. Its objective is to expand Brazil’s national capacity to develop strategic health technologies, with a focus on technological autonomy, health sovereignty, and strengthening the domestic health industry.

The program is based on the diagnosis that there is a “valley of death” between academic research and the transformation of knowledge into products, processes, and services that can effectively be incorporated into the market and Brazil’s public healthcare system (SUS). In the innovation literature, the “valley of death” refers to the set of challenges involved in transforming scientific knowledge into products and services available on the market. These challenges are diverse, ranging from financial constraints to compliance with regulatory requirements.

Speaking at the event “Sector Overview of Radical Innovations in Health: Current Perspectives and Pathways for Building the National Program for Radical Innovation in Health,”* held at Sindusfarma, Fernanda De Negri, Secretary of Science, Technology and Innovation in Health at the Ministry of Health, emphasized that the PNIRS seeks precisely to fill this intermediate space between basic research, technological development, regulation, production, and incorporation. This objective is associated with reducing external dependence and addressing Brazil’s trade deficit and dependence on imported health products, based on the idea that Brazil must develop its own innovations capable of competing globally and being commercialized internationally.

The PNIRS will operate through Radical Innovation in Health Anchor Centers (Centros-Âncora de Inovação Radical em Saúde), which will provide scientific and technological infrastructure, specialized services, technical, regulatory, and intellectual property support, and execute selected R&D&I projects. The Brazilian Center for Research in Energy and Materials (CNPEM) has been recognized as the inaugural Anchor Center. According to Secretary Fernanda De Negri’s remarks at Sindusfarma, CNPEM was selected due to its scale, infrastructure, excellence, translational capabilities, and openness to collaborating with companies and the productive sector.

Below, we examine the main aspects of the PNIRS, as well as the opportunities it may create.

2. Main Features of the PNIRS

2.1. Concept of Radical Innovation

Article 4 of the Ordinance defines radical innovation as the development or introduction of products, processes, services, or technological platforms that are new to the domestic or international market and characterized by a high degree of technological risk, significant impact potential, and the ability to transform scientific, productive, healthcare, or regulatory capabilities in the health sector.

This definition is important because it justifies a public policy aimed at higher-risk projects that may not otherwise be financed through traditional funding mechanisms or by private-sector investment alone.

2.2. Program Objectives

The formal objectives of the PNIRS include:

• Accelerating the transformation of scientific knowledge into products, processes, and services of interest to the SUS;

• Expanding Brazil’s technological development capacity in health;

• Supporting technologies at different stages of maturity;

• Increasing productive-sector access to advanced infrastructure;

• Promoting interaction among academia, government, industry, healthcare services, and regulatory authorities; and

• Strengthening technological autonomy and health sovereignty.

Fernanda De Negri’s remarks at Sindusfarma reinforced that the program was designed as an “innovation funnel,” capable of receiving projects at both early and advanced stages of technological maturity, with ongoing assessments and decisions regarding continuation, redirection, or termination.

2.3. PNIRS Guidelines

The PNIRS establishes six guiding principles:

• Addressing structural SUS challenges through high-impact scientific, technological, and productive solutions.
• Strengthening Brazil’s scientific, technological, and industrial base in order to reduce vulnerabilities and expand the country’s strategic autonomy in critical health-related areas.
• Promoting integration and cooperation among government, science and technology institutions (ICTs), industry, regulatory authorities, and civil society at national and international levels.
• Fostering translational research and emerging/disruptive technologies, including new molecules, advanced therapies, medical devices, biotechnologies, digital health solutions, and other strategic technologies.
• Coordinating interministerial and cross-sector public policies that align science, technology, innovation, industry, regulation, and health.
• Continuously monitoring and evaluating results, impacts, and lessons learned to ensure the program’s continuous improvement.

The actions planned under the PNIRS are organized around four pillars:

• Infrastructure;

• Provision of technological services to industry;

• Support for health innovation projects; and

• Coordination among innovation ecosystem stakeholders.

3. Selection of Anchor Centers

3.1. Inaugural Anchor Center

The Ordinance expressly recognizes CNPEM as the inaugural PNIRS Anchor Center. The program’s initial implementation will occur through legal instruments executed between the Ministry of Health and CNPEM.

3.2. Criteria for New Anchor Centers

Other institutions may be accredited as Anchor Centers by an act of the Secretariat of Science, Technology and Innovation in Health, provided they demonstrate, among other requirements:

• Scientific and technological excellence;

• Experience in translational research and health technology development;

• Experience in partnerships with industry; • Capacity to manage complex innovation projects;

• Infrastructure compatible with strategic technologies and industry demands; and

• A management agreement or equivalent instrument ensuring administrative autonomy, operational flexibility, and execution capacity.

According to the Secretary’s remarks at Sindusfarma, the intention is not to create numerous centers but rather to work with a limited number of highly qualified institutions with scale and capabilities comparable to CNPEM. Additional accreditations may occur as specific needs arise, particularly when required infrastructure is unavailable at the inaugural center.

4. Selection of Projects

4.1. General Framework

The PNIRS will operate through a portfolio of strategic radical innovation projects in health aimed at addressing priority SUS challenges and developing strategic health technologies.

R&D&I projects will be selected on a rolling basis by a Selection and Monitoring Committee, based on criteria such as innovation, health relevance, scientific and technological potential, economic and regulatory feasibility, and contribution to national productive autonomy.

4.2. Minimum Process Stages

The selection process will include, at a minimum:

• Proposal submission;

• Eligibility analysis;

• Technical evaluation;

• Selection;

• Execution;

• Periodic monitoring; and

• Decisions regarding continuation, redirection, termination, or progression to subsequent development stages.

This structure reflects the “funnel” described by the Secretary: more projects enter the process than ultimately reach completion, and the Committee continuously evaluates milestones, feasibility, and the need for reorientation or discontinuation.

4.3. Selection Criteria

The Ordinance establishes the following criteria:

• Scientific and technological merit;

• Potential impact on the SUS;

• Potential for innovation and value creation for Brazil;

• Technical and economic feasibility;

• Regulatory feasibility;

• Qualifications of the proposing team; and

• Alignment with SUS priority challenges.

Projects must also be structured into development phases with intermediate milestones monitored by the Selection and Monitoring Committee. Projects that fail to achieve milestones or demonstrate economic or regulatory feasibility may be discontinued.

4.4. Committee Composition

The Committee must comprise recognized experts with experience in health innovation and technologies, ensuring diversity of profiles, including:

• Academic and scientific expertise;

• Experience in industry and health innovation;

• Specialists in health regulation; and

• Representatives of the Anchor Centers.

5. PNIRS Governance

The governance structure will consist of four bodies:

• Executive Coordination;

• Selection and Monitoring Committee;

• Advisory Council; and

• Anchor Centers.

The Selection and Monitoring Committee is responsible for selecting R&D&I projects and monitoring their intermediate milestones, as described above.

The Executive Coordination will establish guidelines, strategic priorities, criteria for project selection, redirection, continuation, or termination, and will monitor implementation, results, and impacts. It will be composed of representatives from the Executive Secretariat of the Ministry of Health, the Department of Science and Technology, and the Department of the Health Economic-Industrial Complex.

The Advisory Council will serve a consultative and strategic role and will include representatives of Brazilian health-sector companies, ICTs, innovation ecosystem entities, and other strategic institutions. Its functions will include proposing priorities, assessing alignment with SUS and industry needs, monitoring results, and suggesting adjustments. According to the Secretary, the Council will be a key mechanism for providing stability to the program and transforming it into a State policy by keeping industry and other stakeholders engaged in evaluating and supporting its effectiveness.

orting its effectiveness.

The PNIRS creates significant opportunities for companies, ICTs, startups, investors, and institutions supporting health innovation. Key opportunities include:

• Access to CNPEM infrastructure, including laboratory, translational, and technological development capabilities that would be difficult for individual companies or startups to replicate.
• Sharing of technological risks, enabling more efficient allocation of public and private resources to high-risk, high-impact projects.
• Closer interaction with the SUS as a source of innovation demand, allowing projects to be designed from the outset around healthcare, regulatory, and incorporation needs.
• Potential use of technological procurement mechanisms, particularly for public challenges where no market solution yet exists or where the technological pathway is not fully established.
• Strengthening Brazil’s biotechnology ecosystem through greater coordination among centers of excellence, industry, startups, investment funds, regulators, and public-sector demand.

These opportunities should be approached as an active strategic agenda. The sooner stakeholders understand the program’s selection criteria, infrastructure access mechanisms, intellectual property framework, and regulatory requirements, the greater their chances of developing competitive and legally sound projects.

7. Recommendations for Capturing Opportunities

Capitalizing on opportunities generated by the PNIRS should encompass at least two fronts: active monitoring of the program’s implementation and the technical, regulatory, legal, and institutional preparation of stakeholders interested in submitting projects.

7.1. Active Monitoring

Active monitoring within the context of the PNIRS includes:

• Maintaining a regulatory and institutional watch over Ministry of Health acts, public calls, notices, agreements with CNPEM, Committee deliberations, and governance documents.
• Monitoring opportunities for engagement with the Ministry of Health, CNPEM, Anvisa, Conitec, industry associations, investment funds, and potential corporate partners.

7.2. Positioning and Preparing in Advance

Preparation should begin before specific calls for proposals or tenders are issued and should encompass technical, regulatory, legal, and institutional aspects, including:

• Mapping internal projects that may fit SUS priority challenges and strategic health technologies.
• Classifying each project according to its Technology Readiness Level (TRL), regulatory stage, need for CNPEM infrastructure, dependence on public or private partners, and intellectual property risks.
• Preparing a preliminary dossier containing a technical summary, innovative differentiators, development gaps, regulatory plan, intellectual property plan, and projected SUS impact.
• Defining an intellectual property negotiation strategy in advance.
• Anticipating contractual models for R&D&I, technological services, confidentiality, material transfer, licensing, and commercialization.
• Developing an institutional narrative linking radical innovation, national technological autonomy, reduction of SUS vulnerabilities, regulatory feasibility, and production/scaling capability.
• Closely monitoring the formation of the Advisory Council and opportunities for industry participation, as this body may influence priorities, perceptions of alignment with SUS needs, and future program adjustments.

The Life Sciences & Healthcare team at Souto Correa Advogados remains available to answer any questions regarding this matter.