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—subjects previously governed primarily by regulations. Accordingly, the law aims to improve legal certainty for public policies aimed at strengthening the Health Economic-Industrial Complex (CEIS).

Law No. 15.471/2026 was enacted amid a review of the national instruments for productive development used over recent decades and a debate on the roles of public and private actors in innovation and technology transfer policies in healthcare. Throughout its legislative process, the bill incorporated mechanisms that expand the potential participation of private companies in the productive and technological development instruments envisaged for CEIS.

Key innovations of Law No. 15.741/2026

The new law establishes partnership instruments to stimulate domestic production of strategic products for health, research, development, innovation, and technology transfer, as well as to leverage government purchasing power. The aim is to reduce Brazil’s technological and production dependence in the health sector. The law also expands the list of eligible participants for production development policies and establishes specific rules for public procurement, including cases in which bidding is waived and preference is given to domestic products.

Creation of the CEIS National Health Strategy

Law No. 15.471/2026 consolidates a legal framework for policies concerning productive development, technology, and innovation in healthcare. It also provides a legal basis for instruments previously governed primarily by regulations. The Productive Development Partnerships (PDPs) and the Local Development and Innovation Program (PDIL) now have express legal provisions. The Health Technology Orders (Etecs), already provided for in the Brazilian Innovation Law, are incorporated into the broader strategy to strengthen CEIS as a research, development, and innovation instrument focused on the healthcare sector.

Creation of Strategic Healthcare Companies (EES)

EES are public or private legal entities accredited by the Executive Branch to engage in the development, innovation, and production of Strategic Healthcare Products (PES) within the framework of CEIS partnership instruments. This allows PDPs and PDILs to be structured exclusively between private entities.

This is a change to the current model, which only allows these arrangements only with the participation of public institutions and/or ICTs in conjunction with private entities.  EES will also play a central role in health industry policy and be able to access specific funding mechanisms, regulatory priority, preferential participation in certain government initiatives, and differentiated public procurement instruments. To qualify as an EES, an entity must meet production, technological, regulatory, and economic-financial capability requirements.

Creation of the Strategic Healthcare Products (PES) category

The new category encompasses goods, services, and solutions—whether productive, technological, or informational—deemed essential for health security, national production autonomy, and the sustainability of the Brazilian Unified Health System (SUS).

The development is significant because the current PDP framework relies on the Matrix of Productive and Technological Challenges in Health, which aims to identify priority challenges and vulnerabilities for the SUS. By establishing the PES category, the rule creates a framework for formulating CEIS policies and for selecting technologies deemed strategic by the government.

New contractual and economic framework for PDPs

To improve economic predictability and legal certainty for PDP projects, the rule establishes a consensus-based demand plan. This plan includes pre-defined reference volumes for public procurement, with the Ministry of Health’s acquisition of products serving as the government’s counterpart to PDP projects.

Furthermore, prices must decrease over the partnership’s term, in line with those charged by the SUS (and, where applicable, in other countries), and have an additional discount after patent protection expires. The law also outlines scenarios for termination, cancellation, and compensation, as well as mechanisms for reallocating demand among projects linked to the same public health policy.

Specific provisions for Indirect Benefits and Expenses (BDI)

PDP contracts must separately break down the PES price and the costs related to technology transfer by adopting Indirect Benefits and Expenses (BDI). The previous PDP regulations did not include an equivalent mechanism.

Furthermore, failure to comply with contractual obligations may result in specific consequences, such as the reimbursement of amounts received as BDI in the event of unjustified default. The calculation methodology, eligible costs, and operational parameters for BDI still require regulation by the Executive Branch.

Strengthening mechanisms for technology internalization and vertical integration of production

The new legal framework places greater emphasis on domestic production of APIs, Critical Technology Components (CTCs), and other essential elements of the healthcare supply chain. The law reinforces requirements for full access to transferred technology, local mastery of technological knowledge, and the development of domestic production capacity. For biotechnological products, Law No. 15.471/2026 also provides for the transfer of and access to the Master Cell Bank (MCB), a key element for technological internalization.

Liability for intellectual property rights

The Executive Branch will not be held liable for infringements of intellectual property rights committed by third parties within the scope of PDPs.

Expansion of industrial policy and public procurement instruments in the health sector

The legal framework provides for the following scenarios:

• • waiver of bidding processes to procure products developed under PDPs, PDILs, and Etecs;
  • exclusive tenders for certain Strategic Health Products produced by EES;
  • use of preference margins for domestic products;
  • centralized procurement and the participation of companies in consortia or special purpose entities for specific projects.

Accreditation and de-accreditation of Strategic Health Companies

Only legal entities previously accredited by the Executive Branch may qualify as Strategic Health Companies (EES), provided they meet the requirements for technical, operational, economic-financial, regulatory, and production capacity.

Accreditation is particularly relevant because EES status is now required to access a range of instruments provided under the new law, including economic incentive mechanisms, regulatory priority, and participation in initiatives related to the production and development of PES.

Law No. 15.471/2026 also establishes a specific de-accreditation regime, which may occur either at the initiative of the government or at the request of the company itself. The de-accreditation process must factor in national sovereignty, external vulnerability, productive and technological development, and the risk of shortages within the SUS. The law also stipulates that a company may be required to maintain its EES status for a specified period, taking into account technological portability and the obsolescence of the PES.

The legal framework also stipulates that any actions taken prior to de-accreditation that violate the accreditation conditions are null and void. This could impact corporate reorganizations, the disposal of strategic assets, or structural changes made by companies accredited as EESs.

Presidential vetoes

Mandatory technology offset for imported PES acquisitions

The vetoed provision required that, when procuring or developing imported PES, companies adopt technology compensation mechanisms in healthcare, to be formalized under future regulations. If upheld, the provision would allow certain international acquisitions to be linked to the transfer of technological, industrial, or commercial benefits that support national development.

Measures to protect the competitiveness of EES

The vetoed provision empowered the Executive Branch to adopt tariff policies and trade defense measures to protect the competitiveness of EES, such as aligning import tax rates with domestic market conditions and conducting ongoing assessments of trade practices that could be detrimental to the sector.

Amendments to Law No. 6.360/1976

The vetoed changes include:

• • the amendment to the legal concept of reference medicine;
  • the restriction on importing certain products without a health authorization when they are manufactured domestically by a Strategic Health Company; and
  • the certification of good manufacturing practices as a legal requirement for the marketing authorization of medicines and pharmaceutical ingredients.

The Brazilian Congress may still uphold or overrule the vetoes, either in whole or in part. Overriding the veto requires an absolute majority of both representatives and senators. If the vetoes are not reviewed within 30 days of their receipt by Congress, the remaining legislative deliberations will remain suspended until the vote is concluded.

Issues pending regulation

Several key elements of the ENSCEIS legal framework still require regulation by the Executive Branch:

• technical requirements, procedures, and criteria for accrediting and de-accrediting EESs;
• the definition of PES and the criteria for their selection and updating;
• the selection process for entering into PDPs and the criteria for public and private stakeholders to participate in projects;
• the methodology for calculating, composing, monitoring, and potentially reimbursing BDIs;
• parameters applicable to the agreed demand plan and the mechanisms for acquiring the products resulting from the PDPs;
• the operationalization of PDILs, including requirements for project submission and selection;
• legal instruments, selection criteria, and operational mechanisms of the Etecs;
• the implementation of regulatory priority and other incentive mechanisms for EES, including the parameters applicable to the financing lines provided by the BNDES;
• transition criteria between the regime currently governed by GM/MS Ordinance No. 4.472/2024 and the new model introduced by Law No. 15.471/2026.

In this context, it will be essential to monitor not only the issuance of regulatory acts, but also the application of the new regime to PDPs that have already been approved or are currently ongoing.

Demarest’s Life Sciences and Healthcare team remains available to provide any further clarification that may be required.