New legal framework for healthcare creates Strategic Healthcare Companies and broadens private-sector participation in Brazil’s Health Economic-Industrial Complex
On 20 July 2026, the President of Brazil, Luiz Inácio Lula da Silva, enacted Law No. 15,471/2026, which established the National Health Strategy for the Health Economic-Industrial Complex (Estratégia Nacional de Saúde do Complexo Econômico-Industrial da Saúde – ENSCEIS). Its purpose is to strengthen domestic production of products, inputs, technologies, medicines, equipment and materials that are essential to Brazil’s healthcare system, reducing reliance on imports.
Law No. 15,471/2026 came into force on 21 July 2026, i.e., on the date of its publication in Brazil’s Federal Register. This law also amends Law No. 6,360/1976 (which establishes Brazil’s health surveillance regime), Law No. 14,133/2021 (Brazil’s Public Procurement and Administrative Contracts Law) and Law No. 8,080/1990 (Law that governs the Public Health System in Brazil), thereby embedding healthcare industrial policy into core statutory frameworks on health surveillance, public procurement and the organization of the public health system (SUS). Previously, this policy was set out only in secondary legislation and administrative rules.
Private pharmaceutical industry gains prominence under the new framework for Brazil’s Health Economic-Industrial Complex
The new statutory framework formally broadens private-sector participation in healthcare productive-development policy, allowing accredited private companies to take on roles previously associated mainly with public laboratories in the context of Productive Development Partnerships (Parcerias para o Desenvolvimento Produtivo – “PDPs”) and other instruments designed to strengthen the Health Economic-Industrial Complex (Complexo Econômico-Industrial da Saúde – “CEIS”).
As a result, the private sector will be able to operate with greater legal certainty, within a State policy now enshrined in statute and aimed at fostering Brazil’s healthcare industrial policy.
Under this statutory arrangement, Brazilian privately owned laboratories may qualify as Strategic Healthcare Companies (Empresas Estratégicas de Saúde – EES). Accordingly, they may be accredited as institutions eligible to receive technology transfers from another private partner, potentially a multinational company.
The new model may also expand opportunities for multinational pharmaceutical companies seeking to structure local manufacturing, technology-transfer or domestic supply-chain development strategies. The creation of the EES category may provide greater institutional predictability for long-term projects aimed at internalising production capabilities considered strategic for SUS.
Particularly relevant for the pharmaceutical sector is the strategic recognition of the domestic production of active pharmaceutical ingredients, an area traditionally marked by significant dependence on foreign suppliers. The new policy seeks to encourage the strengthening of critical stages of the production chain, potentially stimulating investment in local manufacturing and technological development.
Relevance of its statutory status
From a legal and regulatory perspective, Law No. 15,471/2026 is relevant because it transforms the concepts of health sovereignty and strengthening the CEIS into a public policy structured by statute, rather than merely a programme-level governmental guideline.
By amending Brazil’s Organic Health Law and Public Procurement Law, the statute seeks to connect health planning, productive development, technological innovation and the State’s purchasing power, allowing public healthcare demand to be used as an instrument of industrial and technological policy. The ultimate objective is to effectively integrate Brazil into global value chains in the healthcare industry.
Law No. 15,471/2026 is also justified by the diagnosis, made evident during the pandemic, that external dependence on critical inputs, equipment and technologies undermines the response capacity of the SUS in public-health emergencies.
Relevance of the new legal framework for the private pharmaceutical sector
For the private pharmaceutical sector, the new legal framework is important because it creates the category of EES meaning companies – private or public – accredited to operate in segments considered essential to national healthcare policy, such as the production or development of IFAs, medicines, medical-hospital equipment, inputs, components, systems, subsystems and raw materials.
EESs may be eligible for specific economic and industrial incentive mechanisms provided for in the legislation and its implementing regulations, including differentiated conditions in certain public procurement processes, financing instruments and policies designed to stimulate the production of strategic products for the SUS.
In practice, Law No. 15,471/2026 creates a legal-regulatory status for companies in the sector, with potential implications for investment, industrial planning, technology partnerships and strategies for access to Brazil’s public healthcare market.
By creating the EES category, the legal text brings public laboratories, Brazilian private companies and subsidiaries of multinational groups into the same institutional environment for productive development, supporting collaborative models for innovation, technology transfer and expansion of domestic production capacity.
From the perspective of the pharmaceutical industry, the main innovation introduced by the new legal framework is the creation of a permanent mechanism integrating industrial policy, healthcare policy and the State’s purchasing power. The establishment of EESs is likely to increase the relevance of factors such as local production capacity, research and development activities, technology transfer and alignment with the strategic priorities of the SUS, all of which may influence investment decisions, the location of manufacturing plants, the execution of productive-development partnerships and access to Brazil’s public healthcare market.
Minimum conditions for qualification as an EES
To qualify as an EES, institutions must cumulatively meet the following requirements:
- their corporate purpose must include productive activities, research, scientific and technological development, as well as the development of an industrial base for the implementation of strategic healthcare planning; and
- they must have, in Brazil: (a) an industrial facility for manufacturing the Strategic Healthcare Product (Produto Estratégico de Saúde – PES); (b) a track record of productive activity and research, development and innovation; and (c) the capacity to ensure continuity and expansion of production in Brazil.
Regulatory impacts for the pharmaceutical industry
The creation of EESs also has significant regulatory implications for the pharmaceutical sector. Although Law No. 15,471/2026 does not directly amend the technical health-regulatory requirements applicable to the registration, manufacture or sale of medicines, it introduces a new institutional element that may influence the interaction between industrial policy, health regulation and access to the public market.
First, companies seeking accreditation as EESs will need to demonstrate installed production capacity in Brazil, a track record of research, development and innovation activities, and the ability to ensure continuity of supply of strategic products. In practice, these requirements are likely to place a premium on local production structures and sustained investment in technological development, factors that may influence corporate decisions on plant location, technology transfer and the expansion of operations in Brazil.
In addition, the new legal framework may encourage the internalization in Brazil of production stages considered critical to national health sovereignty, including the manufacture of IFAs and other activities of greater technological complexity. This movement may lead to greater integration between the regulatory, industrial and commercial strategies of companies operating in the Brazilian pharmaceutical market.
From a regulatory compliance perspective, obtaining and maintaining EES status is likely to require ongoing monitoring of compliance with the statutory and regulatory requirements to be established by the Executive Branch. Accordingly, in addition to the traditional obligations relating to health-regulatory authorizations, Good Manufacturing Practices, pharmacovigilance and traceability, companies will need to closely monitor the criteria for accreditation, maintenance and any subsequent review of their qualification as EESs.
Another relevant aspect concerns the potential prioritization of products considered strategic for the SUS. If the implementing regulations for the new law establish specific incentives, procurement mechanisms or financing linked to EESs, pharmaceutical companies may begin to incorporate, into their regulatory and portfolio strategies, criteria relating to the classification of medicines, vaccines, IFAs and other technologies as Strategic Healthcare Products (Produtos Estratégicos de Saúde – PES).
Finally, the new legal framework reinforces the convergence between health policy, industrial policy and innovation policy, requiring companies to operate in an increasingly integrated manner across regulatory, legal, market-access, government-relations, business-development and industrial-operations functions. In this context, the secondary regulations implementing Law No. 15,471/2026 will be decisive in defining the scope of the benefits, obligations and opportunities associated with the new EES regime.
The Life Sciences & Healthcare team at Souto Correa Advogados remains available to clarify any questions on this topic.