15 set 2026

Brazil’s Public Health System (SUS): Law No. 15,471/2026 Strengthens the Purchasing Power and Consolidates Strategic Partnerships

Carolina Caiado and Ana Carolina Rocha

Following the establishment of the Economic-Industrial Health Complex (CEIS), which brings together public and private organizations dedicated to research, development, innovation, production, and the supply of goods, services, and technologies essential to Brazil’s Unified Health System (SUS), the creation of the National Strategy for the Economic-Industrial Health Complex (Enceis) is now being celebrated, through the enactment of Law No. 15,471/2026[1].

Since 2023, when Decree No. 11,464[2] was issued to establish the CEIS, the healthcare regulatory framework has been progressively refined with the aim of strengthening the sector’s productive and technological autonomy, expanding the country’s capacity for innovation, and reducing dependence on foreign suppliers. Within this context, Enceis consolidates the sector’s main instruments of reinforcement.

Law No. 15,471/2026 established SUS’s purchasing power as a strategic tool aimed at reducing the country’s external dependence on medicines, vaccines, and medical devices, creating mechanisms to strengthen public laboratories and expand the population’s access to health technologies.

With the creation of Enceis, three partnership instruments that structure the CEIS have become permanent:

(i) Partnerships for Productive Development (PDP), aimed at technology transfer and domestic production of medicines, vaccines, and other products of strategic importance to meet SUS’s needs;
(ii) the Local Development and Innovation Program (PDIL), designed to foster the local development of projects focused on innovative solutions of high relevance to SUS;
(iii) Technological Procurement Orders in Health (Etecs), aimed at financing research with high technological risk, with the possibility of the government subsequently contracting the solutions developed.

Strategic Products and Companies

Products originating from these partnerships are classified as Strategic Health Products (PES), a category that covers goods, services, and productive, technological, or informational solutions essential to health security, productive autonomy, the sustainability of SUS, or the response to public health emergencies.

The new law also creates the qualification of Strategic Health Company (EES), establishing a set of requirements for companies to be classified as such, always with a focus on fostering research and technological innovation activities geared toward healthcare and contributing to the expansion of the country’s industrial capacity. Once qualified, EES companies gain access to incentives, such as priority in the review and processing of their regulatory filings, as well as support and tools to encourage research, development, and innovation, including through the provision of financial resources.

As an additional incentive, EES companies will be able to access credit lines from Brazil’s National Bank for Economic and Social Development (BNDES) on terms more favorable than those practiced in the market, with reduced interest rates, longer amortization periods, and grace periods for principal repayment — details of which are still pending regulation under the new law.

New Rules

The new legislation also amends the Public Procurement Law by creating a new case for waiver of competitive bidding under Article 75 of Law No. 14,133/2021[3]. In cases specifically provided for under this new legal provision, public administration entities will be able to purchase PES without conducting a bidding process. This is, however, an exception — the general rule for public healthcare sector procurement remains the requirement of competitive bidding.

Still with respect to amendments to existing legislation, the Organic Health Law was expressly amended to include within SUS’s scope of activity: (i) the promotion of the CEIS; and (ii) the formulation and implementation of public policy instruments for the CEIS, such as the use of SUS’s purchasing power, financing, regulation, scientific, technological, and industrial development, and other incentives.

Law No. 15,471/2026 introduces mechanisms to foster the development of technologies and the domestic healthcare industry inspired by regulations from other sectors, such as the defense sector, which has its own system of qualifying defense companies and products, preference margins in bidding processes, among other measures. The great merit of the new law lies in using SUS’s purchasing power — the largest public health system in the world — as a tool for developing local industry.

This approach to using SUS’s purchasing power has the potential not only to expand Brazil’s capacity to develop, produce, and innovate in medicines, vaccines, equipment, and other strategic technologies, bringing greater autonomy to SUS, but also to create numerous business opportunities for companies operating in the sector. The Public Law and Government Affairs team will continue monitoring market opportunities for projects and regulatory innovations.

[1] Available at: l15471. Accessed on 08/18/2026.

[2] Available at: D11464. Accessed on 08/18/2026.

[3] Available at: L14133. Accessed on 08/18/2026.

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