Law No. 15.471/2026, published in the Federal Official Gazette on July 21, 2026, established the National Health Strategy for the Health Economic-Industrial Complex (Ensceis), consolidating a national policy aimed at strengthening production, research, and innovation regarding strategic technologies for the Unified Health System (SUS).
The new legislation seeks to reduce the country’s productive and technological dependency, stimulate domestic manufacturing, and expand capacity for research, development, and innovation in the health sector.
For the pharmaceutical industry, this initiative is particularly relevant because the concept of a Strategic Health Product (PES) expressly includes medicines, Active Pharmaceutical Ingredients (APIs), and critical technological components, among other technologies deemed strategic for health security and the sustainability of the SUS.
Strategic Health Companies (EES)
One of the key mechanisms created by Ensceis is the Strategic Health Company (EES), a category that may encompass public and private companies accredited by the Executive Branch.
However, classification as an EES will not be automatic. The legislation establishes minimum requirements, including technical, operational, economic-financial, and regulatory capacity for the implementation, operation, or expansion of industrial facilities dedicated to the production and development of PES.
Companies must also meet—in accordance with regulations—requirements regarding the existence of industrial facilities within the country, a track record of production and R&D&I activities, and the capacity to sustain and expand domestic production.
New opportunities for the pharmaceutical industry
Ensceis structures mechanisms that can expand opportunities for private sector participation in strategic health projects, particularly through Productive Development Partnerships (PDPs), the Local Development and Innovation Program (PDIL), and Technological Orders in Health (Etecs). These mechanisms involve, among other aspects, technological development, technology transfer and absorption, local production, and innovation geared toward the needs of the SUS. The legislation also provides mechanisms to encourage public procurement of Strategic Health Products (PES), including specific scenarios for direct contracting, the possibility of exclusive bidding procedures for products developed or produced by Strategic Health Companies (EES), and the application of a preference margin in certain tenders involving domestic PES.
Regulatory priority and financing
Another point of interest for companies is the provision for priority handling and processing of regulatory matters—including registrations, licenses, and authorizations—for EES. However, this priority will be linked to processes related to research, development, innovation, or production activities concerning PES and will be subject to Executive Branch regulations.
The law also provides for the possibility of the BNDES (Brazilian Development Bank) making credit lines available to EES under favorable terms, including for investments in production infrastructure and innovation projects, subject to specific regulations.
Next steps
Although Ensceis is already in effect, key aspects of its implementation still depend on further regulation—specifically the criteria and procedures for EES accreditation, the verification of technical requirements, and the parameters for applying the mechanisms outlined in the legislation.
For the pharmaceutical industry, this is an opportune moment to monitor these regulations and assess—starting now—how well their projects (involving domestic production, R&D&I, technology transfer, vertical integration of Active Pharmaceutical Ingredients (APIs), and strategic product development) align with the new instruments of the health industrial policy.
The implementation of Ensceis is thus likely to open new avenues for interaction among pharmaceutical companies, public institutions, and Science and Technology Institutions (ICTs), while also creating opportunities related to project structuring, regulatory compliance, technology partnerships, and access to incentive mechanisms and public procurement channels.
This bulletin is for informational purposes only and does not constitute a legal opinion or legal advice.
Evelini Oliveira de Figueiredo Fonseca | evelini.fonseca@nascimentomourao.adv.br
Coordinator and Partner, Environmental, Regulatory, and Biodiversity Law Practice.
Bianca Oliveira Begossi | bianca.begossi@nascimentomourao.adv.br
Partner in the Environmental, Regulatory, and Biodiversity Law practice.
