Brazil’s Ministry of Health (MoH) has been advancing the development of the regulatory framework for the National Health Strategy for the Health Economic-Industrial Complex (ENSCEIS), established by Statute #15,471 of July 20, 2026.
Although the regulation has not yet been officially published, a recent interview with Fernanda De Negri, Secretary of Science, Technology, and Innovation in Health at the MoH, suggests that the new regulatory framework is forthcoming.
According to the Secretary, the MoH is currently working on defining the criteria, procedures, and operational workflows necessary for the implementation of ENSCEIS. The initial regulatory framework is expected to be finalized within the coming weeks, although certain operational aspects may be further detailed through specific regulations and ordinances.
While the statements do not reveal the final content of the regulation, they indicate that the future framework is expected to encompass the various instruments provided for under Statute #15,471/2026. These include Product Development Partnerships (PDPs), the Local Development and Innovation Program (PDIL), Health Technology Procurement Programs (Etecs), technology offsets, and other mechanisms designed to foster innovation.
The main objectives of ENSCEIS are to strengthen Brazil’s domestic production and innovation capacity in the health sector, to reduce vulnerabilities arising from dependence on foreign production and technological capabilities, and to expand access to strategic technologies for the Brazilian Public Healthcare System (SUS).
Our team is closely monitoring the ENSCEIS regulatory rollout and the publication of complementary measures that may govern the implementation of the Strategy.
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