MEDIA & PUBLICATIONS

The article examines Statute #15,471/26, highlighting advances but also warning of flaws, legal uncertainty, and the risk ofreduced competition. 

On June 21, 2026, Statute #15,471 was published, resulting from Bill #2,583/20. The new statute established the National Health Strategy for the Health Economic-Industrial Complex (ENSCEIS in the Portuguese acronym). The term “established” is not technically accurate, since, in substance, the strategy had already been created in 2023 by Decree #11,715, which in turn merely consolidated pre-existing programs, such as the Productive Development Partnerships (PDPs) dating back to 2008. Thus, ENSCEIS incorporates elements of Decree #11,715’s strategy: the use of SUS’ (Brazil’s Public Healthcare System) purchasing power to foster its instruments (Article 3, IX), the instruments themselves (the PDPs, the Local Development and Innovation Program (PDIL), and Technology Procurement Contracts in the Healthcare Sector (Etecs)) (Article 7), and the single source mechanism for contracting without a competitive bidding process (Article 25). In practice, what the new Statute did was to give a statutory basis to a program that had its support only in regulations. With this, in theory, the program would gain greater institutional stability, enhancing its ability to achieve its intended goals. A preliminary reading of the new Statute, however, raises concerns about its capacity to serve as the proper statutory basis: some provisions lacked clarity, important aspects of the policy were not incorporated, and, most importantly, it introduces changes that could unnecessarily prolong exclusivity periods, potentially restricting competition.. 

Read more: Lexology

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  Ricardo Campello

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  Paula Carvalho

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  Vinícius de Lacerda