The statute creates the Strategic Health Company and links accreditation to advantages in SUS procurement.
Law No. 15,471/2026 establishes Ensceis, the Estratégia Nacional de Saúde do Complexo Econômico-Industrial da Saúde (National Health Strategy for the Health Economic and Industrial Complex). Signed on 20 July 2026, it has been in force since publication. In practice, it creates the Empresa Estratégica de Saúde (EES, Strategic Health Company), accredited by the Executive Branch to sell to the SUS (Brazilian public health system) on special terms.
Who may qualify as a Strategic Health Company
Article 5 sets out conditions that the company must meet cumulatively. First, its corporate purpose must include production, research and development. In addition, it must demonstrate technical, operational, economic and financial, and regulatory capacity. It must also have industrial facilities in Brazil for strategic products and a track record of production and research. Lastly, it must show that it is able to maintain and expand production.
An act of the Executive Branch is still to define the technical requirements and the means of evidencing them. For this reason, qualification will only be complete once such regulations are issued. Withdrawal of accreditation may occur ex officio if the company ceases to meet the requirements (Article 6). The Executive Branch may also require the company to remain in that condition for a set period.
What advantages the EES gains in public procurement
The statute grants the EES priority in the examination of registrations, licences and authorisations (Article 33). However, such priority applies only to proceedings connected with research, development, innovation or the production of strategic products.
The public administration may also hold tenders restricted to EES products (Article 26). It may further apply a preference margin, provided that the EES supplies at least 30% of the quantity purchased (Article 27). The BNDES (Brazilian Development Bank) may offer credit with competitive interest rates, adjustable terms and grace periods, under specific regulations (Article 34). The financing conditions have therefore not yet been defined.
How partnerships and contracts with the SUS are affected
The statute provides for three partnership instruments: PDP (Productive Development Partnerships), PDIL (Local Development and Innovation Partnerships) and Encomendas Tecnológicas em Saúde (Technological Procurement Orders in Health) (Article 7). Under a PDP, the contract provides for the purchase, by the Ministry of Health, of the volumes approved in the demand plan (Article 10). Prices must fall over the course of the partnership (Article 11, paragraph 2). The contract must also provide for compensation should the administration terminate it without stated grounds (Article 14, paragraph 1).
There is also a waiver of tender for PDP and Etecs products, in the situations set out in Article 75 of Law No. 14,133/2021 (Brazilian Public Procurement Law) (Article 25). The statute indeed redrafts item XVI of that Article. In addition, it amends Law No. 8,080/1990 (the Brazilian Health System Act) to define the Health Economic and Industrial Complex.
Those wishing to become a Strategic Health Company should monitor the acts of the Executive Branch. These will define the accreditation requirements and the products deemed strategic.
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