Law No. 15,471/2026, which establishes Ensceis, has been enacted
In brief
On July 21, 2026, Law No. 15,471/2026 (“Law No. 15,471/2026” or “Law”) was enacted, establishing the National Strategy for the Health Economic-Industrial Complex (“Ensceis”), an intersectoral strategy that brings together health, industry, science, and technology, with the purpose of ensuring adequate conditions for the delivery of healthcare services, fostering innovation and job creation, reducing external productive and technological dependence, and strengthening the Health Economic-Industrial Complex (“Ceis”). Among its objectives, the following stand out: reducing the productive and technological dependencies of the Unified Health System (“SUS”), boosting research, development, and innovation, achieving self-sufficiency of the production chain, and contributing to the response to health emergencies.
In more detail
Law No. 15,471/2026, which takes effect on the date of its publication, creates the concept of the Strategic Health Company (“EES”), defined as a legal entity, whether public or private, accredited by the Executive Branch upon the cumulative fulfillment of the minimum conditions set forth in the Law and in regulations still to be published, which require technical, operational, economic and financial, and regulatory capacity to carry out a strategic health production plan, in addition to industrial facilities in Brazil for the manufacture of Strategic Health Products (“PES”), a track record of production and research, development, and innovation activities, and the capacity to ensure continuity and productive expansion within the country. Deaccreditation may occur ex officio or upon the EES’s request, and shall always be preceded by an analysis of the risks to national sovereignty, external vulnerability, and shortages within the SUS, and the company may be required to remain in the condition of EES for a specified period. It is important to highlight that, prior to deaccreditation, any acts involving corporate changes, disposal of assets, or reduction of scientific or technological knowledge that entail a breach of Law No. 15,471/2026 shall be null and void. Such restrictions may impact corporate transactions, restructurings, and asset divestitures involving EES.
As partnership instruments, Ensceis provides for the Productive Development Partnership (“PDP”), the Local Development and Innovation Program (“PDIL”), and the Health Technological Orders (“Etecs”).
PDPs shall be entered into following a selection process conducted by the Executive Branch, essentially preserving the framework already established under Ordinance GM/MS No. 4,472/2024, including with respect to full technology access by the Technology Receiving Entity (“ERT”), the domestic vertical integration of the Active Pharmaceutical Ingredient (“API”) and of the Critical Technological Component (“CTC”), and the transfer of the Master Cell Bank (“MCB”) for biotechnological products. As a counterpart, the PDP agreement shall provide for the acquisition by the Ministry of Health of the resulting products, in the previously approved volumes, except in duly justified cases of supply impediment or proven limitation of the productive capacity of the institution executing the PDP, as set forth in an act of the Executive Branch.
The new Law introduces, however, additional requirements regarding price composition, which must break down the value of the PES and the portion allocated to technology transfer, in the form of Indirect Benefits and Expenses (“BDI”). Prices shall be decreasing throughout the term of the partnership and consistent with those charged in procurements carried out within the SUS prior to the execution of the partnership and, where applicable, with those charged in other countries, and products under a valid patent shall be subject to an additional discount immediately upon patent expiration. The provision on BDI consolidates, at the statutory level, the model developed by the Department of Science, Technology and Innovation in Health of the Ministry of Health (“SCTIE/MS”) under Informative Note No. 17/2025-DECIS/SCTIE/MS, prepared in compliance with Federal Court of Accounts (“TCU”) Ruling No. 1014/2025, which breaks down the PDP price into Manufacturing and BDI.
With respect to contractual liability, the PDP agreement must include clauses setting forth the conditions for termination or cancellation of the contract, pursuant to Law No. 14,133/2021, including indemnification in the event of unilateral termination by the Public Administration without proper grounds, but no indemnification shall be due when the failure results from technological risk, as evidenced by technical and financial assessment. In the event of unjustified breach, the contract shall provide for the reimbursement of amounts received as BDI. The Law also establishes the rule that, in the case of PDPs concerning the same product, the one that first demonstrates supply capacity shall be responsible for fully meeting the Ministry of Health’s demand until the others meet the requirements.
The PDIL requires the mandatory participation of a Scientific, Technological and Innovation Institution (“ICT”) or of a public health producer in partnership with an EES. Execution may provide for phased payments, based on the delivery of validated intermediate results, and the execution of an amendment for scope expansion or term extension. If the intended result is not fully achieved by the end of the term, the Executive Branch may, subject to a technical and financial audit, extend the term or terminate the project. Lastly, the Etecs shall have their legal instruments governed by an act of the Executive Branch, in compliance with the provisions of Law No. 10,973/2004 (“Innovation Law”).
Law No. 15,471/2026 also waives the bidding requirement for the acquisition of PES arising from PDPs and Etecs in the cases set forth in Law No. 14,133/2021, notably for the transfer of technology of strategic products to the SUS and for the acquisition of PES supplied by public producers through a support foundation (a provision redesigned by Law No. 15,471/2026 itself). Under the PDIL, the waiver depends on the prior incorporation of the PES into the SUS, which, in practice, requires the administrative process conducted by the National Committee for Health Technology Incorporation in the SUS (“Conitec”). The Public Administration may also conduct bidding processes exclusive to EES, apply a preference margin to domestic PES (subject to a minimum of 30% of productive capacity), and allow consortia, including in the form of a special purpose entity (“SPE”). EES shall also have priority in the review and processing of their regulatory proceedings, including registrations, licenses, and authorizations, and the Brazilian Development Bank (“BNDES”) may make available credit lines with favorable conditions, as per specific regulations.
It is important to note that vetoes were imposed on, among others: (a) the mandatory health technology offset in the acquisition of imported PES or in their development, due to the potential increase in the price of strategic products and the expansion of SUS costs, in addition to the fact that Law No. 14,133/2021 already provides for this possibility; (b) the linkage of the import tax policy to the competitiveness of EES, as it would restrict the Executive Branch’s discretion in conducting economic and trade policy; and (c) the amendment to Law No. 6,360/1976 that would prohibit the importation of unregistered products manufactured in Brazil by EES, except in specific circumstances, as it would excessively restrict the Ministry of Health’s authorization possibilities, to the detriment of SUS management.
