On July 21, 2026, Law No. 15,471/2026 was published, establishing the National Health Strategy for the Health Economic-Industrial Complex (ENSCEIS), aimed at fostering innovation and strengthening the Health Economic-Industrial Complex (CEIS). The law allows for new arrangements among private parties. Below is a review of the main points.

Presidential Vetoes


Four provisions of Bill 2,583/2020 were vetoed:

  • The requirement of a technological offset in health (transfer of technological, industrial, or commercial benefits) as a condition for the acquisition of imported Strategic Health Products (PES);
  • The setting of import tariff scales and trade defense measures for Strategic Health Companies (EES);
  • The change to the concept of Reference Medicine (the product used as a benchmark for the registration of generics and similar drugs), which would have come to allow, as a reference, a product not produced in the country; and
  • The provisions that would have exceptionally allowed the importation of products manufactured by EES in Brazil without sanitary registration, as well as the requirement of good manufacturing practices certification for the registration of medicines and inputs.

The vetoes will now go to the National Congress for review, which may uphold or overturn them.

New Legal Entities Under ENSCEIS


ENSCEIS's objectives are organized around seven pillars, with emphasis on:

  • reducing the productive and technological dependencies of the Unified Health System (SUS) and expanding access to healthcare;
  • encouraging research, development, and innovation in health technologies and services;
  • expanding, modernizing, and driving the digital and ecological transition of the CEIS;
  • achieving self-sufficiency in the production chain and generating new business opportunities in the country; and
  • preparing for and responding to health emergencies.

The law defines a PES as goods, services, and productive, technological, or informational solutions whose access, availability, domestic development, or technological mastery are considered essential to sanitary security, productive autonomy, or the response to public health emergencies. PES include medicines, medical devices, Active Pharmaceutical Ingredients (IFA), Critical Technological Components (CTC), and digital health technologies, and will be further defined by an act of the Executive Branch.

At the institutional level, the law amended the SUS Organic Law (Law No. 8,080/1990) to expressly include, within the scope of SUS's activities, the promotion of the productive, technological, and innovation development of the CEIS, defined as the country's existing economic, productive, and technological health base.

Another entity created under the law is the EES, defined as a legal entity, public or private, accredited by the Executive Branch upon cumulative satisfaction of minimum conditions set forth in the law and its regulations, including maintaining an industrial facility in Brazil for the manufacture of PES and a track record of production, research, development, and innovation activities.

The law grants EES priority treatment in regulatory processes related to PES, as well as the possibility of priority status in public selection processes and calls for proposals related to the research, development, innovation, and production of PES. Favorable-terms credit lines may also be made available through Brazil's National Bank for Economic and Social Development (BNDES).

It is worth highlighting three points of attention: (i) EES will be subject to an accreditation and de-accreditation process by the Executive Branch, which will take into account risks to national sovereignty, external vulnerability, and potential shortages within the SUS; (ii) a company may be required to remain accredited as an EES for a fixed period, taking into account the portability and technological obsolescence of the relevant PES; and (iii) acts that result in noncompliance with the legal conditions prior to de-accreditation are deemed null and void, including amendments to the company's articles of incorporation, the disposal of assets, and the reduction of scientific or technological know-how — a point that may prove relevant in the context of corporate and commercial transactions. The Executive Branch will need to issue regulations addressing the technical requirements and procedures for demonstrating and evaluating the conditions described above.

Key Instruments: PDP, PDIL, and Etecs


The new law provides for three legal partnership instruments. Of these, the PDP and PDIL already had some degree of infra-legal regulation under Ministry of Health (MoH) Consolidation Ordinance No. 5/2017:

  • Productive Development Partnership (PDP): defined as a cooperation partnership, established by agreement, between an EES and public institutions, Scientific, Technological, and Innovation Institutions (ICTs), or other private entities, aimed at the development, transfer, and absorption of technology for the local production of strategic products intended to meet SUS demands. The central change here is the possibility of cooperation between private parties. The law expressly requires full access to the transferred technology and disclosure of the degree of domestic verticalization of the IFA and CTC, and, for biotechnology products, the transfer of access to the Master Cell Bank (BCM). In the event of termination or cancellation, the executing parties will be entitled to indemnification where the termination is unilateral and unjustified on the part of the public administration, except where a proven technological risk exists, in which case no indemnification will be owed; conversely, amounts received as Indirect Benefits and Expenses (BDI) must be reimbursed in the event of unjustified noncompliance with contractual obligations.
  • Local Development and Innovation Program (PDIL): a strategic alliance between an EES and public institutions or ICTs for the local development of projects aimed at innovative solutions for the SUS, requiring that each project mandatorily involve an ICT or a public health producer in partnership with an EES.
  • Technological Health Commissions (Etecs): the engagement of ICTs, private nonprofit entities, or companies to carry out research, development, and innovation activities that involve technological risk.

Public Procurement and Price Formation


The law waives the bidding requirement for the acquisition of PES arising from a PDP, Etecs, or PDIL, provided the prices are market-compatible, and expanded the bidding waiver to cover the acquisition of strategic products supplied by public producers through support foundations. The public administration may also conduct exclusive bidding processes for PES produced by EES and apply a price preference margin to domestic PES that comply with Brazilian technical standards, available to EES capable of producing at least 30% of the quantity to be acquired. Centralized purchases and the participation of companies in consortia, including in the form of a special purpose entity, are also authorized.

In PDPs, the counterpart obligation consists of the acquisition by the MoH of the products resulting from the partnership, in the volumes and quantities previously approved in accordance with the agreed demand plan, except in duly justified cases involving a supply impediment or a proven limitation of production capacity. In such cases, price formation will be tied to the product's market price and must itemize the costs of the technology transfer in the form of BDI. Prices must decrease over the term of the PDP and must be compatible with those charged in prior contracts within the SUS and, where applicable, in other countries, with a mandatory additional discount applied to purchases made immediately following the expiration of the product's patent term. Where multiple PDPs relate to the same product, the partnership that first demonstrates supply capacity and meets the qualification requirements will be responsible for fulfilling the MoH’s full demand, until such time as the others meet the conditions needed to begin supplying. The law also provides that the Executive Branch will not be held liable for intellectual property infringements committed by third parties within the scope of PDPs.

Next Steps


The new law takes effect on the date of its publication, and is expected to require a review of the MoH’s existing regulatory acts related to this subject matter.

The following items remain pending regulation:

(i) the technical requirements and procedures for the accreditation and de-accreditation of EES;

(ii) the selection process for entering into PDPs;

(iii) the methodology for calculating the BDI applicable to PDPs;

(iv) the selection process and requirements for PDIL projects;

(v) the legal elements and instruments applicable to Etecs;

(vi) the list of PES subject to public procurement rules;

(vii) the specific regulation governing the bidding waiver for acquisitions under the PDIL;

(viii) the procedures for conducting centralized PES acquisitions;

(ix) the criteria and minimum elements for tender notices and PES procurement instruments, including with respect to the formalization of consortia; and

(x) the implementation of regulatory priority and other incentives for EES, including the terms of the BNDES credit lines.

The Life Sciences & Health practice can provide further information on this topic.