This Tuesday, July 21, Statute #15,471 of July 20, 2026, was published, establishing the National Health Strategy for the Health Economic-Industrial Complex (ENSCEIS). The Statute, which originated from Bill #2,583/2020, also amends Statute #8,080/1990 (the “SUS Act”) and Statute #14,133/2021 (the “Public Procurement and Administrative Contracts Act”) in order to enable some of the new measures.

The aforementioned National Strategy had already been established in 2023 by Decree #11,715, albeit under a different name: “National Strategy for the Development of the Health Economic-Industrial Complex.” Statute #15,471 essentially maintains that strategy but introduces some important changes that could draw criticism if used as measures creating market reserves. Its main effect, however, was elevating the strategy to the statutory level, turning a government program into a State program, something the market had long been calling for.
 

Below are the key aspects of the new Statute:
 

Regarding the ENSCEIS
 

The ENSCEIS largely incorporates the design of the strategy established by Decree #11,715: leverage the state’s purchasing power, specifically that of the Brazilian Public Healthcare System (SUS), in the procurement of medicines and other health products, in order to promote technology transfer among players in the Healthcare Economic-Industrial Complex (CEIS).
 

The objectives of the ENSCEIS are virtually the same and relate to reducing SUS’s production and technological vulnerabilities; expanding universal healthcare access; lessening the CEIS production chain’s reliance on imports; and fostering research, development, and innovation (Article 4).
 

Statute #15,471 also adopts a large part of the concepts established by Ministry of Health (MoH) regulations related to Decree #11,715. For example, the concepts of Strategic Health Product (PES), Critical Technological Component (CTC), Public Institution (IP), Private Entity (EP), technological portability, and Technology Receiving Entity (ERT) have been maintained. Statute #15,471, however, introduces a new concept: the Strategic Health Company (EES), defined as a legal entity accredited by the Executive Branch to participate in ENSCEIS instruments and benefit from some of its measures, such as financing and even an exclusive bidding process. Statute #15,471 established general requirements for EES accreditation, which include having in the country an “industrial facility for manufacturing PES”; a “track record of productive activity and research, development, and innovation”; and the “capacity to ensure the continuity and expansion of production in the country” (Article 5). The accreditation, disaccreditation, and governance procedures will be set out in specific regulations (Article 6).
 

The following instruments were also retained: Product Development Partnerships (PDP); Local Development and Innovation Program (PDIL); and Health Technology Orders (Etecs) (Article 7).
 

Regarding PDPs
 

The Statute’s main innovation was to bring to the statutory level part of the framework that, until then, had been dealt with only through sub-legislative MoH acts: GM/MS Ordinance #1,354/2023 (laying down rules for implementing the National Strategy for the Development of the Health Economic-Industrial Complex); #2,261/2023 (establishing the Matrix of Productive and Technological Challenges in Health); and # 4,472/2024 (specifically addressing PDPs).
 

While preserving the Executive Branch’s authority to regulate the matter, the Statute sought to govern key structural elements of the Program, such as:
 

• The requirement of a prior selection process for choosing partners. The Statute does not provide details, leaving this to the regulations (Article 8);
• The requirement that, in the selection process, the degree of domestic vertical integration of the Active Pharmaceutical Ingredient (API), CTCs, and other inputs or industrial processes deemed critical be presented, together with a technical-economic feasibility study (Article 9, Paragraph 2);
• The requirement that the product supply agreement, which serves as the consideration for the technology transfer, be formalized in a specific contract, distinct from what the Statute designates as a “PDP contract” (Article 9);
• The requirement that the Technology Receiving Entity (ERT) be guaranteed full access to the knowledge and technologies needed to produce the Strategic Health Product (PES) (Article 9, Paragraph 1), which, in the case of biological products, must include the Master Cell Bank (Article 9, Paragraph 4);
• The requirement that, at the end of the PDP term, the Executive Branch verify whether the technology transfer has been completed, which will entail examining, at a minimum, whether the related contractual obligations have been met, whether the registration with Anvisa (the Brazilian FDA) has been obtained for the PDP product manufactured domestically, and whether the corresponding Good Manufacturing Practices certificate has been secured for that production line (Article 13).
   

Some provisions deserve special attention, as, depending on how they are applied, they could lead to changes in the dynamics of PDPs:
 

The Statute requires the PDP contract to specify the volumes and quantities of the product to be supplied, which must be approved in advance according to an agreed-upon demand plan (Article 10). It was common, when demand for a drug within SUS increased in a given year, to adjust the quantity to be supplied, with a corresponding reduction in the price to be paid. This adaptation may face constraints because of this provision, as one possible interpretation is that volumes and quantities will no longer be treated as mere demand estimates but will become objective parameters. Thus, any adjustments would be limited by the rule in Article 125 of the Public Procurement and Administrative Contracts Act, which only allows increases and decreases of up to 25% of the contract’s updated initial value.
 

The Statute requires the PDP contract to include the product’s market price broken down into its components, showing the amount corresponding to the product itself and the amount of the costs related to the technology transfer, in the form of Indirect Benefits and Expenses (BDI), as per regulations (Article 11). Greater transparency in the composition of the price paid for the product under a PDP has been a longstanding demand of Brazil’s General Accounting Office, which may now be met by this new provision. The current regulation already required the proposed price to be justified based on “the value of the product and the technology” (GM/MS’ Ordinance #4,472, Annex, Article 8, Paragraph 3), but the provision in Statute #15,471 is clearer and may lead to a requirement for greater detail on this point.
 

The Statute also establishes that prices must decrease over the course of the PDP and be consistent with those charged within SUS before the partnership was entered into (Article 11, Paragraph 2), maintaining what was already set out in the regulation (GM/MS’ Ordinance #4,472, Annex, Article 8, Paragraph 4). To ensure compliance with these provisions, the Statute also provides for permanent price monitoring mechanisms (Article 12) and an additional discount for purchases made after the product’s patent expires (Article 11, Paragraph 3). This appears to be the only circumstance in which the Statute requires an adjustment (specifically, a reduction) of the product’s price during the PDP.

Finally, the Statute reinforces that the MoH will not be held liable for any infringement of intellectual property rights committed within the scope of PDPs (Article 15). This was already the Ministry’s stance, but the inclusion of an express provision to this effect in the Statute likely stems from a history of litigation involving patent infringement in PDPs, which has impacted the progress of some partnerships.

The Statute also governs situations of contract termination, indemnification, technological risk, and reimbursement of amounts related to technology transfer costs, as well as establishing criteria for supply when there is more than one PDP concerning the same PES (Article 14).
 

Regarding the PDIL
 

Statute #15,471 incorporates into the statutory text the design the PDIL already had in the MoH regulations, as an instrument aimed at promoting production development, technical improvements, and local innovation (Article 16).

The Statute also requires a prior selection process before entering into PDIL projects, as per the regulation to be issued (Article 19), and establishes that projects must necessarily involve a Scientific, Technological and Innovation Institution (ICT) or a public health producer, in partnership with an EES (Article 18).
 

In light of the PDIL’s characteristic feature of involving greater risk in achieving its objective, Statute #15,471 provides for the possibility of payment in stages, upon attainment of the agreed-upon partial results. Moreover, if the project’s term expires without its objective being met, it will be possible to complete the project by preparing its final report, or to extend its duration through an amendment, which may even provide for an expansion of its scope (Articles 20 and 21).
 

Regarding Etecs
 

Statute #15,471 merely provides for Etecs as one of the ENSCEIS instruments and assigns to the Executive Branch the task of regulating them (Article 23).
 

Regarding the ENSCEIS procurement regime
 

As with other topics, Statute #15,471 incorporates the current procurement dynamic for its instruments (PDP, PDIL, and Etecs) without the need for a prior bidding process, both by referencing provisions of the Public Procurement and Administrative Contracts Act that set forth existing direct contracting scenarios (e.g., Article 75, Item XII, applicable to PDPs), and by specifically providing that bidding is waived for the acquisition of PES resulting from PDPs, Etecs, as well as PES developed or produced within the scope of a PDIL, provided it has been incorporated into SUS (Articles 24 and 25).
 

Statute #15,471 also established rules for contracting PES with a view to the period after the conclusion of a PDP or PDIL:
 

The Statute provides that a bidding procedure may be conducted exclusively for the acquisition of PES developed or produced by EES (Article 26). This is a significant change from the strategy design previously established by Decree #11,715 and could be subject to criticism, among other reasons, for potentially creating a market reserve.
 

The Statute also provides for the possibility of using a margin of preference, but does not make clear in which situation (Article 27). By stipulating that margins of preference may be applied in bids involving domestic PES, pursuant to Article 26 of the Public Procurement and Administrative Contracts Act, Statute #15,471 does not clarify whether this application will occur in bids where imported drugs compete with nationally produced ones, using the margin of preference exactly under the terms of Article 26 to benefit domestic products, or whether the margin will be applied as an additional scenario, aimed at bids involving only domestic PES. It will be important to monitor how the regulation addresses this issue.
 

Finally, Statute #15,471 also provides for the possibility of centralized procurement of PES (Article 29) and allows the participation of companies grouped in a consortium or formed as a special purpose entity, subject to the conditions set out in regulation (Article 31).

Regarding the presidential vetoes
 

Statute #15,471 was published with vetoes of three articles compared to the text previously approved by the Brazilian Congress.
 

Among the vetoed provisions are those that would have provided for the adoption of technology offset mechanisms in certain acquisitions of imported PES, the establishment of a specific tariff treatment for EES, and an amendment to Statute #6,360/1976 that would have imposed restrictions on importing certain products without sanitary registration when domestic production by an EES existed.
 

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