Bill 2.583/2020 is approved in the Senate and creates a legal framework for the Health Industrial Complex [2026]

On Tuesday (June 30), the Federal Senate approved Bill 2.583/2020, which establishes the National Health Strategy of the Economic-Industrial Health Complex (CEIS) as a legal framework for the sector’s industrial policy. The text, which had already passed the Chamber of Deputies in July 2025, now proceeds for presidential sanction.

The bill was authored by Congressman Doutor Luizinho (PP/RJ) and was reported in the Senate by Senator Rogério Carvalho (PT/SE), who emphasized in plenary that the proposal “fills a gap in the legislation on the subject” by transforming into law what until now was supported only by infralegal norms.

What Bill 2.583/2020 establishes

The bill creates the National Health Strategy, a set of guidelines and instruments aimed at encouraging the national production of medicines, vaccines, equipment, and essential medical supplies for the Unified Health System (SUS).

Among the established guidelines are:

The strengthening of SUS and the guarantee of access to health technologies
The training of human resources for the sector
The prevention and combat of epidemics
The incentive for national production of medicines and medical devices
The international insertion of strategic Brazilian companies
The use of the State’s purchasing power to stimulate local production

Strategic Health Company (EES) — the core of the new framework

One of the central elements of the Bill is the creation of the legal figure of the Strategic Health Company (EES). To qualify as an EES, a company must meet minimum conditions, such as:

Have an industrial facility in Brazil for the manufacturing of strategic health products (PES)
Present a history of productive activity and innovation
Have the capacity to ensure continuity and productive expansion in the country

Accredited companies will have access to significant incentives:

Priority in regulatory procedures — registrations, licenses, and authorizations with priority treatment
Priority in public calls for research, development, and innovation
Facilitated access to BNDES credit lines — with competitive rates, adjustable terms, and grace period
Differentiated import tariffs, compatible with the competitiveness of national industry

Furthermore, the proposal authorizes public administration to conduct exclusive tenders for the purchase of products developed by strategic companies. In other bids, a preference margin of up to 20% may be applied over the price of the winning product, provided that the national good follows Brazilian technical standards and the EES can supply, at minimum, 30% of the contracted quantity.

Accreditation will be done by act of the Executive Branch, which may de-accredit the company in case of risks to national sovereignty or the supply of SUS. There will also be permanent monitoring of prices practiced in national and international markets.

The problem the Bill seeks to solve is the external dependence of the health sector

Brazil imports about 90% of active pharmaceutical ingredients (APIs) used in drug production, and the health sector’s trade deficit exceeds US$ 10 billion annually. Dependence is especially critical for high-complexity medicines — oncological, biological — and high-tech equipment, such as CT scanners and magnetic resonance imaging.

The COVID-19 pandemic dramatically exposed this vulnerability. The country faced shortages of ventilators, PPE, and active ingredients for vaccines, and suffered from logistical difficulties in acquiring essential raw materials. It was in this context that Bill 2.583/2020 was presented in May 2020.

The processing — the path to approval

Bill 2.583/2020 underwent a long processing, passing through committees, replacing rapporteurs, and accumulating opinions over six years:

Date	Event
12/05/2020	Presentation in the Chamber by Rep. Doutor Luizinho (PP/RJ)
2021-2024	Rapporteurs Juscelino Filho, Alexandre Padilha, and Clodoaldo Magalhães; public hearings
08/07/2025	Approved in the Chamber — 316 votes in favor, 110 against
30/06/2026	Approved in the Senate — Rapporteur Rogério Carvalho (PT/SE)
2026	Proceeds for presidential sanction

Amendments and the clash with the clinical research industry

During its processing in the Senate, the bill received 29 amendments. Of these, 24 were approved, with drafting changes to improve legislative technique without altering the essential content. Three were rejected in committees and two did not pass the plenary.

The rapporteur Rogério Carvalho defended the rejection: “By waiving the requirement for industrial installation in the country and admitting mere commercialization as a criterion for accrediting strategic health companies, the proposal detaches the foreseen public incentives, which are precisely for the effective internalization of productive capacity and the mastery of manufacturing processes in national territory.”

Next steps

The text approved in the Senate now proceeds to the Palácio do Planalto, where President Lula may sanction it fully or veto specific provisions. Given that the government is the proposer of the NIB and that the rapporteur in the Senate is from the allied base, full sanction is the most probable scenario.

If approved without vetoes, the new law will come into effect immediately, paving the way for the accreditation of the first Strategic Health Companies and the operationalization of the foreseen incentives.

What to observe going forward

The approval of Bill 2.583/2020 is a milestone, but implementation will be the real test. Some points deserve attention:

Regulation: the Executive Branch will need to define objective criteria for the accreditation of EES and for the list of strategic health products
Budget: the incentives (BNDES credit, differentiated tariffs) depend on budgetary allocations and financing capacity
Price monitoring: the price monitoring mechanism will be essential to avoid distortions
Articulation with patent policy: national drug production involves intellectual property issues that the Bill does not directly address

Brazil has already demonstrated, in critical moments like the pandemic, that the capacity to internally produce health supplies is a matter of sovereignty. It remains to be seen whether the legal framework now approved will be sufficient to transform this capacity into reality.