Bill #1,580/2026 stems from a diagnostic study prepared by the Secretariat for Economic Reforms of the Ministry of Finance (SRE/MF), which identified price‑cap differentials of up to 80% among clinically equivalent medicines, attributable not to differences in efficacy, safety, or production costs, but rather to historical and regulatory factors. The authors of the bill also rely on IBGE data, according to which medicines account for 65% to 70% of households’ direct out‑of‑pocket health expenditures, as well as on data from the SRE/MF itself indicating that the pharmaceutical industry’s revenues increased by 55% between 2020 and 2023, while the volume of units sold grew by only 13% over the same period.

From a regulatory standpoint, the bill introduces Article 5‑A into Statute #10,742/2003, establishing that the CMED shall adopt a methodology for the progressive equalization of price caps among medicines sharing the same active ingredient, concentration, pharmaceutical form, route of administration, and therapeutic indication. The methodology must be anchored to the lowest existing price cap within the relevant group, and equalization based on the highest cap is expressly prohibited, except where supported by a specific technical justification. The methodology must also be preceded by a competitive impact assessment. Biological medicines, orphan drugs, and medicines protected by patents may be subject to differentiated treatment, provided that such treatment is duly justified and technically substantiated. The bill further requires a public consultation period of no less than 60 days for the definition of the methodology, as well as the preparation of an annual monitoring report, to be published by the CMED.

The newly proposed Article 6‑A, in turn, prohibits health insurance providers, hospitals, and other healthcare service providers from automatically using the price cap as a basis for remuneration or reimbursement, requiring instead that they adopt as a reference the prices effectively paid for medicines. The CMED will have 90 days from the publication of the law to issue the equalization rules, in accordance with the statutory guidelines.

The bill was introduced on April 1, 2026, and is currently at an early stage of legislative review, with no rapporteur appointed to date. We will continue to monitor its progress and remain available to provide impact assessments and strategic guidance on regulatory engagement.

Our team is available to assist in interpreting the bill and in adapting to the upcoming new regulatory landscape.

For more information, please contact us at info@lickslegal.com.