Compulsory Licensing in Brazil (2026): The Mounjaro Case
In the first quarter of 2026, and particularly over the past few weeks, compulsory licensing has re-emerged as a recurring legislative theme in Brazilian Congress. This renewed momentum is illustrated by Bill #157/2026, introduced in the Senate and brought into the spotlight in March as part of the ongoing congressional debate on access to high-cost medicines.
The bill proposes amendments to the Industrial Property Law to authorize compulsory licensing based on “public interest in oncological health,” yet does so in markedly broad and abstract terms. This lack of technical specificity typifies the current wave of initiatives, which appear more reactive than structurally aligned with the legal and economic complexities of innovative pharmaceutical products.
Specifically with respect to tirzepatide, on February 6th, 2026, the Brazilian Senate received Bill #160/2026, a proposal aimed at enabling a compulsory licensing (“CL”) mechanism for tirzepatide (Mounjaro) allegedly to expand access to obesity treatment in Brazil’s Unified Health System (SUS)[1]. The proposal does not, by itself, grant a compulsory license. Rather, if approved by Congress, the Executive Branch would then be authorized to issue a temporary, non‑exclusive license grounded in Article 71 of the Brazilian Patent Statute (LPI), provided that additional statutory conditions are met. The Bill ties any such measure to a prior technical analysis by the Brazilian Food and Drug Agency (ANVISA), to determine insufficient supply, excessive pricing, or a relevant public‑health impact—criteria set out in the draft bill to substantiate both a public‑interest declaration and compliance with the LPI requirements applicable to CL.
From a procedural standpoint, Bill #160/2026 remains at an early stage, as it has only just entered the Brazilian Senate and must still clear committee review and the Plenary, before moving to the Brazilian House of Representatives and, ultimately, to presidential sanction.
In parallel, on February 9 this year, the Brazilian House of Representatives approved an urgency regime for a separate Bill #68/2026 declaring tirzepatide-based medicines to be of public interest. Even if approved, an actual CL would still require a separate Executive Branch act, subject to the constraints of the LPI and to the safeguards introduced by Statute #14.200/2021 during the COVID-19 pandemic.
Following the 2021 reform during COVID-19, Article 71 of the LPI, which had already allowed compulsory licensing in cases of emergency or public interest, was amended to: (i) recognize international health emergencies and congressionally recognized nationwide calamities as valid triggers for such declarations, whether by statute or Executive act, (ii) extend CL to patent applications, and (iii) require publication, within 30 days, of a list of potentially relevant patents or applications, with stakeholder consultation and defined parameters for remuneration. Any CL must be ex officio, temporary, and nonexclusive, and must rest on a finding that the patent holder or licensee does fails to meet the actual public need. These procedural steps and substantive predicates confirm that CL remains a last-resort remedy, not a routine instrument of price regulation.
Brazil’s track record helps separate rhetoric from outcomes. In 2007, Brazil issued its first-ever CL for a patented medicine: the Efavirenz case. The decision was formalized through Decree #6.108/2007, following a declaration of public interest by the Ministry of Health. At the time, Efavirenz was used by approximately 38% of HIV/AIDS patients in Brazil. The price offered by Merck, the patent owner, was USD 1.59 per tablet, resulting in an annual cost of USD 580 per patient, totaling approximately USD 42.9 million in 2007 alone. In contrast, generic versions from Indian manufacturers were available for USD 0.45 per tablet, or approximately USD 163–166 per patient per year. Although Merck offered a 30% discount during negotiations, the Brazilian government rejected the proposal.
The CL authorized the Ministry of Health to import generic Efavirenz from WHO-prequalified Indian laboratories. In parallel, the government initiated a plan to develop local production capacity. However, despite these efforts, full local API production was never effectively achieved.
Around 2017-2018, CL was publicly referenced as leverage in the Spinraza dossier for a high-cost rare-disease therapy. Officials from the Ministry of Health publicly referenced the possibility of issuing CL, widely understood as a form of price pressure. Policy subsequently shifted toward a risk-sharing agreement (RSA) pilot, which ultimately was executed. No CL was issued.
During COVID19, Congress reengineered the CL toolkit by enacting Statute #14.200/2021 to proceduralize emergencies, yet no CL was executed during the pandemic. Instead, Brazil’s operational response favored regulatory acceleration and supply agreements, reinforcing a historical pattern: CL is retained as an available legal instrument but is rarely used in practice and only under exceptional, fact-intensive circumstances.
That history matters when the conversation turns to tirzepatide. Mounjaro is already approved in Brazil for type 2 diabetes and, since June 9, 2025, for chronic weight management. In parallel, ANVISA launched a priority analysis track for GLP-1 class dossiers (including semaglutide and liraglutide), specifically designed to stabilize supply and encourage local production, a deliberate strategy to expand access through competition and manufacturing capacity, rather than through compulsory licensing.
In addition, Health Minister Alexandre Padilha publicly stated that the Government will follow WHO guidance and does not currently support CL for GLP‑1 “pens”, pointing instead to regulatory pathways, competition, and forthcoming class expiries as the preferred access mechanisms. In parallel, pharmaceutical industry associations, notably within the generics segments, issued a joint public manifesto opposing the indiscriminate use of CL, reinforcing the perception that the current push reflects an isolated, election‑season initiative, rather than coherent Executive Brach policy.
Likewise, following a meeting held on February 12, 2026, with Interfarma (the association representing Brazil’s pharmaceutical R&D industry), Vice President and Minister of Development, Industry, Commerce and Services Geraldo Alckmin reaffirmed opposition to the tirzepatide-related bills. Alckmin emphasized that such measures introduce legal uncertainty, reduce regulatory predictability, and risk discouraging investment in the pharmaceutical ecosystem.
From a legal and practical perspective, even if Bills #160/2026 and #68/2026 were enacted, any CL would remain untenable (and arguably unlawful), absent full compliance with the remaining statutory and constitutional predicates. Beyond a purely legislative signal, Article 71 of the LPI still requires an ex officio Executive act following a valid public‑interest or emergency declaration, a documented finding that the patentee or licensee is failing to meet public demand, and strict adherence to the safeguards introduced by Statute #14,200/2021 and Implementing Decree #3,201/1999. Constitutionally, any severe restriction on industrial property rights must satisfy Article 5, XXIX, which protects patents subject to social interest and to Brazil’s technological and economic development. A CL, therefore, demands a specific, evidence‑based public‑interest justification. On the present record — approvals already in force, a regulatory priority lane designed to expand class competition, and no demonstration of chronic shortage— those predicates are not met.
Authors:
Eduardo Hallak (Partner)
Juliana Neves (Partner)
Juliana Libman (Attorney at Law)
[1] Brazil’s Unified Health System (SUS) is the country’s publicly funded, universal healthcare system, constitutionally established to provide free medical services to the entire population.
