By Brazil Stock Guide – Brazil’s leading pharmaceutical associations are voicing concern over congressional proposals to relax compulsory licensing rules, arguing that the measures could undermine legal certainty and deter investment in research, development and local manufacturing. Lawmakers have framed the initiative as a way to expand access to medicines, but industry representatives say the approach oversimplifies a structurally complex issue.
Among the most vocal groups is Sindusfarma, the São Paulo pharmaceutical industry union representing both domestic and multinational manufacturers, including producers involved in local industrial operations and supply chains. Interfarma, which represents research-based pharmaceutical companies and global innovators active in Brazil, has also expressed reservations about weakening intellectual property protections and the potential impact on clinical research and pipeline investment.
In parallel, Alanac — which brings together national laboratories and generic drug producers — has emphasized the need for regulatory stability to maintain long-term productive capacity and technology transfer flows. Industry leaders argue that compulsory licensing is internationally recognized as an exceptional tool, reserved for emergencies or clearly defined public interest cases, not as a routine industrial policy mechanism.
According to the manifesto circulating in Brasília, breaking patents alone does not ensure faster access to medicines. Pharmaceutical production requires complex technological capabilities, infrastructure and structured knowledge transfer processes that can take years to become viable. Associations warn that abrupt changes to patent policy could weaken investor confidence, disrupt public-private partnerships and affect the long-term sustainability of Brazil’s health industrial ecosystem.
Senate to Assess Temporary Patent Break for Mounjaro
The debate gained urgency after the Federal Senate confirmed it will review Bill 160/2026, introduced by Senator Dra. Eudócia (PL-AL), proposing the suspension of patents for Mounjaro and Zepbound, drugs that can be prescribed for weight loss. The project would allow temporary, non-exclusive suspension of patent rights in the public interest, enabling domestic production if regulatory and sanitary requirements are met.
Under the proposal, compulsory licensing could be granted in cases of insufficient supply, elevated prices or significant public health impact, subject to technical analysis by Anvisa, Brazil’s health regulator. The bill cites precedents such as the 2007 compulsory license for Efavirenz, an HIV treatment, and the 2021 authorization allowing temporary patent suspension for vaccines and medicines during the Covid-19 pandemic.
Health Minister Alexandre Padilha said on Tuesday (10) that the federal government does not support the bill. “We will position ourselves in line with what the World Health Organization says, and at this moment there is no such debate there,” he said, signaling that the executive branch is not aligned with the proposal under review in Congress.
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