[CTC] Brazil’s Right to Balance IP and Public Health

[Arthur Stamoulis]

*SouthNews No. 535, 17 September 2025*


*Brazil’s Right to Balance IP and Public Health*

*Submission to USTR defends Brazil’s lawful use of TRIPS flexibilities*


*By Nirmalya Syam*

In response to the United States Trade Representative's (USTR) Section 301
investigation into Brazil's intellectual property (IP) policies
<https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=d0f4f35622&e=4b8d039b1d>,
Prof. Carlos Correa, Executive Director of the South Centre, submitted
written comments defending Brazil's IP framework and its use of public
health safeguards.


The submission affirms that Brazil’s IP regime is fully consistent with its
international obligations — and that its approach to public health and
innovation reflects a legitimate, lawful policy balance under the Agreement
on Trade-Related Aspects of Intellectual Property Rights (TRIPS).


The USTR alleges that Brazil fails to provide “adequate and effective”
protection of IP rights. However, Brazil has implemented a patent framework
that meets — and in some respects exceeds — its obligations under the World
Trade Organization’s (WTO) TRIPS Agreement. This includes provisions such
as pipeline patent revalidation and patent term extensions.


Brazil’s IP system also incorporates public health safeguards that TRIPS
explicitly allows. These include compulsory licensing, rigorous patent
examination to avoid unjustified monopolies, and the use of legal
exceptions like the Bolar and experimental use clauses. The submission
emphasizes that Brazil’s exercise of these flexibilities is both legally
sound and rooted in its constitutional duty to ensure access to healthcare.


Brazil’s universal public health system (SUS) has played a vital role in
responding to major public health challenges such as HIV/AIDS and hepatitis
C. Measures to ensure access to affordable medicines — including price
negotiations and, in one case, a compulsory license — have helped fulfill
that mandate while remaining firmly within the legal space TRIPS provides.


Importantly, Prof. Correa notes that there is no evidence of systemic bias
or discrimination against patent holders in Brazil. Judicial and
administrative mechanisms remain fully available for enforcement of IP
rights, and Brazil’s legal system has ruled against certain TRIPS-plus
provisions in favour of constitutional protections.


What is concerning, however, is the use of Section 301 — a unilateral trade
tool — to pressure countries into adopting standards beyond their WTO
obligations. As we note in the comments, this practice risks undermining
the credibility of the multilateral trading system and the balance that
TRIPS was designed to achieve. A WTO panel has previously cautioned that
even the threat of such action can disrupt the equal footing that WTO rules
are meant to provide.


Hence, it is critical to stress that Brazil is operating within the bounds
of international law. It is using the policy space allowed under TRIPS to
pursue its health and development objectives. These actions are not trade
violations — they are lawful, necessary, and aligned with the Doha
Declaration on Public Health and the TRIPS Agreement.


The USTR should reconsider its approach and recognize that
development-oriented IP policies, especially those supporting public
health, are not only legitimate — they are vital. All WTO members,
including Brazil, should be able to exercise their rights under TRIPS
without facing undue pressure or unilateral sanctions.


*Author: Nirmalya Syam is Senior Programme Officer of the Health,
Intellectual Property and Biodiversity Programme (HIPB) at the South
Centre. *




*SouthNews is an e-newsletter service of the South Centre providing
information and news on topical issues from a South perspective.To view
other articles in SouthNews, please click **here*
<https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=986d3a3df3&e=4b8d039b1d>

*.For more information, please contact Anna Bernardo of the South Centre:
Email **abernardo at southcentre.int* <abernardo at southcentre.int>*.*
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