Investigation launched by Washington echoes pressure from major pharmaceutical companies and baselessly accuses Brazil of failing to adopt intellectual property protection measures.
The United States (US) government is pressuring Brazil to establish intellectual property measures that undermine the country’s autonomy in making public health decisions, and may delay or even prevent the availability of more affordable medicines for people living in Brazil.
This pressure comes as part of a broader investigation by the Office of the United States Trade Representative (USTR) into policies and practices allegedly discriminating against or illegally restricting trade with the US. Among the many issues under investigation – such as tariffs, the ethanol market, and electronic payment systems – the US also aims to interfere with Brazil’s intellectual property protection policies.
Médecins Sans Frontières (MSF) submitted comments to the US government’s investigation and is expected to take part in the related hearing, scheduled for 3 September 2025 in Washington, DC. This continues MSF’s long-standing opposition to USTR processes that are designed to pressure countries to not use public health safeguards and to implement intellectual property protection measures that go beyond international obligations, including those undertaken by the US.
“People’s lives should never be used as bargaining chips in trade negotiations. The US must stop using trade policy to uphold corporate monopolies at the expense of patients,” said Mihir Mankad, director of advocacy and global health policy at MSF USA.
Forcing Brazil to adopt intellectual property measures that far exceed international agreement requirements will only make medicines even more inaccessible. The world should see this for what it really is: an attack on the right to health and on the established legal instruments available to countries to realize it.
These US practices have interfered with the rights and obligations of several countries, not only Brazil, to ensure the protection of public health and promote access to medicines. In order to shield the interests of pharmaceutical companies, the USTR has previously pressured many countries, including India, China, Malaysia, Chile, and Colombia over patentability criteria, the use of compulsory licensing, the absence of additional market exclusivities, and other related matters.
MSF has witnessed the harmful effects of policies that put commercial interests before people. Since MSF often relies on medicines, vaccines, and diagnostic tests purchased from national governments, barriers to availability and affordability directly affect our ability to provide care and respond effectively to medical needs in the places we work.
For example, patent and data exclusivity barriers block access to affordable generic versions of lenacapavir for HIV prevention, delayed access to affordable generic versions of bedaquiline for the treatment of drug-resistant tuberculosis, restricted expansion of medicines and medical devices for diabetes treatment, and high prices for rapid molecular tests such as GeneXpert, all of which limit the availability of these medical tools in resource-limited settings, including those where MSF works.
As part of the current investigation against Brazil, we focused our submission on three intellectual property and pharmaceutical product issues: patent application backlogs, counterfeit products, and unfair commercial use or disclosure of test data.
The US must stop using trade policy to uphold corporate monopolies at the expense of patients
The USTR’s investigation document criticizes the time taken to review patent applications due to the potential impact this process may have on the effective duration of patent protection. However, these criticisms are unfounded, because patent applicants can block competitors from entering the market as soon as an application is filed, meaning there does not have to be any impact on the effective duration of patent protection. Additionally, Brazil’s patent examination policy complies with international obligations, and so does not need to be adapted. It is also rigorous which, unlike some countries that adopt only a formal examination of patent applications, prevents the issuance of the kind of low-quality patents that restrict competition and limit access to health technologies. Therefore, retaining a system of substantive search and examination under which all patent applications must be reviewed before being granted to ensure that patentability criteria are met is essential
Regarding border measures related to counterfeit products, MSF has long warned that overly broad anti-counterfeiting rules increase the risk of legitimate generic medicines being wrongly seized by customs authorities. This can lead to harmful delays for people who need access to lifesaving medicines. Furthermore, the detention and potential destruction of medicines mistakenly classified as counterfeit may create a chilling effect on the international trade of generic medicines.
The USTR’s investigation also criticizes Brazil’s alleged lack of protection against unfair commercial use and unauthorized disclosure of tests and other data generated to obtain approval for the marketing of pharmaceutical products. However, Brazilian law already adopts adequate measures against the improper use and disclosure of test data. What it does not include is so-called ‘data exclusivity’, which the USTR has previously pressured countries to adopt, even though doing so would go beyond the protections required under international agreements.
Data exclusivity prohibits regulatory agencies from referring to test data submitted by the company that generated the data as part of the regulatory approval process for generic medicines. This forces the generic manufacturer to repeat clinical trials in humans just to resubmit all the data to demonstrate the product’s efficacy and safety. Repeating clinical trials on humans when the efficacy of a product is already known is a violation of ethical principles of human research. Data exclusivity also goes beyond what is required in the TRIPS Agreement, and can increase the cost of developing generic medicines which in turn may delay or block their market entry.
“The United States is putting the commercial interests of pharmaceutical companies above the interests of all people who need access to medicines,” said Rachel Soeiro, coordinator of MSF’s Access Americas Hub. “The pressure may lead to measures that will make it even harder to access medicines, even during a global health crisis, as we recently witnessed.”
