MSF denounces that US trade pressure may interfere with access to medicines in Brazil

These US practices have interfered with the right and obligation of several countries, not only Brazil, to ensure the protection of public health and promote access to medicines. In order to shield pharmaceutical company interests, the USTR has historically threatened countries such as India, China, Malaysia, Chile, Colombia, and many others over patentability criteria, the use of compulsory licensing, the absence of additional market exclusivities, and other related matters.

In this context, MSF witnesses the harmful effects of policies that protect commercial interests to the detriment of patients’ needs. 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 our operations.

Concrete examples include patent and data exclusivity barriers that block access to affordable generic versions of lenacapavir for long-acting HIV prevention, delayed access to affordable generic versions of bedaquiline for drug-resistant tuberculosis, restricted expansion of medicines and medical devices for diabetes treatment, and high prices for rapid molecular tests such as GeneXpert, which limit their availability in resource-limited settings, including those where MSF runs projects.

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 USTR’s investigation document criticizes the time taken to review patent applications and its potential impact on the duration of protection. These criticisms are unfounded because Brazil’s patent examination policy is rigorous and complies with international obligations. Unlike some countries that have adopted only a formal examination of patent applications, Brazil has 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. Rigorous examination standards are essential to prevent the issuance of low-quality patents, which restrict competition and limit access to health technologies.

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 life-saving 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. But 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 historically pressured countries to adopt, even though it goes beyond protection required under international agreements.

Data exclusivity is a measure that increases the cost of developing generic medicines, in addition to being a serious violation of ethical principles in human research. It prohibits regulatory agencies from referring to test data submitted by the company that generated the data (the reference medicine) as part of the regulatory approval process for generic medicines. This forces the generic manufacturer to resubmit all the data—including information obtained only through human studies (clinical trials)—to demonstrate the product’s efficacy and safety, and not just the data related to quality and therapeutic equivalence of the medicine, as currently required in Brazil.

“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.”