Strengthening ANVISA: A Pivotal Moment for U.S.-Brazil Cooperation

This was originally published as an op-ed in Portuguese in JOTA.

As Latin America’s largest economy, Brazil is a key player in the global healthcare market. At the heart of its regulatory framework is ANVISA, Brazil’s Health Regulatory Agency that has safeguarded the safety and efficacy of essential products, including pharmaceuticals, vaccines, and medical devices, for over two decades. Now, faced with a critical staffing crisis, ANVISA's ability to maintain its high standards, and its reputation as a global reference national regulatory authority ensuring the safety, efficacy, and quality of regulated health products that can support millions of patients in the country is under threat, with repercussions that extend far beyond Brazil’s borders.

Addressing this challenge is crucial for businesses from all countries invested in Brazil’s health sector and global supply chains. The U.S. Chamber of Commerce’s Brazil-U.S. Business Council recognizes ANVISA’s crucial role and stands ready to support the agency through advocacy, promoting regulatory convergence between the U.S. and Brazil, and facilitating public-private partnerships to strengthen its capacity and effectiveness.

The Silent Backbone of a Global Health Network

ANVISA is no ordinary regulator. Overseeing over 20% of Brazil’s GDP, the agency is responsible for industries that touch nearly every aspect of daily life—pharmaceuticals, medical devices, food, cosmetics, and more. ANVISA’s regulations ensure that products entering the market meet stringent safety and efficacy standards, providing a crucial line of defense for public health in Brazil. ANVISA’s importance stretches beyond Brazil: it is a trusted partner of the U.S. Food and Drug Administration (USFDA) and a leader in regulatory alignment across the Americas and at the global level. This leadership and partnership with the USFDA has enabled faster, more effective and efficient product approvals in Brazil and a more resilient Brazilian and global health supply chain.

However, ANVISA is facing a critical challenge. By the end of 2024, approximately 500 ANVISA employees, nearly 25% of its current workforce, are expected to begin retiring due to retirements with only 50 replacements authorized. For an organization already operating below optimal staffing levels, this reduction is expected to create bottlenecks in critical areas such as product approvals, inspections, and border control. With 1,604 current civil-service employees complemented with 400 support staff, but with a need for at least 1,250 additional staff, ANVISA’s ability to fulfill its mandate is at risk. This concern affects first and foremost Brazilian patients and the Brazilian health system, but also the Brazilian health industrial complex and global health product supply chain that rely on effective and timely regulatory processes to remain competitive. Efficient regulatory systems are essential not only for ensuring timely access to products but also for bolstering Brazil’s position as an attractive destination for investment including research, development and production. ANVISA’s effectiveness directly influences Brazil’s capacity to grow sectors like biotechnology, pharmaceuticals, and medical technology. A delay in regulatory approvals could slow innovation, affect job creation, delay access to life saving products, and undermine Brazil’s broader economic growth ambitions.

The Stakes for Brazil’s Role in Competitive Global Health Product Supply Chains

ANVISA’s effectiveness and efficiency are a critical foundation to a competitive Brazilian health industrial complex that delivers for patients and the healthcare manufacturing base that works with and in Brazil. Brazil is also a key healthcare trading partner for the U.S., with billions of dollars in medical products exchanged each year.

Brazil’s production capacity offers resilience in the face of global supply chain disruptions. But for this potential to be fully realized, ANVISA must be equipped to handle the growing demand for regulatory oversight. If the agency falters, it could create bottlenecks leading to delays in the supply of essential products like life-saving medications and medical devices, which would have global consequences outside of Brazil, such as shortages in broader Latin America, Africa, Southeast Asia, the U.S. and Europe.

Turning Crisis into Opportunity: Deepening U.S.-Brazil Regulatory Cooperation

While the challenges facing ANVISA are serious, they present a unique opportunity to deepen regulatory cooperation between the U.S. and Brazil. Over the years, ANVISA and the USFDA have built a solid foundation for collaboration, sharing best practices and aligning on critical regulatory issues. Expanding this cooperation could help ANVISA manage its current staffing crisis while laying the groundwork for long-term improvements in regulatory efficiency.

One potential area of opportunity is leveraging existing frameworks like the Agreement on Trade and Economic Cooperation (ATEC) between the U.S. and Brazil. By expanding this agreement to include more specific provisions for healthcare product regulation, both countries can benefit from smoother, faster processes for regulatory approval and product flow. Technical cooperation between ANVISA and the FDA, including staff exchanges and training programs, could also help bridge the skills gap that will inevitably arise as senior staff retire.

Recommendations for Securing the Future of ANVISA

 To help ANVISA meet current and future demands, we propose the following key steps:

1. Immediate authorize the hiring of new staff: The Brazilian government should urgently authorize hiring at least 600 new positions at ANVISA to maintain effective regulation and prevent healthcare sector bottlenecks.
2. Accelerate modernization efforts: ANVISA should prioritize the modernization of its IT systems and implement artificial intelligence tools to streamline its regulatory processes, improve efficiency, and reduce the workload of the current staff.
3. Engage in U.S.-Brazil information exchange and technical cooperation including examination of the USFDA coordination with U.S. Customs and Border Protection (USCBP) for U.S. health product imports.
4. Enact legislative reforms to align staffing with regulatory scope: The Brazilian Congress should revise legislation to scale ANVISA's workforce in line with its growing responsibilities, enabling the agency to better manage Brazil's expanding healthcare industry.

A Future-Forward Approach

Although the Brazilian government has recently finished negotiations with regulatory agencies, addressing key issues like salary adjustments and proposing measures to fill vacant positions, this does not address the impending ANVISA staffing crisis which is a separate issue tied to ANVISA’s authorizing legislation and the number of ANVISA staff designated therein. ANVISA has a long history of adapting to challenges and finding innovative solutions, however the time is opportune to solidify the agency’s operational funding and structure to best lead in the face of modern global health realities.

For Brazilian and U.S. businesses, a well-resourced ANVISA means a more predictable, effective and reliable regulatory environment. It means faster patient access, approvals for new products, more reliable supply chains, smoother trade relations, a more credible ANVISA on the world stage, and continued access to one of the most important markets in Latin America. Together, Brazil and the U.S. can turn this challenge into an opportunity for deeper cooperation and stronger health outcomes. The U.S. Chamber of Commerce and the Brazil-U.S. Business Council are committed to working with both governments to support ANVISA in overcoming these challenges and fostering a resilient healthcare system.

About the authors

Leonardo Abranches