On September 17, 2026, the Brazil Program hosted an online event on recent regulatory and policy developments shaping Brazil’s healthcare sector and what they could mean for research, innovation, investment, production, and access to health technologies.
Mariana Faria, director and senior advisor for external relations, partnerships, and resource mobilization at the Pan American Health Organization (PAHO), moderated the conversation. Panelists were Angela Kung and Camila Parise, partners in life Sciences & healthcare at Brazilian law firm Pinheiro Neto Advogados; Francisco Caccavo, technical officer for innovation and production policies for essential medicines and health technologies at PAHO; and Gina Mejia, head of regulatory affairs for Brazil and Latin America at Amgen.
The discussion centered on two recent measures: the Clinical Research Law and the National Strategy for the Health Economic-Industrial Complex (CEIS). Panelists also examined the future of Productive Development Partnerships (PDPs), regulatory cooperation in Latin America, and whether Brazil’s expanding research and production capacity could improve access to health technologies across the region.
A New Framework for Clinical Research
Kung described the Clinical Research Law as the country’s first comprehensive legal framework for research involving human participants. Previously, clinical research was governed by a combination of administrative resolutions, agency guidelines, and ethical rules. The law establishes a national research ethics system defines the responsibilities of sponsors, researchers, institutions, participants, and ethics committees.
Kung highlighted several changes intended to make the approvals more predictable and efficient. These include a risk-based approach to ethical review, a single ethics review instead of the previous two-level process for some studies, and clearer timelines for reviews by ethics committees and Brazil’s Health Regulatory Agency (Anvisa). Panelists also pointed to Brazil’s diverse population, large health care system, and established research community as advantages for clinical research. Kung argued that the framework could make better use of these assets by combining greater legal certainty with more efficient approvals.
CEIS, PDPs, and Local Production
Parise focused on the CEIS strategy, which establishes a legal framework for strengthening Brazil’s capacity to develop and produce medicines, vaccines, medical devices, active pharmaceutical ingredients (APIs), and other strategic health products.
Much of the discussion turned on the future of PDPs, which use technology transfer to support local production of products deemed strategic for Brazil’s health system. Under the new framework, PDPs can also be established between private companies under certain conditions, extending a model that previously required a public laboratory as a partner.
Parise also discussed other instruments designed to support local innovation and the development of new health technologies. She noted, however, that core elements of the framework still depend on implementing regulations from the Ministry of Health, including eligibility requirements for companies and the definition of strategic health products.
Regulatory Cooperation and Access to Innovation
Mejia placed Brazil’s regulatory changes in a broader Latin American context. She highlighted Anvisa’s growing international standing and argued that strong regulation is important not only for patient safety but also for creating the predictability needed for research, investment, manufacturing, and access to new technologies.
The discussion focused in particular on the Rio de Janeiro Declaration and the potential for greater regulatory cooperation among Latin American countries. Mejia emphasized that cooperation does not require countries to give up their own regulatory authority. Instead, greater reliance on assessments conducted by trusted regulators could allow agencies to use their resources more efficiently while maintaining national decision-making. She also noted that the next challenge will be implementation. While there are already signs of greater cooperation among regulators in the region, the procedures needed to translate these commitments into regular practice are still being developed.
Implications for the Region
Caccavo examined what Brazil’s policies could mean for Latin America and the Caribbean. He noted that the region remains highly dependent on imports of active pharmaceutical ingredients and other health technologies, and that much of its scientific research does not translate into products that can be manufactured and brought to market.
In his view, Brazil’s frameworks could have effects across the region. Caccavo highlighted the emphasis on technology transfer, local production of active ingredients and critical components, and support for earlier stages of research and innovation. Building these capabilities in Brazil could contribute to more regional suppliers, greater competition, and the development of products designed around the health priorities of Latin America and the Caribbean.
Panelists also discussed PAHO’s regional procurement mechanisms as one way Brazilian production could reach a wider market.
What to Watch
Implementation was the recurring concern. Brazil has put in place new legal and policy frameworks connecting clinical research, innovation, production, regulation, and access, but several parts of this architecture are still incomplete.
Panelists identified four questions to watch: whether greater regulatory certainty produces more clinical research and innovation; whether Brazil’s industrial policies attract both domestic and foreign investment; whether closer regulatory cooperation speeds access to health technologies; and whether Brazil’s expanding capabilities can strengthen health production and supply resilience.
