Special Section: Latin America
Cooperation and Reliance: What’s Next for Latin America?
DIA Europe 2023 Latin America Town Hall
Sérgio Cavalheiro Filho
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Leonardo Semprun

t DIA Europe 2023, representatives from Latin America National Regulatory Authorities (NRAs), multilateral organizations, academia, and industry (see below) shared their collaborative experiences to help the region’s regulators build trust in research and regulation (and more efficiently use resources) in their jurisdictions, in the first Latin America Town Hall presented by DIA Europe.

Latin America is one of the fastest-growing regions of the world both in demographics and economics. This brings new challenges for NRAs, industry, and other stakeholders, not only because of the growing complexity and volume of new products under regulatory oversight but also because of other emerging technologies and ever-changing public health needs.

There are more than 20 regulated markets in Latin America, most of them completely autonomous, divergent, and with different levels of regulatory maturity. According to the Pan American Health Organization (PAHO) report Strengthening Regulatory Systems in the Americas, approximately 23 percent of NRAs in this region have a prominently positioned regulatory system, which means that they have the most complete and strict legal bases and organizational frameworks for regulation. But other NRAs in the region, even those with foundational frameworks, still face regulatory gaps.

International Regulatory Collaboration

Brazil’s regulator, ANVISA, has expanded its international collaboration in different ways over recent years. They recognize that being part of international forums not only contributes to strengthening regulatory processes in Brazil but also allows ANVISA to be part of relevant decision-making processes. The agency also maintains a number of bilateral agreements and confidentiality arrangements with regulators of different levels of maturity across the globe to enable the sustainable sharing of information and best practices. Another way ANVISA invests in cooperation is by participating in collaborative projects like FDA’s Project Orbis. ANVISA aims to become a WHO-Listed Authority (WLA) soon.

WHO, on the other hand, emphasizes the Collaborative Registration Procedure (CRP), a mechanism that enables working closely with other Member States and their regulatory experts, provides recipient countries with the information they need to trust others, and relies on (applies reliance to) what other countries have approved through prompt certification. The Latin America Town Hall WHO representative explained that the CRP is a well-received, proven mechanism that fosters trust and expedites information sharing between countries. At the same time, the CRP reduces duplication of effort and enables evidence-based decision-making in many countries that cannot afford to perform regulatory assessments and inspections of their own.

Town Hall participants also shared that the European Medicines Agency (EMA) has long been a reference agency for different authorities in Latin America (and beyond) and has participated in discussions and projects that pioneer international collaboration and other innovative ways of working. Collaboration and cooperation between EU Member States have existed as prominent features since the very creation of this agency. They further noted that EMA applies a high degree of transparency in its activity and procedures, something that every NRA aiming at becoming a reference at the regional or international level should target.

Driving Factors for Agreements Among Regulators

International agreements among NRAs have been in place for many years to facilitate the exchange of scientific and technical communication on medicines and other products, with confidentiality being the key issue. No specific international instruments establish standards for the structure or contents of such international agreements, but they facilitate reliance mechanisms by providing a guide and supporting required actions without undermining the legal jurisdiction of NRAs.

From the NRA perspective, one authority can only rely on the assessment of another based on their understanding of the other’s decision, which means that efficient and integral information sharing is key. This is one of the major benefits of agreements between regulators: they facilitate the exchange of information. However, Confidentiality Agreements and Memorandums of Understanding (MoU) are only a start; in Latin America, they have allowed NRAs to exchange information, but trust building is a principle that regulators should keep in mind throughout their daily work. The pandemic provided an opportunity for NRAs to formalize some interactions and relationships that already existed into written agreements, which in turn fostered even more interactions between these agencies and industry.

The COVID-19 health emergency made it evident that hurdles to regulatory reliance and cooperation persist in Latin America. The major obstacle is regulators lacking the capacity, tools, and adequate regulatory frameworks to engage in some of these activities. At the same time, the will of countries in the region to collaborate was boosted during the pandemic, and understanding the importance of regulatory trust, collaboration, and work-sharing has been gaining momentum in the region.

The Path Forward

The Latin America Town Hall advanced the multistakeholder view that the region’s health ecosystem must support regulatory systems focused on convergence, reliance, and recognition; on optimizing the efficiency of regulatory activities; and on adding value through regulation that benefits patients. The role of WHO as a multilateral facilitator, and especially implementing the Global Benchmarking Tools (GBT) and the WHO-Listed Authorities (WLA) system, which can further promote regulatory convergence, harmonization of approaches, and international cooperation, will contribute to improving good regulatory practices in the region.

Challenges for Latin America will continue to include the growing need for advanced regulatory expertise due in part to the disruptively innovative clinical application of cell and gene therapies and other products in the industry pipeline. Regulatory reliance on trusted reference NRAs will not only be expected but necessary in this context.

In Latin America, there can be skepticism towards the pharmaceutical industry; industry and NRAs are often seen as having different if not opposite points of view. This perception must be revisited, because regulators and industry work towards a common goal: enabling the access and supply of safe, effective, and quality medical products to benefit patients by strengthening dialogue and mutual understanding.

Latin America Town Hall participants: Mariana Roldão Santos: WHO; Leonardo Dutra: Brazilian Health Regulatory Agency (ANVISA); Larry Liberti: Temple University School of Pharmacy; Cammilla Gomes: Roche, Latin America Regulatory Network of the European Federation of Pharmaceutical Industries and Associations (EFPIA); Heraclio Rodríguez: Sanofi, on behalf of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).