SANTA MARTA, Colombia, (PAHO) - The Pan American Health Organization (PAHO) on Thursday, reaffirmed its commitment to regulatory harmonization and health self-reliance in Latin America and the Caribbean, during a side event at the 4th Summit of heads of state and government of the Community of Latin American and Caribbean States (CELAC) and the European Union (EU), co-organized by the Spanish Agency for International Development Cooperation (AECID) and Spain's Health State Secretariat.

During his remarks at the side event Collaboration for Regulatory Harmonization and Health Self-Sufficiency in Latin America and the Caribbean – Institutional Opening, PAHO Director, Dr Jarbas Barbosa, emphasised the need to strengthen local and regional capacities to ensure timely, equitable, and sustainable access to essential health technologies.

He also highlighted that the COVID-19 pandemic placed health sovereignty at the center of the global agenda, noting that“health challenges in the region are increasingly complex-from emerging infectious diseases to the rise of chronic illnesses-which put pressure on health systems and national budgets.”

Dr Barbosa called for moving from dialogue to action, emphasising that forums such as the EU–CELAC Summit“must translate into concrete projects” capable of delivering tangible results for countries in the region. He also highlighted the need to strengthen national regulatory agencies in Latin America and the Caribbean and to promote a more integrated regional market that encourages investment in the production of medicines and health technologies.“PAHO's Revolving Funds are a key instrument to advance this goal,” he added.

To face these challenges, PAHO has focused its efforts on two strategic pillars: strengthening regulatory systems and building local production capacity.

Since 1999, the Pan American Network for Drug Regulatory Harmonization (PANDRH) has provided shared guidelines that enable countries to ensure that locally produced medicines and health products are safe, effective, and of high quality. This regulatory harmonisation also facilitates local production and reduces dependence on external suppliers.

“In this spirit, bi-regional collaboration between Europe and Latin America represents a unique opportunity to accelerate access to health innovations and advance toward global convergence,” Barbosa said.

Regarding local production, PAHO has promoted the development of strategic technologies through its Regional Platform on Innovation and Production of Health Technologies, including regional mRNA vaccine production centers in Argentina and Brazil, which are making progress on vaccines against influenza A and leishmaniasis, helping prepare the region for future pandemics.

PAHO's regional revolving funds have also facilitated access to vaccines, medicines, and diagnostics at affordable prices-benefiting approximately 180 million people in the past two years and achieving up to 50% savings on public health supplies.

Last month, during PAHO's 62nd Directing Council, Member States approved the policy to expand equitable access to high-cost health technologies, reaffirming the region's commitment to regulatory harmonisation and local production.

Dr Barbosa stressed that the interconnection between strong regulations, local production, and access to quality care enables Latin America and the Caribbean to become more autonomous and resilient in an ever-changing health landscape.

“We can achieve even more by working together-coordinating efforts with partners such as Spain, the European Union, and public and private actors,” he said.

The EU–CELAC Summit side event was a strategic opportunity to advance this agenda.

International cooperation and strategic agreements

This week, PAHO and AECID signed a memorandum of understanding to support PAHO's work through unrestricted contributions to back initiatives aimed at strengthening health systems in Latin American and Caribbean countries.

Dr Barbosa also signed a memorandum of understanding with the Spanish Agency for Medicines and Health Products (AEMPS)-a government agency under Spain's Ministry of Health. The agreement seeks to strengthen the region's regulatory capacities and promote harmonisation and convergence around the safe and rational use of medicines and health technologies.

Participation in the Summit and Business Forum

On Sunday, Dr Barbosa will participate as an observer in the plenary of heads of state and government of the 4th EU–CELAC Summit. He will also take part in a panel on health investment organised by the business forum, held in parallel to the summit.

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