Mercosur Launches Ambitious Plan to Achieve Pharmaceutical Independence
A new regional initiative aims to bolster health security and economic competitiveness by reducing reliance on foreign drug manufacturers.
Mercosur nations are embarking on a pivotal effort to reshape their pharmaceutical landscape with the launch of the Regional Pharmaceutical Integration Project. Unveiled during Brazil’s Pro Tempore Presidency in 2025, the initiative seeks to strengthen the bloc’s health autonomy and foster greater productive integration within the region. The project, spearheaded by the FarmaBrasil Group and supported by key industry players from Argentina, Paraguay, and Uruguay, addresses critical vulnerabilities in access to medicines and the production of essential pharmaceutical inputs.
Addressing a Critical Dependence
Currently, Mercosur countries are heavily reliant on imports for active pharmaceutical ingredients (APIs) and complex medications, leading to a growing trade deficit in pharmaceutical products. Despite possessing significant scientific, productive, and regulatory capabilities, these resources remain fragmented and lack cohesive regional coordination. The Latin American medicines market, estimated at US$93.1 billion in 2024 with Brazil as the dominant force, still sees the region holding a marginal role in pharmaceutical innovation and advanced technological development. Global supply chains, largely controlled by India and China, further expose Mercosur nations to disruptions and vulnerabilities.
A Collaborative Strategy Built on Complementary Strengths
The core of the project lies in leveraging the unique strengths of each Mercosur member. Argentina, represented by Eduardo Franciosi, CEO of Cilfa, is positioned as a leader in biosimilar development and clinical trials. Brazil brings to the table substantial infrastructure, large-scale production capacity, and established technological alliances with institutions like Fiocruz and the Butantan Institute. Paraguay is emerging as a competitive player with growing pharmaceutical manufacturing and cost advantages, while Uruguay contributes a robust regulatory framework and a history of international cooperation.
“The general objective of the Regional Pharmaceutical Integration Project is to build an integrated and sustainable capacity for the production of APIs, vaccines and biosimilars,” stated a senior industry official. “Strengthening the health autonomy of Mercosur and its industrial competitiveness is paramount.”
Key Pillars of the Integration Project
The project outlines several key objectives, including:
- Expansion of regional pharmaceutical production.
- Establishment of a unified Mercosur public procurement program.
- Creation of a network of multicenter clinical trials.
- Mobilization of coordinated financing mechanisms.
- Progress towards regulatory convergence among national agencies.
Plans include the formation of a regional consortium of laboratories, a shared portfolio of strategic medicines, and the implementation of tax incentives and technological cooperation programs. Investment in advanced training for biotechnology and regulatory professionals, alongside initiatives to attract and retain skilled workers, are also central to the strategy.
Financing and Public Procurement: Building a Sustainable Ecosystem
A crucial component of the project is the articulation of regional public purchasing through coordinated national contracting and agreements with organizations like the Pan American Health Organization (PAHO) and the European Union. Integrating into the Revolving Fund and Strategic Fund is seen as essential for guaranteeing consistent demand and achieving productive sustainability.
To fuel this ambitious undertaking, the creation of a Mercosur Pharmaceutical Innovation Fund is proposed, drawing on both reimbursable and non-refundable regional resources. Estimates suggest that developing the biological value chain, particularly for APIs and complex biologics, will require investments totaling hundreds of millions of dollars.
Regulatory Harmonization and Regional Clinical Trials
Parallel to production and financing efforts, the project emphasizes regulatory convergence. This includes establishing a common repository of clinical data, a regional observatory of good practices, and fostering technical exchange programs between regulatory agencies in Brazil (Anvisa), Paraguay (Dinavisa), and Uruguay. Furthermore, the development of a network of multicenter clinical trials, operating under unified governance, will enhance regional research capabilities and improve access to innovation.
Political Backing and a Vision for the Future
Brazil’s Minister of Health, Alexandre Padilha, formally endorsed the project by signing a letter to President Luiz Inácio Lula da Silva for consideration at the upcoming Mercosur Summit. PAHO’s director, Jarbas Barbosa, underscored the strategic importance of the initiative, emphasizing that health autonomy is a critical issue for Latin America – economically, strategically, and for public health. He noted that the pandemic highlighted the urgent need for increased regional production and procurement.
According to PAHO data, regional pharmaceutical production has already seen a significant increase, rising from 1.5% to 23% of the total volume acquired by the Revolving Fund in just two years. Projections indicate that regional sources could supply up to 40% of the volume and 65% of the value of vaccines purchased in the future. This project, therefore, represents a roadmap for strengthening the Health Economic-Industrial Complex and building a more competitive and resilient model prepared for the health challenges ahead.
