On April 16, 2025, the Intergovernmental Negotiating Body (INB) finalized the text of the World Health Organization (WHO) Pandemic Agreement, which was adopted on May 20, 2025, during the 78th World Health Assembly. This landmark document, submitted by the Director-General on May 14, 2025, aims to prevent, prepare for, and respond to pandemics by integrating the One Health approach along with principles of equity and solidarity. For the pharmaceutical industry, the Agreement presents both an opportunity for innovation and a challenge to balance profit with social responsibility.
The text is the outcome of negotiations that began in 2021 (Decision SSA2(5)) and continued with the extension of the INB mandate in 2024 (WHA77/20). Led by Co-Chairs Precious Matsoso (South Africa) and Anne-Claire Amprou (France), the agreement reflects a global compromise. Comprising 40 articles divided into three chapters, it addresses prevention, equitable access to health products, and international cooperation—aiming to redress the inequalities exposed during the Covid-19 pandemic.
The One Health Approach as a cornerstone
Article 5 places the One Health approach at the heart of the strategy, promoting multisectoral collaboration to address the drivers of infectious diseases at the human–animal–environment interface. Parties are encouraged to develop national policies, including joint training programs and measures to prevent zoonotic spillover, while safeguarding livelihoods and food security. This approach creates opportunities for the pharmaceutical industry to invest in research and development (R&D) on emerging diseases, particularly in low- and middle-income countries. However, as highlighted in Article 5.2, it also demands resources and effective coordination.
Global Equity and Access to Health Products
Equity lies at the heart of Articles 10, 11, and 12. Article 10 promotes sustainable and geographically diversified local production, encouraging manufacturing facilities in low- and middle-income countries through public–private investments. Article 11 facilitates “agreed” technology transfer, including non-exclusive licenses for manufacturers in least developed countries. The Pathogen Access and Benefit-Sharing System (PABS System, Article 12) introduces a multilateral mechanism for sharing pandemic-potential pathogens and the resulting benefits, such as vaccines and therapies. During a pandemic, participating manufacturers are required to allocate 20% of their output to the WHO—at least half of it as a donation—to ensure equitable access based on public health risk.
Although innovative, the PABS System raises questions about its operational feasibility, particularly regarding industry participation in high-demand scenarios. For the pharmaceutical sector, this entails a reassessment of intellectual property strategies, in line with the Doha Declaration on TRIPS, to balance global access with economic incentives.
Supply Chains and Sustainable Financing
Article 13 establishes the Global Supply Chain and Logistics Network (GSCL Network), coordinated by the WHO, to ensure rapid and equitable access to health products during emergencies, with a particular focus on low- and middle-income countries. Article 14 promotes transparency in procurement agreements and discourages excessive national stockpiling. Article 18 introduces a Coordinating Financial Mechanism to support pandemic preparedness and response capacities, set to become operational within 12 months of the Agreement’s entry into force. The mechanism aims to mobilize innovative funding sources, but its success will depend on sufficient financing and strong international cooperation.
For the pharmaceutical industry, these provisions create opportunities for partnerships with global institutions, but also require adaptation to transparent and inclusive governance models—impacting supply chains and production strategies.
Italy’s Stance: Sovereignty or Isolation?
On May 20, 2025, Italy abstained from voting on the WHO Pandemic Agreement, alongside 10 other countries—including Poland, Russia, Israel, and Slovakia—while 124 nations voted in favor and 46 were absent. The official justification, as reported by ANSA, cited the need to “reaffirm state sovereignty in the management of public health matters.” The decision sparked widespread criticism, with concerns that abstention could isolate Italy scientifically and limit its participation in global mechanisms such as the PABS System and the GSCL Network.
Some observers have linked the abstention to domestic pressure from vaccine-skeptical groups and a sovereigntist narrative that views the WHO as encroaching on national health policies. However, the lack of a detailed statement from the Italian government has left room for speculation. Italy’s position risks undermining critical collaborations for access to vaccines and technologies—particularly at a time when global cooperation is essential to address transnational threats such as pandemics.
Italian Debate Heats Up
In recent days, debate over Italy’s abstention has intensified. International sources suggest the decision was influenced by a political climate emphasizing health sovereignty, with some figures criticizing the WHO for an alleged lack of transparency. However, as of May 24, 2025, no detailed official statements have been issued by the Ministry of Health or the national government. Italy’s position remains ambiguous, raising concerns about alienating international partners and limiting access to shared resources, as outlined in the PABS System.
The comparison with other abstaining countries, such as Slovakia—where Prime Minister Robert Fico openly criticized the Agreement due to vaccine skepticism—highlights a broader trend of rejecting multilateral mechanisms in favor of national approaches. This could have repercussions for the Italian pharmaceutical industry, which risks being excluded from global manufacturing and distribution networks.
Challenges and Opportunities for the Pharmaceutical Industry
The Agreement positions the pharmaceutical industry at the center of global health efforts—but it also presents significant challenges. Diversifying production (Article 10) requires substantial upfront investments, while technology transfer (Article 11) may face resistance from companies keen to protect their patents. The PABS System, with its requirement to share 20% of production, could reduce profit margins, particularly for multinational firms.
Yet the opportunities are considerable: collaboration with the WHO could open access to new markets in low- and middle-income countries, and the incentives for R&D (Article 9) support innovation in vaccines and zoonotic therapies. However, Italy’s stance risks limiting these opportunities—potentially excluding the country from strategic partnerships and undermining the global competitiveness of its pharmaceutical sector.
A Critical Perspective: between Ideals and Reality
The Agreement represents a step forward toward fairer pandemic governance, but its reliance on the “availability of resources” may hinder implementation in less developed countries. The non-binding nature of certain recommendations (Article 19.6) risks weakening its effectiveness, leaving room for divergent national interpretations. Italy’s abstention adds to these uncertainties, raising doubts about its ability to contribute to a cohesive global system.
For the pharmaceutical industry, striking a balance between profit and social responsibility will be essential. Without concrete incentives, companies may continue to prioritize high-income markets, undermining equity goals. The Conference of the Parties (Article 19) will need to ensure rigorous monitoring to guarantee compliance.
An interconnected future at risk
The WHO Pandemic Agreement—with its One Health approach and focus on equity—outlines an ambitious roadmap for a more pandemic-resilient world. Italy’s abstention, however, reveals tensions between sovereignty and global cooperation, with potential consequences for both the pharmaceutical sector and public health. For the industry, the future hinges on the ability to embrace global partnerships; for Italy, overcoming political divisions will be critical to avoid isolation in an increasingly interconnected world.
