After great fanfare and over two years of political negotiations, 194 World Health Organization (WHO) member states failed to finalise a historic Pandemic Agreement, an international treaty designed to fortify global pandemic preparedness, implement mechanisms for prevention of the same, and reduce unconscionable inequities that were painfully obvious during the COVID-19 pandemic.
The 77th World Health Assembly, or WHA (May 27-June 1, 2024), in Geneva, witnessed two significant developments for global health governance. First, it agreed on a package of amendments to the International Health Regulations (IHR) 2005, drawn from 300 proposals for reform by governments of both the global north and south, and extensively negotiated over the last two years. The IHR amendments aim to enhance the ability of countries to prepare for and respond to Public Health Emergencies of International Concern (PHEIC) and introduce a new category for urgent international response — a Pandemic Emergency (PE). The amendments aim to ensure equitable access to health products during health emergencies and to mobilise financial resources to support developing countries in building and maintaining core health system capacities required under the IHR. Notably, the amendments emphasise solidarity and equity, while mandating the creation of a National IHR Authority for better coordination.
Second, the 77th WHA extended the mandate of the Pandemic Treaty negotiating body, namely, the intergovernmental negotiating body (INB), stipulating that the proposed WHO Pandemic Agreement must be completed as soon as possible. The outcome should be submitted for consideration at the 78th World Health Assembly in May 2025, or earlier if possible, at a Special Session of the World Health Assembly in 2024.
Pathogen Access and Benefit Sharing
Three key contentious issues in the latest draft of the Pandemic Agreement remain significant obstacles to its adoption: a pathogen access and benefit sharing (PABS) mechanism; technology transfer, local production, and intellectual property; and the One Health approach which emphasises coordinated public health measures based on animal, human, and environmental health. These core provisions, which are fundamental to achieving a safer and fairer world, are stalled due to geopolitical discord and competing interests between higher- and lower-income countries. Skilled diplomats and political leaders must understand that international cooperation and mutual solidarity are a win-win for global health security.
The most contentious issue in the pandemic agreement negotiations has been the Pathogen Access and Benefit Sharing (PABS) system in Article 12, often seen as the “heart” of the agreement. The imperative for PABS emerged in response to the gross inequities in treatment access and vaccine distribution witnessed during the COVID-19 pandemic. The PABS system aims to ensure that genetic resources and pathogen samples shared from developing countries (which are the most likely sources for such pathogens), are reciprocated with corresponding benefits such as vaccines and diagnostics that result from research and development on samples and data provided from the Global South. The latest proposal suggests that manufacturers of vaccines and diagnostics — primarily based in wealthy countries — using genetic information from pathogens in low- and middle-income countries, would commit to donating a portion of their products to WHO for global distribution based on the principles of need and effectiveness.
Low- and middle-income countries (LMICs) are pushing for a guarantee of at least 20% of shared pandemic products, while many high-income countries argue that 20% should be the maximum limit, and some rich countries will not even agree to 20%.
Technology transfer, intellectual property
Intellectual property protections, rich-world hoarding, export restrictions, and manufacturing limitations all contributed to vaccine inequity during the COVID-19 pandemic. The transfer of technology, know-how, and skills is often a crucial step toward preparing for and responding to pandemics. Strong provisions for technology transfers and local production could potentially compensate for the failures in PABS negotiations. Above all, technology transfer and intellectual property waivers are needed to ensure diverse manufacturing capacities globally so that LMICs are no longer reliant on “charity” from high-income countries and can maintain self-sufficiency.
Next to PABS, the fierce division over governance of production and technology transfer, and its implications on intellectual property, outlined in Articles 10 and 11, has significantly delayed negotiations. The central issue is the conditions for technology transfer to “facilitate sustainable and geographically diversified production” through mechanisms such as product information sharing and use of WTO- Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities such as compulsory licensing. There remains a lack of consensus on the transfer of ‘know-how’ and the binding nature of these transfers. High-income countries advocate for Voluntary and Mutually Agreed Terms (VMAT), but the use of VMAT language could discourage countries, particularly LMICs, from adopting mandatory approaches recognised under the TRIPS Agreement.
Disagreement also mounts over the so-called ‘peace clause’ which requires member states to respect the use of the TRIPS flexibilities and not exercise any direct or indirect pressure to discourage the use of such flexibilities.
One Health
The draft Agreement requires member states to adopt a pandemic preparedness and surveillance approach that recognises the interconnection between the health of people, animals, and the environment and promotes a coherent, integrated, coordinated, and collaborative effort among all relevant organisations, sectors, and actors, as appropriate. High-income countries, particularly the European Union, strongly support One Health. However, LMICs view it as an unfunded mandate that imposes an additional burden on their already strained resources.
The enduring obstacle in international law is its enforcement. Given the lack of robust compliance mechanism and, consequently, the lack of real accountability in International Health Regulations (IHR), implementation of the Pandemic Agreement remains a critical concern. The proposed Conference of Parties (COP) will play a crucial role in this regard by taking stock of its implementation and reviewing its functioning every five years. The latest draft of the agreement has proposed the COP to consider establishing, at its first meeting, an inclusive, transparent, and effective monitoring and evaluation system, in a manner consistent with the IHR. In the forthcoming negotiations, it remains to be seen how countries, especially wealthy nations, respond to this proposal.
A core aim of the Pandemic Agreement — beyond ensuring the immediate availability of medical products during emergencies — should be to promote long-term and sustainable access to these products by diversifying production and enhancing regional manufacturing capabilities. Issues of pathogen access and technology transfer are not mere technicalities; they are essential to the success of the pandemic agreement once it is adopted. With the recent amendments to the IHR and the ongoing Pandemic Agreement negotiations, the world has already made unprecedented strides in international law. The coming months of negotiations are crucial. This treaty is not just for the next pandemic but also serves as a blueprint for a more equitable and resilient global health system.
Kashish Aneja is Lead, Initiatives in Asia, O’Neill Institute for National and Global Health Law, Georgetown University. Sam Halabi is Director, Centre for Transformational Health Law, O’Neill Institute for National and Global Health Law. Lawrence Gostin is Distinguished Professor and Director, World Health Organization Collaborating Centre for National and Global Health Law, O’Neill Institute, Georgetown University
