In March 2021, an extraordinary call for a pandemic treaty was issued by 25 heads of government and international agencies, marking a pivotal moment in global health governance. The ninth meeting of the Intergovernmental Negotiating Body (INB), the final leg of negotiations for the 30-page World Health Organization (WHO) Pandemic Agreement, commenced last week (March 18). This is the most momentous time in global health since 1948. As we approach the World Health Assembly in late May, where the final draft will be presented for approval, the fate of the Pandemic Agreement hangs in the balance, with the risk of collapse looming large amidst contentious debates.
The key features
The WHO Pandemic Agreement aims to address the systemic failures revealed by the COVID-19 crisis, with the goal of strengthening global defences and averting future pandemics from spiralling into catastrophic human crisis. The world’s first pandemic treaty aims to “strengthen pandemic prevention, preparedness and response” with “equity as the goal and outcome”. It addresses the searing inequity witnessed during the COVID-19 pandemic including a lack of preparedness in countries and the lack of coordination at international levels.
The draft negotiating text covers several issues, that includes pathogen surveillance, health-care workforce capacity, supply chain and logistics, and tech transfer to support the production of vaccines, diagnostic tests and treatments, and the waivers of intellectual property (IP) rights. It seeks to strengthen surveillance for pathogens with “pandemic potential”. The Agreement requires countries to also commit to better managing antimicrobial resistance, strengthening their health systems and sanitation, and making progress toward universal health coverage. Separate talks at WHO aim to amend the International Health Regulations, which compel countries to report health emergencies within their borders.
There is a significant emphasis throughout the text on equitable access to medical products. This theme shows up across provisions from language on principles, articles on preparedness, production, technology transfer, access and benefit sharing, supply and procurement.
The current negotiating texts have also proposed an establishment of the Conference of Parties (COP) to oversee the implementation of the Pandemic Agreement. The proposed establishment of a COP suggests that the Agreement could be a classic international treaty adopted under Article 19 of the WHO Constitution as opposed to the alternative Article 21 opt-out regulations.
At the ongoing negotiations, the developing countries have largely embraced the revised negotiating text (perhaps for the first time in two years of negotiations), while the developed countries uniformly criticised it, stating that the text now contains elements that are ‘redlines’ for them including on financing and matters related to IP. Countries including Australia, Canada, the European Union, the United Kingdom, and the United States went to the extent of referring to the text as a ‘step backwards’. Other than the few major substantive disagreements, there is also a general disagreement on the modalities for the conduct of these negotiations in this final stretch.
India, representing the South-East Asia region, has emphasised the importance of clarity on obligations vis-à-vis responsibilities, especially between developed and developing countries, to effectively operationalise equity within the Agreement.
The concerns
The most contentious aspect of the Agreement, essentially between developing countries, and others, mostly developed countries and some stakeholders, lies in the establishment of a global system for sharing pathogens and their genetic codes, while ensuring equitable access to the ‘benefits’ derived from research, including vaccines. Developing countries are hesitant to share information on pathogen spread and evolution if they perceive little in return, a situation exacerbated during the COVID-19 pandemic by “vaccine nationalism”.
To address this issue, the current draft of the Agreement proposes a quid pro quo mechanism, formally titled the WHO Pathogen Access and Benefit-Sharing (PABS) System that compels countries to share genome sequence information and samples with WHO-coordinated networks and databases. In return for access to these data, manufacturers of diagnostics, therapeutics, and vaccines will be required to provide 10% of their products free of charge and 10% at not-for-profit prices. The current text of the provision aims to establish legal obligations on benefits-sharing for all users of biological materials and genetic sequence data under PABS.
A robust PABS system, particularly for low- and middle- income countries, including some African nations, seems non-negotiable for promoting equity in access to medical countermeasures. On the other hand, many developed countries and the pharmaceutical industry are not satisfied with the language on access and benefit sharing in the current negotiating text, including the perceived trade-offs. The challenge of global governance, enforcement, and accountability is the second major sticking point of the Agreement negotiations. Without adequate accountability and enforcement mechanisms built into the Agreement, the whole endeavour is merely an exercise in symbolism. The absence of adequate enforcement capabilities also hampers coordination efforts for pandemic countermeasure stockpiles, the deployment of international medical response teams, as well as monitoring and data sharing.
The Agreement risks being rendered ineffective even if the Global North was to reach a consensus on key issues such as technology transfer, the PABS System, and intellectual property waivers, without robust enforcement mechanisms.
The existing International Health Regulations are already legally binding. However, they failed to prevent unjust travel or trade restrictions, and hoarding of vaccines and other medical countermeasures during the COVID-19 pandemic.
Proposals for a decision-making body, comprising the COP along with a secretariat, have been included in the negotiating text. However, it remains uncertain whether negotiators will reach consensus on this structure. This model mirrors the UN Framework Convention on Climate Change (UNFCCC) summits, where all nations receive equal voting rights.
One of the thorniest issues within the Agreement negotiating text is the proposed requirement for firms that received public financing to waive or reduce their intellectual property royalties.
What next?
The current round of negotiations in Geneva ends this week, with the goal of reaching a consensus decision by the World Health Assembly at the end of May. The risk of a watered-down Agreement, driven by the imperative to secure consensus, remains palpable. Although the draft Agreement touches upon most of the relevant concerns that unfolded during the recent pandemic, much of the language around contentious issues such as IP waivers is arguably watered down by referring to national circumstances and using best endeavour language.
To be sure, this is a mammoth ask. One of the potential outcomes of not reaching an Agreement is not ruled out. Failing to reach an agreement would, however, be a serious blow. The Pandemic Agreement represents a critical step towards rebuilding trust and coordination between nations, acknowledging that no single government or institution can confront the threat of future pandemics in isolation.
Kashish Aneja is a Delhi-based lawyer and Lead, Asia at the O’Neill Institute for National and Global Health Law, Georgetown University
