Last updated November 1, 2023
Written by: Molly Moss, Global Health Policy Officer, United Nations Foundation
Since its inception in December 2021, the Intergovernmental Negotiating Body (INB) has conducted six formal meetings and numerous informal discussions to consider the purpose and scope of a new legal instrument to prepare the world for future pandemics. On October 16, the INB released a new version of the WHO Pandemic Agreement, also known as the “Pandemic Accord” or “Pandemic Treaty”. If so decided by Member States on November 6, this draft will serve as the baseline text for negotiations moving forward.
With three chapters instead of eight, the structure of the text is a significant departure from the zero draft that was released in February 2023. The latest draft also includes concrete legal language that is more conducive to text negotiations. Compared with earlier versions, there are several creative new provisions that aim to realize the long-held goal of “operationalizing equity” by promoting fairer distribution of medical countermeasures and greater self-sufficiency in the context of future pandemics. While some articles of the new text include extensive and well-developed language, other articles are considerably less mature, increasing the likelihood that they will not be finalized by the World Health Assembly in May 2024, the target date for adopting the Agreement.
Of the three chapters, the substantive provisions in this version fall under Chapter II, titled “The world together equitably: Achieving equity in, for, and through pandemic prevention, preparedness, and response.” Aligned with the recommendation by Member States, this chapter has been revised to follow the chronological arc of prevention, preparedness, and response for pandemic threats. Several other interesting and significant changes are worth examining.
Within Chapter II, the specificity and level of nuance between Articles varies significantly. For example, Article 8 on Preparedness Monitoring and Functional Reviews is vague and essentially serves as placeholder language. Article 8, Paragraph 4 calls for Parties to establish “a global peer review mechanism to assess pandemic prevention, preparedness and response capacities and gaps” (i.e., the Universal Health Preparedness Review, which is being debated alongside the accord negotiations). This leaves space for further discussion on the details of such a mechanism and signals that Member States may not conclude the details of the arrangement by May 2024.
On the other hand, Articles 9 through 13 are the real heart of the instrument. The level of detail included in these Articles reflects extensive consultation among Member States in recent months. The contents indicate significantly increased ambition over the zero draft and some provisions will likely lead to spirited debate.
Article 9 on research and development (R&D) offers specific approaches for protecting the outputs of that research from becoming exploited by private interests. Article 9 urges Parties to promote public dissemination of research results when public funding is used. It similarly discourages the use of confidentiality provisions for pandemic products that result from publicly funded research in an effort to ensure they’re accessible as public goods.
Article 10 on sustainable production and Article 11 on transfer of technology and know-how were previously contained within a single Article in the zero draft. That they have been separated and elaborated in this version is favorable for developing countries, with language that leans toward easing policies and creating new pathways for sharing pandemic products throughout the production cycle. These Articles are likely to spur much debate in negotiations.
Article 10 aims to reduce the gap between supply and demand at the time of a pandemic by diversifying the geographic distribution of global manufacturing. It retains earlier language that calls for manufacturers who’ve received significant public financing to grant permission to other manufacturers, particularly in developing countries, to use their intellectual property and know-how to create pandemic-related products.
Article 11 proposes ways to incentivize and compel transfer of technology and know-how. While the Article opens with a commitment to doing this under “mutually agreed terms,” it’s difficult to imagine manufacturers voluntarily offering technological specifications and manufacturing process documents for pandemic products to an open database, as proposed in the text.
The lynchpin of the draft Agreement is Article 12, which establishes a multilateral Pathogen Access and Benefit Sharing System (WHO PABS System). The PABS System is designed to help countries share pathogens and genetic sequence data, as well as the medical countermeasures that may arise from research on these pathogens. The text outlines an approach to ensure “rapid, systematic, and timely sharing of WHO PABS Material, as well as, on an equal footing, timely, effective, predictable and equitable access to pandemic-related products, and other benefits, both monetary and non-monetary…”
Access and Benefit Sharing mechanisms are complex, and many components of the proposed WHO PABS System will require substantial additional negotiation – including a WHO coordinated lab network; specific governance and review mechanisms; and a standard material transfer agreement. Suggesting that Member States plan to prioritize this issue in upcoming negotiations, the text proposes that all components of the WHO PABS System will become operational no later than May 31, 2025.
The primary benefit offered by the proposed PABS System will garner a lot of debate on its own. The text proposes that, in the event of a pandemic, the PABS System will afford real-time access by WHO “to a minimum of 20% (10% as a donation and 10% at affordable prices to WHO) of the production of safe, efficacious and effective pandemic-related products for distribution based on public health risk and need.” The proposal explores additional creative ideas for benefit sharing, including collaboration among manufacturers and researchers to improve know-how and tiered-pricing or other cost-related arrangements such as no-loss/no-profit arrangements.
Linked to a potential platform for accessing medical countermeasures, Article 13 establishes the WHO Supply Chain Network but leaves it open to the Conference of the Parties – which will be established by the accord – to develop guidelines on modalities and collaboration. The Article includes a lengthy list of what the network should do to match supply and demand for pandemic products. But again, there are plenty of details that will take time to negotiate, and Parties are only expected to undertake the effort before May 31, 2025.
Other noteworthy points in Chapter II include strong commitments to support health workers (Article 7), foster whole-of-society approaches that include civil society and address youth and gender disparities (Articles 7 and 16), and combat misinformation by strengthening public health and pandemic literacy (Article 18). Many commitments also center on realizing universal health coverage as a fundamental step to ensuring strong health systems that meet the full needs of pandemic prevention, preparedness, and response (Articles 6 and 20). Avoiding the contentious language “Common But Differentiated Responsibilities” used in the zero draft, the text instead offers “recognition of the different levels of capacity” amongst Parties for developing and implementing the provisions. To this end, Articles 5, 6, and 7 conclude with a call to cooperate to enhance financial and technical support.
Article 20 focuses on sustainable financing to achieve the goals of the agreement, with particular emphasis on supporting developing countries. It proposes for the Conference of Parties to establish a “capacity development fund” no later than December 31, 2026. This mechanism aims to ensure the provision of adequate, accessible, new and additional, and predictable financial resources through annual contributions from Parties to the Agreement; contributions from recipients of the WHO PABS System; and voluntary contributions from parties to the Agreement. The draft also proposes an endowment that draws contributions from relevant sectors benefitting from pandemic prevention, preparedness, and response efforts and from philanthropic organizations. Curiously, there is no linkage to the World Bank’s Pandemic Fund indicated in the text.
Chapter III is devoted to institutional arrangements and final provisions of the Agreement. Arrangements currently propose that the Conference of Parties (COP) will review the implementation and outcome of the Agreement every three years. Per Article 31, the Agreement will be open for signature at the WHO headquarters in Geneva immediately following its adoption at the 77th World Health Assembly, from May to June 2024, and thereafter at the United Nations headquarters in New York, from June 2024 to June 2025. Lastly, Article 33 mandates that the Agreement shall enter into force one month following the fortieth Parties’ formal approval of the Agreement.
The seventh meeting of the INB will be held in two parts starting November 6 to 10 and concluding December 4 to 6. Since its release on October 16, Member States and relevant stakeholders have scrutinized the new text and consulted in capitals and amongst each other. During the upcoming discussions, Member States will provide general reactions to the text and then decide whether to proceed with this document as the basis of further negotiation. If they do, it will mark a new phase of work on the agreement and allow line-by-line text editing to begin in earnest. Given the drastic evolution from earlier versions, Member States’ feedback is likely to be plentiful, and big reactions on intellectual property, technology transfer, and financing are anticipated. Time will soon tell whether the process further entrenches well-worn fault lines between developed and developing countries on the most effective approaches to securing the world against future pandemics.
Molly Moss covers policy issues related to global health governance, antimicrobial resistance, and Universal Health Coverage. Molly manages the Foundation’s official relations status with the World Health Organization and also supports engagement on health issues among UN Member States in New York. Prior to the UN Foundation, Molly worked for the Center for Global Health at the University of Colorado, focusing on immunization, pediatric infectious disease research, and research ethics. During her time at the University of Colorado, Molly earned her Master of Public Health in community and behavioral health. She holds a bachelor’s degree in medical anthropology from Hampshire College.
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