GENEVA (AN) — When nations reconvene on a new pandemic agreement, they will grapple with at least 17 draft text proposals for a new regulatory framework.
The talks resume on Monday, centered on a fundamental disagreement between countries that want a legally binding system for sharing pathogens and benefits and those that prefer a voluntary, contract-based approach to protect intellectual property.
Its adoption is a key condition for the treaty to be opened for signing and ratification by at least 60 countries. The annex must be completed by mid-April of next year to be considered by the 2026 World Health Assembly.
The overall agreement, adopted in May, marks only the second time in the World Health Organization's history that it has used its constitutional authority to create a legally binding treaty.
The stakes are significant. The COVID-19 pandemic killed more than 14.9 million people and cost the global economy an estimated $12.5 trillion in lost output, a figure that underscores the economic imperative of a global preparedness strategy.
This comes as a proposed $10.5 billion global fund for pandemic preparedness, a figure from a joint analysis by the World Bank and the WHO, has been proposed. It would cost a fraction of the devastation the treaty seeks to prevent.
In recent months, financial support for global public health has receded dramatically, partly due to the U.S. planned withdrawal from WHO.
An analysis of the 17 draft text proposals by Arete News shows a clear division over over the potential use of several legal mechanisms as part of a proposed annex on pathogen access and benefit-sharing, known as PABS, that is central to a wider conflict.
Wealthier nations are primarily concerned about the impact on pharmaceutical innovation and trade.
Developing nations want a more equitable global health architecture, and are demanding a legally binding framework to regulate the pharmaceutical industry. Their push stems from the challenges faced during the COVID-19 crisis, when high-income countries purchased more than half of all vaccine doses.
The inequity is exemplified by the case of South Africa, which shared information on the Omicron variant only to face travel sanctions. A new coalition, the Group for Equity, composed of 33 developing countries including Brazil, India, and South Africa, seeks to address this. It proposes granting WHO non-exclusive licenses to products developed from shared pathogens.
The group wants the licenses to include the provision of the full regulatory dossier, technical know-how, and any necessary materials, while using three key legal and technical mechanisms proposed to ensure equity in a new pandemic treaty.
First is a Standard Material Transfer Agreement, which provides a legally binding contract that governs the sharing of biological materials, such as pathogen samples.
Second is a Data Access Agreement, a similar type of legal agreement, but one that applies specifically to the sharing of digital data, such as a pathogen's genetic sequence.
Third is a Digital Object Identifier, which is used to track the pathogen and its associated data as they move through the global research and development system.
Together, these mechanisms are meant to create a transparent, auditable system for sharing pathogens and their related data, which is essential to the "benefit sharing" component of the agreement.
By contrast, the E.U. and its member nations have submitted a proposal that prioritizes a voluntary, contract-based approach to protect intellectual property rights.
The debate over IP was apparent during negotiations over the term "mutually agreed," with a footnote added to clarify that it would not undermine existing rights under other agreements, such as the WTO's TRIPS Agreement.
That position is reinforced by Switzerland, with backing from Israel, which has proposed deleting references to "health products" from key articles of the International Health Regulations amendments.
Critics contend this would leave the distribution of medical tools to be governed by market forces. Switzerland also proposed a "simulation exercise" to be co-hosted with a Global South nation to test the PABS system in a real-time outbreak scenario.
A proposal from China suggests a manufacturer’s access to the pathogen-sharing system be contingent on their home nation being a party to the pandemic agreement.
The provision would exclude U.S. manufacturers from the global health data-sharing mechanism, as the Trump administration, immediately upon assuming office in January, gave one-year notice that the U.S. would withdraw from WHO.
The negotiation process, which took over three years, has been compared to the decade it took to finish WHO's only other opt-in treaty, the Framework Convention on Tobacco Control, or FCTC. As WHO Director-General Tedros Adhanom Ghebreyesus has said, "the next pandemic will not wait," so nations must be ready.
WHO member nations have established a new Intergovernmental Working Group, or IGWG, to lead the final stage of negotiations. It met for the first time in July and is co-chaired by Brazil's U.N. Ambassador Tovar da Silva Nunes and the U.K.'s Matthew Harpur, Deputy Director of the Department of Health and Social Care.
In addition to negotiating the PABS annex, the IGWG has been tasked with preparing for a formal conference and coordinating a financial instrument.
