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The 78th session of the World Health Assembly (May 19-27) is all set to adopt the WHO Pandemic Agreement (PA). This move hinges on the commitment to develop the Pathogen Access and Benefit Sharing (PABS) system as an annex to PA. In fact, the ratification of the PA will begin only after finalising the PABS.
A multilateral mechanism, the PABS facilitates access to pathogens and their genomic sequence data (GSD) for researchers and manufacturers, in exchange for a fair and equitable share of the benefits derived using such shared resources, including vaccines, therapeutics, and diagnostics (VTDs). Currently, Article 12 of the PA establishes PABS, requiring participating VTD manufacturers to donate 10 per cent of real-time production to the WHO during pandemic emergencies and additionally reserve up to 10 per cent at affordable prices, depending on capacities. However, the operational details, including additional benefit-sharing commitments, need to be outlined in the PABS annex.
Developed countries, under the guise of openness, are advancing a PABS model that expands their control over infrastructure like laboratories and databases, and their industries’ access to pathogens and data, without committing to benefits. They push for a PABS that facilitates ‘unregulated’ sequence data sharing and disconnects access from benefit-sharing. This model, driven by scientific lobbies from developed countries, leveraging their ties in developing countries, deviates from the principles of the UNESCO Open Science Recommendation (2021). In the absence of regulation, database managers from developed countries can unilaterally determine access conditions or even suspend access to researchers. It can promote biopiracy and increase biosecurity risks. Reinforcing the status quo, dominated by a few powerful states, fails to guarantee equitable access to health products.
Need for early access
It is in the interest of developing countries that the PABS expedites and prioritises the distribution of VTDs to affected populations through WHO, while ensuring access to pathogens and data to scientists and researchers via WHO-administered, trusted channels. Currently the PA guarantees priority supplies through WHO only during pandemic emergencies — that is, after the highest alert.
However, to prevent pandemics, such priority access must be promoted from the early stages of pandemic-potential disease outbreaks. During past outbreaks such as Covid-19, Ebola, and Mpox, manufacturers prioritised purchases by high-income countries, sidelining WHO requirements. Pathogens and GSD were shared but without proper benefit-sharing agreements, resulting in inefficient and inequitable public health responses.
India needs to play an active role in shaping a robust PABS framework, not only for global health equity but also to strengthen its own health security. A well-designed PABS can help Indian manufacturers gain access to pathogens as well as manufacturing licences, and ensure timely VTD delivery to frontline workers. It will also help preserve India’s role as the ‘pharmacy of the world’, avoiding disruptions like the Covid-19 export bans. Also, the monitoring of the dual-use risks of shared pathogens and data is key to health security. Therefore, it is important to ensure that PABS has an effective traceability mechanism.
So far, India’s principled stand in the negotiations — on traceability of shared data, balancing regulatory harmonisation, and rejecting blanket indemnity for vaccine producers — has been successful. But to truly lead, India must proactively form alliances — to shape the text, and anchor equity in the PABS annex.
(The writer is a senior researcher with non-profit Third World Network. Views are personal)
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Published on May 18, 2025
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