Indian Council of World Affairs

Abstract: With adoption of the Pandemic Agreement last year, the efforts for opening it for signature have begun. The biggest roadblock in that process is the drafting and the adoption of the Pathogen Access and Benefit-Sharing system (PABS) Annex. Described in Article 12 of the Agreement, the PABS Annex is a crucial component of the Pandemic Agreement because it operationalises the obligation of inter-country sharing of PABS Materials and Sequence Information and the obligation of inter-country sharing of benefits arising from the utilization of such materials and information. The negotiations on the Annex are in the process now. They are likely to be finished by May 2026. This issue brief provides a background on the Annex and the Agreement and highlights the main points of contention.

Introduction

The WHO Pandemic Agreement is an international treaty governing global pandemic prevention, preparedness, and response capacities. The Agreement sets out multilateral procedure to deal with the situation of a pandemic emergency, i.e. a public health emergency of international concern relating to a communicable disease. The Agreement was envisaged in the wake of the COVID-19 pandemic. The Agreement was adopted on 20^th May 2025, but will not open for signature until the adoption of the Annex on the Pathogen Access and Benefit-Sharing system. The Annex, described in Article 12 of the Agreement, on a Pathogen Access and Benefit-Sharing has been under negotiations since 10^th July 2025. The adoption of the Annex is scheduled to occur at the 79th World Health Assembly in May of this year. Even after the adoption of the Annex, the Agreement will enter into force only after 60 ratifications.[i]

The PABS Annex

Through resolution WHA78.1, the 78^th World Health Assembly established an Intergovernmental Working Group (IGWG) for drafting and negotiating the PABS Annex. The adoption of the Annex will happen at the 79th World Health Assembly. The fifth meeting of the Intergovernmental Working Group (IGWG) on the WHO Pandemic Agreement held a session from February 9^th to February 14^th 2026. The discussion on the draft PABS (Pathogen Access and Benefit-Sharing) Annex text was continued from its last session. 

The PABS Annex will govern the implementation of the PABS system envisaged by the Pandemic Agreement in its Article 12. The Annex will set out the provisions governing the multilateral system established by the Pandemic Agreement for “the rapid and timely sharing of PABS Materials and Sequence Information and, on an equal footing, the rapid, timely, fair and equitable sharing of benefits arising from the sharing and/or utilization of PABS Materials and Sequence Information for public health purposes.”[ii]

In the fifth meeting of the IGWG, the Zimbabwean representative spoke on behalf of the African group.  She said that the countries that share pathogen and genomic data made a sovereign contribution to a global public good, often under uncertain conditions. She emphasised the need to make commitment of equitable benefit-sharing of diagnostics, therapeutics, and vaccines legally binding and time-bound, instead of leaving it to voluntary implementation. Equity required, she said, ‘access’ was not be separated from ‘benefit-sharing’.[iii]

In the fourth meeting, which happened in January 2026, the PABS Annex and the roadblocks in its implementation were discussed with relevant stakeholders.[iv] The lack of adequate and proper data bases for PABS Materials and Sequence Information was emphasised. It was pointed out that most databases were on pathogen sequence, instead of on more general biological materials. The fact that how most databases were located in High Income countries was pointed out, and the need to bridge the pathogen sequence data base capacity gap and infrastructure gap. In respect of PABS benefit-sharing, it was asserted that the provisions of the Annex, which obligate the Member states to share data but put no such obligation of benefit-sharing on the users, were violative of the equal-footing principle and Article 12 of the Pandemic Agreement.

India, in its representation to the Intergovernmental Negotiating Body during the 78th Session of the World Health Assembly held from 19th through 27th May 2025 in Geneva, had called the PABS Annex the soul of the Pandemic Agreement.[v] India highlighted the issues of access to critical raw materials for diversified geographical production and the recognition of digital health as an enabler of an equitable pandemic response. India underlined that the recommendations by WHO were non-binding in nature, and emphasized the sovereign rights of Member States to adopt legislation to ensure manufacturers’ accountability.[vi]

The Pandemic Agreement

Historical background

The World Health Organisation (WHO) was set up as a specialised agency under the aegis of the United Nations for the promotion and protection of “health of all peoples”.[vii] The Independent Panel for Pandemic Preparedness and Response was set up by the WHO in 2020. The Panel made recommendations to set new and measurable targets and benchmarks for pandemic preparedness and response capacities.[viii] Importance of pandemic preparedness is highlighted by two recent and important findings. First, the increasing number of measles outbreaks in children and adults have resulted from large numbers of unvaccinated individuals being exposed to a highly transmissible virus. Second, the spread of influenza A(H5N1) viruses has been observed between species, including from birds and mammals to humans, due to mutations associated with increased transmissibility.[ix] These findings underscore the importance of ongoing surveillance of emerging H5N1 strains, particularly those associated with livestock exposure, as well as the need for pandemic preparedness and early prevention measures.

There are two provisions in the Constitution of the WHO which allow it to adopt legal norms to accomplish its objectives: Article 19 and Article 21. Article 19 enables the Health Assembly, comprising delegates representing the Member states, to adopt an agreement or a convention “with respect to any matter within the competence of the Organisation.” Whereas Article 21 enables the Health Assembly to adopt regulations in respect of certain listed matters. Only states that ratify the treaty adopted under Article 19 become members of the Conference of Parties (CoP). The regulations adopted under Article 21 are generally expected to have near-universal membership.[x] As the treaty is likely to be adopted under Article 19 of the WHO constitution, only states that have ratified the treaty would be members of the Conference of Parties (CoP). The International Health Regulations revision under Article 21 is expected to have near-universal membership. Another difference between the two is that a Member State may reject the regulations adopted under Article 21 or make a reservation without providing any reasons for doing so. However, a legal instrument adopted under Article 19 must be generally accepted, and reasons must support any non-acceptance. The International Health Regulations (IHA), 1969, are an example of regulations adopted under Article 21. The IHR did not provide for any provisions for financial collaboration to raise funds or share tools like vaccines, or the transfer of the technologies needed to produce them.[xi] The Intergovernmental Negotiating Body (INB), set up by the Health Assembly in 2021 to draft and negotiate an agreement, convention or other instrument on pandemic prevention and response, had two options: either to revise the IHR or to adopt a new treaty to prevent another pandemic. But the IHR, last time revised in 2005 after the outbreak of the SARS epidemic, failed to prevent the outbreak of any pandemic.[xii] Consequently, a need was felt to bring in a Pandemic Agreement.

The Independent Panel for Pandemic Preparedness and Response was set up by the WHO to “provide an evidence-based path for the future, grounded in lessons of the present and the past to ensure countries and global institutions, including specifically WHO, effectively address health threats.”[xiii] The Panel based its work on “insights and lessons learned from the health response to COVID-19 as coordinated by WHO”. Beginning in September 2020, the Panel examined why Covid-19 became a global health and socio-economic crisis. The Panel published its findings in its report, ‘Covid-19: Make it the last pandemic’ in May 2021. Amongst several recommendations, the report made a recommendation for the adoption of “a Pandemic Framework Convention within the next six months, using the powers under Article 19 of the WHO Constitution, and complementary to the IHR, to be facilitated by WHO and with the clear involvement of the highest levels of government, scientific experts and civil society.”[xiv] This recommendation paved way for the Pandemic Treaty.

In March 2021, a group of world leaders announced an initiative for a new treaty on pandemic preparedness and response.[xv] This initiative was taken to the World Health Organization (WHO) and was negotiated, drafted, and debated by the newly-established Intergovernmental Negotiation Body (INB). The negotiations on the Pandemic Treaty failed to reach any clear conclusion before the 2024 World Health Assembly. But the proposed treaty negotiations continued till May 2025, when it was  finalised and presented to the 78th World Health Assembly, and formally adopted by the Assembly on 20^th May 2025.[xvi]

Contents

The WHO Pandemic Agreement document outlines the principles, approaches, and tools to enhance international coordination for pandemic prevention, preparedness, and response, including equitable and timely access to vaccines, diagnostics, and therapeutics.[xvii] The two most important and contentious aspects of the Agreement are: PABS system and Transfer of Technology.

The WHO Pandemic Agreement sets up a mandatory Pathogen Access and Benefit-Sharing (PABS) for the rapid and timely sharing of “materials and sequence information on pathogens with pandemic potential” as well as the rapid, timely, fair and equitable sharing of benefits arising from the sharing and utilisation of PABS Materials and Sequence Information for public health purposes.[xviii] The system becomes operational only “in the event of a pandemic emergency”.

The Agreement defines a “Pandemic emergency” as a public health emergency of international concern which is caused by a communicable disease and:

(i) has, or is at high risk of having, wide geographical spread to and within multiple States; and 

(ii) is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and 

(iii) is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and 

(iv) requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-of-society approaches.[xix]

The “public health emergency of international concern” means an extraordinary event which constitutes a public health risk to other States through the international spread of disease and potentially requires a coordinated international response.[xx]

‘Transfer of Technology’ was defined by WHO in 2011 as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible and authorized party.”[xxi] The WHO guidelines emphasize capacity-building as essential for technology transfer. They say that the capabilities of the Sending Unit (SU) and at the Receiving Unit (RU) should be similar.[xxii] They also say that adequately trained staff should also be available or should be trained at the RU.[xxiii]

The Agreement intends to enable a sustainable and geographically diversified production of pandemic-related health products, but provides for the transfer of technology and cooperation on related know-how for the production of pandemic‑related health products, in particular for the benefit of developing countries, only on a ‘mutually-agreed’ basis.[xxiv] A footnote to the Annexe in the Treaty defines “as mutually agreed” as willingly undertaken and on mutually agreed terms, without prejudice to the rights and obligations of the Parties under other international agreements. This means transfer of technology under the Agreement is a voluntary commitment, not a binding one; whereas, the sharing of pathogen sequence and other materials is a binding commitment.

The Agreement requires a manufacturer to sign a legally binding contract under which he is required to make available to the WHO a rapid access targeting at least 20 per cent of his real time production of safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the pandemic emergency, a minimum of 10 per cent of his production has to be made available as a donation, and the remaining percentage is to be reserved at affordable prices to the WHO.[xxv] This proposed mechanism was meant to address the vaccine inequity witnessed during COVID-19 and to improve access in developing countries, especially Low and Middle Income Countries (LMICs).[xxvi] The Treaty provision means that 80 per cent of the vaccines, treatments, or diagnostics are likely to stay with the countries with technology and manufacturing capabilities.

The Agreement further provides that the distribution of these vaccines, therapeutics, and diagnostics is required to be done on the basis of public health risk and need, and particular attention has to be paid to the needs of the developing countries.[xxvii]

Conclusion

An international treaty on pandemic prevention, preparedness, and response is a welcome step towards achieving global health security, given that the COVID-19 pandemic brought to the surface the global divide in the production and distribution of vaccines. A study shows that eighty per cent of the global population had access to around five per cent of the total COVID-19 vaccines in the world, and the remaining twenty per cent population accounted for around ninety-five per cent of the COVID-19 vaccines.[xxviii] During the COVID pandemic, the developing countries, like India and South Africa, backed by the least developed countries, requested the WTO to suspend patents relating to COVID-19 for a temporary period to ensure equitable access to “vaccines, medicines, and other new technologies needed to control the pandemic.”[xxix] The Pandemic Agreement, in its current form, is silent on the sharing of intellectual property. A pandemic treaty should require states to enact national laws for sharing the rights to inventions, data, and access to know-how and biological resources before a pandemic strikes for effective prevention.[xxx] There should be binding provisions in the Pandemic Agreement requiring the states to waive the intellectual property rights on relevant technology needed for pandemic response.[xxxi] Access to patent rights alone, though absolutely necessary, without voluntary sharing of manufacturing know-how, will not be sufficient to encourage production of generic or biosimilar health products necessary to prevent a pandemic.[xxxii] The setting up of a global repository of intellectual property for technologies to detect, prevent, control, and treat a pandemic can be a better option than just leaving all to bilateral negotiations between the Members and the Manufacturers. But such a repository cannot be solely left to voluntary sharing by intellectual property owners because that would put too many lives at risk. The Agreement does not address these challenges.  As far as the PABS Annex is considered, it must consider the access and the benefit-sharing on an equal footing and with equity, and resolve all future roadblocks in the operationalization of an effective PABS system.

*****

*Parnil Yodha, Research Analyst, Indian Council of World Affairs, New Delhi.
Disclaimer: Views expressed are personal. 

Endnotes

[i] Dr Patrick Butchard and Bukky Balogun (May 2025), What is the WHO Pandemic Treaty?, House of Commons Research Briefings https://researchbriefings.files.parliament.uk/documents/CBP-9550/CBP-9550.pdf Accessed on September 20, 2025

[ii] Draft Annex, https://apps.who.int/gb/igwg/pdf_files/IGWG3/A_IGWG3_3-en.pdf

[iii] https://www.who.int/news-room/events/detail/2026/02/09/default-calendar/fifth-meeting-of-the-intergovernmental-working-group-(igwg)-on-the-who-pandemic-agreement

[iv] https://www.who.int/news-room/events/detail/2026/01/20/default-calendar/resumed-fourth-meeting-of-the-intergovernmental-working-group-(igwg)-on-the-who-pandemic-agreement

[v] https://apps.who.int/gb/statements/WHA78/PDF/India-16.2.pdf

[vi] https://apps.who.int/gb/statements/WHA78/PDF/India-16.2.pdf

[vii] Constitution of the World Health Organisation

[viii] https://theindependentpanel.org/wp-content/uploads/2021/05/COVID-19-Make-it-the-Last-Pandemic_final.pdf

[ix] Dinah V. Parums (2025). Editorial: The 2025 World Health Assembly Pandemic Agreement and the 2024 Amendments to the International Health Regulations Combine for Pandemic Preparedness and Response. Medical science monitor: International Medical Journal of Experimental and Clinical Research, 31, e950411.

[x] Barbara Stocking et al. (2023), Governance of Health Emergencies, The Lancet, Volume 401, Issue 10393, 2035

[xi] Nina Schwalbe, Susanna Lehtimaki & Elliot Hannon (2025), The pandemic treaty: A forensic review of process and pitfalls, Global Public Health, 20(1), 2522916

[xii] David P. Fidler (June 7, 2024), The amendments to the international health regulations are not a breakthrough. Think Global Health. https://www.thinkglobalhealth.org/article/amendments-international-health-regulations-are-not- breakthrough;  Accessed on September 4, 2025.

[xiii] https://theindependentpanel.org/wp-content/uploads/2021/05/COVID-19-Make-it-the-Last-Pandemic_final.pdf

[xiv] https://theindependentpanel.org/wp-content/uploads/2021/05/COVID-19-Make-it-the-Last-Pandemic_final.pdf

[xv] Dr Patrick Butchard and Bukky Balogun (May 2025), What is the WHO Pandemic Treaty?, House of Commons Research Briefings https://researchbriefings.files.parliament.uk/documents/CBP-9550/CBP-9550.pdf Accessed on September 20, 2025

[xvi] Dr Patrick Butchard and Bukky Balogun (May 2025), What is the WHO Pandemic Treaty?, House of Commons Research Briefings https://researchbriefings.files.parliament.uk/documents/CBP-9550/CBP-9550.pdf Accessed on September 20, 2025

[xvii] Dinah V. Parums (2025). Editorial: The 2025 World Health Assembly Pandemic Agreement and the 2024 Amendments to the International Health Regulations Combine for Pandemic Preparedness and Response. Medical science monitor: International Medical Journal of Experimental and Clinical Research, 31, e950411.

[xviii] WHO Pandemic Treaty, Annex art. 12

[xix] WHO Pandemic Treaty, Annex art. 1(c)

[xx] WHO Pandemic Treaty, Annex art. 1(g)

[xxi] WHO guidelines on transfer of technology in pharmaceutical manufacturing, WHO Technical Report Series, No. 961, 2011

[xxii] WHO guidelines on transfer of technology in pharmaceutical manufacturing, WHO Technical Report Series, No. 961, 2011

[xxiii] WHO guidelines on transfer of technology in pharmaceutical manufacturing, WHO Technical Report Series, No. 961, 2011

[xxiv] WHO Pandemic Treaty, Annex art. 11

[xxv] WHO Pandemic Treaty, Annex art. 12(6)(a)

[xxvi] Mohammad Zakiul Hassan et al. (2025), From Reaction to Resilience: The WHO Pandemic Agreement as a Blueprint for Global Health Equity, International Journal of Infectious Diseases 158, 107944

[xxvii] WHO Pandemic Treaty, Annex art. 12(6)(b)

[xxviii]Moosa Tatar, Jalal Montazeri Shoorekchali, Mohammad Reza Faraji and Fernando A Wilson (2021), International COVID-19 vaccine inequality amid the pandemic: Perpetuating a global crisis? Journal of Global Health, 11:03086

[xxix] Ann Danaiya Usher (2020), South Africa and India push for COVID-19 patents ban, The Lancet, 396(10265), Pp. 1790 - 1791

[xxx] Katrina Perehudoff et al. (2021), A pandemic treaty for equitable global access to medical countermeasures:

seven recommendations for sharing intellectual property, know-how and technology, BMJ Global Health

2022;7:e009709

[xxxi] Katrina Perehudoff et al. (2021), A pandemic treaty for equitable global access to medical countermeasures:

seven recommendations for sharing intellectual property, know-how and technology, BMJ Global Health

2022;7:e009709

[xxxii] Katrina Perehudoff et al. (2021), A pandemic treaty for equitable global access to medical countermeasures:

seven recommendations for sharing intellectual property, know-how and technology, BMJ Global Health

2022;7:e009709