[GUEST ESSAY] Principles to Guide the Pathogen Access-and-Benefit Sharing System [PABS] in a Pandemic Agreement; Update: Proposal to Buy More Time to Operationalize PABS by May 2026
Newsletter Edition #79 [Treaty Talks]
Hi,
In order to bridge the schism between countries on key matters at stake in the negotiations towards a new Pandemic Agreement, a range of stakeholders are working behind-the-scenes to help push towards a logical conclusion in this three year old process.
We have noted before, how many negotiators see the Pathogen Access-and-Benefit Sharing System as a litmus test for equity in the overall reforms of Pandemic Prevention, Preparedness and Response. A test that WHO member states are at risk of failing, pending a minimum threshold for consensus.
In today’s edition, we bring you another guest essay from scholars who have been engaged on this topic. Authors Lawrence Gostin et al, have distilled four key principles that they argue is the bedrock for a viable PABS mechanism. (See their previous piece A Robust PABS System: Make or Break for the Pandemic Accord )
We also bring you a quick update on a new proposal that seeks to buy more time to operationalize PABS. We briefly discuss what this means for the overall negotiations.
Starting today we will be publishing a number of updates every week in the run up to the World Health Assembly beginning May 27, 2024. Thank you for reading and for your understanding, as we try to keep pace with swiftly changing dynamics around these discussions.
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I. GUEST ESSAY
Four Principles to Guide a Pathogen Access-and-Benefit Sharing System for Pandemic Preparedness and Response
By Lawrence O. Gostin, Sam F. Halabi & Jayashree Watal
Gostin is Distinguished University Professor, Georgetown University and Director, O’Neill Institute for National and Global Health Law, Washington, D.C., USA. Halabi is the director of the Center for Transformational Health Law and a professor at Georgetown University’s School of Health. Watal is Visiting Professor, National Law University Delhi, India.
As the 77th World Health Assembly approaches, global health diplomats are scrambling to finalize a comprehensive agreement on pandemic preparedness, prevention, response, and recovery that covers the broadest range of factors: national resilience and surveillance; protection of the vulnerable; technology transfer and local manufacturing; and management of supply chains, among others.
One of the most critical areas for agreement, and its ultimate success, is the structure and function of a pathogen access-and-benefit sharing system (PABS) through which countries will provide biological samples and associated data, including genetic sequence data, to a centralized system. Those developing products from the access to such biological materials and associated data will promise to share resulting benefits, which must be meaningful.
Such a mechanism is central to a world prepared for the next pandemic, yet, the actual details of PABS have become yet another forum for Global North versus Global South interests and disagreements to play out.
In the modern era, this divergence of interests is marked by the Convention on Biological Diversity which codified the already well-established legal principle that sovereign nations hold title to the resources within their territories and spelled it out in the context of biological resources.
The CBD became the legal anchor for Indonesia to claim that the WHO-administered system that made use of its influenza samples for purposes of global pandemic preparedness, also served to enrich the companies that produced medicines and vaccines, which were unaffordable and unallocated to Indonesia’s large population.
The resulting Pandemic Influenza Preparedness Framework was constructed to address this juxtaposition of global public health preparedness, and the realities of wealth exploitation and distribution at stake with animal and human pathogens.
After the PIP Framework was adopted in 2011, the CBD Conference of the Parties finalized the terms of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, creating a more definite instrument to enforce benefit-sharing under the burgeoning transactions attributed to ABS.
National and regional approaches to implementation of the Nagoya Protocol followed, with the role of genetic sequence data ascending as a new point of inquiry and concern. Some governments interpreted genetic sequence data as falling within the treaty’s scope, and adopting national laws codifying such, while others determined that information per se was not covered. A fresh set of access-and-benefit disagreements had been launched.
It is not possible to fully reconcile these decades of disagreement in the context of PABS within the current timelines to conclude these negotiations. Indeed, the nature of the pathogens and associated data magnifies this issue in global politics as recent episodes and epidemiological modeling suggest that the next pandemic pathogen is likely to emerge in the Global South, rather than the Global North.
All this could mean that states parties set out broad principles for PABS, but set a future date certain, say within 12-18 months, to develop a full PABS mechanism. Still, getting that mechanism fully formed and adopted at the World Health Assembly in May would be the optimal outcome.
We do believe strongly that a well-designed Pathogen Access and Benefits Sharing (PABS) system can be a bridge between the Global North and South. And it must be if the world is to get to the finish line on a Pandemic Agreement.
As the name “Access and Benefit Sharing” implies, “access” to scientific information is a win-win because everyone – governments, their citizens and residents, and their industries – benefit from rapid sharing of scientific information to facilitate research and development of lifesaving medical countermeasures (MCMs).
“Benefit sharing” is also in the world’s collective interests, not simply because equity is a universal value (which it is), but also because equitable access to diagnostics, vaccines, and therapeutics for populations in need helps contain outbreaks and limit new variants, protecting everyone.
For those participating in, or following the negotiations, it is well understood that agreement on a PABS system could make all the difference between successful adoption of a WHO Pandemic Agreement at the World Health Assembly in May and the collapse of talks after more than two years of intense diplomatic discussions. Failure in the negotiations would be devastating for global public health after all the suffering, lives lost, and economic destruction of the COVID-19 pandemic.
To advance vital negotiations on a Pandemic Agreement now at a critical stage in Geneva, we advance four principles for a PABS system that can serve as a bridge to health security and justice for everyone—North and South. The success of the Geneva negotiations will require compromise as well as a common commitment to advance science, security, and equity. We believe it can be done.
1) Full and transparent scientific exchange:
It is important that a PABS system supports rapid sharing of biological samples, genomic sequencing data (GSD), and other scientific information for pathogens with epidemic or pandemic potential. The rationale is that that these data are critical to more effective surveillance and risk assessment, which benefits all countries. Just as important, without rapid and transparent scientific exchange, we cannot create the tests, vaccines, and medicines we need to save lives. Instead of taking, say, 6-12 months to develop a vaccine when a pandemic strikes, it could take double that time, or more. Such delays would cost lives everywhere.
2) Real-time, needs-based sharing of medical countermeasures:
All those using pathogens or their GSD in the development of MCMs should agree to share a substantial percentage of any MCM production, say, no less than 20%, in real time and at a no-profit (at cost) price, for allocation to low- and middle-income countries (LMICs) as needed to protect the most vulnerable wherever they live. This 20% could be further modified based on risk, need, and resource distribution. For example, it may be comprised of 10% donation and 10% at cost, a so-called “10+10.”
Parties should also avoid pre-purchasing agreements for quantities of MCMs that far exceed their needs, which can create worldwide supply shortages. Allocation by an evidence-based and independent agency like WHO that is guided by public health risk and need in its allocation operations reduces the impact of vaccine supply shortages and potential hoarding.
A risk/need based allocation strategy also reduces the changes of using vaccines or other medical products to advance agendas other than those related to public health considerations. In other words, evidence-based allocation would obviate the pernicious effects of vaccine diplomacy experienced during the COVID-19 pandemic.
The rationale is that equity and justice are universal human values, central to the human experience. But even beyond equity, fair allocation of MCMs also makes everyone safer. When we deploy MCMs to populations most in need, outbreaks can be better contained, the most lives can be saved, and dangerous variants can be diminished. That benefits everyone as it minimizes the disastrous human and economic consequences of pandemics.
3) Financial contributions:
All parties to the PABS system should agree to financial payments to WHO or a trusted intermediary according to a fair and equitable negotiated formula. This is consistent with the Partnership Contributions that parties to the Pandemic Influenza Preparedness (PIP) Framework have already agreed to. Upfront, meaningful financial contributions are necessary to make MCMs available in a timely and affordable way for LMICs. The COVID-19 pandemic demonstrated the importance of adequate financing of MCMs to help ensure their timely availability everywhere.
4) The PABS system should be multilateral, not transactional:
PABS should not be thought of as a tit for tat arrangement. That is, “I give you a pathogen sample or its GSD and in return you give me resources.” It is only happenstance that a virus may be found in Country X and not Country Y where resources are based. Both countries (and the entire world) need medical countermeasures.
If the system were purely transactional, it would be less fair, and make everyone less safe. A transactional system would be less safe because sharing of scientific information would be truncated and limited only to the parties to the transaction. That would impede rapid development of MCMs. And it would be unfair because people of every country who are in need are equally deserving of life protection and the right to health.
A multilateral system provides a greater degree of legal certainty – valuable to all parties. This important element would be provided by an access and benefit system that fulfills the collective multi-lateral approach that Article 4(4) of the Nagoya protocol envisions as an alternative to the transactional, bilateral structure that Nagoya also allows. It is this legal certainty which offers both providers and users substantial value, making a collective and multilateral approach like PABS a win-win-win — a win for public health security, a win for public health equity, and a win for a rules-based system that provides predictability and minimizes uncertainty for all stakeholders.
In summary, every country, whatever their income level, would benefit from a robust PABS system that has four key elements: scientific exchange; real-time, needs-based sharing of pandemic products; and financial obligations—all within a legally binding multilateral system. These principles cannot fully reconcile all the disagreements unfolding now, but they can guide a constructive conversation toward a system that balances preparedness, equity, and fairness.
We are at an inflection point in the modern history of global health. It is going to take political will, diplomatic skill, and some compromise to secure a historic pandemic agreement that makes the world safer and fairer. We have no choice but to succeed.
Get in touch with the authors: Lawrence Gostin <gostin@georgetown.edu>, Sam Halabi at <sfh9@georgetown.edu> and Jayashree Watal <jw458@georgetown.edu>
II. BRIEF UPDATE
Proposal to Buy More Time to Operationalize PABS by May 2026
In an indication that suggests the extent to which a new Pandemic Agreement can be watered down, there is now a proposal to buy more time until May 2026 in order to operationalize the modalities around a Pathogen Access and Benefits Sharing System.
This has been a key demand of many developed countries who have often argued for more time to finalize the PABS mechanism. Deferring reaching consensus on such a mechanism, could mean a loss of leverage for developing countries who have been proponents of the PABS system in the context of a new Pandemic Agreement, some experts and diplomats believe.
Given how difficult the discussions have been not just on PABS, but on the various aspects of the Pandemic Agreement, it is of little surprise that such a proposal is now being considered with mere weeks remaining ahead of the May 2024 deadline set for the conclusion of these negotiations. The Bureau of the Intergovernmental Negotiating Body is expected to come up with another iteration of its proposal for a negotiating text on April 18th.
The proposal to buy more time to finalise PABS was presented by Thai diplomat Viroj Tangcharoensathien, a Vice-Chair of the Bureau who has steered these discussions over the last few months. This was discussed at an informal consultation with member states last week, according to Geneva-based diplomatic sources.
A presentation made at the meeting states: “Terms, conditions and operational modalities of the PABS System shall be further defined in a legally binding instrument that is operational no later than 31 May 2026.”
The proposal has streamlined elements that reflects some of the suggestions made by countries – but appears to have been shaped by conditions put forth by developed countries including on tiered pricing, and limiting the scope of application of the mechanism to pandemics and not Public Health Emergencies of International Concern (PHEICs). There are also no elements in the proposal to suggest clear obligations that could have a binding effect such as on manufacturers or on participating entities such as lab networks.
It also lacks crucial details on user registration, kinds of benefits-sharing, database governance concerns that have been flagged by developing countries. (See our prior report on the elements of the proposals suggested by developing countries)
Recall that more than 70 developing countries have been aligned on the need for a PABS system with specific emphasis on how benefits have to be shared.
Excerpts from the presentation:
Objective:
A multilateral access and benefit sharing system for pathogens with pandemic potential, the “WHO Pathogen Access and Benefit-Sharing System” (PABS System), shall be established to ensure rapid, systematic and timely sharing of PABS Material and Information (as such term is defined in this Pandemic Agreement) for public health risk assessment, and, on an equal footing, timely, effective, predictable and equitable access to pandemic-related health products, and other benefits, both monetary and non-monetary, arising from such sharing.
(The definition of WHO PABS Material and Information would be included in Article 1. and include physical material and genetic sequence data.)
Foundations of the PABS System:
a) Equal footing;
b) Universal application;
c) not impede research and innovation;
d) Complementarity with the Pandemic Influenza Preparedness Framework;
e) Inclusive, transparent governance, review and accountability mechanism;
f) Consistency with objectives of CBD & Nagoya Protocol and recognition as a specialized international access and benefit-sharing instrument.
PABS System core components and elements:
Modalities, terms and conditions to be determined and agreed, for:
a) Rapid, systematic & timely sharing of PABS Material and Information, and all relevant information; and
b) Fair, equitable & timely sharing of benefits, both monetary and non-monetary, at a minimum:
• (i) in the event of a pandemic; and
• (ii) annual monetary contributions from PABS System users, to be used by WHO to improve pandemic prevention, preparedness and response.
c) A mechanism to ensure the fair and equitable allocation & distribution of pandemic-related health products based on public health risks, needs, and demand.
Additional benefit-sharing options
a) encourage manufacturers from developed countries to collaborate with manufacturers from developing countries;
b) tiered-pricing or other cost-related arrangements; and
c) encourage laboratories in WHO coordinated laboratory networks to actively seek the participation of scientists from developing countries.
Activists at Third World Network pointed out: “It is not clear from the proposal to postpone the PABS negotiations that there is a similar scaling down of ambition with regard to other articles of the pandemic instrument. The danger of separating and postponing the PABS system negotiations from the rest of the pandemic instrument is that this could result in the effective decoupling of access from the benefit sharing. This is because obligations on surveillance and data sharing under Articles 4 (surveillance), 5 (one health) and 6 (preparedness) could result in sharing of pathogens or their data without an operational PABS system. This would take away the pressure from developed countries to engage in PABS system negotiations.”
(Also see detailed analysis from TWN on the various elements of the PABS provisions suggested by developing countries. Developing countries proposed streamlined PABS text at INB9)
To what extent such a proposal will pass muster will remain to be seen. Without an effective PABS, developing countries are likely to qualify support for the conclusion and consensus towards a new Pandemic Agreement. The INB is scheduled to meet for a resumed session of its ninth meeting during April 29th-May 10th.
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