Explaining Stephanie Switzer, Adam Strobeyko, Mark Eccleston-Turner, Sylvain Aubry, and Michelle Rourke’s suggestions on the Pandemic Agreement’s Annexure on Pathogen Access and Benefit-Sharing (“PABS”) system, in the first part of her two-part post on the Annexure, Srishti Gaur assesses their feasibility and potential implications. Srishti is a third-year student at National Law University, Delhi. Her previous posts can be accessed here.
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© WHO / Christopher Black (image from here)Beyond the Tip of the Iceberg: Delving into the Entanglements of the PABS Annex (Part I)
By Srishti Gaur
After more than three years of negotiations, the World Health Organization (“WHO”) has concluded the 35-page Pandemic Agreement (“PA”) aimed to address future global health emergencies (see here). The impetus for the conceptualization of this instrument emerged at the height of the spread of Omicron, when the Member States of the WHO acknowledged the severe limitations of the existing global health governance framework. As reported, equitable access to vaccines could have saved about 1.3 million lives, however, a mix of an uncoordinated system coupled with global inequalities contributed to turning the pandemic into a large-scale, human-made crisis.
The PA is a legally binding agreement under Article 19 of the WHO Constitution. While the core text has been finalized (its critical analysis can be found here), it is to be followed by the drafting of Annexure on Pathogen Access and Benefit-Sharing (“PABS”) system through an Intergovernmental Working Group (“IGWG”). Only after the adoption of the PABS Annex, the WHO PA will be open for signature and henceforth, considered for ratification. The negotiations of PABS are not without their own share of hurdles, but are worth the pains since they form a crucial aspect of the PA.
Against this backdrop, policy experts (Stephanie Switzer, Adam Strobeyko, Mark Eccleston-Turner, Sylvain Aubry, and Michelle Rourke) have authored a paper (available here), putting forward a set of suggestions on certain pivotal aspects of the Annex and issues that require closer consideration, which this two-part blog post will unpack and probe into.
The first part will focus on suggestions advanced in the aforementioned piece and assess their feasibility and potential implications. The second part will widen the lens to focus on additional considerations that the Annex should attempt to address. Through this, the purpose is to chalk out key design choices that are determinative, among other factors, of whether PABS become a meaningful instrument or end up as another missed opportunity in global health governance.
What is PABS?
Before we jump into suggestions that the paper proposes regarding the PABS Annex, it is pertinent to understand the PABS mechanism.
Samples of pathogens of infectious diseases are critical to the development of medical countermeasures, and this development predominantly takes place in developed countries. Historically, the Global North used genetic sequences from the South as freely available goods and developed them as privatized property. To counter these injustices, PABS was developed as a transactional mechanism to trade sovereign rights in pathogen samples for fair and equitable sharing of the benefits arising from their use. This quid pro quo arrangement prioritizes contribution instead of distributing benefits on a public health needs basis (more can be read here).
The 2010 Nagoya Protocol on Access and Benefit Sharing (henceforth “Protocol”), a supplementary agreement to the 1992 Convention on Biological Diversity (“CBD”), places an international obligation on the parties to the Protocol to ensure that benefits arising from the use of genetic resources, which are provided by another country, are shared fairly and equitably. It further categorizes pathogens as genetic material, placing the PA under the ambit of the Protocol. Article 4(2) of the Protocol allows parties to implement other agreements provided it does not run counter to the basic objectives of the Protocol.
Suggestions Put Forth
Avoid fragmentation and build on existing systems
PABS is not the first ABS regime to be set-up, other frameworks, notably the Pandemic Influenza Preparedness Framework (“PIP Framework”), have previously laid mechanisms to govern ABS related to the influenza virus. The authors of the paper underscores that the PABS system cannot function in an institutional vacuum and recommend that it situate itself in the larger web of regulations and mechanisms laid by the CBD, the Nagoya Protocol, and the PIP.
If the PABS mechanism is capable of meeting its commitments, then the superseding of the PIP framework can also be considered. Running parallel systems for the purpose of ABS can potentially lead to a patchwork of regulations, overlapping at certain points and risks uncertainty and fragmentation in implementation.
While this is needed, the recommendation does not expand on how the required interaction will play out with other instruments. For instance, though the piece does not address the International Health Regulations, which act as complementary norms to global health governance, the PABS and IHR frameworks overlap but their methods of implementation diverge. The 2024 amended version of IHR laid down the definition of ‘pandemic emergency’ (Article 12, A77/A/CONF/14). In such emergencies, IHR provides immense executive power to the WHO and its Director-General to manage them, which could even extend to compelling access to materials and data without offering any incentives to share benefits resulting from the material. This tension demonstrates that the PABS Annex will have to clarify its relationships with other instruments to ensure complementarity than conflict.
Increase transparency in Negotiations
The article under discussion advocates for the preparation of a document, after every meeting of the IGWG, describing the discussion that took place and putting them out for public access. Instead of making negotiations a closed-door event, it should be made available to public scrutiny. Currently, only textual proposals submitted to the IGWG are available in the public domain, and not other documents.
In addition to this recommendation, the IGWG can also consider establishing a review mechanism to assess the performance of the Annex after its adoption. It can, thereafter, provide insights to effectively conduct its operations since previous experiences with ABS regimes show that challenges often crop up during the implementation phase.
Ensure Evidence-based Policy Design and Mutual Learning
The paper authored by Switzer et al suggests that the IGWG should try to incorporate the experiences of experts and invite them to the discussion to ensure that the PABS mechanism generates more benefits than costs. The question arises that who these experts can be – the experts should not just be limited to the scientific society but also involve civil society, indigenous population, local communities, and any other relevant actor whose insights would add to the understanding of PABS. What can be further noted is that Article 21.7 of the PA allows subsidiary bodies to be created, opening doors to advisory structures. For instance, an intergovernmental panel can be built on the lines of the Intergovernmental Panel on Climate Change or the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services.
In a welcome development, the recent Annex negotiations moved towards deciding in favour of involving experts in the panel. The only contention is whose recommended expert(s) will make it to the panel because the affiliation of an expert can alter the gears of discussion, making it a debate of considerable institutional as well as political consequence.
Incorporation of Traditional Knowledge related to Genetic Material
The piece in discussion suggests that the PABS Annex should incorporate traditional knowledge (“TK”) to be in line with the PA (whose Preamble expressly acknowledges TK), the Nagoya Protocol, and the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge.
This suggestion carries weight, in my view, from three perspectives: first, traditional knowledge has been significant in previous outbreaks – for instance, during the 2014 Ebola outbreak, traditional burial practices were integrated into public health response. To achieve the One Health approach of WHO, which builds on the interdependence of human, animal, and environmental health, the inclusion of TK becomes important.
Second, for the PA to qualify as a Specialized International ABS Instrument (“SII”), Article 4(4) of the Protocol requires the instrument to regulate both access and sharing of benefits, while being consistent with the Protocol’s objectives, which specifically provides for the inclusion of traditional knowledge. Without being recognized as an SII, every access request to a pathogen sample could remain stuck in the national ABS regime-related procedures, delaying global response during such high-stakes times. Moreover, Article 12.4 of the PA posits that the treaty is consistent with the Nagoya Protocol – to make this position a reality, the PABS Annex must squarely engage with TK.
Lastly, from a broader perspective, the rights of indigenous and local communities cannot be interfered with without their prior and informed consent to access TK related to genetic resources – a principle also protected under Article 31 of the UN Declaration on the Rights of Indigenous Peoples (UNDRIP). Ensuring the inclusion of TK is vital for the inclusive and equitable mandate of PABS.
Distinguish between regulation and traceability of PABS material and sequence information
The paper puts forth that the difference between pathogen samples and genetic sequence data (“GSD”) needs to be well-articulated. This so because the former refers to the physical material that can be isolated and stored, with which the WHO has had prior experience under the PIP Framework; the latter, on the other hand, is the digital representation of the genetic information contained within those pathogens which the WHO has never worked with. Currently, the WHO does not have a policy to govern the GSD and to trace and regulate the sharing of material and the benefits arising from it.
Building on this point, it is worth noting that without a robust governance structure in place, it risks reducing the implementation of PABS to voluntary adherence. COVID-19 is an example of such a situation where developing countries have provided access to pathogen samples to the WHO but this was not reciprocated as no such benefits from the utilization of the pathogen sample were shared.
Taking this into cognizance, in the earlier draft of the PA, the WHO introduced a system wherein genetic sequence data would be uploaded, and this PABS Genetic Sequence Data (“GSD”) would be tagged accordingly and notify the users till the end product. However, it was flawed as users will be able to access GSD without providing their contacts or any registration. It is imperative to note that this glaring loophole, which undermines the integrity of benefit-sharing, should not make it to the Annexure as it runs counter to the principle of transparency and accountability. Instead of this anonymous access to GSD, the users must be mandated to register themselves and verify their identities.
Malaysia’s proposal to the IGWG also addresses the tracing issue, providing for mandatory user registration, acceptance of a legally binding Data Access Agreement (DAA) and Digital Object Identifiers (DOIs). Taken together, all these measures could strengthen accountability in the system.
Funding of the PABS mechanism
One of the concerns the policy experts raise is the issue of funding. Their paper notes that the negotiations on PABS have yet to address the question of funding or infrastructure – whether to build on the pre-existing laboratories or develop new facilities is still uncertain. Past experiences show that the Plant Treaty’s Multilateral System and domestic ABS regimes have failed to generate monetary returns. At a time when the WHO has been going through a budget crisis, monetary considerations become have specifically important.
This financing concern, in my understanding, also ties to the earlier point on avoiding fragmentation. For instance, the CBD recently launched the Cali Fund, where major entities or companies benefitting from the use of digital sequence information are expected to contribute a portion of their profits or revenue to the Fund. Linking PABS finances to such broader international initiatives could help with funding and avoid creating competing systems. The need of the hour is for the IGWG to provide clarity on sustainable financing to ensure urgent public health needs are addressed without replicating the shortcomings of previous regimes.
Contractual Mechanism
Apart from the suggestions proposed in the paper, I believe that a standardized contractual mechanism can also be useful to further guide the governance of PABS. An effective precedent for this is the FAO International Treaty on Plant Genetic Resources for Food and Agriculture, which established a multilateral system for allowing access to plant genetic material through a Standard Material Transfer Agreement (“SMTA”). An SMTA can be understood as a standardized contract that lays down terms and conditions governing the exchange of plant genetic material and ensures that its benefits are shared equitably. It requires recipients of genetic material to commit to certain specific benefit-sharing commitments.
In terms of contractual structure, the Africa Group proposed that the WHO should have individual legally binding contracts with the manufacturers that join PABS to ensure accountability and enforceability. It will be more effective if such a framework is put into place wherein the rights and responsibilities for users are laid and benefit-sharing commitments are embedded into legally binding terms. This can be accompanied by a surveillance mechanism to monitor compliance of the PABS system.