A Little Fairer is Not Good Enough: Why ABS Will NOT Ensure Equity [GUEST ESSAY]
Newsletter Edition #55 [Treaty Talks]
Hi,
Of the many areas where global health legal scholars disagree, one of the more urgent matters in the context of new rules on health emergencies is whether a multilateral system on Access and Benefits Sharing [ABS] will work in health.
In today’s guest essay, written in response to an earlier one [Squaring The Circle On Equity in a Pathogen Access And Benefit Sharing System], scholars argue that the Pandemic Influenza Preparedness Framework is not the ideal model for a new ABS mechanism. They are of the view that the proposed ABS mechanism - as framed in transactional terms - will not address the goals of equity. Read on.
Geneva Health Files is keen to host diverse perspectives to contribute to a rich discussion in a way that informs the work of governments negotiating international health policy. We hope you find these insights from scholars useful.
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Until later.
Best,
Priti
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I. GUEST ESSAY
A Little Fairer is Not Good Enough: Why ABS Will NOT Ensure Equity
By Michelle Rourke, Law Futures Centre, Griffith University, Brisbane, Australia; Abbie-Rose Hampton, King's College London, London, UK; Mark Eccleston-Turner, King's College London, London, UK; Stephanie Switzer, University of Strathclyde, Glasgow, UK.
Access and benefit-sharing (ABS) has been a mainstay of international law for more than 30 years, but it is hard to find concrete examples of it resulting in fair and equitable outcomes.
More specifically, its use in global health via the World Health Organisation’s Pandemic Influenza Preparedness (PIP) Framework remains untested because there has not been an influenza pandemic since it entered into force in 2011 – this is the main trigger for the sharing of benefits in the form of vaccines and other medical countermeasures. We have repeatedly argued that there are very good reasons to think it will fail if and when it is called upon to deliver equitable access to countermeasures to low- and middle-income countries (LMICs) during a pandemic. Despite this uncertainty, the negotiations for a Pandemic Agreement have used the PIP Framework as a model to deliver equitable benefit-sharing during future pandemics.
The flaws in pathogen ABS
In our view, the pathogen ABS model in the most recent draft of the Pandemic Agreement (and, indeed, the use of ABS in a public health setting at all), cannot deliver equity. The Pandemic Agreement’s “Pathogen ABS System” (PABS System) ties what should be two separate public health problems together:
High-income countries (HICs) want early warning of any pandemic threats that they believe are most likely to come from LMICs. This requires access to up-to-date pathogen samples (and genomic data) sourced from all countries, which can be passed on to researchers and pharmaceutical companies to develop countermeasures, should the need arise.
LMICs have never received fair and equitable access to the pandemic-related products that are generally produced in HICs, even if the development of these products was reliant upon access to samples of pathogens and/or data originating in (or isolated from) LMICs.
By tying these two problems together, the PABS System proposed in Article 12 of the current draft of the Pandemic Agreement, is supposed to create interlocking incentives for both LMICs and HICs to address these problems simultaneously.
Under the proposed system, if LMICs provide their samples to the WHO, the WHO will provide the samples to HICs and pharmaceutical companies, and then they, in turn, can provide their pandemic-related products to the WHO to be distributed by the WHO to LMICs during the next pandemic. That all sounds a lot more complicated than an alternative set of solutions, which could look something like:
Mandate the sharing of pathogens and associated data for the benefit of all.
Obligate HICs to help build domestic and regional prevention, preparedness and response capacities in LMICs (e.g., primary health care facilities and manufacturing capacity), so LMICs can address health crises on their own. This is to ensure that LMICs do not have to rely on the “generosity” of HICs during the next pandemic, since we all know HICs only speak of “international solidarity” after, and not during, a pandemic. Incidentally, this would also be for the benefit of all.
And when proponents of ABS admit that the best a Pathogen ABS System (or “PABS+ System”) could do is make the world a little fairer, maybe we need to go back to the drawing board and come up with something that is materially fairer.
And while we're at it, we need to ask ourselves why we are framing vaccines and other essential products as “benefits” that countries can go into a pool to win if they behave themselves properly and provide their sovereign materials (pathogen samples) to the Pathogen ABS System? Does the “right to health” not already include access to vital medicines (irrespective of whether governments hand over their raw materials)? Why are we (further) commodifying such a fundamental right using the ABS transaction?
Securing the “access to pathogens” side of the ABS transaction
While the benefit-sharing mechanism under the PIP Framework (in the form of access to vaccines and medical countermeasures) is untested, it has nevertheless encouraged LMICs to relinquish control over their influenza virus samples. In return, the PIP Framework has secured promises from pharmaceutical companies for 420 million doses of influenza vaccine, but these are not actual vaccine doses, just numbers on a spreadsheet. You can bet your bottom dollar that during the next influenza pandemic, vaccine nationalism exercised by the world’s wealthiest nations will again pose a crisis of equity and justice for LMICs.
Irrespective of what the non-binding PIP Framework says, HICs are not likely to export a single dose of pandemic vaccine to the WHO until they have met their own domestic needs. Indeed, there is nothing in the PIP Framework to prevent this. HICs have shown the world time and time again that they cannot be trusted to show solidarity with LMICs during an emergency. So LMICs must secure genuine benefits before the next pandemic, and HICs should be on the hook to deliver them.
Recognition as a “Specialized International ABS Instrument” under the Nagoya Protocol?
Now let's talk about the other problem the WHO and pharmaceutical manufacturers want to solve: the fact that countries have sovereign rights over their pathogen samples under the Convention on Biological Diversity (CBD) and the associated Nagoya Protocol on Access and Benefit Sharing (NP). Countries have no obligation to share their genetic resources under these agreements, they just have to “endeavour to create conditions to facilitate access to genetic resources for environmentally sound purposes” (Article 15, CBD [emphasis ours] and see Article 8, NP). And using these rules, countries have withheld pathogen samples from HICs and pharmaceutical manufacturers to attempt to negotiate bilateral ABS agreements. They are well within their rights to do so under the CBD and NP, but the whole process of negotiating a bilateral ABS agreement is seriously time-consuming and resource intensive. And when there's a health emergency, delays caused by engaging in the ABS process can cost lives.
The perception is that a PABS System will solve this inefficiency problem by turning on multilateral ABS (with pre-negotiated ABS terms and lower transaction costs) and turning off bilateral ABS. But it won't. The current draft of the Pandemic Agreement states: "The WHO PABS System shall be recognized as a specialized international access and benefit-sharing instrument within the meaning of paragraph 4 of Article 4 of the Nagoya Protocol". Article 4(4) of the NP states:
"This Protocol is the instrument for the implementation of the access and benefit-sharing provisions of the Convention. Where a specialized international access and benefit-sharing instrument applies that is consistent with, and does not run counter to the objectives of the Convention and this Protocol, this Protocol does not apply for the Party or Parties to the specialized instrument in respect of the specific genetic resource covered by and for the purpose of the specialized instrument" (emphasis ours).
There are a few problems with this:
A "specialized international ABS instrument" is a category under the NP. Not all WHO Member States have signed up to the NP, so the membership of the WHO and NP are not the same. More generally, the criteria and process for designating a specialized international instrument under Article 4(4) of the NP is yet to be determined by the Parties to the NP. However, as a matter of international law, it is not clear that the parties to the Pandemic Agreement would have the legal authority to unilaterally make such a declaration. It may be that it is the Meeting of the Parties to the NP (MOP) – and not the membership of the WHO – that has “the authority to assess, determine, review or terminate the status of instruments as specialized international access and benefit-sharing instruments” under Article 4(4) of the NP.
Part of the criteria for deciding whether an agreement constitutes a specialized international instrument under Article 4(4) of the NP is likely to turn, at least in part, on the question of legal certainty in “respect to access to genetic resources or traditional knowledge associated with genetic resources, including, as appropriate, the application of prior informed consent, and to benefit-sharing”. However, terms such as “pathogens of human pandemic potential” – which are still under negotiation at the WHO – are subjective and are not terms of art for either the legal or scientific community. Furthermore, the PABS System does not even consider the possibility of pathogen-related traditional knowledge held by Indigenous Peoples and local communities, which could be a factor if the PABS System was to take a One Health approach to pathogen sharing. Of course, an additional likely criterion for whether an agreement is a specialized international instrument is whether it produces fairness and equity in respect of the sharing of benefits. But as we know, based upon the PIP Framework, we cannot presume that a PABS System will deliver fairness and equity until it is tested in a pandemic.
The mere existence of a multilateral ABS mechanism, even if it is classified a specialized international instrument, will not stop the CBD and NP being the default legal regime for pathogens (i.e. bilateral ABS is remains the default). If we turn to the PIP Framework, countries can exercise their sovereign authority by sharing their influenza viruses with human pandemic potential under the terms of the PIP Framework, or they can share the samples bilaterally in accordance with their own laws and policies (that implement the ABS provisions of the CBD and NP). That is, the PIP Framework only results in the disapplication of the NP for the specific samples that countries choose to share under the terms of the PIP Framework, not for the entire category of influenza viruses with human pandemic potential. The same will be true for specific samples of “pathogens with human pandemic potential” to be shared under the Pandemic Agreement.
Additional issues on PABS
And finally, if this PABS System is a fait accompli (which it appears to be, despite its best sales pitch being “it's better than nothing”), then it must be stated that:
If the PABS System is genuinely consistent with, and does not run counter to the objectives of the CBD and NP, then all countries maintain their sovereign rights over the pathogen samples extracted from their territories. LMICs should use this fact to fight for (and get) “better than nothing”.
Any PABS System should take a One Health approach to pathogen sharing and should therefore involve all members of the quadripartite group: , the WHO, the World Organisation for Animal Health (WOAH), the United Nations Environment Program (UNEP) and the Food and Agriculture Organisation of the UN (FAO). There’s an argument to be made that any PABS System that genuinely takes a One Health approach – a guiding principle of the Pandemic Agreement – should not just sit under the auspices of the WHO, but rather should take a “multisectoral, interdisciplinary and interinstitutional (approach to) cooperation”.
If a PABS System is to cover all pathogens with human pandemic potential, then regardless of how this term is defined, it would clearly subsume the PIP Framework, which becomes obsolete if the PABS System is considered a viable pandemic benefits-accumulation and distribution mechanism.
Fairness and equity must be based on more than vaccine donations
After the calamitous response to the COVID-19 pandemic, and the fact that HICs (once again) hoarded more vaccine doses than needed to adequately protect their populations, we can’t help but think that “a little fairer” is not good enough. If the Parties to the negotiations are genuine in their commitment to equity and solidarity, they must offer more than the flimsy charity and good intentions we see in the current draft. We should be particularly wary of any system (like the proposed PABS System) that leaves LMICs at the mercy of good faith donations from HICs during a pandemic (even via a “trusted intermediary”); this just reinforces the spectacularly flawed status quo.
A materially fairer approach would give LMICs adequate pre-pandemic support to build primary health care capacity and regional response capabilities, including in manufacturing countermeasures. That way there will be no need for LMICs to withhold pathogen samples to secure access to the supplies and medicines they already have a human right to receive. Other parts of the Pandemic Agreement’s draft text make provision for benefits that can be delivered before as well as during a pandemic, such as the transfer of technology and know-how (Article 11) and sustainable production (Article 10). However, these provisions are replete with soft directives such as the requirement that Parties shall encourage manufacturers to provide non-exclusive, royalty-free licenses to other manufacturers, particularly in developing countries. To encourage is not the same as to require, and LMICs should fight for solid benefits up-front rather than the mere potential to receive HIC-leftover products in the next pandemic.
We have argued elsewhere that the Pandemic Agreement provides the ideal opportunity to reimagine equity within global health. This requires the world to move beyond the flawed transactional model of ABS that forces (mostly) LMICs to trade their pathogens for the possibility of vaccines and other medical countermeasures at some indeterminate time in the future. We can and should do better; a little fairer sometime in the future is not good enough.
Get in touch with the authors: via Mark Eccleston-Turner at mark.eccleston-turner@kcl.ac.uk
II. PODCAST CORNER
The promise and perils of future health technology
This episode is about a conversation on new advances in technologies that are transforming public health practice. The discussion explores the promise and perils of artificial intelligence (AI), big data, infodemics and the importance of culturally appropriate innovations.
While speaking with Florence 2.0, an AI health worker, host Dr Garry Aslanyan tries to get advice on leading a healthier lifestyle. Yara Aboelwaffa, co-founder of Health 2.0 Egypt, talks about the fastest-growing innovations in the Middle East. And Tim Mackey, co-founder of a health care big data startup, shares the realities of attracting funding for public health-focused innovations.
Garry Aslanyan is the host and executive producer of the Global Health Matters podcast. You can contact him at: aslanyang@who.int
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