Squaring The Circle On Equity in a Pathogen Access And Benefit Sharing System [Guest Essay]

Newsletter Edition #50 [Treaty Talks]

Nov 01, 2023

Hi,

Geneva Health Files is a clearing house for original reporting, analyses, and opinions capturing the goings-on in global health. It has been our effort to cater to our niche readership of decision-makers by bringing a range of views to make discussions on global health policy-making richer.

In this edition, I am pleased to bring you a guest essay by eminent legal scholars Lawrence Gostin and Jayashree Watal who present their views on a system for Access and Benefits Sharing in the context of current negotiations in global health. They suggest improved access obligations and a binding up-front contingent contribution for a Pandemic Response Products Fund for low and middle income countries. Such contributions need to be based on a fair and equitable, negotiated formula, they argue.

Read on. Write to us and to the authors with your thoughts.

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I. GUEST ESSAY

Squaring The Circle On Equity in a Pathogen Access And Benefit Sharing System

By Jayashree Watal and Lawrence O. Gostin

Research and development (R&D) needed to manufacture and deliver key pandemic response products (PRPs) such as diagnostics, vaccines, and therapeutics requires access to novel pathogen samples and their genomic sequencing data (GSD). Yet, many low and middle-income countries (LMICs) understandably do not want to share pathogens and GSD unless they can ensure that the benefits of R&D will be equitably distributed.

Many believe that without an agreed Pathogen Access and Benefits Sharing (PABS) system (or some other mechanism to ensure equitable access), neither of the two pandemic preparedness negotiations at the World Health Organization (WHO) can be successfully concluded. The WHO is currently negotiating two historic agreements, one on substantially amending the International Health Regulations (IHR) and the other on a new Pandemic Agreement (also known as the Pandemic Treaty). We acknowledge that an PABS system may not eventually ensure robust equity, yet it currently stands the best chance to make the world a little safer and fairer. This makes it worth our while to think about how to make PABS work for equity.

Pandemic Influenza Preparedness (PIP): A Model for ABS

The immediate precedent for an PABS system is WHO’s Pandemic Influenza Preparedness (PIP) Framework, which is a legally non-binding agreement concluded in 2011, based on principles laid down in an environmental treaty called the Convention on Biological Diversity (CBD), 1992. States parties to the CBD subsequently agreed in 2010 to specific details of access and benefit sharing (ABS) in the Nagoya Protocol on Access and Benefit Sharing (NP).

Under the CBD and NP, parties are obliged to provide access to genetic resources found in their territories, subject to prior informed consent and on mutually agreed terms, in exchange for fair and equitable sharing of monetary or non-monetary benefits.

Since pharmaceutical and researchers hosted by rich countries need access to genetic resources that are more abundantly found in poorer countries, this is the trade-off that LMICs pushed for and obtained in the broader context of the CBD and NP.

The PIP Framework can qualify as a specialized ABS agreement on specific genetic resources, namely influenza viruses of pandemic potential; and, if recognized as one, it need not apply the rules under the NP so long as it is in line with its objectives.

The objective of the NP as stated in its Article 1 is: “…the fair and equitable sharing of the benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components.”

While an ABS system is to a certain extent “transactional,” in the sense of a quid pro quo between the provider of the genetic resources and the recipient, in the PIP Framework there is no direct nexus between a country sharing genetic resources and GSD, and its receipt of benefits in exchange. Rather, it provides a multilateral system to facilitate both access to virus samples and GSD, and equitable distribution of vaccines, diagnostics, and therapeutics against pandemic influenza.

These products would be delivered to the WHO, which in turn would make decisions on the allocation of these benefits to LMICs based on principles of fairness. Thus, the WHO is the trusted, independent intermediary. The WHO has to date secured agreements covering approximately 420 million doses of pandemic influenza vaccine and 10 million treatment courses of antivirals that can be sent to countries in need at the time of the next influenza pandemic.

The PIP Framework also includes a Partnership Contribution which is an annual cash contribution of US$ 28 million given to WHO by influenza vaccine, diagnostic and pharmaceutical manufacturers that use the WHO Global Influenza Surveillance and Response System (GISRS). To date, the WHO has received about US$266 million through this mechanism.

Although the PIP Framework remains untested as there has not been an episode of pandemic influenza since its adoption, it remains an apt model for LMICs supporting a PABS in WHO Pandemic Agreement negotiations. Its two obvious shortcomings are that it does not cover pathogens with pandemic potential beyond novel influenza viruses and is not a legally binding treaty. Its “access” language, moreover, appears stronger than the text on “benefits”.

We understand, and agree with, the argument that full and rapid exchange of scientific information, including novel pathogens and GSD (the “access” side of the equation), should be decoupled from the equitable distribution of the fruits of research and development, including vaccines and therapeutics (the “benefits” side of the equation). Advocates of decoupling believe that the equitable distribution of PRPs is unlikely to happen through a PABS and this should not be seen as a “benefit” in exchange for access to pathogens, but should be seen as part of the right to health in LMICs, with which we agree.

We nevertheless believe there are good reasons for WHO State Parties to the Pandemic Agreement to negotiate what we call a PABS+ system, which improves upon the PIP Framework. Article 12 in the 16 October draft WHO Pandemic Agreement put out by the Intergovernmental Negotiating Body allows for such negotiations. Such a system would apply to the broad range of pathogens capable of spurring a future pandemic, would be binding for those WHO Member States that choose to join the Pandemic Agreement, and would have a built-in financing mechanism.

Image Credit: Photo by Mike van Schoonderwalt, Pexels.

Suggested Elements of PABS+

The details of our proposed PABS+ system are as follows:

Our proposed PABS+ system in the Pandemic Agreement would require a binding up-front contingent contribution to a “LMIC PRP Fund” by all WHO States joining the Agreement, with a view to speedily procuring PRPs for LMICs. Thus, all WHO States Parties to the Agreement would have to make payments to a trusted intermediary according to a fair and equitable, negotiated formula. Contingent funding by low- and lower-middle-income countries (LLMIC), must be fully supported through grants and/or concessional financing by the Multilateral Development Banks. Again, this must be negotiated and agreed to specifically under the Pandemic Agreement.
Economists have put forward credible ideas on such funding. To be a workable solution, this contingent LMIC PRP Fund must amount to a substantial sum early into a future pandemic, at minimum US$ 5 billion. In turn, WHO State party to the Pandemic Agreement would be obligated to immediately make physical samples and GSD of novel pathogens readily available.
Since it is important that the Pandemic Agreement and the IHR create an improved access obligation, our proposed PABS+ system must be part of both negotiating processes.
All those using pathogens or their GSD in the development of PRPs, however accessed, will have to sign a Standard Materials Transfer Agreement (SMTA) with a trusted intermediary (to be decided in the Pandemic Agreement), agreeing to share a substantial percentage of any PRP production, no less than 20%, in real time, at a no-profit-no-loss price, for allocation to LMICs as needed to end the pandemic. Recognizing that many of these entities may fail to produce sufficiently efficacious PRPs, the intermediary will only enforce the SMTAs of those whose products are proved safe and effective, for example through the WHO’s Emergency Use Listing process. We believe that charitable donations of PRPs are an unsustainable way to enhance supplies and ensure equitable access during a pandemic.
In addition, all SMTA signatories, whether called upon to contribute PRPs in real time or not, shall commit in the SMTA to make quarterly cash contributions to the LMIC PRP Fund as soon as production/commercialization of PRPs commence, in a small, fixed proportion of their global sales revenue, say 5%, amounting to an annual sum of, say another $5 billion. Again, not unreasonable as the annual global revenues from COVID-19 vaccines alone in 2021 and 2022 reportedly amounted to around $64 billion.
It would be up to the government in the host country, i.e., where an entity that uses pathogens or their GSD is located, to ensure compliance with the signing of the SMTA. In many cases this would require enacting/modifying specific domestic legislation to require this.
Clearly, the intermediary to be decided upon, needs to be independent and efficient, with transparent governance features to engender trust among HIC/LMIC donors, SMTA signatories as well as LMIC beneficiaries. The WHO needs to play a central role but may, or may not, be the intermediary. This must be left to the negotiators to decide.
To make the above obligations meaningful, an effective compliance mechanism, supported by a combination of incentives and possible sanctions administered by the same independent intermediary, should be negotiated as part of the PABS+ system.

Key Reasons to Adopt a PABS+ System:

States Parties to CBD and NP can already subject pathogens to access requirements under their domestic ABS laws. According to an industry-funded study, of the 137 countries with ABS regimes, at least 77 restrict physical access to pathogens, and 39 also restrict access to GSD. This diversity of domestic laws, and the legal uncertainties of NP, do not bode well for access to the needed pathogens with pandemic potential.
Although Article 8 (b) of the NP urges accelerated access during health emergencies, there are no time limits for sharing pathogen samples or GSD following a novel outbreak. Domestic ABS requirements vary considerably – a recipe for disastrous delays in sharing key information needed to develop PRPs. The Pandemic Agreement can correct this by setting time limits and imposing other requirements for rapid sharing of pathogens and GSD.
Similarly, the precise nature of benefits in exchange for pathogen and GSD access is unclear under the NP. Article 8(b) has weak optional language on considering “expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries”. The Pandemic Agreement can make this obligation more precise, as delineated above.
More importantly, the PABS+ system can mandate monetary contributions to a fund by all States Parties to the Pandemic Agreement as well as entities that directly or indirectly rely on the pathogen to manufacture PRPs, as set out above. Our proposal would be more politically palatable to high-income countries (HICs) than their having to make up-front grants from tax revenues or donations of PRPs in kind, as was done during COVID-19.
Finally, from the perspective of LMICs, their maximum realistic leverage for timely and equitable access to PRPs would come from a PABS+ system; and for HICs it would be both morally correct as well as in their own self-interest - of ending the pandemic as quickly as possible at the lowest possible cost - to support the proposed system.

Learning from the Response to COVID-19

The singular failure of the COVID-19 response was the the lack of timely funding for LMIC procurement and deployment. (High-income countries also pre-purchased vast vaccine supplies creating a global shortage). It took COVAX fifteen months from the start of the pandemic to raise $10 billion to cover 30% of LMICs, accounting for 60-75% of the delay in deployment of PRPs to LMICs. One of the key lessons learned from the COVAX facility is that equitable access to PRPs for LMICs needs both adequate and timely funding so that needed PRPs are available in LMICs at about the same time as they are in HICs.

While the World Bank’s Pandemic Fund focuses on pandemic preparedness by investing to improve LMIC health systems, a LMIC PRP Fund would be focused on an equitable response. This should be welcomed by HICs, given that the direct global losses of COVID-19 through 2024 were estimated to be as high as $13.8 trillion, to which many more trillions of dollars need to be added as the indirect losses.

As long as a novel virus like SARS-CoV-2 circulates unchecked globally, the more likely it is that dangerous variants will emerge, causing devastating health and economic consequences in both high and low-income countries. It is, therefore, in every country’s national interest to support equitable access to vaccines and therapeutics.

In sum, the world would be much better prepared to respond to a future pandemic with a binding PABS+ system with a built-in financing mechanism in place that would oblige those accessing physical pathogen samples and their GSD to contribute both a substantial proportion of their production of PRPs in real time as well as a small, fixed share of their global revenues to a LMIC PRP Fund, supplemented by up-front contributions by WHO States Parties to the Pandemic Agreement.

A PABS+ system would rapidly procure and fairly distribute PRPs to LMICs, with the objective of ending the pandemic everywhere as quickly as possible. Undoubtedly, the effectiveness of a PABS+ will depend on the detail of what is eventually negotiated, but the WHO Pandemic Agreement negotiations offer an historic opportunity for global solidarity, rather than leave each WHO Member State to make selfish and self-interested policies, as occurred during the COVID-19 pandemic.

Get in touch with the authors: Lawrence Gostin <gostin@georgetown.edu> and Jayashree Watal <jw458@georgetown.edu

Snakebite gurus reveal untold truths

In this episode, our guests tackle snakebite, a topic suggested by one of our research partner organizations, the Oswaldo Cruz Foundation (Fiocruz) in Brazil. While snakebite is a neglected public health issue, the World Health Organization (WHO) estimates that each year, 5.4 million people are bitten by snakes, and up to 137,880 people die from snake bites.

Host Garry Aslanyan speaks with Fan Hui Wen and Thea Litschka-Koen, snakebite gurus in Brazil and Eswatini, respectively, who reveal untold truths about snake bites in their communities and the complexities associated with producing and administering antivenom. Diogo Martins, the research lead for snakebite at Wellcome in the United Kingdom, makes the case for why we should consider snakebite a global health issue.

Listen here

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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III. WHAT WE ARE READING

A Fragile State of Preparedness: 2023 Report on the State of the World's Preparedness: GPMB

COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities: USITC

Discussion paper on the Interplay between Patents and Trade Secrets in Medical Technologies: WIPO

Improving public access to medicines while promoting pharmaceutical innovation: European Parliament

Regulations the top hurdle to make medicines in Africa, officials say: Devex

IV. NEXT WEEK

WHO: Intergovernmental Negotiating Body: 6–10 November and 4–6 December 2023

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