Pathogen Access & Benefit Sharing System: A Key to Operationalize Equity in Pandemic Preparedness & Response [GUEST ESSAY]
Newsletter Edition #58 [Treaty Talks]
Fairness is a fundamental principle in health and law. With discussions in Geneva on the reforms in global health increasingly reaching a crescendo, legalese dominates these considerations towards binding norms. Often, the vital notion of fairness is forgotten.
In today’s edition we bring you a guest essay on how a proposed new system on accessing information on pathogens and the resulting benefits could potentially lead to better outcomes on equitable access to medical products during health emergencies.
Author Sangeeta Shashikant, from Third World Network, followed the negotiations on the Pandemic Influenza Preparedness Framework very closely. She has also been involved in its governance. From her rare vantage point on these issues, she offers her insights on why the PIP model can be adapted for the better, in the context of a new pandemic agreement, and for the amendments to the IHR. She combines a historical perspective, along with the practical learnings from the PIP experience, to distill some pointers for consideration in the current discussions.
Watch this space for more.
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I. GUEST ESSAY
Access and Benefit Sharing System: A Key to Operationalize Equity for Pandemic Preparedness & Response
By Sangeeta Shashikant, Third World Network
In recent weeks, much has been published on access and benefit sharing and its role in promoting equity in the context of ongoing negotiations at the World Health Organization (WHO). Critics argue that ABS "cannot deliver equity," but this article aims to address and debunk some of their key arguments.
Why Access and Benefit Sharing? Why the PIP Framework?
In 2005, developing countries, especially desperate South-East Asian countries hardest hit by the H5N1 outbreaks, failed to get access to vaccines developed using flu virus strains circulating in affected countries, shared through the network of laboratories known at that time as “Global Influenza Surveillance Network” (GISN).
Manufacturers prioritized supplies to rich countries that had provided financial grants for production and signed advance purchase agreements to be at the front of the supply queue during an influenza outbreak. Moreover, WHO-designated laboratories, e.g. the US Centres for Disease Control (CDC), a WHO Collaborating Centre and pharmaceutical companies with whom biological samples and sequence information were shared in good faith, also claimed patents over parts of materials shared (e.g. genes/sequences) and their use in the development of diagnostics, therapeutics and vaccines. The GISN system lacked a regulatory framework governing the sharing of influenza viruses of pandemic potential (IVPP) and, with that, a system for transparency, accountability and equity.
These issues came to a head at the 60th World Health Assembly (WHA) in 2007 when more than 20 developing countries brought this issue to the WHA, seeking a better equitable system.
After more than a week of intensive negotiations, WHA Resolution 60.28 was agreed to, acknowledging “the need for effective and transparent international mechanisms aimed at ensuring fair and equitable sharing of benefits, including access to, and distribution of, affordable diagnostics and treatments, including vaccines, to those in need, especially in developing countries, in a timely manner”. This recognition was only made possible by leveraging the rights developing countries have under international law through the Convention on Biological Diversity (CBD). The CBD, with near universal membership, recognises the sovereign rights of States over their biological resources and stipulates that access to genetic resources requires prior informed consent (PIC) and fair and equitable benefit sharing arising from the utilization of genetic resources on mutually agreed terms.
The Nagoya Protocol on Access and Benefit Sharing, established in 2010 under the CBD, further expands on the implementation of the benefit-sharing right, also providing the option to establish a multilateral access and benefit-sharing (ABS) system with standardized terms for specific genetic resources (see below on specialized international instrument).
In 2009, the recurrence of inequality during the H1N1/swine flu outbreak spurred negotiations that began in 2007, ultimately culminating in the adoption of the Pandemic Influenza Preparedness Framework (PIP Framework) in 2011.
The persistent inequity observed during the H5N1 outbreaks is not isolated. Recent reports reveal a standstill in affected countries' access to Ebola treatments, even after two years of approval and five Ebola virus disease (EVD) outbreaks. The global COVID-19 pandemic also showcased staggering disparities in access between developed and developing countries.
PIP Framework Benefit-Sharing Supports Pandemic Flu Preparedness
The PIP Framework marked the first time WHO Members committed “to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits,” considering them “as equally important parts of the collective action for global public health”, thus transforming “GISN” into a Global Influenza Surveillance and Response System (GISRS). Importantly, its focus is no longer merely on the sharing of IVPP but also access to vaccines and the sharing of other benefits.
The PIP Framework uses Standard Material Transfer Agreements (SMTAs) to govern access to PIP materials by WHO-designated GISRS laboratories and other entities such as manufacturers of vaccines, diagnostics and pharmaceutical products. SMTA1, applicable to the GISRS network of laboratories, makes clear that the use of shared materials should be in accordance with the agreed WHO terms of reference, and neither the provider nor recipient laboratories should seek to obtain any intellectual property on the materials. Transfers of PIP materials from the laboratories to entities outside the GISRS, such as manufacturers, are on condition the manufacturer has signed an SMTA 2 with WHO.
SMTA 2 lists non-monetary benefit-sharing options that a manufacturer agrees to provide to WHO during an influenza pandemic. Currently, 14 legally binding SMTA2 contracts exist, with WHO reporting to have secured more than 400 million doses in the event of a pandemic (i.e. 10 of every 100 doses of vaccine manufactured, of which 8 will come to WHO at no cost to be supplied as they are manufactured during a pandemic). This represents four times the amount of vaccine the organization had access to during the 2009 HIN1 pandemic. WHO has also secured access to 10 million treatment courses of antivirals 250,000 diagnostics kits and 25 million syringes through the SMTA2.
Furthermore, the PIP Framework (section 6.14.3) mandates annual monetary benefit sharing (also known as “partnership contributions) to WHO of US$28 million (equivalent to 50% of GISRS running costs) from influenza product manufacturers that use GISRS. As of 18 October 2023, monetary contributions totalled US$297 million, with 70% allocated to capacity-building activities aimed at strengthening global pandemic influenza preparedness and 30% retained for influenza pandemic emergencies. These funds have supported 131 countries in starting or improving their laboratory and surveillance systems. WHO notes that the COVID-19 response benefited from PIP's country-focused capacity strengthening, with at least 35 countries using this foundation to develop their COVID-19 vaccine deployment plans.
Critics often disparage the ABS model, claiming the SMTA2s remain untested in the absence of a recent influenza pandemic and that if there was an influenza pandemic, “the world’s wealthiest nations will again pose a crisis of equity and justice for LMICs”. However, this critique applies to any mechanism or obligation in the ongoing WHO negotiations on the pandemic instrument — they remain untested until the next pandemic. These should not be grounds to reject the ABS approach. The operational success of the PIP Framework demonstrates its efficacy in supporting pandemic preparedness and response.
Legally binding contracts, signed with major influenza vaccine manufacturers like GSK, Sanofi, and Sequiris, position WHO at the forefront of supply during a pandemic. WHO expresses full confidence that manufacturers will uphold their obligations. The PIP Framework is built on trust and the equal footing principle whereby the sharing of materials and sequence information for developing pandemic influenza products is linked to access to vaccines and other benefits, thus incentivizing each stakeholder to fulfil its commitment, fostering international cooperation and solidarity, crucial for managing an influenza pandemic.
ABS is firmly rooted in international law
States have sovereign rights over their biological resources, with the right to set terms for allowing access to such resources, including the terms for fair and equitable benefit sharing arising from the utilization of their resources. These legal rights contained in the CBD and its Nagoya Protocol are globally accepted, rendering the debate over whether ABS is transactional inconsequential.
Interestingly, developed countries, Big Pharma, and others erroneously label the ABS system as transactional while championing the inherently transactional intellectual property system. These entities persistently advocate for the continued necessity of monopolies that predominantly benefit a privileged few.
When sharing biological materials, a "material transfer agreement" is customary – a contractual document outlining terms. Even genetic sequence data access requires adherence to specific terms, as seen with GISAID. A multilateral ABS system, like the PIP Framework and proposed PABS, standardizes this approach and operationalizes benefit-sharing through the adoption of standard material transfer agreements at the multilateral level.
Critics argue that framing vaccines and other essential products as “benefits” is tantamount to commodifying the right to health using the ABS transactions. While access to health products is a part of the “right to health”, these rights are not self-executing. Mechanisms have to be put in place to operationalize the “right to health”. A multilateral ABS system (e.g. the PIP Framework) contributes towards the realization of the right to health through its requirements, especially those reflected in its legally binding SMTAs.
A multilateral ABS system goes beyond mere transactions. Sharing of biological materials, including sequences, is motivated by the existence of a fair, transparent and accountable system that sets out rules to prevent exploitation of the system by better-resourced laboratories (usually based in developed countries) or by developers and manufacturers seeking to maximise profits at the expense of lives in developing countries. The benefits received are consolidated at the multilateral level to be used to support WHO Members for pandemic preparedness and response according to their public health needs.
WHO Negotiations: Proposals to Operationalize Equity
In the ongoing WHO negotiations, an effective Pandemic Access and Benefit Sharing System (PABS) is considered to be a crucial mechanism for operationalizing equity. A large number of developing countries have jointly proposed textual suggestions amending the flawed Article 12 text suggested by the Intergovernmental Negotiating Body (INB) Bureau in document A/INB/7/3. Text proposed by developing countries stresses the need for WHO Members to agree on the details of SMTAs as part of the INB negotiation process.
The text further proposes the need for benefit-sharing commitments beyond ad hoc donations, to be contained in a legally binding contract between WHO and developers/manufacturers of pandemic-related products. These include a legal commitment to provide at least 20% of real-time production to WHO at no cost during a PHEIC and/or pandemic, placing WHO at the front of the supply queue, to comply with the WHO allocation mechanism, and to grant non-exclusive licenses through WHO to developing country manufacturers to expand production and supply of pandemic-related products (including technology and know-how for that purpose) needed in developing countries.
The PABS proposal complements other suggestions by developing countries aimed at supporting pandemic preparedness and response by building and strengthening capacity in developing countries. These include obligating Parties to subject the provision of public funds for R&D to conditions that will facilitate equitable access such as affordable pricing and licensing of technology. There is also the suggestion of a WHO Production and Distribution Mechanism to facilitate geographically diversified production and distribution of pandemic-related products through the designated production facilities and sharing of technologies.
These proposals aim to obligate governments and the WHO Secretariat to take specific action to support developing countries to prepare for the next pandemic. Until now, developed countries have been reluctant to embrace substantial, concrete obligations for promoting equity. Even if they were to undertake such commitments, concerns about compliance persist. Developed countries are notorious for failing in their obligations, e.g. the failure to provide finance and technology to developing countries in the context of the UN Framework Convention on Climate Change (UNFCCC). Hence, mere obligations on developed countries to help build domestic and regional prevention, preparedness and response capacities in developing countries, as suggested by some critics, is wholly insufficient.
This reinforces the need for an effective complementary PABS system that places relevant benefit-sharing obligations on the users of PABS materials (e.g. developers/manufacturers of pandemic-related products) and sets out rules that ensures its operations are equitable, transparent and accountable, for only such a win-win equitable system can motivate timely sharing of PABS materials including sequence information.
Further, it is suggested that a PABS system “would clearly subsume the PIP Framework, which becomes obsolete”. This should not be the case. It should operate side by side with the PIP Framework. This intent is evident from the Bureau text, which states it should be implemented “in a manner to ensure mutual complementarity with the Pandemic Influenza Preparedness Framework”.
One Health and the PABS system.
While a “One Health” approach aims to link human health to plant, animal, environment and even planetary health, it primarily is about bio-surveillance, sparking serious concerns it will result in the transfer of genetic resources and related data from the Global South to the North.
There are also other apprehensions, such as the financial burden on developing countries and the impact on trade and national sovereignty. Therefore, a thorough examination of the scientific evidence and a complete understanding of the implications of One Health is imperative before taking on any obligations in this area. It is essential to limit such surveillance only to those pathogens posing a threat of causing a public health emergency of international concern or a pandemic and to apply the PABS system to such pathogens accordingly. Given that PABS focuses on human health, anchoring it within the WHO is the most suitable approach.
The Status of a Specialized International Instrument
Critics often needlessly complicate the issue of the designation as a “Specialized International Instrument” (SII), possibly aiming to discredit the ABS model. However, the matter is straightforward. The CBD and the Nagoya Protocol primarily follow a bilateral approach, requiring permission and benefit sharing for access to genetic resources. Yet, Article 4(4) of the Nagoya Protocol acknowledges the potential for a specialized ABS instrument at the multilateral level, addressing delays in accessing biological materials. For an instrument to be considered a SII, it has to be “consistent with” and “not run counter” to the objectives of the CBD and the Nagoya Protocol.
Criteria for determining SII are presently under consideration in the CBD, set to be discussed at the 5th Meeting of Parties to the Nagoya Protocol. Despite this, the PIP Framework functions effectively. More than 1200 biomedical samples have been shared, and dozens of virus sub-types have been recorded.
In 2016 an expert review group concluded the PIP Framework is a “bold and innovative tool for pandemic influenza preparedness. What is perhaps most important with respect to SII in the context of the ongoing WHO negotiations is to ensure that any consideration of SII is supported by concrete evidence that the PABS system is consistent with the objectives of the CBD and the Nagoya Protocol and functions to deliver fair and equitable benefit sharing for pandemic preparedness and response as agreed.
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