A Robust PABS System: Make or Break for the Pandemic Accord [Guest Essay]
Newsletter Edition #78 [Treaty Talks]
Hi,
We reported last week that the success of reaching consensus towards a new Pandemic Agreement at the World Health Organization, hinges on the possibility of member states agreeing on a new mechanism to facilitate the access to information on pathogens while also committing to share benefits. We were also told that without such a dedicated system for global health, a new legal instrument to govern pandemics may not become a reality. Worse, negotiators also indicated the possibility of a plurilateral mechanism on Access and Benefits Sharing if a global mechanism is not established.
In today’s guest essay, scholars Lawrence O. Gostin & Jayashree Watal, delve further into monetary contributions and non-monetary benefits of such a mechanism (This is in response to our earlier story on rising industry interest in such a mechanism). They have suggestions for negotiators on ways to use the contributions to this mechanism, in order to make this system workable for all countries, in particular low and middle income ones.
The authors have also previously published a piece in these pages from November 2023. (See: Squaring The Circle On Equity in a Pathogen Access And Benefit Sharing System).
An iteration of the draft Pandemic Agreement is underway and is expected on April 18th. Countries continue to disagree on what a PABS mechanism should look like.
Apart from providing our readers with original reporting, we are keen on bringing diverse perspectives from global health experts. Get in touch with us if you wish to access our audience of diplomats, decision-makers, scholars, the private sector and other experts who shape global health policy.
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Priti
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I. GUEST ESSAY
A Robust PABS System: Make or Break for the Pandemic Accord
By Lawrence O. Gostin & Jayashree Watal
Gostin is Distinguished University Professor, Georgetown University and Director, O’Neill Institute for National and Global Health Law, Washington, D.C., USA.
Watal is Visiting Professor, National Law University Delhi, India.
In the Geneva Health Files, we proposed a robust Pathogen Access and Benefits (PABS) system that imposes binding obligations on users of biological materials and genetic sequence data (GSD) to make mandatory monetary contributions. PABS is necessary but not sufficient to ensure equity. There is still important work to do on intellectual property waivers and technology transfers. But PABS is important. The Africa Group and the Equity Group are unlikely to acquiesce to a treaty without a strong PABS system. At the same time, GHF recently reported that the pharma industry is warming up to PABS, but wants unconditional access sans benefit sharing obligations. That’s a non-starter.
Article 12 of the March 7th negotiating text released by the INB Bureau adopts the monetary platform we proposed, but not entirely in the way we recommended. Here, we propose vital improvements to Article 12 that are important for the demandeurs for equity. We focus on monetary contributions but also recognize the importance of non-monetary benefits such as real-time contributions from manufacturers out of their production.
1. Access
The first part of PABS is access and open scientific exchange. The March negotiating text provides a credible, enforceable obligation on Parties to ensure rapid, systematic and timely access to both biological materials of pathogens with pandemic potential and the genetic sequence data (GSD) for such pathogens. Open scientific exchange is a necessary condition for rapid development of life-saving medical countermeasures (MCMs), such as diagnostics, therapeutics and vaccines. The advancement of science in times of crisis should keep everyone safer.
2. Credible benefit-sharing obligations
The second part of PABS is benefit-sharing, which needs to be an equally credible, enforceable obligation on Parties. The promise of a Pandemic Accord from the very beginning was to change a deeply inequitable system, as evidenced during the COVID-19 pandemic. Mandatory benefit sharing is necessary to ensure rapid, systematic and timely access to MCMs by low- and middle-income countries (LMICs).
Such an obligation on Parties cannot in any manner or form be weaker than the obligation on LMIC Parties to promote access to pathogens and GSD. In addition to benefit obligations being equivalent in strength and clarity to the one on access, both obligations need to be such that the Parties upon whom they falls can reasonably fulfil their obligations.
3. Monetary contributions
There are powerful reasons why timely and adequate financing of the procurement of MCMs is the key to significantly mitigating profound inequities. It is only fair that all manufacturers of MCMs, while taking into account their size, nature and capacities, should contribute to a fund under PABS. Financial obligations should be imposed irrespective of whether Parties are users of biological materials, including those obtained through WHO-coordinated laboratory networks (CLNs), or of GSDs, including those obtained through the PABS sequence databases (SDBs).
This PABS Fund should be used not only to support PABS, but also to finance the gap in the timely distribution of MCMs to LMICs, since this is an important part of benefit-sharing expected by governments, given the inequity they experienced during COVID-19.
4. Contribution of pandemic-related products by manufacturers
Real-time contributions of relevant diagnostics, therapeutics and vaccines produced by the manufacturer during a public health emergency of international concern (PHEIC) or a pandemic must be adequate to meet at least the most immediate real-time needs of LMICs based on their public health risks, needs, and demand. In this context, a commitment by manufacturers of MCMs to contribute 10% free of charge and 10% at not-for-profit prices as included in paragraph 6(b) of Article 12 appears to be low but it may not be realistic to expect this number to change at this stage.
We suggest adding a commitment in PABS contracts that those who seek access to biological resources and related GSD for commercial purposes should make further contributions to LMICs, as needed and according to their capacity, during a PHEIC or a pandemic. Additionally, the Pandemic Agreement could charge the Conference of the Parties (COP) with increasing non-monetary contributions over time.
5. Obligations of Parties on benefit-sharing, including on conditions placed on manufacturers of MCMs
In order to bring the benefit-sharing obligations on an equal footing with those on access, paragraph 8 of draft Article 12 should read instead as follows, removing language that weakens benefit-sharing obligations:
“The Parties shall
cooperate andtake appropriate measures, such as conditions in public procurements or on public financing of research and development, prepurchase agreements, or regulatory procedures, toencourage and facilitate as manyensure that manufacturers located in their territoriesas possible toenter into standard PABS contracts as early as possible.”Similarly, in order to ensure that the global community never witnesses the shameful vaccine nationalism seen during COVID-19, the text in paragraph 9 of Article 12 should read as follows:
“During a pandemic, each Party
in a position to do sowith stocks of PRPs beyond their immediate needs shall, within available resources and subject to applicable laws and in line with Article13, set aside a portion of its total procurement of relevant diagnostics, therapeutics or vaccines in a timely manner for use in countries facing challenges in meeting public health needs and demand for relevant diagnostics, therapeutics or vaccines.”
6. Compliance provisions in PABS
It is unclear in the current proposed text how compliance with the obligations in PABS can be ensured. We reiterate our earlier suggestion that Parties that are the host country to entities that use pathogens or their GSD ensure acceptance and compliance with the PABS contracts, even if this would require enacting/modifying specific domestic legislation. Ensured domestic enforcement should enhance compliance with benefit-sharing obligations in the Pandemic Agreement.
In addition, WHO should possess and use its clout to influence manufacturers to comply with PABS. The language in paragraph 10 of Article 12 should be strengthened to read:
“WHO shall use measures such as prequalification and the WHO Emergency Use Listing Procedure to
promote the PABS System and encourageensure that manufacturerstoconclude standard PABS contracts and comply with these and other conditions laid down in the PABS.”
We agree that the contracts signed between the WHO and other entities under PABS should, as far as possible, be made public, while safeguarding a limited number of provisions that need to be kept confidential for strictly necessary commercial reasons.
7. Relationship with the Convention on Biological Diversity (CBD) and the Nagoya Protocol
We applaud the Co-Chairs of the INB and the WHO secretariat for finding a neat solution to the problem of the relationship of the PABS to the Convention on Biological Diversity (CBD) and the Nagoya Protocol (NP) in the draft Article 12 (para 12). The text states:
“The Parties who are Parties to the Convention on Biological Diversity and its Nagoya
Protocol recognizes that the PABS System, when fully operational, is consistent with and does not run counter to the objectives of the Nagoya Protocol; shall function as a specialized international access and benefit-sharing instrument; and is the applicable access and benefit-sharing system for biological materials and GSD for pathogens with pandemic potential.”
This should put to rest any doubts that commentators had expressed on whether PABS is a specialised international ABS instrument under the NP. In our earlier article we had argued that the Pandemic Influenza Preparedness (PIP) Framework could 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. It is clearly important that parties common to the CBD/the NP and to the Pandemic Agreement endorse that this is the case and this language should remain in the text.
8. The “Last Mile” in Achieving Equity
We believe that Parties to the WHO Pandemic Agreement should go the extra mile to ensure that the PABS agreed upon is meaningful and contributes to the rapid, systematic and timely access to the relevant pathogens and their GSD as well to meaningful, fair and equitable benefit sharing in terms of timely and adequate access to the resulting PRPs for LMICs. Access and benefit sharing should not be seen as a quid pro quo. Both are needed in a non-transactional multilateral system that can be enforced. We have not proposed a single benefit-sharing obligation that in the real world is too cumbersome, costly, or difficult to implement.
A weak, ineffective PABS is as good as a non-existent PABS. Watered down benefit-sharing obligations will not fly with the African Group and many developing countries.
We are just weeks away from the May Assembly. A breakdown in negotiations would be disastrous after all the grand promises and grinding negotiations. A framework that guarantees a robust, fair, and just PABS system can, and must be, successfully negotiated.
Get in touch with the authors: Lawrence Gostin <gostin@georgetown.edu> and Jayashree Watal <jw458@georgetown.edu
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