Countering the Pandemic Threat Through Global Coordination on Vaccines The Influenza Imperative (2022) / Chapter Skim
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3 Pathogen Sharing for Influenza Vaccine Production
3 Pathogen Sharing for Influenza Vaccine Production
Pages 59-78
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From page 59... ...
Sharing viral pathogens, either the organisms themselves or their genetic sequence data, provides the means to identify vaccine targets. Modern molecular techniques allow faster development of effective vaccines, as demonstrated by the production of COVID-19 vaccines in 1 year in 2020 using platform technologies (Agrawal et al., 2021)
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From page 60... ...
At the same time, it also reinforced that timely sharing of viruses and associated information, such as genetic sequence data, requires attention to the benefits that may be derived from them. These events resulted in a major change.
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From page 61... ...
The initiation of the PIP Framework discussions marked the start of the trust-rebuilding process among countries. Ultimately, the process successfully facilitated virus sharing in the years after the framework was adopted.
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From page 62... ...
. Although it would be unrealistic to argue that the right to health positively requires states to share pathogen samples and benefits, human rights considerations can be part of more detailed policy and legal considerations used to advocate cooperation or censure obstructionist behavior.
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From page 63... ...
and its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization (adopted in 2010) , and the PIP Framework (adopted in 2011)
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From page 64... ...
This has allowed WHO to secure access to 11.3 percent of global pandemic influenza vaccine production. This can support the vaccination of priority groups in countries without influenza vaccine manufacturing capacity, but it is insufficient to cover the entire populations of LMICs.
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From page 65... ...
Limitations of Access and Benefit Sharing Mechanisms and Barriers to Global Coordination There is a lack of consensus on what "utilization of genetic resources" means, what is considered a common good, and the extent to which the Nagoya Protocol applies to pandemic influenza viruses (under the PIP Framework) : Coordinated by an Falls Under the PIP Falls Under the Type of Pathogen Existing Multilateral Framework Nagoya Protocol Mechanism Influenza viruses with human Yes Yes Yes pandemic potential Seasonal influenza No Yes No Genetic sequence No Not clear No data (Influenza)
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From page 66... ...
In 2016, an expert review found that the PIP Framework is "a bold and innovative tool for pandemic influenza preparedness, is being well implemented, and that the principle of the PIP Framework of placing virus sharing and benefit sharing on an equal footing remains relevant today" (WHO, 2016b, p.
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From page 67... ...
It recognizes the sovereignty of a country to determine how its genetic resources are used, requires that access to genetic resources must have the prior informed consent of the effective or originating country, and specifies that those resources can only be accessed by negotiating mutually agreed terms that include benefit sharing. In May 2019, the WHA requested that the WHO Director-General prepare a report on the public health implications of implementation of the Nagoya Protocol.
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From page 68... ...
Issues of public availability for genetic sequence data are more concerned with ensuring appropriate credit for the work and data privacy issues. The report also raised two broad challenges for human pathogen sharing.
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From page 69... ...
The Framework also does not specifically encompass genetic sequence data in its definition of what is covered by its benefit-sharing provisions. Contemporary global governance structures, such as the multilateral commitments under the PIP Framework, have yet to be tested by a serious influenza pandemic (NASEM, 2019)
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From page 70... ...
The Nagoya Protocol's strong emphasis on benefit sharing is a potent tool to ensure ABS, but public health emergencies suggest that benefit sharing be balanced by pathogen sharing. The extent to which the Nagoya Protocol is applicable to the pandemic influenza context is an open question.
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From page 71... ...
This ecosystem was largely not activated for the COVID-19 pandemic; the IHR did not cover sample, genetic sequence, or benefit sharing; little attention was paid to the Nagoya Protocol in the extreme situation posed by COVID-19 largely because the virus' fast and wide spread bypassed the protocol's sovereigntybased foundation; and the PIP Framework was not applicable because its scope is restricted to pandemic influenza (and no similar ABS mechanism exists for other pathogens with pandemic potential)
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From page 72... ...
In October 2020, India and South Africa proposed that the WTO allow all countries the legal right under international trade rules to choose not to grant or enforce patents and other IP related to COVID-19 drugs, vaccines, diagnostics, and other technologies and materials until widespread vaccination is in place globally and the majority of the world population has developed an immunity (Menezes, 2021)
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From page 73... ...
In a 2021 research paper, the South Centre represented the views of CSOs, arguing that to be in line with the May 2020 WHA-approved "COVID-19 Response" Resolution (WHA 73.1) , WHO member states need to recognize COVID-19 responses as a global public good and "any unjustified obstacles must be removed, and TRIPS flexibilities should be strengthened" (Menezes, 2021)
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From page 74... ...
It is still necessary for the PIP Framework to be modified to include genetic sequence data. • While it remains theoretically possible for the PIP Framework to be expanded to include seasonal influenza, other viruses, and genetic sequence data, it does not appear to be a realistic option to scale up the pandemic influenza–specific framework to encompass other respiratory pathogens with pandemic potential.
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From page 75... ...
In a potential pandemic situation, this behavior in sharing viruses and associated information could have very serious implications for delaying a pandemic response. • A new agreement should address and resolve issues raised by the Nagoya Protocol for sharing influenza viruses and other pathogens with pandemic potential, including genetic sequence data.
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From page 76... ...
2020. The pandemic influenza preparedness framework as an access and benefit sharing mechanism.
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From page 77... ...
2021a. The public health implications of implementation of the Nagoya Protocol, Report by the Director-General.
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