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Access by Design, Benefits if Convenient: A Closer Look at the Pandemic Influenza Preparedness Framework's Standard Material Transfer Agreements.

Identifieur interne : 000180 ( PubMed/Curation ); précédent : 000179; suivant : 000181

Access by Design, Benefits if Convenient: A Closer Look at the Pandemic Influenza Preparedness Framework's Standard Material Transfer Agreements.

Auteurs : Michelle F. Rourke

Source :

RBID : pubmed:30637812

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Abstract

Policy Points Securing access to pathogen samples for research purposes is crucial for pandemic preparedness and responding to infectious disease outbreaks. The Pandemic Influenza Preparedness Framework (PIP Framework) is the only pathogen-specific international access and benefit-sharing (ABS) instrument. This analysis reveals that during an influenza pandemic, the PIP Framework will safeguard access to virus samples but may not be as effective in delivering the associated benefits, like vaccines and antivirals, to countries in need. The PIP Framework's deficiencies must be addressed before an influenza pandemic and before this ABS model is extended to other human pathogens.

DOI: 10.1111/1468-0009.12364
PubMed: 30637812

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Michelle F. Rourke
<affiliation>
<nlm:affiliation>Griffith Law School, Griffith University and Australian Defence Force Malaria and Infectious Disease Institute.</nlm:affiliation>
<wicri:noCountry code="subField">Griffith University and Australian Defence Force Malaria and Infectious Disease Institute</wicri:noCountry>
</affiliation>

Le document en format XML

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<nlm:affiliation>Griffith Law School, Griffith University and Australian Defence Force Malaria and Infectious Disease Institute.</nlm:affiliation>
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<term>Global Health</term>
<term>Humans</term>
<term>Influenza, Human (prevention & control)</term>
<term>International Cooperation</term>
<term>Orthomyxoviridae</term>
<term>Pandemics (prevention & control)</term>
<term>Specimen Handling (standards)</term>
<term>Transfer Agreement</term>
<term>World Health Organization</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Accord transfert malade</term>
<term>Coopération internationale</term>
<term>Grippe humaine ()</term>
<term>Humains</term>
<term>Organisation mondiale de la santé</term>
<term>Orthomyxoviridae</term>
<term>Pandémies ()</term>
<term>Prélèvement biologique (normes)</term>
<term>Santé mondiale</term>
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<term>Prélèvement biologique</term>
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<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en">
<term>Influenza, Human</term>
<term>Pandemics</term>
</keywords>
<keywords scheme="MESH" qualifier="standards" xml:lang="en">
<term>Specimen Handling</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Global Health</term>
<term>Humans</term>
<term>International Cooperation</term>
<term>Orthomyxoviridae</term>
<term>Transfer Agreement</term>
<term>World Health Organization</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Accord transfert malade</term>
<term>Coopération internationale</term>
<term>Grippe humaine</term>
<term>Humains</term>
<term>Organisation mondiale de la santé</term>
<term>Orthomyxoviridae</term>
<term>Pandémies</term>
<term>Santé mondiale</term>
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<div type="abstract" xml:lang="en">Policy Points Securing access to pathogen samples for research purposes is crucial for pandemic preparedness and responding to infectious disease outbreaks. The Pandemic Influenza Preparedness Framework (PIP Framework) is the only pathogen-specific international access and benefit-sharing (ABS) instrument. This analysis reveals that during an influenza pandemic, the PIP Framework will safeguard access to virus samples but may not be as effective in delivering the associated benefits, like vaccines and antivirals, to countries in need. The PIP Framework's deficiencies must be addressed before an influenza pandemic and before this ABS model is extended to other human pathogens.</div>
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<Month>04</Month>
<Day>12</Day>
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<Year>2020</Year>
<Month>03</Month>
<Day>01</Day>
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<ISSN IssnType="Electronic">1468-0009</ISSN>
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<Volume>97</Volume>
<Issue>1</Issue>
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<Year>2019</Year>
<Month>03</Month>
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<Title>The Milbank quarterly</Title>
<ISOAbbreviation>Milbank Q</ISOAbbreviation>
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<ArticleTitle>Access by Design, Benefits if Convenient: A Closer Look at the Pandemic Influenza Preparedness Framework's Standard Material Transfer Agreements.</ArticleTitle>
<Pagination>
<MedlinePgn>91-112</MedlinePgn>
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<Abstract>
<AbstractText>Policy Points Securing access to pathogen samples for research purposes is crucial for pandemic preparedness and responding to infectious disease outbreaks. The Pandemic Influenza Preparedness Framework (PIP Framework) is the only pathogen-specific international access and benefit-sharing (ABS) instrument. This analysis reveals that during an influenza pandemic, the PIP Framework will safeguard access to virus samples but may not be as effective in delivering the associated benefits, like vaccines and antivirals, to countries in need. The PIP Framework's deficiencies must be addressed before an influenza pandemic and before this ABS model is extended to other human pathogens.</AbstractText>
<AbstractText Label="CONTEXT">The World Health Organization (WHO) adopted the Pandemic Influenza Preparedness Framework (PIP Framework) after being forced to grapple with the demands of developing countries for the fairer distribution of vaccines and antivirals created using influenza viruses isolated from within their territories. Though adopted as a nonbinding resolution, the PIP Framework has been praised for its novel legal approach to access and benefit-sharing (ABS), using Standard Material Transfer Agreements (SMTAs) to create binding terms and conditions on both providers and users of PIP biological materials. The PIP Framework's SMTA1 regulates the movement of influenza viruses with human pandemic potential through the WHO's Global Influenza Surveillance and Response System (GISRS) as it operates to monitor the spread of seasonal influenza and detect the emergence of pandemic strains. Member States give consent to the WHO to transfer their materials to third parties under the terms of a negotiated SMTA2. The SMTA2 details benefits such as vaccines and antivirals to be made available to the WHO for distribution in the event of an influenza pandemic.</AbstractText>
<AbstractText Label="METHODS">I analyzed the PIP Framework, its SMTAs, and secondary sources to determine whether the PIP Framework will effectively function as an ABS instrument during an influenza pandemic.</AbstractText>
<AbstractText Label="FINDINGS">The SMTAs do not create any direct or binding agreements between Member States and third-party recipients of influenza viruses. In the lead-up to and during a pandemic, the SMTA1 secures access to influenza viruses for the WHO, and the SMTA2 secures access for commercial users of virus samples, but the SMTA2 may be ineffective in securing tangible benefits for the sovereign providers of those materials.</AbstractText>
<AbstractText Label="CONCLUSIONS">As the international community starts to consider how to best regulate access to nonpandemic influenza pathogen samples, it is imperative that we first address the shortcomings of the only pathogen-specific international ABS instrument available, and we should do so before it is put to the ultimate test.</AbstractText>
<CopyrightInformation>© 2019 Milbank Memorial Fund.</CopyrightInformation>
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<Keyword MajorTopicYN="Y">World Health Organization</Keyword>
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