Exploring Lessons Learned from a Century of Outbreaks Readiness for 2030: Proceedings of a Workshop (2019) / Chapter Skim
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7 The Development of the PIP Framework: Global Lessons on Equity and Fairness for Pandemic Preparedness
7 The Development of the PIP Framework: Global Lessons on Equity and Fairness for Pandemic Preparedness
Pages 91-100
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From page 91... ...
Steven Solomon, principal legal officer at WHO, described the technical process behind the PIP Framework's negotiations, and Anne Huvos, manager of the PIP Framework Secretariat at WHO, provided an overview of the challenges to and opportunities for the PIP Framework moving forward. The discussion was moderated by Keiji Fukuda, director and clinical professor, School of Public Health, The University of Hong Kong.
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From page 92... ...
Wibisono described that the delegation was advised to approach the manufacturer of the antiviral oseltamivir, but the manufacturer informed that the government of Indonesia would have to wait 2 years to receive the medication because the product was sold out based on advance purchase commitments. In response, the Indonesian minister of health announced in December 2006 that Indonesia would no longer share its H5N1 virus samples with WHO Collaborating Centers.1 The minister of health said that the GISN process was inequitable because vaccines produced from samples shared by developing countries were less likely to be available to those countries' populations.
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From page 93... ...
. The negotiation process around this issue took years to resolve and was challenging, Lange remarked, but it was ultimately concluded successfully in May 2011 with the passage of the World Health Assembly Resolution 64.5 and the development of the PIP Framework.
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From page 94... ...
Solomon noted that the issue continues to this day; the World Health Assembly will convene in 2019 to consider the implications of the Nagoya Protocol for the PIP Framework, and negotiations could continue for several more years. POTENTIAL CHALLENGES AND OPPORTUNITIES FOR THE PIP FRAMEWORK Anne Huvos, manager of the PIP Framework Secretariat at WHO, described how the PIP Framework contributes at an international level and what challenges remain for it.
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From page 95... ...
Given the nature of the contracts signed as a part of the PIP Framework, the increasing use of genetic sequence data could potentially impede WHO's access to vaccines and to other critical pandemic response products. Contracts must be signed by any entity that receives physical PIP biological materials from GISRS.
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From page 96... ...
Potential conflicts between the Nagoya Protocol and the PIP Framework might disrupt the global system, which relies on the timely, rapid, and broad sharing of viruses to develop effective seasonal influenza vaccines. Huvos said that moving forward with the PIP Framework will require robust communication strategies that emphasize the public health importance of the framework for all countries and for their populations.
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From page 97... ...
DISCUSSION Keiji Fukuda, director and clinical professor, School of Public Health, The University of Hong Kong, observed that the PIP Framework emerged as a solid solution to a difficult situation in a way that balanced two important and noncompeting values while satisfying the member states and other stakeholders who substantially contributed to the discussions. He said the PIP Framework is unique because "it goes beyond merely stating principles to actually acting on it.
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From page 98... ...
He added that, in his experience, many health ministers believe that the problem of pathogen sharing has been solved by the PIP Framework since failures to share other types of pathogens have not yet had a negative global impact. Huvos remarked that the PIP Framework's narrow scope only covers pandemic influenza vaccines, so the first priority should be to create a framework to share seasonal influenza viruses before moving on to non-influenza pathogens.
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From page 99... ...
A single base pair in a genetic sequence could be tweaked to make it an essentially different organism, which would create another series of legal and regulatory problems. Fukuda remarked that this multiplicity of conceptual and legal issues people had raised about the Nagoya Protocol are complex because the protocol was developed with an environmental focus while the PIP Framework was developed with a public health focus.
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