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investigatory mandate nor enforcement provisions in the event of a deliberate event or state noncompliance.68 Pandemic Influenza Preparedness (PIP) Framework The PIP framework provides a global approach to encourage influenza virus sample sharing and to commit manufacturers to equitably providing vaccines, treatments, and diagnostics during influenza pandemics and annually contributing funds to WHO for influenza pandemic preparedness.53 The PIP framework is widely considered to be a significant global achievement, but it has limits. Neither seasonal nor animal influenza are covered under the framework, limiting its applicability to pandemic influenza strains. Questions persist about which of the remaining countries* will ratify the Nagoya Protocol to the Convention on Biological Diversity, and about the implications of this provision for viral sample sharing. Numerous barriers, ranging from intellectual property restrictions to slow inter-country coordination, limit the speed with which specimens are shared across borders. Slow or nonexistent specimen sharing affects the development, validation, and production of new medical countermeasures, as well as the continuing participation of industry and R&D stakeholders, which expect to benefit from their voluntary contributions to the framework.55 According to the 2018 Annual Progress Report, only 21 * At the date of this publication, 120 States Parties have ratified the Protocol, including the European Union, which obligates its member countries to be subject to the Protocol’s requirements. 32 countries have received support through the benefit-sharing mechanism of the PIP framework have written, exercised, or begun developing influenza pandemic preparedness plans.69 A related, ongoing concern among government and R&D stakeholders is that the deployment of potentially billions of vaccines (were such a stockpile of effective vaccines to be available at some time during a pandemic) to countries will be of questionable benefit if the plans, infrastructure, and distribution networks are not in place to vaccinate their populations. As such, the WHO Global Influenza Strategy promotes stronger country capacity by encouraging countries to implement tailored influenza programs, including national pandemic preparedness plans; establish infection prevention and control practices; and develop better vaccines, treatments, and diagnostics.54 The Partnership for Influenza Vaccine Introduction (PIVI) provides technical assistance to middle- and low-income countries for routine seasonal influenza vaccination programs. These programs can support local vaccine markets by establishing predictable vaccine demand, while aiding countries in identifying the networks that will be needed to distribute vaccines to high-priority populations during a pandemic.70 It will be important for WHO to continue to call on countries to develop pandemic influenza preparedness plans, practice sustainable seasonal influenza immunization programs, and prepare a logical system of vaccine allocation within countries and regions. While agreements exist for influenza preparedness (see Box 4), similar international frameworks that promote preparedness measures (including virus sample sharing) more broadly for other respiratory pathogens do not exist. In the absence of a PIP-style framework for other respiratory diseases, countries seeking access to specimens must negotiate bilateral material transfer agreements with potentially dozens or more countries, a challenging and time-consuming process that is vulnerable to legal bottlenecks. It remains to be seen whether the PIP framework could emerge as an ad hoc model for access and benefit sharing during a severe respiratory epidemic or pandemic or if countries will scramble to arrange their own bilateral agreements.55 33 Box 4: Pandemic Influenza: A Preparedness Model for Other Respiratory Pathogens? While a range of high-threat respiratory diseases are known to exist, preparedness for pandemic influenza has received by far the greatest attention from international, national, and local stakeholders. For example, researchers and manufacturers possess the technical know-how and ability to develop, test, and manufacture medical countermeasures for the influenza virus, a capability that does not yet exist for coronavirus, enterovirus, and other contagious respiratory subgroups. Preparedness for seasonal influenza, including routine surveillance, annual immunization campaigns, and specimen sharing, has contributed to a practical knowledge base and infrastructure that can be leveraged following the emergence of a strain with human pandemic potential. Fears that a pandemic strain may be overdue, especially following the devastation caused by past biological events, including the 1967-68 and 1918-19 influenza pandemics, have also focused global attention on this pathogen. Pandemic influenza preparedness comprises a range of international and national agreements and frameworks pertaining to areas as diverse as medical countermeasures, surveillance and detection systems, crossborder specimen sharing and access to benefits, infection prevention and control practices, and networks of distribution for medical countermeasures. An interdisciplinary range of stakeholders are actively involved in these processes, including the scientific research community, academia, international agencies, national health ministries, the private sector and pharmaceutical industry, the healthcare sector, intellectual property lawyers, and others. These programs are not without their shortcomings or criticisms, and their effectiveness during a high-impact influenza pandemic remains to be seen. Nevertheless, there exists a stark disparity between the level of readiness for pandemic influenza and other potential high-impact respiratory pathogens. It is important to more fully understand the systems that have been built for influenza and consider the extent to which they would be of value for responding to other high-impact respiratory pathogens, and the extent to which they could be a model for building new systems for other respiratory threats. Pandemic Influenza Preparedness (PIP) framework—PIP was adopted by the World