Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise (2021) / Chapter Skim
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1 Introduction
1 Introduction
Pages 15-28
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From page 15... ...
Effective national PHE preparedness and response requires the capabil ity to produce, procure, and use medical countermeasures (MCMs) 1 and, given the inevitable complexity, a highly effective coordinating mechanism among the core federal agencies and an array of nonfederal partners.
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RATIONALE AND STUDY CHARGE In light of the catastrophic experience of the COVID-19 pandemic, the committee looks to a future in which PHEMCE is a critical coordination node for all-of-government MCM preparedness and response infrastructure in a malicious or natural PHE. The purpose of this report is to help ensure that the United States has an effective and efficient coordinating mechanism to anticipate health security threats and, to the extent possible, be prepared to limit their impact with the appropriate MCMs.
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and SNS Annual Review, are completed. The PHEMCE Branch is deliberately managed outside of ASPR program authorities to ensure a separation of policy and program determinations and reduce potential inappropriate influence by program staff on policy decisions.
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Once a material threat determination has been issued, HHS assesses the potential public health consequences of the identified agent, determines the needs for countermeasures, evaluates the availability of current countermeasures and the possibility of development of new countermeasures. They are assisted by the interagency Weapons of Mass Destruction Countermeasures Subcommittee.
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Components reporting to the EEC included topicspecific Integrated Program Teams (IPTs) and the Flu Risk Management Meeting; Project Coordination Teams focused on acquisition and established as needed by the BARDA director; the Emerging Infection Diseases Working Group; the Public Readiness and Emergency Preparedness (PREP)
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Stakeholder Engagement Structure Figure 1-2 is a graphical representation of PHEMCE stakeholder engagement structure from this era, depicting mission components in yellow, federal agencies in blue (within HHS) and green (outside of HHS)
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. The specific engagement paths for nonfederal agencies are not specified in Figure 1-2, but the external stakeholders identified as PHEMCE partners include industry, academia, professional societies, state, local, tribal, and territorial entities, and the American public.
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. BARDA and partners, including CDC, used the results to prioritize HHS funding to deploy acquisition plans for the MCM.
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Over the years, PHEMCE developed valuable and deliberative processes, but COVID-19 demanded urgent and new capacity leadership paradigms, provided by OWS without involving the PHEMCE mechanism. The committee also heard testimony and commentary indicating OWS was built on two decades of PHEMCE activities and used its personnel, staff,
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ABOUT THIS REPORT Study Approach and Scope This report offers a new vision for how PHEMCE can optimize the development and use of MCMs for future PHEs, serving as the consistent, resilient, and steadfast coordinating entity for MCMs that is critical to effective PHE preparedness and response. The following principles guided the committee's deliberations and resulting recommendations.
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Report Audiences and Uses This report is intended for the immediate use, by request, of ASPR and federal PHEMCE partners engaged in strengthening PHEMCE. The committee hopes that the report will find audiences among all PHEMCE stakeholders: the White House; congressional members; federal partners; state, tribal, local, and territorial governments; private-sector developers, manufacturers, and distributors; public health; and health care.
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The risks from emerging infectious diseases pose a growing threat to population health. Intentional acts of bioterrorism remain.
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2021b. Operation Warp Speed: Accelerated COVID-19 vaccine development status and efforts to address manufacturing challenges.
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