WASHINGTON — As learned during the COVID-19 pandemic, the U.S. Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) should be re-envisioned to better protect the nation from future threats, including bioterrorism attacks, pandemics, and emerging infectious diseases, says a new report from the National Academies of Sciences, Engineering, and Medicine. The report identifies four priority areas for PHEMCE’s improvement: recommitting to its mission; revising its operations and processes; enhancing collaboration with nonfederal partners; and navigating legal and policy issues that have impeded PHEMCE objectives.

Many government agencies and private stakeholders and partners are involved in responding to public health emergencies, and they must be well organized and well equipped to do their work, the report says. Led by the Office of the Assistant Secretary for Preparedness and Response (ASPR), PHEMCE was created to serve this function.

Composed of several federal agencies, PHEMCE is tasked with ensuring the nation has access to medical countermeasures (MCMs) needed to save lives, such as antibiotics, antivirals, vaccines, and personal protective equipment, during a public health emergency.

The secretary of the U.S. Department of Health and Human Services, and, in turn, the ASPR, should ensure PHEMCE fully implements its mandate, as codified in 42 U.S. Code 300hh-10A, to act as the nation’s major coordinating body for all aspects of U.S. MCM preparedness and response. The report outlines a series of recommendations to enhance PHEMCE’s ability to deliver on its critical mission, and serve as a trusted partner to its varied stakeholders.

PHEMCE should establish an advisory committee of nonfederal partners, to benefit from their expertise and to ensure transparency in its activities, the report says. These nonfederal partners have the ability to develop, manufacture, distribute, and administer the medical countermeasures for which PHEMCE is responsible. The advisory committee would provide strategic guidance on topics including supply chain and stockpiling considerations, private-sector partnerships for medical countermeasures development, and equitable allocation and distribution of limited resources.

The ultimate measure of PHEMCE’s effectiveness is whether it delivers needed medical countermeasures at the right time, in the right place, to the right people, the report says. PHEMCE should use meaningful outcome metrics, and perform rigorous and regular testing and evaluations of its capabilities and capacities to prepare for and respond to public health emergencies. It should consider working with an objective third party to perform these evaluations. In addition, it should establish an integrated and accessible data system to support monitoring, evaluation, and quality management of end-to-end MCM activities. That system should be available to nonfederal partners and stakeholders.

PHEMCE also makes recommendations to HHS about the type and amount of MCMs to include in the Strategic National Stockpile (SNS). However, PHEMCE has not conducted an annual review of the SNS since 2016, which hampered early response to the COVID-19 pandemic. To understand and address these shortcomings, PHEMCE should commission an independent, evidence-based root cause assessment of SNS-specific lessons learned from COVID-19 and other public health emergencies.

As MCM preparedness is also an international effort, PHEMCE should formalize and expand coordination with global entities including the Coalition for Epidemic Preparedness Innovations, Gavi, UNICEF, and the American Red Cross. It should look for lessons in the practices and experiences of bodies with different goals, capabilities, and national and organizational cultures, says the report.

The study — undertaken by the Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) — was sponsored by the HHS Office of the Assistant Secretary for Preparedness and Response. The National Academies are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.

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