PHEMCE Structure
The Assistant Secretary serves as the principal advisor on federal public health and medical preparedness and response4 to the Secretary of HHS. As part of this role, the Assistant Secretary leads and coordinates the PHEMCE, ultimately using the PHEMCE’s assessments to inform MCM decision making.
While the Administration for Strategic Preparedness and Response (ASPR) is the head of each of the functions5 outlined in the PHS Act, the PHEMCE’s design ensures coordinated input from USG agencies. If the PHEMCE is successful, the federal government will have a coordinated portfolio of MCMs available in federal stockpiles such as the SNS, available for deployment to State, Local, Tribal, and Territorial (SLTT) governments.
As stated above, the PHEMCE is chaired by the Assistant Secretary and made up of the Director of CDC, Director of NIH, Commissioner of the FDA, Secretary of Defense, Secretary of Homeland Security, Secretary of Agriculture, Secretary of VA, and the Director of National Intelligence. Each of these principals coordinates within their own organizations to bring technical expertise to the PHEMCE related to their mission space. From there, the Assistant Secretary evaluates, synthesizes, and presents MCM recommendations to the Secretary of HHS.
Existing technical teams, both formalized and non-formalized, will provide technical expertise. The Assistant Secretary relies on these technical teams, comprised of subject matter experts from across the PHEMCE, to bring together information regarding threats, early R&D, advanced R&D, monitoring and surveillance, manufacturing and supply chains, regulatory science, procurement and stockpiling, and the deployment, distribution, dispensing, and administration of MCMs. The PHEMCE does not recreate each of these functions; rather, the PHEMCE builds on the existing infrastructure for these activities and informs the recommendations for the Secretary of HHS.
Statute6 also directs the PHEMCE to solicit and consider input from SLTT public health departments and officials. ASPR accomplishes this by engaging SLTT public health departments and officials via routine engagement from ASPR regional offices, formalized webinars, and targeted partnerships. By considering end-users, PHEMCE members can ensure that they are optimizing the USG's investments in an MCM portfolio.
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4 42 U.S.C. § 300hh–10 - Coordination of preparedness for and response to all-hazards public health emergencies, “(1) Leadership—Serve as the principal advisor to the Secretary on all matters related to Federal public health and medical preparedness and response for public health emergencies.”
542 U.S.C. § 300hh–10a - Public Health Emergency Medical Countermeasures Enterprise, (c) Functions. (1) In general
The functions of the PHEMCE shall include the following:
(A) Utilize a process to make recommendations to the Secretary regarding research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization with respect to countermeasures, as defined in section 247d–6b(c) of this title, including prioritization based on the health security needs of the United States. Such recommendations shall be informed by, when available and practicable, the National Health Security Strategy pursuant to section 300hh–1 of this title, the Strategic National Stockpile needs pursuant to section 247d–6b of this title, and assessments of current national security threats, including chemical, biological, radiological, and nuclear threats, including emerging infectious diseases. In the event that members of the PHEMCE do not agree upon a recommendation, the Secretary shall provide a determination regarding such recommendation.
(B) Identify national health security needs, including gaps in public health preparedness and response related to countermeasures and challenges to addressing such needs (including any regulatory challenges), and support alignment of countermeasure procurement with recommendations to address such needs under subparagraph (A).
(C) Assist the Secretary in developing strategies related to logistics, deployment, distribution, dispensing, and use of countermeasures that may be applicable to the activities of the strategic national stockpile under section 247d–6b(a) of this title.
(D) Provide consultation for the development of the strategy and implementation plan under section 300hh–10(d) of this title.
642 U.S.C. § 300hh–10 - Coordination of preparedness for and response to all-hazards public health emergencies, “(d)(2)(H) incorporate input from Federal, State, local, and tribal stakeholders.” Enterprise is an overarching term that comprises both members and partners.
