Delivering on PHEMCE’s Mission
Presentations to the committee revealed a lack of clarity regarding Public Health Emergency Medical Countermeasures Enterprise’s (PHEMCE’s) mission, scope, and responsibilities. One knowledgeable speaker described PHEMCE as a “policy shop,” a second as advisory in nature, and a third as overseeing the development and stockpiling of medical countermeasures (MCMs) (Mair, 2021). Speakers also displayed confusion about relationships among the Assistant Secretary for Preparedness and Response (ASPR), the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Strategic National Stockpile (SNS), and PHEMCE.
Although all presenters agreed that PHEMCE’s roles included coordinating the development, production, and availability of MCMs, they defined the MCMs within PHEMCE’s purview differently. For example, some individuals considered only therapeutics, such as medicines and vaccines, while others added personal protective equipment (PPE) consistent with the definition of MCMs in federal law.1,2 Some presenters defined MCMs as just the products, while still others included information sharing and distribution to the level of medical providers. Some speakers also interpreted PHEMCE as primarily engaged in supplying the MCMs needed to counter bioterrorism, while others noted the broader mandate, supported by PHEMCE’s statutorily directed functions and the Pandemic and All--
1 (2015). 42 U.S. Code § 300hh-10a—Public Health Emergency Medical Countermeasures Enterprise.
2 (2017). 42 U.S. Code § 247d-6b—Strategic National Stockpile and Security Countermeasure Procurements.
Hazards Preparedness Act (PAHPA), which also covers emerging infectious diseases and pandemic threats beyond influenza (e.g., COVID-19).
The recent White House report American Pandemic Preparedness: Transforming Our Capabilities calls for strong MCM program management, setting as a goal that the lead agency “manage this crucial national endeavor with the seriousness of purpose, commitment, and accountability of an Apollo Program” (White House, 2021). PHEMCE, as originally conceptualized, could do so. However, for PHEMCE to fulfill this role, a unified view of the underlying principles that define PHEMCE’s mission, role, scope, and responsibilities will be required.
PHEMCE’S MISSION AND SCOPE
PHEMCE was established in 42 U.S. Code 300hh-10a as an advisory body with the mission “to advance national preparedness for natural, accidental, and intentional threats by coordinating medical countermeasure-related efforts within HHS [U.S. Department of Health and Human Services] and in cooperation with PHEMCE interagency partners” (HHS, 2015).4 Past MCM-related efforts have traditionally focused on developing and procuring products. Experiences from the COVID-19 pandemic and past influenza pandemics have highlighted the importance of the entire mission of PHEMCE and the need to leverage protections under the Public Health Readiness and Emergency Preparedness (PREP) Act to make MCMs accessible to the public. PREP Act declarations support PHEMCE interagency activities to develop and administer MCMs, including through ensuring the availability of associated ancillary supplies (e.g., needles, ventilators), personnel (e.g., medical providers, pharmacists, MCM manufacturing personnel), and infrastructure. The committee found this mission statement encoded in the 42 U.S. Code to be appropriate. PHEMCE should continue to engage with internal and external stakeholders to ensure that the overall mission is clear, activities are conducted by relevant federal agencies and other partners as necessary, and funding gaps to achieve the mission are clear to decision makers.
GUIDING PRINCIPLES FOR PHEMCE
Presentations to the committee and a recent GAO report highlighted concerns raised by interagency partners regarding the 2018–2020 restructuring of PHEMCE that resulted in a lack of clarification on how decisions are made, challenges in collaborating effectively, and issues with transparency (GAO, 2021). These findings point to the need for a re-envisioned PHEMCE to guide decision making and operations with a set of principles in order to deliver on the mission. Previous frameworks to allocate scarce
MCMs, including the COVID-19 vaccine, provide a basis to consider foundational principles that must be adopted to maximize benefits to the public and mitigate health burdens of the most vulnerable (NASEM, 2020). Based on past PHEMCE reports, public discussions, committee members’ experiences, and good government and business practices, the committee recommends four sets of principles that should guide PHEMCE decisions and policies: (1) ethics, (2) operations, (3) strategy, and (4) budget.
Guidance documents related to PHEs and response often prominently discuss ethics. Many factors support this practice, but perhaps the most important is that allocating crucial and scarce resources falls to government and institutions; when the population perceives that allocation to be flawed, it may erode trust, which can increase the difficulty of successfully responding to the public’s needs. Thoughtful planning for an entity such as PHEMCE, whose tasks prominently feature emergency preparedness and response, will incorporate ethical principles (IOM, 2012; NASEM, 2020).
Different guidance documents related to PHEs offer various selections of ethics principles. Maximizing benefits to the public while alleviating adverse health impacts are core ethical principles that must guide all PHEMCE activities, as highlighted in past Strategy and Implementation Plans (SIPs) (HHS, 2012, 2014). Beyond this basic public health function, several substantive principles, which state values and goals, and procedural principles, which tell us how to accomplish those goals, are specifically relevant. The principles of trust, fairness, transparency, accountability, and stewardship discussed here address essential ethical principles that should be upheld by any government entity. Presentations made to the committee and lessons learned from COVID-19 underscored the need for PHEMCE activities to adhere to this set of principles during times of preparedness, PHEs, and periods of transformation.
Maintaining trust in and across PHEMCE is fundamental to delivering on its mission of securing and delivering MCMs, working as a reliable partner for internal and external entities. PHEMCE cannot fulfill its mission unless it demonstrates it is worthy of trust and is a trusted partner. The below mentioned principles of fairness, transparency, and accountability also support trust, by demonstrating that PHEMCE’s goals and processes have a solid ethical foundation. Demonstrating its adherence to these operational principles will also cultivate trust with members and external part-
ners. Trust must be addressed in terms of both the public and federal and nonfederal partners and stakeholders:
- Public trust is critical to effectively implement PHEMCE policies and deliver on its mandate (Martin et al., 2020). Without that, acceptance, and recognition of the importance of MCM, adoption efforts can be severely hampered. Establishing or building on existing trusted, two-way communication channels (see Chapter 4) can preempt misinformation and build trust in PHEMCE’s work.
- Among federal and nonfederal partners and stakeholders, trust in and across PHEMCE can be cultivated by demonstrating it is a reliable business partner in producing outcomes, promoting innovation, and adapting to change. Incorporating partners and stakeholders in the PHEMCE decision-making process is one way to build trust in MCM preparedness and response activities led by PHEMCE interagency members (see Chapter 4). Improved two-way communication and greater transparency, discussed below, also foster trust in and across PHEMCE.
The central ethics principle for a public entity charged with protecting public health is fairness. Fairness here can be defined as both the outcome of mitigating injustice and inequities and creating procedures likely to promote just outcomes. Fair policies should promote health equity across populations, with consideration to race, ethnicity, income, gender, location, abilities, and age. These actions must treat both individuals and organizations fairly to ensure equitable health care delivery, access to public health services, and distribution of resources. Fairness does not require that all people are treated equally, but differences in treatment or access to resources must support important and clearly stated values, including equity. For instance, older adults have had a particularly high risk of serious illness with COVID-19, so they received early access during the initial vaccine roll-out. First-come, first-served approaches to delivering scarce resources in PHEs are often criticized because they unfairly disadvantage those with challenges in mobility and transportation (NASEM, 2020).
Processes that enhance fairness include proactively engaging with stakeholders who have been underrepresented in policy formation and implementation, including underresourced health providers, public health providers, and community organizations. Fair policies must attend to the disparate needs of different and vulnerable populations, including pregnant people, older people, and children. Engaging with historically underserved populations, with a focus on building community resilience in public health
preparedness and response, is one way to make sure that PHEMCE practices do not contribute to health inequities (Plough et al., 2013; Powell et al., 2020; Wells et al., 2013).
Experiences from the early days of COVID-19 provide an example of how a lack of fairness in MCM delivery can lead to health inequity. For instance, the dearth of PPE in the SNS forced health facilities to seek additional PPE on the international market, which had a critically different impact on different populations. Medical institutions with substantial budgets were able to outbid health facilities with limited resources. Nonprofit, independent nursing homes serving urban populations with high rates of poverty especially encountered great difficulty in obtaining adequate PPE for staff and patients, many of whom were minorities. This contributed to the high numbers of fatalities among both residents and workers at nursing homes in the earliest phase of the pandemic (McGarry et al., 2020; Seelye et al., 2020).
Transparency applies to PHEMCE’s practices in a number of key domains, including documentation, effective communication among agency and commercial partners, and security concerns. PHEMCE must commit to legally required recordkeeping for how key decisions are made and by whom. Meeting minutes should be maintained with regular report submissions to Congress, which has long been required but was not observed in recent years (GAO, 2021). A Quality Management System (QMS), as discussed in Chapter 3, can provide the structure needed to support documentation practices. Formally, required documentation must be supplemented by the formal and informal communications needed to make PHEMCE a trusted partner for its many stakeholders. Without that trust and predictability, it cannot fulfill its mission.
Concerns may arise about sharing information that is proprietary or has national security sensitivity. Transparency must be weighed against the ethical and operational costs of restricting access to information. To meet its transparency obligations, PHEMCE should have a formal procedure for justifying any such restrictions, and those decisions should be documented for independent review. Greater transparency can also be achieved via an advisory committee with the ability to provide oversight and review of PHEMCE actions (see Chapter 4).
Accountability requires that decisions are evidence based, the rationale is clear, and PHEMCE has coordinated input from federal agencies and other partners to reach collaborative decisions. PHEMCE’s actions should
also demonstrate commitment to long-term, public well-being and remain independent of undue political influence (Fernandez Lynch et al., 2021). Accountability is enhanced by formal processes and regular reassessment, such as through metrics-based evaluations or unbiased after-action reviews of emergency responses, to learn how to improve practices (see Chapter 3). One option would be to have such evaluations conducted by a knowledgeable third party, such as GAO. To ensure that decisions are based on available evidence, PHEMCE will need senior government officials (cabinet members, presidential appointees) who demand objective action, supported by independent experts who can review its work.
As a steward of public funds, PHEMCE must demonstrate responsible management of resources, especially in the scarcity and time pressure that characterize PHEs. A commitment to stewardship must be reflected in PHEMCE processes and by ensuring MCMs maximize benefit to the public. PHEMCE’s role in MCM preparedness and response requires an enterprise that manages resources efficiently in day-to-day work, without compromising on quality. This enables PHEMCE member agencies to respond rapidly to meet emergent needs during a PHE. Stewardship also requires that the costs (e.g., money, time, manpower, socioeconomic disruption) associated with making MCMs available are balanced against improved public health protection, and MCM utility in a multitude of public health emergency contexts (Lurie, 2021).
Additional operational principles are crucial for PHEMCE’s successful function: effectiveness, adaptability, systems approach, collaboration, and metrics-driven were mentioned frequently in presentations to the committee as areas where PHEMCE could be improved.
For PHEMCE to be effective, MCM will need to be successful from conception through production, storage, delivery, and actual use. Effectiveness requires that evidence-based decisions lead to desired impacts:
- Evidence-based decisions—PHEMCE products and operations require a sound decision-making process informed by the best-available evidence. PHEMCE must also have access to relevant expertise to guide decision making for MCM planning and implementation. In rapidly evolving PHEs, evidence is often sparse, hard to obtain, or disputed; PHEMCE will need to leverage judgment from trusted experts.
- Impact—PHEMCE must demonstrate impact, for partners and the public, by ensuring that MCM with demonstrated efficacy reach affected populations in a timely manner to mitigate potential harm. This impact includes successfully managing the entire MCM life cycle, from conception through development, production, storage, distribution, and use. To protect elements of public health identified by its mandate, PHEMCE must ensure effective MCMs are available or rapidly obtainable to respond to a range of PHEs, with inventories monitored to allow stakeholder planning.
PHEMCE’s role in preparing for and responding to PHEs requires that it is able to respond nimbly to unexpected and evolving situations (HHS, 2017). PHEMCE must address both new opportunities and threats and ensure the long-term project investment needed to see progress (Altevogt, 2021). Specific processes, including for obtaining authorization, funding, reprogramming funds, contracting, and development, must explicitly allow for supporting both preparedness and acute emergency response phases. Mechanisms for risk sharing between PHEMCE member agencies and partners is also essential to support adaptability while maintaining trust in the enterprise (see Chapter 4).
Investment in the MCM system, in addition to the products, is needed to deliver on PHEMCE’s mission (Hatchett, 2021). Taking a systems approach requires considering the life cycle of each MCM asset across the portfolio, including facilities, supply chains, quality management, and workforce, from development to delivery stages, and results in prioritizing across scenarios.
A systems approach also requires appropriate engagement and communication with the public throughout the MCM life cycle. For this to be successful, PHEMCE member agencies must make efforts to understand and prioritize end-user needs across the system—which is critical to equity. Delivering on the historical end-to-end mission will require member agencies to sustain meaningful engagement with and sufficient resourcing of actors across the system, in addition to end users at state and local levels (Lamprecht, 2021).
PHEMCE requires formal authority to convene public- and private-sector actors, allocate budgets, and coordinate joint decision making among
its partners.3 PHEMCE structure and processes should facilitate collaboration and trust at interagency, interagency, and individual staff levels with the ability to adapt quickly per the needs of activities. PHEMCE’s role also requires meaningful relationships and coordinating mechanisms able to provide both continuity and rapid response adaptation with federal agencies, private companies, and state or local entities (see Chapter 4).
It is essential to measure in order to constantly improve PHEMCE’s capability to prepare and respond. Metrics are necessary to facilitate quality improvement by benchmarking within and across organizations, monitor progress toward goals, enhance performance (see Chapter 3), ensure accountability, meet end-user needs, and track impact (Swann, 2021). Robust metrics are required for each of PHEMCE’s functions.
Under the requirements of section 2811(d) of the Public Health Service Act (PHSA) and amended by section 102 of the PAHPRA, ASPR must “develop and submit to the appropriate committees of Congress a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats” (HHS, 2017) in consultation with the directors of PHEMCE member agencies annually. However, the SIP was last published in December 2017 (GAO, 2021). As recommended in the National Strategy for a Resilient Public Health Supply Chain, reporting annually will help ensure that Congress remains informed about the most current state of MCM preparedness (HHS, 2021).
PHEMCE’s strategy should have short-, mid-, and long-term goals that are developed and shared with nonfederal and private-sector partners and stakeholders. PHEMCE’s strategy must include objectives consistent with its mission, directed by status, which describe how it will deliver the right products, at the right time, and to the right population, such as the following:
- Identifying, aligning, and communicating the operational role of each member and enterprise partner in executing PHEMCE process and outcome.
- Establishing and monitoring annual product development goals with member-specific responsibilities in the process and progress measured with functional metrics.
3 (2015). 42 U.S. Code § 300hh-10a—Public Health Emergency Medical Countermeasures Enterprise.
- Monitoring the industrial base for vulnerabilities in MCM production and distribution and, when identified, acting to mitigate them.
- Establishing a transparent system for MCM distribution and administration.
- Establishing an accountable lead from a PHEMCE member agency to provide a smooth transition of leadership between emergency phases.
Under section 2811(b)(7) of the PHSA, ASPR is required to submit a coordinated 5-year budget plan for PHEMCE, with annual reviews and updates (HHS, 2019). The multiyear budget plan requirement can be better leveraged by adopting a life cycle management approach and aligning budget planning across all PHEMCE member agencies. In consideration of budget requirements, PHEMCE must consider all members’ budgetary resources. While many MCM development efforts are vital to long-term capabilities, these efforts ultimately become useless when there is no long-term budget planned to continue the purchase of the developed MCMs. The disparity between investment in initial development particularly through BARDA and the ability for the SNS to continue long-term investment without more resources is untenable.
A life cycle management approach to MCM, with detailed budget plans covering all stages —from requirements setting to distribution—will help to ensure that funds are sufficient for various stages of development. More accurate funding allocation can be achieved through a probabilistic approach based on anticipated project success. Furthermore, joint, complementary budget submissions, with harmonized agency schedules and functions across all PHEMCE agencies, would clarify true costs of MCM activities throughout the life cycle to avoid a product in development encountering a budget gap (Korch, 2021; Swann, 2021). Translating the true costs of end-to-end product development through the SNS Annual Review is essential to support a robust annual budget recommendation to the HHS secretary in order to fully meet preparedness and response goals. As the costs of both development and procurement are also subject to market forces, negotiations, etc., PHEMCE needs strong authority to negotiate on pricing.
The National Strategy for a Resilient Public Health Supply Chain recommends supplementing these reporting requirements with annual budget analysis “to advance MCM preparedness in a fiscally responsible manner, industrial base expansion, commercial supply chain and inventory solutions, and the SNS” (HHS, 2021). These reforms’ success depends on member agencies’ authority to implement the budget and congressional willingness to approve budget requests.
The definition of PHEMCE’s mission, scope, and responsibilities has evolved with the nature of public health needs over the past two decades. The committee recognizes that opinions differ about PHEMCE’s appropriate role, past performance, and current activities. Given the varied public health threats facing the nation, and the reality that the different federal agencies will continue to work on aspects of MCM preparedness and response, a coordinating body is and will always be needed. PHEMCE is that body, and its scope, authorities, and responsibilities should reflect its original mandate as the nation’s primary coordinating body for MCMs.
Guiding principles in ethics, operations, strategy, and budget are necessary to provide a foundation to evaluate or redesign PHEMCE operations to meet its specific key goals. These principles present a road map for those functions that permit PHEMCE to fulfill its core mission.
RECOMMENDATION 1. REAFFIRM THE PHEMCE MANDATE.
The Secretary of the U.S. Department of Health and Human Services and, in turn, the Assistant Secretary for Preparedness and Response should recognize the critical functions of PHEMCE and reaffirm PHEMCE’s mandate as the nation’s major coordinating body for all aspects of U.S. medical countermeasures preparedness and response programs, as directed by 42 U.S. Code 300hh-10A.
The administration and congressional leadership must provide PHEMCE with the resources and authorities, both budgetary and human, necessary to achieve that mission.
RECOMMENDATION 2. ADOPT A SYSTEMS APPROACH.
PHEMCE should conduct its business under the framework of clear ethical, operational, strategic, and budget goals.
RECOMMENDATION 3. ENSURE THAT PHEMCE STRATEGIES REFLECT THE PERSPECTIVES OF, AND PROVIDE ACTIONABLE GUIDANCE TO, ITS PARTNERS AND STAKEHOLDERS.
PHEMCE should ensure that the perspectives of its partners and stakeholders are incorporated into the PHEMCE Strategy and Implementation Plan and multiyear budget.
These documents should clearly specify roles, actionable objectives, accountability, measurable benchmarks, timelines, and budget requirements to enable nonfederal and private-sector PHEMCE partners to
make informed, responsible decisions for planning and engagement. PHEMCE members and representatives should be of sufficient government rank to enable efficient recommendation development and implementation.
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