Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise (2021) / Chapter Skim
Currently Skimming:
Summary
Summary
Pages 1-14
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
2 MCMs are "biologics, drugs, or devices that can be used to diagnose, prevent, protect from, or treat conditions associated with chemical, biological, radiological, or nuclear (CBRN) threats, or emerging infectious diseases and, MCMs may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease" (FDA, n.d.)
|
From page 2... ...
revising PHEMCE operations and processes; (3) collaborating more effectively with external public and private partners needed for the entire life cycle of MCMs, from research through use; and (4)
|
From page 3... ...
Chapter 2 proposes guiding principles for redesigning PHEMCE's system. The committee advocates four sets of principles to guide PHEMCE decisions and policies: • Ethics o Trust building: creating strong relations among PHEMCE member agencies and partners by linking plans to outcomes, promoting innovation, and respecting diverging opinions; o Fairness: ensuring that PHEMCE planning and response opera tions promote health equity and do not exacerbate existing health inequities related to race, ethnicity, income, gender, loca tion, abilities, and age; o Transparency: making PHEMCE processes accessible, com municating with partners and stakeholders, and creating ap propriate records, with explicit procedures for making and documenting exceptions for national security or intellectual property;
|
From page 4... ...
• Strategic objectives o Aligning with PHEMCE's mission, describing how the right products, but also people and services, will be delivered to the right population, at the right time; and o Articulating in the annual Strategy and Implementation Plan, as mandated by section 2811(d) of the Public Health Service Act (PHSA)
|
From page 5... ...
ENSURING DEFENSIBLE PHEMCE RECOMMENDATIONS Sound Business Practices in a Changing Environment PHEMCE must develop and sustain the mutually supporting formal and informal processes required for effective business practices. Formal pro
|
From page 6... ...
PHEMCE may also look to procedures recently recommended by the National Academies' Committee on Equitable Allocation of Vaccine for the Novel Coronavirus to set priorities, including • Adopting widely acceptable ethical principles to maximize benefits, mitigate health inequities, and promote fairness, transparency, and evidence-based actions; • Translating those factors into transparent operational metrics; • Setting priorities in terms of those metrics; • Using readily available data to estimate those metrics and monitor progress; • Conducting sensitivity analyses to create contingency plans; and • Establishing two-way dialogue with stakeholders to communicate and address concerns related to the priorities.
|
From page 7... ...
A robust data system is required to collect and analyze KPIs along with other indicators needed by the quality management system, with the flexibility to adapt to changing MCM preparedness or response requirements, while also continuously collecting and analyzing other types of data that are important for preparedness planning and response activities.
|
From page 8... ...
Additional examples establish the precedent of an advisory committee. One is the Federal Emergency Management Agency's National Advisory Committee, which focuses on decisions in the emergency preparedness and response space, similar to PHEMCE.
|
From page 9... ...
Transparency, Two-Way Communication, and Clarifying Expectations with Nonfederal and Private-Sector Partners, Stakeholders, and the Public As the nation's MCM coordinating body, PHEMCE must be a reliable partner in MCM priority setting, development, and distribution. To this end, PHEMCE must establish and maintain two-way communication across the enterprise, creating shared expectations and keeping the p arties apprised of potential changes.
|
From page 10... ...
Per the National Strategy for a Resilient Public Health Supply Chain, a re-envisioned PHEMCE must create appropriate incentives and commitments for private-sector engagement if it is to help promote a resilient and adaptable public health sup
|
From page 11... ...
U.S. efforts to improve MCM development and delivery must consider opportunities for global coordination, leveraging relationships with international governmental, nonprofit, and industry organizations that are recognized leaders in MCM preparedness.
|
From page 12... ...
Thus, PHEMCE must be aware of issues related to and, to the extent of its power, ensure research support; fair, documented, and efficient procurement processes; and adequate supply, while minimizing COIs and providing appropriate incentives to industry partners. MCM research regulation and FDA marketing authorization path • ways: MCM development requires establishing and monitoring compliance with safety and effectiveness standards.
|
From page 13... ...
Although HHS and PHEMCE partner agencies have some tools and programs intended to help, nongovernmen tal partners nevertheless may remain reticent about entering the MCM market if they do not perceive these programs as adequately addressing their concerns, particularly in light of high-profile bank ruptcies in the space. Addressing and Solving Emergency Legal Issues in Real Time The legal and regulatory landscape underpinning PHEMCE has been evolving in response to PHEs such as COVID-19, which have presented novel legal questions and actual and perceived regulatory barriers.
|
From page 14... ...
11. Identify, assess, and resolve the perceived or actual legal barriers that may impede PHEMCE objectives.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.