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Overview

With this year’s flu season being the worst in more than a decade and the increasing threat that biological weapons pose to the United States, Congress has begun its regular reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). PAHPA’s focus is to improve the United States’ readiness for public health and medical preparedness during emergencies caused by infectious diseases, natural disasters or chemical, biological, radiological or nuclear (CBRN) agents. The consequences of being ill-prepared for these situations can be catastrophic in both human and financial terms. The reauthorization will help to maintain the gains made since PAHPA’s introduction in 2006 and encourage new response initiatives and programs focused on medical surge capacity, research and development in medical countermeasures (MCMs) and critical preparedness of states and localities.

Why was PAHPA introduced?

On December 19, 2006 President George W. Bush signed PAHPA into law, however the origins of the law date back to the 9/11 attacks in 2001 which revealed flaws in public health infrastructure including medical preparedness and response times by agencies in emergencies. Since the attacks, Congress has passed various laws including the 2002 Bioterrorism Act and the 2004 Project BioShield Act. As funding for the Bioterrorism Act was nearing expiration, Congress was looking for an enhanced version of the legislation which took into consideration the lessons learned from the 9/11 terrorist attacks, hurricanes Katrina, Rita and Wilma (2005) and the threat of an influenza pandemic. The Act is scheduled to be reauthorized every five years, with its current expiration date on September 30, 2018.

The 2013 Act

The impact of current programs, such as the Hospital Preparedness Program (HPP) and Public Health Emergency Preparedness (PHEP) Cooperative Agreement, has created a network of scientists, academics and policy makers committed to preparedness against biological threats, including the development of MCMs which take years of sustained investment. According to the Assistant Secretary of Preparedness and Response (ASPR), since PAHPA’s passage in 2006, 31 MCMs have been approved or licensed by the Food and Drug Administration (FDA).

More information on each title of the Act can be found HERE.

● Title I: Strengthening National Preparedness and Response for Public Health Emergencies
● Title II: Optimizing State and Local All-Hazards Preparedness and Response
● Title III: Enhancing Medical Countermeasure Review
● Title IV: Accelerating Medical Countermeasure Advanced Research and Development

2018 Outlook

Congress is currently reviewing the bipartisan discussion draft, with the most notable change being control of the Strategic National Stockpile (SNS) shifting from the Centers for Disease Control and Prevention (CDC) to ASPR within the Department of Health and Human Services (HHS). This decision was first announced in the release of President Donald Trump’s Fiscal Year 2019 Budget proposal and aims to enhance the leadership structure leading to more efficient responses in emergencies.

While the World Health Organization (WHO) declared the end of the West Africa Ebola epidemic in June 2016, the outbreak in the Democratic Republic of Congo in 2017 is a stark reminder that the Ebola virus is still a considerable threat to public health. Challenges must be overcome in PAHPA’s reauthorization to ensure adequate preparedness is in place for future public health emergencies caused by the Ebola virus, including funding and technical support in advanced development activities for public-private partnerships that provide vaccines and therapeutics to the SNS.

Additionally, the Senate Health, Education, Labor and Pension (HELP) Committee and House Committee on Energy and Commerce have been urged by more than 50 health care advocacy groups to provide incentives for antibiotic development in the reauthorization. This may be a technical and financial risk as, unlike other therapeutic products, the U.S. government is typically the only purchaser of MCMs. However, the risk is critical in order to tackle threats such as antimicrobial resistance (AMR). Experts believe another priority includes supporting a fund dedicated solely to public health emergency response that will form a connection between preparedness funding and supplemental emergency funding for major disasters.

Although much progress has been made since 2001 the laws must be continually fine-tuned to ensure we are well equipped for the unimaginable, from chemical attacks to cybersecurity incidents.

Key Facts

● The most recent flu season claimed the lives of 178 children, making it among the deadliest for children on record, according to CDC (8/5/18)
● A severe global influenza pandemic could cost approximately 1% of global GDP, as estimated by The World Bank
● HHS and CDC have both stated that the development of other MCMs, like antivirals, is critically important to mitigate emerging pandemics before effective vaccines become available

Definitions

Strategic National Stockpile: is the United States’ storage supply of antibiotics and vaccines. Within 12 hours of declaration of a national emergency the division will distribute a ‘push package’ of pharmaceutical and medical supplies to local health authorities in affected areas that may be overwhelmed by the crisis.

Office of the Assistant Secretary of Preparedness and Response: is an office which was created by PAHPA who focus within the field of medical and public health preparedness on the following: identifying gaps and inefficiencies in activities, coordinating grants, carrying out drills to address gaps in policies and provide updates on response activities.

Links to Other Resources

● Bipartisan Policy Center – Budgeting for Medical Countermeasures: An Ongoing Need for Preparedness: https://bipartisanpolicy.org/wp-content/uploads/2018/02/BPC-Health-Budgeting-For-Medical-Countermeasures-An-Ongoing-Need-For-Preparedness.pdf

● House Committee on Energy and Commerce – SubOversight Examines U.S. Public Health Biopreparedness as Congress Works to Reauthorize PAHPA: https://energycommerce.house.gov/news/press-release/suboversight-examines-u-s-public-health-biopreparedness-as-congress-works-to-reauthorize-pahpa/

● Public Health Emergency (PHE) – Pandemic and All-Hazard Preparedness Reauthorization Act: https://www.phe.gov/Preparedness/legal/pahpa/Pages/pahpra.aspx

● The World Bank – Pandemic Preparedness and Health Systems Strengthening: http://www.worldbank.org/en/topic/pandemics

● Trust for America’s Health – A Funding Crisis for Public Health and Safety: State by State Public Health Funding and Key Health Facts 2018: http://healthyamericans.org/assets/files/TFAH-2018-InvestInAmericaRpt-FINAL.pdf

● U.S. Department of Health and Human Services – Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Multiyear Budget Fiscal Years 2016-2020: https://www.phe.gov/Preparedness/mcm/phemce/Documents/2017-myb.pdf