Pandemic and All-Hazards Preparedness and Advancing Innovation Act


The Pandemic and All-Hazards Preparedness and Advancing Innovation Act is legislation introduced and passed by the U.S. Congress in 2019 that aims to improve the nation's preparation and response to public health threats, including both natural threats and deliberate man-made threats.
A previous bill, the Pandemic and All-Hazards Preparedness Act, was signed into law in 2006 and reauthorized in 2013 in order to create a system that prepares for, and responds to, public health threats that could turn into emergencies.
The 2019 bill was introduced by U.S. Senators Richard Burr, Bob Casey, Lamar Alexander, and Patty Murray. Congress passed the bill and sent it to President Trump for his signature in June 2019..

Background

After the September 11, 2001 terrorist attacks and the anthrax attacks that followed, a critical need arose: to develop and stockpile medical countermeasures needed to protect people from chemical, biological, radiological, nuclear and pandemic threats.
However, medical countermeasures that address these types of threats, such as anthrax or the plague, have little or no commercial market. Therefore, the government needed to incentivize the private market to develop them. To do so, Congress passed the Project BioShield Act in 2004. That law created a federal program called the Special Reserve Fund to incentivize development of these types of medical countermeasures.
Since 9/11, the United States has faced a number of additional sizable public health emergencies. The anthrax attacks of 2001, the destruction caused by Hurricane Katrina in 2005, and the Ebola outbreak in 2014 all raised alarm and concern about how the government should prepare for, and respond to, such events. Because of these events, Congress has attempted to vastly improve the federal government's ability to address these threats.
In 2006, passage of the Pandemic and All-Hazards Preparedness Act, among other things, created the Biomedical Advanced Research and Development Authority to provide companies with money and technical assistance in the advanced research and development of medical countermeasures.
Several key existing laws give authorities, budgets and policies and procedures to several government agencies tasked with responding to public health emergencies.
When disasters such as wildfires, hurricanes, and disease outbreaks strike, many sectors play a role in saving lives. According to the American Health Association, PAHPA is “the backbone of our nation’s health security” by giving the U.S. Department of Health and Human Services the authority to respond to disasters.
After implementing the 2013 PAHPA reauthorization, Congress recognized certain federal programs, policies and procedures that needed improvement. The purpose of the 2019 PAHPAI bill is to implement these improvements.

Bioterrorism and antimicrobial resistance

PAHPAI focuses on a variety of threats, but pays special attention to two specific threats: bioterrorism and “antimicrobial resistance.”
Bioterrorism occurs when a person or group of people intentionally release germs that can cause serious illness or death. Depending on the type of germ, sometimes bioterrorism attacks can go almost completely undetected by technology because the biological agents are so microscopic in size.
Another emerging public health threat that is causing concern is the increase in “microbial resistance” among infectious diseases. Microbial resistance occurs when a person who has an infectious disease is given a countermeasure, such as an antibiotic medicine, and it does nothing to help the person get better.
Therefore, one of the goals of the PAHPAI law is to develop new therapies that are effective at treating infectious diseases.

Provisions of the legislation

An “authorization” bill in Congress is legislation that creates, or continues, the existence of federal agencies and programs. Authorization bills also define the terms and conditions under which the agencies and programs operate, authorize Congress to appropriate funds to those programs, and spell out how the programs must use their funds. Therefore, a “reauthorization” bill is legislation that redefines these specifics for federal agencies and programs.
PAHPAI reauthorizes federal government programs that were established in the past by the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. The law makes significant changes and improvements to the agencies and programs under those two laws, in order to make the federal government more effective at preventing and responding to public health security threats such as bioterrorism attacks or disease outbreaks.
PAHPAI focuses on making changes in the law in order to improve the government's response to a number of public health threats, including:
The legislation is divided among seven titles which are described below.

Title I - Strengthening the National Health Security Strategy

Title I changes the National Health Security Strategy so that it includes a detailed description of all public health threats, as well as the processes to respond to each type of threat and emergency. It also adds zoonotic disease and disease outbreaks related to food and agriculture into the National Health Strategy.
The NHSS is a vision, set forth by HHS, to responding and managing public health emergencies. According to HHS:
The 2019-2022 National Health Security Strategy provides a vision to strengthen our nation’s ability to prevent, detect, assess, prepare for, mitigate, respond to, and recover from disasters and emergencies. It describes strategies to improve readiness and adapt operational capabilities to address new and evolving threats. By coordinating a whole-of-government approach that engages external partners and supports public health authorities and health care stakeholders, we can better safeguard the health and well-being of people across the country.
The NHSS is created every four years by HHS and the Office of the Assistant Secretary for Preparedness and Response.

Title II - Improving Preparedness and Response

Title II is further divided into 10 sections:
Title III is further divided into six sections:
Title IV is further divided into five sections:
Title V is further divided into five sections:
Title VI is further divided into seven sections:
Title V is further divided into seven sections:

Original law

In 2006, during the 109th Congress, Senator Richard Burr introduced S. 3678, the Pandemic and All-Hazards Preparedness Act. It passed Congress and was signed into law by President George W. Bush.
Senators Richard Burr and the late Edward Kennedy spearheaded the original legislation.

First reauthorization

In 2013, the original Pandemic and All-Hazards Preparedness Act of 2006 needed to be reauthorized. Senator Richard Burr introduced S. 242, the Pandemic and All-Hazards Preparedness Reauthorization Act. The bill, however, never made it to a full vote in the Senate. In the House, Rep. Mike Rogers introduced the same legislation, H.R. 307. That bill passed Congress and was signed into law by President Barack Obama.

Second reauthorization

In 2018, during the 115th Congress the law once again needed to be updated and reauthorized. Senator Burr introduced S. 2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018. The bill made it through committee consideration but never reached a full vote in the Senate. In the House, Rep. Susan Brooks introduced companion legislation, H.R. 6378. Brooks’ bill passed the House, but was never considered in the Senate. Once the 115th Congress ended, both bills were effectively dead.
The following year, in 2019 during the first year of the 116th Congress, Senator Burr re-introduced the All-Hazards Preparedness and Advancing Innovation Act as S. 1379. The bill was passed by Congress and sent to President Donald Trump for his signature on June 13, 2019..

Table summary of legislative versions

S. 1379 procedural history

The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 was introduced in the Senate by Richard Burr on May 8, 2019. On May 15, the Senate Committee on Health, Education, Labor, and Pensions passed the bill by unanimous consent. That same day, the full Senate passed the bill by voice vote.
On June 4, the House passed the bill by voice vote. The legislation was sent to President Trump for his signature on June 13, 2019.