The physical space of the MSK Library is scheduled to close to visitors on Friday, May 17, 2024. Please visit this guide for more information.
The physical space of the MSK Library is scheduled to close to visitors on Friday, May 17, 2024. Please visit this guide for more information.
The International Health Regulations (IHR) 2005 are an instrument of international law that is legally-binding on 196 countries, including the 194 WHO Member States, to build the capability to detect and report potential public health emergencies worldwide. IHR require that all countries have the ability to detect, assess, report, and respond to public health events.
The IHR grew out of the response to deadly epidemics that once overran Europe. They create rights and obligations for countries, including the requirement to report public health events. The Regulations also outline the criteria to determine whether or not a particular event constitutes a “public health emergency of international concern”. The World Health Assembly first adopted IHR in 1969 to cover six diseases. Over the years, the IHR were revised multiple times.
Countries reference IHR (2005) to determine how to prevent and control global health threats while keeping international travel and trade as open as possible. IHR (2005) also includes specific measures countries can take at ports, airports and ground crossings to limit the spread of health risks to neighboring countries, and to prevent unwarranted travel and trade restrictions.
One of the most important aspects of IHR (2005) is the requirement that countries detect and report events that may constitute a potential public health emergency of international concern (PHEIC).
PHEIC is a formal designation by the World Health Organization (WHO) of "an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response" that is declared in response to a "serious, sudden, unusual, or unexpected", which "carries implications for public health beyond the affected state's national border" and "may require immediate international action."
Once a WHO member country identifies an event of concern, the country must assess the public health risks of the event within 48 hours. If the event is determined to be notifiable under the IHR, the country must report the information to WHO within 24 hours. Some diseases always require reporting under the IHR, no matter when or where they occur, while others become notifiable when they represent an unusual risk or situation.
When a PHEIC is declared, WHO helps coordinate an immediate response with the affected country and with other countries around the world.
The Secretary of the Department of Health and Human Services (HHS) may, under section 319 of the Public Health Service (PHS) Act, determine that: a) a disease or disorder presents a public health emergency (PHE); or b) that a public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists.
Duration and Notification: The declaration lasts for the duration of the emergency or 90 days, but may be extended by the Secretary. Congress must be notified of the declaration within 48 hours, and relevant agencies, including the Department of Homeland Security, Department of Justice, and Federal Bureau of Investigation, must be kept informed.
Prior to issuing the declaration, the Secretary should consult with public health officials as necessary.
Once a PHE is declared, the following can be authorized.
By presidential authority, the DPA allows federal agencies to expedite and expand the supply of materials and services from the U.S. industrial base by requiring companies to prioritize government contracts to promote and support national defense, emergency preparedness and response, and critical infrastructure. The DPA affords the President emergency authority to exert control over domestic industries in ways that would be considered "anti-American" under normal conditions.
Access "no year" funds from the fund to rapidly respond to immediate needs resulting from the PHE, including facilitating coordination among federal, state, local, public, and private health entities affected by the PHE, facilitating and accelerating advanced research and development of medical countermeasures, strengthening biosurveillance and laboratory capacity, and supporting initial emergency operations related to preparation and deployment of National Disaster Medical System teams.
Allow the CDC to access the fund to prevent, prepare for, or respond to an infectious disease emergency.
Under Section 1135 of the Social Security Act, the HHS Secretary can waive or modify certain requirements as necessary to ensure to the maximum extent feasible that, in an emergency area during an emergency period, sufficient health care items and services are available to meet the needs of individuals Medicare, Medicaid, and CHIP, and that providers of such services in good faith who are unable to comply with certain statutory requirements are nonetheless reimbursed and exempted from sanctions for noncompliance, absent fraud, or abuse.
Waiver or Modification of Requirements Under Section 1135 of the Social Security Act
Modifies the practice of telemedicine by overriding some measures in the act to allow for to the HHS Secretary to designate patients, patient locations, and use of controlled substances during a public health emergency.
Under Section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, the FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain criteria are met, including when there are no adequate, approved, and available alternatives.
The 2013 Pandemic and All-Hazards Preparedness Reauthorization Act amended Section 564 of the FD&C to provide more flexibility to the HHS Secretary to authorize the FDA to issue an Emergency Use Authorization. As amended, the Secretary now may determine that there is a public health emergency or significant potential for a public health emergency that affects, or has significant potential to affect, national security or the health and security of U.S. citizens living abroad and involves a biological, chemical, radiological, or nuclear agent or disease or condition that may be attributable to such agent(s). The Secretary may then declare that the circumstances justify emergency authorization of a product, enabling the FDA to issue an EUA before the emergency occurs.
Public Health Emergency Determinations to Support an Emergency Use Authorization
The 1998 Disaster Relief and Emergency Assistance Act (Stafford Act) allows for federal natural disaster assistance for state and local governments in carrying out their responsibilities to aid citizens. The Act gives FEMA the responsibility for coordinating government-wide relief efforts. The Federal Response Plan includes contributions from 28 federal agencies and non-governmental organizations, such as the American Red Cross.
December 2, 2022 - Statement From HHS Secretary Becerra on mpox emergency declaration
March 31, 2023 - Renewal of Determination that a Public Health Emergency Exists Nationwide as a Result of the Continued Consequences of the Opioid Crisis
May 11, 2023 - HHS Secretary Xavier Becerra Statement on End of the COVID-19 Public Health Emergency