Merck Manual

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Professional Version

Public Health Law

By

Donald L. Noah

, DVM, DACVPM, College of Veterinary Medicine and DeBusk College of Osteopathic Medicine, Lincoln Memorial University

Last review/revision Dec 2022

International Public Health Law

The World Health Organization (WHO), founded in 1948, is a specialized agency of the United Nations with a broad mandate to act as a coordinating authority on international health issues. Headquartered in Geneva, Switzerland, and composed of 194 member states, WHO works worldwide to promote health, keep the world safe, and serve the vulnerable. Its overarching mission is “attainment by all peoples of the highest possible level of health,” and its current goals are to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and to provide an additional billion people with better health and well-being.

The World Health Assembly (WHA), composed of representatives from WHO’s 194 member states, is the supreme decision-making body for WHO. It is convened annually and is responsible for selecting the director-general, setting priorities, and approving WHO’s budget and activities. Every 6 years, WHA negotiates and approves a work plan for WHO, and every 2 years it approves a biennial budget for the work plan. The annual WHA meeting in May also serves as a key forum for nations to debate important health policy issues.

Finally, WHO administers the International Health Regulations, or IHR (2005), helping countries work together to save lives and livelihoods threatened by the international transmission of diseases and other health risks. They entered into force on June 15, 2007, and are binding on 194 countries across the globe, including all WHO member states. The IHR (2005) aim to prevent, protect against, control, and respond to the international transmission of disease while avoiding unnecessary interference with international traffic and trade. The IHR (2005) are also designed to reduce the risk of disease transmission at international airports, ports, and ground crossings. Born of an extraordinary global consensus, the IHR (2005) strengthen the collective defenses against the multiple and varied public health risks that today’s globalized world is facing and that have the potential to be rapidly transmitted through expanding travel and trade. The IHR (2005) establish a set of rules to support the global-outbreak alert and response system and to require countries to improve international surveillance and reporting mechanisms for public health events and to strengthen their national surveillance and response capacities.

Some diseases always require reporting under the IHR (2005), no matter when or where they occur; others become notifiable when they represent an unusual risk or situation.

Always Notifiable:

  • Smallpox

  • Poliomyelitis due to wild-type poliovirus

  • Human influenza (flu) caused by a new subtype

  • Severe acute respiratory syndrome (SARS)

Potentially Notifiable:

  • Other diseases that might be transmitted quickly through a nation or region (eg, cholera, plague, or a viral hemorrhagic fever like Ebola)

  • Other biological, radiologic, or chemical events that meet IHR criteria

  • Serious illnesses of unknown origin

The World Trade Organization (WTO), recognizing that there is much common ground between trade and health, also addresses international health issues through its agreements on public health with WHO. These agreements address key issues for those who develop, communicate, or debate policy issues related to trade and health. They also recognize that countries have the right to take measures to restrict imports or exports of products when this is necessary to protect the health of humans, animals, or plants. Eight specific health issues are covered:

  • infectious disease control

  • food safety

  • tobacco

  • environment

  • access to drugs

  • health services

  • food security

  • some emerging issues, such as biotechnology

In each case, examples of challenges and opportunities in implementing coherent trade and health policies are provided.

Specifically, WTO and WHO have main agreements on the following issue areas (see WTO Agreements & Public Health):

  • Technical barriers to trade (TBT)

  • Sanitary and phytosanitary (SPS) measures

  • Trade-related intellectual property rights (TRIPS)

  • Trade in services (GATS)

Domestic Public Health Responsibilities and Function in the US

Within the US, the public health system is a complex network of people and organizations in both public and private sectors that collaborate in various ways at national, state, and local levels to promote and protect public health. The governmental public health system is made up of public health agencies from the federal government, 51 states (including the District of Columbia), 2,794 local governments, and 565 federally recognized tribal agencies. Because of the broad flexibility that states have in defining their public health role, the governmental public health infrastructure throughout the US is extremely varied.

The US Constitution makes no specific provision for health or public health. Therefore, in accordance with the Tenth Amendment, these powers are reserved by the states. This power is generally understood to include the essential role of protecting and promoting health through population-wide actions. To fulfill this public health role, state health departments have a wide range of responsibilities, including the following six governance functions:

  • Policy development: Lead and contribute to the development of policies that protect, promote, and improve public health while ensuring that the agency and its components remain consistent with the laws and rules (local, state, and federal) to which it is subject.

  • Resource stewardship: Ensure the availability of adequate resources (legal, financial, human, technological, and material) to perform essential public health services.

  • Legal compliance: Exercise legal authority as applicable and understand the roles, responsibilities, obligations, and functions of the governing body, health officer, and agency staff.

  • Partner engagement: Build and strengthen community partnerships through education and engagement to ensure the collaboration of all relevant stakeholders in promoting and protecting the community’s health.

  • Continuous improvement: Routinely evaluate, monitor, and set measurable outcomes for improving community health status and the ability of the public health agency’s governing body to meet its responsibilities.

  • Oversight: Assume ultimate responsibility for public health performance in the community by providing necessary leadership and guidance in order to support the public health agency in achieving measurable outcomes.

State Public Health Structure

"Structure" refers to a state health department’s placement within the state government’s larger organizational infrastructure. In 55% of all states, the state health department is freestanding or independent. Some of these independent departments focus exclusively on public health, while others include such health care–related functions as the administration of Medicaid. In 45% of all states, the health department is one unit in a larger umbrella agency (or "superagency") that includes a variety of functions, such as mental health services, public assistance, longterm care, or human services, in addition to traditional public health functions.

State health departments serve multiple public health functions, some of which are shared or assumed by sister agencies in state government (eg, licensure of health professionals, regulation of indoor air quality, or regulation and inspection of health care facilities). Despite a wide range of governance structures, each state’s health department is generally the primary public health authority within the state and plays a key role in supporting the delivery of public health services.

Primary Sources of State Public Health Authority

Police power: Authority of “police power” usually is invoked to protect the common good. Not synonymous with criminal enforcement, this authority establishes means by which a community promulgates and enforces self-protective measures. Examples include regulation of health care professionals and facilities; establishment of health and safety standards; quarantine, health, and inspection laws to limit the transmission of infectious diseases; mandatory vaccination programs; age restrictions for drinking alcohol and purchasing tobacco products; and requirements for speed limits, seatbelts, and helmets.

Parens patriae power: This is the power of the state to serve as guardian of persons under legal disability. Examples include juveniles and the legally insane.

State constitutional power: These authorities are granted under each individual state constitution (varies by state).

Local Public Health Structure

States typically have at least two levels of local governments: counties and municipalities (which can include cities, townships, towns, boroughs, villages, and hamlets). The role and regulatory structure of local health departments can vary as widely as the types and sizes of jurisdictions served. For example, local health departments in large metropolitan areas may have a broad range of functional capacities similar to, and in some cases more developed than, those of state health departments. In contrast, small local health departments often provide a narrow set of public health services. Local health departments can be structured as a locally governed health department, a branch of the state health department, a state-created district or region, a department governed by and serving a multicounty area, or any other arrangement that has governmental authority and is responsible for public health functions at the local level. In addition, the public health community in each jurisdiction includes individuals and public and private entities engaged in activities that affect the public’s health.

The following standards, developed by the National Association of County and City Health Officials (NACCHO), are public health services that a typical local health department provides:

  • Monitor health status and understand health issues facing the community.

  • Protect people from health problems and health hazards.

  • Give people information they need to make healthy choices.

  • Engage the community to identify and solve health problems.

  • Develop public health policies and plans.

  • Enforce public health laws and regulations.

  • Help people receive health services.

  • Maintain a competent public health workforce.

  • Evaluate and improve programs and interventions.

  • Contribute to and apply the evidence base of public health.

Selected General Federal Emergency Legal Authorities

In response to a number of high-consequence terrorist attacks, natural disasters, and disease outbreaks, the federal government has strengthened its legal preparedness for all types of public health emergencies. These activities addressed a variety of concerns related to emergency declarations, quarantine and isolation, licensure and liability of health care workers, and mutual aid.

Homeland Security Act of 2002

The Homeland Security Act merged 22 disparate agencies and organizations into the new Department of Homeland Security (DHS), including the US Coast Guard and the Federal Emergency Management Agency (FEMA). The act charged DHS with securing the nation against terrorist attacks and carrying out the functions of all transferred entities, including acting as a focal point regarding natural and anthropogenic crises and emergency planning.

Robert T. Stafford Disaster Relief and Emergency Assistance Act of 1988

The Stafford Act authorizes the president to declare a “major disaster” or “emergency” in response to an event (or threat) that overwhelms state or local government resources. Declaration under the act triggers access to federal technical, financial, logistical, and other assistance to state and local governments. The governor of an affected state must first respond to the disaster and execute the state’s emergency plan before requesting that the president declare a major disaster or emergency, and the governor must certify that the magnitude of the emergency exceeds the state’s capability. As of 2013, tribal leaders can also request a Stafford Act declaration from the president. The president may declare an emergency without the request of a governor or tribal leader if the emergency involves “federal primary responsibility” (eg, an event occurring on federal property).

National Emergencies Act

This act authorizes the president to declare a “national emergency.” The declaration of emergency must specify the powers or authorities made available by virtue of the declaration.

Public Health Service Act

Originally passed in 1944, this act has been amended several times to facilitate various types of responses:

  • Public health emergencies: Authorizes the secretary of the Department of Health and Human Services (DHHS) to determine that a public health emergency exists if “1) a disease or disorder presents a public health emergency; or 2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists.”

  • General grant of authority for cooperation: This grant states that the secretary of DHHS shall assist states and local authorities in preventing and suppressing communicable diseases and help state and local authorities enforce quarantine regulations.

  • Strategic National Stockpile: The stockpile (including drugs, vaccines, biologics, medical devices, and other supplies) is maintained by the secretary of DHHS, in collaboration with director of CDC, and in coordination with the secretary of DHS, to provide for the emergency health security of the US. The DHHS secretary may deploy stockpile assets in response to an actual or potential public health emergency to protect public health or safety, or as required by the secretary of DHS.

  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002: This act amends the Public Health Service Act to “improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.” The act requires the secretary of DHHS to “develop and implement” a coordinated strategy in the form of a national preparedness plan.

  • Regulations to control communicable diseases: These regulations authorize the secretary of DHHS to make and enforce regulations “to prevent the introduction, transmission, or spread of communicable diseases” into the US from foreign countries or from one state into another. These regulations also authorize the apprehension, detention, examination, and conditional release of individuals with certain communicable diseases that are specified in an executive order of the president.

  • Executive Order 13295 (amended) ("Revised List of Quarantinable Communicable Diseases"): This order identifies the nine communicable diseases (cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, SARS, and pandemic influenza), for which an individual can be apprehended, detained, examined, or conditionally released by federal public health authorities.

  • Interstate quarantine (42 CFR part 70): This allows the CDC director to take measures to prevent the transmission of communicable diseases from one state into another, including in the event the Director determines that the measures taken by the health authorities of a state are insufficient to prevent such transmission of communicable disease.

Emergency Management Assistance Compact (EMAC) of 1996

Enacted by every state, this agreement facilitates resource sharing among member states during an emergency. A governor’s declaration of emergency and request for assistance triggers EMAC for the requesting state. An assisting state then responds to the request by providing the needed resources. Further, EMAC establishes that the requesting state is responsible for compensating the assisting state for any expenses incurred.

Pandemic and All-Hazards Preparedness Act of 2006

This act identifies the secretary of DHHS as the lead federal official for public health emergency preparedness and response. It also provides new authorities to develop countermeasures, establishes mechanisms and grants to continue strengthening state and local public health security infrastructure, and addresses surge capacity by placing the National Disaster Medical System under the purview of DHHS.

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

This act established streamlined mechanisms to facilitate certain medical countermeasure preparedness and response activities without having to issue an Emergency Use Authorization (EUA), which can be a time- and resource-intensive process. These new authorities are focused on medical products for use in chemical, biological, radiologic, and nuclear emergencies.

Social Security Act

This act authorizes the secretary of DHHS to waive or modify certain requirements of Medicare, Medicaid, and the State Children’s Health Insurance Program during certain emergencies.

Public Readiness and Emergency Preparedness Act of 2005

This act authorizes the secretary of DHHS to issue a declaration that provides immunity from tort liability for claims of loss (except willful misconduct) caused by, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats, and conditions determined by the secretary to constitute a present or credible risk of a future public health emergency.

Emergency Use Authorization

The secretary of DHHS may, at the request of the secretary of DHS or the Department of Defense (DoD), declare that circumstances exist to justify an EUA for an unapproved drug, device, or biological product, or for an unapproved use of an approved drug, device, or biological product.

Volunteer Protection Act of 1997

This act supports and promotes the activities of organizations that rely on volunteers by providing the volunteers some protections from liability for economic damages arising from activities that relate to the work of the organizations. To be found not liable for the injury caused by a negligent act or omission, the act says, volunteers must have been acting within the scope of their responsibilities in the nonprofit or governmental agency. Volunteers must have appropriate licensure or certification, if required for their duties; they must not have acted with gross negligence, reckless disregard, willful or criminal misconduct, or flagrant indifference; and they must not have been intoxicated at the time the injury occurred.

Posse Comitatus Act of 1878

This act generally prohibits the use of federal military personnel in a law enforcement capacity within the US, unless authorized by the US Constitution or an act of Congress. Certain exceptions exist, such as when DoD aids the Department of Justice (DoJ) in responding to an emergency situation involving a weapon of mass destruction.

Insurrection Act of 1807

This act grants authority to the president to call the National Guard into federal service if there is an insurrection in any state or if a state fails to uphold the constitutional rights of its citizens.

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