James Hodge, Jr

Excerpted from: James Hodge, Jr., Bioterrorism Law and Policy: Critical Choices in Public Health, 30 Journal of Law, Medicine and Ethics 254 (Summer, 2002)

 Given the nation's current level of preparedness for bioterrorism, a large- scale bioterrorist attack would be unprecedented in its impact on morbidity and mortality in the U.S. population. The limited, intentional spread of anthrax has shown that public health (and other) authorities are not fully prepared to handle a large-scale bioterrorism event. Preparing for a bioterrorism event should become a central mission of federal, state, and local public health, law enforcement, and emergency authorities. As part of this mission, the public health community, law- and policymakers, and society in general must address a series of critical choices.

Understanding the duty of government to protect the public health

  Perhaps the most important choice is also the most difficult to make: What is the government's duty to protect the public health in response to a bioterrorism event? Few discount the responsibility of government to respond to a bioterrorism event, but what is the extent of this response? Consistent with the traditional police powers of state governments to protect the health, safety, and general welfare, government's duty to protect the public's health may be viewed as comprehensive and extensive. This includes virtually any governmental action needed to control the threat in the population. Thus, to fulfill its responsibility to ensure the public's health, state public health authorities could (as they have in the past) temporarily constrain certain civil liberties, require private sector participation in public health objectives, shut down potentially harmful industries, destroy contaminated property, deport or prevent the entry of individuals who may infect others, ration supplies, and control the flow of information.

  Do governmental duties to protect the public's health allow public health authorities to go further? Bioterrorism experts suggest that the intentional release of smallpox through just a few outlets could quickly spread the disease and leave hundreds of thousands of unvaccinated Americans dead in a few months. At the apex of this type of human tragedy, can authorities temporarily ignore constitutional principles that respect individual liberties (e.g., rights to due process, travel, assembly, or privacy) or maintain the structure of government (e.g., federalism or separation of powers)? Concerning the latter powers, for example, can federal health authorities, who lack broad police powers, command state public health authorities to participate in a federal, national response to a bioterrorism event that is limited to one state (and thus not seen as an interstate matter or a threat to national security)? The federal government may lack the constitutional power to do this under existing interpretations of federal commerce powers consistent with principles of federalism. Can we choose to ignore such legal interpretations to accomplish public health objectives? In reality, it is unlikely that any bioterrorism event, even one that it initially localized to one state, would be viewed solely as a state matter when it is highly predictable that the bioterrorism agent will spread to other states.

Declaring a public health emergency

Responding to a bioterrorism event may require public health authorities to exercise broader powers than they traditionally employ. Who should choose when to declare a public health emergency and under what criteria? Many state legislatures presently fail to specify whether a bioterrorism event may justify a state of emergency status, leaving this decision to executive authorities. Though state executive authorities need some discretion, statutory laws must better define the conditions for declaring public health emergencies. Otherwise, a state of emergency may be called unjustifiably.

  The Model State Emergency Health Powers Act gives public health authorities the ability to exercise enhanced powers to protect individuals and manage property upon the declaration of a public health emergency by the state governor. The Model Act broadly defines a "public health emergency" as:

     an occurrence or imminent threat of an illness or health condition that: (1) is believed to be caused by bioterrorism or the appearance of a novel or previously controlled or eradicated infectious agent or biological toxin; and (2) poses a high probability of any of the following harms: (a) a large number of deaths in the affected population; (b) a large number of incidents of serious permanent or long-term disability in the affected population; or (c) widespread exposure to an infectious or toxic agent that poses a significant risk of substantial future harm to a large number of people in the affected population.

Thus, under this definition, the declaration of a public health emergency may follow (1) the occurrence or imminent threat of an illness or health condition, (2) caused by bioterrorism or the appearance of novel or previously controlled diseases through any means, (3) that poses a high probability of a significant number of current or future deaths or disabilities. These criteria serve as guides, but may allow for the declaration of a public health emergency for bioterrorism events that do not justify restrictive public health controls. Consider, for example, the definition of "bioterrorism" used in the Model Act:

    the intentional use of any microorganism, virus, infectious substance, or biological product that may be engineered as a result of biotechnology, or any naturally occurring or bioengineered component of any such microorganism, virus, infectious substance, or biological product, to cause death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism in order to influence the conduct of government or to intimidate or coerce a civilian population.

On its face, this definition might include the actions of persons who have recently attempted to infect others with anthrax through the mail. This may be unlikely, however, because their actions may not pose "a high probability" of a large number of human deaths or incidents of serious permanent or long-term disability, as defined under "public health emergency." From a public health perspective, this limited interpretation of the criteria for declaring a public health emergency may be preferable. It would be unwise to declare a public health emergency for an event that involves an infectious agent, but does not otherwise pose a significant risk to the public's health.

  Consider, for example, an individual with HIV who intentionally tries to spread the virus to dozens of others through his own risky behavior (e.g., unprotected sex, unsafe sharing of needles for injecting drugs). Numerous individuals have attempted to intentionally infect others with HIV in documented cases across the United States. Their activities probably were not motivated by an intent to "influence the conduct of government." Yet, depending on how a governor, or a court reviewing the governor's authority, may define what it means to "intimidate" or "coerce," or what constitutes a "population" (is it the population of a state, a county, a city, or a neighborhood?), the individual with HIV may be said to be engaging in bioterrorism. Depending on whether there is a high probability of a large number of human deaths or disabilities as a result, a governor could declare a state of public health emergency pursuant to the Model Act. This is problematic because (1) public health and law enforcement authorities have not traditionally viewed such persons as bioterrorists, but rather as mere criminals; and (2) declaring a public health emergency in these cases is an extreme response to a limited public health threat.

  Additional refinement of the criteria for responding to a bioterrorism event through the declaration of a public health emergency is important where infringements of civil liberties and the legitimacy of public health activities are at stake. The criteria may be strengthened by employing more restrictive measures during a public health emergency depending on the severity of the disease threat.

Defining the roles of federal, state, and local public health authorities

  There is no central public health system in the United States. Instead, a collaborative workforce of federal, state, and local authorities work in conjunction with other inter-level agencies (e.g., environmental protection agencies; departments of housing, labor, or civil rights) to accomplish public health outcomes. In this system, public health roles and responsibilities of the federal, state, and local levels of government are complex and unclear. As stated above, state public health authorities act pursuant to broad police powers that authorize the government to act in the interests of protecting or promoting the health, safety, or general welfare of the population. Some public health functions are delegated by states to local governments. A federal agency's power to act in the interest of public health is, comparably, more limited in the use of authorized powers. It must rely on its delegated authority pursuant to Congress's powers to protect national security, regulate interstate commerce, tax and spend, or promote the constitutional principles of the Fourteenth Amendment (e.g., due process, equal protection).

  A large-scale bioterrorism event will accentuate existing uncertainties in the distribution of public health powers. It may also prove to be a catalyst for redefining roles for the future. The critical choice for public health authorities is not to decide where the power to protect the public health lies or which level of government has the primary power to act, but rather where the leadership to respond to a bioterrorism event will derive. If leadership capacity is properly developed, public health authorities can use their respective powers to bring about desired goals.

  Through agencies such as the Department of Health and Human Services (DHHS), its subsidiary Centers for Disease Control and Prevention (CDC), and the newly created Office of Homeland Security, the federal government has taken a leadership role in response to existing and future bioterrorism threats. There are many reasons state and local public health authorities might defer to this leadership initiative. First, the federal government has greater financial resources at its disposal to respond to a bioterrorism threat. Second, it may be in a better position to negotiate the price of needed vaccines, drugs, or supplies, or to suspend the patent rights of high-demand medications. These techniques were recently used by President George Bush and DHHS in negotiations with the German drug company Bayer, concerning the sale of Cipro, the antibiotic used to treat anthrax. Third, most significant bioterrorism threats will exceed the boundaries of any single state, thus requiring a national, coordinated response. Fourth, the federal government may be better able to rapidly develop personnel and institutional expertise in monitoring and identifying the existence of new or emerging infectious pathogens. Fifth, bioterrorism may also constitute a threat to national security (the protection of which is specifically a federal responsibility). Finally, imminent warnings of bioterrorism activity may come through national intelligence or federal law enforcement agencies that can coordinate public health responses through federal agencies.

  Choosing to assign a primary leadership role to the federal government for responding to bioterrorism threats does have its drawbacks. Federal public health authorities may be slowed by inter-organizational or bureaucratic problems. As well, they are not well-positioned to serve on the frontline of defense to a bioterrorist attack. State and local public health authorities, in conjunction with private sector health-care workers, will in most cases be the first to detect potential bioterrorism activity through effective surveillance. Federal authorities may facilitate detection by sharing resources or intelligence data. However, detection of a potential bioterrorism threat through state and local public health authorities is distinct from the response functions of the federal government. Clarifying these roles will improve response capabilities and public accountability over time.

Investigating bioterrorism from the public health or criminal perspectives

  Beyond setting roles and responsibilities among the various levels of government is the need for public health authorities to choose how to coordinate with law enforcement and national security authorities. Unlike the spread of naturally occurring diseases that can be monitored and controlled exclusively through public health authorities, a bioterrorism event always features an unlawful element. Bioterrorism, by definition, is the product of criminal activity. Existing and newly passed federal antiterrorism laws, for example, criminalize the mere possession of certain biological agents. Every bioterrorism event thus involves a criminal investigation that is outside the purview of public health authorities. How should public health and criminal authorities choose to collaborate? Should they collaborate at all?

  From either side's perspective, clearly they should collaborate. Public health and criminal authorities need to know of potential or actual health threats to the population in order to take steps to prevent or mitigate threats. Each can learn from the other about these threats without jeopardizing their differing central missions, provided that the exchange of information is confidential, accomplished through high-ranking personnel, and consistent with existing federal intelligence laws and federal or state privacy laws that may limit the sharing of some data.

  Second, after a bioterrorism event has materialized, should public health authorities assist criminal investigators at the federal, state, or local level? Prevailing public health practice suggests they should not. Public health authorities resist participating in criminal investigations primarily because there is the potential that public health authorities could be seen by community members as health police. Yet, prevailing public health practice does not typically involve the spread of disease through criminal activity. In some cases where criminal activity has been at the source of potential infection (e.g., intentional spread of HIV, intentional contamination or pollution of air or water), public health authorities have worked with criminal investigators in limited ways to stymie a public health threat. Bioterrorism events may justify a greater working relationship between criminal and public health authorities that the public may not only understand, but support.

  If public health and criminal authorities must work in collaboration to control a bioterrorism event, who takes primary jurisdiction over an investigation, given an outbreak? In many of the places where anthrax exposures recently occurred, criminal authorities quickly asserted their jurisdiction over exposure sites to gather evidence and any other facts needed for their investigations. The potential for public health and criminal authorities to clash in executing their responsibilities is evident, especially where the primary criminal or intelligence authorities may be federal (e.g., the FBI, the Central Intelligence Agency), and the responding public health officials are primarily state or local. The only choice for public health officials in these circumstances may be to defer to law enforcement or intelligence authorities for a period of time as the investigation proceeds, but to encourage collaborative sharing of data to allow both sets of authorities to accomplish their respective goals.

 Restricting individuals for the sake of public health

During a bioterrorism attack that involves the potential for mass casualties or disabilities, public health authorities may need to employ powers that restrict individual activities and behaviors. The Model Act, for example, allows public health authorities to quarantine or isolate persons believed to be exposed to or infected with a contagious disease during a public health emergency. In addition, authorities can encourage persons to be vaccinated or treated where necessary to prevent the spread of a contagious disease. Persons who refuse to be vaccinated or treated may, if needed, be quarantined or isolated.

  Such measures have traditionally been used by public health authorities to control the spread of contagious disease. Few question their potential value in accomplishing the same, despite their potential to infringe on human rights. The critical choice for public health authorities during a bioterrorism emergency is how to balance these restrictive measures with civil liberties. There may be strong legislative and public support for the use of highly restrictive powers during a bioterrorism crisis. Yet, constitutional principles and public health practices emphasizing an ethic of voluntarism intimate that not every restrictive measure can be taken. Professor Lawrence O. Gostin has summarized the modern constitutional criteria for exercising confining public health powers:

    . A compelling state interest in confinement. Public health authorities must have a compelling interest that is substantially furthered by civil confinement. Only persons who are truly dangerous (i.e., pose a significant risk of transmission) can be confined.

    . A "well-targeted" intervention. Interventions that confine individuals must be well-targeted to accomplishing public health objectives. Thus, interventions that are over- or underinclusive may be constitutionally impermissible if they deprive individuals of liberty or equal protection without justification. For example, the quarantine of every person within a geographic area is overinclusive if some members would not transmit infection. Underinclusive interventions would restrain some, but not all, potentially contagious persons, and thus be open to criticisms of being arbitrary or purposefully discriminatory.

    . The least restrictive alternative. Public health authorities should not resort to civil confinement if they can achieve their objectives through less drastic means (although it is not likely that they have to use extreme or unduly expensive means to avoid confinement).

    . Procedural due process. Persons subject to confinement for public health purposes are entitled to some form of procedural due process depending on the nature and duration of the restraint. The Model Act requires a court order prior to the isolation or quarantine of any individual, unless emergency circumstances demand otherwise. In all cases, individuals have the right to a hearing and counsel to contest their confinement.  

Allocating scarce resources

  In virtually any widespread and rapidly developing bioterrorism event, available public health resources will quickly be taxed. Scarce resources may include physical goods (e.g., vaccines, medical treatments and supplies, hospital beds, isolation or quarantine facilities), personnel (e.g., physicians, nurses, other health-care workers, epidemiologists, lab technicians), and services (e.g., laboratory testing, mental health counseling). Attempts to hoard existing supplies or personnel by competing governmental units or private sector groups may be expected. The private sector may be disinclined to donate its facilities for public health goals, or participate in the vaccination, treatment, or confinement of exposed or infected individuals. Concerning these issues, the Model Act allows state executive authorities to confiscate hoarded supplies, take possession of facilities or other property for public health purposes, and seek the assistance of medical personnel during a public health emergency.

  A critical and unresolved choice for public health authorities is how to allocate scarce resources. There is no uniform, central proposal governing the distribution of limited resources during a public health emergency. In fact, such a proposal may be ill-advised. Public health authorities may need the discretion, depending on the circumstances of the specific bioterrorism event, to decide how best to allocate limited resources. Ad hoc allocation decisions, of course, leave open the possibility of egregious, unfair, or discriminatory distributions of limited resources. Is it predictable that: (1) wealthier individuals (or nations) will have access to potentially life-saving treatments over persons of lesser wealth; (2) persons in the military will be vaccinated before civilians; or (3) public health investigators will attend to health threats to legislators over other governmental workers? Each of these choices, which are based on actual decisions made during the recent anthrax exposures in the United States, may be supported or contested on various legal, political, and ethical grounds.

  Public health and other governmental authorities must be guided by a fair set of principles in making their allocation decisions. These principles include:

    . Promoting the public's health. Any decision relating to allocating scarce resources during a public health emergency should be principally motivated by the need to promote the public's health to the highest extent possible, and not by outside political or social pressures.

    . Providing incentives to help. To provide incentives to individuals to participate in public health efforts, certain resources may be allocated to protect the health of public health personnel or health-care workers (and their families) working to control the spread of disease or treat infected individuals.

    . Respecting each individual. Distribution of limited resources may naturally tend to favor persons in government or those with sufficient wealth or stature in the community. Public health authorities need to determine a method of distributing resources evenly across at-risk populations to protect the public's health. Specific care should be taken to avoid making decisions that discriminate against equally situated individuals.

    . Prioritizing immediacy over potential. The distribution of limited vaccines or treatments should be made with consideration of the immediate health consequences to affected populations rather than the potential impact on unaffected groups. Thus, for example, if a particular group of individuals living in one county of a state is presently susceptible to smallpox infection due to a localized outbreak, those persons should be vaccinated to the exclusion of other state residents who may be vulnerable in the future, provided such vaccinations are consistent with controlling the epidemic.

These principles will not resolve every difficult question, but they may provide some guidance as public health authorities struggle to decide how to allocate dwindling resources during an emergency.