Pandemic influenza is an illness that is both more medically serious than its seasonal counterpart and more threatening socially in that it is capable of spreading rapidly and widely within and among populations. Current concerns have focused on the so-called "avian flu" strain of influenza A (H5N1), and significant expenditures of public funds and human resources are being devoted to both the prevention of, and the response to, the pandemic if it materializes. On paper, local public health practitioners in the United States have substantial powers at their disposal to respond to pandemic flu or other public health emergencies. However, they must not only be aware of the existence of this authority but also have access to the infrastructure of personnel, expertise, processes, and paperwork required to use these powers effectively and fairly. For guidance, public health officials might review the specific steps taken by their counterparts in parallel public health threats. For example, a Centers for Disease Control and Prevention (CDC) report of a 2004 measles outbreak in Iowa outlines the "Ten principles of modern quarantine" and offers a list of "Essential questions to review regarding quarantine authority."1 These evocative questions transcend the bare statutory foundations for quarantine and isolation and help the local public health practitioner operationalize the powers that he or she possesses.
Comprehensive and explicit operational advice on legal matters relating to pandemic flu may be gleaned from two especially useful projects. The Public Health Law Program of the CDC has developed a course titled "Public Health Emergency Law (PHEL): A CDC Foundational Course for Front-line Practitioners,"2 a set of course materials specifically aimed at the legal preparation that is required in anticipation of pandemic flu. Equally useful, the CDC's "HHS Pandemic Influenza Plan"3 (PHLP) provides a comprehensive blueprint for local flu preparation, and devotes a considerable amount of space to the specific legal groundwork that should be laid before the pandemic arrives. While the "black-letter" law related to pandemic management is not especially complicated, the procedural requirements and operational mechanisms of many public health options are complex and may not be fully in place to respond to a threat of pandemic influenza's character and magnitude. As a result, legal preparation, especially at the local level, will be essential to ensure both an effective and appropriate response to looming pandemic threat.4 Using the insight and guidance in the CDC's PHEL and PHLP projects, as well as other sources, this essay highlights and summarizes the importance of devoting a significant amount of time, ensuring that the legal aspects of influenza management and control have been sufficiently reviewed by a legal preparedness team working in close conjunction with state and local public health task forces.
As an initial matter, local legal experts need to determine which individuals and bodies at local, state, and federal levels can declare public emergencies, under what conditions, and what these declarations mean for public health, officials, funding, and authority. All jurisdictional levels-local, state, and federal-have both public health authority in general, and emergency powers specifically. Some powers overlap, some are exclusive. An understanding of the nature and dynamic of jurisdictional interactions is important before the crisis materializes. For example, legally mandated surveillance and early warning systems may be in place in jurisdictions in which "novel influenza," deaths from influenza, or flu-like syndrome is a reportable illness. But not all states have modified their list of reportable illness or incorporated disease or employed other requirements that will allow maximum early warning against an impending influenza outbreak. While some alternative "surveillance" methods might be developed, they would have to conform to the spectrum of legal protections, both state and federal, that protect the confidentiality of medical information.
Most obviously, local pandemic flu task forces and public health officers need to acquire explicit working and knowledge of the jurisdiction's laws regarding isolation and quarantine. Local officials should know the scope and limits of federal and state public health laws to understand the interaction, intersection, and coordination of jurisdictional action. For example, local and state authority will be far better suited for the management of many actions, while federal law will often play the essential role in areas such the limitation on interstate and international travel (see unit 2 in reference 2). The mechanical requirements of quarantine, isolation, and confinement on a wide-scale implementation for this type of crisis should be fully explored and in place in advance. For example, it will be important to have predrafted and specifically designed legal orders, motions, and other documents and forms for quarantine and isolation actions for homes, healthcare facilities, other holding facilities, and electronic monitoring. Preparedness plans should include a clear understanding of the length of a legitimate confinement and the legal grounds and scientific threshold on which such decisions will be made. While versions of such documents probably exist in most jurisdictions, they should be reviewed and vetted for applicability to pandemic flu. The range of remedies for violation of such orders should be explored and the criteria of whether and how and when to pursue confinement, civil or criminal fines, injunctive relief, or criminal prosecution for defiance of a public health order should be resolved (see unit 3 in reference 2 and part 2 and Appendices 1 and 2 in reference 3).
To the extent possible, precrisis coordination with courts, clerks-of-court, and law enforcement to provide early education, preparation, and a preview of measures that may come would also be advisable. Quarantine and isolation statutes invariably include procedural safeguards such as notice, hearings, and appeal. Because these devices will likely be relied on more frequently and on a different scale than before, it is vital to sketch out in advance the plans to provide timely and fair hearings and appeals for affected persons. Judges or hearing officers might agree to serve "on-call" to accommodate timely hearings and rulings. If very large numbers of individuals come under a confinement order, innovative hearings arrangements may have to be made and should including volunteer ready counsel willing to provide representation in order to protect due process concerns of those who are affected by orders (see unit 3 in reference 2). Indeed, part of the legal preparedness should include not only a public education movement but also education of the bar (both judges and attorneys) on the legal nature of the public health actions likely necessary if a pandemic materializes.
Legal preparation and accompanying education of the public, the legal community, and law enforcement render potentially controversial public health actions transparent. Public health practitioners will be able to inform and educate the public cogently of the precise measures that will be taken, their justifications, the processes that will be used, and public and individual options for appeal and redress. Transparency and understanding may increase compliance and acceptance, and affected persons and populations know that the measures are being applied consistently and evenhandedly. Public transparency and education regarding public health legal actions may also mute the postemergency reaction politically and legally.
Similar predrafted documents and mechanical structures are especially important in anticipation of either broad or narrow "exclusion" orders banning public meetings, public transportation, other limits on public assembly designed to decrease transmission, or any of the available alternatives such as voluntary "snow days," work quarantines, other forms of "shelter-in-place," cordon sanitaire, and the mandated use of masks and gloves (see unit 3 in reference 2). These measures are far less frequently used than quarantine and isolation and therefore probably less known to not only the public health officials and legal officials but the general population as well. They pose their own set of operational and legal and constitutional challenges, which should be explored and resolved.
An influenza vaccination specific to avian flu is unlikely to be universally available initially in the emergency. If a vaccination of choice is developed, what legal considerations will affect its distribution and mandated use? On what grounds and for what designated groups may vaccination be required and at what penalty or consequence for refusal? In addition, the standards and conditions under which individuals can be exempted from the requirement should be resolved in advance. Those who produce or distribute vaccinations might be vulnerable to liability charges after the emergency if side effects of the vaccine cause injuries. Therefore, a comprehensive preparedness plan would provide both appropriate liability protection for companies that produce vaccines and a system of reasonable compensation for those hopefully few individuals who are harmed by the vaccines. Despite its flaws, the Swine Flu Act of 1976 is an example of preparatory action addressing these issues.5 Resolving intellectual property issues and the commercial risks and benefits of manufacturing and stockpiling antiviral remedies will be important as well. Compulsory licensure may or may not be a wise option depending on the advent, evolution, and natural evolution of a pandemic, but some fair yet effective adjustment of corporate financial incentives may be necessary to ensure that exiting and future pharmacologic remedies are available in the quantities required in a timely fashion.6 While adjustments to the liability and compensation system and corporate incentives for vaccine production are an integral part of preparedness, these issues are likely beyond the reach and influence of most rank-and-file, frontline public health officers who will have other challenges facing them. Still, this relatively predictable set of issues would be better resolved before the potential becomes actual. Public health authorities should know the legal limits of their vaccination demands and recommendations that they make, and protection from suit and compensation for vaccine-related liability should be explored (see unit 3 in reference 2).
Emergency measures are likely to infringe on what are ordinarily considered private property rights. Public health officials should anticipate the need to deny people access to various types of private property, commercial and otherwise, in order to contain the spread of influenza. In other instances, the government, through a public health officer, will need to confiscate of commandeer property to use to help manage the emergency. Prohibiting access to property, while sometimes controversial, is justified on the basis of the state's police power to protect the public from dangerous conditions. It may include, depending on the jurisdiction, administrative public health orders, evacuation, public nuisance actions, or other mechanisms. Ordinarily, no compensation is provided to property owners. In contrast, if property is "taken" for public use, even during emergencies, the 5th Amendment of the Constitution requires that the owners be compensated for the "taking." In the first instance, closing and evacuation orders should be anticipated and drafted in advance while providing the owners necessary due process requirements of notice and an opportunity to be heard. Criteria for reopening and reentry should also be delineated and clear. This process, too, should be resolved and documented beforehand so that delay is minimized and the public is fully protected from dangerous locations. When property is taken for permanent or temporary state use, the rules and procedures for compensation should be clear to all parties from the outset of the emergency (see unit 4 in reference 2).
Individuals denied access to their workplaces will suffer loss in wages. Businesses lose customers. The destruction of potentially infected animals and crops-birds in the case of avian flu-may be recommended as a means of limiting wider spread of infection. Will the targets of isolation and quarantine orders be eligible for workers' compensation reimbursement? Will the owners' of health clubs, day care centers, restaurants, movie theatres, shopping malls, and night clubs be compensated in any way for their losses if public health officials close the sites for a prolonged period? How will the owners of property or supplies commandeered for the public good be compensated? Appropriate due process considerations should, of course, be planned and available, but it would also be useful to explore and resolve in advance the compensation options, if any, that might be offered to individuals who lose property or business as a direct result of public health measures. Such knowledge might play an important role in decreasing confusion and resistance and in encouraging compliance to legitimate and fairly applied burdens. Moreover, advanced notice and negotiation with property holders is likely to increase their willingness to volunteer the use of their properties for the public good-a consequence far superior to some form of seizure or condemnation.
In a pandemic setting, public health officers will likely need the help of state employees in other agencies, volunteer civilians, healthcare professionals of all ilk, and sometimes state employees from other jurisdictions. The documents and "mutual aid agreements" that will allow seamless reassignment of state employees should be explored well before they are needed as should the legal rights and liabilities of volunteers as well as their liabilities and relationship to the state. Many states already have intrastate emergency management agreements in place. These compacts should be scrutinized for their specific applicability for the needs generated by a pandemic threat. The licensure and liability status of borrowed out-of-state healthcare professionals should be resolved early, as well the applicability of the state's Good Samaritan statute (see unit 5 in reference 2).
Public health officials should consult with attorneys early in preparation to lay the framework for future action, enforce it during the crisis, and manage repercussions after the emergency has passed. Public health practitioners without access to a full-time experienced public health attorney should identify readily available and reliable legal counsel. Few general attorneys will have the knowledge and insight, without preparation, for the challenges of the public health official. The public health practitioner should choose an attorney who understands the underlying responsibilities and professional mandate of the public health enterprise. Working together, public health practitioner and attorney should craft the most effective yet fair means of responding to the pandemic threat facing the community. Wise legal advice should, at the same time, free the public health officer's hands, protect the public's rights, and prevent the public health officers from distractions caused by exaggerated legal fears.7 Public health emergencies frequently require decisive and sometimes controversial action. It is important for all to understand that in most instances public health practitioners enjoy broad protection from personal liability for the decisions they make under statutory authority. Some jurisdictions grant them the shield of either sovereign or official immunity from suits based on actions performed in the course and scope of their official duties. In most instances, even decisions that are subsequently proven unwise or mistaken are protected if they were made in "good faith."8 Because some or many of the decisions that will have to be made during a full-blown influenza pandemic are likely to be unpopular, public health officers should be aware of the very substantial legal protections they enjoy in their specific jurisdictions so that the public's health is not jeopardized by unfounded legal fears.
During a public health crisis or emergency, official enthusiasm and public tolerance for decisive, even dramatic, action is frequently high. It is not until the urgency has passed that the source and scope of public health authority are widely questioned. Frequently, the discussion then begins to focus on recrimination, perceived wrongs, and sometimes accountability for losses. Virtually all public health action in any context burdens some individual or group of individuals, even if ultimately justified. The dramatic action likely required in response to a pandemic influenza outbreak is likely to raise even more distress either during or after the crisis. Actions that are carefully planned, justified, and executed are easier to defend retrospectively than those made in panic and confusion.
Many states, either implicitly or explicitly, have followed the guidance provided by the CDC's "Foundational Course for Front-Line Practitioners" and the "HHS Pandemic Influenza Plan."9 The latter provides a valuable "Checklist of legal considerations for pandemic influenza" and a fact sheet, "Practical steps for legal preparedness" (see part 2 and Appendices 1 and 2 in reference 3). As a result, very good state materials are already available in many states. But given the likely realities of the presentation of the pandemic, local public health, legal and medical resources will play a crucial role. Consequently, it is important as well that local health officers exploit these materials and others to ensure that immature and nonspecific legal processes and ambiguities are not an impediment to the safe, efficient, and fair management of the pandemic that everyone hopes will never come.
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