1. Letters to Editor.pdf

8/14/2019 1. Letters to Editor.pdf

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special supplement the national action agenda for public health legal preparedness

In June 2007, the Centers for Disease Control andPrevention, (CDC) and eighteen multidisciplinarypartners convened the rst National Summit on

Public Health Legal Preparedness. This Summit waswithout precedent in terms of the broad expertise andstature of the invited participants and its aims. Thepurpose of this working meeting was to provide a struc-tured opportunity for senior ofcials and leaders froma wide array of sectors and disciplines to take measureof public health legal preparedness as it stands today,and to develop a shared, national action agenda sup-portive of law-based strategies to address potential

public health emergencies such as pandemic inuenzaand other emerging threats. This supplemental issueto the Journal of Law, Medicine, and Ethics containsstatus papers developed by leading experts in the eldsof public health and public health law, and presentsthe Summits work product: a shared national actionagenda for public health legal preparedness.

Public health legal preparedness has been dened asthe attainment by a public health agency or system ofspecied legal benchmarks or standards that contrib-ute to effective prevention of disease, disability, anddeath. The Summit and the resulting national actionagenda were framed around the four core elements of

legal preparedness: 1) legal authorities based in scienceand/or on contemporary principles of jurisprudence;2) competency in applying law to public health goals;3) cross-sector and cross-jurisdiction coordination oflaw-based interventions; and 4) information on legalpreparedness best practices. The strategic goal of theSummit to contribute to the nations developmentof full legal preparedness for all types of public healthemergencies was established by the Summits 7-member, multidisciplinary planning committee (seeappendix a). Within that goal, the Summits purpose

was to bring together subject matter experts from awide spectrum of relevant sectors and jurisdictions,and foster their best thinking in developing an agendafor action for public health legal preparedness, withan emphasis on emergencies, for implementation bypolicy makers, practitioners, and partners across thewide spectrum of sectors and jurisdictions.

The 242 Summit participants included seniorpolicy makers and practitioners from federal, state,tribal, and local government public health agencies;healthcare; law; emergency management; the judi-ciary; law enforcement; elected state and local of-

cials; and representatives of philanthropic and pro-fessional organizations. Participants were organizedinto highly interactive workgroups, each of whichfocused on gaps, needs, and opportunities related toone of the four core elements of public health legalpreparedness. The workgroup methodology ensuredthat each participant had multiple opportunities tocontribute actively to formulation of the Summitwork product. In plenary sessions, nationally recog-nized leaders in public health and medicine, law, andemergency preparedness offered distinctive, but com-plementary, perspectives on public health emergencypreparedness.

Because of the historic importance of the Summit,the organizers sought to reect in these proceedingsboth the spirit and substance of the meeting. The goalof the editors has been to ensure an accurate record ofthe Summit, while at the same time providing a practi-cal tool for use by public health practitioners and theirpartners in legal preparedness efforts. This report,therefore, presents the plenary papers establishing theframework for the Summit workgroup deliberations,four papers assessing the current status of legal pre-paredness across the four core areas, and four papers

PREFACEMontrece M. Ransom, Wilfredo Lopez,

Richard A. Goodman, and Anthony D. Moulton


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that identify candidate areas for action in each of thefour core areas of legal preparedness. The appendicesinclude a roster of the Summit planning committee, alisting of Summit participants, as well as a list of thepartners that convened the Summit.

The papers identifying options for action are

intended to serve both as frameworks and as a spring-board for further work. It is important to note thatthe ndings and conclusions in this action agenda arethose of the authors and do not necessarily representthe views of the U.S. Government or the organizationswith which the authors are afliated. Every govern-ment and private organization active in public healthemergency preparedness is invited to review the actionpapers and identify options it may wish to pursue.

Meeting the goals of this published action agendabeneted from extraordinary efforts by the Summitplanning committee, invited participants, the Sum-

mit speakers and presenters, and the editing team. Inparticular, we thank Dr. Richard Besser and the staffof CDCs Coordinating Ofce of Terrorism Prepared-ness and Emergency Response for their support ofthis endeavor. We would also like to acknowledge the

important contributions from the following staff mem-bers, interns, and fellows: Melissa Thombley, J.D.,Public Health Law Fellow; Andrea Hines, ProgramAnalyst; Kevin Cartwright, Web Developer; VeronnicaHobbs, M.P.H., Public Health Prevention Service Fel-low; Morjoriee White, M.P.H., Public Health Law Fel-

low; Erin Lichtenstein, J.D. Candidate, Public HealthLaw Intern; Elenora Connors, J.D./M.P.H. Candidate,Public Health Law Intern; Chinyere Ekechi, J.D.,Emerging Leader; Rachel Weiss, J.D., Editor of CDCs

Public Health Law News; Karen McKie, M.L.S., J.D.,Public Health Legal Consultant; and Daniel Stier, J.D.,Senior Public Health Analyst. Finally, wed be remissif we did not acknowledge the unfailing support andefforts of the many others who were involved in theSummit, including the participants, collaboratingorganizations, workgroup rapporteurs and facilitators,and primary authors of all the papers. The dedication

and many contributions of all these persons and orga-nizations ensured the success of the Summit and thedevelopment of this action agenda toward the goal ofimproving the nations legal preparedness for all pub-lic health emergencies.


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P

ublic health legal preparedness is a core foun-dation of our ability to ensure the nation is

prepared to prevent, respond to, and reducethe adverse health effects of public health emergen-cies and disasters. Without clear legal authorities, ourpreparedness and response enterprise suffers fromunnecessary commotion at the very times we mostneed clarity.

Over the past six years, our nation has witnessedunprecedented efforts to build preparedness andresponse capabilities at the same time when we hadbeen called on to collectively respond to unprec-edented incidents. Public health legal preparednesshas been a key element in those efforts. We continue

to learn and apply lessons from real-world events withthe objective of strengthening our ability to heed thecall to respond when needed.

In June 200, the Centers for Disease Control andPrevention and partners convened the rst NationalSummit on Public Health Legal Preparedness, amilestone event in national public health prepared-ness. The 242 invited participants represented anexceptional group of thought leaders from every levelof government, and from a broad range of sectors,including professional organizations, non-prots, andacademe. The collective real-life experience, diversebackgrounds and broad spectrum of expertise that

Summit participants brought to the table are a testa-ment to the nature of our enterprise we all must playa role in our preparedness and response efforts. Thosewe serve our entire nation will look to us for lead-ership and measure our success by our ability to pre-

vent or reduce the adverse health effects of all-hazardsdisasters, whether naturally occurring or man-made.

This multidisciplinary approach is paramount toaddressing public health issues in general, but evenmore in the area of public health preparedness andtimes of crisis, when only highly coordinated effortscan assure timely implementation of life-saving solu-tions. Without this multidisciplinary approach, andespecially without the interconnectedness of publichealth and law, todays generations would not be thebeneciaries of the many major public health accom-plishments of the 20th century (immunization, motorvehicle safety, etc.). The Summit presented an invalu-able, rst of its kind opportunity to learn from each

other and build trust; the more we understand andappreciate our respective roles, responsibilities andauthorities, the better prepared we will be for the chal-lenges ahead of us so that we, as a society, continue toclaim public health victories. To that end, as we striveto develop new and strengthen existing collabora-tions, partnerships and public health legal tools, wemust, at the same time, be considerate of the possiblyfragile balance of the protection of the community andthe common good and the protection of individualliberties.

Our interdependence requires us to focus on maxi-mizing opportunities for partnership and collabora-

tion. The Summits proceedings, contained herein inan action agenda format, provide just such opportuni-ties. The status papers and companion action agen-das focus on the core elements of public health legalpreparedness: 1) legal authorities; 2) competencies; 3)coordination; and 4) information and best practices.We encourage you to read these papers closely, and tocontinue the dialogue about these topics among yourcolleagues and those you serve.

We look forward to continuing our partnership andcollaboration with you to ensure a nation prepared.

Craig Vanderwagen, M.D., is the Assistant Secretary forPreparedness and Response, U.S. Department of Health andHuman Services, Washington, D.C. Tanja Popovic, M.D.,Ph.D., F(AAM), AM(AAFS),is the Chief Science Ofcer at theCenters for Disease Control and Prevention, Atlanta, GA.

FOREWORDRADM W. Craig Vanderwagen and Tanja Popovic


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Iwould like to begin by discussing the legal andadministrative framework of the role of the fed-eral government in public health. At the heart of

it is, of course, the Constitution. At the Departmentof Health and Human Services (HHS) we depend, asdoes much of the federal government, on our powerto regulate interstate commerce. Since the SupremeCourt in 1942 removed essentially any restraint fromthe meaning of interstate commerce in Wickard v. Fil-burn,1the federal government has been regulating withwide latitude, in spite of small and, arguably, equivo-cal reverses in recent years. However, even though the

Supreme Court no longer provides any real constitu-tional check on the federal governments interstatecommerce power, some other restraints persist. Forexample, many parts of the health system have tradi-tionally been deemed inherently state functions, suchas the licensing and disciplining of doctors, nurses,and pharmacists, as well as the practice of medicineitself. The federal government has hesitated to treadacross these areas, for fear of disturbing long-estab-lished patterns of regulation that work effectively atthe state level.

The constitutional right of citizen groups and busi-nesses to petition the government is another check

on the federal government. For example, even dur-ing the potential outbreak of monkeypox in 2003, forwhich we needed to prevent the distribution and saleof prairie dogs, in crafting the ban we needed to workcarefully around the prairie dog lobbys potential con-cerns. In fact, there is virtually no group in Americathat is not organized and striving to be heard by the

government. This is, of course, as it should be, even ifit sometimes makes life uncomfortable for those of usrepresenting the federal government.

While the 10th Amendment is unfortunately for-gotten by many, we at the Department of Health andHuman Services are bound to carry out only thatwhich is delegated to us. We do not have a plenarypower to regulate. We cannot just establish power forourselves, and we have to defer to the states when theyhave a system in place. For example, HHS does notgenerally run hospitals, administer vaccines, providephysicians or nurses, or establish quarantines. In fact,

most of my presentation focuses on what powers wedo not possess.Section 247d of the U.S. Code and Section 319 of

the Public Health Service Act gives the Secretary ofHealth and Human Services a great deal of authorityin the event of a public health emergency. It says:

If the Secretary determines, after consultation withsuch public health ofcials as may be necessary, that

(1) a disease or disorder presents a public healthemergency; or

(2) a public health emergency, including signicantoutbreaks of infectious diseases or bioterroristattacks, otherwise exists, the Secretary may takesuch action as may be appropriate to respond tothe public health emergency, including makinggrants, providing awards for expenses, and enter-ing into contracts and conducting and supportinginvestigations into the cause, treatment, or preven-tion of a disease or disorder as described in para-graphs (1) and (2).

Eric D. Hargan, J.D.,is the Acting Deputy Secretary of theU.S. Department of Health and Human Services.

Setting Expectations for the FederalRole in Public Health EmergenciesEric D. Hargan


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Obviously, this cannot mean that the federal govern-ment can do whatever it wants simply by declaring apublic health emergency. Herein we nd the distinc-tion between authorization and appropriation. Justbecause part of the federal government has statutorypower to do something, it cannot practically do it if it

lacks the funds. For example, in a public health emer-gency, the Secretary largely cannot use money thatalready has a dedicated use and the Public HealthService Act acknowledges this. The Secretary cannotjust shut down Alzheimers research at the NationalInstitutes of Health (NIH) in order to hire nurses torespond to an earthquake in California; NIH researchhas its own money set aside by Congress in the bud-get bill, and, with small exception, not even the Presi-dent, much less the Secretary, can re-appropriate thatmoney or sequester or otherwise switch it around oncethe budget bill is signed. In other words, the HHS

budget, as enormous as it is, is not a big checkbook tobe drawn on by the Secretary as he sees t. As an aside,while the Secretary can draw from the Public HealthEmergency Fund, it is a dry hole, since Congress hasnever actually put any money into it.

The public health emergency declaration does allowuse of some waivers of programs and other powers,but despite what some people think, it is nowhere nearas sweeping as a declaration of martial law. The healthlaws are just not the right place to look for that. Asfar as this topic goes, it is better to look at the PosseComitatus Act,2the Insurrection Act3(which has been

tediously renamed), and others, and not to our healthlaws, tempting as it may seem.What does this all mean, from a practicable per-

spective? How are we acting under our authority? Iwill explain by discussing several of the most signi-cant public health challenges we are faced with. Someof the threats we at HHS are charged by the Presidentand Congress to prepare against are manmade, likebioterrorist attacks. Some are natural, like pandemics.I will begin with bioterrorism, an area that our friendshere at the Centers for Disease Control and Preven-tion conduct a great deal of work on.

Bioterrorism is a terrifying concept, and the idea for

using biological agents to spread disease and death isan old idea. While it is fortunately more feared thanpracticed, and security specialists are more concernedwith nuclear and radiological devices, it should benoted that the only uses of advanced terrorism deviceshave been bioterror ones: the anthrax attacks of 2001.

Since September 11, 2001, we have taken a numberof steps to prepare against the threat of a bioterror-ist attack. Thirty days after the attacks, we put for-ward the Bioterrorism Act of 2002,4which developedcritical new bioterrorism authorities for the HHS and

gave the Department broad new authorities to protectthe nations food supply. The Act also allowed us cer-tain critical waiver and response capabilities across abroad range of our programs so we could react and bemore responsive in an emergency. These capabilitiesare focused around two main areas that use Congress-

appropriated funds: assisting and encouraging statesand communities in their preparedness efforts, andbuilding up our knowledge, infrastructure, and mate-rial. Examples of related steps are that:

We have provided more than $7 billion since2001 for state and local preparedness.

We have increased our spending on bioterrorismand counterterrorism activities from $273 mil-lion in 2001 to a requested $4.3 billion for nextyear.

Through Project Bioshield, we are providing new

tools to improve medical countermeasures pro-tecting Americans against a chemical, biological,radiological, or nuclear attack.

We have worked with every state to developresponse plans.

We are piloting a Cities Readiness Initiative toupgrade capabilities for the rapid distributionof antibiotics across large urban areas duringemergencies.

We have expanded and enhanced our Labora-tory Response Network to aid in detection andsurveillance.

We have built stockpiles of needed drugs andsupplies.

But, in my opinion, the most signicant threat to pub-lic health that we face today is not a bioterrorist attackbut an inuenza pandemic, the current possibilitybeing known as bird u. The issue of pandemic pre-paredness is a timely one, because we are overdue butunder-prepared for a reoccurring natural disaster suchas a pandemic. Pandemics are a biological fact, as his-tory has shown us time and time again. We know thatviruses and bacteria are constantly mutating, adapt-ing and attacking. And when pandemics strike, they

not only cause a great deal of sickness and terrible lossof life, but they reshape nations.

Why are we so concerned right now? This is a goodquestion, since H5N1 virus infection, the one that sci-entists are most worried about, is currently a bird dis-ease. The problem with this strain of inuenza is two-fold: it is new and it is deadly. H5N1 has not developedsustained or efcient human-to-human transmission,but it has already infected 313 people and killed 191.That is a mortality rate of over 60 percent. In contrast,the 191 pandemic had a mortality rate of at most 6

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percent. And our epidemiologists tell us we are over-due for another pandemic.

When it comes to pandemics, there is no rationalbasis to believe that the early years of the 21st centurywill be different than the past. If a pandemic strikes,it will come to the United States and to communities

all across the world. Of course, a pandemic might nothappen for years or even decades. There is a certaincynical but natural view that this alarm about the birdu is all hysteria. And there is a certain political cal-culation that would instruct us to do nothing. TonyAbbott, the health minister of Australia, said, In theabsence of a pandemic, almost any preparation willsmack of alarmism. If a pandemic does break out,nothing thats been done will be enough.5

However, we are convinced that, whether or not weare facing an imminent pandemic, we should be bet-ter prepared for a pandemic. A century ago, Americas

health system was much less sophisticated in general,but its capacity for dealing with mass infectious dis-ease was much more robust. Waves of disease wereexpected, and sanitaria, mass public health programs,quarantines, and adult immunization programs weremore common and more widely accepted.

Another thing that the previous age of public healthhas us beat cold on is local preparedness. And localpreparedness must be the foundation of pandemicreadiness, because in case of a national pandemic,there is going to be no unaffected area from which todraw health workers and others to take care of patients

in affected areas; thus, at some point in a pandemic,every local community has to make do with its ownresources. In emergency preparedness, we usuallythink of and exercise single short disaster scenarios,like a hurricane. But as terrible as a hurricane can be,as, for example, was Hurricane Katrina, it is physicallyan event primarily of regional signicance. It had aregional impact, it was limited in time (in spite of thecontinuing repercussions in the region), and volun-teers and supplies from around the world poured intothe area. Think instead about a pandemic: it will havea sudden, national impact. It will not last for a coupleof days, but rather for months or even over a year, in

multiple waves. Instead of people racing to the affectedarea to provide comfort and assistance, people will bestaying home, many afraid to go into the affected areato lend help and support. It is a different construct forwhich we have to prepare.

And if none of us prepares, as a pandemic outbreakspreads, and outbreaks in communities reach theirpeak, the disaster will spiral downward, affectingeveryone, everywhere. Due to the ubiquitous natureof a pandemic, it is dangerously unrealistic to expectthe federal government to be able to swoop in and

x everything. That is why it is important that everycommunity have its own plan and be able to rely onits own resources as it ghts the outbreak or antici-pates an imminent one. That is why it is vital that weunderstand the role of the federal government versusthe role of states and communities when it comes to

pandemic readiness.We have delineated our role as the federal govern-

ment to include ve main objectives:

Disease monitoring, Stockpiling countermeasures, Developing vaccines, Establishing communications plans, and Setting up local plans.

First, disease monitoring. HHS Secretary Leavitt usesa metaphor when describing this goal. Think of the

world as a vast forest, thick with underbrush and deadtrees. It is very vulnerable to re. A single spark canburst into a great inferno that is extremely difcult toput out. But if you are there right after the spark ignitesso you can extinguish it, you can limit the damage. Webelieve that could be true with a pandemic. If we areable to discover the spark quickly, there is a chance wecan extinguish it and stop a pandemic. Therefore, weare building a network of nations to cooperate in dis-ease monitoring. Likewise, we need communities inthe United States with sophisticated systems to watchfor the emergence of disease.

Second, we must have stockpiles of anti-viral medi-cations and other supplies. We are building up suppliesof antivirals such as Relenza and Tamiu and subsi-dizing our states antiviral purchases as well. There isa nuance when it comes to stockpiling countermea-sures, however. People imagine an airlift, probably bythe armed forces, of medicines from a large federalstockpile. The federal government steps in and savesthe day! Unfortunately, our readiness exercises haveshown us that stockpiles are not the problem. Distri-bution is the problem. Unless you can get medicine tothose who are sick within 24 to 36 hours, the size ofyour stockpile will not much matter. And, as the expe-

rience of 191 showed, soldiers who might be carryingout those airlifts get sick just like everyone else.

Parenthetically, if I seem like I am belaboringthe military point, it is because it is always the rstrecourse of people wanting to wish away this distribu-tion problem, and no expert in this area that I knowof thinks the military can solve this problem. Manypeople seem to think that in any disaster, the federalgovernment can simply step in and x everything.That is an unrealistic worldview, however. Instead,when it comes to distributing stockpiles, it is the state


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and local plans that will spell the difference betweendefeat and victory. Thus, we have been working tohelp states set up distribution plans and to investi-gate how to partner with additional groups like theU.S. Postal Service.

Third, we need vaccines. Fortunately, a vaccine that

produces an immune response in humans was devel-oped last year and approved by the FDA. We are test-ing it, and getting through the bumps in the road onthat. Of course, we are working on this vaccine with noassurance that H5N1 will be the virus to develop intoa pandemic, but we need to be as prepared as we can.We are also spending several billion dollars to improvevaccine and antiviral production capacity, purchasevaccines and antivirals, and conduct research on newproduction technologies.

Fourth, preparedness needs to include communica-tions plansas well. We all need the capacity to inform

people without inaming them, so there is not panic.In this area, SARS was a wake-up call. Across theworld, only ,000 people got sick, with 00 of themdying, but it paralyzed the Chinese and Canadianeconomies for several weeks and caused several billiondollars worth of economic disruption.

The fth and most important objective is thatevery state, every Indian tribe, every city, every school,every business, every church, and every family needs a

planthat addresses the unique challenges they wouldface. During a pandemic, there will not be any unaf-fected areas from which to draw health care workers

to take care of patients in affected areas, so at somepoint in a pandemic, every local community has tomake do with its own resources. And when it comesto pandemics, any community that fails to prepare expecting that the federal government can or willoffer a lifeline will be tragically wrong. Leadershipmust come from governors, mayors, county commis-sioners, pastors, school principals, corporate planners,the entire medical community, individuals, and fami-lies. For when a pandemic comes, we believe it will hiteverywhere in a short period of time.

All governments have plans established to ensurecontinuity of government in case of a decapitat-

ing event, like an assassination. Many governmentsalso have plans to ensure continuity in the event ofa degrading event, like a pandemic. But how manycities, businesses, or schools have plans for ghtingoutbreaks with their own resources when as many as30 to 40 percent of their workforce are absent for 6to weeks? If none of us prepare, then as the pan-demic spreads and outbreaks reach their peak, theconsequences would cascade. Medical centers wouldbe overwhelmed. Schools would close. Transporta-tion would be disrupted. Food and fuel would run

out. There would be power and telecommunicationsoutages.

Therefore, to help mobilize the American people intheir planning efforts, we are making available exten-sive information resources including planning guidesand checklists targeted toward specic groups. We

have released more than a dozen so far, to help busi-nesses, schools, health care services, to individuals andfamilies, and many more categories. We have adopteda comprehensive approach with these guides, and theycover everything from assigning a person responsiblefor coordinating preparedness planning, to develop-ing an education and training program to ensure thateveryone understands the implications of pandemicinuenza, to determining how vaccines and antiviralswould be used.

We will continue to release guides as we developthem. These checklists and plans, along with a great

deal of other useful material, such as hundreds of pagesof technical guidance we have provided to state andlocal health ofcials and providers, can be found onthe Web site . Pandemicu.gov serves as our governments one-stop access pointto pandemic and avian u information. And, since allthe information is online, anyone around the world ismore than welcome to use them. As countries, states,local groups, and individuals carry out preparednessactivities, they may nd weaknesses in our plans andwe need to discover these while we still have the timeto correct them.

There is the possibility that a pandemic might nothappen for years or even decades. Some people maythink that our preparation is a waste and that weare being alarmist. In reply, I can only say that thesepeople are right until they are wrong. And the con-sequences of them being wrong are greater than theconsequences of us being wrong. We probably can-not prevent a pandemic. But preparation can delayits onset. Preparation is likely to reduce the peak ofa pandemic to a level that is much less overwhelmingthan it could have been, bringing it down to a numberof cases that could be cared for. Preparation is likelyto save lives.

Even if it is a long time before a pandemic strikes,there are real benets to preparing now:

We would have established new vaccinetechnology,

We would have the capacity to manufacturevaccines much more quickly than we currentlydo,

Annual u would be much less of an issue, and We would be better prepared against any medical

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Over the past few years, we have been confronted witha variety of disasters, from hurricanes to bird u to ter-rorist attacks. We have learned a great deal about whatresponse efforts do and do not work. We are imple-menting all of the reports that have been issued, andare working to patch the aws in the system.

But one fundamental aw persists in the publicimagination: people seem to think that, if only it wereproperly administrated, that the federal governmentshould or even could push state and local authorityaside in the aftermath of any disaster. This is neitherfederal doctrine nor realistic there are limits to whatbureaucrats, even highly-trained bureaucrats, can do.To tie this back to the point I made earlier, the federalgovernment is constitutionally one of plenary statepower, with federal authority primarily depending onone clause of the Constitution and one set of SupremeCourt decisions for its wider powers. Even though

there are also statutory powers, which give us broadauthority, they are not paired with appropriations toimplement them.

Therefore, when it comes to emergency prepared-ness, though unforeseen by the founding fathers, theConstitution and all sense of practicality agree: there

must be a balance of federal and state roles, with thestates virtually owning entire responsibilities in thisarea.

We may never perfectly balance the role of the fed-eral government against the obligations of states andcommunities in preparing against all possible disas-

ters. But each day that we prepare, each day that wehash out these questions while we have the luxury oftime, we make ourselves more ready and more capableof an effective response.

We are not prepared yet. But we are more preparedtoday than we were yesterday. And, with enough peo-ple aware and engaged, we will all be more preparedtomorrow than we are today. Thank you.

References1. Wickard v. Filburn, 317 U.S. 111 (1942).2.Posse Comitatus Act, 1 USC 135 (17).3.Insurrection Act, 10 U.S.C. 331 - 10 U.S.C. 335.

4.Bioterrorism Act of 2002, 42 USC 201 et. seq.5. Tony Abbott, Minister for Health and Ageing, Bracing for the

Worst, country report for Pandemic Flu Conference, Ottawa,October 25, 2005,available at (last visited November29, 2007).


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A. IntroductionPublic health emergencies have occurred throughouthistory, encompassing such events as plagues andfamines arising from natural causes, disease pandem-ics interrelated with wars (such as the inuenza pan-demic of 1918-1919), and industrial accidents such asthe 1986 Chernobyl disaster, among others. Law andlegal tools have played an important role in address-ing such emergencies. Three prime U.S. examples areCongressional authorization of quarantine as early as1796,1legally mandated smallpox vaccination upheldin a landmark 1905 U.S. Supreme Court ruling,2and

the Presidents 2003 executive order adding SARS tothe federal governments list of quarantinable com-municable diseases.3

The public health emergencies of the present bothactual and potential pose equally serious threats butdo so in the context of greatly magnied expectationsthat stem directly from the attacks of September 11,2001, and the immediately following anthrax attacks.These events transformed the environment in whichgovernment agencies public health, emergencymanagement, law enforcement, and others workto address public health emergencies in the U.S. As aresult, public health emergencies now are seen under

the intense spotlight of national security concerns.The agencies charged to prepare for, and respond to,public health emergencies at all levels face extraordi-nary expectations for safeguarding the nation frompotentially catastrophic health threats.

Other trends have further transformed the operatingenvironment for public health emergency prepared-ness, including, for example: the rapid emergence ofnew threats to the publics health, such as SARS andinuenza A (H5N1); the expectations of elected of-cials and the public for effective emergency responseon an accelerated timeline and on a 24/7 always onbasis; and, certainly not least, expansion in the originsand scope of public health threats from the local andregional levels to the national and global levels.

The public health emergencies the nation facestoday require urgent and highly complex responses

that involve multiple governments, agencies, jurisdic-tions, and social sectors. They also may require theuse of many public health tools rooted in legal author-ity, such as disease surveillance; control of movementthrough quarantine and isolation; government use ofprivate property; allocation of vaccines, medicine andmedical supplies; and evacuation of populations.

The nation needs modern legal tools to enable rapid,effective responses to such highly complex challenges.Many states and communities, like the federal govern-ment and partners at every level, have worked hard tostrengthen legal preparedness beginning even beforethe attacks of September and October 2001. Most, if not

all, states have updated their public health emergencylaws since then. Many have conducted training in legalpreparedness and have incorporated legal issues intopreparedness exercises. Further, beginning in 2002,legal preparedness has been an explicit focus of CDCsprogram of preparedness grants to the states.4

In spite of this progress, continually emergingevents such as the case of a U.S. citizen who trav-eled internationally in 2007 while infected with a dan-gerous form of tuberculosis underscore that muchremains to be done. The driving impetus for the 2007

Georges C. Benjamin, M.D., F.A.C.P., is the Executive Di-rector of the American Public Health Association.Anthony D.Moulton, Ph.D.,is the Co-Director of the Public Health LawProgram at the Ofce of the Chief of Public Health Practice,Centers for Disease Control and Prevention.

Public Health Legal Preparedness:A Framework for ActionGeorges C. Benjamin and Anthony D. Moulton


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National Summit for Public Health Legal Prepared-ness was the planning committees conviction that itis critical to take measure of the current status of legalpreparedness, identify gaps as well as opportunitiesfor improvement, and shape a plan of action that allconcerned professionals and organizations can pursue

toward the strategic goal of full legal preparedness forpublic health emergencies of all kinds. The commit-tee was fully cognizant that any improvements in legalpreparedness for public health emergencies will helpstrengthen legal preparedness for many non-emer-gency public health concerns as well.

B. A Conceptual FrameworkThe conceptual framework used to organize the delib-erations of the 2007 Summit had two parts. First wasthe following denition of the term public healthemergency preparedness articulated in early 2007

by an expert panel convened at the request of the U.S.Department of Health and Human Services (HHS):

The capability of the public health and health caresystems, communities, and individuals, to prevent,protect against, quickly respond to, and recoverfrom health emergencies, especially those whosescale, timing, or unpredictability threatens to over-whelm routine capabilities.5

The panel further identied sixteen key componentsof a well-prepared community of which the second

was what the panel called legal climate.The second part of the Summits conceptual frame-work was rst published in a 2003 article that intro-duced and dened the term public health legal pre-paredness (closely congruent with the HHS panelsterm) as follows:

Public health legal preparedness is the attainmentby a public health systemof specied legal bench-marks or standards essential to the preparedness ofthat system.6

In the same article four core elements of public health

legal preparedness were further identied as:

Laws and legal authoritiesLaws and legal authorities (i.e., statutes, regu-lations, ordinances, court rulings, and otherauthoritative statements by government bod-ies) are foundational to public health legalpreparedness.

Competency in using laws effectively and wiselyPublic health professionals need to know the

legal powers they have and how best to applythem. Public health emergency legal prepared-ness depends also on emergency responders, lawenforcement ofcials, judges, hospital managers,and many others knowing the legal authoritiesheld by public health ofcials as well as their own

relevant legal powers and limitations.

Coordination of legally based interventions acrossjurisdictions and sectorsCoordination is important precisely becausemany public and private organizations typicallytake part in responding to public health emergen-cies, and do so across multiple jurisdictions. Thisadds further complexity to the operating environ-ment that surrounds public health.

Information on public health laws and best

practicesInformation resources are the fourth core ele-ment of public health legal preparedness. Thesevaried resources include, for example, practitio-ner guides to the established public health lawsof a given jurisdiction, updates on relevant newlaws and court rulings, and science- or experi-ence-based best practices in using laws to supportpublic health interventions.

C. Case Studies of the Core Elementsof Public Health Emergency Legal

PreparednessThis section presents examples from real-world pub-lic health practice to illustrate how policymakers andpractitioners in public health and related sectors canuse this conceptual framework in shaping and apply-ing law as a public health tool. The examples of publichealth emergencies and other acute public health con-cerns stemming from highly diverse causes reectrecent public health history as well as the experienceand perspectives of author GCB, a former state healthcommissioner.

When Laws and Legal Authorities Are Uncertain

or UnknownIn early 2001, a Baltimore, Maryland journalist pub-lished a report on a cluster of young women who hadcontracted severe conjunctivitis potentially associatedwith the use of cosmetic lenses that had been sold with-out prescriptions, and hence illegally, by a number ofBaltimore City beauty salons. In light of the signicanthealth risks, the governor, attorney general, and pressdemanded to know how the sales had been permittedand expected immediate corrective action.


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An urgent need was to determine rapidly which fed-eral or state agencies, if any, had jurisdiction to act.Review of alternative courses of action determinedthat the U.S. Food and Drug Administration lackedenforcement authority and that the Maryland Boardof Optometry had no legal authority to intervene. The

state health department lacked powers specic to thistype of public health danger but had broader protec-tion powers that might be used.7

The state health department weighed such optionsas issuing public health advisories, seeking an attor-ney generals order to declare the sales illegal, issuingagency cease and desist orders, and even seeking newlegislative authority. The composite course chosen wasto issue cease and desist orders to known retailers, toseek injunctions against non-compliant retailers, andto issue health advisories through the media. As aresult, the number of illegal sales declined although

there were some ongoing reports of injuries from theinappropriate sale and use of the implicated lenses.Later, in 2003, the state legislature passed a bill spe-cically empowering the state health department toprohibit the sale of cosmetic lenses without a validprescription.8

While relatively limited in scope, this case illus-trates by extension the critical role law plays in effortsto protect the public from untested or even fraudulentproducts or practices sold during public health emer-gencies. An egregious example is the large number ofunvalidated tests and treatments for anthrax contact

promoted and sold following the anthrax attacks of2001. Within eight weeks of the rst anthrax attack,the Federal Trade Commission issued warnings tomarketers of bogus products to cease those activi-ties subject to potential civil and criminal penalties.9Appropriate, tested laws should be in place well beforethe occurrence of an emergency so that public healthand other agencies can apply them to support timely,effective response.

The Difference that Competency in Applying PublicHealth Law MakesPublic health ofcials contrasting uses of isolation laws

in two contemporary cases illustrate the importanceof public health legal competency, i.e., the require-ment to understand the public health legal authoritiesavailable for dealing with a specic health threat, legalconstraints on their use, and the steps and proceduresthrough which they can best be implemented.

From July 1998 until May 1999, a California countyhealth department quarantined and detained in thecounty jail a multi-drug resistant tuberculosis (MDRTB) patient who had not complied with her treatmentplan nor with a health department order for examina-

tion. The detention order did not give a specic rea-son for detention nor did it communicate the patientsrights to request release, to a hearing, or to counselas afforded by the states TB control laws. Further,that order held the patient in the jail until comple-tion of the prescribed course of treatment. After some

ten months incarceration, and after consulting withthe county counsel, the health department issued arevised order correcting the documentary and proce-dural deciencies of the rst order. The patient wasprovided counsel and a hearing, leading to her uncon-ditional release.

The patient then led two lawsuits. The state Courtof Appeals upheld a trial court ruling, nding that thecounty health ofcer and health department had actedin direct violation of the states 1997 statutory pro-scription on such use of jails; the appeals court issueda parallel, separate prohibition specic to the involved

county. The federal lawsuit resulted in the countysmaking a $1.2 million settlement to the patient. Bothoutcomes might well have been avoided had the publichealth ofcials whose paramount concern undoubt-edly was to protect the communitys health fullyunderstood the procedural requirements of, the legalconstraints under, and the legislative intent of, thestates TB control laws.10

A contrasting example one that illuminates compe-tency in the application of public health law involveda Montana college student who was diagnosed withMDR TB in 2006. In 2003, as part of its public health

emergency preparedness efforts, the Montana legis-lature had claried its statutory isolation and quar-antine authorities. In the summer of 2006, the statehealth department began conversations with localhealth departments regarding their need to under-stand how to implement isolation and quarantine pro-tocols effectively to meet federal grant requirementsfor public health emergency preparedness.

The state and cognizant local health departmentswere aware of the students desire to travel interna-tionally at the time they learned that she had MDRTB. It was determined that her local health depart-ment should issue an isolation order restricting the

students travel and that was done. Because the stu-dent would have had to depart from an airport locatedin a different county, that countys public healthdepartment issued a second order specically barringight from that airport. Further, to prevent air travelfrom any other city, notice of the case and of the travelrestrictions was communicated to the regional CDCquarantine ofce and also to the airline. The studentcomplied with the order and her treatment regimen.She was permitted to travel, within specied param-eters, to a hospital where timely and appropriate


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treatment was initiated; ultimately, she was allowedto return home when she no longer was contagious.11

Coordination in the Use of Public Health LawsIn the summer of 1997, commercial shermen reportedlarge sh kills on three Maryland rivers. Laboratory

tests conrmed that the organismPesteria piscicidawas present in the affected waters at toxic levels andwas the probable cause of the sh kills. Virginia sh-ermen operate from the shore across Chesapeake Baywhere a similar organism was identied in Virginiawaters and was associated with a high incidence oflesions in sh there as well.

A local internist stated in the media that he hadtreated shermen for rashes, lethargia, and memoryloss.12 There was unjustied but nonetheless wide-spread public concern even with the safety of Chesa-peake Bay seafood. Concern was heightened after a

medical team reported ndings of short-term memoryloss and neurological ndings in sherman exposed tothe waters where acute sh kills occurred. An urgentneed thus existed for accurate, consistent informationto reach the public throughout the region.

Mounting a coordinated response to the Pesteriaoutbreak became complicated because of the largenumber of government jurisdictions involved. Federalagencies had uncertain authority to intervene. Mul-tiple state agencies in both Maryland and Virginia hadpotential roles. Additional complexity stemmed fromthe necessary and appropriate roles played by several

Maryland county governments.The Maryland Department of Health and MentalHygiene ultimately closed affected Maryland riverspursuant to orders issued by local health departmentsuntil the outbreaks had ceased.13Virginia, however,chose not to close its affected waters. The two statesdivergent approaches were widely publicized, contrib-uting to public confusion about the danger. In addi-tion, Maryland attributed some difculties in enforc-ing river closure to public confusion about the actionsit had taken. River closure entailed additional chal-lenges and problems because of the substantial eco-nomic losses suffered by sherman prohibited from

working on the affected rivers.This case illustrates challenges posed by public

health emergencies in complex jurisdictional settings.Similar complexity was seen at far more acute levelsand on a global basis during the 2003 SARS outbreakwhich accelerated such improvements in public healthlaw as the 2005 International Health Regulations andled, at the national level, to extensive changes in Cana-dian federal and provincial public health emergencylaws.14

Why Information on Legal Preparedness BestPractices is CrucialWhen a pet ferret bit a child at a sleepover in a Mary-land home in 1994, the county health ofcer was con-fronted with the need to apply both public health andlegal preparedness best practices.

Risk of rabies exposure and transmission of rabies tothe child was the immediate concern as was the poten-tial for the ferret to bite others. The public health bestpractice at the time was to monitor the child closelyand to euthanize the ferret and test tissue for rabies.Implementation, however, was complicated by therefusal of the childs physician and family to give thechild post-exposure rabies prophylaxis.

The parent of the child whose ferret was involved,upon receiving a legal order from the health depart-ment to deliver the ferret for testing and destruction,initially refused to do so. The county health depart-

ment then petitioned the court, under applicable stateand county law, to require the owners to turn the ani-mal over. The court granted the request, nding thatthe health department acted within the legitimateboundaries of its police powers. The autopsy studiesdetermined that the animal did not have rabies.

Upon the owners appeal, the appellate court upheldthe trial court ruling, nding, in part, that the states

decision to destroy biting ferrets is, as a mat-ter of law, a lawful use of the States police powersbecause it is rationally calculated to protect the

public health.15

This case demonstrates how important it is thatpublic health ofcials employ the legal best practicesapplicable to a given public health threat, i.e., applica-tion of the pertinent legal authorities by ofcials com-petent in their use and with coordination across therelevant jurisdictions and sectors. In many cases, bestpractices may encompass such additional complica-tions as using private property for a public purpose orseizing or destroying it to protect the public.

D. The Core Elements and the 2007

National SummitThese cases demonstrate that any attempt to assessand improve legal preparedness for public healthemergencies indeed, for any public health purpose must address all four of the core elements. Anyattempt that focuses on only one element, such as lawsand legal authorities, will be incomplete and addressonly one facet of the required solution.


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These cases also show that the conceptual frame-work of which the core elements are part can havedirect utility for those who wish to take practicalaction to make law a better tool for public health pre-paredness. This is why the four core elements formedthe organizing basis for the deliberative sessions of the

2007 National Summit, for the papers prepared beforethe Summit assessing the current status of legal pre-paredness, and for the action agenda papers that weregenerated during the Summit. This is not to imply,however, that the four core elements constitute animmutable orthodoxy. To the contrary, the exercise oflegal authorities and tools during future public healthemergencies undoubtedly will broaden understandingof the contribution the core elements make to effectivelegal preparedness and may even lead to identicationof additional elements.

The four action agenda papers that appear later in

this publication present the results of the rst system-atic attempt to identify options for practical steps tostrengthen legal preparedness for all-hazards publichealth emergencies. The many partner and stakeholderorganizations that are active in public health emer-gency preparedness will tailor the individual optionsto their own priorities as well as to their capacity tocontribute to implementation of the options. Any indi-vidual organization is likely to nd that it can contrib-ute more to strengthening one or two core elementsthan to others. Here, too, is an example of the helpful,practical effect of the framework: no single organiza-

tion need feel the weight of having to contribute to allfour of the core elements. Instead, by aligning theirefforts, the concerned partners will help strengthen allthe core elements.

This paper opened by dening public health legalpreparedness as attainmentof specied legal bench-marks or standards essential to the preparedness of apublic health system. Implementation of the optionsoffered in the action agenda papers in ways thatreect the unique needs and priorities of the concernedjurisdictions in effect will give practical denition tothose benchmarks and standards. Equally important,implementation will engage policymakers and profes-

sionals across a wide spectrum of sectors and jurisdic-tions in advancing the Nations legal preparedness forpublic health emergencies and for public health risksof many other kinds.

AcknowledgementsThe authors gratefully acknowledge valuable contributions fromRichard A. Goodman, M.D., J.D., M.P.H., Centers for DiseaseControl and Prevention; Joan Miles, J.D., Director, Montana StateDepartment of Health, Denise Pizzini, J.D., Montana State Depart-ment of Health, Daniel OBrien, J.D., Ofce of the Maryland Attor-ney General, and Sudevi Ghosh, J.D., HHS Ofce of the GeneralCounsel, Centers for Disease Control and Prevention Branch.

References1. R. A. Goodman, P. L. Kocher, D. J. OBrien, and F. S. Alexander,

The Structure of Law in Public Health Systems and Practice,in R. A. Goodman, M. A. Rothstein, R. E. Hoffman, W. Lopez,G. W. Matthews, eds.,Law in Public Health Practice(New York:Oxford University Press, 2007): 45-68.

2.Jacobson v. Massachusetts, 197 US 11 (1905).3. Executive order 13295, 2003, available at (last visited November28, 2007).

4. CDC, Procurement and Grants Office, Guidance for FiscalYear 2002 Supplemental Funds for Public Health Prepared-ness and Response for Bioterrorism [Announcement number99051-Emergency supplemental], Atlanta, Georgia, February15, 2002.

5. C. Nelson, N. Lurie, J. Wasserman, and S. Zakowski, Concep-tualizing and Dening Public Health Emergency Preparedness,American Journal of Public Health 97, Supplement 1 (2007):S9-S11.

6. A. D. Moulton, R. N. Gottfried, R. A. Goodman, A. M. Murphy,and R. D. Rawson, What Is Public Health Legal Preparedness?Journal of Law Medicine & Ethics31, no. 4 (2003): 372-383; R.A. Goodman, A. Moulton, and G. Matthews et al, Law and Pub-lic Health at CDC, MMWR55, Supplement (2006): 29-33.

7. Maryland Board of Pharmacy, Public Board Meeting, May 16,2001, available at (last visited November 28, 2007).

8. Maryland Department of Health and Mental Hygiene, Ofce ofPublic Relations. Dateline SHMS,A Message from the Secretary,June 3, 2003, available at (last visited Novem-

ber 28, 2007).

9. Federal Trade Commission, FTC Cracks Down on Marketers ofBogus Bioterrorism Defense Products, Press Release, available at (last visitedNovember 28, 2007).

10. Public Health Institute, Public Health Law Program, TB andthe Law Project:Souvannarath Case Study, 2003, available at (last visitedNovember 14, 2007). See also Souvannarath v. Hadden, 95Cal. App. 4th 1115 (2002).

11. Private communication with the Montana State Department ofHealth and Human Services, August, 2007.

12. R. A. Goodman, P. L. Kocher, D. J. OBrien, and F. S. Alexander,The Structure of Law in Public Health Systems and Practice,in Goodman et al., supra note 1, at 45-68.

13. Maryland State Department of Natural Resources, Summary ofPesteria Investigations in Maryland, October 6, 1997, avail-

able at (last visited November 28,2007).

14. D. P. Fidler, Revision of the World Health Organizations Inter-national Health Regulations, American Society of Interna-tional Law Insights, April 2004, available at (last visited November 14, 2007).

15.Raynor v. Maryland Department of Health and Mental Hygiene,676 A.2d 978, 110 Md.App. 165 (Md.Sp. App. 1996).


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IntroductionThis paper provides an overview of recent US Depart-ment of Health and Human Services (HHS) initia-tives and efforts under the leadership of the GeneralCounsel, the Secretary, and the President regard-ing legal preparedness for public health emergen-cies. In addressing this topic, the paper focuses onfour core elements comprising public health legalpreparedness:

(1) effective legal authorities to support necessarypublic health activities;

(2) competencies of public health professionals toknow and then to apply those laws;(3) coordination of the application of laws across

jurisdictions (local, state, tribal, federal, andinternational) and across multiple sectors; and

(4) information and best practices in public healthlaw.1

This papers review of four core elements of publichealth legal preparedness also implicates commonthemes and issues that are at the center of constitu-tional law, including:

Federalism Individual rights Separation of powers

Laws and Legal AuthoritiesThe rst element of legal emergency preparedness

effective laws and legal authorities is the central,substantive aspect of public health legal prepared-

ness. The matter of legal authority presents particu-larly salient and uniquely important constitutionaland administrative law issues to government lawyers.By comparison, for many lawyers in private practice,seldom does a legal question center on what the legalauthority is for a clients actions; rather, the lawyersfocus is to identify the extent of the governmentsauthority to effectively impose a requirement. In con-trast, for lawyers advising federal agencies and of-cials, the question of legal authority is the rst andmost important issue to consider for every legal prob-lem. Lawyers who advise federal clients who are fun-

damentally, constitutionally limited to exercise onlyenumerated powers are well-situated to recognizethe genius of the Framers who wrote into the Consti-tution that the federal government shall have only theauthorities provided in the Constitution, and all otherpowers shall be reserved to the States. While Congresshas legislated broadly in many public health areas,every federal government action involving expendi-tures from purchasing vaccine stockpiles to support-ing travel must be based in some way on a constitu-tional and/or statutory authority.

At the federal level, with respect to public health mat-ters, Congress has relied on key constitutional author-

ities, including the commerce clause2(both its inter-state and foreign clauses) and the spending clause3 toprovide the Executive Branch with many legal author-ities. For federal actions in public health, the primarystatutory legal authority is the Public Health Service(PHS) Act.4This law can be traced to August 14, 1912,when it was enacted into law as An Act to change thename of the Public Health and Marine-Hospital Ser-vice to the Public Health Service, to increase the payof ofcers of said service, and for other purposes.5Atthat time, the Public Health Service Act comprised

Demetrios L. Kouzoukas, J.D.,is the Deputy General Coun-sel at the U.S. Department of Health and Human Services.

Public Health Emergency LegalPreparedness: Legal Practitioner

PerspectivesDemetrios L. Kouzoukas


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only two sections and one-half page of text. Today, itscompilation is many times greater in length. (One ofthe predecessors of the PHS Act dates to 1796, whenCongress passed the rst National Quarantine Actafter extensive debate regarding whether quarantineshould be a federal or state function.6)

In recent years, identication of the need for addi-tional Federal laws particularly to deal with thethreats of bioterrorism and pandemic inuenza, andto clarify roles and responsibilities in public healthresponses in the modern administrative state hasprompted HHS to work with Congress to enact theseadditional laws. The new laws encompass a broadspectrum of authorities:

The Pandemic and All-Hazards PreparednessAct of 2006 (PAHPA),7establishes the AssistantSecretary for Preparedness and Response (ASPR)

and enhances ASPR authorities for leading theFederal Government in emergency prepared-ness and response.8It also enhances grants toStates and localities for surveillance activitiesand improvement of medical surge capacity. Inaddition, PAHPA establishes the BiomedicalAdvanced Research and Development Authority(BARDA)9which facilitates HHS collaborationwith other Federal agencies, relevant indus-tries, academia, and others regarding advancedresearch and development of countermeasuresand pandemic or epidemic products.

The Public Readiness and Emergency Prepared-ness Act (PREP Act)10within the Department ofDefense Appropriations Act of 200611providesliability immunity for administration of coveredcountermeasures specied in a declaration by theSecretary of HHS. It also establishes a process toprovide compensation to covered persons underthe declaration.

The Public Health Security and BioterrorismPreparedness Response Act of 2002 enhancednational preparedness and planning, estab-lished the Strategic National Stockpile and theNational Disaster Medical System by statute,

authorized the Secretary of HHS to award grantsand cooperative agreements to improve state andlocal preparedness for response to public healthemergencies, established enhanced require-ments regarding the handling of select agentsand toxins, and partially authorized BioSense a national program intended to improve thenations capabilities for developing near real-timehealth situational awareness.12

The Project Bioshield Act of 2004 establishedauthorities to encourage the research and devel-opment of specic countermeasures (such asdrugs and vaccines for bioterrorism agents) thatwould otherwise lack a commercial market, andestablished a process for emergency use of inves-

tigational products for civilians.13

Some other changes in Federal law have been minor,but nevertheless important. For instance, in 2002, theHHS quarantine authorities were amended to providethat neither those authorities nor its implementingregulations should be read to supersede or preemptany provision in state law unless the state law conictswith the exercise of federal authority.14This is a clearexample of a common occurrence in public health law the co-existence of federal and state authorities andthe resulting challenges created for policymakers in

deciding at what level action should be taken in theface of a public health emergency and how best tocoordinate with other levels of government.

Importantly, the Supreme Court has made clearthat although the federal government has the author-ity to preempt (or override) state laws, the federal gov-ernment cannot commandeer and/or direct the useof state governmental assets in order to further a fed-eral regulatory scheme relating to state governmentalpowers.15Thus, for example, a federal law command-ing state legislatures to pass a particular law would beconsidered unconstitutional, although requiring such

a law as a condition for receipt of relevant federal fundswould generally be permissible. As a result of this con-stitutional design, all the governmental stakeholdersin public health have a role in using their authoritiesin concert and no single entity is usually in charge ofeverything.

In identifying, enacting, and implementing legalauthorities, another important limitation besidesthe doctrine of enumerated powers is the provi-sion of safeguards for the individual rights that areenshrined in the Constitution. Public health actions,even (and perhaps especially) during a public healthemergency, must comport with the Bill of Rights and

the 14th Amendment as they have been interpreted bythe courts. Although federal courts historically havebeen deferential to the Executive Branch in mattersof public health, such deference cannot be presumedor relied upon in any particular case. Therefore, legalemergency preparedness necessarily encompasseslawyers advice and policymakers planning withregard to the inevitability that the independent judi-ciary will balance the governments legitimate need toprotect the publics health against individuals rights.One important and current example of policymak-



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ers planning in this regard is evident in the publishednotice of proposed rulemaking for the Control of Com-municable Diseases issued by HHS CDC.16

CompetenciesLegal authority is without effect if the lawyers who

advise on and policymakers who implement the lawsare neither prepared nor able to offer advice and actdecisively, and appropriately, when the time comes. Inthis regard, HHS has invested substantially in plan-ning and training efforts. The information resourcePandemicu.gov provides one access portal to the arrayof plans, training options, and policies developed byHHS and offered to help prepare the nation for publichealth emergencies. These documents have been sub-jected to rigorous review to ensure legal sufciencyand accuracy. In addition, HHS Ofce of the GeneralCounsel serves on continuity of operations teams and

participates in key exercises and simulations.There is, however, one underestimated and vitally

important aspect of legal competency that is quite dif-cult, if not impossible, to train for: sound legal judg-ment. Even the most realistic training cannot simu-late the personal, mental, and emotional pressurespresented by an actual crisis. Fundamentally, the mat-ter of sound legal judgment is one of personal choices,and pubic health and emergency management hiringprocesses for lawyers should include consideration ofexpectations for a lawyer seated at the table during anemergency.

The attribute of sound legal judgment, as a compo-nent of legal competency, is tightly intertwined withthe following three roles for legal counsel:

First, during an emergency, a primary role ofthe public health lawyer is to advise whether anaction is legally permissible. In this regard, it iscrucial especially given the potentially severeconsequences posed by many public healthemergency threats that legal counsel be able toeffectively and judiciously distinguish betweenlaw (those limits and procedures that are inher-ent in a nation of laws, including the protection

of individual rights), administrative bureaucracy(procedural requirements that present no reallegal risk and can be remedied or waived), andpolicy questions that cannot be answered throughlegal reasoning.

The second important role of the public healthlawyer is to think creatively and put options onthe table. For example, during the HurricaneKatrina response, there was a need for medi-cal personnel beyond what the federal and stategovernments were ordinarily able to provide, and

resulting concerns of liability protections. Thelegal problem was that medical personnel will-ing to play a role had concerns about the avail-ability of liability protections. The solution to thelegal problem was the appointment of medicalpersonnel as temporary, uncompensated federal

employees, thereby allowing for their integrationinto HHS eld medical operations, including theavailability of tort liability coverage under theFederal Tort Claims Act.17

The third important role of the public health law-yer is to be a zealous advocate for their client bythinking of the client and by informing the clientof long-term institutional legal risks for the cli-ent, at the very time the client is instead focusedon providing assistance to others. The publichealth lawyer can include advice about testinglegal theories in particular fact patterns and

the clients reputation in judicial forums which,under a separation of powers, will independentlydecide the facts and the law in a particular case.Similarly, lawyers have uniquely trained to con-stantly anticipate what lawyers for other partiesinvolved in an issue or matter will claim, say, ordo and this is information a client needs andwants in making informed policy judgments.

A nal point on competencies is that attorneys andtheir clients also need to educate and train one anotherregarding their respective roles. Clients need to learn,

in advance of an emergency or other crisis, about theinherent ambiguities of law, and attorneys need tolearn from clients what kinds of legal advice can beoptimally utilized by the client.

CoordinationIn the context both of federalism and ever-increas-ing global inter-connectivity, effective coordination ismore crucial than ever. This encompasses coordina-tion among lawyers regarding the respective roles oftheir clients, and coordination among various local,state, federal, and international public health ofcialsregarding their respective roles and the exercise of

legal authority.For example, one issue involving coordination in

emergency preparedness within the structure of feder-alism is that of professional licensing. Since the stateshave authority to enact their own varying require-ments regarding professional licensing, an importantquestion is under what emergency circumstances mayphysicians practice medicine in a state where they arenot ordinarily licensed. HHS has worked with statesto address this and also relies on authorities enactedby Congress to help develop solutions to this perfect


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storm of federalism. For example, HHS throughits Health Resources Services Administration hasdeveloped the Emergency System for Advance Reg-istration of Volunteer Health Professionals (ESAR-VHP), a program that supports a national network ofState operated systems that register and verify the cre-

dentials of health professional volunteers in advanceof an emergency.18In addition, the PHS Act authorizesthe Secretary to develop and implement a plan underwhich personnel, equipment, medical supplies andother resources of the PHS and other agencies withinHHS can be used to control epidemics and meet otherhealth emergencies or problems.19

Information and Best PracticesFinally, the most practical and most operational ele-ment of legal emergency preparedness is the sharingof information and best practices among the public

health law community.The concept of the OODA loop is a useful analogue

for considering public health information and bestpractices for emergencies. The OODA loop, originatedby the U.S. military strategist Colonel John Boyd, com-prises four overlapping and interacting processes formaking battleeld decisions: (1) Observe, (2) Orient,(3) Decide and (4) Act.20The practical implicationsof this concept are that decision makers rst mustdevelop situational awareness by observing. Second,they must orient themselves by processing situationalinformation against the backdrop of prior experience

and analyzing how the information presents issuesin relation to systems values and capabilities. Third,they must move beyond these steps to make decisions.Fourth, organizations and individuals must act toimplement the decisions. The aggregate effect of thisconcept is that applying and completing its steps morerapidly than an adversary will help to overcome ordefeat the adversary. In public health emergency pre-paredness, the enemy is a naturally occurring or man-made disease or health threat, as well as its resultantsocial consequences. The time cycle for such threatscan vary tremendously from situation to situation, butit can be short in those cases, it is crucial that legal

advice be available and thoughtful and thorough. Thiscan be achieved through the sharing of knowledge andinformation, and by coordinating extensively withinand external to public health organizations.

As examples of the application of these principles,within HHS, legal practitioners in the Ofce of theGeneral Counsel have:

Collaboratively prepared model documents, iden-tied and analyzed relevant legal authorities, andprovided practice pointers and risk assessments

as a means of giving thought to the application ofthese situations in advance.

Extensively shared knowledge developed throughthis work throughout HHS and through infor-mal means such as regular conference calls andmeetings.

Institutionalized the responsibility for legal emer-gency preparedness issues by creating a seniorposition to coordinate legal advice on emergencypreparedness issues across HHS Ofce of theGeneral Counsel from our CDC branch to ourFood and Drug Division, to coordinate our inter-nal efforts for legal public health preparedness,and to coordinate our communications on thesematters with legal partners in other agencies.

Participated in national and multi-sector meet-ings, such as the National Summit on PublicHealth Legal Preparedness, which bring together

public health ofcials, their counsel, the judiciary,and legislators to maximize public health legalpreparedness.

ConclusionOne additional aspect of public health legal prepared-ness not explicit among the four core elements, butaddressed within the Summits context, is the humanelement. The human element encompasses the notionthat in the course of preparing for and responding topublic health problems, and while preserving the par-amount need for legal objectivity, the lives and needs

of individuals who can be so dramatically affected bypublic health threats always must be kept in mind as areality rather than a hypothetical abstraction.

As an example, during the response to HurricaneKatrina, as lawyers in HHS Office of the GeneralCounsel were carrying out many of the functionsdescribed above, a decision was made to communicatewith colleagues in the private sector to learn from themdirectly the nature and scope of challenges confrontingthem. A primary purpose for doing this was to identifyrsthand potential and important legal concerns ofhealth care provider entities and, as a result, use theinformation to improve the legal advice given to HHS

policymakers. The American Health Lawyers Associa-tion agreed to organize a conference call that includedcounsel for health care providers in the areas affectedby Katrina and leadership of the HHS Ofce of theGeneral Counsel. These private-sector colleagues wereinvited to describe and share the issues with which theywere dealing. Given an opportunity to speak directlyto HHS most senior lawyers, the private sector law-yers did not suggest that their clients needed waiversof regulations, nor did they assert that governmentaction or precedent in a particular area was inhibiting


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their clients response. Rather, the lawyers reportedhow they were tiring from many days of 24-hour crisismanagement; how their clients staffs were runningout of food, water, and stamina; and that their great-est concern was about keeping the oodwaters at bayso that hospitals could continue operating to care for

the sick and injured. While the exchange validated theimportance of coordinating, it also poignantly under-scored the human element that must never be forgot-ten in public health legal preparedness.

These issues of law and public health are ones thatsocieties have been struggling with for a very long time.For example, the Greek Byzantine Emperor Justinian,facing possibly the rst recorded pandemic in 532AD, instituted a quarantine law for persons travelingto Constantinople from areas where the plague wasspreading.21But the literature suggests that even longbefore that, there were public health benets provided

during the Athenian plague of 430 BC from mea-sures including the institution of isolation in two cit-ies in Greece, as well as the separation of animals andhumans in the areas outlying Athens.22As an objectlesson in the importance of public health is shapinghistory and civilizations, many historians believe thatthe Athenian plague led to Athens loss to the Pelopon-nese/Spartans.23Inuenced in part by such historicalcontext, the federal government, from the top-downand bottom-up, has embarked on a course to be therst generation in human history to be prepared for apandemic. Public health legal preparedness is a cru-

cial part of this ambitious objective.

References1. A. D. Moulton, R. N. Gottfried, R. A. Goodman, A. M. Murphy,

and R. D. Rawson, What Is Public Health Legal Preparedness?Journal of Law, Medicine & Ethics31, no. 4 (2003): 372-383.

2. U.S. Const. art. I, 8, cl. 3.3. U.S. Const. art. I, 8, cl. 1.4.Public Health Service Act, 42 U.S.C. 201-300 (2007).5.Id.6.Act of May 27, 1796, ch. 31, Stat. 474 (repealedby Act of Febru-

ary 25, 1799, ch. 12, 1, Stat. 619).7.Pandemic and All-Hazards Preparedness Act of 2006 101-406,

42 U.S.C. 201 (2006).8.Id.9.Id.10.Public Readiness and Emergency Preparedness Act of 2005,

Pub. L. No. 109-148, Div. C, 119 Stat. 2818, 42 U.S.C. 201(2007).

11.Department of Defense Appropriations Act of 2006, Pub. L. No.109-148, Div. A, 119 Stat. 2744 (enacted H.R. 2863).

12.Public Health Security and Bioterrorism Preparedness andResponse Act of 2002 121-127, 131, 42 U.S.C. 201 (2007).

13.Project Bioshield Act of 2004, Pub. L. No. 108-276, 118 Stat.835 (codied as amended in scattered sections of 41 and 42U.S.C.).

14. 42 U.S.C. 264(e).15.New York v. U.S., 505 U.S. 144, 149,112 S.Ct. 2408 (1992).16. Control of Communicable Diseases, 70 Fed. Reg. 71892 (pro-

posed Nov. 30, 2005) (to be codied at 42 C.F.R. 70 & 71).17.Federal Tort Claims Act, 28 U.S.C. 1291, 1346, 1402, 2671-

2680 (2000).18. Emergency System for Advance Registration of Volunteer

Health Professionals (Ver. 2, June 2005).19. SeePublic Health Service Act, supra note 4.20. John Boyd, Organic Design for Command and Control (May

1987).21. O. P. Schepin and W. V. Yermakov,International Quarantine 11

(Madison, CT: International Universities Press, 1991).22. H. N. Couch, Some Political Implications of the Athenian

Plague,Transactions and Proceedings of the American Philo-logical Association 66 (1935): 92-103, at 92-93, 95.

23. Id.


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IntroductionPublic health legal preparedness begins with effectivelegal authorities, and law provides a key foundationfor public health practice in the United States. Lawsnot only create public health agencies and fund them,but also authorize and impose duties upon govern-ment to protect the publics health while preservingindividual liberties.1As a result, law is an essential toolin public health practice2and is one element of pub-lic health infrastructure, as it denes the systems andrelationships within which public health practitionersoperate.3

For purposes of this paper, law can be dened as arule of conduct derived from federal or state constitu-tions, statutes, local laws, judicial opinions, adminis-trative rules and regulations, international codes, orother pronouncements by entities authorized to pre-scribe conduct in a legally binding manner. Publichealth legal preparedness, a subset of public healthpreparedness,4is dened as attainment of legal bench-marks within a public health system.5Law is one offour core elements of public health legal preparedness(the remaining three competencies, information,and coordination are each the subject of individualpapers that follow).

In this paper we briey describe the evolution andstatus of essential legal authorities for public healthpreparedness. Our review focused on three specicpreparedness initiatives health care system surgecapacity, the Pandemic and All-Hazards PreparednessAct, and implementation of the International HealthRegulations. These issues do not represent the entirerange of legal preparedness nor the only relevant per-spectives. The limited scope of this paper prevents acomprehensive treatment of these and other issues weconsidered. Rather, we chose these three initiativesbecause they exemplify the span of public health legal

preparedness from the state and local, federal, andinternational perspectives.After a brief overview of these initiatives, we describe

several themes that emerged during our review. First,the series of events from September 11, 2001 and theanthrax attacks later that year to Hurricane Katrinain 2005 prompted a urry of legislative and regula-tory activities that sought to provide new authorities6at every level, modernize public health law,7and reor-ganize Federal preparedness and response functions.8Collectively, these legal reforms sought to improve thelegal frameworks for the attainment of public healthpreparedness. Reviewing this legal landscape raises

Brian Kamoie, J.D., M.P.H.,is the Deputy Assistant Secretary and Director for Policy and Strategic Planning at the Ofce ofPolicy and Strategic Planning, Ofce of the Assistant Secretary for Preparedness and Response, U.S. Department of Health andHuman Services. Robert M. Pestronk, M.P.H.,is the Health Ofcer and Director of the Genesee County Health Departmentin Michigan. Peter Baldridge, J.D.,is the Senior Staff Counsel of the Ofce of Legal Services in the California Department of

Health Services. David Fidler, J.D.,is the James L. Calamaras Professor of Law at Indiana University School of Law. LeahDevlin, D.V.M., is the Health Director of the Division of Public Health at the North Carolina Department of Health and Human

Services.George A. Mensah, M.D., F.A.C.P., F.A.C.C.,is the Chief Medical Ofcer and Associate Director for Medical Affairs atthe National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention. MichaelDoney, M.D.,is the Quarantine Medical Ofcer of the Division of Global Migration and Quarantine at the National Center for

Preparedness, Detection, and Control of Infectious Diseases, Centers for Disease Control and Prevention.

Assessing Laws and LegalAuthorities for Public Health

Emergency Legal PreparednessBrian Kamoie, Robert M. Pestronk, Peter Baldridge, David Fidler,

Leah Devlin, George A. Mensah, and Michael Doney


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the questions of whether new laws and legal authori-ties are still needed, as well as whether the publichealth community is making the most effective use ofexisting authorities.

An additional question is whether existing lawsform a barrier to achieving effective preparedness

and response to public health emergencies. How weimprove health care system surge capacity while com-plying with a patchwork of existing laws is a challengeat the state and local levels. Finally, the paper serves asa foundation for the companion paper that addressesgaps and potential limitations in existing authoritiesthat merit consideration for action.

BackgroundThe 20th century witnessed signicant public healthachievements, from advancements in the control ofinfectious diseases and motor vehicle safety to vacci-

nation and worker safety.9Additionally, the preventionand control of non-communicable chronic diseases,such as heart disease and stroke and their associatedrisk factors, represent one of the greatest public healthachievements of the past century.10Law played a keysupportive role in these achievements.11Among theessential legal authorities that enable such achieve-ments are laws that establish public health and relatedagencies, confer authorities upon those agencies toact (e.g., public health surveillance and investigation,environmental regulation, and public health interven-tions), and provide funding to those agencies.

Most notable, for purposes of this paper, may be theevolution of laws that relate to emergency prepared-ness and response, and the subset of those laws thataddress the preparedness of the public health systemto respond to emergencies and disasters.

At the state level, the primary legal authority torespond to emergencies has been the police power, orthe authority of the state to enact laws and regulationsthat protect the health, safety, and welfare of citizens.12The police power is among the powers reserved to thestates under the Tenth Amendment to the U.S. Con-stitution.13The type of laws and regulations enactedunder this authority that have a direct impact on pub-

lic health include disease reporting and medical sur-veillance, personal control measures (e.g., mandatoryvaccination), trafc safety, and nuisance abatement.

At the federal level, the Constitution empowers thefederal government to regulate matters that affectpublic health through the Commerce Clause,14whichauthorizes regulation of interstate and foreign com-merce, and Congressional authority to tax, spend, andaddress national security and foreign affairs.15Basedon these broad foundational authorities, federal lawregarding the response to emergencies and disasters

has evolved over time to reect an emphasis on anall-hazards approach that enables preparedness andresponse to emergencies and disasters, both naturaland manmade, including terrorism.

The primary framework for federal emergencyresponse authority is the Robert T. Stafford Disaster

Relief and Emergency Assistance Act,16 which out-lines the programs and processes through which thefederal government provides disaster and emergencyassistance to state and local governments, tribes, eli-gible private nonprot organizations, and individualsaffected by a major disaster or emergency as declaredby the President. The primary federal public healthresponse authority is the Public Health Service Act,17

which authorizes the Secretary of the Department ofHealth and Human Services to, among other actions,declare a public health emergency in response to theintroduction and spread of communicable diseases,

bioterrorism, or other situation that threatens thepublics health.

The evolution of these legal frameworks over the 20thcentury and the development of comprehensive emer-gency management systems such as the National Inci-dent Management System (NIMS) and the NationalResponse Plan (NRP) have deviated from traditionalcivil defense and hazard-specic legislation and sys-tems to focus on an all-hazards approach organizedunder the general framework of homeland security.This general homeland security framework includesthe statutes, regulations, and the Presidential direc-

tives that, among other actions, created the Depart-ment of Homeland Security and the White HouseHomeland Security Council and required a wide rangeof preparedness and response planning. Recent legis-lation18requires the development of a National HealthSecurity Strategy to address the preparedness of thenation to respond to public health emergencies, whichis a similar framework to U.S. government nationalsecurity19and homeland security20strategies.

Coupled with this new all-hazards approach andfocus is the evolution of safeguards to protect indi-vidual liberties against unconstitutional governmentaction. These safeg

Documents

1. Letters to Editor.pdf