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121

59 Admin. L. Rev. 121

Administrative Law Review

Winter 2007

Article
Lawrence O. Gostin a1 Benjamin E. Berkman aa1

Copyright (c) 2007 American Bar Association; Lawrence O. Gostin; Benjamin E. Berkman

PANDEMIC INFLUENZA: ETHICS,

LAW, AND THE PUBLIC'S HEALTH

Editor's Note

This Article originally was scheduled to appear in Volume 58, Number 3, of this publication, as part of the Administrative
Law Review's 2006 Symposium, Cracks in the System: The Adequacy of the U.S. Healthcare Regulation in a Global Age.
We decided to present this Article in this issue to allow the authors to work closely with the World Health Organization
and to account for the constantly changing nature of this field of study.

Table of Contents

Introduction 123
I. Medical Countermeasures: Vaccines and Neuraminidase Inhibitors 127
A. General Considerations 127
B. Planning and Market Incentives 130
C. Sound Regulation 131
D. Scientific Information and Intellectual Property 133
E. Liability and Compensation 135
F. Ethical Allocation of Scarce Resources 136
1. Prevention/Public Health 137
2. Scientific/Medical Functioning 137
3. Social Functioning/Critical Infrastructure 137
4. Medical Need/Vulnerability 138
5. Intergenerational Equity 138
6. Social Justice/Equitable Access 138
7. Global Justice 139
8. Civic Engagement/Fair Processes 139
II. Public Health Strategies: Ethical and Human Rights Concerns 140
A. The Importance of Public Health Interventions 140
B. Ethics and Human Rights 141
1. International Human Rights 142
a. The Universal Declaration of Human Rights (UDHR) 143
b. International Covenant on Civil and Political Rights & International Covenant on 143
Economic, Social and Cultural Rights
c. Regional Conventions: The European Convention on Human Rights and Fundamental 145
Freedoms and Its Protocols, and The American Convention on Human Rights
2. Valid Limitations on Human Rights 145
3. Public Health Ethics 147
a. Public Health Necessity 147
b. Reasonable and Effective Means 147

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c. Proportionality 148
d. Distributive Justice 148
e. Trust and Transparency 149
D. Public Health Interventions 150
E. General Ethical Themes in Public Health Responses to a Pandemic 150
1. Community Participation 150
2. Expanded Research Agenda 151
3. Resource Allocation 152
4. International Cooperation and Coordination 153
F. Public Health Surveillance 154
1. Global Responsibility to Develop Core Surveillance Capacities 155
2. Mitigating Privacy and Autonomy Risks 156
G. Limiting Animal/Human Pathogen Interchange 157
1. Avoiding Proximity 157
2. Due Process and Compensation for Culling Decisions 158
3. Mitigating the Economic Impact of Trade Restrictions 159
H. Community Hygiene and Hospital Infection Control 160
1. Encouraging Community Hygiene 161
2. Ensuring the Appropriate Use of Hospital Infection Control 162
I. Decreased Social Mixing/Increased Social Distance 164
1. Government Authority and Accountability 165
2. Workplace Closings 166
3. Provision of Necessities 167
J. International Travel and Border Controls 168
1. Economic Impact of International Travel and Border Controls 169
2. Governmental Transparency and Coordination 170
3. Civil Liberties 170
K. Isolation and Quarantine 171
1. Legal Authority 172
2. Due Process (Natural Justice) 172
3. Monitoring and Enforcement: Voluntary or Least Intrusive Means 173
4. Ensuring Safe, Humane Implementation of Isolation or Quarantine 174
Conclusion 175

*123 Introduction

Highly pathogenic Influenza A (subtype H5N1) (H5N1 or virus) has captured the close attention of policymakers who
regard pandemic influenza as a national security threat. 1 The virus already is endemic in avian populations in Southeast
Asia, with serious outbreaks now in Africa, Europe, and the Middle East. 2 H5N1 has moved steadily to many regions
of the world, surfacing in Europe as far north as Germany, as far west as France, 3 and as far south as the Mediterranean
and Adriatic seas. 4 The virus has spread to the Middle East in Iraq, Iran, Saudi Arabia, and Egypt. 5 It has emerged in
impoverished countries such as Nigeria and transitional economies such as India. 6

Modeling suggests that the virus will eventually affect the entire globe through a number of transmission mechanisms
such as commerce, migratory birds, and a highly mobile population. 7 International trade and travel will play a major role
in the spread of the virus. The majority of the outbreaks in Southeast Asia have already been attributed to the movement
of poultry and poultry products. 8 Frequent travel makes it difficult to contain a pandemic. However, even if trade and
travel were severely *124 restricted, it is possible that migratory birds still would bring the virus to other continents. 9

At present, the spread of the H5N1 strain is mainly confined to animal populations. While the virus is highly contagious
among birds, 10 it is still rare in humans because of a significant species barrier. 11 Confirmed cases of human infection
have nonetheless been reported. As of May 29, 2006, 224 cases of H5N1 have been reported, with 127 deaths. 12 Most

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of these cases are attributable to close contact with infected poultry, particularly at poultry farms and markets, cock-
fighting venues, or when poultry is used as backyard pets. 13 While a few cases of human-to-human transmission have
occurred, principally resulting from intimate household contact, transmission is not common beyond one person. 14
The virus appears to be highly pathogenic when occurring among humans, with a reported death rate exceeding 50%. 15
However, because of possible under-reporting, the prevalence, transmissibility, and fatality of H5N1 remain uncertain.

A series of compounding possibilities make it likely that a new influenza pandemic could emerge, although the timeframe
and virulence are uncertain. The first five of the following six essential prerequisites for a pandemic have already occurred:
(1) a novel viral subtype is identified in animal populations such as swine or poultry, (2) the virus spreads to animals
in a wider geographic setting, (3) the virus jumps from animals to humans inefficiently, (4) the virus more efficiently
spreads from animals to humans, (5) inefficient human-to-human transmission is documented, and (6) efficient human-
to-human transmission emerges. Through adaptive mutation or viral reassortment, the H5N1 virus could become highly
transmissible among humans, thus leading to a pandemic outbreak. 16

Recent evidence that an avian influenza virus caused the 1918 pandemic lends credence to the theory that current
outbreaks could have pandemic *125 potential. 17 Historically, the number of deaths during a pandemic has varied
greatly depending on the number of people who become infected, the virulence of the virus, and the effectiveness of
preventive measures. 18 Such variables lead to great difficulty in establishing accurate predictions of mortality, and as a
result, estimates differ considerably. A mild pandemic, like the 1957 and 1968 pandemics, is likely to cause the death of
89,000 to 207,000 people in the United States 19 and 2 million to 7.4 million people globally. 20 Conversely, other studies
that extrapolate from the severe 1918 pandemic indicate that in the absence of intervention, an influenza pandemic would
lead to 1.9 million deaths in the United States and 180 million to 369 million deaths globally. 21

Characteristic Moderate (1957/68-like) Severe (1918-like)

Illness 90 million (30%) 90 million (30%)
Outpatient medical care 45 million (50%) 45 million (50%)
Hospitalization 865,000 9,900,000
ICU Care 128,750 1,485,000
Mechanical Ventilation 64,875 742,500
Deaths 209,000 1,903,000
Department of Health and Human Services (HHS) Health Outcomes: Number of Episodes of Illness, Healthcare
Utilization, and Death Associated with Moderate and Severe Pandemic Influenza Scenarios 22

*126 An influenza pandemic would also result in massive economic disruption. So far, the virus's global economic
impact has been fairly limited. The rural areas of Southeast Asian countries currently are experiencing the principal
economic effects, which relate mostly to the losses of poultry and to governmental control measures such as the culling
of birds. In Asia, the total direct economic costs due to the H5N1 outbreak amount to $10 billion. 23 Small and medium-
sized farmers, who often have no alternative sources of income, have felt the impact the H5N1 outbreak most acutely.
Further, the H5N1 outbreak has severely affected trade in poultry at the domestic, regional, and international level
because many countries prohibit the importation of poultry meat from affected regions.

Since great uncertainties exist about the timing, virulence, and general scope of a future human influenza pandemic, any
estimate of the economic impact is merely suggestive. On a global scale--extrapolating from the economic disruptions
associated with Severe Acute Respiratory Syndrome (SARS)--a 2% loss of global gross domestic product (GDP) ($800
billion) can be expected. 24 If the outbreak were more severe, it could result in a global GDP loss of 6% or $3.2 trillion. 25
Within the United States, a severe pandemic would lower the U.S. GDP by as much as 5%, and a milder pandemic
might reduce the U.S. GDP by about 1.5%. 26 In addition to these direct costs, a global flu pandemic would implicate

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a considerable loss of global work output. 27 Commerce would sharply decline as people avoid public spaces. The labor
supply would shrink as workers become ill or stay home to care for others. The lack of an active workforce would place
at risk essential goods and services such as food and water, electricity and gas, and transportation systems.

*127 Further, therapeutic countermeasures (e.g., vaccines and antiviral medications) and public health interventions
(e.g., infection control, social separation, and quarantine) form the two principal strategies for prevention and response.
Many of the barriers to effective interventions are technical and have been thoroughly discussed elsewhere. 28 This
Article focuses on the formidable legal and ethical challenges that have yet to receive sufficient attention. 29 Part II
examines the major medical countermeasures under consideration as an intervention for an influenza pandemic. This
Part evaluates the known effectiveness of these interventions and analyzes the ethical claims relating to distributive
justice in the allocation of scarce resources. Part III discusses public health interventions, exploring the hard tradeoffs
between population health on the one hand, and personal (e.g., autonomy, privacy, and liberty) and economic (e.g.,
trade, tourism, and business) interests on the other. This Part focuses on the ethical and human rights issues inherent in
population-based interventions. Pandemics can be deeply socially divisive, and the political response to these issues not
only impacts public health preparedness, but also reflects profoundly on the kind of society we aspire to be.

I. Medical Countermeasures: Vaccines and Neuraminidase Inhibitors

A. General Considerations

Industrialized countries place great emphasis on scientific solutions. Vaccination and, to a lesser extent, antiviral
medication (neuraminidase inhibitors: oseltamivir (Tamiflu®) or zanamivir (Relenza®)), are perhaps the most important
medical interventions for reducing morbidity and mortality associated with influenza. 30 In the $6.7 billion Department
of Health and Human Services (HHS) influenza plan, $4.7 billion is allocated *128 for cell-based vaccine technology and
stockpiling experimental vaccine, and $1.4 billion for antiviral medicines. 31 Congress recently appropriated $3.8 billion
to address pandemic influenza. 32 While Congress appropriated less money than HHS requested, Congress preserved
the focus on medical countermeasures. The overwhelming majority of this money is to be spent on the development and
purchase of vaccines and antivirals. 33

Internationally, countries have followed suit, devoting the majority of their resources towards medical countermeasures.
For example, Russia is planning to have an antiviral stockpile sufficient to cover their entire population. 34 Other
countries have set less ambitious coverage goals (such as Belgium--30%, Germany--20%, Italy--10%) 35 but still will
be forced to allocate large amounts for antivirals. Most industrialized countries also are investing significant sums for
vaccine development and stockpiles. 36

Despite the promise of medical countermeasures, there is a chronic mismatch of public health needs and private control
of production. Vaccine production has been unreliable even for seasonal influenza, which is the leading cause of vaccine-
preventable mortality; only a fraction of the recommended population is vaccinated each year. 37 For example, the
United States lost half of its seasonal influenza vaccine supply in 2004-2005 when the United Kingdom withdrew Chiron
Corporation's license because of bacterial contamination. 38

The best way to ensure pandemic preparedness is to increase the baseline for seasonal countermeasures. The World
Health Organization (WHO) asserted that better use of vaccines for seasonal epidemics would help to ensure that
manufacturing capacity meets demand in a future pandemic. 39 Even though this approach is a good long-term solution,
more immediate *129 solutions are needed. 40 Moreover, supply is difficult to increase because of the lack of market
incentives, intellectual property concerns, regulatory hurdles, and liability fears, as discussed below.

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Despite these concerns, the global distribution of influenza vaccines is increasing rapidly, but questions remain about
global distributive justice. In 2003, over 291 million doses were distributed globally. 41 This is almost forty million doses
more than in 2001. 42 Unfortunately, only 35% of all doses reach the developing countries. Moreover, 85% of the world's
supply of influenza vaccine is produced by companies located in eight industrialized countries: France, Germany, Italy,
the Netherlands, the United Kingdom, the United States, Canada, and Australia. 43 Consequently, 40% of the doses
used in central and eastern Europe, 60% of the doses used in the Western Pacific and Southeast Asia, and almost 100% of
the doses used in Latin America, the eastern Mediterranean, and Africa are imported from one or more of the vaccine-
producing developed countries. 44 It is quite likely that in the face of a new pandemic, governments will not export
any of their nationally produced vaccines until domestic demand is satisfied. 45 For example, to ensure coverage for
approximately half of its population, Canadian health officials have negotiated a contract with their domestic producer
to provide five million doses of influenza vaccine. 46 Health officials in other countries have tried to reach similar
agreements without success. 47 Further complicating matters is recent evidence that H5N1 floods the bloodstream with
the virus, further calling into question the effectiveness of antivirals and vaccines. 48

Moreover, the U.S. government has become too focused on specific pathogens, disproportionately devoting resources
towards developing medical countermeasures for the disease of the moment. Whether the threat is anthrax, smallpox,
bioterrorism, or influenza, the government targets the immediately salient threat rather than strengthening the public
health infrastructure so that it can recognize and respond to a range of risks. *130 States would bear a high proportion
of these costs. 49 This “one bug, one drug” mentality is ineffective because it is impossible to predict and prepare for the
wide variety of threats that society could face. 50 Developing medical countermeasure technologies and public health
interventions that could respond to a wide range of emerging biological threats would be a better use of resources.

B. Planning and Market Incentives

The nation's goal must be to build a system that will ensure a stable, economically viable supply of vaccines capable of
meeting potentially massive public needs in a just manner. Public and private strategies rather than private markets are
most likely to succeed because of the unique risks and constraints of vaccine production. 51 Private market forces create
suffer failures such as high investment costs, limited or variable markets, and regulatory non-compliance, each of which
inhibits vaccine development. As vaccine manufacturers leave the industry, they create a risk of severe shortages. In
1967, twenty-six companies were licensed to distribute vaccines in the U.S. market, but less than half of this number are
licensed today. 52 Only four companies currently supply influenza vaccines, with only two manufacturing domestically--
MedImmune (live attenuated influenza virus, intranasal (FluMist®)) and Sanofi Pasteur. 53

The Institute of Medicine recommends a National Vaccine Authority (NVA) to advance the development, production,
and procurement of vaccines. 54 With or without an NVA, the government can create incentives by boosting demand
through seasonal vaccine awareness programs, issuing purchasing contracts, and providing price guarantees or subsidies.
Recognizing the need to increase output and availability, the G7 Finance Ministers recently announced a pilot Advance
Market Commitment for vaccines of public health importance. 55

*131 Even if vaccination supplies adequately meet mass needs, the distribution of the vaccines to the population
remains problematic. Each year, drug companies produce millions of influenza vaccines but never distribute them. 56
Pandemic influenza would require mass vaccination in a short window of time, probably within months of the advent
of an outbreak. Federal stockpiles must meet needs at the local level, requiring systems for transportation, storage, and
safe administration of the vaccine. If two doses are required to achieve immunity, health service providers may need a

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call-back system or immunization registry. At present, the federal strategic plan fails to resolve these vital issues, instead
delegating them to the states. 57

C. Sound Regulation

The vaccine industry must overcome rigorous regulatory hurdles to achieve safety and efficacy while avoiding increased
costs and delays. To start, vaccines contain living organisms, making the threat of contamination greater than with drugs.
Therefore, vaccines must adhere to higher purity standards than pills because they often are administered by injection. 58
Accordingly, the Food and Drug Administration (FDA) plays an active role during the development of the vaccine, as
well as in its licensing. 59 Before licensure, the FDA reviews the data from clinical trials to assess the product's safety
and effectiveness. 60 After licensure, the FDA conducts regular manufacturing practice inspections to ensure that the
manufacturing facility produces a consistent product. 61 Violations found during these inspections can result in the loss
of a manufacturing license; companies must go through a lengthy reapplication process before the FDA allows them to
continue producing vaccines for public consumption. Additionally, the FDA requires manufacturers to test each lot of
vaccine for contaminants before public release. 62

*132 Departing from these onerous regulations, the FDA amended its drug and biological product policies in 2002 in
response to the possibility of a serious and immediate health threat. 63 Under the so-called “Animal Rule,” the FDA
may approve drugs and biological products for marketing based on animal studies when human studies are unethical or
infeasible. 64 The revamped procedure streamlines the process for quickly developing medical countermeasures in the
face of a bioterrorism attack or pandemic outbreak. 65 While this may be an effective regulatory strategy, critics are
concerned that the relaxed requirements could put large numbers of human lives at risk 66 because animal models often
do not accurately predict human responses to drugs or biological products. 67 Using multiple species testing can mitigate,
but not entirely remove, this concern. 68 Thus, the first human users essentially will be involved in a clinical trial. While
an immediate threat may justify the need for a streamlined approval process, more public education is required, and care
must be taken to avoid abusing the process.

In addition to the federal regulatory regime, states also regulate vaccines. For instance, three states, California, 69
Iowa, 70 and New York, 71 regulate thimerosal-containing vaccines, while bills are pending in other states. Because
influenza vaccines contain thimerosal, this legislation could undermine federal plans. In addition to federal and state
regulation, agencies in other countries regulate vaccines. Therefore, industry faces multiple, overlapping regulatory
requirements, which must be reconciled.

Recognizing that this problem of overlapping regulatory requirements is an issue nationally and internationally, the
FDA and the European Medicines Evaluation Agency (EMEA) recently published “regulatory pathways for licensing
of pandemic vaccines.” 72 Since manufacturers must *133 be licensed and begin commercial production in advance of,
or soon after, the start of a pandemic, regulatory requirements should be timely, efficient, and well-coordinated.

D. Scientific Information and Intellectual Property

The rapid global dissemination of scientific information will be necessary to effectively respond to a pandemic outbreak.
Such dissemination would require the speedy collection and sharing of data involving surveillance and scientific
discovery. For example, comparing sequence data from each isolated case allows scientists to better understand and
track the movement and evolution of the virus. 73 However, sharing information about H5N1 has been problematic.

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Scientists do not want to release their data until they have received published credit. 74 Similarly, many countries
want to keep information confidential to protect national security and intellectual property (IP) interests. Therefore,
international coordination is necessary to facilitate research. Such coordination should include exchanging study results
to avoid duplication, 75 defining expectations and regulations to avoid conflicts in export and import, and supporting
standardization to avoid quality divergence in industrialized and developing countries. 76 In an attempt to encourage
collaboration, the WHO has maintained a restricted database, accessible by only a handful of laboratories. 77 Recently,
this system has been criticized for being unnecessarily secretive. 78 Rather than allowing broad-based access to the data
that would facilitate scientific research, the WHO has denied access to many groups.

It is equally important to share manufacturing and technical information. Potential patent disputes should be anticipated
in advance because they have significant cost implications for commercial vaccines. The H5N1 virus is most effectively
grown in fertilized chicken eggs with modification through reverse genetics. 79 However, this is a patented technology. 80
*134 Newer cell-based technologies, which promise more efficient mass production, are also subject to IP protection. 81
Although IP affords incentives for innovation, it can also impede rapid and large-scale vaccine production in a public
health emergency.

The Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) allows countries to grant compulsory
licenses to ensure access to essential medicines in a public health emergency. 82 Compulsory licenses, which afford the
right to produce a product without the patent holder's authorization, are usually discussed in the context of life-saving
medications for resource-poor countries; however, some have considered compulsory licenses to ensure adequate Tamiflu
production. 83 Hoffmann-La Roche Inc., the patent-holder until 2016, stated that the global demand is well in excess of
production capacity. 84 It will take ten years of constant production for the company to produce enough of the drug to
treat twenty percent of the world's population. However, the company opposes compulsory licensing, citing the scarcity
of raw materials, the complex manufacturing process, and the necessity of patent protection to create incentives. 85

Whatever the merits of compulsory licensing, antivirals will have only limited utility in a pandemic. Gaining access to
Tamiflu on time would entail visiting a physician or pharmacist. Because influenza is maximally infectious early in the
course of the disease, doctor or pharmacy visits would seriously risk transmission to the public. Moreover, antiviral
medications remain only partially effective against H5N1 and may not be effective against a human strain of the virus. 86
The potential for mass use and patient noncompliance within the five-day course of treatment pose a risk of drug
resistance. 87 Consequently, reliance on stockpiling antivirals, although probably helpful in reducing hospitalizations,
will not significantly impede a pandemic.

*135 E. Liability and Compensation

Tort liability for the pharmaceutical industry and fair compensation for patients offers a sound dual approach to
vaccine policies. The Public Readiness and Emergency Preparedness (PREP) Act, enacted in December 2005, makes
manufacturers immune from liability under federal and state law with respect to all claims resulting from the use of
medical countermeasures during a pandemic influenza. 88 The liability protections only apply to products administered
or used during the effective period of the declaration of a public health emergency issued by the Secretary of HHS. 89

The PREP Act also authorizes the Secretary to develop a compensation program for injured individuals. Such a system
already exists in the national Vaccine Injury Compensation Program (VICP), but it needs reform. The VICP created
a no-fault system that pays for injuries caused by specific immunizations 90 and Congress added influenza to VICP in
2005. 91 The Federal Claims Court adjudicates compensation based on a Vaccine Injury Table. To recover, claimants

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must show that a listed vaccine caused their injury. Compensation comes from a Compensation Trust Fund financed
by a tax levied on each administered dose. 92

Patients can opt-out of VICP, causing a sustained critique that legal liability represents a major disincentive for the
industry. The President's influenza plan virtually bans all lawsuits except for willful misconduct and assigns liability
determinations to a political figure--the HHS Secretary. 93 The political critique, however, overstates the negative
influence of liability on vaccine production. Influenza vaccine litigation remains rare, with only ten reported cases during
the past twenty years, most of which culminated in small-scale settlements. 94

*136 Also, mass usage of an untried vaccine during a public health emergency could result in numerous adverse events.
For instance, health care workers and patients might be less likely to volunteer without a fair compensation system, as the
failed smallpox vaccination campaign demonstrated. 95 On the other hand, a no-fault system, like VICP, would provide
relief for injured patients and greater certainty for industry. Experimental H5N1 vaccines currently are not covered under
VICP, so the new vaccine would need to be added. Moreover, VICP has become adversarial, burdensome on claimants,
and time consuming. 96 A reformed system must account for important issues, such as an overwhelmed program resulting
in delays, insufficient money in the compensation trust fund, and injustices caused by excessive burdens placed on patients
injured by a new vaccine. In return, the industry should be spared strict liability lawsuits, while remaining liable for
recklessness or gross negligence.

F. Ethical Allocation of Scarce Resources

Considerable scientific uncertainty remains in predicting an influenza pandemic. Moreover, it is certain that there will
be extreme scarcity of medical countermeasures in the short-term. Although H5N1 vaccines are in clinical trials, 97
companies cannot meet mass needs without dramatic improvements in production facilities and technologies (e.g., cell-
based cultures and dose sparing). 98 Estimates suggest that the current combined global manufacturing capacity is
only capable of making vaccines for 450 million people. 99 This is an optimistic estimate because it assumes low-dose
vaccination, even though this dose might not be fully effective. 100 Given international trade law, which affords a single
company exclusive manufacturing rights, along with complex production processes, the same scarcity might occur with
antivirals. The United States, for example, has limited capacity, with only two domestic vaccine suppliers and no priority
over purchasing orders for Tamiflu. 101

*137 The most challenging question facing bioethics is how to ration scarce, life-saving resources: “Who shall live when
not all can live?” 102 “Blind justice” might dictate a random allocation of scarce interventions, such as a lottery or a first-
come, first-served system. Yet, this procedure seems unsatisfying when life-saving countermeasures can be targeted more
cost effectively. American society has accepted “need” as the singular principle for allocation of seasonal (interpandemic)
influenza vaccine--e.g., the elderly and health care workers. 103 Given the devastating social, economic, and political
ramifications of a serious pandemic, the following rationing criteria are worth consideration.

1. Prevention/Public Health

As the historic mission of public health is prevention, countermeasures to impede transmission should be a high priority.
Thus, where feasible, rapid deployment of vaccines or prophylaxis to groups at risk of acquiring infection should be used
to contain localized outbreaks. For example, ring vaccination of direct contacts in a family, congregate setting, or local
community could be an effective intervention that would maximize lives saved.

2. Scientific/Medical Functioning

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If the first political priority is public health, then it is essential to protect individuals who innovate and produce vaccines
or antivirals, provide treatment, and protect the public's health. These are critical social missions necessary to save lives
and provide care for the sick. Consequently, priority should be given to key personnel in developing countermeasures,
delivering health care, and devising public health strategies.

3. Social Functioning/Critical Infrastructure

A large-scale pandemic could result in key sectors of society being unable to function. Many actors and elements are
necessary for the public's health and safety: first-responders, security, essential product and *138 services, critical
infrastructure, and sanitation. Similarly, the continued functioning of governance structures, such as the executive,
legislative, and judicial systems, is important.

4. Medical Need/Vulnerability

As mentioned, medical need is a widely accepted rationing principle. This criterion focuses on reducing serious illness
and death among the most vulnerable individuals. It requires a scientific or epidemiologic judgment about at-risk groups
that may vary. Seasonal influenza disproportionately burdens infants and the elderly, but highly pathogenic strains may
affect young adults, as occurred with the Spanish flu.

5. Intergenerational Equity

The “medical need” criterion often favors the elderly because they are the most vulnerable to influenza complications.
However, interventions may be less beneficial to the elderly than to younger, healthier populations. Vaccines, for
example, may be less effective in older people because of poor immune system function. 104 All human lives have equal
worth, but interventions targeted toward the young may save more years of life. Would a “fair innings” principle militate
in favor of children, young adults, and pregnant women?

6. Social Justice/Equitable Access

What does justice tell us about how to ration scarce, life-saving resources? The foregoing criteria have a clear utility
but focus on key personnel and sectors such as government, biomedical researchers, the pharmaceutical industry, health
care professionals, and essential workers or first-responders. These apparently neutral categories mask injustice. In each
case, individuals gain access to life-saving technologies based on their often high-status employment. This kind of health
planning leaves out individuals who are either unemployed or employed in “non-essential” jobs--a proxy for the displaced
and devalued members of society. Consequently, public health planning based on pure utility, while understandable,
fails to have sufficient regard for the disenfranchised in society. 105

Social justice demands more than “fair” distribution of resources in circumstances of extreme health emergency. The
interests of vulnerable populations are undermined well beyond the detriments to their health. A *139 failure to act
expeditiously and with equal concern for all citizens, including the poor and less powerful, harms the whole community
by eroding public trust and undermining social cohesion. It signals to those affected and to everyone else that the basic
human needs of some matter less than those of others, and it thereby fails to show the respect owed to all members of
the community. 106

7. Global Justice

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Justice is not bound by national borders but binds the human community around the globe. Scholars such as Martha
Nussbaum 107 have drawn attention to the justice requirements of a shared humanity beyond citizenship. Realistically,
however, resources will go to those countries where products are owned and manufactured. Major influenza vaccine
producers operate and distribute almost exclusively in Europe, North America, Australia, and Japan. 108 This can have
devastating consequences for resource-poor countries that cannot compete economically for expensive countermeasures.
If all human life has equal value then there would be a strong moral justification for fair rationing from a global
perspective. Even from a less altruistic perspective, there are reasons to invest in poor regions. Improved surveillance
and response can help in early detection and containment of outbreaks, affording universal benefits.

8. Civic Engagement/Fair Processes

Public cooperation in a health emergency is more likely if citizens accept the fairness and legitimacy of allocation
decisions. Advance discussion of ethical principles keeps the public informed and engages them in a participatory
decisionmaking process. A pilot project on civic engagement found that stakeholders and citizens-at-large, at a high
level of agreement, chose a functioning society and reducing deaths as priorities in vaccine allocation. 109 This altruistic
consensus is comforting but may not reflect real behavior in a time of crisis, which could involve hoarding, stockpiling,
and black marketeering. Citizens will agree to fair allocation if they believe the allocation process is fair. However, if
they believe that others are jumping the queue through influence or money, they will be less likely to behave selflessly.
This is all the more reason for transparent decisionmaking processes in advance of a pandemic.

*140 Planning for an influenza pandemic is vital to success. It requires scientific innovation, modern laws, and ethical
action. Private markets cannot create stable supplies of life-saving countermeasures or assure fair allocations. Rather,
constructive partnerships among government, industry, and the community can vastly improve survival and functioning
in an impending crisis.

II. Public Health Strategies: Ethical and Human Rights Concerns

A. The Importance of Public Health Interventions

The United States has placed a high value on medical countermeasures to prevent or contain a future influenza
pandemic. 110 Given the limitations of medical countermeasures, however, public health interventions will be vital tools
for slowing the spread of an emerging pandemic. Two recent IOM reports have also determined that the United States'
emergency medical system is “at the breaking point.” 111 In spite of these medical infrastructure concerns, Congress
recently appropriated only $350 million to upgrade state and local capacity--about 9% of the $3.8 billion total allocation
for pandemic influenza. 112 Furthermore, this limited funding will be significantly eroded by a recent $105 million cut
in federal support for state public health 113 and an unfunded mandate for states to purchase antiviral drugs. 114

This Part focuses on traditional public health interventions, drawing lessons from past influenza pandemics 115 and the
outbreaks of Severe Acute Respiratory Syndrome (SARS). 116 Unfortunately, public health *141 strategies are difficult
to evaluate. First, evidence of effectiveness is often historical or anecdotal, with few systematic studies. 117 Adequate
resources for population-based research are urgently needed. 118 Second, an intervention's effectiveness depends on
the transmission pattern, which cannot be fully understood in advance. Key issues in the transmission pattern include
viral shedding (infectivity during pre- and post-symptomatic stages); mode and efficiency of transmission (large droplet,
aerosol, contaminated hands and surfaces, etc.); incubation period (two days between infection to the start of symptoms);
and serial interval between cases. 119 Third, an intervention's usefulness depends on the pandemic phase. In the pandemic
alert period, surveillance, medical prophylaxis, and isolation are important tools. Yet, “[d]uring the pandemic period,

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the focus shifts to delaying spread . . . through population-based measures.” 120 Thus, the key question is which measure,
or combination of measures, works best at each stage of the pandemic? Multiple, targeted approaches are likely to be
most effective, but they can have deep adverse consequences for the economy and civil liberties. Even using the most
optimistic scenario, containing an emerging H5N1 pandemic at its source will only delay, not stop, mass transmission
because of likely simultaneous introductions of the pathogen. 121

The remainder of this Article will examine the ethical and legal issues associated with public health interventions.
However, first it is necessary to identify the human rights and ethical principles that will guide this analysis.

B. Ethics and Human Rights

Pandemics can be deeply socially divisive, and the political response to these issues not only impacts public health
preparedness, but also is important to a good and decent society. It is for this reason that it is particularly important
to show respect for public health ethics and *142 international law--particularly human rights law--when developing
national policy for pandemic influenza. This Section sets out the relevant ethical principles that should be considered
when planning to combat a highly pathogenic pandemic influenza outbreak.

1. International Human Rights

Basic human rights are inherent to all people because they are human; they are universal, so that people everywhere are
“rights-holders;” and they create robust duties for the state. 122 State duties encompass the obligations to not interfere
directly or indirectly with the enjoyment of human rights, to prevent private actors from interfering with human rights,
and to take positive measures to enable and assist individuals and communities to enjoy their rights. Basic human rights
are protected under international law so that a state can no longer assert that systematic maltreatment of its own nationals
is exclusively a domestic concern. 123

The main sources of human rights law are the Universal Declaration of Human Rights and two international covenants
on human rights: the International Covenant on Civil and Political Rights (ICCPR) and the International Covenant on
Economic, Social and Cultural Rights (ICESCR), as well as an optional protocol to ICCPR. 124 The United Nations has
promulgated numerous treaties dealing with specific human rights violations including racial and gender discrimination,
the rights of children, genocide, and torture. 125 Human rights are also protected under regional systems, including those
in the Americas, Europe, and Africa. 126

*143 a. The Universal Declaration of Human Rights (UDHR)

The UDHR, adopted in 1948, identified specific rights and freedoms that deserve promotion and protection. The UDHR
was the international community's first attempt to establish a common standard of achievement for all peoples and all
nations to promote human rights. The UDHR represents a milestone in the struggle of humanity for freedom and human
dignity, stating that human rights are self-evident and the highest aspiration of the common people. Article 1 proclaims
that all human beings are born free and equal in dignity and rights.

The Universal Declaration is not a treaty, but a resolution with no explicit force of law. Nevertheless, its key provisions
have so often been applied and accepted that they are now widely considered to have attained the status of customary
international law. 127 The United Nations' General Assembly has declared that the principles embodied in the Universal
Declaration “constitute basic principles of international law.” 128 Moreover, it has “acquired a moral and political
authority equal to that of the [United Nations] Charter.” 129 In any event, the Declaration has inspired and influenced

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many international conventions and is reflected in national constitutions, legislation, and in the decisions of national
and international tribunals.

Most relevant to the ethics of public health interventions, the UDHR provides that all people have the right to freedom
from arbitrary arrest, detention, or exile; the right of movement and residence within and between the borders of each
state, and the right to freedom from discrimination. While the UDHR served as the preliminary description of rights,
two binding covenants, the ICCPR and ICESCR, followed.

b. International Covenant on Civil and Political Rights & International Covenant on Economic, Social and Cultural
Rights

The ICCPR imposes an immediate obligation to respect and to ensure civil and political rights. A sister covenant,
the ICESCR, requires state parties “to take steps, individually and through international assistance and co-operation,
especially economic and technical, to the maximum of its *144 available resources, with a view to achieving
progressively the full realization of the rights recognized . . . by all appropriate means, including particularly the adoption
of legislative measures.” 130 The language of progressive realization and maximum resources may have been inserted
because economic and social rights typically require greater funding and more complex solutions than civil and political
rights. Still, the Committee on Economic, Social and Cultural Rights, established by the ICESCR, made clear that
state parties have immediate obligations. Steps towards the goal of full realization must be taken within a reasonably
short time. States parties have a minimum core obligation to ensure the satisfaction of each of the rights and should
immediately implement legislation and judicial remedies to ensure non-discrimination in the exercise of economic and
social rights. 131

These covenants provide a number of rights that are relevant to the implementation of public health interventions
including the right to freedom from cruel, inhumane, or degrading treatment or punishment; the right to freedom of
movement and residence; the right to freedom from arbitrary detention; and most notably the right to health. The right
to health encompasses the international obligation for all nations to promote and protect the health of its civilians,
especially by facilitating access to basic health care services. The right to health, however, is not equivalent to a right
to health care, nor is it an absolute right. It must be evaluated against both the means available to the state and the
biological and socio-economical characteristics of the individual concerned. 132 Furthermore, the right to health cannot
be seen in a vacuum; it depends on the realization of other human rights such as the right to life, the right to privacy
and the right to non-discrimination. The right to health thus encompasses a broad spectrum of socio-economic factors
and must be extrapolated to the underlying determinants of health such as hygiene, housing, environment, and clean
drinking water. 133

*145 c. Regional Conventions: The European Convention on Human Rights and Fundamental Freedoms and Its
Protocols, and The American Convention on Human Rights

The European Convention on Human Rights and Fundamental Freedoms and its protocols (European Convention) and
the American Convention on Human Rights (American Convention) identify many of the same rights and liberties as the
Universal Declaration, including the right to privacy, 134 the right to be free from inhumane or degrading treatment, 135
the right to freedom of movement, 136 and the right to be free from discrimination--all of which public health measures
could violate. 137

2. Valid Limitations on Human Rights

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Human rights have transcending value, but international law allows restrictions when necessary for the public good. The
ICCPR's most fundamental guarantees are so essential as to be absolute and no state may derogate from them, even in
a time of an emergency. The ICCPR, however, allows state parties to suspend most other civil and political rights in
times of national crisis. The state must officially proclaim the public emergency and cannot engage in discrimination.
The principal conditions for restraints on civil and political rights are that they must be prescribed by law; enacted within
a democratic society; and necessary to achieve public order, public health, public morals, national security, public safety,
or the rights and freedoms of others. 138 However, state parties may not impose restrictions aimed at the destruction of
rights or their limitation to a greater extent than provided in the Covenant. 139

*146 The Siracusa Principles, conceptualized at a meeting in Siracusa, Italy, are widely recognized as a legal standard
for measuring the validity of limitations on human rights. 140 The Principles make clear that even when the state acts
for a good reason, it must respect human dignity and freedom. Echoing the language of the ICCPR, the Siracusa
Principles require that state limitations must be in accordance with the law; based on a legitimate objective; strictly
necessary in a democratic society; the least restrictive and intrusive means available; and not arbitrary, unreasonable,
or discriminatory. 141 International tribunals have relied on the Siracusa Principles to require states to use the least
restrictive measure necessary to achieve the public health purpose. 142

It is far more difficult to think about legitimate limitations on economic, social, and cultural rights. The ICESCR permits
“such limitations as are determined by law only in so far as this may be compatible with the nature of these rights and
solely for the purpose of promoting the general welfare in a democratic society.” 143 Because the ICESCR includes a
right to health, it is best to conceptualize as valid “limitations” those measures necessary to attain health protection for
the population. For example, the Covenant requires states to take steps aiming at “prevention, treatment and control
epidemic, endemic, occupational and other diseases.” 144 Thus, compulsory measures such as vaccination, treatment, or
isolation would be permitted only if necessary to protect public health.

*147 3. Public Health Ethics

These international human rights principles stress the importance of individual rights and freedoms, but make clear
that freedoms can be restricted when the public health is threatened. Striking a balance between the individual and the
collective can be a difficult task, especially under conditions of scientific uncertainty and crisis. Therefore, it is important
to articulate the values of public health ethics that should influence pre-pandemic planning.

a. Public Health Necessity

Public health powers are exercised under the theory that they are necessary to prevent an avoidable harm. Early meanings
of the term “necessity” are consistent with the exercise of police powers: to necessitate was to “force” or “compel” a
person to do that which he would prefer not to do, and the “necessaries” were those things without which life could not
be maintained. 145 Government, to justify the use of compulsion, therefore, must act only in the face of a demonstrable
health threat. Public health officials must be able to prove that they had “a good faith belief, for which they can give
supportable reasons, that a coercive approach is necessary.” 146

The standard of public health necessity requires, at a minimum, that the subject of the compulsory intervention must
actually pose a threat to the community. In the context of infectious diseases, for example, public health authorities
could not impose personal control measures (e.g., mandatory physical examination, treatment, or isolation) unless the
person was actually contagious or, at least, there was reasonable suspicion of contagion. While this standard is obviously
resistant to precise definition, it is important that countries clearly delineate what criteria for suspicion will be used and
provide procedural safeguards.

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b. Reasonable and Effective Means

Under the public health necessity standard, government may act only in response to a demonstrable threat to the
community. The methods used, moreover, must be designed to prevent or ameliorate that threat. In other words, there
must be a reasonable relationship between the public health intervention and the achievement of a legitimate public
health objective. Even though the objective of the legislature may be valid and beneficial, a public health intervention
must be an effective means of combating the *148 public health threat. A policy that entails personal burdens and
economic costs is only justified if the government can demonstrate that there is a reasonable chance of protecting the
public health. 147 Because it is extremely difficult to exactly define “reasonable chance” for all potential situations, the
government has the burden of proof and has to engage in ongoing evaluation of the public health intervention and its
effectiveness.

c. Proportionality

The public health objective may be valid in the sense that a risk to the public exists, and the means may be
reasonably likely to achieve that goal--yet a public health regulation is unethical if the human burden imposed is wholly
disproportionate to the expected benefit. Public health authorities have a responsibility not to overreach in ways that
unnecessarily invade personal spheres of autonomy. This suggests a requirement for a reasonable balance between the
public good to be achieved and the degree of personal invasion. If the intervention is gratuitously onerous or unfair, it
may overstep ethical boundaries.

d. Distributive Justice

This ethical principle requires that the risks, benefits, and burdens of public health action be fairly distributed, thus
precluding the unjustified targeting of already socially vulnerable populations. Tom Beauchamp and James Childress
view distributive justice as the “fair, equitable, and appropriate distribution in society determined by justified norms that
structure the terms of social cooperation.” 148

In the context of public health, this principle requires that officials act to limit the extent to which the burden of
disease falls unfairly upon the least advantaged and to ensure that the burden of interventions themselves are distributed
equitably. 149 Thus, in the exercise of compulsory powers, distributive justice requires a fair allocation so as not to burden
unduly particularly vulnerable populations. Distributive justice has been viewed as so central to the mission of public
health that it has been described as its core value. As Dan Beauchamp has said, “[t]he historic dream of public health . . .
is a dream of social justice.” 150

*149 Distributive justice does not merely require a fair allocation of risks and burdens. It also recognizes that public
health often distributes benefits such as vaccines, treatment, or other services. Problems of fair benefits allocation arise
under conditions of scarcity, where there is a competition for resources. This might occur, for example, with a scarcity
of medical treatment in the midst of an influenza pandemic.

e. Trust and Transparency

Public health officials have the responsibility to involve the public in the process of formulating public health policies as
well as to explain and justify any infringement on general moral considerations. Public health officials should honestly
disclose relevant information to the public. Accordingly, citizens should have the right to request and receive information.
Moreover, citizens' input should be solicited. 151

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The need for transparency stems in part from the government's ethical imperative to treat citizens with respect by offering
reasons for policies that infringe on moral considerations. 152 Transparency also is essential to create and maintain
public trust and accountability. 153 Openness and accountability are important to public health governance because of
their intrinsic value and capacity to improve decisionmaking. Citizens gain a sense of satisfaction by participating in
policymaking and having their voices heard. Even if the government decides that personal interests must yield to common
needs, the individual feels acknowledged if she is listened to and her values are taken into account.

Transparency also has instrumental value because it provides a feedback mechanism--a way of informing public policy
and arriving at more considered judgments. Open forms of governance engender and sustain public trust, which benefits
the public health enterprise more generally. Without public support, and the voluntary cooperation of those at risk,
coercive public health interventions would be difficult to achieve. The populace must be able to trust that its government
is acting in its best interest.

*150 In the following Sections, we examine ethical issues raised by major public health interventions available for
combating influenza. These interventions often present hard tradeoffs between population health on the one hand, and
personal and economic interests on the other. Each Section describes a proposed public health intervention and explains
the ethical problems connected with its implementation. An ethical solution to these problems will follow. Because of the
incredible strains that pandemic-created crises put on even the best laid plans, in addition to the difficulty in asserting one
set of ethical ideals, each Section will also discuss the mitigating factors that might make an ethical “ideal” impracticable.
The accompanying recommendations are designed to promote the ultimate ethical ideal, but in a manner sensitive to the
practical realities of a pandemic. However, before beginning the ethical analysis of specific public health interventions,
it is useful to define these tools, as well as to articulate some of the general themes that run throughout this Article.

D. Public Health Interventions

Given the limitations of medical countermeasures, public health interventions will be vital for slowing the spread
of an emerging pandemic. 154 The following Section will briefly identify and describe the various interventions. The
Sections after that will explore general ethical concerns that permeate all influenza pandemic public health interventions.
Subsequent sections will discuss each intervention in detail, focusing on ethical issues and drawing lessons from past
influenza pandemics 155 and the outbreaks of SARS. 156

E. General Ethical Themes in Public Health Responses to a Pandemic

1. Community Participation

The WHO's 1948 constitution states that “[i]nformed opinion and active co-operation on the part of the public are of the
utmost importance in improving health.” 157 Community participation in pandemic preparedness *151 and response
is critically important and ethically required. The ethical principles of trust and transparency require that the public be
involved in decisions affecting their lives. During a pandemic, many actions taken will impose losses on members of
society, both in terms of money and autonomy. Similarly, actions not taken will leave society at risk of disease. Public
health policymakers must use education and input from the public to balance the risks of action versus inaction. This
will help ensure that the policies ultimately adopted are well-suited to local circumstances and values.

At the national level, community participation will include advocacy, delivery of services, cost-sharing, and support
to patients. Each person should have the opportunity to contribute to public discourse and thus must be adequately
informed instead of being “managed” by the authorities. The government needs to identify its priorities, expectations, and

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financial capacity. Thus, an ethically appropriate policy in one country, or even one city, may be ethically inappropriate
in another because of varying norms and differing benefits or losses caused by intervention.

Community participation has a positive impact on the success of project development and implementation and
can reduce alienation of socially excluded groups. 158 Time and resource constraints may considerably complicate
community outreach programs during a pandemic. Consequently, governments must gain the public's trust by providing
it with adequate and accurate information well in advance. Of course, some issues will develop very quickly or
unexpectedly during a pandemic, precluding advance information. In this case, governments should provide necessary
information as quickly as possible, and community involvement in decisionmaking should be as great as allowed by
the circumstances of a situation. When expediency does not allow full community involvement before policies are
enacted, a post-enactment review process is particularly important to ensure transparency and accountability and should
incorporate community involvement.

2. Expanded Research Agenda

The government must consider all possible strategies because it is difficult to predict and evaluate the effectiveness of any
specific intervention. The key question is which measure, or combination of measures, works best at each stage of the
pandemic. A number of considerations make this difficult to answer. First, evidence of effectiveness is often historical
or anecdotal, with few systematic studies *152 available. 159 Second, an intervention's effectiveness depends on the
pandemic's transmission pattern, which is unpredictable. 160 Third, an intervention's usefulness depends on the stage
of the pandemic. In the pandemic alert period, surveillance, medical prophylaxis, and isolation are important tools.
Yet, during a pandemic, the focus shifts to delaying spread through non-pharmaceutical measures. 161 Evaluation of
effectiveness is important not only from a public health perspective, but also from an ethical perspective. To the extent
that interventions impose costs and burdens on individuals or the population, they are ethically warranted only to the
extent that they are effective and proportionate in terms of benefits and burdens.

Multiple targeted approaches are likely to be most effective, but they can have significant adverse consequences for
the economy and civil liberties. As such, governments should employ the least restrictive options possible. Given this
principle and the uncertain utility associated with public health interventions, evidence of effectiveness is important and
relevant to the ethical implications of public health interventions. Therefore, adequate resources for population-based
research are urgently needed. 162

3. Resource Allocation

Perhaps the greatest ethical issues of pandemic preparedness and response deal with the allocation of scarce resources. A
pandemic will overtax the immediately available resources of even the richest countries on the planet while overwhelming
less wealthy countries. For example, in 1918, influenza-related mortality was highest in the least developed parts of the
world and lowest among the wealthiest countries. 163 Given the greater baseline levels of mortality, the higher prevalence
of HIV/AIDS (and many other diseases such as malaria and tuberculosis), and reduced access to health care that is found
in many developing countries, one can reasonably expect these countries to experience greater morbidity and mortality
from influenza in a modern pandemic as well. At the same time, these countries will have the least resources available
to protect their citizens and to slow the transmission of the disease.

*153 The demands of distributive justice require that resources be expended equitably, with attention paid to meeting
the needs of those who are most vulnerable. In the context of pandemic influenza, this means that resources must be used
in a fashion that can alleviate the greatest amount of human suffering and death. If the developing world is at the greatest
peril from the disease, then wealthy countries have a duty to assist them to provide the greatest degree of protection
that is feasible given the worldwide scarcity of resources. Furthermore, at least early in a pandemic, resource sharing

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will benefit both wealthy and developing countries. Models of influenza transmission indicate that a pandemic can be
stopped early on if adequate resources are used, 164 but all available measures are expected only to slow transmission
once a full-fledged pandemic is underway. 165 To the extent that a pandemic is likely to begin in a less developed country,
effectiveness of the intervention demands that wealthy countries assist poorer countries to combat a nascent pandemic.

Additionally, in all countries, a fair system for allocating health-promoting resources must be developed, as the demand
for medical care, hygienic measures, and other resources is likely to exceed the supply. This should be done with attention
paid to obtaining the greatest degree of health promotion possible. To the extent possible, there should be transparency
and broad participation in the rationing scheme.

4. International Cooperation and Coordination

The protection of the public health and national risk management is primarily the responsibility of national authorities.
All countries therefore should develop a national influenza preparedness plan. In designing a justifiable containment
strategy, each state needs to consider state-specific factors such as national political structures and principles, educational
and cultural environment, the prevalence of the virus, and the strengths and weaknesses of the state's health care system.
While different national approaches ordinarily are not a problem, considerable variation in response plans could prevent
or delay an efficient response in a multi-country public health emergency. 166 Cooperation among national authorities
and coordination by international bodies is therefore necessary. 167

*154 The WHO put particular emphasis on cooperation and coordination in its 2005 International Health Regulations
(the Regulations), a revision of the 1969 text. The Regulations require countries to develop, strengthen, and maintain core
public health capacities to detect, assess, and notify the WHO of events that may constitute a public health emergency of
international concern via National IHR Focal Points in each State Party. 168 In June 2007, the Regulations will become
legally binding on all WHO Member States, except those that have rejected them or submitted reservations. In light
of the concern surrounding avian influenza, in May 2006, the 59th World Health Assembly adopted Resolution 59.2,
which called upon WHO Member States to comply immediately and voluntarily with the provisions of the Regulations
relevant to the pandemic influenza risk.

In addition to cooperation at the state level, there is a need for cooperation between international agencies. The response
to a pandemic, especially in its early stages, will be borne by many international agencies, including the WHO, the Food
and Agriculture Organization (FAO), and the World Organization for Animal Health (OIE). Additionally, national
entities, such as the Centers for Disease Control and Prevention (CDC) in the United States, will be responsible for
picking up international burdens during a pandemic. It will be important for knowledge gained by one entity to be
disseminated quickly to other entities. Further, given the scarcity of resources that will be available to stem a pandemic,
it will be important that work done by one agency not be unnecessarily duplicated by others--efforts spent unnecessarily
will trade off with other, potentially life-saving efforts.

F. Public Health Surveillance

Surveillance is the backbone of public health, providing essential data to understand the epidemic threat and inform
the public. Surveillance strategies include rapid diagnosis, screening, reporting, case management reporting, contact
investigations, and monitoring trends. It is clear that surveillance will be necessary to quickly identify and respond to a
pandemic influenza outbreak. The revised regulations require that, once a country identifies a signal suggesting human-
to-human transmission, the country must immediately investigate and notify WHO of the event because any human
influenza caused by a new subtype must be reported to *155 WHO. The “triggering criteria” of early pandemic activity
cannot be fully set out ahead of time. Public health officials should thus be vigilant and report all plausible signals that
a pandemic virus may be emerging.

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1. Global Responsibility to Develop Core Surveillance Capacities

Ideally, all countries would have the capacity to perform core surveillance functions. However, such a recommendation
is impractical for many developing countries, which often lack the resources for animal or human surveillance and
containment of outbreaks. 169 Specifically, in sub-Saharan Africa, the capacity for veterinary and human surveillance
is limited or nonexistent. 170 In this and in other impoverished regions, allocating resources for the development or
improvement of surveillance infrastructure may divert resources from a country's other, more immediate needs. 171 It
can be difficult, for example, to convince the government of a developing country that has a high incidence of HIV or
malaria to invest scarce resources towards the monitoring of a potential influenza threat.

Developed countries should be aware of this tradeoff and take measures to ensure that enhanced surveillance does
not occur at the expense of managing the multitude of ongoing public health threats many developing countries face.
Recognizing this imperative, many countries have pledged significant funds to meet the costs estimated by the World
Bank to contain avian influenza. 172 These funds will only temporarily address the need for surveillance, however. The
avian flu threat might not manifest itself for years, and future pandemics are almost certain to occur. Thus, it would be
desirable to pursue the larger goal of creating sustainable public health systems across the globe. To this end, WHO's
Commission on Macroeconomics and Health estimates that industrialized countries would have to spend $27 billion in
2007 to meet global needs for essential public health services. 173

*156 2. Mitigating Privacy and Autonomy Risks

Surveillance poses privacy risks as governments must collect sensitive medical information from patients, travelers,
migrants, and other vulnerable populations. 174 Many countries have data protection statutes; however, these laws often
make exceptions for surveillance in the context of a public health threat. 175 In a crisis situation, however, disclosure
may be warranted when the immediate use of the information is necessary for an important public health purpose and
disclosure is restricted to the confines of the public health system. Under these circumstances, the identity of the affected
person should be protected as much as possible. The inclusion of any uniquely identifiable characteristics, such as a name,
government identification number, fingerprint, or phone number should be avoided, particularly when the information is
released outside of the public health system. Cases should stay anonymous or encrypted when reasonably feasible. Only
the minimum amount of information necessary to achieve the goal should be released, and to as few people as possible.

Screening and testing also can pose serious threats to a person's privacy and bodily integrity. Ideally, public health
officials should receive the individual's informed consent prior to performing any medical tests; however, in rare cases,
mandatory testing might be necessary to advance the public good. A mandatory testing policy may be permissible when
it is clearly necessary and effective in protecting the public health, it is performed by competent public health officials,
and the least intrusive means are being used. At a minimum, compulsory testing should be limited to individuals known
or at least suspected to be infected and should be done in a fair and non-discriminatory way. In addition, the individuals
whose rights are being infringed should be informed of the reasons for the infringement.

Countries should enact public health information privacy laws to require justifiable criteria for data disclosure and to
prohibit wrongful disclosures, for example, to employers, insurers, and immigration or criminal justice authorities. 176
Whenever a government authorizes or mandates the *157 disclosure of identifiable health data, it should make public
the proposed use of the data, the reason for disclosure, and the extent to which third parties can have access to the data.

G. Limiting Animal/Human Pathogen Interchange

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Close proximity between animals and humans poses serious risks as novel pathogens mutate and jump species. 177
Live bird markets, traveling poultry workers, fighting cocks, and migratory birds are vectors for spreading avian
influenza. 178 Recently, Influenza (A) H5N1 also has spread to tigers, 179 leopards, 180 pigs, 181 domestic cats, 182 and
stone martens. 183 Consequently, an early preventive strategy is critical to limiting animal/human interchange. Strategies
to diminish the risk include separation of animal and human populations, health and safety in animal farming, and
proper management of diseased or exposed animals.

1. Avoiding Proximity

Safe farming practices and the separation of animals and humans are critically important from a public health and
economic perspective. Avoiding proximity between animals and humans can reduce the risk that the avian H5N1 virus
will mutate and jump species. 184 The separation is hard to accomplish, however, given a culture of close contact
between animals and humans in most countries. For example, the domestication of poultry is often necessary for family
survival 185 and in many African and Asian countries, backyard chickens are kept not only for food but also as pets. 186
As one researcher reports, in Hong Kong, “thousands of residents are avid birdwatchers and Kowloon's famed Bird
Garden is one of the world's largest marketplaces for exotic birds of all kinds.” 187 Given these *158 cultural norms,
policies separating animal and human populations can cause not only economic hardship but also social unrest. Thus,
governments and health care sectors should publicize clear rationales for such separation orders and should initiate and
facilitate constructive public discussion about measures that can be taken to suppress the transmission of the virus.

2. Due Process and Compensation for Culling Decisions

Given that disease containment strategies can have a profound impact on the lives of individuals, it is ethically imperative
that governments carefully construct their animal control policies. While mass slaughter of diseased and exposed animals
seems to be the most logical way to achieve eradication of H5N1, it raises significant ethical concerns. A massive culling
of birds can have a devastating economic toll on the poultry industries of the affected nations and the livelihoods of all
classes of poultry owners, producers and their employees. Economic studies further indicate that those hardest hit by
culling of flocks are individual farmers whose sole source of income generation is their poultry. 188 While culling has
already played an important role in combating the current avian influenza strain, more convincing scientific evidence of
its effectiveness in combating a pandemic influenza is needed for it to be ethically acceptable. Moreover, the appearance
of H5N1 in wild birds and mammals has significantly diminished the possible advantages culling could bring.

For culling decisions to be justified, the public benefit should outweigh the personal and economic burdens placed on
individuals. Judicial procedures are necessary to fairly balance societal interests and the interests of affected individuals.
Governments should incorporate due process into their culling procedures by creating an a priori procedure for fair
reviews of a decision to cull. Affected individuals should receive some notice of the proposed containment measure and
be permitted to consult with counsel; if they cannot afford counsel, the government should provide one; a subsequent
hearing should be held as soon as possible after the decision to cull; and the hearing should be held before an independent
and accountable tribunal so as to allow farmers and families to protest erroneous or arbitrary decisions. Ideally,
individuals should be allowed to appeal the tribunal's final order.

The extent to which procedures can be implemented depends, however, on the urgency of the emergency and the
availability of resources. Public health officials might have to mitigate the ideal procedural standards in certain
circumstances. Therefore, at the very least, to ensure non- *159 discrimination and proportionality, public health
officials need to publicly justify their decisions and the criteria applicable to the proposed measures. Moreover, the
process by which decisions are made should be open to scrutiny, and the basis upon which decisions are made should
be publicly accessible. Transparency and community participation in the decisionmaking process will enhance trust and

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acceptance. Post hoc review measures should be put in place to ensure that decisionmakers are accountable for their
actions.

The economic impact of culling decisions, especially on small farmers, is significant. Consequently, the principles of
distributive justice and reciprocity require adequate compensation as an ethical imperative. 189 This compensation
could include providing alternate sources of food if culling involves depleting a family's source of nourishment. A
recommendation of this nature will be useless, however, without financial aid from developed countries. In light of
the economic consequences, when poultry export industries and the livelihood of farmers are at stake, it is uncertain
that affected countries and individuals will be sincere about reporting the extent to which their flocks are infected. 190
Adequate compensation and open communication will, however, increase the incentive to report outbreaks. In addition,
education programs should be directed to decreasing the stigma and social hostility toward infected people and countries.
International cooperation and coordination will be essential.

3. Mitigating the Economic Impact of Trade Restrictions

Avian influenza causes severe financial and trade impacts. Recent H5N1 outbreaks have adversely affected industry
profitability, employment, household livelihoods, and, potentially, food security, in many countries around the globe.
Hundreds of millions of domesticated fowl have been culled or have died of infection, devastating domestic poultry
production. 191 The overall impact of the current strain of avian influenza hurts all livestock sectors by increasing
price volatility and generating uncertainties in markets. Research shows that “[t]he short-term costs to economies are
considerable, and even short-term market impacts have long-term implications for trading patterns, policy formulation,
longer-term investment in the sector, and overall industry and sector development.” 192

*160 The detection of the avian influenza virus threatens not only to transform the eating habits of the population,
but also to sharply curtail the export market. Many countries have introduced large-scale import controls and bans in
response to outbreaks. For example, the United States and India ban the import of all birds from affected areas; 193
European authorities ban poultry and feathers from the Black Sea region; 194 Japan bans the import of all poultry
products from France; 195 China, Japan, Malaysia, Singapore, and the Republic of Korea banned imports from the
United States following a reported outbreak of a less virulent strain of avian influenza. 196 Some countries even prohibit
the importation of birds from nations that vaccinate their flocks, arguing that the vaccines (although usually protective)
mask symptoms in infected birds. 197 When considering a trade restriction, ethical considerations should balance the
risk to the public's health against the harm that will be done by the restriction.

Nuisance bans on poultry imports because of small, localized outbreaks of the H5N1 virus in exporting countries
should be avoided. In May 2005, the OIE advised governments to “allow trade to occur from certain zones or
from compartments within a country even though avian influenza may be present in a completely separate zone or
compartment in that country.” 198 To that end, the regionalization of bans should be promoted. Timely dissemination of
all relevant information about influenza outbreaks, interactions among animal and human health authorities, and rapid
containment and eradication of the virus where it has emerged are necessary conditions for regional bans to be effective.

H. Community Hygiene and Hospital Infection Control

Hygienic measures to prevent the spread of respiratory infections are broadly accepted and have been widely used
in previous influenza pandemics 199 and the SARS outbreaks, although with uncertain benefits. 200 *161 Infection
control includes hand-washing, disinfection, respiratory hygiene, and personal protective equipment (PPE). 201 Evidence
supports the use of hand hygiene and hospital infection control measures, but the effectiveness of disinfection, respiratory

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hygiene, and PPE in the community is unclear. 202 Research is needed to understand the appropriate role of community
hygiene in a future pandemic. For example, mask use was common during the 1918 influenza pandemic and SARS
outbreaks, but no controlled studies have evaluated its effectiveness. 203

1. Encouraging Community Hygiene

Even if hygienic measures are effective, professionals and the public must use them properly and sustainably. Infection
control is challenging (e.g., appropriately-fitted N95 respirators) and must be used reliably until the risk subsides.
Studies demonstrate inconsistent infection control in hospitals, and the general public has not uniformly adopted even
basic hygiene practices such as hand-washing. 204 During the SARS epidemic, people in affected areas used protective
measures inconsistently. 205

It is important to accurately inform the public of the need for hygienic measures, including the uncertainty of the
measures' effectiveness. In past epidemics, misinformation has been rampant, leading to substantial public anxiety,
reliance on word of mouth for knowledge, and purchase of ineffective and expensive products. 206 Issues of distributive
justice arise because ineffective or inaccurate communications will impact the most marginalized members of society
most heavily. Marginalized members of society are those without access to alternative, credible sources of information
and those for whom wasting resources would have the greatest adverse effects. Finally, information should be provided to
the public so individuals are able to make informed decisions about their health. The information disseminated through
public education campaigns should be clear, uncomplicated, and not sensational or alarmist. Research indicates that
panic is rare during civil emergencies, but that providing clear, *162 consistent, credible, and instructive information
will assist the public in coping with fear. 207 It is important to avoid information that fails to treat members of the public
as rational agents. The public should be treated as a partner, enhancing the principle of transparency.

Planning for community-level preparedness should account for variations in settlement patterns. Different types
of settlements will present unique risks and challenges during a pandemic. Similarly, communities' unique cultural
characteristics can interact with emergency preparedness endeavours. Public education campaigns are difficult when
multiple languages are spoken in a community and when individuals have varying levels of literacy and access to media.
Preparation plans must account for these geographic and cultural differences. They also must include diverse media
sources, which can be achieved by encouraging community involvement in the planning and implementation process
and by utilizing leaders from community subpopulations.

A lack of mass media infrastructure will impede broad dissemination of information in some areas. Resource constraints
also prevent some populations from receiving messages that are distributed via costly media and a lack of governmental
infrastructure may make dissemination of messages much more difficult. Furthermore, media may not be universally
available to cater to particular subpopulations and insufficiently educated portions of the population.

However, countries should strive to reduce these problems by using existing communication networks. Health care
workers and trusted community sources should be consulted and informed about hygiene measures in order to assist
communication efforts by tailoring messages and making them accessible to target audiences. Messages should be posted
in places such as markets, where the whole community is likely to see them.

2. Ensuring the Appropriate Use of Hospital Infection Control

Guidance exists to prevent the SARS-associated corona virus from spreading quickly in hospitals. 208 Disinfection,
hand hygiene, PPE, and aerosol-generating procedures should be standard hospital practices. 209 Because of the
historically high attack rate of influenza among health care workers, 210 the high degree of transmission from people not

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demonstrating *163 clinical illness, 211 and the ease of transmission in crowded areas, 212 health practitioners who do
not practice strict infection control may amplify disease transmission. It is vital to train health care workers and monitor
the use of such measures. This could be done through legal oversight or licensing requirements.

There also are ethical concerns relating to hospital infection control and distributive justice. The level of resources that
can be dedicated to infection control will vary substantially between and within countries. Recognizing this, a fair system
of allocating scarce infection control resources should be developed. It is important to involve hospital staff in planning
for the implementation of heightened infection controls and the creation of a fair system for determining who carries
out high-risk tasks. Cultural sensitivity should be employed and control methods that require restricting valued personal
and cultural behaviors (such as the shaving of beards to properly fit masks) should be carried out through consultation
with affected people. Additionally, one should ensure that the implemented policies reflect the best available scientific
research.

Nations should create training and monitoring programs to ensure that hospitals effectively use standard infection
control procedures. Training programs are most effective when based on available science and provide practitioners with
the information needed to minimize risks to them and their patients. Programs should be created with the involvement
of practitioners, while implementation of these programs should be adapted to the specific features of health care
institutions.

Limitations may impede countries' abilities to implement an ideal training and monitoring program. Some countries
will lack the resources to purchase adequate PPE for a disease of long duration, while other countries may lack
sufficient health care infrastructure to implement new programs on a speedy basis. Civil unrest may impede monitoring
of programs. In such cases, legal infrastructure may have to be developed to enforce compliance with training and
monitoring efforts.

Alternatives exist for countries facing substantial limitations. The strictness of infection control may have to be relaxed;
for example, surgical masks may have to be substituted for N95 respirators. If areas do not have access to isolation
rooms, segregating infectious patients into separate wards or hospitals or recommending home stay for mildly ill patients
may be appropriate. Additionally, training without full oversight may be necessary should monitoring become infeasible.

*164 Countries will also have to develop a method to ration scarce protective equipment. Governments will have to
determine how to distribute masks and other PPE in a fair manner. Such plans should give serious consideration to
questions of justice and seek to find a rationing scheme that maximizes health protection. Plans should be devised openly,
with an opportunity for both experts and the public to be heard. It is important to enact a fair distribution process.

Additionally, policymakers will have to address the problem of critical shortages in infection control and patient care
equipment (e.g., particulate respirators, surgical facemasks, hand sanitizers, disinfectants, ventilators, intensive care
beds, and the like). 213 Given the potential duration and scope of a pandemic, even increased production of PPE will be
overwhelmed by the demand, especially if use in hospitals and the community is widespread. International collaboration
will be needed to address this problem. Further research is needed to develop reusable respirators 214 and to determine
the effectiveness of alternatives to N95 respirators. 215 It is critical that research is conducted collaboratively and that
results are shared in a fashion that fosters trust and transparency. Cooperation between companies, governments, and
researchers will facilitate improved production and greater efficiency at meeting shortages of equipment.

I. Decreased Social Mixing/Increased Social Distance

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Past experience shows that social separation and community restrictions form a significant response to pandemics. 216
There is limited evidence that school closure reduces seasonal influenza transmission, 217 and it is assumed that decreased
social mixing slows the spread of respiratory disease. 218 Thus, societies have closed public places and cancelled public
events in the face of pandemics. As fear rises, individuals may shun social gatherings. Predicting the effect of policies
to increase social distance is difficult because infected persons and their contacts may be displaced into other settings,
and individuals may voluntarily separate in response to perceived *165 risk. 219 For these reasons, additional research
needs to be conducted on behavior during epidemics and the effects of social distancing on transmission.

Social separation, particularly for long durations, can cause loneliness and emotional detachment, disrupt social and
economic life, and jeopardize individual rights. Community restrictions raise profound questions of faith (religious
worship), family (funeral attendance), and protection of the vulnerable (food, water, clothing, medical care).

1. Government Authority and Accountability

Undoubtedly, most judicial systems would uphold reasonable community restrictions, but legal and logistical questions
loom: Who has the power to order closure, under what criteria do they have such power, and for how long? What
threshold of disease should trigger closure, and should thresholds be different for different entities? Under what
circumstances should compensation for closures be paid? What should be the penalties for non-compliance? Enforcement
and assurance of population safety remain critically important, but unanswered, questions in most countries.

One might fear that governments would restrict personal liberties unnecessarily. This could occur through implementing
restrictions before they are needed, extending restrictions beyond a disease crisis, or enacting restrictions that do not
decrease influenza transmission. In these situations, closures could encroach on the important values of necessity
and proportionality. Furthermore, it is important to remember that restrictive policies will be borne most heavily by
those with the fewest resources, so errant social distancing actions have distributive justice implications. Lastly, one
might worry that governments would use social distancing in a discriminatory fashion, scapegoating ethnic or religious
minorities, or using social distancing to pretextually crack down on dissidents who assemble to protest.

Ideally, questions of government authority and accountability would be answered by policy decisions made before a
pandemic hit and created as part of an open and transparent process that encourages input from all portions of society.
Governments should explicitly define who has the power to order social distancing strategies, and for what period of
time. Governments should also clearly state the criteria under which such power is exercisable and clearly delineate the
legitimate bases for any differential treatment. Penalties should be proportional to offenses and not based on irrational
fears or discriminatory beliefs.

*166 However, one must recognize that detailed pandemic influenza preparations are not the highest priorities for many
countries dealing with important and immediate concerns. Furthermore, some countries lack the legal and governmental
infrastructures to implement the ideal plan outlined above. At the very least, governments should dedicate themselves
to non-discrimination and transparency before an influenza pandemic occurs. It is important that social distancing
policies are implemented fairly and with broad planning involvement. This will not only help safeguard important ethical
considerations, but also will improve the likelihood that the public will accept social distancing. Given that compliance
with social distancing instructions will be difficult to enforce, public acceptance is critical to the measures' success.

2. Workplace Closings

Workplace and school closings present difficult ethical issues. Apart from the uncertainty of their effectiveness, the
most important questions are those of distributive justice. Workplaces represent the livelihoods of both employees and
entrepreneurs, so closing them can cause severe financial hardships. Lost profits caused by closures may force companies

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to go out of business, leading to job losses and other economic hardships. These problems may have a significant
effect on anyone, but especially for those living at a subsistence level. Prior to an emergency, public health authorities
should cooperate with industry and trades unions to establish mutually agreeable work closure procedures. However,
for situations where workplaces should close but do not, employment protections are needed for workers who wish to
comply with a social distancing order against the wishes of their employer. Similarly, one can imagine businesses closing
in compliance with instructions, but workers seeking other work for need of income. Government needs mechanisms
to encourage compliance with a social distancing order. Though governments should retain the legal power to enforce
closures if absolutely necessary, it would be preferable to subsidize lost profits and incomes as necessary. The latter
approach was used extensively in countries affected by SARS for people placed in quarantine. 220

Practical constraints prevent some countries from being able to enact this solution. Many countries have more pressing
needs than addressing a potential pandemic. Furthermore, some countries may be unable to provide compensation for
closure. In 1918, each wave of the pandemic lasted for *167 several months, and most locations were hit by multiple
waves. 221 The amount of resources needed to compensate for lost income or profits for this amount of time may be well
out of the reach of many of the world's governments.

In light of these constraints, governments should, at the very least, weigh seriously the risks to health and welfare from
workplace closures and other social distancing measures against the preventive effects on disease transmission. For each
country, the balance of risks may be resolved differently, depending on the country's resources and financial situation of
the population. Countries should consider tactical closures if necessary. Perhaps only those entities that most facilitate
transmission should be closed. Schools have been identified as a primary driver of seasonal influenza 222 and are also
believed to be a substantial factor during pandemics. Countries might also consider using closures as a means to buy
time for other preparations. Finally, closures could be implemented until the level of disease in a community exceeds a
predetermined level and then relaxed, with the hope of slowing the initial spread of disease through the community.

3. Provision of Necessities

If people are instructed to avoid public places or if those places are required to close, there will be a need for people to
procure food, medicine, and other necessities. Similarly, stoppage of mass transit may prevent people from being able
to access facilities that remain open, and it may prevent some people from being able to seek medical care. There is a
distributive justice concern relevant to all of these issues--namely, those with the least resources are least likely to be
able to procure additional resources before closures occur. They are also the least likely to have private transportation
available to seek medical care. Thus, they are both less likely to be able to receive care and more likely to have to remain
in homes with infectious people.

Ideally, governments would set up networks for the distribution of necessary provisions to citizens' homes. Distribution
would be conducted in a manner that takes into account ease of access in particular communities. It would be consistent
and reliable and provide necessities such as food and medicine for the duration of social distancing measures. It should
also be conducted in such a manner that minimizes interaction with potentially infectious people and infection control
precautions should be employed to decrease the likelihood that supply distributors will vector disease. Transportation
for medical care should be provided as needed by *168 personnel who are apprised of the risks involved and provided
with appropriate personal protective equipment. Similarly, a program should be put in place for the removal of bodies
from homes in a safe and efficient manner.

Resource constraints and logistical difficulties are likely to impede such a program in many areas. Many governments
may lack the resources to provide food, medicine, and other necessities to its citizens during a pandemic. Even if the
resources are available, the workforce needed to conduct distribution may be absent, especially at the height of a

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pandemic. Furthermore, there may be a lack of people who want to interact closely with potentially infectious people to
allow such a system to function. This may be especially true for medical transport and mortuary services.

At the least, governments should try to facilitate the provision of resources before areas are affected by disease. To the
extent possible, governments should give advance warning of disease and make recommendations about how much food,
medicine, and other supplies should be stockpiled. If possible, governments should provide these for people unable to
afford their necessities. Governments should provide access to medical care to the greatest extent possible and assign
public safety officers for this purpose. Governments also should provide a means by which people who have recovered
from influenza (and are therefore immune), could assist others in the provision of necessities.

J. International Travel and Border Controls

Transnational public health law is increasingly important in global health, as evidenced by the WHO's International
Health Regulations and national agencies' proposed communicable disease regulations. 223 These legal initiatives reflect
recommendations for border controls by the WHO. 224 Transnational containment measures can include entry or exit
screening, reporting, health alert notices, collection and dissemination of passenger information, travel advisories or
restrictions, and physical examination or management of sick or exposed individuals. These kinds of powers were
exercised in Asia and North America during the SARS outbreaks, although their effectiveness is not established. 225 The
IHR also *169 authorizes sanitary measures at frontiers or on conveyances, such as inspection, fumigation, disinfection,
pest extermination, and destruction of infected or contaminated animals or goods. 226

1. Economic Impact of International Travel and Border Controls

Sovereign nations seek to safeguard their citizens' health from external threats, even in a global world where people,
animals, and goods rapidly travel across state boundaries. Although border protection is legitimate, it can severely
disrupt travel, trade, and tourism. The World Trade Organization (WTO) defends free commerce but permits science-
based trade restrictions to protect the public's health. 227 As with trade restrictions, protection of the public's health
needs to be balanced against the global economic impact of any travel restrictions or border control policies. Closure of
borders will have an enormous global economic impact. World travel and tourism account for about 10% of global GDP
and 8% of global jobs, generating more than $4 trillion in economic activity and over 200 million jobs in 2005. 228 During
the SARS outbreaks, tourism in Asia dropped 30% to 80% for various countries in the region. After travel bans were
put in place, almost half the planned international flights to Southeast Asia were cancelled. Even Australia saw a 20%
decline in international arrivals. Even if countries will not officially close their borders during an influenza pandemic,
voluntary social distancing would disrupt trade, transport, and travel. 229 In fact, studies suggest that European travel
bookings have already diminished due to H5N1 fears. 230

Given the sensitivity of economic disruptions of trade and travel during a pandemic, international coordination of
border control policies is essential to avoid misunderstanding and promote cooperation. While the economic impact of
a pandemic will be considerable for both developed and developing countries, the long-term consequences will be harder
to overcome for the latter. Industrialized countries should be aware of this when making decisions with transnational
impact. Governments should only take those measures that are necessary to address the actual risk to the community.
Travel and border control measures should be implemented in a non-discriminatory fashion, and only when the harms
caused by the intervention are proportionate to the benefits.

*170 2. Governmental Transparency and Coordination

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Given the transboundary nature of travel advisories as well as the economic impact they can have on affected countries,
it should be left to the WHO to issue transparent and clearly justified travel recommendations in accordance with
the revised IHR. Individual countries should communicate all relevant information on the emergence of a public
health threat to the international community. Ultimately, it is the responsibility of the national government to use any
policy instruments available to ensure compliance with the requirements of the new IHR. Reporting and surveillance
responsibilities may be beyond the capacity of developing countries. The industrialized countries should show solidarity
and be open in the way they carry out health protection responsibilities.

Fear of infection and uncertainty about the risk and virulence of the virus can have a negative impact on the global
economy. Reactive and uncoordinated national actions to close borders or embargo trade could fuel unfounded
fears in the early days of a pandemic, similar to the early stages of the SARS epidemic when public fears were
amplified by concerns that some governments were withholding information about the disease. To avoid unwarranted
travel disruptions and economic burdens governments have the responsibility to honestly disclose credible scientific
information as early as possible.

3. Civil Liberties

International travel and border control also can infringe upon civil liberties. The freedom of movement is a basic right
protected by national laws and international treaties, but it is subject to limits when necessary for the public's health. 231
In particular, these strategies can present serious privacy risks. For example, containment measures may require the
travel industry to collect and disclose passenger data. 232 Privacy burdens are justified only if necessary to obtain high-
quality surveillance data and in accordance with fair information practices. To avoid discrimination and to ensure
proportionality, public health officials should inform the affected individuals about the reasons for the infringement, the
intended use of the information and the extent of third parties access to the data.

*171 K. Isolation and Quarantine

The terms “quarantine” and “isolation” often are used interchangeably, but they are, in fact, distinct. The modern
definition of quarantine is the restriction of the activities of asymptomatic persons who have been exposed
to a communicable disease, during or immediately prior to the period of communicability, to prevent disease
transmission. 233 In contrast, isolation is the separation, for the period of communicability, of known infected persons in
such places and under such conditions as to prevent or limit the transmission of the infectious agent. 234 Quarantine and
isolation can be accomplished by various means, including having the person stay in his or her home, restricting travel out
of an affected area, or having the individual stay at a designated facility. 235 Whatever techniques are used, it is important
to treat symptomatic, potentially exposed, and non-exposed populations differently. It would be inappropriate to place
infected individuals in the same room as those who are only potentially exposed.

Isolation and quarantine were used widely in Asia and Canada during the SARS outbreaks in 2003. 236 In Toronto,
between 13,000 people 237 and 30,000 people 238 were quarantined. In Beijing and Taiwan those numbers were even
higher--specifically, 30,000 people in Beijing and 131,000 people in Taiwan were quarantined. 239 While quarantine and
isolation played a major role in the containment of SARS, they will be less appropriate as containment measures during a
pandemic influenza. Unlike SARS, influenza's transmission characteristics allow little time for isolation and quarantine.

*172 Whatever their effectiveness, quarantine and isolation are the most complex, not to mention legally and ethically
controversial, of the public health powers. Quarantine and isolation represent the tension between the interests of society
in protecting and promoting the health of its citizens and the individual's rights of privacy, non-discrimination, freedom
of movement, and freedom from arbitrary detention. 240 The legitimacy of such coercive public health powers rests on a

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careful balancing of these competing interests, 241 with the public benefit outweighing the burden quarantine may place
on individual rights. Additionally, each country should comply with the internationally agreed upon Siracusa principles,
which hold that restrictions of liberty should be legal, proportionate, necessary, and according to the least restrictive
means that are reasonably available. 242

1. Legal Authority

Clearly defined jurisdictional boundaries and limits on governmental power are necessary to create public accountability.
Statutory criteria should incorporate rigorous scientific measures of risk and allow quarantine only when necessary for
the public's health. Governments should use coercive health measures only when a disease is known through extensive
scientific study to be contagious. Moreover, governments should limit application of the measures to those actually
exposed to the disease. 243

Occasionally, resource and time constraints will justify immediate government action without prior medical testing of
each individual. In addition, the availability of accurate tests and competent medical staff can be limited. However, to
ensure the legitimacy of such measures, public health authorities should fully and honestly disclose their reasons for
action and allow community participation in such decisions. Transparency will enhance public trust and acceptance of
the proposed containment measures. 244

2. Due Process (Natural Justice)

In addition to substantive protections, judicial procedures--specified in terms of the process, rather than the outcome--are
necessary to ensure the legitimate use of isolation and quarantine. Ideally, quarantine and isolation *173 would affect
only those that are actually infected with H5N1. However, such infallibility is unlikely. Therefore, governments should
design judicial procedures that reach toward the more feasible goal of protecting the public health while minimizing
human rights violations and ethical concerns.

Of particular concern is the protection of groups of people--especially minority populations--from the inappropriate
use of state power. Regardless of a country's judicial system and infrastructure, governments should avoid restrictions
on individual movement that are arbitrary, unreasonable, or discriminatory. Isolation or quarantine orders should last
no longer than scientific review justifies. Public health officials should publicly explain their decisions and re-evaluate
any orders on a regular basis. Moreover, countries should have procedural mechanisms for groups to challenge the
unjustified use of quarantine or isolation power.

As important as individual due process rights are, the urgency of a pandemic outbreak might preclude individual
hearings. Many countries do not possess the judicial infrastructure to cope with the volume of hearings that would
result from a mass quarantine, particularly since the high morbidity and mortality associated with a highly pathogenic
influenza pandemic would strain the already existing infrastructure. However, developing countries with strong judicial
infrastructures should maintain individualized due process to the extent feasible.

3. Monitoring and Enforcement: Voluntary or Least Intrusive Means

Quarantine and isolation should be voluntary whenever possible. When mandatory containment is necessary,
governments should first apply the least restrictive measures followed, when necessary, by a graded application of more
restrictive measures. 245 For example, while Canadians generally complied voluntarily with quarantine requests during
the SARS outbreak, 246 public health officials elsewhere--including China, Hong Kong, and Singapore--had to use
more coercive measures. In Hong Kong, barricades and tape were used to confine infected residents in a large housing

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complex. 247 In Singapore, three telephone calls were made per day *174 to the home of each quarantined individual
to confirm compliance. 248 Surveillance cameras were placed in homes where people were quarantined, and inhabitants
were required to take their own temperatures on camera to avoid fraud. 249 Electronic wrist or ankle-bands also were
used as enforcement measures. 250

Different countries have different norms and needs, and one must view different enforcement measures in the context
of what a given society considers to be reasonable. At a minimum, the monitoring and enforcement measures adopted
should have a logical and proportionate relationship to the achievement of the public health objective and should be
implemented in a fair and non-discriminatory manner. Finally, all measures taken should be culturally accepted and
collectively approved by the populace. 251

4. Ensuring Safe, Humane Implementation of Isolation or Quarantine

When quarantine and isolation are necessary, the principle of reciprocity obliges society to provide those affected with the
necessities of life during the period of quarantine, including safe and humane housing, as well as high quality medical care
and psychological support. Recent studies have confirmed that quarantine imposes serious financial and psychological
hardships on affected individuals: about 30% of quarantined individuals suffer from post-traumatic stress disorder and
depression. 252 All countries should be required to provide and pay for these basic needs. Furthermore, quarantine needs
to be implemented in a humane manner that is sensitive to gender, religious, and ethnic issues.

Distributive justice requires that officials limit the extent to which the personal and economic burdens of a public health
threat fall unfairly upon individual citizens. To this end, governments and national and international organizations
should stockpile medical supplies and food in an effort to fairly and equitably address any lack of resources and amenities.
A pandemic influenza will require solidarity among nations and collaborative approaches that set aside traditional values
of self-interest and territoriality.

*175 Conclusion

Preparing for an influenza pandemic presents difficult challenges, many of which transcend mere scientific effectiveness.
Even when successful, coercive public health interventions can have deep, adverse consequences for economic and civil
liberties. Therefore, it is vital that individual rights are sacrificed only when necessary to protect the public health. As
such, laws must clearly establish the criteria for the exercise of such emergency powers and provide adequate due process
to minimize infringements on individual rights.

The threat of an influenza pandemic is real and could affect millions of lives. If such a disaster occurs, we must not allow
the widespread erosion of individual rights to compound the tragedy. We must form an immediate political and social
response to the effect coercive public health measures will have on civil liberties. Only then are we equipped--ethically
as well as scientifically--to deal with the impact of a global pandemic.

Footnotes
This paper is an expanded version of a two-part series: Lawrence O. Gostin, Medical Countermeasures for Pandemic
Influenza: Ethics and the Law (Part I), 295 J. Am. Med. Ass'n 554 (2006); Lawrence O. Gostin, Public Health Strategies for
Pandemic Influenza: Ethics and the Law (Part II), 295 J. Am. Med. Ass'n 1700 (2006). Professor Gostin and Mr. Berkman
acknowledge the able assistance of Deborah Rubbens, L.L.M., and John Kraemer, JD Candidate, Georgetown University
Law Center.

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a1 Lawrence Gostin is Associate Dean and Professor of Law, Georgetown University Law Center; Professor of Public Health,
the Johns Hopkins University; and Director, Center for Law and the Public's Health, a Collaborating Center of the World
Health Organization and Centers for Disease Control and Prevention.
aa1 Benjamin Berkman, J.D., M.P.H, Sloan Fellow in Biosecurity Law and Policy, Center for Law and the Public's Health,
Georgetown University Law Center.
1 See U.S. Dep't of Health and Human Servs., HHS Pandemic Influenza Plan 60 (2005) [hereinafter HHS Pandemic Influenza
Plan], available at http:// www.hhs.gov/pandemicflu/plan/pdf/HHSPandemicInfluenzaPlan.pdf; Homeland Security Council,
National Strategy for Pandemic Influenza 2 (2005) [hereinafter National Strategy for Pandemic Influenza], available at http://
www.whitehouse.gov/homeland/nspi.pdf.
2 See World Health Organization (WHO), Avian Influenza--Spread of the Virus to New Countries, Feb. 21, 2006, http://
www.who.int/csr/don/2006_02_ 21b/en/index.html.
3 See id.
4 See id.
5 See id.
6 See id.
7 See Ira M. Longini et al., Containing Pandemic Influenza at the Source, 309 Sci. 1083, 1083 (2005); H. Chen et al.,
Establishment of Multiple Sublineages of H5N1 Influenza Virus in Asia: Implications for Pandemic Control, 103 Proc. of the
Nat'l Acad. of Sci., 2845, 2845 (2006) [hereinafter Implications for Pandemic Control].
8 See Implications for Pandemic Control, supra note 7, at 2845, 2849.
9 See Dennis Normile, Evidence Points to Migratory Birds in H5N1 Spread, 311 Sci. 1225, 1225 (2006).
10 See Laurie Garrett, Avian Flu Update, Foreign Aff., Sept.-Oct. 2005, available at http://
www.foreignaffairs.org/20050701faessay84401/laurie-garrett/the-next-pandemic.html.
11 See The Writing Committee of the World Health Organization Consultation on Human Influenza A/H5, Avian Influenza
A (H5N1) Infection in Humans, 353 New Eng. J Med. 1374, 1379 (2005) [hereinafter Avian Influenza A (H5N1) Infection
in Humans].
12 See WHO, Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO, May 29, 2006,
available at http:// www.who.int/csr/disease/avian_influenza/country/cases_table_2006_05_29/en/.
13 See Tran Tinh Hien et al., Avian Influenza A (H5N1) in 10 Patients in Vietnam, 350 New Eng. J. Med. 1179, 1181, 1183 (2004).
14 See WHO, Avian Influenza: Significance of Mutations in the H5N1 Virus, Feb. 20, 2006, available at http://www.who.int/
csr/2006_02_ 20/en/index.html.
15 Samson S.Y. Wong & Kwok-yung Yuen, Avian Influenza Virus Infections in Humans, 129 Chest 156, 156 (2006).
16 See Robert G. Webster et al., H5N1 Outbreaks and Enzootic Influenza, 12 Emerging Infectious Diseases 3, 3-4 (2006).
17 See, e.g., Jeffrey K. Taubenberger et al., Characterization of the 1918 Influenza Virus Polymerase Genes, 437 Nature 889,
889 (2005) (asserting that the 1918 influenza virus polymerase genes more closely resembled avian-like flu strains than those
of a reassortant virus); Terrence M. Tumpey et al., Characterization of the Reconstructed 1918 Spanish Influenza Pandemic
Virus, 310 Sci. 77, 79 (2005).
18 See WHOHO, Avian Flu vs. Pandemic Flu (2005), available at http:// www.wvdhhr.org/healthprep/common/
avian_vs_pandemic_flu.pdf.

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19 See Laurie Garrett, The Next Pandemic?, Foreign Aff., July-Aug. 2005, available at http://
www.foreignaffairs.org/20050701faessay84401/laurie-garrett/the-next-pandemic.html (describing the Centers for Disease
Control and Prevention's (CDC) prediction of the impact of a “medium-level epidemic”); U.S. Dep't of Homeland Sec., Flu
Pandemic Morbidity/Mortality, available at http:// www.globalsecurity.org/security/ops/hsc-scen-3_flu-pandemic-deaths.htm
[hereinafter Flu Pandemic Morbidity/Mortality] (last visited Feb. 1, 2007).
20 See WHO, Avian Influenza: Assessing the Pandemic Threat, (2005) [hereinafter Avian Influenza: Assessing the Pandemic
Threat]; World Health Organization, supra note 18.
21 See, e.g., Flu Pandemic Morbidity/Mortality, supra note 19 (discussing studies performed by the Departments of Homeland
Security and Health and Human Services); Michael T. Osterholm, Preparing for the Next Pandemic, 84 Foreign Aff. 24, 26
(2005). Notably, seasonal (interpandemic) influenza causes worldwide yearly epidemics resulting in 1 to 1.5 million infections.
Id.
22 Estimates are based on extrapolation from past epidemics in the United States and can be found in the HHS Pandemic
Influenza Plan. For the original table, along with other information regarding HHS's planning assumptions, see HHS,
Pandemic Planning Assumptions, http:// www.pandemicflu.gov/plan/pandplan.html (last visited Feb. 9, 2007).
23 See World Bank, Report by Global Program for Avian Influenza and Human Pandemic, in Economic Impact
of Avian Flu, available at http:// web.worldbank.org/WBSITE/EXTERNAL/COUNTRIES/EASTASIAPACIFICEXT/
EXTEAPREGTOPHEANUT/ 0,,contentMDK:20713527~pagePK:34004173~piPK:34003707~theSitePK:503048,00.html
(last visited Feb. 1, 2007); United Nations Economic & Social Commission for Asia and the Pacific, An Effective Regional
Response to the Threat of a Pandemic, in 2 Socio-Economic Policy Brief 1 (2005), available at http:// www.unescap.org/esid/
hds/avianflu/policy-brief-n1-Oct2005.pdf.
24 See The World Bank East Asia and Pacific Region, Spread of Avian Flu Could Affect Next Year's Economic
Outlook, available at http:// siteresources.worldbank.org/INTEAPHALFYEARLYUPDATE/Resources/EAP-Brief-avian-
flu.pdf (last visited Feb. 1, 2007).
25 See Sherry Cooper, The Avian Flu Crisis: An Economic Update, available at http:// www.bmonesbittburns.com/economics/
reports/20060313/report.pdf (last visited Feb. 1, 2007).
26 See Congressional Budget Office, A Potential Influenza Pandemic: An Update On Possible Macroeconomic Effects and
Policy Issue s (2006), available at http://www.cbo.gov/ftpdocs/72xx/doc7214/05-22-Avian%20Flu.pdf [hereinafter A Potential
Influenza Pandemic] (summarizing the United States government's preparations for an avian flu pandemic).
27 See The World Bank East Asia and Pacific Region, supra note 24.
28 See World Health Organization Writing Group, Nonpharmaceutical Interventions for Pandemic Influenza, International
Measures, Emerging Infectious Diseases 81, 81 (2006) [hereinafter Nonpharmaceutical Interventions for Pandemic Influenza]
(noting that difficulties in influenza control include “peak infectivity” early in illness and short intervals between cases, among
other factors).
29 See, e.g., Jaro Kotalik, Preparing for an Influenza Pandemic: Ethical Issues, 19 Bioethics 422, 424 (2005). For an example
of this lack of attention to law and ethics, see HHS, MEDICAL OFFICES AND CLINICS PANDEMIC INFLUENZA
PLANNING CHECKLIST (2006), available at http:// www.pandemicflu.gov/plan/medical.html#3. This document purports
to be a “checklist to help medical offices and ambulatory clinics assess and improve their preparedness for responding to
pandemic influenza.” Id. However, it does not address the myriad legal and ethical issues that will arise.
30 See Timothy C. Germann et al., Mitigation Strategies for Pandemic Influenza in the United States, 103 Proc. of the Nat'l
Acad. of Sci. 5935, 5935 (2006); Anthony B. Iton, Rationing Influenza Vaccine: Legal Strategies and Considerations for Local
Health Officials, 12 J. Pub. Health Mgmt. Prac. 349 (2006); Klaus Stöhr & Marja Esveld, Will Vaccines be Available for the
Next Influenza Pandemic?, 306 Sci. 2195, 2195 (2004).
31 See A Potential Influenza Pandemic, supra note 26; Stephen Spotswod, HHS Flu Plan Aims to Lift Vaccine Supply, U.S.
Med. (2005), available at http://www.usmedicine.com/article.cfm?articleID=1210&issueID=82.

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32 See Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act of
2006, Pub. L. No. 109-148, 119 Stat. 2680, 2782-87 (2005); see also A Potential Influenza Pandemic, supra note 26.
33 HHS, Pandemic Planning Update, Mar. 13, 2006, at 2.
34 Bird Flu: Country Preparations, BBC News, Feb. 21, 2006, http:// news.bbc.co.uk/2/hi/health/4380014.stm.
35 Id.
36 Id.
37 Scott A. Harper et al., Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization
Practices, 54 Morbidity & Mortality Wkly. Rep. 1, 2-3 (2005); Kathleen M. Neuzil & Marie R. Griffin, Vaccine Safety--
Achieving the Proper Balance, 294 J. Am. Med. Ass'n 2763, 2763 (2005).
38 Susan Thaul, Vaccine Policy Issues: Congressional Research Service Report for Congress 7 (2005) [hereinafter CRS Report].
39 See WHO, World Health Assembly, Strengthening Pandemic Influenza Preparedness and Response 5 (2005), available at
http:// www.who.int/csr/disease/influenza/A58_13-en.pdf.
40 See id.
41 See WHO, Global Distribution of Influenza Vaccines, 2000-2003, 40 Wkly. Epidemiological Rec. 79, 357, 366 (2004), available
at http:// www.who.int/wer/2004/en/wer7940.pdf.
42 See id.
43 See David S. Fedson, Pandemic Influenza and the Global Vaccine Supply, 36 Clinical Infectious Diseases 1552, 1553 (2003),
available at http:// www.journals.uchicago.edu/CID/journal/issues/v36n12/20633/20633.web.pdf.
44 See id. See generally John M. Barry, The Great Influenza: The Epic Story of the Deadliest Plague in History (2004).
45 See Barry, supra note 44; Stöhr & Esveld, supra note 30, at 2196.
46 See Fedson, supra note 43, at 1154-55.
47 See id. at 1555.
48 See G. F. Rimmelzwaan et al., Pathogenesis of Influenza A (H5N1) Virus Infection in a Primate Model, 75 J. Virol. 6687,
6688-89 (2001).
49 .See, e.g., HHS Pandemic Influenza Plan, supra note 1, at 6 (illuminating some of the responsibilities that states and local
planners might face, including: distributing information, planning for vaccine distribution, and implementing immunization
registries).
50 Kendall Hoyt, Bird Flu Won't Wait, N.Y. Times, Mar. 3, 2006, at A23.
51 See WHO, Vaccines for Pandemic Influenza 10 (2004) [hereinafter Vaccines for Pandemic Influenza].
52 See Patricia M. Danzon et al., Vaccine Supply: A Cross-National Perspective, 24 Health Aff. 706, 706 (2005).
53 See David Brown, How U.S. Got Down to Two Makers of Flu Vaccine, Wash. Post, Oct. 17, 2004, at A01.
54 See Council of the Institute of Medicine, Appendix 1: Statement on Vaccine Development 262 (2001).
55 Ctr. for Global Dev., Global Health Policy: G-7 to Pilot Advance Market Commitments 1 (2005), available at http://
blogs.cgdev.org/vaccine/archive/2005/12/.
56 See HHS Pandemic Influenza Plan, supra note 1, at 24 (citing the need for the availability of at least 81 million treatments,
which is enough for about 25% of the U.S. population).

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57 See id. at 7 (declaring that states and communities should have their own plans in case of an outbreak); see also National
Strategy for Pandemic Influenza, supra note 1, at 24 (positing that one pandemic response action would be to administer the
vaccine according to state and local distribution plans).
58 CRS Report, supra note 38, at 1.
59 See id. at 11-14 (presenting some of the Food and Drug Administration's (FDA) review methods, including fast-track drug
development and accelerated approval).
60 Id. at 14.
61 See id. at 7 (describing the FDA's emphasis on the safety and effectiveness of the vaccines).
62 See id. at 2-3 (stating that each lot is evaluated based on its purity and potency).
63 21 C.F.R. §§ 314.600-314.650, 601.91 (2005).
64 See id. § 314.610 (showing that the animal tests must prove that the drug product is “reasonably likely” to benefit humans).
65 See id.
66 Andrew Pollack & William J. Broad, Anti-Terror Drugs Get Test Shortcut, N.Y. Times, May 31, 2002, at A1.
67 Kathi E. Hanna, Extraordinary Measures for Countermeasures to Terrorism: FDA's “Animal Rule,” 32 Hastings Ctr. Rep.
9, 9 (2002).
68 Id.
69 Cal. Health & Safety Code § 124172 (West 2006).
70 Iowa Code Ann. § 135.39B (2006).
71 See N.Y. Pub. Health Law §2 (McKinney 2005) (prohibiting women who know they are pregnant from being vaccinated
with an influenza faccine that contains more than 1.25 micrograms of mercury per 0.50 milliliter dose, provided that the
Commissioner of Public Health makes a yearly determination that an adequate supply of such low mercury vaccines exists).
This provision goes into effect in 2008. Id. § 3.
72 See Vaccines for Pandemic Influenza, supra note 51, at 13 (stating that this gives companies a more predictable environment
for developing and producing the vaccine).
73 Martin Enserink, As H5N1 Keeps Spreading, A Call to Release More Data, 311 Sci. 1224, 1224 (2006).
74 See id. (quoting an Italian scientist who says, “[i]f publishing one more paper becomes more important, we have our priorities
messed up”).
75 Stöhr & Esveld, supra note 30, at 2196.
76 Julie Milstien et al., Divergence of Vaccine Product Lines in Industrialized and Developing Countries, http://www.who.int/
immunization_ supply/divergence_vaccines.pdf (last visited Feb. 1, 2007).
77 See Secret Avian Flu Archive, N.Y. Times, Mar. 15, 2006, at A26 (noting that restrictions might encourage otherwise reluctant
scientists to share their findings on a limited basis prior to publication).
78 See id. (mentioning an Italian scientist who has refused to reveal her data to the WHO's secret database that holds the genetic
information of the virus).
79 Emily Singer, Pandemic Fears Hatch New Methods in Flu Vaccine Industry, 11 NATURE MED. 4, 4 (2005), available at
http:// www.nature.com/nm/journal/v11/n1/full/nm0105-4a.html.

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80 Erika Check, WHO Calls for Vaccine Boost to Prepare for Flu Pandemic, 432 Nature 261, 261 (2004).
81 Id. (noting that one company holding a patent on technology might accelerate the process of vaccine selection).
82 Other Use Without Authorization of the Right Holder, Part II, § 5, art. 31, Agreement on Trade-Related Aspects of Intellectual
Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, available at
http://www.wto.org/english/docs_e/legal_e/27-trips_04c_ e.htm.
83 Keith Bradsher, Pressure Rises on Producer of a Flu Drug, N.Y. Times, Oct. 11, 2005, at C1.
84 See id. (clarifying that Tamiflu would have to produce at its full capacity).
85 Id.
86 Frederick G. Hayden, Perspectives on Antiviral Use During Pandemic Influenza, 356 Biological Sci. 1877, 1877-81 (2001).
87 See id. at 1880 (explaining the possibility of a loss of the drugs' efficacy, even for those treated over shorter periods of time).
88 See Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act,
2006, Pub. L. No. 109-148, 119 Stat. 2680, 2818 (2006); see also A Potential Influenza Pandemic, supra note 26, at 12.
89 Id.
90 See HHS, Health Res. and Servs. Administration, National Vaccine Injury Compensation Program: Fact Sheet (2006),
available at http:// www.hrsa.gov/vaccinecompensation/fact_sheet.html.
91 Id.
92 26 U.S.C. §§ 4131, 9510 (2000).
93 See The HHS Pandemic Influenza Plan: Hearing Before the H. Comm. on Government Reform, 109th Cong. 9 (2005)
(statement of Michael Leavitt, Secretary, HHS) (setting out the guidelines for liability protections); see also HHS Pandemic
Influenza Plan, supra note 1, at 33 (considering the effects of the protections on vaccine manufacturers, distributors, and
healthcare providers).
94 See Michelle M. Mello & Troyan A. Brennan, Legal Concerns and the Influenza Vaccine Shortage, 294 J. Am. Med. Ass'n
1817, 1818-19 (2005) (charting the results of lawsuits against influenza vaccine manufacturers, most of which resulted in
summary judgment in favor of the defendants).
95 See Inst. of Med., The Smallpox Vaccination Program: Public Health in an Age of Terrorism 68 (Alina Baciu et al. eds., 2005).
96 See Myron Levin, Vaccine Injury Claims Face Grueling Fight, L.A. Times, Nov. 29, 2004, at A1 (noting that a young girl
became mentally retarded, physically handicapped, and legally blind after a routine vaccination).
97 See Nat'l Insts. of Allergy and Infectious Disease, Nat'l Insts. of Health, Questions and Answers: H5N1 Avian Flu Vaccine
Trials (2006), available at http://www3.niaid.nih.gov/news/QA/H5N1QandA.htm (stating that the National Institute of
Allergy and Infectious Disease began their first clinical trial in April 2005).
98 Singer, supra note 79, at 4.
99 See David. S. Fedson, Preparing for Pandemic Vaccination: An International Policy Agenda for Vaccine Development, 26 J.
Pub. Health Pol'y 4, 12 (2005) (discussing the possibility that people will require two doses of the vaccine because most people
will never have been infected with an influenza virus).
100 Meredith Wadman, Race is On for Flu Vaccine, 438 Nature 23, 23 (2005).
101 Gardiner Harris, U.S. Stockpiles Antiviral Drugs, but Democrats Call Pace Too Slow, N.Y. Times, Mar. 2, 2006, at A21.
102 John D. Arras, Ethical Issues in the Distribution of Influenza Vaccines, Yale J. Biology & Med. (forthcoming 2006).

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103 HHS, HHS Pandemic Influenza Plan, APPENDIX D: NVAC/ACIP RECOMMENDATIONS FOR PRIORITIZATION
OF PANDEMIC INFLUENZA VACCINE AND NVAC RECOMMENDATIONS ON PANDEMIC ANTIVIRAL
DRUG USE, available at http:// www.hhs.gov/pandemicflu/plan/appendixd.html (last visited Feb. 1, 2007); Anthony B. Iton,
Rationing Influenza Vaccine: Legal Strategies and Considerations for Local Health Officials, 12 J. Pub. Health Mgmt. Practice
349, 349 (2006); James G. Hodge, Jr. & Jessica P. O'Connell, The Legal Environment Underlying Influenza Vaccine Allocation
and Distribution Strategies, 12 J. Pub. Health Mgmt. Practice 340, 340-41 (2006).
104 Elizabeth M. Gardner et al., Age-Related Changes in the Immune Response to Influenza Vaccination in a Racially Diverse,
Healthy Elderly Population, 24 Vaccine 1609, 1610 (2006).
105 See generally Lawrence Gostin & Madison Powers, What Does Justice Require for the Public's Health?, 25 Health Aff. 1053
(2006).
106 Id.
107 See generally Martha C. Nussbaum, Patriotism and Cosmopolitanism, in For Love of Country? ix, 4 (Martha C. Nussbaum
ed., 2002) (advocating for an allegiance to the worldwide community of human beings).
108 Vaccines for Pandemic Influenza, supra note 51, at 4.
109 Public Engagement Pilot Project on Pandemic Influenza, Citizen Voices on Pandemic Flu Choices 7 (2005).
110 See Lawrence Gostin, Public Health Strategies for Pandemic Influenza: Ethics and the Law, 295 J. Am. Med. Ass'n 1700,
1700 (2006) (noting that 90% of spending on pandemic preparation is devoted to countermeasures) [hereinafter Public Health
Strategies for Pandemic Influenza].
111 Inst. of Med., Hospital-Based Emergency Care: At the Breaking Point, available at http://www.iom.edu/
CMS/3809/16107/35007.aspx (last visited Feb. 1, 2007); Inst. of Med., Emergency Medical Services at the Crossroads, available
at http://www.iom.edu/CMS/3809/16107/35010.aspx (last visited Feb. 1, 2007).
112 Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act of 2006,
42 U.S.C. § 247, Pub. L. No. 109-148, 119 Stat. 2680, 2786 (2005).
113 HHS, FY 2005 Budget in Brief 105 (2005), available at http:// www.hhs.gov/budget/05budget/fy2005bibfinal.pdf.
114 Jeffrey Levi et al., Working Group on Pandemic Influenza Preparedness: Joint Statement in Response to Department of
Health and Human Services Pandemic Influenza Plan, 42 Clinical Infectious Diseases 92, 93 (2006).
115 See generally Barry, supra note 44, at 5 (expounding on the lessons learned in the great influenza pandemic of 1918, which
the author describes as “the first great collision between nature and modern science”).
116 Lawrence O. Gostin et al., Ethical and Legal Challenges Posed by Severe Acute Respiratory Syndrome: Implications for the
Control of Severe Infectious Disease Threats, 290 J. Am. Med. Ass'n 3229, 3229 (2003).
117 But see Neil M. Ferguson et al., Strategies for Containing an Emerging Influenza Pandemic in Southeast Asia, 437 Nature 209,
209-10 (2005) (modeling systematically the pandemic spread of influenza in Southeast Asia and using studies done previously
by the United States and Britain to show the downward trend of deaths that may be caused by an influenza pandemic).
118 Inst. of Med., The Future of the Public's Health in the 21st Century 17 (2003) [hereinafter The Future of the Public's Health
in the 21st Century].
119 See Nonpharmaceutical Interventions for Pandemic Influenza, supra note 28, at 82-83.
120 Id. at 88 (noting that difficulties in influenza control include “peak infectivity” early in illness and short intervals between
cases, among other factors).

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121 Christina E. Mills et al., Pandemic Influenza: Risk of Multiple Introductions and the Need to Prepare for Them, 3
Pub. Libr. Sci. Med. 1, 4 (2006), available at http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/
journal.pmed.0030135.
122 Sofia Gruskin & Daniel Tarantola, Health and Human Rights (Francois-Xavier Bagnoud Center for Health and Human
Rights, Working Paper Series, Working Paper No. 10, 2000), available at http:// www.hsph.harvard.edu/fxbcenter/
FXBC_WP10-Gruskin_and_Tarantola.pdf.
123 See Louis B. Sohn & Thomas Buergenthal, International Protection of Human Rights 5 (1973).
124 See Universal Declaration of Human Rights, G. A. Res. 217(III), U.N. GAOR, 3d Sess., U.N. Doc. A/810 (1948);
International Covenant on Civil and Political Rights, Dec. 19, 1966, 999 U.N.T.S. 171 [hereinafter ICCPR]; International
Covenant on Economic, Social and Cultural Rights, Dec. 19, 1966, 993 U.N.T.S. 3 [hereinafter ICESCR].
125 See generally International Convention of All Forms of Racial Discrimination, Dec. 21, 1965, 660 U.N.T.S. 195; ICCPR,
supra note 124; ICESCR, supra note 124; Convention on the Elimination of All Forms of Discrimination Against Women,
Dec. 18, 1979, 1249 U.N.T.S. 13; Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or
Punishment, Dec. 10, 1984, 1465 U.N.T.S. 85; International Convention on the Protection of the Rights of All Migrant
Workers and Members of Their Families, G.A. Res. 45/158, U.N. GAOR, 45th Sess., Supp. No. 49, U.N. Doc. A/45/149
(Dec. 18, 1990).
126 See Convention for the Protection of Human Rights and Fundamental Freedoms, Nov. 4, 1950, 213 U.N.T.S. 222; African
[Banjul] Charter on Human and Peoples' Rights, June 27, 1981, 21 I.L.M. 58; American Convention on Human Rights, Nov.
22, 1969, 1144 U.N.T.S. 123.
127 See Restatement (Third) of Foreign Relations Law of the United States § 702 (1987) (listing the following state practices as
violating customary international law (CIL): genocide; slavery; murder or causing the disappearance of individuals; torture or
other cruel, inhuman or degrading treatment or punishment; prolonged arbitrary detention; systematic racial discrimination;
and consistent patterns of gross violations of internationally recognized human rights).
128 Creola Johnson, Quarantining HIV-Infected Haitians: United States' Violations of International Law at Guantanamo Bay,
37 How. L.J. 305, 314 (1994).
129 David W. Johnston, Comment, Cuba's Quarantine of AIDS Victims: A Violation of Human Rights?, 15 B.C. Int'l & Comp.
L. Rev. 189, 194 (1992).
130 ICESCR, supra note 124, at art. 2.
131 See Committee on Economic, Social and Cultural Rights, General Comment 3, The Nature of States Parties' Obligations,
5th Sess., 1990, ¶ 5, Compilation of General Comments and General Recommendations Adopted by Human Rights Treaty
Bodies, U.N. Doc. HRI/GEN/1/Rev.7 (May 12, 2004).
132 See Committee on Economic, Social and Cultural Rights, General Comment 14, The Right to the Highest Attainable Standard
of Health, 22d Sess., 2000, ¶ 4, Compilation of General Comments and General Recommendations Adopted by Human Rights
Treaty Bodies, U.N. Doc. HRI/GEN/1/Rev.7 (May 12, 2004).
133 See id. ¶¶ 8, 11.
134 See Eur. Council, Convention for the Protection of Human Rights and Fundamental Freedoms as amended by Protocol No.
11, Nov. 1, 1998, Art. 8, available at http://www.echr.coe.int/NR/rdonlyres/D5CC24A7-DC13-4318-B457-5C9014916D7A/0/
EnglishAnglais.pdf [hereinafter Fundamental Freedoms]; American Convention on Human Rights, Nov. 22, 1969, 1144
U.N.T.S. 123, art. 11.
135 See Fundamental Freedoms, supra note 134, art. 3.

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136 See Eur. Council, Protocol No. 4 to the Convention for the Protection of Human Rights and Fundamental Freedoms as
amended by Protocol No. 11, Nov. 1, 1998, Europ. T.S. 46, Art. 2, available at http:// www.echr.coe.int/NR/rdonlyres/
D5CC24A7-DC13-4318-B457-5C9014916D7A/0/EnglishAnglais.pdf.
137 See Fundamental Freedoms, supra note 134, art. 14.
138 See ICCPR, supra note 124, art. 12 ¶ 3, art. 18 ¶ 3, art. 19 ¶ 3, art. 21, art. 22 ¶ 2 (permitting “limitations” or “restrictions”
on the freedom of movement, religion, expression, assembly, and association).
139 See The Siracusa Principles on the Limitation and Derogation Provisions in the International Covenant on Civil and Political
Rights, 7 Hum. Rts. Q. 3, 7 (1985) [hereinafter Siracusa Principles] (calling for all limitation clauses to be interpreted strictly
and in favor of the human right at issue).
140 See U.N. Econ. & Soc. Council (ECOSOC), Status of the International Covenants on Human Rights, U.N. Doc. E/
CN.4/1985/4 (Sept. 28, 1984).
141 Id. ¶¶ 15-21.
142 See Enhorn v. Sweden, 2005 Eur. Ct. H.R. 1; Robyn Martin, The Exercise of Public Health Powers in Cases of Infectious
Disease: Human Rights Implications, 14 Med. L. Rev. 132, 134 (2006) (expounding on the European Court of Human Rights'
use of the substantive requirements of Article 5 that the court consider all alternatives such that it is clear that less severe
measures have been considered and that there is no arbitrariness in the deprivation of liberty in any and all circumstances
(citing Chahal v. U.K., 1996 Eur. Ct. H. R. 22414/93)).
143 The language of Article 4 suggests that cultural, economic, or social rights can be limited on grounds of the public's health.
The Committee on Economic, Social and Cultural Rights, however, stresses that states have the burden of justifying each
element of Article 4: powers must be in accordance with the law, including international human rights, in the interest of
legitimate aims, and strictly necessary for the general welfare in a democratic society. Public health powers also must be
the least restrictive, of limited duration, and subject to review. ECOSOC, Sub-Comm. on Econ., Soc. & Cultural Rights,
Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights:
General Comment No. 14, U.N. Doc. E/C.12/2000/4 (Aug. 11, 2000), available at http:// www.unhchr.ch/tbs/doc.nsf/(symbol)/
E.C.12.2000.4.En?OpenDocument [hereinafter General Comment 14].
144 Id. art. 12(2)(c).
145 The Concise Oxford Dictionary of Current English 728 (6th ed. 1976).
146 James F. Childress et al., Public Health Ethics: Mapping the Terrain, 30 J.L. Med. & Ethics 170, 173 (2002).
147 Id.
148 Tom L. Beauchamp & James F. Childress, Principles of Biomedical Ethics 327 (4th ed. 1994).
149 See Council for International Organizations of Medical Sciences, International Guidelines for Ethical Review of
Epidemiological Studies, 19 Law, Med. & Health Care 247 (1991); Council for International Organizations of Medical
Sciences, Report of the Fifth CIOMS Core Group Meeting on the Revision of 1991 International Guidelines for Ethical
Review of Epidemiological Studies (2005).
150 Dan E. Beauchamp, Public Health as Social Justice, in New Ethics for the Public's Health 105 (Dan E. Beauchamp & Bonnie
Steinbock eds., 1999).
151 See Childress et al., supra note 146, at 174; Public Health Leadership Society, Principles of the Ethical Practice of Public Health
3 (2002), available at http://www.apha.org/codeofethics/ethicsbrochure.pdf [hereinafter Principles of the Ethical Practice of
Public Health].

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PANDEMIC INFLUENZA: ETHICS, LAW, AND THE PUBLIC'S..., 59 Admin. L. Rev. 121

152 Principles of the Ethical Practice of Public Health, supra note 151, at 4; Jayne Parry & John Wright, Community Participation
in Health Impact Assessments: Intuitively Appealing but Practically Difficult, 6 Bulletin of the World Health Organization
388, 388 (2003), available at http:// www.who.int/bulletin/volumes/81/6/parry.pdf.
153 See Parry & Wright, supra note 152, at 388 (citing the Gothenburg consensus paper, which “makes clear the need for
participation to underpin the assessment process in order to maintain values of democracy, transparency and equity”).
154 See Gostin et al., supra note 116, at 555 (emphasizing that “where feasible, rapid deployment of vaccines or prophylaxis
to groups at risk of acquiring infection should be used to contain localized outbreaks”); Gostin, supra note 110, at 1700
(elaborating that during the pandemic alert phase of an outbreak important intervention measures include “surveillance,
medical prophylaxis, and isolation”).
155 See generally Barry, supra note 44 (chronicling the developments in the 1918 influenza epidemic).
156 See Gostin et al., supra note 116, at 3229-36.
157 WHO Const. pmbl., available at http:// www.searo.who.int/LinkFiles/About_SEARO_const.pdf (last visited Feb. 1, 2007)
(stating that “[i]nformed opinion and active co-operation on the part of the public are of the utmost importance in the
improvement of the health of the people”).
158 See Parry & Wright, supra note 152 (noting that community participation also may “reorient power relationships with the
professional decision-makers”).
159 But see Neil M. Ferguson et al., supra note 117, at 213-14 (delineating various models and data sources used to predict the
success of possible interventions).
160 See Nonpharmaceutical Interventions for Pandemic Influenza, supra note 28, at 92 (adding that because of this and other
uncertainties, “WHO guidance is subject to revision based on additional information”).
161 See id. at 88-93 (describing measures such as social distancing, procedures for those leaving or entering infected zones, and
hygiene measures and personal protection).
162 The Future of the Public's Health in the 21st Century, supra note 118, at 6.
163 Niall P.A.S. Johnson & Juergen Mueller, Updating the Accounts: Global Mortality of the 1918-1920 “Spanish” Influenza
Pandemic, 76 Bull. Hist. Med. 105, 105-15 (2002).
164 Neil M. Ferguson et al., Strategies for Mitigating an Influenza Pandemic, 442 Nature 448 (2006).
165 Id. at 210-12.
166 Lawrence O. Gostin et al., The Model State Emergency Health Powers Act: Planning for and Response to Bioterrorism and
Naturally Occurring Infectious Diseases, 288 J. Am. Med. Ass'n 622, 624 (2002).
167 Id.
168 David P. Fidler & Lawrence O. Gostin, The New International Health Regulations: An Historic Development for
International Law and Public Health, 33 J. Law, Med. & Ethics 85 (2006); WHO, Revision of the International Health
Regulations (2005), available at http://www.who.int/csr/ihr/WHA58_3-en.pdf (last visited Feb. 1, 2007) [hereinafter Revision
of the International Health Regulations].
169 Public Health Strategies for Pandemic Influenza, supra note 110.
170 Cathy A. Petti et al., Laboratory Medicine in Africa: A Barrier to Effective Health Care, 42 Clinical Infectious Diseases 377
(2006).
171 See id. (contending, however, that failure to improve surveillance infrastructure ultimately costs more as “unreliable and
inaccurate laboratory diagnostic testing leads to unnecessary expenditures”).

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172 See Beijing Declaration, International Pledging Conference on Avian and Human Pandemic Influenza, Jan. 18, 2006,
available at http:// siteresources.worldbank.org/PROJECTS/Resources/40940-1136754783560/beijingdeclaration.pdf; World
Bank, Avian and Human Influenza: Financing Needs and Gaps 8 (2005), available at http:// siteresources.worldbank.org/
PROJECTS/2015336-1135192689095/20766293/AHIFinancingGAPSFINAL12-21.pdf.
173 See Comm'n on Macroeconomics and Health, WHO, Macroeconomics and Health: Investing in Health for Economic
Development 11 (2001), available at http://www.emro.who.int/cbi/pdf/CMHReportHQ.pdf (adding that the funding required
would increase over time, rising to $38 billion by 2015).
174 See generally Ronald Bayer & Amy Fairchild, The Limits of Privacy: Surveillance and the Control of Disease, 10 Health Care
Analysis 19 (2002) (discussing the “ethics of surveillance” through analysis of the history of surveillance and reporting in the
context of HIV and other infectious diseases).
175 See, e.g., Eur. Parl. and Council Directive 95/46, arts. 3, 13, 1995 O. J. (L 281) 35 (EC); Health Insurance Portability and
Accountability Act (HIPAA), 42 U.S.C. § 1320 (1996).
176 See Lawrence O. Gostin et al., Informational Privacy and the Public's Health: The Model State Public Health Privacy Act,
91 Am. J. Pub. Health 1388 (2001).
177 See William B. Karesh & Robert A. Cook, The Human-Animal Link, 84 Foreign Aff. 38, 38, 42 (2005).
178 See Avian Influenza A (H5N1) Infection in Humans, supra note 11, at 1374.
179 See Roongroje Thanawongnuwech et al., Probable Tiger-to-Tiger Transmission of Avian Influenza H5N1, 11 Emerging
Infectious Diseases 975 (2005).
180 See Food and Agricultural Organization (FAO), Avian Influenza-- Related Issues, http://www.fao.org/ag/AGAinfo/subjects/
en/health/diseases-cards/avian_issues.html [hereinafter FAO Report] (last visited Feb. 1, 2007) (reporting that the avian flu
has been detected in a leopard in Thailand).
181 See id. (noting that in Vietnam the avian flu virus has been discovered in a limited number of pigs).
182 See WHO, H5N1 Avian Influenza in Domestic Cats (Feb. 28, 2006), http://www.who.int/csr/don/2006_02_28a/en.
183 See WHO, Avian Influenza--H5N1 Infection Found in a Stone Marten in Germany (Mar. 9, 2006), http://www.who.int/csr/
don/2006_03_09a/en.
184 See Public Health Strategies for Pandemic Influenza, supra note 110, at 1701.
185 See Playing Chicken with Bird Flu, N.Y. Times, Feb. 21, 2006, at A18.
186 See id.
187 Mike Davis, The Monster at our Door: The Global Threat of Avian Flu 45 (2005).
188 FAO Report, supra note 180.
189 Karesh & Cook, supra note 177.
190 See Lydia Polgreen, Nigeria Tries TV Jingles, Anything to Chip Away at Ignorance of Spreading Bird Flu, N.Y. Times, Feb.
26, 2006, at 17 (“The rapid spread of the disease to neighboring states, along with the near-impossibility of enforcing bans
on moving birds around the country, has led veterinary experts to conclude that the virus will be nearly impossible to stamp
out in Africa.”).
191 Dennis Normile, Are Wild Birds to Blame?, 310 Sci. 426, 426 (2005).
192 Toby Moore & Nancy Morgan, Avian Influenza: Trade Issues 6 (2006), available at http://www.cast-science.org/cast/news/
aviantrade.pdf.

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PANDEMIC INFLUENZA: ETHICS, LAW, AND THE PUBLIC'S..., 59 Admin. L. Rev. 121

193 Cntrs. for Disease Control and Prevention, Embargo of Birds from Specified Countries (2005), available at http://
www.cdc.gov/flu/avian/outbreaks/embargo.htm.
194 Commission Decision 2006/7/EC, art. 1, 2006 O. J. (L. 205) 1 (EC).
195 Andrew Jack et al., Farmers Angry as 20 Countries Ban French Poultry Imports, Fin. Times, Feb. 28, 2006, at 3.
196 FAO Report, supra note 180.
197 Elaine Sciolino, The Discovery of Avian Flu on a Turkey Farm Sends French Poultry Industry Into a Tailspin, N.Y. Times,
Feb. 26, 2006, at 17.
198 Moore & Morgan, supra note 192, at 4.
199 Influenza: A Report of the American Public Health Association, 71 J. Am. Med. Ass'n 2068 (1918).
200 See WHO, Hospital Infection Control Guidance for Severe Acute Respiratory Syndrome (SARS) (2003), available at http://
www.who.int/csr/sars/infectioncontrol/en/ [hereinafter Hospital Infection Control Guidance]; Centers for Disease Control
and Prevention, Public Health Guidance for Community-Level Preparedness and Response to Severe Acute Respiratory
Syndrome (SARS) (2005), available at http:// www.cdc.gov/ncidod/sars/guidance/I/index.htm.
201 See Hospital Infection Control Guidance, supra note 200.
202 See generally Influenza: A Report of the American Public Health Association, supra note 199; Bernard Lo & Mitchell H.
Katz, Clinical Decision Making During Public Health Emergencies: Ethical Considerations, 143 Ann. Internal Med. 493
(2005); Centers for Disease Control and Prevention, Community Containment Measures, Including Non-Hospital Isolation
and Quarantine (2004), available at http://www.cdc.gov/ncidod/sars/guidance/D/index.htm.
203 Nonpharmaceutical Interventions for Pandemic Influenza, supra note 28.
204 See, e.g., Amer. Soc. for Microbiology, Hand Washing Survey Fact Sheet, available at http://www.washup.org/assets/
fact_sheet.pdf (last visited Feb. 1, 2007).
205 Janice Y.C. Lo et al., Respiratory Infections During SARS Outbreak, Hong Kong, 2003, 11 Emerging Infectious Diseases
1738 (2005).
206 Lesley Rosling & Mark Rosling, Pneumonia Causes Panic in Guangdong Province, 326 Brit. Med. J. 416 (2003).
207 Thomas A. Glass & Monica Schoch-Spana, Bioterrorism and the People: How to Vaccinate a City Against Panic, 34 Clinical
Infectious Diseases 217, 218-20 (2002).
208 See, e.g., Hospital Infection Control Guidance, supra note 200.
209 Id.
210 C. Beguin, B. Boland & J. Ninane, Health Care Workers: Vectors of Influenza Virus? Low Vaccination Rates Among Hospital
Health Care Workers, 13 Am. J. Med. Qual. 223, 223, 227 (1998).
211 C. Fraser et al., Factors that Make an Infectious Disease Outbreak Controllable, 101 Procs. of the Nat. Acad. of Sci. 6146,
6151 (2004).
212 Nonpharmaceutical Interventions for Pandemic Influenza, supra note 28.
213 Donald G. McNeil, Jr., States and Cities Lag in Readiness to Fight Bird Flu, N.Y. Times, Feb. 6, 2006, at A1 (predicting that
67% of all intensive care beds would be filled with patients suffering from influenza).
214 Inst. of Med., Reusability of Facemasks During an Influenza Pandemic: Facing the Flu 63 (2006), available at http://
www.nap.edu/catalog/11637.html.

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215 Id. at 68.

216 See Avian Influenza: Assessing the Pandemic Threat, supra note 20, at 6. See generally Alexandra Minna Stern & Howard
Markel, International Efforts to Control Infectious Diseases, 1851 to the Present, 292 J. Am. Med. Ass'n 1474 (2004).
217 Anthony Heymann et al., Influence of School Closure on the Incidence of Viral Respiratory Diseases Among Children and
on Health Care Utilization, 23 Pediatric Infectious Disease J. 675, 677 (2004).
218 Nonpharmaceutical Interventions for Pandemic Influenza, supra note 28, at 81.
219 Ferguson et al., supra note 117, at 211-12.
220 Mark A. Rothstein et al., Quarantine and Isolation: Lessons Learned from SARS 139 (2003), available at http://
www.louisville.edu/medschool/ibhpl/images/pdf/SARS%20REPORT.pdf.
221 Johnson & Mueller, supra note 163, at 107.
222 See Ferguson et al., supra note 117; Germann et al., supra note 30.
223 HHS., Quarantine, Inspection, Licensing Rule, 42 C.F.R. §§ 70-71 (2005).
224 WHO, WHO SARS Risk Assessment and Preparedness Framework (Oct. 2004), available at http://www.who.int/csr/
resources/publications/CDS_CSR_ARO_ 2004_2.pdf; Inst. of Med., Quarantine Stations at Ports of Entry: Protecting the
Public's Health (2005).
225 See David M. Bell & World Health Organization Working Group on Prevention of International and Community
Transmission of SARS, Public Health Interventions and SARS Spread, 2003, 10 Emerging Infectious Diseases 1900 (2004);
Ronald K. St. John et al., Border Screening for SARS, 11 Emerging Infectious Diseases 6 (2005).
226 See Revision of the International Health Regulations, supra note 168; see also 42 C.F.R. §§ 70-71.
227 See, e.g., Appellate Body Report, European Communities--Measures Affecting Asbestos and Asbestos-Containing Products,
¶ 172, WT/DS135/AB/R (Mar. 12, 2001).
228 See Cooper, supra note 25.
229 See id.
230 See id.
231 Shapiro v. Thompson, 394 U.S. 618 (1969); General Comment, Human Rights Comm., Continuity of Obligations Under the
International Covenant on Civil and Political Rights, U.N. Doc. CCPR/C/21 (1999).
232 Ctrs. for Disease Control and Prevention, “Regulatory Impact Analysis of Proposed 42 C.F.R. Part 70 and 42 C.F.R. Part
71,” available at http://www.cdc.gov/ncidod/dq/nprm/docs/draft_ria_final.pdf (last visited Feb. 1, 2007).
233 See id. at 541-43 (describing two forms of quarantine: absolute and modified); see also Daniel S. Reich, Modernizing Local
Responses to Public Health Emergencies: Bioterrorism, Epidemics, and the Model State Emergency Health Powers Act, 19
J. Contemp. Health L. & Pol'y 379, 406-07 (2002) [hereinafter Modernizing Local Responses]; Revision of the International
Health Regulations, supra note 168 (defining quarantine as “the restriction of activities and/or separation from others of
suspect persons who are not ill ... in such a manner as to prevent the possible spread of infection or contamination”).
234 See Control of Communicable Diseases Manual 539-40 (Abram S. Benenson ed., 16th ed. 1995) (describing six forms of
isolation: strict, contact, respiratory, tuberculosis, enteric precautions, drainage/secretion precautions); see also Marguerite
M. Jackson & Patricia Lynch, Isolation Practices: A Historical Perspective, 13 Am. J. Infection Control 21 (1985).
235 U.S. Dep't of Homeland Sec., Flu Pandemic Mitigation: Quarantine and Isolation, available at http://www.globalsecurity.org/
security/ops/hsc-scen-3_flu-pandemic-quarantine.htm. (last visited Feb. 1, 2007).

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236 See Gostin et al., supra note 116.

237 Jane Speakman, Quarantine in Severe Acute Respiratory Syndrome and Other Emerging Infectious Diseases, 31 J.L. Med.
& Ethics 63 (2003).
238 Id. at 5.
239 Id.
240 Id. at 3.
241 Id. at 4.
242 See Siracusa Principles, supra note 139.
243 See Modernizing Local Responses, supra note 233.
244 Daniel Markovitz, Quarantines and Distributive Justice, 33 J.L. Med. & Ethics 323, 323 (2005); David Heyman, Ctr. For
Strategic and Int'l Stud., Model Operational Guidelines for Disease Exposure Control 16-17 (2005), available at http://
www.csis.org/media/csis/pubs/051102_dec_guidelines.pdf.
245 WHO Pandemic Influenza Draft Protocol for Rapid Response and Containment, at 11-12 (Jan. 27, 2006), available at http://
www.who.int/csr/disease/avian_influenza/guidelines/RapidResponse_27%2001.pdf.
246 Univ. of Toronto Joint Ctr. for Bioethics, Pandemic Influenza Working Group, Stand on Guard for Thee: Ethical
Considerations in Preparedness Planning for Pandemic Influenza 13 (2005), available at http:// www.utoronto.ca/jcb/home/
documents/pandemic.pdf.
247 Nola M. Ries, Public Health Law and Ethics: Lessons from SARS and Quarantine, 13 Health L. Rev. 1, 3 (2001), available
at http:// www.law.ualberta.ca/centres/hli/pdfs/13-01/13-1-01_Ries.pdf.
248 Rothestein et al., supra note 220, at 25.
249 See id.; see also Ries, supra note 247, at 3.
250 See Rothestein et al., supra note 220, at 25.
251 Id.
252 See, e.g., Laura Hawryluck et al., SARS Control and Psychological Effects of Quarantine, Toronto, Canada, 10 Emerging
Infectious Diseases 7 (2004) (recording incidences of Post-Traumatic Stress Disorder (PTSD) among individuals quarantined
during the Canadian SARS outbreak).

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