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106 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 2010 VOL. 34 NO. 2 © 2010 The Authors. Journal Compilation © 2010 Public Health Association of Australia Law, ethics and pandemic preparedness: the importance of cross-jurisdictional and cross-cultural perspectives Belinda Bennett and Terry Carney Faculty of Law, University of Sydney, New South Wales Abstract Objective: To explore social equity, health planning, regulatory and ethical dilemmas in responding to a pandemic influenza (H5N1) outbreak, and the adequacy of protocols and standards such as the International Health Regulations (2005). Approach: This paper analyses the role of legal and ethical considerations for pandemic preparedness, including an exploration of the relevance of cross-jurisdictional and cross-cultural perspectives in assessing the validity of goals for harmonisation of laws and policies both within and between nations. Australian and international experience is reviewed in various areas, including distribution of vaccines during a pandemic, the distribution of authority between national and local levels of government, and global and regional equity issues for poorer countries. Conclusion: This paper finds that questions such as those of distributional justice (resource allocation) and regulatory frameworks raise important issues about the cultural and ethical acceptability of planning measures. Serious doubt is cast on a ‘one size fits all’ approach to international planning for managing a pandemic. It is concluded that a more nuanced approach than that contained in international guidelines may be required if an effective response is to be constructed internationally. Implications: The paper commends the wisdom of reliance on ‘soft law’, international guidance that leaves plenty of room for each nation to construct its response in conformity with its own cultural and value requirements. Key words: avian flu, pandemic management, ethics, regulatory models. Aust NZ J Public Health. 2010; 34:106-112 doi: 10.1111/j.1753-6405.2010.00492.x Submitted: April 2009 Revision requested: July 2009 Accepted: September 2009 Correspondence to: Professor Belinda Bennett, Faculty of Law, University of Sydney, New South Wales 2006. Fax: (02) 9351 0200; e-mail [email protected] A revised version of a paper presented at the 2nd Annual Biosecurity Symposium ‘Integrating Knowledge, Implementing Change’ 9-10 February 2009 Footbridge Theatre, University of Sydney. Research for this paper is supported by a Discovery Grant from the Australian Research Council. T here were three influenza pandemics during the 20th century (in 1918, 1957 and 1968), the first of which killed at least 40 million people worldwide, far exceeding the 8.3 million military deaths during World War I. 1 In recent years, outbreaks of highly pathogenic avian influenza (H5N1) and an increasing number of human cases of H5N1 infection, have led to growing concern about another potentially deadly world pandemic of human influenza. In 2009, the World Health Organization (WHO) declared the first influenza pandemic of the 21st century – not from H5N1 as feared, but from the international spread A/H1N1 swine influenza. 2 Although the H1N1 pandemic has been relatively mild to date, WHO has warned countries in the northern hemisphere to prepare for a second wave of the pandemic 3 and the potential for H5N1 and H1N1 viruses to combine into a new deadly influenza strain remains a sobering possibility. 4 The WHO has recognised the importance of legal and ethical issues to pandemic planning in its proposed ‘unified’ approach, but responding to pandemic influenza raises a great number of social equity, health planning, regulatory and ethical dilemmas that may prove problematic. Pandemic influenza, either in the form of the current A/H1N1 pandemic or in the form of human-to-human transmission of the avian (H5N1) influenza virus, should it emerge, may well affect Australia’s regional partners, greatly compounding dilemmas posed by diversity of cultural, legal and value systems within the region. Asian countries are already experiencing a heavy proportion of human global cases of H5N1: of 440 cases, including 262 deaths, from avian influenza to August 2009, Indonesia experienced 141 cases (115 deaths), Vietnam 111 (56 deaths), and Thailand 25 (17 deaths). 5 H1N1 has been far more widespread. By late August 2009 the WHO Regional Office for the Americas had recorded 110,113 cases with 1,876 deaths, WHO’s European office reported more than 42,557 cases with at least 85 deaths, WHO’s South-East Asian office had reported 15,771 cases with 139 deaths and WHO’s Regional Office for the Western Pacific had reported 34,026 cases with 64 deaths. 6 These figures are, however, almost certainly an underestimate of the number of actual cases as countries are no longer required to test and report individual cases of H1N1. 6 While the number of human deaths so far appears relatively small by comparison with the pandemics of the 20th century, the potential for another deadly pandemic is very real. The pool of human infection with H5N1 is such that the WHO noted in 2005 that “[a]ll prerequisites for the start of a pandemic had been met save one, namely the onset of efficient human-to-human transmission”. 1 Infectious diseases Article

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Page 1: Law, ethics and pandemic preparedness: the importance of cross-jurisdictional and cross-cultural perspectives

106 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 2010 vol. 34 no. 2© 2010 The Authors. Journal Compilation © 2010 Public Health Association of Australia

Law, ethics and pandemic preparedness:

the importance of cross-jurisdictional and

cross-cultural perspectives

Belinda Bennett and Terry CarneyFaculty of Law, University of Sydney, New South Wales

Abstract

Objective: To explore social equity, health

planning, regulatory and ethical dilemmas

in responding to a pandemic influenza

(H5N1) outbreak, and the adequacy of

protocols and standards such as the

International Health Regulations (2005).

Approach: This paper analyses the

role of legal and ethical considerations

for pandemic preparedness, including

an exploration of the relevance of

cross-jurisdictional and cross-cultural

perspectives in assessing the validity

of goals for harmonisation of laws and

policies both within and between nations.

Australian and international experience

is reviewed in various areas, including

distribution of vaccines during a pandemic,

the distribution of authority between

national and local levels of government,

and global and regional equity issues for

poorer countries.

Conclusion: This paper finds that

questions such as those of distributional

justice (resource allocation) and regulatory

frameworks raise important issues about

the cultural and ethical acceptability of

planning measures. Serious doubt is

cast on a ‘one size fits all’ approach to

international planning for managing a

pandemic. It is concluded that a more

nuanced approach than that contained in

international guidelines may be required if

an effective response is to be constructed

internationally.

Implications: The paper commends

the wisdom of reliance on ‘soft law’,

international guidance that leaves plenty

of room for each nation to construct its

response in conformity with its own cultural

and value requirements.

Key words: avian flu, pandemic

management, ethics, regulatory models.

Aust NZ J Public Health. 2010; 34:106-112

doi: 10.1111/j.1753-6405.2010.00492.x Submitted: April 2009 Revision requested: July 2009 Accepted: September 2009Correspondence to: Professor Belinda Bennett, Faculty of Law, University of Sydney, New South Wales 2006. Fax: (02) 9351 0200; e-mail [email protected]

A revised version of a paper presented

at the 2nd Annual Biosecurity Symposium

‘Integrating Knowledge, Implementing

Change’ 9-10 February 2009 Footbridge

Theatre, University of Sydney. Research for

this paper is supported by a Discovery Grant

from the Australian Research Council.

There were three influenza pandemics

during the 20th century (in 1918,

1957 and 1968), the first of which

killed at least 40 million people worldwide,

far exceeding the 8.3 million military

deaths during World War I.1 In recent

years, outbreaks of highly pathogenic avian

influenza (H5N1) and an increasing number

of human cases of H5N1 infection, have led

to growing concern about another potentially

deadly world pandemic of human influenza.

In 2009, the World Health Organization

(WHO) declared the first influenza pandemic

of the 21st century – not from H5N1 as

feared, but from the international spread

A/H1N1 swine influenza.2 Although the

H1N1 pandemic has been relatively mild

to date, WHO has warned countries in

the northern hemisphere to prepare for

a second wave of the pandemic3 and the

potential for H5N1 and H1N1 viruses to

combine into a new deadly influenza strain

remains a sobering possibility.4 The WHO

has recognised the importance of legal and

ethical issues to pandemic planning in its

proposed ‘unified’ approach, but responding

to pandemic influenza raises a great number

of social equity, health planning, regulatory

and ethical dilemmas that may prove

problematic. Pandemic influenza, either in

the form of the current A/H1N1 pandemic or

in the form of human-to-human transmission

of the avian (H5N1) influenza virus, should it

emerge, may well affect Australia’s regional

partners, greatly compounding dilemmas

posed by diversity of cultural, legal and value

systems within the region.

Asian countries are already experiencing

a heavy proportion of human global cases

of H5N1: of 440 cases, including 262

deaths, from avian influenza to August

2009, Indonesia experienced 141 cases

(115 deaths), Vietnam 111 (56 deaths), and

Thailand 25 (17 deaths).5 H1N1 has been far

more widespread. By late August 2009 the

WHO Regional Office for the Americas had

recorded 110,113 cases with 1,876 deaths,

WHO’s European off ice reported more

than 42,557 cases with at least 85 deaths,

WHO’s South-East Asian office had reported

15,771 cases with 139 deaths and WHO’s

Regional Office for the Western Pacific had

reported 34,026 cases with 64 deaths.6 These

figures are, however, almost certainly an

underestimate of the number of actual cases

as countries are no longer required to test

and report individual cases of H1N1.6 While

the number of human deaths so far appears

relatively small by comparison with the

pandemics of the 20th century, the potential

for another deadly pandemic is very real.

The pool of human infection with H5N1 is

such that the WHO noted in 2005 that “[a]ll

prerequisites for the start of a pandemic

had been met save one, namely the onset of

efficient human-to-human transmission”.1

Infectious diseases Article

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2010 vol. 34 no. 2 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 107© 2010 The Authors. Journal Compilation © 2010 Public Health Association of Australia

On 23 May 2005 the World Health Assembly therefore called on

Member States to develop and implement national preparedness

plans.7 Australia and the South East Asian region have developed

national influenza preparedness plans based on WHO guidelines.1,8

The Australian Management Plan for Pandemic Influenza was

released for comment in June 2005 before being finalised in 2006,9

the same year the Interim National Pandemic Influenza Clinical

Guidelines were published.10

Estimates of the impacts of a flu pandemic are highly speculative.

Between its 2006 modelling of a ‘worst case’ scenario of 71 million

deaths worldwide and its most recent predictions in mid 2008, the

World Bank revised its assessment of loss of world gross domestic

production. Earlier it has estimated a 3.1% drop (or about US$ 2

trillion) but now puts this as high as 4.8% (or US$ 3 trillion).11,12

Furthermore, it has been noted that developing countries would be

hardest hit, because of their higher population densities and poverty

that accentuate the economic impacts.12 A recent New Zealand

Treasury Report estimated that the economic impact of the A/H1N1

pandemic would be less than the 0.7% drop in GDP modelled under

a mild pandemic scenario.13 While the milder-than-expected impact

of H1N1 to date is encouraging, particularly in light of the global

financial crisis, the pandemic is not yet over and it will be some

time before we are in a position to make final assessments of the

full impact of this pandemic on the global economy.

Whatever the range of impacts, the features of the flu pandemics

encountered to date predispose them to affect both the undeveloped

and the developed world, and to do so at times not tied to the usual

‘winter flu’ season or to target the usual sub-populations of the

old and the young, Tong14 points out. Although influenza typically

strikes hardest at the very young and the very old, the WHO has

noted that during the 1918 pandemic “99% of deaths occurred

in people younger than 65 years”.1 This disproportionate impact

on the young is also evident in the current H1N1 pandemic with

WHO noting: “To date, most severe cases and deaths have occurred

in adults under the age of 50 years, with deaths in the elderly

comparatively rare. This age distribution is in stark contrast with

seasonal influenza, where around 90% of severe and fatal cases

occur in people 65 years of age or older.”3

These features challenge orthodox ethical and legal frameworks,

such as potentially altering the calculus of theories of distributional

justice (favouring treatment of the most gravely ill), or liberal

principles regarding construction of legislation to balance

achievement of social goals against incursions on individual

rights. However, responses to ‘emergencies’ and the resolution of

difficult ethical conundrums may not necessarily attract a single

consensus of the type presumed by WHO and other guidelines

for national action.

Legal preparedness in Australia and its region

In common with other countries influenced by Chadwick’s

championing in 19th century Britain of the clean water, sanitation

and quarantine models of public health, Australia has an extensive

array of emergency management tools with which to respond to

a pandemic.15 However, these tools work best for regional issues

arising within the borders of the States and Territories that are

the successors in title to all except the quarantine powers of their

colonial predecessors.

Problems arise in crafting a coordinated approach to a

national challenge, due to the latitude for different approaches

to implementation of pandemic planning between the States/

Territories, as illustrated when Queensland followed the national

pandemic plan and briefly encouraged food stockpiling during the

2009 swine flu episode, before falling into line with the national

view that this would unsettle the public. Federal divisions of power

and responsibility are a particular issue,16,17 as is the potential for

division of approach between the two levels of government,18

consequent on the political legacy of sovereign power of the

States. The various techniques and avenues for harmonisation of

laws are one way of dealing with this,19 including consideration

of options such as a checklist for each jurisdiction to use for

benchmarking, consultation around elimination of more egregious

forms of disharmony, a ‘model act’, referral of powers or national

legislation based on federal powers.18

To date, the milder checklist or guideline measures have

been favoured in Australia,9,10 but this was tested by the recent

A/H1N1 outbreak of swine flu. In the US, the Pandemic and

All-Hazards Preparedness Act of 2006 adopted a similar low-key

cooperative strategy of developing and deferring to ‘action plans’

across the different levels of government, but it was criticised

for its lack of national guidance and planning failure during the

notorious Hurricane Katrina episode.20 Concerns included the

lack of specificity of the evidence-base in national frameworks

for assessing compliance by emergency preparedness plans and

entitlement to federal funding (potentially compounding lack of

preparedness in non-complaint jurisdictions).20 Such reservations

about cooperative federalist models of governance resonate with

Australian experience of ‘blame game’ federalism, indicating

that similar issues may arise in this country. Clarity of purpose

of the plan is another potential problem. Even renovated laws in

a well-prepared State jurisdiction such as North Carolina (where

pathbreaking legal and ethical planning was conducted), make

fine distinctions between ‘isolation’ and ‘quarantine’ orders that

the public (and professions) may find hard to follow.21 Other

problematic aspects include: defining the ‘emergencies’ able to

trigger the special powers; deciding how ‘much’ preparedness

is adequate; and measuring actual (as compared to apparent)

readiness.22 While some of these differences can be accounted for

by the different historical, constitutional and cultural legacies of

Australia and the US, it casts some doubt on the prevailing models

of governance of the issue. More broadly, differences may arise

between competing approaches, such as between liberalism and

communitarianism, both in crafting overall regulatory responses

of national governments to such emergencies, and in shaping

confidence in such measures depending on the values and beliefs

held by members of the public.23 For instance the US leans

much further towards so-called classical liberalism (privileging

Infectious diseases Law, ethics and pandemic preparedness

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108 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 2010 vol. 34 no. 2© 2010 The Authors. Journal Compilation © 2010 Public Health Association of Australia

autonomy or the ‘right to be left alone’) while Australia broadly

favours a utilitarian liberal rationale permitting overriding of

autonomy on the basis of harm to others, or undue risk.

The importance of clarifying relationships between different

levels of government was highlighted in a Canadian report on

the experience of dealing with severe acute respiratory syndrome

(SARS). Drawing on a metaphor of firefighting to articulate the

need for emergency preparedness, the Canadian report noted:

“We expect that firefighters and fire engines from different

jurisdictions will come together seamlessly to contain an

emergency. In the public health field, this seamlessness can only

come about from effective preparedness and coordination by public

health authorities at the local, provincial, federal and territorial

levels. As with firefighting, there must be knowledge of common

operating procedures, compatible training and equipment, and

most importantly, prior agreements for mutual assistance in

emergencies requiring a sudden surge capacity.”24

Clarity in the legal frameworks for public health is a critical

part of providing an enabling infrastructure to support the work

of public health officials when responding to public health

emergencies. The confusion and duplication potentially created

by lack of legal clarity can complicate and obstruct effective

emergency responses.

There is also a critically important ‘supra-national’ element to

any effective national response, due to the mobility of populations

and ease of international travel in a globalised world. The capacity

for infectious disease to spread along international travel routes

dramatically shortens the time needed for the spread of a pandemic,

compromising our capacity to respond if large parts of the world

are affected simultaneously. To date these pressures have resulted

in support for ‘soft-law’ initiatives or cooperative models of

governance. In recent times this global governance dimension has

found expression in initiatives such as the International Health

Regulations,25,26 and, closer to home, guidelines developed by

regional organisations such as APEC.27 In 2007, the WHO’s revised

International Health Regulations (2005) (IHR (2005)) took effect.28

The purpose and scope of the IHR (2005) are, in the words of

Article 2, to “prevent, protect against, control and provide a public

health response to the international spread of disease in ways that

are commensurate with and restricted to public health risks, and

which avoid unnecessary interference with international traffic and

trade”. The IHR (2005) require States to develop the capacity “to

detect, assess, notify and report” public health events (Article 5.1)

and assess and notify events that may constitute a “public emergency

of international concern”. The IHR contain a decision instrument

to assist states in this process. While the IHR are an important tool

in international public health law there are also other more radical

and as yet largely unexplored sources of international law, including

the Security Council of the UN, which might potentially play a

role in managing a major pandemic disaster in light of changed

assessments of risks to security within a globalised world29 and the

growing understanding of the potential for infectious diseases to

present risks to domestic and global security.30

The Asia-Pacif ic Economic Cooperation (APEC) has

developed guidelines to assist Member States in planning for

pandemic influenza. The APEC Guidelines also recognise the

role for law in pandemic planning, calling on APEC Members

to inter alia:

• “Work towards ‘preventive action’ as a priority initiative,

including improved regional capacity on surveillance and

detection, infection control, containment and communication

strategies as well as reviewing and reinforcing relevant

laws.”27

• “Take steps to ensure that border control, quarantining,

surveillance and screening measures are designed to

comprehensively address containment and infection issues

while limiting the impact on trade in most goods and

services.”27

• “In line with the International Health Regulations (2005), and

WTO Agreements, to prevent, protect against, control and

provide a public health response to the international spread of

disease in ways that are restricted to public health risks, and

which avoid unnecessary interference with international traffic

and trade.”27

As argued above, legal frameworks play a vital role in supporting

effective public health responses to infectious diseases. Yet legal

frameworks do not emerge in a vacuum. They are informed by

ethical, cultural and historical assumptions and principles that

guide the direction of legal development. Law and public health

ethics (in its various forms or schools31) are both critical parts of

pandemic planning and emergency preparedness.

A role for ethicsThe WHO has recognised the importance of according separate

attention to the ethical issues raised in pandemic planning. In its

Checklist for Influenza Pandemic Preparedness Planning, the

WHO highlights the importance of legal frameworks to support the

required response measures during a pandemic. These measures

commonly include ethical minefields such as: limitations on

freedom of movement with the enforcement of quarantine, use

of private premises for hospitals, off-licence use of medicines,

compulsory vaccination and maintenance of essential services.32

Other legally contentious issues identified by WHO include:

“the advantages or disadvantages of a declaration of a state of

emergency during a pandemic”; the legal and policy basis for

vaccination of healthcare workers, essential services workers and

individuals at high risk; liability for unforseen adverse events from

vaccines or anti-viral medication; and the inclusion of influenza

within occupational health and safety laws.32

A range of ethical issues also arise in pandemic planning. These

issues include: priority setting for access to vaccines and antiviral

medications; rights and duties related to social distancing measures,

isolation, quarantine and border control; the duties of health

professionals to treat patients during a pandemic; and international

ethical obligations to provide assistance to poorer countries and

countries in need.33 As WHO has noted: “A publicly discussed

ethical framework is essential to maintain public trust, promote

Bennett and Carney Article

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2010 vol. 34 no. 2 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 109© 2010 The Authors. Journal Compilation © 2010 Public Health Association of Australia

compliance, and minimise social disruption and economic loss.”33

While an effective vaccine is a key part of pandemic planning,34

no country has sufficient vaccine supplies and the lead time of three

to six months to develop an effective vaccine for a new strain means

that non-pharmaceutical measures will be important, particularly

in the early stages of a pandemic.35 Non-pharmaceutical measures

include community hygiene such as cough etiquette, social

distancing measures such as closure of schools and cancellation

of major sporting events, infection control within hospitals (during

the SARS crisis healthcare workers were disproportionately among

those infected36), isolation and quarantine, and restrictions on

cross-border and international movement of people.37-39

Responding to pandemic influenza raises a great number of

social equity, health planning, regulatory and ethical dilemmas,

few of which have yet been addressed. For example, one vital

issue stemming from limited vaccine supply is the ‘distributional

justice’ issue of resource allocation, including identification of

priority and high-risk groups for receipt of vaccines and the ethical

foundations for decisions. In common with other ‘triage’ issues in

allocation of health resources,40 there are various ways of domestic

rationing of vaccines,41 including possible priorities for essential

workers, children, intergenerational equity questions, and social

justice issues regarding the poor or the powerless. At the economic

or regulatory level, questions arise about optimal incentives

for manufacture of vaccines, streamlining and harmonising

overlapping regulatory requirements for new medicines, and

liability for unforseen adverse events associated with emergency

use of new vaccines.41

There are also global and regional equity issues for poorer

countries, similar to issues in world poverty and international

development. Inequality, poor health and disease are ready partners.

Despite the impact of infectious disease on large numbers of

people across the globe, western bioethics has traditionally paid

little attention to infectious diseases.42 These issues are not simply

issues for the developing world. Global health inequalities are both

unethical and contrary to the interests of individual countries.43

In the increasingly globalised world that we all live in, risks to

health are shared by us all. SARS provided a dramatic reminder

of this a few years ago26,44 and avian influenza may yet provide a

far more dramatic reminder. Poorer countries may lack the health

resources and infrastructure necessary to meet the challenges of a

severe pandemic.45 It is commonly pointed out that germs do not

recognise borders and outbreaks of infectious disease can escalate

rapidly across the globe. The development of effective public health

infrastructures in all countries, both rich and poor, is an essential

aspect of managing health risks in a globalised environment.

Difference and public health ethicsThe ethical challenges posed in the management of pandemics

throw into high relief differences between the practice of clinical

medicine and public health.46 Much of health and medical law

has traditionally focused at the individual level, concentrating on

interactions between doctors and their patients, and the legal and

ethical issues associated with new technologies such as assisted

conception and genetics. In contrast, public health law focuses

on the law’s role in supporting health at the community and

population level.46

Clinical medicine is based mainly on catering to the immediate

suffering or needs of individual patients, and is often personalised

around the values and preferences of known individuals, and the

emotional tug that, say, intensive care of premature babies may

have on the public. Public health by contrast is focused on longer-

range population-wide measures, taking the form of preventive

interventions or other parametric changes to disease vectors.

Its ultimate aim is to reduce the future incidence of disease and

morbidity, such as through anti-smoking campaigns, reduction

of cholesterol levels or avoidance of obesity. Yet the ethical base

for public health measures to deal with issues on the scale of a

pandemic are less well developed than for clinical medicine.47

For example, it raises more squarely principles of ‘distributive

justice’ associated with the protection of vulnerable populations

such as the disabled, the poor, children and the elderly, and ethnic

or NESB minorities.48

One manifestation of the difference is in the way triage questions

present. In clinical medicine hard choices about rationing of

medical care are avoided as inappropriate, or are implicitly sought

to be defended (in areas such as care of the frail aged) on the basis

of measures such as favouring the foreseeable ‘adjusted quality

years of life’. In public health the temptation is to rely on objective

cost-benefit assessments, and longer time horizons. In disaster

management triage this has been summed up some commentators

as ‘doing the most for the most’, irrespective of age or perceived

‘worth’.40 This does not mean that public emotions like fear of

disaster will not play a part. As Quigley and Harris49 point out,

the cost of stockpiling tamiflu (oseltamivir) in anticipation of an

avian flu outbreak is high and of dubious utility. It may be good

public relations, but its efficacy (if any) and distributional impact

(will it ‘save’ the old rather than the likely very high numbers of

young and fit victims) is unknown, though a scientific case can be

mounted for taking better advantage of any future inter-pandemic

years.34 As Gostin and Gostin have recently argued, this may call

for a new ethical paradigm, a ‘population-based’ perspective,

where “utility is not measured by enhancing short-term individual

preferences, but by maximising overall societal welfare; savings

in pain, disability and life within the populace”.50 Other ethical

differences, however, present in determining the form of the

legislative (quarantine and emergency powers) and public policy

dimensions of public health responses to pandemics. Important

issues arise in determining the balance between coercive state

powers and human rights,15,47,51 and the role for law in assisting

and supporting preparedness across diverse cultural and legal

contexts.52,53 Differing weightings of factors, or indeed differences

in the overall ethical paradigms, have been found to account for

variation in the laws and policies in Europe.54 The same was

true of the highly regarded ethically-grounded framework for

pandemic response planning developed in North Carolina, where

that state endorsed most of the values and priorities developed by

Infectious diseases Law, ethics and pandemic preparedness

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110 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 2010 vol. 34 no. 2© 2010 The Authors. Journal Compilation © 2010 Public Health Association of Australia

the Joint Centre for Bioethics in Ontario, Canada, save for a sharp

rejection of the Canadian inclusion of ‘communitarian’ principles

of solidarity and stewardship.14

Closer to home, in the Asia-Pacific region, differing ethical

outlooks and perspectives are also important. The defining

characteristic of the countries of the Asian region is their difference

over many variables, including not only the architecture (and

origins) of their legal system, but their cultural, economic and

social status. This has important ramifications for the extent to

which harmonisation of laws, institutions or health practices is

desirable, or the capacity to harness and mobilise ‘social capital’

in an emergency response.55 The emphasis on Confucian family

and community values ahead of individual autonomy,52 for

example, highlights the need for development of ethical and legal

frameworks for pandemic preparedness that are culturally relevant.

Quarantining of individuals is less viable in rural subsistence

economies dependent on family labour, or isolated from medical

services and information. Children as a source of spread of

infection may not be so readily managed by the device of closing

schools or public places, when life is crowded and communal.

The social capital predicated as available under Confucian values

may be the envy of more ‘selfish’ western developed societies, but

changed labour markets and social mobility may have undermined

its social reality, paradoxically leaving a minimalist state health

and welfare system unable to cope with demands of a large-scale

pandemic.

Within the Pacific region, pandemic preparedness is complicated

by the fact that most public health laws in the Pacific are out of date

often having been originally based on British public health laws,

and there is a lack of resources to update them.56 Such updates are

necessary to incorporate contemporary understandings of public

health law, particularly in relation to the operation of state powers,

and in order to ensure that Pacific nations are able to meet their

obligations under the International Health Regulations.56

WHO has recognised the need to adapt global guidelines for

local contexts, noting: “Since specific decisions will depend

on local circumstances and cultural values, it will be necessary

to adapt this global guidance to the regional and country-level

context, with full respect to the principles and laws of international

human rights.”33

The importance of recognising difference and cultural specificity

in the development of appropriate legal and ethical measures for

pandemic preparedness presents complex issues about whether it

is ever truly possible to develop a ‘global bioethics’.57 Additional

complexities arise when bioethics meets human rights,58-60 for

human rights are typically expressed in terms of universal values

and entitlements, and tend to best guarantee so-called ‘negative’

or liberal rights (such as to autonomy) rather than ‘positive’ rights

such as a right to health or other social rights of citizenship. Indeed,

as bioethics is reshaped by human rights discourses there are new

possibilities to develop deeper, more nuanced understandings

of ethics premised on the inherent dignity of all persons and an

express recognition of the need for bioethics to address global

inequities and disadvantage.

As Rosemarie Tong14 has observed in respect of western legal

systems, “the kind of ethics most likely to persuade people to do

their duty and more is not a rights-based, duties-based, or utility-

based ethics, but a care-based ethics”. Ethical approaches based

on care and relational ethics14,61-63 provide another indication of

the need to look beyond the dominant individual-focused ethics

shaping clinical care, where Kantian autonomy (consent to

healthcare) or Millean principles of ‘harm to others’ are uppermost

(e.g. in the use of coercion in mental health treatment). Wendy

Parmet for example has recently questioned the appropriateness

of a Millean harm to self/others rationale for US quarantine laws

on the bases that too much room is left for executive power (and

arbitrariness) and that it fails Mill’s test of showing a sound ethical

foundation for the public health services themselves.64 This is

slightly unsettling given the prominence of utilitarian liberalism

as the foundational paradigm for public health legislation, but as

Gostin and Gostin observe, the assumptions such as that actions

are either self- and other-regarding actions, or that actors either

have or lack capacity, are much more nuanced than many analyses

may suggest.50

Of course there is still purchase in public health policy, especially

for ethical frameworks that address the bases and limits around

the use of coercion to isolate, or treat victims of a pandemic. But

the calculus of risk/harm is not the usual one contemplated by

philosophy and private law (such as the tort of negligence). Instead

of determining the proportionality of the coercive intervention

based on the individual risk to the public by reason of being

infected, the debate in public health management is about levels

of global statistical risk within populations, the pathways of spread

of infection to the disease-free portion of the population, and the

‘critical mass’ effects of given levels of infectivity within the

population. While the first of these is familiar as the philosophical

grounding for measures such as mass immunisation of children

or compulsory seat belt laws, the latter two are more challenging.

Pathways of spread of infection, and the critical mass of infected

individuals within a population do not follow a straight line. They

often involve either geometric curves or even sudden jump changes

in risk levels, as small increases in numbers of infected individuals

lead to escalating risk levels or cliff effects. As a consequence,

individuals find themselves almost instantly converted from being

trusted to autonomously self-govern their disease to someone

who is to be compelled to enter perhaps very spartan quarantine

facilities. As demonstrated by the reaction of the members of

the Australian lacrosse team placed in isolation in South Korea

during the recent A/H1N1 episode,65 the philosophical foundation

or ‘fairness’ of such public health actions is not understood at all

by the public and the popular media.

The ethical challenges are not confined to the interests of citizens

who become infected. The question of the expression and limits of

the ethical duty to treat on the part of health workers faced with

risks of serious illness or death,66-68 including, at the extremes, the

case for the medical equivalent of military conscription should

the pool of workers fall too low, or place unreasonable burdens on

particular groups (such as young singles) needs to be considered.

Bennett and Carney Article

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2010 vol. 34 no. 2 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 111© 2010 The Authors. Journal Compilation © 2010 Public Health Association of Australia

Furthermore, we need to recognise that health professionals in

developing countries may be at greater risk of infection than

their developed country counterparts due to the impact of global

disparities in health resources, running the risk that as Reiheld

noted in the American Journal of Bioethics in 2008 “[a]n absolute

duty to treat thus demands more of those who have less”.69 Even

in less fraught circumstances there are distributional justice issues

with regard to whether danger money incentives should be paid.

Similar questions are posed for other essential services workers,

along with tricky economic and social decisions about what the

core activities may be.14

Together with the challenges of deciding priorities for rationing

access to treatment and other necessary supports, there is a rich

set of complex ethical questions to be answered in pandemic

planning.

ConclusionThis paper has analysed the role of legal and ethical

considerations for pandemic preparedness, including cross-

jurisdictional and cross-cultural perspectives bearing on the

feasibility of harmonisation of laws and policies both within and

between nations.

As the WHO has noted, law is an essential ingredient in the

construction of sound national polices for managing a flu or other

pandemic, because the choices and issues entailed are such that: in

the words of the WHO “[t]hese decisions need a legal framework to

ensure transparent assessment and justification of the measures that

are being considered, and to ensure coherence with international

legislation (International Health Regulations)”.32 Ethical issues

are critical to the development of legal frameworks for pandemic

influenza because as WHO notes “[t]hey are part of the normative

framework that is needed to assess the cultural acceptability of

measures such as quarantine or selective vaccination of predefined

risk groups”.32

The soft-law guidance by the WHO towards development of

national pandemic plans is superficially attractive to the extent that

it leaves scope for variations in national approaches that reflect

cultural, institutional or other differences. However, it carries

some considerable baggage. The US experience with Hurricane

Katrina and in tailoring plans to local state conditions suggests

that soft-touch governance and cooperative federalism, have

their limitations and highlight the need for these limitations to be

expressly considered as part of pandemic planning. For developed

economies, the implicit endorsement of western philosophical

concepts of individual autonomy, and utilitarian liberal bases for

public health interventions, is shown to be problematic for certain

sections of the public who come from different cultural traditions

or who do not share those assumptions. For Asia and the Pacific,

it is argued that the challenges are heightened by factors such

as markedly lower levels of resources, sharply limited roles of

the state in the domain of health and government services, and

cultural traditions that emphasise collective extended family or

community responsibility. Checklists that assume a rural division

of labour, or a service capacity to support an individual outside

their subsistence economy and isolated community, will require

considerable adaptation to accord with local conditions. As the

swine flu experience in Australia has so graphically demonstrated

in exposing the limitations of pre-ordained plans with presumptive

actions linked to pandemic ‘stages’, what is critical is the capacity

to make flexible and responsive decisions in light of public health

assessments of the actions required.

Our argument is that the cultural and ethical acceptability of

pandemic planning measures require to be more flexible and more

nuanced than is currently envisaged in international guidelines

if an effective response is to be constructed internationally. As

shown by the APEC Guidelines, there is potential for regional

measures to supplement (and refine) international instruments and

guidelines. These may take the form of institutional coordination

of planning, training and responses to regional disease outbreaks,

or even culminate in bi-lateral or regional treaties. Time will tell,

but such options are consistent with the argument in this paper

regarding the fallacy of the notion that ‘one size fits all’, and the

wisdom of reliance on soft law international guidance that leaves

plenty of movement for each nation to construct its response in

conformity with its own cultural and value requirements, and for

the scope of this movement to be expressly included in pandemic

planning.

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