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Copenhagen, Denmark
Eleventh Futures Forum on the ethical governance of pandemic influenza preparedness
Keywords
DISEASE OUTBREAKS – ethics – prevention and control
INFLUENZA, HUMAN – prevention and control
DISASTER PLANNING – organization and administration
PUBLIC HEALTH – ethics
DECISION MAKING
EUROPE
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ISBN 978 92 890 7186 4
Written by Elke Jakubowski with contributions from Shouka Pelaseyed
Concept and design: Tuuli Sauren, Brussels, Belgium
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Eleventh Futures Forum on the ethical governance of pandemic influenza preparedness
Eleventh Futures Forum
on the ethical governance
of pandemic influenza preparedness
Copenhagen, Denmark
28–29 June 2007
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Eleventh Futures Forum on the ethical governance of pandemic influenza preparedness
CONTENTS
Page
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.
Pandemic influenza planning in countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.
Ethical considerations in developing a public health response to pandemic influenza:
the work of who. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.
Principles for ethical decision-making in pandemic influenza planning. . . . . . . . . . . . . . 11
4.
National provisions for ethical decisions in influenza pandemic planning and response. 15
5.
National decision-making structures on pandemic influenza planning and response. . . 20
6.
Endorsing ethical principles through public involvement . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.
Conclusions and recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
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WHO Futures Fora series
WHO Futures Fora aim to stimulate free debate among high-level policy-makers over emerging
public health issues and to address these issues proactively. They are designed to offer policy
options for public health decision-making. Their objective is approached through a series of
meetings in an impartial environment, offered by WHO.
The Futures Fora are a platform for sharing know-how and developing strategies to address
new public health challenges. Practical policy-making experience is mainly presented through
case studies from countries. The meetings are held regularly with some degree of informality
and under the Chatham House Rule to ensure confidentiality. When all or part of a meeting is
held under the Chatham House Rule, participants are free to use the information received, but
neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may
be revealed. The WHO Regional Office for Europe publishes the main findings and conclusions
of the Fora in policy briefings on its web site (http://www.euro.who.int/futuresfora). Rather than
reflecting consensus and providing recommendations, these briefings delineate the range of
policy options available in countries in addressing specific challenges and opportunities for
health.
Previous Fora have focused on: rapid response decision-making, cooperation in the face of
terrorism, ethics of health systems, evidence-based recommendations, crisis communication,
unpopular public health decisions, patient safety, governance and public participation, and
equity in health.
Eleventh Futures Forum on the ethical governance of pandemic influenza preparedness
Introduction
Forum topic: ethical governance of pandemic influenza
preparedness
By adopting the Health for All update in 2005 (1), the Member States in the WHO European Region promoted
ethical governance as a value-based principle for health policy-makers in the Region. Ethical governance is a
policy concept underpinning fair, equitable, transparent and accountable approaches to policy-making, and
thereby contributing to improving the performance of health systems. But how is this concept applied in
practice? The Eleventh Futures Forum reviewed some countries’ experience in applying ethical governance
approaches to a major contemporary policy concern: preparedness for an influenza pandemic.
This topic was chosen to enable participants in the Forum to review and discuss generic principles and instruments
of ethical governance. Thus, the findings deriving from the Forum may apply also to other contemporary
concerns with health policy and systems. Pandemic influenza preparedness is a future-oriented health policy
concern of high priority to WHO for several reasons.
First, the 20th century showed that, although rare, influenza pandemics are recurrent events. Three occurred in
the 20th century and, in view of the periodicity of events, the 21st century may likewise experience influenza
pandemics.
Second, influenza pandemics occur with the emergence of new influenza viruses that have not previously
circulated among human beings, so that people have not developed immunity to them. Such a new virus has
been detected and monitored for about 10 years: the virus that causes avian influenza. Although this virus
primarily infects birds, it has caused a number of laboratory-confirmed cases of influenza among human
beings in the past few years. In the WHO European Region, outbreaks caused by influenza A/H5N1 in animal
populations were first observed in Kazakhstan and the Russian Federation in 2005. Since then, 28 countries
have experienced animal outbreaks. In the first quarter of 2006 there were 20 laboratory-confirmed human
cases with 9 fatalities: 8 cases and 5 deaths in Azerbaijan, and 12 cases and 4 deaths in Turkey. No human
H5N1 outbreaks have been reported since January 2007, but outbreaks were observed in poultry in the Czech
Republic, Germany, Hungary, the Russian Federation, Turkey and the United Kingdom. The occurrence of
bird-to-human and human-to-human transmission, as well as the high mortality of previously healthy people
who became infected with the virus, has alerted the international health community to prepare better for an
influenza pandemic that may soon emerge.
Third, it is feared that, owing to the magnitude and speed of international travel, an influenza pandemic will
spread much quicker across country borders than in the past, possibly becoming even a global problem. All
countries therefore need to be as well prepared as possible, and can learn much from each other about how to
optimize preparedness.
Fourth, influenza pandemic preparedness seemed to be a particular appropriate topic for the Eleventh Futures
Forum because ethical considerations are especially relevant in planning for a pandemic. For example, it is
assumed that, particularly at the outset of a pandemic, countries may experience a substantial shortage of
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Eleventh Futures Forum on the ethical governance of pandemic influenza preparedness
pandemic-specific vaccines and possibly also trained and prepared human resources. In such a case, decisions
will have to be made on how to allocate the available resources, including vaccines and other supplies. Thus,
decision-makers and clinicians will need to have principles and criteria beforehand, which they can then use
to make rapid, justifiable decisions at the very outset of a pandemic. Again, such tools for decision-making in
countries in the case of an influenza pandemic may be tested on other policy concerns.
Fifth, WHO’s emphasis on pandemic influenza preparedness has to be regarded in light of its broader work
on health security in 2007 (2,3) and is closely related to the coming into effect of the International Health
Regulations (IHR) on 15 June 2007 (4). The IHR aim to prevent, protect against and control public health
threats of international concern. They provide WHO with the mandate to ensure that countries assess and
notify the international community of any event (a manifestation of disease or an occurrence that creates the
potential for disease) that may constitute such a threat, as well as any health measure implemented in response.
Explicitly for the case of influenza, all cases of human influenza caused by a new virus subtype must be notified.
The IHR were adopted by all WHO Member States and are legally binding for all but three.
In summary, the topic of the Eleventh Futures Forum was regarded as a concrete policy-making example that
participants could use to discuss broader and more generic ethical governance approaches in European health
systems.
Scope and purpose of the Forum
The Eleventh Futures Forum aimed to review and discuss ethical governance principles and instruments to
improve the performance of health systems. Pandemic influenza planning was chosen as the topic for discussion,
as most of the Region’s 53 Member States had adopted action plans. In addition, the countries were developing
ethical considerations for these plans, since few of them discussed such issues, or offered systematic ethical
justification and criteria for decisions (5).
There are a number of key ethical questions for decision-making in an influenza pandemic. For example,
decision-makers could ask: how to ensure equitable, fair and cost-effective access to curative drugs, vaccines and
medical treatment; how to set priorities for medical treatment; and how to allocate resources to prevent and
treat influenza.
The Futures Forum aimed to provide an opportunity for European countries jointly to review their experience
and discuss such unsolved questions regarding the ethical governance of influenza preparedness. Its purpose was
to enable the participants to identify good practices, exchange and learn from experience in ethically governing
pandemic influenza preparedness and identify some of the knowledge gaps. It was hoped that the Forum would
thereby contribute to global work on the ethics of pandemic influenza planning, and, through the exchange
of experience with the tools countries are using for ethical policy-making, further promote and concretize the
policy principles of ethical governance of health systems in the WHO European Region. The Forum thereby
also aimed to feed into the work of the WHO Regional Office for Europe in preparing its European Ministerial
Conference on Health Systems in June 2008, of which governance will be a major topic.
This Forum was held in continuation of the series’ cycle relating to the theme of health systems governance,
drawing on previous Fora on the ethics of health systems, health systems governance and public participation,
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WhyFutures
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Forum
Introduction
Governance
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Participation?
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on on
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influenza
preparedness
How to balance listening to the public and remaining firm in pursuing health objectives
steering towards equity in health and other topics. The Forum and this report also took account of findings of
the WHO global project on addressing ethical issues in pandemic influenza planning (5).
Structure of this report
Following this introduction, Chapter 1 reports on the state of pandemic influenza planning with respect to the
underlying principles of ethical considerations. Chapter 2 reports on WHO’s work on ethical considerations
in developing a public health response to pandemic influenza. Chapter 3 presents some possible guiding
principles for ethical decision-making on the example of setting priorities for the distribution of medical goods.
Chapter 4 presents case studies from Norway, Switzerland and the United Kingdom on their ethical frameworks
for pandemic influenza planning. Chapter 5 discusses national decision-making structures for pandemic influenza
planning and response, presenting a case study from Belgium. Chapter 6 deals with public participation in
ethical questions of pandemic influenza preparedness, and presents views on whether to incorporate the public’s
view in planning for a pandemic. Chapter 7 provides the Forum’s conclusions.
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Eleventh Futures Forum on the ethical governance of pandemic influenza preparedness
1. Pandemic influenza planning in countries
The Forum was attended by representatives from 12 European countries; all had adopted
preparedness plans for pandemic influenza and regularly provided reviews and updates according
to international guidance from WHO and the European Centre for Disease Prevention and Control
(ECDC). The formal incorporation of ethical considerations – as integral parts of the action plans or
through distinct ethical frameworks – varied between countries, but there was consensus that most plans required
more work in making ethical principles and criteria for decision-making more explicit. ECDC’s review of the
plans in this context was thought to be an important step towards further improving their ethical aspects.
Belgium has a national plan that focused on addressing the implications for local government and the private
sector. Two bodies provide advice on ethical considerations: the national bioethics committee, an independent
organ reporting to Parliament, and the high-level council of health, which makes recommendations on pandemic
influenza planning to the Government. Some current ethical issues concern migration: for example, how to
include Belgian citizens living abroad and how to plan for multinational communities such as that in Brussels.
In Cyprus a plan was finalized and launched in 2005; ethical aspects were discussed during a recent ECDC
review mission. Cyprus is in a very particular situation when it comes to ethics, for example, related to equitable
access to vaccines and care. One reason is that the population of Cyprus triples during the summer. In addition,
Cyprus has opened its borders to refugees during crises in the Middle East. Further, the Government is
concerned about protecting Cypriots residing in other countries. The country had ordered stockpiles of vaccines
to be able to vaccinate 10% of the population by the end of 2007. Nevertheless, while a bioethics community
is effectively addressing these questions on the national level, more attention needs to be paid to regional-level
implementation.
Municipalities in Denmark are responsible for developing strategies to prevent and treat diseases. National
guidance addresses all sectors other than health. The country has a contingency preparedness plan, and is
following it. For example, stockpiling of influenza vaccines is restricted to that required by the regulations set
out in the plan, and would not cover the whole population in a pandemic. Thus, criteria are needed to decide
on the population groups to be prioritized for vaccination in such a case, and ethical principles and criteria for
decision-making in a pandemic need to be made much more explicit in the plan.
France developed an influenza pandemic preparedness plan in 2004, published it in 2005 and has revised it
twice since then. The plan sets out the overall strategy, the organizational structure and the mechanisms for
working during a pandemic, and includes scenarios for decision-making. A parliamentary hearing assessed
the plan. Its second chapter sets out some ethical considerations, based on the recommendations of a national
symposium intended to provide ethical guidance for the plan. The symposium underlined the importance of
social mobilization in ethical pandemic influenza preparedness. Discussions on the ethical aspects of technical
collaboration with less developed countries during a pandemic, including providing tools, are also taking place.
The next step in planning will be at the level of the seven regions of France.
In Germany the national pandemic influenza preparedness plan (published in 2005, updated in 2007) already
has regional equivalents in all 16 federal states. Oseltamivir (Tamiflu) stockpiles enable treatment for 20% of
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influenza
planning
countries influenza preparedness
Eleventh Futures Forum Pandemic
on the ethical
governance
of in
pandemic
the population. The country’s national plan was discussed and agreed by high-level federal and state politicians
in working groups. Three aspects need to be considered in prioritizing vaccines or antiviral medication:
1. ethical values;
2. the best theoretical way to act on them; and
3. the logistical capacity and feasibility of the approach.
In Germany the first are identified as the goal of maximizing the reduction of morbidity and mortality in a
pandemic. For the second, modelling work could contribute greatly to determining an approach; here, Germany
is building capacity. At any rate, it appears that, even when groups most at risk were identified, which might
only be possible when a pandemic had started, choosing the way to go may not be straightforward. For example,
if elderly people were identified as being at the highest risk of death, it may still be better to vaccinate children
first because this approach could prevent transmission and reduce the momentum of the pandemic, thereby
lowering the chance of infection more efficiently. Assuming one had found the answers and identified the risk
groups and the groups to prioritize, more questions may arise. For example, if people with chronic illnesses
should be prioritized, who comprised this group? For example, would an immune-suppressed patient take
priority over a person suffering from diabetes or the other way around?
Here the third aspect, the feasibility of any strategy, comes into play, which may be the main strength of Germany’s
approach. The discussion with many stakeholders at the level where decisions have to be implemented led to a
very pragmatic decision laid down in the pandemic plan. The goal is to reduce morbidity and mortality, and,
after the vaccination of health care workers and essential service personnel, the population would be vaccinated
by year of birth, starting with the young.
Israel has had a national influenza preparedness plan for more than three years. To maintain official awareness of
the plan, the country carried out two simulation drills of pandemic influenza scenarios involving all ministries
and the army. The drills focused on the distribution of oseltamivir (Tamiflu) in the case of a pandemic; stockpiles
are established for 25% of the population. In spite of progress in pandemic preparedness, some questions
remain open, many of which have ethical dimensions. One field of concern, as in other countries, is the problem
of ensuring consistency between neighbouring countries’ quarantine plans to enable effective protection of
populations. In addition, there are many potential tensions between groups within countries. For example, can
governments ensure that different cultural and ethic groups accept the principles underlying priority setting?
And how can one explain to a mother who is a health care worker that she is entitled to vaccination while her
husband and children are not?
ECDC has reviewed Luxembourg’s pandemic preparedness plan and other preparedness activities. Ethical
considerations are not a specific focus of the plan and require more work during future updates. As do other
countries, Luxembourg focuses on better addressing cross-border cooperation issues. For example, about 60%
of Luxembourg’s workforce comes from abroad. Would these people be protected by national law or through
their home countries? In this context, more intensive work would be useful to make peer reviews of national
plans to limit the inconsistencies regarding these cross-border issues.
The Netherlands has worked on pandemic influenza preparedness for many years, undertaking many exercises.
The stockpiling of sufficient doses of oseltamivir (Tamiflu) has created a feeling of effective preparedness, but
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Eleventh Futures Forum on the ethical governance of pandemic influenza preparedness
concern remains that, in a real influenza pandemic, the situation might still be chaotic, as people’s lives would
be at stake. Certainly, more work on ethical norms and standards in consensus with other ministries would be
helpful.
Norway published its first preparedness plan in 2001, and has updated it in line with WHO recommendations
several times. A national committee was established to put different aspects of the plan in operation, such as
ensuring the supply of vaccines to at least 5% of the population. The committee had secured a commitment
from industry to provide a sufficient vaccine supply. In this phase of Norwegian preparedness planning, ethical
considerations are considered extremely important. Although remedies supply is assessed as sufficient according
to WHO and ECDC standards, there is no guarantee that it would meet actual needs during a pandemic.
Portugal launched its national influenza pandemic preparedness plan in 2006. An ECDC review mission was
felt to be useful in raising awareness of ethical considerations. The focus at the national level is on assisting the
regions to develop their own pandemic preparedness plans.
San Marino has drafted a pandemic preparedness plan but not yet launched it, while some questions remain
about collaboration with Italy on issues affecting both countries. For example, which country would close
the borders in case of a pandemic, or how could health care or other workers working across the borders be
protected?
In Sweden public health policies and legislation are developed and adopted at the national level, but implemented
at the regional and municipal levels. The country adopted its national contingency plan for influenza preparedness
in 2005 and has further developed it since then. The plan provided guidance for regional-level planning for
pandemic influenza preparedness. In a review of the plan, an expert advisory committee found that it required
further work to incorporate ethical considerations. For example, the committee advised that the plan should
more explicitly address ethical criteria and arguments for prioritizing prevention and treatment of certain
population groups in case of a pandemic. This was in concordance with findings of a review mission of ECDC
and WHO in spring 2007.
Switzerland started pandemic preparedness planning 10 years ago, revisiting the plans periodically. The last
update of the national plan took place in 2006. The current revision of the updated plan focuses on personal
hygiene and pre-pandemic vaccines. The 26 cantons are expected to finalize their own plans during 2008. A big
political challenge is to get other sectors involved with pandemic planning, as this is still understood as the task
of the health sector in Switzerland. Communication and transparency of information were seen as major ethical
tasks, as people must understand the criteria upon which certain decisions are based.
The United Kingdom has had a pandemic influenza preparedness plan for many years. Recent revisions
focused on making it cross governmental and introducing an ethical framework for decision-making in case
of an influenza pandemic. Principles for ethical decision-making were tested in a public consultation prior
to finalizing the framework for pandemic influenza preparedness. The consultation strongly rejected the fair
innings argument, on the basis that age should not be a criterion for prioritization. The fair innings argument
promotes the egalitarian concept of equal opportunities, which implies that a child or young adult has a stronger
claim to protection than an elderly person who has been able to live a full life-span, so that vaccination should
prioritize younger people.
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Eleventh Futures Forum on the ethical governance of pandemic influenza preparedness
2. Ethical considerations in developing a public
health response to pandemic influenza:
the work of WHO
About the WHO project
WHO ran a project on ethical issues in pandemic influenza planning from 2005 to
2007 (5). Its objective was to identify Member States’ considerations in developing a
public health response to pandemic influenza. Four working groups addressed different
aspects of pandemic influenza planning, identified in a consultation with Member States in
May 2006:
1. equitable access to therapeutic and prophylactic measures;
2. the ethics of public health measures in response to pandemic influenza;
3. the role and obligations of health care workers during an outbreak of pandemic influenza; and
4. issues arising between governments when developing a multilateral response to a potential outbreak of
pandemic influenza.
The groups’ reports were discussed at a global consultation in October 2006, and WHO issued a summary
publication on ethical considerations for developing a public health response to pandemic influenza (6). A
series of regional and country support activities was organized to contextualize the global report. The following
summarizes the project.
Definition of ethics and sources of ethical judgement
Ethics is a puzzling term with numerous connotations. The WHO project used ethics as a way to describe how
people should ideally act. Thus, the focus of ethics is on human behaviour and a normative standard is attached
to it: namely, that from an ethical perspective, one can assess what is right and wrong in human behaviour.
Substantive ethics provide for human behaviour in terms of what to do, and procedural ethics relate to the way
to do it.
Ethical judgments may have a number of possible sources or points of reference: personal values, religious beliefs,
social norms and laws. Laws may promote ethical values but they also may have non-ethical justifications. Any
laws should ideally be subject to ethical analysis, but ethical considerations go beyond legal considerations.
Ethical considerations have cultural underpinnings.
General ethical considerations related to pandemic preparedness
A number of general considerations come into play in addressing the ethics of pandemic influenza preparedness.
First, this involves striking a balance between people’s rights, interests and values. Second, ethical judgments
need to be brought into conjunction with the scientific evidence base. At the outset of an influenza pandemic,
evidence is likely to be rare, so that ethical judgments will need to close a time gap. When scientific evidence
becomes available, however, reviewing ethical judgments in light of this new evidence is equally important.
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Eleventh Futures Forum on the ethical governance of pandemic influenza preparedness
A balance must also be struck in relation to resource constraints, which will determine the extent of possible
ethical judgment related to, for instance, the level of possible vaccination coverage. No matter what choices are
to be made, ethical policy-making will always require a certain degree of transparency, public engagement and
social mobilization.
Priority setting and equitable access to prophylactic and
therapeutic measures
The issue of priority setting and equitable access to prophylactic and therapeutic measures was addressed by
the first working group in the WHO project and is further elaborated in Chapter 3 of this report. The working
group acknowledged the importance of the decision-making process. It stated that policy questions need to be
distinguished from clinical judgments, and focused much discussion on how to separate the two. For instance, if
a policy rules that the medically worst-off patients should be prioritized, then clinicians must still identify them.
This eventually opens the possibility of leaving priority-setting decisions to the clinical level. This possibility
needs to be addressed at the policy level; ideally the clinical decision would naturally take account of an existing
policy.
The working group also had two principal considerations as to the criteria for priority setting: utility to society
and equity. Decisions based on utility, for instance, could give essential health service workers priority in
prophylactic and therapeutic measures, so that they would continue to ensure the functioning of the health
system, or be based on the likelihood that medical intervention would reduce transmissibility or diminish
the societal burden of disease in another way. In contrast, decisions based on equity could give priority to
the medically worst-off patients, those at greatest risk of dying or particularly vulnerable population groups.
Chapter 3 further elaborates on these notions using the concrete examples of vaccination, antivirals and
mechanical ventilation.
Obligations of and to health care workers
Working group three dealt with obligations of and to health care workers, and faced considerable difficulties
in reaching consensus, including detailing the concept of obligation. Obligations might be based on morals,
contracts or professional orders, or on other legal provisions that are enacted regardless of morals, contracts
or orders. For instance, a government might pass a law requiring heath professionals to come to work in a
pandemic influenza. There was consensus that obligations to work during a pandemic must be balanced against
others, such as professionals’ duty to their children; on continuous duty during a pandemic, such professionals
would require time or alternative means to provide such care. Obligations also need to be balanced against
individual rights and interests.
The group recommended that countries devote some attention to developing policies defining health professionals’
obligations in an influenza pandemic. This process should, for instance, involve not only government players
but also professional societies, unions and others.
In addition, the group addressed the difficulty of clearly defining health professionals. For instance, would
they comprise only the physicians and nurses working around influenza patients or include any other medical
support staff? Even within the medical and nursing professions, how will countries define essential health care
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Ethical considerations
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the work of WHO
workers in case of an influenza pandemic? The working group also discussed whether obligations should be
defined for work within a professional’s usual terms of reference or extend beyond them.
Further, there was some level of agreement that the enforcement of obligations should take account of the
principles of necessity and proportionality: that is, they should be restricted to cases when clear benefits are to
be expected.
Governments’ obligations to health care workers were also discussed. Evidently, health care workers’ increased
obligations would need to bring them some gains. For instance, if health professionals take additional risks
and larger workloads during a pandemic, they will expect governments and employers to contribute equ