Stockpiling Antiviral Drugs for Pandemic Influenza:
The Key Ethical Principles[1]
Prepared by
Ethics Subcommittee of the Advisory Committee to the Director,
Centers for Disease Control and Prevention[2]
November 28, 2007
The National Strategy for Pandemic Influenza emphasizes that
planning and preparedness are shared responsibilities of all levels of
government, businesses, and individuals.
This concept of “shared responsibility” has been proposed for the
purchase and stockpiling of antiviral drugs in preparation for pandemic
influenza. Antiviral drugs for the treatment of persons who become ill during a
pandemic have been purchased and stockpiled by the federal and state
governments. A working group that
included representatives from government and public health recently recommended
that pandemic antiviral drug strategies be expanded to also include prophylaxis
(preventive use) for healthcare and emergency service providers and for
household contacts of persons who have pandemic illness. Businesses also are encouraged to consider
stockpiling antiviral drugs for their critical employees as a component of a
comprehensive pandemic plan.
The Ethics Subcommittee of the Advisory Committee to the
Director, Centers for Disease Control and Prevention offer these comments on
key ethical considerations relevant to decision making about stockpiling
antiviral drugs. We did not consider a
specified definition of “shared responsibility” realizing that the scope and
meaning of the concept of shared responsibility is dependent upon first
determining among what groups responsibility for purchase of antiviral drugs may
be shared. The candidates are: A) the federal government; B) tribal, state, and
local governments; C) public sector organizations (public hospitals, police and
fire departments); D) private sector organizations (health care organizations,
industry, non-profit organizations); E) insurance companies; F) manufacturers
of antiviral drugs; and G) individuals and families. The alternative to this concept of shared
responsibility is to have the federal government assume full responsibility for
purchasing antiviral drugs for a pandemic influenza response.
Shared responsibility for the purchase of antiviral drugs
among some or all of the above candidates gives rise to the question: how to prepare for pandemic influenza as a public
health emergency in a way that is consistent with ethical principles? An
exhaustive analysis of the concept of shared responsibility would require
examining the likely consequences of all permutations and combinations of the
above candidates as purchasers, and seeing how ethical principles apply to
those consequences. That analysis is well beyond the scope of this document. Instead
we focused on addressing the key ethical principles that should be considered
by decision makers who will be charged with assigning responsibility for the
purchase of antiviral drugs. These key
ethical principles are – effectiveness, efficiency, equity, reciprocity, and
autonomy.
1. Effectiveness:
what arrangement for the purchase and distribution of antiviral drugs will result
in the best overall public health outcome? This is an illustration of the
utilitarian principle that mandates actions or policies that maximize benefits
for the greatest number of people. In the context of pandemic influenza preparedness,
this would mean ensuring that antiviral drugs are stockpiled and can be
appropriately deployed during a pandemic as recommended in order to maximize
health benefits and minimize disease impact for society as a whole. Whereas prophylactic use of antiviral drugs
provides an individual benefit, it also provides community benefits. Protecting healthcare workers and emergency
responders contributes to maintaining health and safety for the entire community. And results of mathematical models suggest
that protecting household contacts of ill persons reduces the transmission of
influenza in communities reducing the overall number of persons who become
infected.
2. Efficiency:
what is the least expensive and quickest arrangement to achieve the desired
ends? In the context of pandemic influenza preparedness, this principle would
call for 1) purchasing the drugs at the cheapest possible price, 2) minimizing
costs associated with maintaining a stockpile and distributing the drugs, 3)
extending the shelf-life of the drugs to reduce the need for periodic
re-purchase, and 4) limiting the quantity of drug purchased to what is
necessary to achieve public health objectives.
There is often an overlap between efficiency and effectiveness:
approaches that reduce costs may allow more drugs to be purchased better
achieving public health outcomes and reducing “opportunity costs” where funds
applied to antiviral drug purchase and stockpiling are not available for other
beneficial uses. Nevertheless, the most economical solution may not be the most
effective for public health outcomes.
3. Equity: how to
ensure fairness, making sure that that the uninsured, the unemployed, the poor,
the homeless, and any marginalized groups or persons geographically isolated in
rural communities have equitable access. The principle of equity is often in
tension with the principle of efficiency, since it will probably cost more
money and take longer to ensure equitable access to antiviral drugs for all
these groups. Equity is likely consistent with effectiveness; for example, the
unchecked spread of influenza in poor neighborhoods would spill over increasing
disease in more affluent areas and overburdening healthcare facilities reducing the availability of resources for
all in the community.
4. Reciprocity:
those who assume occupational risks are entitled to greater protections. The American
Medical Association Code of Medical Ethics states, “A duty to serve overrides
autonomy rights in societal emergencies, even in cases that involve personal
risks to physicians.” If healthcare workers are expected to work during a
pandemic, benefiting their communities, access to recommended protective
measures should be assured.
5. Autonomy:
individuals should make their own health related decisions when those decisions
do not adversely affect the health or safety of the community generally. Promoting autonomy for individuals and
organizations with respect to antiviral drugs also may contribute to a more
effective pandemic response by promoting planning and preparedness generally
As stated above, it was not our intent to conduct an
exhaustive ethical analysis of the concept of shared responsibility. Instead, we start by addressing the following
considerations.
1.
Equity requires that
individuals who cannot afford to purchase antiviral drugs nevertheless have
access to them. This means that purchases should be subsidized or provided free
of charge for those who cannot afford them.
Which one of the sharing partners should do this? How is the ability to
afford determined?
2.
The same question of equity
arises for public or private sector organizations with limited financial resources
and/or competing needs. Purchases would also have to be subsidized for these
organizations.
3.
Effectiveness may require
that access to antiviral drugs be assured for health care personnel who assume
increased occupational risk. Since healthcare workers are necessary to treat
others who get sick, the best overall outcome (reducing the impact of pandemic influenza)
is likely to be achieved if these groups are provided with antiviral drugs for prophylaxis.
Providing medications free of charge or at lowest cost is also supported by the
principle of reciprocity.
4.
An analogous consideration
applies to emergency service workers. Since healthy personnel are necessary for
society to continue to function, the principle of efficiency requires that
access to antiviral drugs be ensured for employees in these organizations.
5.
Achieving maximal effectiveness
(positive health outcomes) depends on the degree of compliance on the part of
individual households and healthcare organizations and providers. That is, the
impact of household antiviral post-exposure prophylaxis on illness attack rates
in communities depends on the proportion of households that comply. The effectiveness of healthcare for a
community also may rely on each hospital preparing adequately. Therefore, reliance
on households and healthcare organizations to purchase and stockpile antiviral drugs
in a system of shared responsibility is likely to have less overall
effectiveness than a system in which the public sector retains initial and
ultimate responsibility for purchase of the drugs.
6. Effectiveness also requires that
antiviral drugs for household post-exposure prophylaxis can be dispensed within
less than two days following the onset of illness in the case-patient. The
infrastructure at the tribal, state and local level is a critical factor in
complying with the principles of efficiency and effectiveness. The argument for
stockpiling in households is that if tribal, state, and local governments cannot
effectively distribute the drugs, having them in the home may result in greater
individual and community protection.
7. Placing the burden on private insurance
companies to purchase antiviral drugs would fail to comply with several ethical
principles. Effectiveness would not be achieved if insurers did not uniformly
comply or if co-pays dissuaded individuals and organizations from purchasing
antiviral drugs. Efficiency would not be achieved because the commercial price
of antiviral drugs exceeds the price paid by the Federal government and because
any individual or organization could purchase antiviral drugs – even if such
purchases were not required for an effective public health response to the
pandemic. Equity would not be achieved because of the millions of uninsured or
underinsured people.
8. If governments, public and private
sector organizations, and individuals have to share responsibility for purchase
of antiviral drugs, so too do the manufacturers of these products have an
obligation to the entire society. Just as companies have reduced the price of
antiretroviral drugs for low-resource countries with a heavy burden of HIV disease,
the pharmaceutical industry has an analogous responsibility to the entire U.S. society
to mitigate the impact of pandemic influenza.
Multiple ethical principles would be served if manufacturers of drugs
take responsibility for accepting a lower profit margin in preparing for a
public health emergency.
9. Placing the burden for purchasing and
stockpiling antiviral drugs on individuals and families, as part of the shared
responsibility, is likely to fail to comply with effectiveness, efficiency, or
equity. Results from a CDC survey indicate that pandemic influenza is not a
major health concern of most Americans (only 1% identified it among their three
leading health concerns); almost half believe that the risk of a pandemic has
been exaggerated (48% versus 45% who believe that it has not been exaggerated);
and fewer than 10% of respondents identified antiviral drugs (Tamiflu) as
something they “personally could do to help prevent the spread of a flu
pandemic.”[3]
These attitudes and beliefs suggest that people are unlikely to stockpile
voluntarily in their homes. This would fail to comply with effectiveness, as
only a certain proportion (perhaps a minority) of households would be
protected. It would fail to comply with efficiency, since the cost is highest
for individual, non-governmental purchases of antiviral drugs. And it would
fail to comply with equity, since those who could least afford to purchase the
drugs would forgo them.
10. If shared responsibility is implemented
in a way that calls for public and private sector organizations to purchase
antiviral drugs for their employees, what should be done about institutions,
organizations, or groups that fail to fulfill their responsibility in such a
shared arrangement? Failure on the part of any groups to fulfill their
responsibility, while consistent with a principle of autonomy, would go against
the principles of effectiveness, efficiency, and reciprocity.
a.
When responsibility is
decentralized, it is inevitable that some organizations will not purchase their
share, decreasing the ability to achieve public health objectives and, if the
non-compliant organizations are in the healthcare or emergency services
sectors, violating the principle of reciprocity.
b.
If organizations or
institutions refuse to buy antiviral drugs as part of shared responsibility, is
there any way to force them to do so? Would doing so violate still another
ethical principle, that of respect for the autonomy of institutions, organizations,
and individuals in a free, democratic society? Alternatively, does the principle of
effectiveness in a public health emergency permit coercive actions that would
otherwise not be ethically acceptable? If so, what mechanisms for enforcement
would be available?
c.
If a scheme for shared
responsibility is put in place but is voluntary, and some institutions do not
purchase the share of drugs for which they are responsible, should government
at some level step in and provide the requisite supply? This solution would
increase effectiveness but also would reduce the likelihood that organizations
and individuals comply with the policy calling for their purchase and
stockpiling of the drugs.
11.
Procedural fairness requires that the process of decision making be transparent, inclusive, impartial, ensure
due process, and be accountable. This requirement includes the need for
community involvement, the inclusion of a wide range of individuals and groups
in the decision making process, and a mechanism for challenge and revision of
the chosen scheme, including the opportunity for revising decisions about
priorities in light of further evidence and changing circumstances.
CONCLUSIONS:
1.
It is important that national recommendations on antiviral drug
strategies (treatment and prophylaxis) recognize the burden that will be posed
and the ethical questions raised in purchasing and stockpiling the drugs. Therefore, those recommendations should be
based on the best scientific evidence, the process for developing the guidance
should be transparent, and the recommendations should be vetted with those who
may bear part of the responsibility for their implementation.
2.
While there are several applicable ethical principles that must be
considered in assessing policy options, the overriding principles are effectiveness
and equity. When the goal of a
health policy is individual protection, it is reasonable for autonomy rights to
take preference. However, when the goal
is public health and individual choice interferes with public good, a strategy
must be chosen that will achieve the community benefits in a way that ensures
fairness.
3.
Although autonomy is an important principle in a democratic society,
greater autonomy in implementing a public health policy is likely to result in
less effectiveness. Autonomy, in
some aspects, may be linked with effectiveness as personal responsibility for
preparedness is likely to extend beyond antiviral drugs alone. On balance,
however, because of the likelihood that many organizations and individuals will
not choose to purchase and stockpile drugs, if effective implementation of the
recommended policy is primary, the public sector will likely need to assume
substantial responsibility either through direct purchase of the antiviral
drugs or by facilitating purchase in a way that best assures broad
compliance.
4.
Devolving responsibility broadly for purchase and stockpiling of
antiviral drugs to organizations and potentially to individuals will inevitably
violate principles of equity and reciprocity, unless the policy can be
strictly enforced or a safety-net created that assures uniform access.
5.
Efficiency becomes a prime principle in order to minimize opportunity
costs. While pursuing effective
public health policy for pandemic preparedness, it is important to recognize
that funds devoted to antiviral drug purchase and stockpiling are likely to be
taken from other beneficial uses. Given
the impossibility of balancing current needs against the risk of a pandemic
which while certain to occur is uncertain in both timing and severity, a
strictly utilitarian approach that relies on determining the best overall
outcome would be impossible. An
additional problem is weighing incommensurate values (e.g., keeping healthcare
and emergency response workers on the job, on the one hand, and providing
bullet-proof vests for policemen on the other).
6.
A policy that maximizes effectiveness, efficiency, and equity would,
from an ethical perspective, be optimal.
[1]
This document was reviewed and approved by the Advisory Committee to the
Director, Centers for Disease Control and Prevention on May 1, 2008.
[2]
Members of the Ethics Subcommittee include John Arras, University of Virginia;
Georges Benjamin, American Public Health Association; Vanessa Northington
Gamble, George Washington University; Thomas Hooyman, Regis University; Bruce
Jennings, Center for Humans and Nature; Mary desVignes-Kendrick, Texas A &
M, ; Barbara Koenig, Mayo College of Medicine; Kathy Kinlaw, Emory University;
Robert Levine, Yale University; Ruth Macklin, Albert Einstein College of Medicine;
and James Thomas, University of North Carolina.
[3]
American Institutes for Research.
Pandemic Influenza Disease and Vaccine Cross-Sectional Survey final
report. Submitted to the Centers for
Disease Control and Prevention and the Office of the Assistant Secretary for
Public Affairs, U.S. Department of Health and Human Services, April 2007
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