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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Chapter 4: Can Mandatory Vaccination of Health Care Professionals during an
Influenza Pandemic ever be Justified?</title></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmc">7161670</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7161670</idno><idno type="RBID">PMC:7161670</idno><idno type="doi">10.1016/S1479-3709(06)09004-2</idno><idno type="pmid">NONE</idno><date when="2006">2006</date><idno type="wicri:Area/Pmc/Corpus">000457</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000457</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Chapter 4: Can Mandatory Vaccination of Health Care Professionals during an
Influenza Pandemic ever be Justified?</title></analytic><series><title level="j">Ethics and Epidemics</title><imprint><date when="2006">2006</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Objectives: To discuss whether, during an influenza pandemic, public health authorities
could be ethically justified in implementing a mandatory vaccination program directed at
health care professionals.</p><p>Methods: Ethical analysis is carried out by examining arguments that can be made in
favor or against such a mandatory measure and by seeking a reasonably balanced position
between them. Arguments under consideration are based on the duties of health
professionals and public health authorities, the consequences of their actions and on
other ethical principles. The importance of relevant empirical data is stressed without
any attempt to review or analyze them systematically.</p><p>Results: Mandatory vaccination of some health care professionals during a serious
pandemic of influenza can be justified, but only under certain limited conditions.</p><p>Conclusions: In the throes of an influenza pandemic, health care professionals (and to
a variable degree, other health care workers) have an ethical obligation to accept
influenza vaccination if it is reasonably safe and effective. The ethical responsibility
of public health authorities is to limit the impact of a pandemic on the population by
all reasonable means, which clearly includes the appropriate use of vaccine.
Consequently, the vaccination of health care staff can be made mandatory under certain
conditions. However, a critical objection to this conclusion, which upholds that a
voluntary vaccination program (an ethically much less problematic intervention) is just
as effective, needs to be addressed.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Beauchamp, T L" uniqKey="Beauchamp T">T.L. Beauchamp</name></author><author><name sortKey="Childress, J F" uniqKey="Childress J">J.F. Childress</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Beguin, C" uniqKey="Beguin C">C. Beguin</name></author><author><name sortKey="Boland, B" uniqKey="Boland B">B. Boland</name></author><author><name sortKey="Ninane, B" uniqKey="Ninane B">B. Ninane</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bernstein, B B" uniqKey="Bernstein B">B.B. Bernstein</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bradley, P" uniqKey="Bradley P">P. Bradley</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Carman, F" uniqKey="Carman F">F. 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<front><journal-meta><journal-id journal-id-type="doi">10.1016/S1479-3709(2006)9</journal-id><journal-title-group><journal-title>Ethics and Epidemics</journal-title></journal-title-group><isbn publication-format="ppub">978-0-76231-311-2</isbn><isbn publication-format="epub">978-1-84950-412-6</isbn><publisher><publisher-name>Emerald Group Publishing Limited</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmc">7161670</article-id><article-id pub-id-type="doi">10.1016/S1479-3709(06)09004-2</article-id><article-categories><subj-group subj-group-type="heading"><subject>Chapter Item</subject></subj-group></article-categories><title-group><article-title>Chapter 4: Can Mandatory Vaccination of Health Care Professionals during an
Influenza Pandemic ever be Justified?</article-title></title-group><contrib-group><contrib contrib-type="editor"><name><surname>Balint</surname><given-names>John</given-names></name></contrib><contrib contrib-type="editor"><name><surname>Philpott</surname><given-names>Sean</given-names></name></contrib><contrib contrib-type="editor"><name><surname>Baker</surname><given-names>Robert</given-names></name></contrib><contrib contrib-type="editor"><name><surname>Strosberg</surname><given-names>Martin</given-names></name></contrib></contrib-group><contrib-group><contrib contrib-type="author"><name><surname>Kotalik</surname><given-names>Jaro</given-names></name></contrib></contrib-group><pub-date pub-type="ppub"><day>09</day><month>11</month><year>2006</year></pub-date><volume>9</volume><fpage>69</fpage><lpage>89</lpage><permissions><copyright-statement>© Emerald Group Publishing Limited</copyright-statement><copyright-year>2006</copyright-year><license license-type="open-access"><license-p>This article is made available via the PMC Open Access Subset for
unrestricted research re-use and secondary analysis in any form or by any
means with acknowledgement of the original source. These permissions are
granted for the duration of the World Health Organization (WHO) declaration
of COVID-19 as a global pandemic.</license-p></license></permissions><self-uri content-type="pdf" xlink:href="S1479-3709(06)09004-2.pdf"></self-uri><abstract><p>Objectives: To discuss whether, during an influenza pandemic, public health authorities
could be ethically justified in implementing a mandatory vaccination program directed at
health care professionals.</p><p>Methods: Ethical analysis is carried out by examining arguments that can be made in
favor or against such a mandatory measure and by seeking a reasonably balanced position
between them. Arguments under consideration are based on the duties of health
professionals and public health authorities, the consequences of their actions and on
other ethical principles. The importance of relevant empirical data is stressed without
any attempt to review or analyze them systematically.</p><p>Results: Mandatory vaccination of some health care professionals during a serious
pandemic of influenza can be justified, but only under certain limited conditions.</p><p>Conclusions: In the throes of an influenza pandemic, health care professionals (and to
a variable degree, other health care workers) have an ethical obligation to accept
influenza vaccination if it is reasonably safe and effective. The ethical responsibility
of public health authorities is to limit the impact of a pandemic on the population by
all reasonable means, which clearly includes the appropriate use of vaccine.
Consequently, the vaccination of health care staff can be made mandatory under certain
conditions. However, a critical objection to this conclusion, which upholds that a
voluntary vaccination program (an ethically much less problematic intervention) is just
as effective, needs to be addressed.</p></abstract><custom-meta-group><custom-meta><meta-name>academic-content</meta-name><meta-value>yes</meta-value></custom-meta><custom-meta><meta-name>rightslink</meta-name><meta-value>included</meta-value></custom-meta></custom-meta-group></article-meta></front><body><sec><title>1 Introduction</title><p>Influenza A viruses are unique in their ability to cause not only seasonal yearly
outbreaks, but also periodic global epidemics – often called pandemics. In the past
century, there have been three pandemics (1918, 1957 and 1968), one of which – the
infamous “Spanish flu” of 1918 – was responsible for 450,000 deaths in the US and 50–100
million worldwide (<xref rid="bib40" ref-type="bibr">Last, 1986</xref>; <xref rid="bib57" ref-type="bibr">Potter, 1998</xref>; <xref rid="bib21" ref-type="bibr">EURO ELSAV, 2002</xref>; <xref rid="bib50" ref-type="bibr">Osterholm, 2005</xref>). A
pandemic will likely occur again when the virus undergoes a major change, a so-called
antigenic shift, and this will make the whole population of the world, even those who
acquired immunity from annual outbreaks, highly susceptible. Although unable to predict
the exact time or severity of the next pandemic, most experts agree that it may occur at
any time (<xref rid="bib17" ref-type="bibr">Dowdle, 2001</xref>). The United States
Centers for Disease Control and Prevention estimate that in the US, when it will occur,
40–100 million persons will become ill, 300,000–800,000 persons will be hospitalized,
and 88,000–300,000 persons will die (<xref rid="bib46" ref-type="bibr">Meltzer, Cox,
& Fukuda, 2000</xref>). A more recent estimate, based on the probability that the
current avian flu strain H5NI could lead to a pandemic that would mimic the one of 1918,
puts the possible death toll to 1.7 million in the United States alone (<xref rid="bib50" ref-type="bibr">Osterholm, 2005</xref>). It is to be expected that
illnesses and deaths, combined with the population's reaction to them, will cause a
major disruption to social and economic life as well as to national and international
infrastructures. In anticipation of and in response to a possible pandemic, many
countries in the world have been developing coordinated strategies that represent major,
complex, public policies that in turn will affect the life of virtually every
citizen.</p><p>Unavoidably, these plans incorporate many ethical values and preferences, refer to
rights and responsibilities and create expectations and obligations. Many ethical issues
that emerge from pandemic plans deserve urgent attention (<xref rid="bib38" ref-type="bibr">Kotalik, 2005</xref>; <xref rid="bib64" ref-type="bibr">Tracy, Upshur,
& Daar, 2005</xref>). This paper will discuss only one of the many issues. Albeit
a rather narrow topic, it is one which, hopefully, will provide a window into some of
the moral complexities of public health interventions designed to control a pandemic
and/or outbreaks of infectious diseases in general.</p><p>One of the effects of an influenza pandemic is that it will create enormous demands on
health care systems and health care workers and will do so for a protracted period,
perhaps 12–24 months. Not only will there be an unprecedented number of sick that
require care, there will also be fewer health care workers available to take care of
them because health care workers themselves – when caring for the infected – are at a
higher risk of infection, illness and death than the general population.</p><p>Understandably, a major concern addressed in pandemic plans is to find ways to protect
health care workers and to make them available for service. There appears to be a
consensus that the most useful tool to keep people well during a pandemic is an
effective vaccine – if one can be successfully developed (<xref rid="bib25" ref-type="bibr">Ghendon, 1994</xref>). But, production of a vaccine can only start after
the pandemic virus is identified. This is a slow and complex process, so that the first
batches will likely be available only four to six months after the new virus is
isolated. Because, in the early stages of a pandemic, the influenza vaccine will be in
short supply, a regular feature of pandemic plans is a prioritization scheme. The
pandemic plans of Canada (<xref rid="bib35" ref-type="bibr">Health Canada, 2004</xref>),
the US (<xref rid="bib65" ref-type="bibr">United States Department of Health and Human
Services, 2004</xref>) and the UK (<xref rid="bib14" ref-type="bibr">Departments,
2005</xref>) all have identified health care workers as the highest priority group.
There is a strong probability that, if the pandemic virus is proven to be highly lethal,
everyone who will be given an opportunity to receive the new vaccine will gladly accept
it. However, if the new virus is not likely to cause deaths to healthy people of middle
age, or if the efficacy or safety of the vaccine is suspicious, then health care workers
may not embrace the idea of a preventive vaccination. Yet, in such situations, there may
be strong epidemiological and operational reasons to make it desirable for all staff
members that are in patient contact to be immunized.</p><p>Health care planners need to be concerned about this type of situation because, as it
stands, the acceptance of yearly vaccination against influenza among health care
professionals and other health care workers has been chronically low even if vaccination
is highly recommended by authorities. It was estimated, at a recent meeting of the US
Advisory Committee on Immunization Practices, that only 36% of hospital workers are
vaccinated each year against influenza (<xref rid="bib22" ref-type="bibr">Fox,
2004</xref>). The vaccination rate of Canadian health care workers during the
2000–2001 influenza season was reported to be 55% (<xref rid="bib59" ref-type="bibr">Public Health Agency of Canada, 2001</xref>). Will health care workers respond
differently during a pandemic and will they all be voluntarily vaccinated? We do not
know. But, we do know that an unwillingness to accept vaccination will add to the
already worrisome “ethical barriers to preparedness” (<xref rid="bib67" ref-type="bibr">Wynia, 2003</xref>). To address this unpredictable factor, pandemic planners in
United States and Canada are cautiously looking into the possibility of using a law to
make such a vaccination compulsory. Typically, the United States’ guide for local- and
state-wide pandemic planning poses this question: “Does State law allow for ‘mandatory’
vaccination of certain groups if vaccination of such groups is viewed by State public
health officials as being ‘essential’ for public safety?” (<xref rid="bib65" ref-type="bibr">United States Department of Health and Human Services, 2004</xref>).</p><p>The question in the title of this paper, therefore, has a practical significance for
the current development of public health policies. But, it is also of theoretical
interest because it can serve as an opportunity to examine the ethical acceptability of
compulsory measures in unusual but very serious health situations. This issue is to be
seen against the background of a larger ongoing debate that is taking place in most
countries between those who promote legally mandatory vaccinations for various
infectious diseases and those who insist that vaccination programs remain voluntary
(<xref rid="bib5" ref-type="bibr">Bradley, 1999</xref>; <xref rid="bib21" ref-type="bibr">EURO ELSAV, 2002</xref>). Given that this is not a legal paper, and
accepting the premise that “(t)he law relating to public health should be based on
ethical values” (<xref rid="bib30" ref-type="bibr">Gostin, 2002</xref>), I will focus on
the ethical acceptability of mandatory vaccination of health care professionals. I will
first examine some principal arguments suggesting that health care professionals have a
moral obligation to accept vaccination and that public health authorities have an
ethical obligation to assure that these people are vaccinated. I will consider if these
arguments can ever be used to justify the imposing of vaccination by law and examine
both the condition for such an imposition and the limits of enforcement. Then, I will
discuss arguments that assert that vaccination during a pandemic must remain voluntary.
Finally, I will make some general observations about these arguments, attempt to create
a balanced position and provide a tentative answer to the question posed in the title of
this paper.</p></sec><sec><title>2 Arguments in favor of mandatory vaccination</title><p>To defend mandatory vaccination, we need to assert that both health care professionals
and public health care authorities have an ethical obligation to assure that such
vaccination takes place and that a mandatory approach is the only way to assure that
this obligation is fulfilled. There are several steps required toward such a
conclusion.</p><sec><title>2.1 Professionalism and the Obligation to Serve</title><p>The first argument that upholds that health care workers have a strong ethical
obligation to accept influenza vaccination is grounded in the notion of
professionalism, and it is simply this: at the time of a flu pandemic, health care
workers have a strong moral obligation to make themselves available to serve; this
obligation in turn creates an obligation to take all the necessary measures to remain
fit and to avoid illness, including the acceptance of vaccination. Three points
support this argument. Firstly, to be a professional means to be someone who
professes. Health professionals explicitly make such an act of profession when they
are accepting an academic degree or graduating, but also, implicitly, on a daily
basis, in the community or organization where they accept patients. They are
professing, that is, declaring their preparedness and readiness to serve the needs of
others (<xref rid="bib54" ref-type="bibr">Pellegrino & Thomasma, 1988</xref>).
This duty, which every health care professional (in the strong sense of the word
“professional” as advocated by Pellegrino and others) has taken on, is proportionate
to the need for his or her services.</p><p>Secondly, it appears that a major flu pandemic will be a public health emergency like
no other. The figures provided above indicate that, except for a major war, no other
foreseeable incident would cause a comparable amount of suffering, death and social
disruption. But, influenza pandemics are infrequent, surfacing about every 30 years or
so. Therefore, a health care worker will likely encounter this situation only once or
twice in his or her professional career. Such a rare, but extremely severe situation
calls for a meticulous adherence to professional duties. The need for services will
hardly ever be greater than in a pandemic situation, so, if there was ever a time to
demonstrate professionalism and a willingness to put the needs of others first, then
it is at the time of a pandemic. The obligation of medical professionals to tend to
the sick during epidemics, in spite of the increased risks, is also argued by Clark,
McCullough and Wynia elsewhere in this volume.</p><p>Thirdly, in order to be able to serve, the health care professional has an ongoing
responsibility to take care of oneself by choice of lifestyle, and to adopt measures
that promote one's physical, mental and spiritual health. Vaccination during a normal
influenza season was found – at least in some studies (<xref rid="bib51" ref-type="bibr">Pachucki et al., 1989</xref>) – to reduce employee absenteeism, so, it
would very likely also reduce sick time during a pandemic. Also, a meta-analysis of
numerous clinical trials indicates that influenza vaccination is moderately effective
in preventing influenza in the general population (<xref rid="bib39" ref-type="bibr">Langley & Faughnan, 2004</xref>). Hence, if vaccination is available, then the
health care worker has an obligation to receive it, unless it is medically
contraindicated. Another way to formulate this obligation would be to say that the
obligation arises from an unwritten social contract between health professionals and
society, which requires that professionals keep themselves always ready to serve.</p></sec><sec><title>2.2 Nonmaleficence and Obligation not to Infect Others</title><p>The second argument is based on the principle of nonmaleficence: do not cause
unnecessary harm or expose patients to avoidable risks. Unvaccinated health care
workers pose a risk to others and could harm the very patients they care for, thus
violating this principle. If vaccination minimizes a risk to patients, then health
care workers have an obligation to accept it. The “do no harm” principle is usually
applied only to interventions that are carried out by health care workers, yet, it is
obviously also relevant in situations where health care workers themselves can become
instruments of harm. It has been suggested that everyone has a moral obligation not to
transmit a communicable disease, if one can avoid it, even for such mild conditions as
a common cold (<xref rid="bib34" ref-type="bibr">Harris & Holm, 1995</xref>). If
there is such an obligation, then it will have an even stronger moral claim on health
care staff than on other people (<xref rid="bib60" ref-type="bibr">Rea & Upshur,
2001</xref>). In order for this argument be valid, it needs to be shown that front
line health care professionals who are not vaccinated will very likely get infected
with the virus, transfer the virus to their patients and cause illnesses or deaths of
patients that would not otherwise occur. It has been difficult to obtain such evidence
for the annual influenza seasonal infections, but most observers feel that such
evidence is now indeed available, and that the transfer of an influenza virus from
staff to patients is not just a theoretical risk. A recent report of the National
Foundation for Infectious Diseases has identified this problem and has recorded a case
study from a pediatric service (<xref rid="bib22" ref-type="bibr">Fox, 2004</xref>).
Nursing home outbreaks have been traced to infected staff (<xref rid="bib9" ref-type="bibr">Coles, Balzano, & Morse, 1992</xref>). A jury in a Coroner's Inquest
in Ontario, Canada determined that staff had played a key role in an outbreak of
influenza leading to deaths in a long-term care facility, and it called for mandatory
vaccination (<xref rid="bib42" ref-type="bibr">Marsh Canada Limited, 1999</xref>).
There are several studies suggesting that if health care workers in long-term care
facilities do get vaccinated, the overall death rate of residents in these facilities
during an influenza season is reduced (<xref rid="bib53" ref-type="bibr">Patriarca et
al., 1986</xref>; <xref rid="bib58" ref-type="bibr">Potter et al., 1997</xref>;
<xref rid="bib7" ref-type="bibr">Carman et al., 2000</xref>). As a result, the
American and Canadian advisory committees on immunization practices and the American
Academy of Pediatrics recommend annual influenza vaccination for health care workers
(<xref rid="bib45" ref-type="bibr">McMillan, 2000</xref>). Researchers have also
found that about a third of front line health care workers develop symptoms during an
influenza season and yet three-quarters of them do not stay home from work. It appears
that peer pressure in health care institutions persuades staff members to keep on
working unless an illness becomes seriously incapacitating. This behavior would be
commendable if it did not further increase the chances of patients getting exposed to
the virus (<xref rid="bib36" ref-type="bibr">Herwaldt, 1993</xref>). The refusal to be
vaccinated would be particularly ethically troublesome during a pandemic if the
vaccine were made preferentially available to health care workers but not to the
general population from which patients come. Immunization against hepatitis B has been
identified to be an ethical obligation of health care providers, based on a duty not
to expose patients to unacceptable risks (<xref rid="bib10" ref-type="bibr">College of
Physicians and Surgeons of Ontario, 1998</xref>) and the same duty could be
postulated to exist during an influenza pandemic.</p><p>To summarize, it could be argued, on the basis of this data, that health care workers
who reject available vaccination during the regular annual influenza outbreaks are
transgressing the important ethical principle of nonmaleficence, and that this would
be the case also during a pandemic.</p></sec><sec><title>2.3 Patient's Vulnerability</title><p>The third argument, not entirely independent, but supportive of the previous
arguments, suggests that the obligation of health care professionals to receive
vaccinations during a pandemic stems from a recognition of the patients’ vulnerability
on one hand and professionals’ accountability on the other. As such, it should be
included among the ethically relevant subject matters that health care professionals
are accountable to patients, employers, professions and society (<xref rid="bib20" ref-type="bibr">Emanuel, 1996</xref>). Getting infected from a professional could
represent a major burden or risk of death to a vulnerable patient, yet the burden of
vaccination on a professional is very slight because the procedure is rapid and has
only minimal side effects (<xref rid="bib60" ref-type="bibr">Rea & Upshur,
2001</xref>).</p></sec><sec><title>2.4 Responsibility of Public Health Authorities</title><p>So far, I have addressed the obligation of health care professionals, but the fourth
argument is based on the ethical obligations of public health authorities. Their role,
stated most broadly, is to promote and preserve the good health of all citizens,
balancing the rights of individuals with the needs of communities (<xref rid="bib40" ref-type="bibr">Last, 1986</xref>). Historically, the prevention and
control of outbreaks of infectious diseases have been among the first tasks in the
purview of public health services and still remains an important contribution to
public well-being. Failing to control an epidemic, if an opportunity to do so were
available, means failing an ethical obligation. The desire not to interfere with any
personal liberties is not sufficient justification to avoid taking action. Hence, if
epidemiological knowledge concerning an influenza pandemic provides a strong
indication that the burden to the population could be reduced by vaccination of health
care professionals, then it can be argued that public health service has an ethical
obligation to take all reasonable measures necessary to vaccinate this group.</p></sec><sec><title>2.5 Legal Enforcement</title><p>If indeed there is a strong moral obligation for health care workers to accept
vaccination, and if public health authorities have a moral obligation to ensure that a
vaccination will be delivered as these arguments suggest, we must ask if there is any
justification for passing a law that will allow making vaccination mandatory. This
raises the complex issue of the relationship between ethics and law that cannot be
elaborated upon here. It is also not possible to discuss the long history of
compulsory vaccination practices that in North America go back more than a hundred
years. It was in 1905, that the US Supreme Court examined a state-enacted, mandatory
vaccination against smallpox, and held that the law was a legitimate exercise of the
State's “police power” to protect the health of its citizens (<xref rid="bib28" ref-type="bibr">Gostin, 2000</xref>; <xref rid="bib66" ref-type="bibr">Welborn,
2005</xref>). Since that time, this power of the state has been challenged many
times or occasionally reduced, yet it has never disappeared (<xref rid="bib52" ref-type="bibr">Parmet, Goodman, & Farber, 2005</xref>). The possibility of
bioterrorism and new infectious diseases further advanced this cause, and mandatory
vaccination is a measure recommended to all American states in the Model State
Emergency Health Powers Act (<xref rid="bib31" ref-type="bibr">Gostin et al.,
2002</xref>).</p><p>During a pandemic situation, it can be argued that public health authorities should
have available to them a legal tool that can be used if it is foreseen that
non-compliance with this pressing moral obligation to accept vaccination would likely
cause severe or irreparable damage to society, such as deaths that could otherwise be
avoided.</p><p>A support for the conclusion that legal enforcement is acceptable presupposes that
influenza vaccination has a highly favorable harm/benefit ratio. Indeed, the
inoculation of an individual is a very minor procedure, with slight discomfort and
only remote risks of serious side effects. Even if it were administered against a
person's wishes, this does not represent a wreckage of some fundamental interests of
that person for the benefit of society (<xref rid="bib29" ref-type="bibr">Gostin,
2001</xref>). On other hand, the benefits to society (and also to the vaccinated
person) could be major, especially if the virus that causes the pandemic is highly
contagious and frequently kills.</p><p>Another way to examine the issue of the acceptability of legal enforcement of
vaccination is to consider the status of social free-riding. This term refers to the
situation when a large majority of health professionals voluntarily collaborate in an
effort that is beneficial for society, but a few are trying to get a free ride, that
is, not participating in order not to inconvenience themselves, yet expecting to be
well regarded and receive the same benefits or privileges as the participants. Such
behavior is contrary to ordinary moral intuition. It is not defensible in common
morality nor by deontological systems, and is problematic even in some interpretations
of act-utilitarianism (<xref rid="bib37" ref-type="bibr">Kornegay, 2004</xref>). If
refusal of vaccination is comparable to free-riding, which is morally indefensible,
then legal steps to discourage such behavior seems warranted.</p></sec><sec><title>2.6 Objections to the above Arguments</title><p>However, a number of things could be said to weaken the above arguments favoring
mandatory vaccination:<list list-type="simple"><list-item><label>(a)</label><p>The influenza pandemic will not be a unique event and not likely that severe;
therefore, no extraordinary moral duties will be generated and no extraordinary
measures should be taken. Experts tend to exaggerate the risk in order to draw
attention and resources to the programs in which they are involved.</p></list-item><list-item><label>(b)</label><p>Public health officials are exaggerating the efficacy of a vaccination to alter
the course of a pandemic. Some critics maintain that the efficacy of the annual
influenza vaccination of health care staff is at best only marginal (<xref rid="bib49" ref-type="bibr">Nicholson, 2000</xref>; <xref rid="bib13" ref-type="bibr">Demicheli, 2001</xref>), and vaccination during a pandemic has
never been scientifically tested, mainly because in previous pandemics there was
never enough vaccine available. Pandemic plans of Canada and US do not provide
any indication as to what effectiveness could be achieved during a pandemic,
even if a theoretical impact of vaccination was incorporated into some
calculation of economic consequences of pandemic (<xref rid="bib46" ref-type="bibr">Meltzer, Cox, & Fukudo, 2000</xref>). Under those
circumstances the vaccine does not warrant any special moral or legal
considerations.</p></list-item><list-item><label>(c)</label><p>A vaccine manufactured for a pandemic is not likely to be entirely safe, and
therefore, each potential recipient should be allowed to make a judgment based
on personal assessment of risks and benefits. Drug research is now market
driven, and a declaration by any party that a new vaccine is safe cannot be
trusted. “Transparency has become a substitute for trust” (<xref rid="bib56" ref-type="bibr">Pope, 2003</xref>) and the processes of manufacturing and testing
vaccines are not currently transparent. There will not be sufficient time in a
pandemic situation for proper clinical trials and, as a result, priority
recipients, like health care professionals, will in fact serve unwittingly as
research subjects. New batches of vaccine sometimes have new side effects that
cannot be anticipated, such as the oculorespiratory syndrome caused by a
vaccination in 2001 (<xref rid="bib61" ref-type="bibr">Skowronski, Bjornson,
Husain, Metzger, & Scheifele, 2004</xref>). An unexpected risk of
vaccination can sometimes emerge only many years later, as was the case with the
virus-contaminated polio vaccines (<xref rid="bib44" ref-type="bibr">McCarthy,
2002</xref>; <xref rid="bib11" ref-type="bibr">Dang-Tan, Mahmud, Puntoni,
& Franco, 2004</xref>). Reporting adverse events is not mandatory and
these events are likely underreported and underestimated.</p></list-item><list-item><label>(d)</label><p>There will be a scarcity of vaccine during a pandemic, and not even all those
who desire it will be able to receive it. Therefore, mandatory vaccination will
be unnecessary.</p></list-item><list-item><label>(e)</label><p>An infected health care worker will not be a significant source of infection
because during a pandemic the virus will be ubiquitous.</p></list-item><list-item><label>(f)</label><p>Those health professionals who do not wish to be vaccinated could be offered
prolonged prophylactic therapy with antiviral drugs, with benefits similar to
vaccination.</p></list-item><list-item><label>(g)</label><p>Health care professionals will not be infecting their patients if they use
infection control procedures and if management policies do not effectively
prevent health care workers from taking time off when ill (<xref rid="bib15" ref-type="bibr">Diodati, 2002</xref>).</p></list-item><list-item><label>(h)</label><p>The notion of professionalism as used in some of the above arguments is
outdated; contemporary health care professionals do not have more obligations
than workers in other sectors to guard their own health or avoid infecting
others.</p></list-item></list></p><p>It should be noted that all of these objections except “(h)” attempt to undermine my
earlier arguments by rejecting some factual assumptions about an influenza pandemic
and vaccination or by interjecting some additional facts. I will return to this
problem in the final section of this paper.</p></sec></sec><sec><title>3 Arguments against mandatory vaccination</title><sec><title>3.1 Principle of Autonomy</title><p>The first and the most obvious argument against mandatory vaccination is based on the
principle of respect for autonomy. We can say that mandatory vaccination of health
care professionals would be a blatant and large-scale transgression of the most
important principle of health care ethics. It would represent a severe and
unacceptable affront to the personal liberty and autonomy of a whole class of
citizens. When a health care professional is facing a sharp end of a needle, he or she
is a patient and deserves all the ethical considerations given to patients.
Vaccination without consent would be an attempted invasion of bodily integrity and as
such, completely out of line with current standards of patient care. Treating health
care professionals in this way would simply be offensive. In support of this argument
could be cited voluminous literature; the defense of patients’ self-determination has
been a prevailing concern of bioethics for at least the first two decades of the
history of this discipline since the term “bioethics” was coined in 1970s (<xref rid="bib2" ref-type="bibr">Beauchamp & Childress, 2001</xref>). While the
position of this principle is perhaps less dominant, there are still strong voices
suggesting that this principle is the most important one, “the first among equals”
(<xref rid="bib26" ref-type="bibr">Gillon, 2003</xref>). Even those theorists who
are critical of the principle of respect for autonomy as a centerpiece of
“principlism” agree that it is necessary to protect the patients’ self-determination.
They would likely support the prohibition of mandatory vaccination along the same
ethical lines as breaking a rule like “do not deprive of freedom” (<xref rid="bib24" ref-type="bibr">Gert, Culver, & Clouser, 1997</xref>).</p></sec><sec><title>3.2 Principle of Least Infringement</title><p>The second argument against mandatory vaccination is based on the principle of least
infringement, which states that a public health intervention that infringes on
liberty, privacy, autonomy and justice is permissible only if no other intervention,
which is as effective but which infringes less on these moral claims, is possible
(<xref rid="bib8" ref-type="bibr">Childress et al., 2002</xref>). It is argued that
mandatory vaccination is unacceptable because it fails to respect the principle of
least infringement. There is another intervention, voluntary vaccination, which would
achieve the goal of mandatory vaccination with less infringement on individual rights.
The proponent of this argument will have to admit that the equivalency of mandatory
and voluntary vaccination in terms of outcome is not proven; however, it is also not
proven that mandatory vaccination of professionals would achieve a higher success rate
than voluntary vaccination. In the absence of such evidence, one way or another, the
least infringing and least burdensome intervention must be preferred. This position
can be supported by numerous studies that indicate that undue concern about
efficiency, adverse effects, misinformation, barriers and disincentives to vaccination
were factors that played a role in the current low rate of acceptance of influenza
vaccination among health care staff. The same and other studies also reported an
improvement of vaccination rates among health care workers if some of these problems
were addressed (<xref rid="bib33" ref-type="bibr">Harbath, Siegrist, Schira, Wunderli,
& Pittet, 1998</xref>; <xref rid="bib3" ref-type="bibr">Beguin, Boland, &
Ninane, 1989</xref>; <xref rid="bib27" ref-type="bibr">Girasek, 1990</xref>; <xref rid="bib19" ref-type="bibr">Eisenfeld et al., 1994</xref>; <xref rid="bib48" ref-type="bibr">Nichol & Hauge, 1997</xref>; <xref rid="bib62" ref-type="bibr">Tamblyn, 1997</xref>; <xref rid="bib7" ref-type="bibr">Carman et al., 2000</xref>;
<xref rid="bib32" ref-type="bibr">Habib, Rishpon, & Rubin, 2000</xref>).
Generally, all these interventions to increase vaccination rates were a part of a
research study and they were not permanent, system wide or comprehensive.</p><p>To buttress this argument, one can point to the fact that health care professionals
have not yet recognized that vaccination acceptance is a matter of professional
ethics. The ethical responsibilities of health care workers arising out of the
availability of influenza vaccination (or other vaccinations) are not referred to by
the codes of medical ethics in the US (<xref rid="bib1" ref-type="bibr">American
Medical Association, 2001</xref>) or in Canada (<xref rid="bib6" ref-type="bibr">Canadian Medical Association, 2005</xref>). With few exceptions, the ethical
relevance of vaccination has not been discussed in medical literature (<xref rid="bib36" ref-type="bibr">Herwaldt, 1993</xref>; <xref rid="bib60" ref-type="bibr">Rea & Upshur, 2001</xref>). As a result, health care workers do not currently
have an ethical motivation to be vaccinated. If all issues that hinder the acceptance
of voluntary vaccination are properly dealt with, then, the argument goes, a voluntary
vaccination program will be just as effective as a mandatory one in assuring that
almost all workers, at least those without medical contraindications, will be
vaccinated. If this is the case, then the only ethically acceptable vaccination
program is a voluntary one because it does not infringe on health care workers’
personal liberty and autonomy.</p></sec><sec><title>3.3 Utilitarian Objections</title><p>The third argument against mandatory vaccination is based on utilitarian reasoning,
and asserts that when the negative effects of compulsion are counted in, there will be
no overall benefit to mandatory vaccination over voluntary vaccination. Firstly, such
a forced measure would give the message that in our society, personal autonomy is
really not that important; it could encourage health care workers themselves to impose
unwanted interventions on their patients. Such an approach would erode the respect for
autonomy in health care in general. In addition, such forceful measures would
demoralize health care workers and make them less effective caregivers. Coercive
measures used on emergency physicians in Quebec and hospital nurses in Ontario were
strongly resisted by the respective professions and thought to have undesirable side
effects (<xref rid="bib18" ref-type="bibr">Editorial, 2002</xref>; <xref rid="bib55" ref-type="bibr">Pengelley & Whary, 2002</xref>). In addition, the
mandatory approach would require surveillance and enforcement that would increase the
cost of pandemic response measures and interfere with the provision of patient
care.</p></sec><sec><title>3.4 Principle of Justice</title><p>The fourth argument against mandatory vaccination is based on the principle of
justice. It declares that it would be unjust to single out health care professionals
for mandatory vaccination if people in other groups are not treated in the same
fashion. It can be argued that, for example, hairdressers and waiters are in just as
much personal contact with large numbers of people who could be infected by them, and
that firefighters and policemen, for example, are just as essential to the well-being
of society as health care professionals. Consequently, there is not a sufficient
morally significant difference between health care workers and many other categories
of workers to justify treating health professionals differently.</p></sec><sec><title>3.5 Safety and Appropriateness</title><p>The final argument is a historical one, which states that public health services, at
least in North America, have a poor record of making the right decision about the
nature of threat to the population and the appropriateness of mass vaccination. In
recent memory, two major national vaccination programs were launched as an emergency
measure, yet eventually, these programs turned out to be unnecessary and risky. In
1976, when a new strain of influenza with pandemic capacity was detected, 46 million
Americans and several million Canadians, on the urging of their governments, accepted
emergency vaccination. But the vaccination campaign came to a premature halt because
of the vaccine's side effects. On the final count, over 500 cases of Guillain-Barré
syndrome and 32 deaths were attributed in the US to this intervention. In addition,
the new virus was never detected outside of the initial isolated outbreak, so there
was no pandemic (<xref rid="bib47" ref-type="bibr">Morrison, Liston, & Abbott,
1976</xref>; <xref rid="bib4" ref-type="bibr">Bernstein, 1981</xref>). In 2002, the
US administration announced a smallpox vaccination plan to protect Americans because
of the threat of a terrorist attack. It expected to administer 450,000 doses of
vaccine to health workers who would be thus prepared to care for patients infected
with the virus. However, the plan ran into opposition. Its acceptance further dropped
after reports of unexpected heart problems possibly associated with the vaccine, and
after the threat of terrorists’ attacks did not materialize. At the end of the year,
the program succeeded in vaccinating only about 10% of the target population and it
came to an end (<xref rid="bib41" ref-type="bibr">Manning, 2003</xref>; <xref rid="bib43" ref-type="bibr">Matthews, Murphy, Lopez, & Orenstein, 2003</xref>).
An argument can be made that the harm and burden of these vaccination programs, which
in retrospect were unnecessary, were reduced because the programs were voluntary. If
these programs would have been implemented as mandatory measures, the burden would
have been more severe and the moral culpability of the experts and decision-makers
would be much greater. Hence, mass vaccination programs should remain voluntary.</p></sec><sec><title>3.6 Objections to above Arguments</title><p>A number of objections can be raised against the validity of the above arguments:<list list-type="simple"><list-item><label>(a)</label><p>The influenza pandemic is such an extraordinarily severe threat to our society,
and its control is so crucial that, if there is a single situation when public
interest should prevail against all personal interest and autonomy, this is the
situation.</p></list-item><list-item><label>(b)</label><p>Because “good health is a form of liberty for all peoples” (<xref rid="bib21" ref-type="bibr">EURO ELSAV, 2002</xref>), mandatory vaccination
will not be an affront to personal liberty if it significantly enhances the
health of society. The autonomy of an individual is expressed foremost by a
person's free decision to be a member of a particular community and by freedom
to leave it. But as long as a person remains a member of a community, the social
contract binds him to accept obligations requested by society together with
benefits provided by that society (<xref rid="bib21" ref-type="bibr">EURO ELSAV,
2002</xref>).</p></list-item><list-item><label>(c)</label><p>Health care professionals, indeed, are a special category of the population,
with manifestly different rights and obligations than other workers in personal
services. Therefore, they can be treated differently than other groups, and this
includes having vaccination imposed on them, without committing an
injustice.</p></list-item><list-item><label>(d)</label><p>The principle of the least infringement does not apply because mandatory and
voluntary vaccination programs are not equally efficient at achieving the goal
of vaccination. At least, there is no proof that a voluntary vaccination
program, even if could be made more acceptable, would ever come close to
recruiting 100% of health care workers. In the absence of such proof, and given
the gravity of the threat from influenza, we have to err on the side of caution
and implement mandatory vaccination.</p></list-item></list></p></sec></sec><sec><title>4 Additional observations</title><p>When we survey various positions on mandatory vaccination, it becomes apparent that
there is a close and critical relationship between empirical data on the one hand and
normative positions on the other. The following two points attempt to address this
conundrum.</p><sec><title>4.1 The Need to Reduce Uncertainty</title><p>Many of these contradictory arguments and objections can be raised only because of
the uncertainty about empirical facts related to influenza, influenza pandemic and
vaccination. I did not attempt to provide a comprehensive review and interpretation of
existing empirical data. When I refer to empirical information in this paper, it is
mainly to show how critical it is to have full and correct data in order to reach a
reasoned ethical assessment. Issues of ethics and policy, of course, cannot be settled
just by clarifying empirical data. However, acceptance of a certain set of empirical
data is an important step that makes it possible to concentrate on discussion of
values, interests, rights, duties and utility when looking for ethically appropriate
public health measures. It is understood that it will be impossible to achieve
complete certainty about many factors, be it the benefits and burdens of vaccination
or the magnitude of future pandemics. Public policy makers have to act in spite of a
residual, perhaps even major, uncertainty (<xref rid="bib40" ref-type="bibr">Last,
1986</xref>; <xref rid="bib12" ref-type="bibr">Dare, 1998</xref>). But assessment of
the degree of the probability of various scenarios and the reduction of uncertainty as
much as science permits are extremely important tasks from an ethics and public health
law perspective (<xref rid="bib23" ref-type="bibr">Gerberding, 2002</xref>).</p></sec><sec><title>4.2 Importance of Empirical Data</title><p>Concerning annual vaccination, it was stated “(d)espite the enormous burden from
influenza, the efficacy, effectiveness and cost benefit of immunizing health care
workers has been little studied” (<xref rid="bib49" ref-type="bibr">Nicholson,
2000</xref>). Similarly, it has to be noted that the national influenza pandemic
plans of Canada, the United States and the United Kingdom do not provide (or refer a
reader to) the kind of empirical data that would make it possible to assess the
ethical acceptability of some of the measures that are proposed by these plans,
vaccination being one of them. Particularly, these plans do not provide any estimates
of staff shortages likely to be caused by influenza, of the benefits of vaccination in
the reduction of absenteeism, of the benefits of diminishing an infection transfer
from staff to patients, of the burdens and risks of vaccination and so on. Yet, any
proposed public health intervention needs to have a significant probability of
benefits and a strong likelihood of a positive risk/benefit ratio in order to be
ethically acceptable. This will be true for measures that will be offered to the
population for voluntary participation; for compulsory measures, the standard has to
be even higher.</p></sec></sec><sec><title>5 Conclusions</title><p>With these reservations, how can we reply to the question in the title of this paper?
It seems that the arguments in favor of mandatory vaccination do not trump the arguments
that are against mandatory vaccination, and vice versa. In such a situation, each of us
is likely to make a personal choice based on our deepest values. Those who favor an
individualistic interpretation of autonomy and strongly believe in the dominant role of
self-determination as a moral foundation of a free society will likely oppose mandatory
measures. My personal preference is a society “which not only promotes individual rights
but accepts collective responsibility to live a collaborative life which promotes
autonomy” (<xref rid="bib16" ref-type="bibr">Doucet & Melchin, 1995</xref>), and if
necessary, I am prepared to prescribe the collaboration in communal interest (<xref rid="bib63" ref-type="bibr">Tauber, 2002</xref>). Hence, I suggest that on balance,
the arguments presented in favor of mandatory vaccination are more convincing than those
against the mandatory approach, providing certain assumptions about pandemic and
vaccination are indeed correct. Of all the objections against this position, I believe
the weightiest one is the assertion that if a voluntary vaccination program for health
care workers were fully implemented, it would be just as effective as a mandatory
program, without the drawbacks of compulsion and enforcement.</p><p>Is it possible then, to arrive at an objective position on the question of mandatory
vaccination that could lead to the formation of a legitimate public policy? I think so.
This can be achieved by constructing a position that respects all reasonable arguments
and gives each of them some role in defining the limits or conditions of the mandatory
measure.</p><p>One way by which this could be achieved is to suggest that, in the event of an
influenza pandemic, mandatory vaccination of health care workers is ethically justified
only if and when all of the following conditions are met with a reasonable degree of probability:<list list-type="simple"><list-item><label>(a)</label><p>The pandemic appears to be so serious that staff absences due to illness would
compromise care and increase morbidity.</p></list-item><list-item><label>(b)</label><p>The pandemic influenza vaccine is effective in terms of preventing clinical
illness and reducing absences from the workplace.</p></list-item><list-item><label>(c)</label><p>The pandemic influenza vaccine is safe, with the understanding that the urgency
of the situation permits only a limited amount of time for testing.</p></list-item><list-item><label>(d)</label><p>The mandatory vaccination program is proven to produce a significantly higher
participation rate than a voluntary program, and this difference is important in
meeting essential objectives of the vaccination program.</p></list-item></list></p><p>The justification of the mandatory program will be further strengthened if,<list list-type="simple"><list-item><label>(e)</label><p>Under conditions of pandemic, unvaccinated health care workers will represent a
significant risk to their patients.</p></list-item></list></p><p>In addition, the justification of a mandatory vaccination would have to be presented in
a manner that allows for scrutiny of the population affected by the measure, and steps
would have to be taken to apply the mandatory vaccination in a consistent way (<xref rid="bib8" ref-type="bibr">Childress et al., 2002</xref>). The meaning of the term
“reasonable degree of probability” in this context would have to refer not only to the
opinion of experts but to the views of the population.</p><p>The above proposal does not claim to be the only possible way of striking the right
balance. There are probably other ways by which the conditions for mandatory vaccination
could be set that would take into consideration the objections without allowing the
objections to defeat the purpose of mandatory vaccination.</p><p>Finally, I would like to comment on the practical implication of the above appraisal of
arguments. Given the difficulties to ethically defend and to sensibly implement
mandatory vaccination, it would be best if mandatory vaccination could be avoided and
its goals achieved by voluntary participation. An important step in this direction is to
initiate, among health care professionals, thorough discussions about an influenza
pandemic in general and about the ethical aspects of vaccination as well as other
personal measures that could minimize the impact of the pandemic. Hopefully, if we have
enough time before the pandemic arrives, this effort can lead to the development of such
a high level of moral commitment of health professionals to the response measures that
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