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Review Article
Ethical and Legal Implications of Elective
Ventilation and Organ Transplantation: ‘‘Medicalization’’ of
Dying versus Medical Mission
Paola Frati,1,2 Vittorio Fineschi,1Matteo Gulino,1Gianluca Montanari Vergallo,1
Natale Mario Di Luca,1and Emanuela Turillazzi3
1Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, University of Rome Sapienza,
Viale Regina Elena 336, 00161 Rome, Italy
2Neuromed, Istituto Mediterraneo Neurologico (IRCCS), 86170 Isernia, Italy
3Department of Legal Medicine, University of Foggia, Ospedale Colonnello D’Avanzo,
Via degli Aviatori 1 , 711 00 Fogg ia, Italy
Correspondence should be addressed to Vittorio Fineschi; vnesc@tin.it
Received 6 December 2013; Revised 24 May 2014; Accepted 31 May 2014; Published 14 July 2014
Academic Editor: Anna Karakatsani
Copyright © 2014 Paola Frati et al. is is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
A critical controversy surrounds the type of allowable interventions to be carried out in patients who are potential organ donors,
in an attempt to improve organ perfusion and successful transplantation. e main goal is to transplant an organ in conditions
as close as possible to its physiological live state. “Elective ventilation” (EV), that is, the use of ventilation for the sole purpose of
retrieving the organs of patients close to death, is an option which osets the shortage of organ donation. We have analyzed the
legal context of the dying process of the organ donor and the feasibility of EV in the Italian context. ere is no legal framework
regulating the practice of EV, neither is any real information given to the general public. A public debate has yet to be initiated.
In the Italian cultural and legislative scenario, we believe that, under some circumstances (i.e., the expressed wishes of the patient,
even in the form of advance directives), the use of EV does not violate the principle of benecence. We believe that the crux of the
matter lies in the need to explore the real determination and will of the patient and his/her orientation towards the specic aim of
organ donation.
1. Introduction
Dening death, like dening life, continues to be a challenge
[1]. Death can be considered in terms of medical, legal,
ethical, philosophical, societal, cultural, and religious ratio-
nales. e medical denition of death is primarily a scientic
issue based on the best available evidence [2]. ere is a
growing consensus that there is a unifying medical concept
of death which can be determined by physicians in two
ways: (1) by showing the irreversible cessation of all clinical
brain functions or (2) by showing the permanent cessation of
circulatory and respiratory functions [3].
2. The Philosophical Paradox of Explanting a
‘‘Live’’ Organ from a ‘‘Dead’’ Body
e process of the “medicalization of dying” and the practice
of transplantation medicine underscore the importance of
dening and conceptualizing death and of identifying the
moment of death. It is obvious that the issues concerning
organ donation and transplantation are closely connected
to many other fundamental philosophical, ethical, and legal
issues, many of them to do with the denition and criteria of
death [4]. What is human death? When does a human being
really die? How can we determine that it has occurred?
Hindawi Publishing Corporation
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2BioMed Research International
e issues of dening and determining death have always
generated a lively scientic and ethical debate that is brought
into sharper focus around the subject of organ donation.
For the recovery of organs, is the neurological determina-
tion of death (brain death) acceptable in patients whose
circulation and respiration are mechanically maintained, or
is the cessation of circulation and respiration (circulatory
death) necessary? In the rst case, is it ethical and/or legal
to consider the individual as a potential organ provider and
to keep him or her alive by specic vital support devices for
thesolepurposeofpreservingtissueviabilityandallowing
organ explant (once consensus has been obtained), with
the subsequent voluntary interruption of vital support? And
lastly, is it really necessary to dene the legal concept of death
in order to proceed to organ transplantation?
ere are two additional fundamental ethical premises in
meeting the donor’s best interests: (i) his/her right to decide
with regard to organ donation (which can be delegated to
relatives) and (ii) certication of the donor’s death. e “dead-
donor rule” refers to the widely accepted ethical and juridi-
cal norm that governs practices of organ procurement for
transplantation: vital organs should be taken only from dead
patients. An intense debate has developed on how to verify
death, and several ambiguities in both brain and circulatory
death determination still need to be resolved. Circulatory-
respiratory or brain tests are widely accepted for dening and
determining death, but there are still several controversial
issues. ere are questions that still need a denitive answer,
such as whether the whole-brain or brainstem criterion is
correct, whether one neurological examination or two should
be required, and the minimum duration of asystole which is
sucient for death to be declared in circulatory death [5].
Finally, a critical controversy surrounds the type of
allowable interventions to be carried out in patients who
are potential organs donors in an attempt to improve organ
perfusion and successful transplantation [6]. It concerns
thedicultbalancebetweenthedoctor’scommitmentto
safeguard the patient’s health versus unnecessary invasive
treatment.
3. ‘‘Elective Ventilation’’:
‘‘Medicalization’’ of Dying versus Medical
Mission—The Hierarchy of Ethics
To meet the growing demand for organs, a number of
initiatives can be envisaged [7]. To this end, the main goal
is to transplant an organ in conditions as close as possible to
its physiological live state. erefore, it is crucial to optimize
specic rules establishing when and how an organ can be
explanted from a dead or dying patient to be transplanted in
a living patient whose life depends on it.
“Elective ventilation” (EV) or “nontherapeutic ventila-
tion” (i.e., the use of ventilation for the sole purpose of
retrieving the organs of patients close to death) is an alter-
native option to oset the shortage of organ donation [8].
is entails targeting patients in a deep irreversible coma
for whom death is believed to be imminent and transferring
them to intensive care units so that articial ventilation can be
initiated as soon as respiratory arrest occurs, thus preserving
the organs until brain death can be established [9]. EV
practice is already common in the United States and Spain.
However, it was banned by the United Kingdom’s Department
of Health in 1994 on the grounds that it was unlawful to
ventilate a patient for the purpose of harvesting organs, as it
did not constitute a procedure undertaken for the patient’s
benet, particularly in the absence of patient consent [10].
orny ethical issues surround the practice of elective
ventilation [11–13], the main one being the potential conict
of (i) the best interests of the “donor” patient (subject to
intensive care) versus (ii) the best interests of the patient
“recipient” of the transplanted organ (who becomes the nal
target of the intensive care provided to the “donor” patient).
EV is essentially a question of weighing the patients’ best
interests. In other words, the medical mission shis its target,
providing intensive care, not for the benet of the “donor”
patient (including the right to die with dignity and not to
prolongthedeathprocess)butforthatofthe“recipient”
patient.
erefore, in this case, the doctor chooses according to
a two-order hierarchical criterion (i) the best interests of
the potential donor patient or (ii) the best interests of the
potential recipient patient, for whom the donor patient can
be sacriced. e latter thus becomes the prevailing criterion.
Indeed, the interests of the donor lie in his or her right to
live or die with dignity (i.e., right to refuse poor quality of
life). However, the best interests of the donor, if these entail
refusingtherapieswhichareunabletoprovideagoodquality
of life or choosing not to prolong the dying process without
dignity, are not guaranteed so as to provide the recipient with
thebestchancetolive.
Finally, the practice of EV raises the question of consent
[14]. Doubts have been cast on the legality of EV on the
grounds that relatives are not permitted to consent to the
treatment of an incompetent person when that treatment is
not in the patient’s best interests. When a patient is trans-
ferred to an intensive care unit and subsequent ventilation
and circulatory support procedures are initiated solely for
the purpose of maintaining the adequate perfusion of organs
until retrieval can be arranged, oering no benet to the
patient undergoing these procedures, can the family’s consent
be considered ethically and legally valid? Can it be assumed
that when an individual consciously chooses to become an
organ donor, he/she also expects the best care of their organs
to ensure successful transplants, thus implicitly agreeing
to EV [15]? Can we accept as coherent the argument put
forwardbyCoggon[16] that when a patient wishes to donate,
measures, such as EV, which are necessary for organ donation
to proceed, serve, rather than deny, the best interests of the
patient? Or are these separate matters? Could a patient’s
advance statement of consent obviate the question and make
EVnotonlyethicallyacceptablebutalsolawful[17,18]?
4. The Legal Italian Context of the Dying
Process of the Organ Donor
In Italy, the law currently in force (law 578/93 and the
Ministerial Decree dated 2008) states the diagnostic criteria
BioMed Research International 3
for the determination of an individual’s death. e premise is
a unifying denition of death as the irreversible cessation of
all whole-brain functions. Cardiac death is dened when the
cardiac arrest lasts long enough to determine the irreversible
cessation of all brain functions. Strict diagnostic criteria have
to be met until a patient is declared dead.
e Italian system regulating the donation of organs is
an “opt-out” one where all citizens over 18 are automatically
registered to donate their organs when they die unless they
actively decide not to. From an ethical and legal perspective,
one must note that an “opt-out” system moves towards the
principle of “assumed consent.”
In this Italian regulatory scenario, some ethical and legal
issues arise regarding the lawfulness of EV.
First of all, since EV is administered in the interests of
a potential recipient and does not fall within the narrow
medical interests of the potential donor, Italian physicians
have to tackle the issue of the extensive medical procedures
that involve signicant discomfort and expense to that
donor. According to the Italian Code of Medical Ethics “the
physician, also taking into account the patient’s will, when
this is expressed, must abstain from persisting in diagnostic
and therapeutic procedures from which it is not possible to
reasonably expect a benet for the patient’s health and/or an
improvement in the quality of life” (art. 16). ere is no doubt
that the practice of EV does not have the therapeutic care
of the patient (suitable donor organ) as its main purpose.
Secondly, since potential organ donors who are eligible for
receiving EV generally lack the capacity to make decisions
as a consequence of their injury, issues arise concerning
consent, the legitimacy of the patient’s relatives to decide,
the decision-making role of the physician, and nally the
value of the patient’s previously expressed will. e Italian
regulatory system does not allow physicians to initiate EV
solely on the grounds of the patient’s hypothetical consent.
An explicit, informed consent is required before any diagnos-
tic/therapeutic act can be performed. Nor does any consent
to EV expressed by the patient’s relatives have any legal value
in the Italian law system unless in the case of a patient
under 18 or in the case of an interdict. Family members
have no power to consent (or dissent) under Italian law.
erefore, the crux of the question of the feasibility of EV
lies in the value of the patient’s previously expressed will
regarding EV itself. e Italian legal system lacks a specic
law on the matter of advance directives and their legal value.
Indeed, an ocial stance expressed by the National Bioethics
Committee (NBC) focuses on the medical obligation to pay
the utmost attention to the person’s will, even if this is
expressed in an advance directive. In 2003, the NBC drew
up conclusive bioethical recommendations which gave full
legitimacy to public advance statements redacted in written
form, devoid of any prospect of euthanasia, compiled with the
help of a physician, as specic and personalized as possible,
and by which the physician should abide even if this is
not compulsory [19]. Moreover, the Italian medical code
underlines the full signicance of an advance directive from
a currently incompetent patient, arming the medical obli-
gation not to elude a previously expressed wish. Many bills
have been draed and presented for approval to the Italian
Parliament during past legislatures, in particular regarding
therequirementsforvalidityandthepossiblecontentsof
the patient’s previously manifested will and also regarding its
potential binding character for the physician who receives
it. In the absence of a comprehensive law, what strongly
emerge are the principles of deontological codication and of
the aforementioned document by the NBC, which postulate
the physician’s duty to respect the patient’s will, even if
previously expressed [20]. e value at stake is essentially
the right of those who are in full possession of their mental
faculties to freely decide. However, several questions remain
unsolved, namely, those regarding the limitations and the
contents of advance directives. Given that the Italian law (law
91/1999) allows all adult and competent citizens to express
their consent/dissent to the donation of organs, might it
not be coherent for the same citizens to give their opinion
on the possible use of EV to make that donation possible
under particular circumstances? For citizens in favor of organ
donation, should the agreement to EV be presumed even in
the absence of expressed consent? Could an advance directive
not allow individuals to specify in advance that under certain
circumstances they would consent to elective ventilation
merely in order to donate their own organs?
ese are the main concerns regarding the practice of EV
thatwillariseintheItaliandebate.
Inthefaceofthecomplexissuesmentionedabove,it
appears natural to raise the question as to whether there is a
correct approach to decision-making that can oer assistance
to the Italian physicians who are faced daily with the issue of
organ donation and elective ventilation.
In the absence of a legal framework regulating the practice
of EV, we believe that a reassuring way might be an approach
to decision-making which emphasizes patient autonomy.
Patient autonomy should be a central principle and
one which physicians ought always to respect. Every action
requires that a person has the capacity and opportunity to
freely and voluntarily make medical choices, and there is no
doubt that even the choice of EV is a medical one. Italian
physiciansandthoseresponsibleforhealthpolicyhaveto
recognize and even promote the autonomous actions of the
patient in this matter. An increasing number of people, also
in Italy, are preparing some form of advance directive to
guide their caregivers as to their wishes, should they lose
the capacity to decide for themselves. However, by far the
greatmajorityofthosewhoarecompetenttodosodoes
not make such directives or give much thought to these
issues.Itissafetosaythat,inItaly,thegreatmajorityof
those who lapse into incapacity for any reason will not
have issued prior directives. It is our contention that all
adult and competent Italian citizens, while expressing their
consent/dissent to the donation of organs as provided by law,
would formulate prior directives specically concerning EV.
Prior to this time, the correct information should be provided
toalloweveryonetomakeaninformeddecisionregarding
this issue. Physicians and patients discuss their mutual values,
those related to health and, in particular, those related to
decisions about death and dying. e key question is whether
theindividual(potentialdonor)hastheabilitytounderstand,
retain, believe, evaluate, weigh up, and use information that
4BioMed Research International
is relevant to a choice regarding organ donation and EV.
Communication between patients and physicians requires
language that conveys meaning and ensures understanding.
Once the potential donor has expressed the wish to donate
his/herorgansand,ifnecessary,toacceptEV,suchadirective
would be determining for physicians.
However,weareawareofthegravityoftheperplexing
problems surrounding the issue of EV. Respect for patient
autonomy is one of a cluster of ethical principles that elevate
thevalueofhumanlifeandisthebasisforthedecision-
making process in medical practice; thus, the weighing
and balancing of all basic principles of medical ethics have
become an essential component of the reasoning process.
We are convinced that protecting the patient’s autonomy
and allowing that patient to attain the specic aim (organ
donation) that he or she surely deems worthwhile place EV
under the constraints of benecence. In a modern view of
medicine, we have the duty to interpret “benet” in terms
of the values or best interests of the patient, rather than in
terms of strictly medical benets. Traditionally, doctors have
veered towards a “medicalized” perspective that has been
heavily dependent on clinical judgment. e requirement
for the determination of best interests encompasses a wider
evaluationofthepatient’sconcerns,ofwhichthemedical
perspective is but one component. Other broader ethical,
social, and moral considerations fall within the best interests
of the person who freely chooses to donate organs [21].
Finally, strict rules are imposed by the Italian death statute,
according to which physicians have the duty to accurately
and reliably determine death. is ensures that the decision
to withdraw extraordinary support is made without coercion
from the transplant team waiting for the patient’s organs
and categorically excludes the possibility of any harm to the
donor, thus leading to a wider acceptance of organ donation
as a social practice. e certainty of death that the Italian law
requires is a very strong guarantee for potential donors.
5. Conclusions
In Italy, there is no legal framework regulating the practice of
EV,norealinformationisissuedtothegeneralpublic,anda
public debate has yet to be initiated. Traditional moralists nd
it unacceptable that elective nontherapeutic ventilation and
resuscitation are used to enable patients, for whom a decision
to stop all therapy has been made, to evolve towards brain
death and organ donation. ey consider it to be disrespectful
of the interests of the donor (patient), which is the medical
mission (benecence model); EV would violate both the
principle of nonbenecence to which Italian physicians are
boundundertheCodeofMedicalEthicsandtheprinciple
of patient autonomy [22]. However, an increasing armation
of the principle of patient autonomy is pervading Italian law
and policy, also through the growing ethical and legal value of
patients’ previously expressed wishes. Recently, some relevant
decisions by the Italian Supreme Court dealt with the issue of
advance directives, which still lack normative references in
our legal system and are the subject of a lively and ongoing
debate. Italian jurisprudence dealt with the problem of the
relevance and validity of will previously expressed by a patient
who, for pathological reasons, is no longer able to express
suchawill.Whatseemstoberelevantisthepredictability
of the event, that is, that it is demonstrable that, even with the
knowledge of what lies ahead, the patient stands by his/her
decision and that all possible events have been foreseen.
In this ongoing cultural and legislative Italian scenario,
we believe that, under some circumstances (i.e., the expressed
wishes of the patient even in the form of advance directives),
theuseofEVcouldfallintothebestinterestsofthepatient
and would thus not violate the principle of benecence. e
physician-patient relationship centers upon unique human
experience; within this relationship the physician can help the
patient to obtain specic aims, which that patient deems to be
worthwhile. Surely the aims of this relationship must include
morally and technically viable decisions made for, and with,
the patient. e fusion of ethical and technical elements in
clinical decisions has great relevance in the central question
we are addressing. Technical and moral elements are not
necessarily the same thing. e best interests of the patient
may go beyond medical interests and may comprise the
patient’s values, goals, and beliefs beyond the narrow medical
interest of health, cure, and prevention of illness and pain.
e patient’s values, wishes, and preferences underpin all
his/her choices. us, when a competent citizen, according to
Italian law, agrees to become an organ donor, is that citizen
really oriented towards those actions that may facilitate the
realization of his/her aim? We rmly believe that the crux
of the matter lies precisely in this point, that is, the need
to explore the real determination and will of the patient
and his/her orientation towards the specic aim of organ
donation.
We also note that it may not be appropriate to assume that
all those that fail to opt out have no objection to becoming
donors. is focuses attention on the urgent need to improve
public awareness and understanding of organ donation in
Italy. In this context, Italian physicians have yet to assume
an important role as a source of information for citizens.
A recent survey on knowledge and attitudes toward organ
donation in Italy demonstrated that the Internet provides
a considerable proportion of information sources (37.2%),
compared to family doctors (5.6%) and school education
(18.6%). Conversely, 68.5% of participants think that family
doctors should provide information regarding donation and
81.9% think schools should also provide such an education
[23]. erefore, fair information and public awareness about
organ donation are needed, and strong eorts must be aimed
at involving Italian physicians in education about donation
and EV.
is is the correct framework in which to evaluate the
feasibilityofEVinItalyandinwhichpatients’previously
expressed wishes become legally and morally pertinent. In
this perspective, it appears to us essential to eliminate any
ambiguity and emphasize that the patient’s right to inuence,
even by means of advance directives, the treatment to which
heorshemightbesubjectedintheeventofsubsequent
incompetence may also encompass the use of nontherapeutic
ventilation for organ donation. e drawing up of advance
directives must be developed and their scope extended to
organ donation and elective resuscitation.
BioMed Research International 5
Conflict of Interests
e authors declare that there is no conict of interests
regarding the publication of this paper.
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