by Nickolaus Ng
Introduction
According to NHS statistics, the prognosis for transplant patients in the UK is generally favourable. NHS data demonstrates positive outcomes for organ transplantation. After one year, survival rates are high: 83% for heart transplants, 94% for liver transplants, 99% for living donor kidney transplants, and 95% for cadaveric kidney transplants.[1]
The statistics indicate favourable outcomes even after five years, with survival rates reaching 71% for heart transplants, 84% for liver transplants, 88% for living donor kidney transplants, and 92% for cadaveric kidney transplants.[2]
Although there are instances of transplant surgeries failing, they generally represent the best course of treatment for organ failure. Vital organs such as the heart and liver are indispensable, making transplants of these organs crucial. Despite the high costs associated with transplant procedures, successful operations can result in cost savings for the NHS. Kidney transplants, for example, offer significant long-term economic benefits compared to providing lifelong dialysis for patients with kidney failure.
According to estimates from the National Institute for Health and Care Excellence (NICE) in 2011, a 25% increase in kidney donors could potentially save the NHS £9.2 million per year.[3] In summary, transplantation surgery is a successful and sometimes cost-effective medical procedure. However, the primary challenge facing the UK's NHS is the inadequate supply of organs to meet the demand for transplants.
Given that the typical waiting period often exceeds a year, it's not unexpected that mortality rates among individuals on the organ transplant waiting list are high. In the 2020/21 period, 487 patients died while on the transplant list or within one year of being removed from it.[4] Moreover, this statistic does not account for the numerous potential recipients who are not added to the waiting list because their physicians anticipate that they may not become eligible for a transplant in time due to the lengthy waiting periods.
However, what delineates when an organ can be taken and when it cannot is the fine line that is characteristic of the Dead Donor Rule.
What is the dead donor rule and brain death?
Cadaveric organ transplantation depends on dead donors whose organs are still able to function in live recipients. This means that (a) the organs can be removed only after someone has died, and (b) that they must be taken immediately after the pronunciation of death. Accurately pinpointing the moment of death is therefore vitally important for doctors to legally take organs away from patients.
However, the concept of death is multifaceted. It does not occur abruptly with all organs ceasing function simultaneously. Rather, it unfolds progressively once irreversible brain death takes place. Brain death entails the permanent loss of consciousness due to the cessation of upper brain function, while the loss of the brain's ability to regulate vital bodily functions such as breathing results from the death of the lower brain regions.
Consider the scenario where resuscitation may be possible. Even if a person's heart can be artificially sustained despite brain death, it raises ethical dilemmas. The introduction of artificial ventilation technology prompted inquiries into whether a declaration of death could be made while a person's heart was artificially supported. This is because continuing ventilation post-brain death facilitates organ retrieval while the donor's heart remains artificially maintained.
Definition of death
The era of multi-organ transplant procurement emerged during the 1960s, a time marked by conflicting interests between organ recipients and donors.[5] This led to the recognition of brain death as both a medical and legal criterion for determining death, primarily driven by the urgent need for organs.[6] Today, the demand for organs continues to far exceed the supply.”[7]
Donation after circulatory death determination is not the preferred option, as this mode of death often results in organs becoming unsuitable for donation. In fact, almost one-third of circulatory death donors are unable to donate their organs.[8] Conversely, organs from donors who are brain-dead are considered optimal for donation, as they can be harvested before circulatory arrest occurs, thus preventing anoxic damage.[9]
In 1968, the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death issued its findings, defining "irreversible coma [with no central nervous system activity]" as a novel criterion for death, known as brain death.[10] With the establishment of what would later be referred to as the "Harvard criteria"[11] for identifying the permanent loss of brain functions, medicine adopted brain death as a valid and distinct definition of death alongside cardiorespiratory death. This shift had an immediate and profound impact on transplantation practices,[12] as patients declared brain dead became optimal organ donors, being considered medically deceased while still possessing organs suitable for donation.
In the UK, there is no statutory definition of death. Instead, determining death involves clinical evaluation, with brain stem death, marked by the irreversible cessation of brain stem function, serving as the definitive criterion for defining and diagnosing death. This is stipulated in a Code of Practice issued by the Academy of Medical Royal Colleges:
“Death entails the irreversible loss of those essential characteristics which are necessary to the existence of a living human person and, thus, the definition of death should be regarded as the irreversible loss of the capacity for consciousness, combined with irreversible loss of the capacity to breathe. The irreversible cessation of brain stem function whether induced by intracranial events or the result of extracranial phenomena, such as hypoxia, will produce this clinical state that therefore irreversible cessation of the integrative function of the brain stem equates with the death of the individual and allows the medical practitioner to diagnose death… There are some ways in which parts of the body may continue to show signs of biological activity after a diagnosis of irreversible cessation of brain stem function; these have no moral relevance to the declaration of death for the purpose of the immediate withdrawal of all forms of supportive therapy.” [13]
Two doctors, each with over five years of registration and proficiency in conducting and interpreting brain stem testing, are required to make the diagnosis of brain stem death.[14] The involvement of both doctors in diagnosing brain stem death should exclude them from being part of the transplant team.[15] After two sets of brain stem tests are conducted, death is pronounced, but legally, the time of death is established by the initial test that confirms brain stem death.[16]
Contentious views on brain death
The Dead Donor Rule posits that no organs can be removed until a person is completely brain-dead or the person’s heart has already stopped beating, otherwise that person cannot be definitively considered deceased.[17] This perception is amplified by the use of mechanical devices to maintain cardiac function. It is commonly assumed that following a diagnosis of brain death, medical practitioners would wait until the individual's heart ceases beating before confirming death.
Regarding the administration of anaesthesia to brain dead patients before organ retrieval, Robert Truog remarks that some critics believe that the brain death criterion is inadequate to ensure that patients cannot experience pain, even at a minimal level, and argue that these individuals should receive anaesthesia as a precaution.[18]
While Truog notes the public considerations on whether brain death is a state of permanent unconsciousness, there is a contention that the notion of brain death is a 'convenient fiction';[19] in particular, Peter Singer has argued that the concept of brain death is relatively uncontroversial given that humans are not the only forms of life on our planet. All living things eventually die, and we can usually discern when something is alive or dead.[20] Going along that line of inquiry, can it not be said that the difference between life and death is so fundamental that the criteria for determining death in humans should also apply to other living things such as dogs and trees? The idea of "brain death" is unique to humans. Why is a different standard of death applied for human beings as compared to other living things?
When warm, breathing, pulsating human beings are declared to be dead, they lose their basic human rights. They are not given life support. If their relatives consent, their hearts and other organs can be cut out of their bodies and given to strangers.
There is a proposition that advancements in medical techniques, allowing for the artificial maintenance of brain stem function, raise questions about the continued relevance of brain stem death.[21] When the concept of brain death was first introduced, it was believed that the death of the brain stem meant the whole body was soon to follow. However, this view is now outdated, as advancements in medical care and technology allow for the artificial maintenance of brain stem functions.[22]
We have learned that individuals with a non-functioning brain stem can remain alive for extended periods. For instance, brain-dead pregnant women have been kept alive for months,[23] and in some cases they have successfully given birth to healthy infants. The idea that the brain stem is the primary regulator of bodily functions is overly simplistic, both biologically and philosophically.[24] Other organs, like the heart, liver, and kidneys, are crucial for the body’s overall function; if any of these organs fail, the organism will ultimately deteriorate without artificial assistance.[25]
Many people who are undeniably alive depend on devices like pacemakers, dialysis machines, or ventilators for their survival. This raises questions about whether there is indeed a single regulatory system in the body. Additionally, we can now replicate certain brain stem functions, indicating that further advancements in this field are likely.
Robert Truog suggests that while the Dead Donor Rule might bolster public trust in organ transplantation, it shifts focus away from the ethical core of organ procurement. He contends that the essence of ethicality lies in ensuring that patients unmistakably near death are relieved of suffering and that their preferences are respected. Truog notes that the Dead Donor Rule rests on the mistaken belief that a clear boundary exists between the dying process and organ procurement and that this misconception has led to the idea that organ procurement is unethical unless it follows the Dead Donor Rule’s guidelines.[26]
However, the author is of the view that organ procurement can be ethical if it ensures the patient is not subjected to unnecessary pain and suffering and respects the patient’s altruistic intentions by acquiring organs in ways that enhance the value of the donor’s gift. Such an ethical approach could greatly increase the number of lives saved through organ transplantation. It is time to recognize the Dead Donor Rule for what it really is: an obstacle to ethical practices for both donors and recipients.
It has been proposed by Savulescu that, with the consent of patients in imminent death situations, organ retrieval from these patients would be considered ethically valid:
“Since I believe we die when our meaningful mental life ceases, organs should be available from that point, which may significantly predate brain death. At the very least, people should be allowed to complete advance directives that direct that their organs be removed when their brain is severely damaged or they are permanently unconscious.” [27]
Permanently comatose patients and anencephalic infants exhibit a cessation of consciousness, characterized by the inactivity of their upper brain while the lower brain remains functional. Since the designation of brain death necessitates the complete cessation of brain activity, such patients are unequivocally considered alive. However, it is arguable that the current definition of death is overly stringent and that certain patient groups, such as those in a permanent comatose state or anencephalic infants, should be reclassified as potential organ donors rather than being regarded as living individuals.
Anencephalic infants are born without a cerebral cortex, resulting in the majority being stillborn or succumbing shortly after birth. Despite their lack of potential consciousness, it may be the case that they possess a functioning brain stem. Given the absence of any chance for an anencephalic infant to recover, initiating artificial ventilation may not align with his or her best interests. The decision to provide ventilation solely for the purpose of facilitating organ donation thus raises ethical concerns about using the infant as a means to an end. While parents may find solace in knowing that their baby's organs could potentially save another child's life, the primary benefit would be for a third party rather than the anencephalic infant herself.
John Robertson suggests that when there is a permanent absence of sentience, as seen in cases like an anencephalic baby or a patient in an irreversible coma, taking of organs will not harm the patient. He argues that a key reason for the requirement that organ donors be declared dead is to prevent harm to the donor during the organ removal process. If a donor is deceased, taking their organs does not pose any risk. However, if the donor is alive, it is typically assumed that organ removal would lead to death or injury.[28]
Conversely, William May raises concerns that such an approach could potentially erode trust in the organ donation system. He argues that using the demand for organ donations to justify declaring certain people dead creates a convoluted and problematic scenario that is difficult to manage. Under various pressures, the criteria for death could expand to include individuals with conditions like anencephaly, hydrocephaly, or microcephaly, leading to a loss of clear distinctions between the dead, the dying, and those in vegetative states.[29]
Indeed, this opportunistic redefinition could have serious implications, eroding trust between patients and healthcare providers, and families will expectedly become less willing to donate organs from genuinely deceased individuals. Relying on convenience and practicality should not guide the redefinition of death.
Circulatory Death
In earlier times, most deceased donors were individuals determined to be brain dead, their heart and lung functions sustained artificially with a ventilator. However, there are now two categories of deceased donation: donation after brain death (DBD) and donation after circulatory death (DCD). DBD donors are those whose death has been confirmed based on neurological criteria. In contrast, most DCD donors are patients for whom imminent death is expected, leading to the cessation of medical treatment. This process is termed "controlled DCD." "Uncontrolled DCD" would involve organ donation after an abrupt and unforeseen death. However, NHS Blood and Transplant notes that "although several transplant units have previously supported uncontrolled DCD organ retrieval from nearby Emergency Departments, these programs are currently inactive."[30]
In the year 2020/21, DCD donors constituted the majority of deceased donors for kidney transplants, accounting for 36% of all such transplants. Moreover, organs from DCD donors, including lungs, livers, pancreases, and even hearts, have been successfully transplanted. Notably, 14% of deceased heart donors during this period were DCD donors.
Bernat identifies an interesting discrepancy between the concerns voiced by families and physicians regarding the definition of death in DBD and DCD donors. Families are more likely to question the genuineness of death in DBD donors, doubting whether they are truly deceased, yet are less troubled by the determination of death in individuals whose heart has ceased beating.[31] Conversely, doctors may have reservations about the possibility of resuscitating individuals with cardiac arrest, while maintaining a firm belief in the diagnosis of brain stem death, affirming the patient's deceased status and thereby allowing organ retrieval.[A4] [32]
Bernat notes that:
“Family members of DCDD donors usually consider the patient to be dead immediately once breathing and heartbeat cease. Physicians, by contrast, do not consider the donor dead at that moment because they worry that breathing or heartbeat might restart spontaneously within a few minutes and that if cardiopulmonary resuscitation (CPR)… or other resuscitative technologies were employed, they might be able to restore circulation, even though these interventions will not be initiated because of a DNR (Do Not Resuscitate) order. They therefore mandate a 5-minute ‘hands off’ period after circulation and respiration cease before declaring death… I have observed the opposite pattern of attitudes in organ donation after brain determination of death (DBDD). Physicians generally accept brain death as equivalent to human death but families often question its validity because they are unfamiliar with the concept of brain death, they erroneously equate brain death with coma, which they know may be reversible, or they intuit that the patient does not appear dead.” [33]
If cardiac criteria are used to diagnose death rather than brain stem tests, the organs undergo in situ perfusion to retain their viability. As per section 43 of the UK’s Human Tissue Act 2004, if a body part is deemed suitable or potentially suitable for transplantation, it is legal to take the necessary steps to preserve the part for transplantation purposes until it is confirmed that consent for transplantation will not be obtained.
Alternatives to the Dead Donor Rule
Is the Dead Donor Rule the only way to protect physicians from legal liability? I disagree. It need not be the only way to protect physicians from legal liability.
While the incorporation of brain death into the medical and legal definition of death was likely to have occurred even without the pressing need for organ donation, this inclusion served as a practical means to reassure the public and healthcare professionals about the ethical and legal soundness of organ procurement. Nonetheless, it is submitted that determining death as per the Dead Donor Rule is a complex process that cannot be expedited. As Caplan asserts, death is a "biological process, not an event",[34] and therefore cannot be oversimplified.
Thus, at its core, death is essentially a "normative concept" that evolves over time in response to societal values and advances in medical knowledge.[35] However, despite its fluid nature, the notion of brain death has become deeply entrenched and vigorously defended by scholars, medical practitioners and legal practitioners alike. This steadfast adherence has hindered critical thinking and innovation in the understanding of death, cementing brain death as the legal definition of death in accordance with the Dead Donor Rule.
The Dead Donor Rule has essentially redefined death to align with the needs of organ transplantation, resulting in unwarranted changes to the definition of death.[36] Lewis and Gardiner suggest that resolving the ethical dilemmas posed by the Dead Donor Rule requires a comprehensive examination of its foundational principles.[37] This entails a revisiting of both the ethical and legal justifications for the Dead Donor Rule. Regarding the ethical rationale, Truog and Miller propose that while it may be considered ethical to harvest vital organs for transplantation from individuals declared dead based on neurological criteria (i.e., brain death), the ethical justification cannot solely rely on the assumption that these individuals are truly deceased.[38] Truog and Miller contend that ethical organ procurement revolves around obtaining patient consent, suggesting that when consent is secured, there is no harm in retrieving vital organs before the patient's death.[39] Similarly, Robert Sade underscores the significance of autonomy, asserting that the cause of death, whether through the withdrawal of life support or not, is irrelevant. According to Sade, the ethical principles of self-determination and informed consent outweigh any considerations of the cause of death.[40]
While the Dead Donor Rule has been instrumental in shielding physicians, particularly transplant surgeons, from legal liability, it is not the only means of ensuring their legal protection. Legal frameworks could evolve to allow physicians to conduct vital organ donation procedures on living individuals. Moreover, alternative legal mechanisms could be devised, such as establishing legally acceptable or defensible forms of homicide for particular medico-legal circumstances. Examples include "imminent death donation" for terminally ill patients or "live donation prior to planned withdrawal" for brain-dead patients. These approaches would support the prioritisation of patient autonomy by ensuring valid informed consent.
[1] NHS Blood and Transplant, Organ and Tissue Donation and Transplantation Activity Report 2020/21 (NHSBT 2021).
[2] ibid.
[3] National Institute for Health and Clinical Excellence, Organ Donation for Transplantation Costing Report: Implementing NICE Guidance (NICE 2011).
[4] ibid.
[5] David Rodríguez-Arias, ‘The dead donor rule as policy indoctrination’ (2018) 48(suppl 4) Hastings Cent Rep 39, 39-42.
[6] ibid.
[7] ibid.
[8] Lisa Rosenbaum, ‘Altruism in extremis—the evolving ethics of organ donation’ (2020) 382(6) N Engl J Med 493, 493-496.
[9] ibid.
[10] Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death, ‘A definition of irreversible coma’ (1968) 205(6) JAMA 337, 337-340.
[11] President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, ‘Defining Death: A Report on the Medical, Legal and Ethical Issues in the Determination of Death’ (US Government Printing Office 1981).
[12] Lisa Rosenbaum, ‘Altruism in extremis—the evolving ethics of organ donation’ (2020) 382(6) N Engl J Med 493, 493-496.
[13] Academy of Medical Royal Colleges, A Code of Practice for the diagnosis and confirmation of death (AoMRC 2008).
[14] ibid, paragraph 3.3.
[15] ibid.
[16] ibid; Re A [1992] 3 Med LR 303.
[17] Zaria Gorvett, ‘The Macabre Fate of ‘Beating Heart Corpses’’ (BBC, 5 November 2016) < https://www.bbc.com/future/article/20161103-the-macabre-fate-of-beating-heart-corpses> (accessed on 30 December 2024).
[18] Robert Truog, ‘Brain death – too flawed to endure, too ingrained to abandon’ (2007) 35(2) Journal of Law, Medicine and Ethics 273, 273-281.
[19] Emily Jackson, Medical Law (6th ed, OUP 2022), 657.
[20] Peter Singer, Rethinking Life and Death: The Collapse of our Traditional Ethics (OUP 1994).
[21] Ian Kerridge et al, ‘Death, dying and donation: organ transplantation and the diagnosis of death’ (2002) 28(2) Journal of Medical Ethics 89, 89-94.
[22] ibid.
[23] Re A (n 16).
[24] ibid.
[25] ibid.
[26] Robert Truog, ‘The price of our illusions and myths about the dead donor rule’ (2016) 42(5) Journal of Medical Ethics 318, 318-319.
[27] Julian Savulescu, ‘Death, us and our bodies: personal reflections’ (2003) 29(3) Journal of Medical Ethics 127, 127-130.
[28] John Robertson, ‘Relaxing the Death Standard for Organ Donation in Pediatric Situations’ in Deborah Mathieu (ed), Organ Substitution Technology: Ethical, Legal and Public Policy Issues (Westview Press 1988), 69-76.
[29] William May, The Patient’s Ordeal (Indiana University Press 1991).
[30] Emily Jackson, Medical Law (6th edn, OUP 2022), 662.
[31] James Bernat, ‘Harmonizing standards for death determination in DCDD’ (2015) 15(8) The American Journal of Bioethics 10, 10-12.
[32] ibid.
[33] ibid.
[34] Arthur Caplan, ‘Death: an evolving, normative concept’ (2018) 48(suppl 4) Hastings Cent Rep 60, 60-62.
[35] ibid.
[36] Robert Truog and Franklin Miller, ‘The dead donor rule and organ transplantation’ (2008) 359(7) N Engl J Med 674, 674-675.
[37] Jennifer Lewis and Dale Gardiner, ‘Ethical and legal issues associated with organ donation and transplantation’ (2023) 41(9) Surgery (Oxford) 552, 552-558.
[38] ibid.
[39] ibid.
[40] Robert Sade, ‘Brain death, cardiac death, and the dead donor rule’ (2011) 107(4) JSC Med Assoc 146, 146-149.
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