Hassall, Jack --- "The Cadaveric Organ Shortage: a result of Australia's organ procurement framework?" [2022] CanLawRw 7; (2022) 19(1) Canberra Law Review 110

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The Cadaveric Organ Shortage: a result of Australia’s

organ procurement framework?

Jack Hassall*

Organ donation and transplantation are effective and well-established treatments, often employed to save lives or significantly improve quality of life. In Australia, organ donation is a respectable – indeed, ‘noble’ – cause, garnering nation-wide support. However, despite Australia’s stated support for organ donation, low levels of actual organ donation (distinct from stated intention to donate) fail to keep abreast with demands for transplantation. With the increased incidence of lifestyle diseases, this demand is anticipated to grow exponentially. This article argues that Australia’s organ donation and transplantation sector needs significant reform if the supply is to meet the demand. Indeed, the nation’s low rate of donation is a testament to the inadequacy of its current system. A lack of harmonisation in the laws and policy used to regulate organ and tissue selection, removal and allocation for transplantation are among the barriers identified that limit the supply of organs from potential donors. This article explores such barriers and provides evidence-based advice and recommendations to develop a long-term strategy to increase organ donation rates. In doing so, it identifies a reform process to translate these recommendations into legislative and policy reform, with aim to confront a persisting issue of health policy that has a profound and detrimental effect upon lives across Australia.

I INTRODUCTION

A Background and Scope

Organ donation and transplantation are ‘effective and well-established treatment[s]’, involving the retrieval of a ‘relatively scarce resource’ from donors for transplantation into compatible recipients, generally in replacement of a failing or failed organ.^[1] Science now enables whole organs, including the heart, lungs, liver, pancreas and kidneys to be donated, as well as organ components and tissues such as the ‘heart valves, corneas, tendons and skin’.^[2] The objective of donation is to ‘save lives or significantly improve quality of life’, owing to the fact that transplantation is a ‘vital, and often last resort treatment for many illnesses and diseases’.^[3] The law distinguishes between live and cadaveric donation, that is from a donor who is alive and from someone who is dead.^[4] This article engages with Australian law regarding cadaveric donation, including questions relating to that law’s impact on donation and transplantation rates and outcomes, and the potential application of mandatory post-mortem ‘harvesting’ of organs as described by the ‘Spanish Model’. It does not engage with proposals for the sale of human organs and tissue, akin to overseas markets for blood and gametes.^[5]

In Australia, cadaveric organ donation and transplantation are governed by legal frameworks operating in each state and territory,^[6] given the Commonwealth does not have an express power and has not enacted authoritative statute to regulate this area.^[7] Despite minor differences between state and territory legislation, all jurisdictions employ the same broad ‘opt-in’ legislative default for donation.^[8] Under an opt-in system, cadaveric donation presupposes an individual’s express and informed consent.^[9] It is premised upon the altruistic donation of organs ‘without expectation of reward or even acknowledgement by those who benefit’.^[10]

Altruistic organ donation under an opt-in system is a respectable – indeed, ‘noble’ – cause that has garnered support from the general public, and is extolled by governments and organisations in Australia.^[11] However, despite Australia’s stated support for and positive outlook on opt-in donation,^[12] the nation is unable to maintain a steady supply of organs equal or near equal to demand, contributing to a disparity between the supply and demand of organs.^[13]

A national survey on Australian organ donation and transplantation activity published in 2021 revealed that at any one time approximately 1,650-1,700 Australians are waitlisted for transplantation per annum.^[14] An additional 12,000 are on dialysis – many of whom require a kidney transplant.^[15] As compared against the reported 1,444 organs received from 548 donors in 2019,^[16] and the 1,270 organs received from 463 donors in 2020,^[17] the number of individuals waitlisted exceeded the supply of organs by approximately 206-256 in 2019, and 380-430 in 2020.^[18] Consequently, low levels of actual organ donation (distinct from stated intention to donate)^[19] continue to fail to ‘keep abreast with demands for transplantation’.^[20] Moreover, as Australia’s population ages, and with the increased incidence of lifestyle diseases including obesity and type 2 diabetes,^[21] the demand for organs is anticipated to grow exponentially.^[22]

The increasing disparity between organ supply and demand necessitates a viable means to translate Australia’s stated commitment to organ donation into a substantive approach to improve actual organ donation rates.^[23] In the search for a sustainable solution to Australia’s organ shortage, there has been considerable public advocacy for the implementation of an ‘opt-out’ system (that is a presumed consent system) of organ donation.^[24] Under an opt-out system, ‘a deceased individual is classified as a potential donor in absence of [express] opposition to donation before death’, typically with disregard for the wishes of that person’s next-of-kin.^[25]

Advocates of the opt-out system rationalise the need for its implementation based on statistical evidence indicating a correlation between the enactment of opt-out legislation in developed international countries and increased donation rates of up to 25-30%.^[26] By way of illustration, reference is often given to the world’s ‘gold standard’ for organ donation – Spain – achieving a rate of 49.61 dpmp (donations per million population), as compared to Australia’s 21.6 dpmp.^[27] The wide variation between donation rates in opt-in versus opt-out countries such as Spain ‘strongly suggests that this is one area of health policy where the right legislation can play an important role’ in improving donation and transplantation rates and outcomes.^[28]

Despite positive public opinion and persuasive quantitative evidence, an opt-out system of donation has yet to be introduced within Australia as it ‘would most likely be destabilising’.^[29] Accordingly, governments and institutions have recommended against the introduction of an opt-out system within Australia,^[30] relying upon published evidence suggesting ‘that legislative change [to an opt-out system] in isolation [would not] bring about a substantial increase in donation rates’^[31] and could not ‘explain the variation between Australia’s opt-in system and opt-out countries such as Spain’.^[32] Several confounding factors other than legislative consent defaults were hypothesised to affect donation rates in the literature.^[33] They include harmonisation (or lack thereof) of the donation and transplantation legislation and policy,^[34] the donor registration system employed, as well as ethical, socio-cultural and religious determinants – although their relative importance is unclear.^[35]

As a result, ostensible risks of legislative intervention have reduced government willingness to initiate moves to enact opt-out legislation,^[36] with official sources concluding ‘there is no clear correlation between opt-out [legislation] and better performance in organ donation’.^[37] For this reason, legislative, institutional and private-sector efforts for the past decade have remained focused on developing and capacitating Australia's existing system.^[38] Yet, the ‘need for transplantation [continues to] exceed the availability of organs’ in 2021.^[39]

Consequently, concern that Australia’s system in its existing form cannot meet current organ demands remains an ongoing source of apprehension for the thousands of Australians awaiting organ transplantation per annum.^[40] Hence, this article argues that Australia must again consider prospects of reform if a viable solution to the organ shortage is to be discerned.

The call for reform provides space for the legal and administrative critique of Australia’s existing system in order to establish and implement a framework capable of mitigating the organ shortage, meeting future demand for organs, and achieving nation-wide best practice. Accordingly, this article fills that space/ gap by critically analysing material from primary and secondary sources using a qualitative and quantitative approach to provide evidence-based advice and recommendations to develop a long-term strategy to increase organ donation rates. In doing so, this article confronts squarely a persisting issue of health policy that has a profound and detrimental effect upon Australian citizens and their families. Its recommendations include proposals for legislative and policy reform alongside providing altruistic, ethical and compassionate advice to ensure Australians are provided with the highest standard of care.^[41]

In addition to providing a credible analysis of organ donation and transplantation laws and policy, this article aims to identify a viable reform process to translate its recommendations into legislative and policy reform.^[42]

This article is divided into six parts – the first being this introduction. Part II is foundational. It evaluates and critiques the legislative instruments, policy, and medical infrastructure underpinning organ donation and transplantation practices within Australia. Relevant considerations of that review include the origins and nature of existing governance, comprising Australia’s legislative frameworks and the clinical and ethical guidelines for cadaveric organ and tissue donation and transplantation.

In Part III, key findings of that review are explicated. It identifies and considers several structural impediments within Australia’s organ donation and transplantation system that impede attempts to overcome the organ shortage, meet future organ demand, and achieve nation-wide best practice. A lack of harmonisation in the laws and policy used to regulate organ and tissue selection, removal and allocation for transplantation are among the barriers identified that limit the supply of organs from potential donors. Part III informs this article’s subsequent statement of recommendations in Part IV.

Accordingly, Part IV provides evidence-based advice and recommendations, comprising wide-ranging legislative and infrastructural reform, to overcome structural impediments within Australia’s existing system in the areas most likely to yield sustainable results over the long-term. As a part of its recommendations, this article calls for the harmonisation of state and territory legislation and policy to generate Commonwealth oversight, as well as calling for greater community participation in the development of a cogent donation framework, rather than continued reliance on a small number of stakeholders to develop that framework.

Part V provides a ‘strategic roadmap to reform’ and explicates the steps required to translate this article’s recommendations into legislative and policy reform.

Finally, Part VI brings together the contents of this article and re-states its aims. It highlights the importance of reform to achieve a ‘gold-standard’ organ donation and transplantation system capable of overcoming the organ shortage, meeting future demand for organs, and achieving nation-wide best practice.

B Methodology

To critically analyse organ donation and transplantation laws and policy in Australia, this article draws on both qualitative and quantitative analysis with a focus on doctrinal and comparative law research methods. A qualitative approach was imperative to characterising and comparing legal principles and practice regarding organ procurement, conducive to discerning the efficacy of Australia’s existing regime. A quantitative approach was advantageous in evaluating the ability of existing governance to increase or decrease donation and transplantation rates. The quantitative analysis took the form of a cross-country statistical assessment of organ donation and transplantation rates,^[43] and includes statistical data derived following the first identified ‘novel case’ of COVID-19.

This article takes a doctrinal approach in assessing primary legislative instruments that underpin state/ territory,^[44] national,^[45] and international^[46] contemporary organ procurement frameworks. This aspect of the methodology was fundamental to critiquing the ‘principles, rules, and values’ associated with those frameworks, conducive to discerning their efficacy within Australia’s state and territory jurisdictions.^[47] This article additionally takes on an element of comparative legal analysis by comparing legislative frameworks on a domestic (that is Australia’s framework) and foreign level (that is Spain’s ‘gold standard’ framework).

II Organ and Tissue Donation in Australia

To provide a meaningful analysis of cadaveric organ donation and transplantation practices within Australia, it is first necessary to identify the laws and policy (comprising the clinical and ethical guidelines) underpinning the selection, removal and allocation of organs for transplantation. This serves to inform the article’s subsequent identification of structural impediments within Australia’s system that impede attempts to overcome the organ shortage, meet future organ demand, and achieve nation-wide best practice.

A Legal Framework

The common law foundations of the laws dealing with cadaveric organs for transplantation were examined in some detail in the Australian Law Reform Commission (ALRC) 1977 report on Human Tissue Transplants.^[48] That report determined that the common law did not establish within it sufficient guidance to address the complexities of organ donation and called for the enactment of legislation to regulate the area.^[49] Following the ALRC’s report, state and territory governments passed human organ and tissue donation and transplantation legislation. As such, organ donation and transplantation are now regulated by the legislative frameworks operating in each state and territory. Legislation between jurisdictions is comparable, but not identical.

Each enactment establishes the ‘provisions for and in relation’ to the removal of human organ and tissue for transplantation, including definitions of tissue, certification of death, and consent to donation.^[50] Part III engages with the literature which has characterised Australia’s state- and territory-based regime as ‘fragmented’, and establishes that regime as a constraining factor which impedes Australia’s ability to increase organ donation and transplantation rates.

The Commonwealth does not possess an express head of power nor has it enacted legislation which enables it to regulate this area. Thus, the Commonwealth is incapable of overriding or imposing regulations on state and territory organ donation and transplantation legislation and practices.^[51] The only relevant Commonwealth statue in this area, the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth), serves to establish the Australian Organ and Tissue Donation and Transplantation Authority (‘the OTA’)^[52] and the Australian Organ and Tissue Donation and Transplantation Board (‘the Board’). The Board is the OTA’s ‘accountable authority’, tasked with ‘[ensuring] the proper, and effective performance of the OTA’s functions’.^[53] Both the OTA and Board are limited to the formulation, supervision and dissemination of ‘policies, protocols’ and information ‘relating to organ or tissue donation and transplantation matters’.^[54] Neither policy nor protocol under the OTA or Board are authoritative; that is, they do not override state and territory law.^[55]

The following subsections identify and evaluate the legislative regime in each Australian jurisdiction.

1 Definition of ‘Organ’ and ‘Tissue’

In all jurisdictions, ‘tissue’ for purposes of donation is defined to include a substance extracted from, or an ‘organ’ or part of an organ from the human body.^[56]

All jurisdictions additionally distinguish between ‘regenerative tissue’ (‘tissue that, after injury or removal, is restored to its original state or replaced... by natural processes of growth and repair’)^[57] and ‘non-regenerative tissue’ (being tissue other than regenerative tissue that the body is unable to replace).^[58]

Tissue may also include ova, spermatozoa^[59] and foetal tissue, although only in relation to cadaveric donation. Hence, ova, spermatozoa and foetal tissue are explicitly excluded in relation to donations by living persons.^[60]

2 Definition and Certification of ‘Death’

Clinical determination and certification of death are essential to the organ donation and transplantation process, indicating when organs may be harvested, as well as when ‘loss of person hood and individual rights occur, efforts to preserve life can cease..., burial or cremation can be undertaken, and religious or social ceremonies that mark the end of a life can be held’.^[61]

Death is foremost a biological state in which cellular activities and organ function irrevocably cease, indicating that function ‘will not resume spontaneously and will not be restored through intervention’.^[62] The precise time of a donor’s death has in the past been a somewhat arbitrary point of discussion within the donation and transplantation sector, although its significance in optimising opportunities to harvest and transplant organs has remained clear.^[63] Historically, the common law definition of ‘death’ was in terms of blood circulation and pulse, or lack thereof.^[64]

The ALRC 1977 report into Human Tissue Transplants^[65] indicated that this definition was inadequate and made the harvesting process virtually impossible as, from a purely medical standpoint, donation typically requires that organs be maintained by a consistent blood supply due to the rapid deterioration of organs after cessation of circulation, and ‘the consequent risks of [their] failure’ following transplantation.^[66] The heart, liver and lungs fall within the ambit of this category of organ.^[67]

Accordingly, the ALRC submitted a recommendation for the introduction of a statutory definition of ‘death’ based primarily upon brain death, and secondarily on cessation of circulation.^[68] The rigor of neurological determination and certification of death enhances the harvesting process and ‘provides certainty to the [deceased’s] family that an individual who meets the criteria is dead’.^[69]

Contemporarily, all jurisdictions bar Western Australia stipulate that death is taken to have occurred where there is irreversible cessation of all functions of the brain or irreversible cessation of circulation of blood within the deceased’s body.^[70] Conditions causing sufficient brain injury to culminate in cessation of brain function include haemorrhagic or occlusive stroke trauma, hypoxic-ischaemic brain injury following cardiac arrest, central nervous system infection(s) and tumours;^[71] and are not taken to include irreversible damage to the brain causing physiological incapacity or intellectual disability.^[72] In Western Australia, the ALRC’s recommended definition of ‘death’ has been omitted from statute as the relevant committee of the state parliament indicated that ‘much more public debate [was] needed on this difficult subject before the definition [was] embodied’.^[73]

In all jurisdictions bar Queensland, where an individual’s respiratory and circulatory functions are maintained artificially, irreversible cessation of that person’s brain function or of blood circulation must be certified by two medical practitioners,^[74] each of whom must have held the position of ‘medical practitioner’ for no less than five years,^[75] before a designated hospital officer can authorise organ harvesting.^[76] Conversely, in these circumstances Queensland statute stipulates that irreversible cessation must be certified by two medical practitioners, who must neither be the medical practitioner attending the person intended to receive the donated organ or tissue, nor the designated officer who is to authorise the harvesting of the organ or tissue for transplantation.^[77]

In certain jurisdictions one of the certifying medical practitioners must, in addition to holding their position for no less than five years, be a specialist neurologist or neurosurgeon, or to have ‘sufficient qualifications and experience’ as stipulated by the relevant statute.^[78] The Australian Capital Territory,^[79] New South Wales,^[80] the Northern Territory,^[81] Queensland^[82] and Western Australia^[83] are among these jurisdictions.

3 Consent to Cadaveric Organ and Tissue Donation

Prior to the introduction of donation and transplantation legislation, there were difficulties to the harvesting of organs of deceased persons. There was no property in an ‘unprepared’^[84] body at common law, so individuals or institutions (for example hospitals) could not acquire ‘rights’ to interfere with a deceased person’s body or their body parts, including organs.^[85] However, in some instances the courts recognised the body as ‘quasi property’ to which ‘next-of-kin’ may have rights,^[86] so far as to entitle next-of-kin to the ‘right to possession of the corpse of the deceased for the purpose of its lawful disposal by burial’.^[87] Nonetheless, obtaining the right to cadavers for reasons of donation was still a matter of potential legal difficulty. Most notably, in some jurisdictions the taking or ‘harvesting’ of organs could enliven statutory offences of ‘misconduct with regard to corpses’ or ‘improperly or indecently interfering with a dead human body’.^[88] The advent of state and territory legislation in this area clarified medico-legal jurisprudence regarding the harvesting of organs for transplantation. Under these laws, it’s lawful in certain circumstances for organs to be taken from a person after death. For purposes of cadaveric donation, the law does not distinguish between adults and children but rather refers to ‘a deceased person’ or a ‘person who has died’.^[89]

In all jurisdictions bar Queensland,^[90] organ and tissue may be removed from a cadaver where a designated hospital officer, after making reasonable enquiries, concludes that the deceased had consented to the removal for the purpose of transplantation before death (or for other therapeutic or medical purposes) and had not withdrawn their consent (distinct from recipient consent to transplantation).^[91] Where these circumstances do not exist, organ and tissue may be removed where a designated hospital officer, after reasonable enquiries, concludes that the deceased had not during their lifetime expressed an objection to the removal, and where a ‘senior available next-of-kin’^[92] has consented to the removal on behalf of the deceased.^[93] Here, the law is instructive of the role that next-of-kin have in the donation process. It indicates that next-of-kin are the ultimate arbiter of consent, although only in absence of a deceased person’s express objection to donation. ^[94]

By extension, if the designated hospital officer is unable to ‘ascertain the existence or whereabouts of the next-of-kin of the deceased person’, the states of South Australia and Victoria and the territories of the Australian Capital Territory and Northern Territory permit that officer to authorise the removal of organ or tissue in their own discretion and authority.^[95] Such provisions are held to reflect an ‘opt-in’ system of donation. This is somewhat counterintuitive as donations made under an opt-in system typically presuppose an individual’s express and informed consent in life. Yet, statute in these jurisdictions permit designated hospital officers to harvest a deceased person’s organs in absence of an instance of objection and next-of-kin – an approach markedly similar to an ‘opt-out’ system of donation.^[96]

The Australian Organ Donor Register (AODR) is the national register for people over the age of 18 to record their consent to donate after death. It is a fundamental element of Australia’s donation and transplantation system, used to guide designated hospital officers when determining a donor’s consent preference.^[97] Those aged 16 and under may also donate, although consent is sought from that person’s next-of-kin at the time of death – an exception to the statutory provisions identified above.^[98] The AODR is administered by the Australian Department of Human Services, on behalf of the Australian Department of Health.^[99] The Department of Human Services provides the necessary infrastructure for registration of consent with the AODR, which may be recorded through: Medicare via myGov, the Express Plus Medicare mobile app, an online form on the DonateLife website, the Australian Organ Donor Register form for Donors, or an online form on the Department of Human Services’ website.^[100]

In addition to the AODR, the South Australian government allows people in that state to register their intent to donate when applying for a driver’s license – an arrangement termed an ‘anomaly’ among the other state and territory jurisdictions.^[101] Donor data is then captured on a respective driver’s license card. This data is routinely transferred from South Australian driver’s license databases to the AODR.^[102] Part III draws a correlation between South Australia’s licensing system and improved donation rates in that state and, in doing so, considers the potential ramifications of adopting those arrangements in other jurisdictions.

4 Australian Organ Donation and Transplantation Authority Amendment Bill 2021

A recent development in the Australian organ donation and transplantation sector was the introduction of the Australian Organ and Tissue Donation and Transplantation Authority Amendment (Governance and Other Measures) Bill 2021 (‘the Bill’) to the House of Representatives on the 16^th of June 2021. The main purpose of that Bill is to amend governance arrangements implemented within the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth) (‘the Act’).^[103]

Current arrangements stipulate that the OTA’s ‘accountable authority’ is the governing Board.^[104] The Bill seeks to appoint the OTA’s ‘Chief Executive Officer’ (CEO) as the accountable authority.^[105] The CEO will be held responsible for: ‘determining the OTA’s objectives, strategies and policies; ensuring the proper, efficient and effective performance of the OTA; and managing the administration of the OTA’.^[106] Accordingly, the current Board will be dissolved under s 28 of the amended Act and replaced by an ‘Advisory Board’ consisting of five to seven members.^[107] The Bill does not serve to increase the OTA’s functions under the Act. Hence, the OTA will still be relegated to the formulation of policy and protocol, neither of which determine state and territory organ donation and transplantation law.^[108]

B TSANZ’s Clinical Guidelines for Organ Transplantation from Deceased Donors

Australia’s organ shortage calls for highly regulated and ‘transparent’ eligibility criteria to ensure the ‘optimal [and equitable] allocation of a scarce resource’,^[109] balancing ‘the needs of individual patients against the need to maximise the overall benefit to the community’.^[110]

The Transplantation Society of Australia and New Zealand (TSANZ) is the body responsible ‘for developing eligibility criteria for organ transplantation, and protocols for the allocation of deceased donor organs to wait-listed patients’ – articulated within TSANZ’s Clinical Guidelines.^[111] Specifically, TSANZ is funded by the OTA to maintain nationally uniform ‘eligibility criteria to ensure that there are equitable and transparent criteria by which patients are listed for organ transplantation’ and ‘allocation protocols to ensure consistency in the criteria by which donated organs are [selected] and allocated’.^[112] Despite this holding, Part III highlights the use of varying donor eligibility criteria between state and territory jurisdictions and, in doing so, establishes this regime as a ‘constraining factor’ that limits the supply of organs from potential donors on a national scale.

Nonetheless, the fundamental constituents of the protocols used to maintain these criterium are explicated below. This informs the article’s identification of structural impediments within Australia’s organ donation and transplantation system that impede donation and transplantation rates.

1 Organ Recipient Eligibility Criteria

Evaluating recipient eligibility for transplantation is a two-step process, involving referral by a specialist clinician of a patient (usually with end stage organ disease) to a local ‘multidisciplinary transplant unit’,^[113] followed by a clinical assessment of that patient’s eligibility to be registered on a transplant waiting list. Clinical assessment is supervised by the referred to multidisciplinary transplant unit, which consists of (at a minimum) a ‘suitably experienced’ transplant surgeon and physician.^[114]

Referral remains a relatively succinct process, with emphasis placed on timely referrals to curb increased risk of patient casualty or harm due to organ failure. By comparison, clinical assessment comprises an extensive range of screening tests designed to assess ongoing patient eligibility for transplantation.

The following subsections engage with the principal components of the recipient assessment process, including the general inclusion and exclusion criteria,^[115] appeal protocols, as well as the provisions for recipient consent to transplantation, and re-transplantation.

(a) General Inclusion and Exclusion Criteria

To remain active on a transplantation waiting list, potential recipients must attend annual consultations to evaluate ongoing ‘medical, psychological and surgical’ eligibility for organ transplantation.^[116] TSANZ’s clinical guidelines outline inclusion and exclusion criteria for the transplantation of specified organs, ‘informing the decision to offer a particular organ to a particular recipient’,^[117] as well as general criteria that apply to all transplantable organs.^[118] General criteria include the ‘presence of age induced comorbidities’, ‘behavioural risk factors’, and an ‘inability to adhere with complex medical therapy’.^[119]

Although age in of itself is not an exclusion criterion, the presence of comorbidities in patients over 70 years of age are likely to ‘exclude the majority of patients from eligibility for transplantation’.^[120] Specifically, research indicates a ‘progressive linear increase in post-transplant mortality with advancing age’ beyond 70 which renders many recipients ineligible.^[121] Comorbidities may be defined as the presence of two or more distinct conditions or diseases in an individual,^[122] which result in ‘unacceptably high risks of mortality... during or after transplantation, more complex clinical management, and increased health care costs’.^[123]

In respect of behavioural risk factors, potential organ recipients may be ineligible for transplantation where lifestyle contraindications ‘increase the risk of poor transplant outcomes’.^[124] Although past lifestyle choices are ethically irrelevant in assessing eligibility (consistent with the ethical principles of ‘anti-discrimination’ in Part II), ongoing and chronic contraindications including illicit and licit substance abuse – such as that of alcohol and tobacco (especially in the case of allographic transplantation)^[125] – influence decision-making regarding recipient eligibility.^[126] To determine the presence of potential contraindications, TSANZ directs multidisciplinary transplant units to undertake both physical and psychological assessments of potential recipients.^[127] These assessment should include ‘screening tests designed to ensure medical suitability for transplantation’, conducted and directed by members of the transplant unit, including a suitably experienced transplant surgeon and physician.^[128] This enables an estimation of the risks and benefits of transplantation on a case-by-case basis.

Finally, a potential recipient’s inability to adhere with complex medical therapy may impact eligibility for transplantation. Accordingly, failure to comply with medical therapy has been linked to increased rates of patient morbidity and medical costs, as well as reduced quality of life.^[129] For this reason, TSANZ and corroborating sources^[130] strongly suggest that recipient eligibility should be withheld if a potential recipient demonstrates ‘nonadherence in the pre-transplantation period’, including failure to attend medical appointments or to observe the requirements of pre-transplant treatment plans.^[131]

Where the preceding criteria exclude a potential recipient from transplantation, the clinical guidelines encourage transplant units to inform that patient (and their referring clinician) of the reasons behind their exclusion.^[132] Where that patient requests additional information regarding their exclusion, the clinical guidelines encourage the decision for exclusion be stayed up until the time that this information becomes available to the patient and their referring clinician.^[133] Upon receiving this information, patients may appeal the relevant decision (discussed below).

(b) Appeal Protocols

The clinical guidelines provide scope for appeal to patients who are refused referral by a specialist clinician for transplantation or are excluded from a transplantation waiting list by a transplant unit during clinical assessment.^[134]

Those seeking appeal for need of a referral are directed to seek a supplementary opinion from another specialist clinician. The potential outcomes of doing so are: (i) that the second specialist clinician does not consider transplantation a potential remedial avenue; or (ii) the specialist clinician considers transplantation a potential remedial avenue and refers the patient to a multidisciplinary transplant unit for assessment against the relevant eligibility criteria.^[135]

Where an appeal is sought for a decision going to a patient’s unsuitability, patients are referred to a new local transplant unit charged with identifying factors that may change or nullify the original decision. If the original decision is upheld, the patient will remain unsuitable. However, there remains further avenue for appeal in the form of a third review by a transplant unit independent of the original and second unit. Outcomes of seeking out a third review are: (i) the third transplant unit’s decision coincides with the original and second unit’s decisions, and the patient’s exclusion is explained to them; or (ii) the third transplant unit places the potential recipient on a transplantation waitlist.^[136]

In the case of intestinal transplantation and vascularised composite allotransplantation, there exists no option for a third review within Australia. This is attributed to the existence of a singular transplant unit specialising in this area.^[137]

(c) Recipient Consent to Transplantation

State and territory organ donation and transplantation legislation do not engage with the laws for and in relation to patient consent to organ transplantation (distinct from consent to donation). Such matters are dealt with exclusively by the clinical and ethical guidelines, and by the common law.^[138] The relevant guidelines define consent as ‘a person’s or group’s agreement, based on adequate knowledge and understanding of [the] relevant material’.^[139] That consent should be characterised as informed and ‘given before transplantation can proceed’.^[140]

Informed consent refers to the ‘process of consenting to medical treatment’ which must be based upon a medical practitioner’s ‘provision of sufficient information’ to a patient, including the inherent ‘material risks’^[141] and outcomes of that treatment.^[142] As patients are not held to be ‘equal in terms of their capacity to understand [this] information’, material risks and outcomes must be provided at a level easily comprehensible to the layperson.^[143]

The rationale underlying the provision of sufficient information to potential recipients prior to transplantation has been expressed by TSANZ in the following terms:

[T]he provisions of adequate counselling and education are critical to the potential recipient’s ability to consider their options and ultimately provide informed consent if they choose to proceed with transplantation in these circumstances.^[144]

The ‘provisions of adequate counselling and education’ are of particular significance nowadays, given the increasing use of sub-optimal organs which can pose an element of risk to recipient health post-transplant.^[145] Organs that are Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) positive fall within the ambit of this category of organ.^[146] Whereas the presence of HIV rules out transplantation in most instances,^[147] the use of HBV- and HCV-positive organs has become less of a barrier to transplantation given the increased prevalence of curative treatments including prophylactic treatments for HBV and HCV antivirals.^[148] Accordingly, where sub-optimal organs are offered to a patient for transplantation, a medical practitioner’s provision of sufficient information should occur ‘early’, ideally ‘at the time of consent to waitlisting’, and should be ‘revisited periodically to take into account changes in patient priorities and health status’.^[149]

Part III engages with literature that draws a correlation between the extended consideration of sub-optimal organs and increased donation and transplantation rates. By extension, the effect of using stringent and overly rigorous eligibility criteria (which deem sub-optimal organs as inappropriate for transplantation purposes) on donation rates is also evaluated.

(d) Re-transplantation Protocols

Organ transplant recipients suffering organ failure of the transplanted organ are entitled to be re-assessed for transplantation. Re-assessment typically revisits the eligibility criteria initially designated for determining eligibility for transplantation;^[150] although, may additionally include the patient’s ability to adhere with medical advice and treatment following the initial transplantation.^[151] The presence of a previous transplanted organ does not impact recipient eligibility, bar where this curbs the likelihood of a successful transplantation outcome.^[152]

The exact impact of re-transplantation protocols on donation and transplantation rates is unknown, as this is not reported in the literature. However, common sense would suggest that there exists a relationship between re-transplantation rates and levels of organ demand. This relationship warrants further investigation. Nonetheless, given the limited scope of this article, attaining and undertaking an independent qualitative/ quantitative review of this data is not possible. As a result, this article does not engage with re-transplantation protocols when furnishing its recommendations to improve organ donation and transplantation rates. An identification of the relevant re-transplantation protocols instead enhances this article’s ability to identify all aspects of Australia’s organ donation and transplantation system, providing context to current standards of medical and procedural practice within the sector.

2 Organ Donor Eligibility Criteria

The framework within which deceased organ donation occurs includes the use of rigorous donor eligibility assessment criteria to ensure the ‘quality, safety and efficacy of organ donation’.^[153] These criteria are ‘based on donor and organ characteristics and... informed by data collected on donation and transplantation practice and outcomes’.^[154] Because donor eligibility assessment often involves grieving next-of-kin, the clinical guidelines call for structured and standardised assessment, utilising best-practice tools, to balance the rigorous requirements of screening with compassion, patience and empathy.^[155]

Criteria include (i) the ‘pathway’ leading to organ donation (that is cessation of brain function or of blood supply), and (ii) the donor’s medical, behavioural and travel history, including the presence of morbidities (including region specific morbidities) relating to that donor’s contraction of diseases such as SARS-CoV-2 (COVID-19), HIV, HBV and HCV.^[156] In all jurisdictions, a donor’s eligibility results are recorded in an ‘Electronic Donor Record’. Donor results are provided to transplant units prior to transplantation of that donor’s organ(s).^[157]

(a) Pathway to Organ Donation

Certification of death remains a significant event when optimising opportunities to harvest and transplant organs.^[158] Death, as established by state and territory legislation, is defined as irreversible cessation of all functions of the brain or irreversible cessation of circulation of blood within a deceased’s body.^[159] The clinical guidelines supplement the law and provide strict criteria and clinical indications for the certification of death, in accordance with the Australian and New Zealand Intensive Care Society’s (ANZICS) Statement on Death and Organ Donation.^[160]

Clinical declarations of death according to the neurological criterium (that is brain death) are only possible where a donor is maintained by a mechanical ventilator, typically occurring where that donor had been undergoing treatment in an intensive care unit (ICU) prior to death.^[161] Organs harvested following brain death provide optimal conditions for subsequent organ transplantation, as compared to organs harvested following cessation of circulation.^[162] However, the number of donor organs retrieved using this pathway is bottlenecked by the low and decreasing incidence of conditions causing brain death, including occlusive stroke, brain trauma, and hypoxic-ischemic brain injury following cardiac arrest. Indeed, organ donations following brain death are possible in fewer than 1% of all organ donations occurring in hospitals.^[163] As a result, approximately <5 out of 548 donors in 2019 and <5 out of 463 donors in 2020 donated following brain death (rounded to the nearest whole number).^[164]

Death declared according to the circulatory criterium (that is cessation of circulation or ischemia) is by comparison prevalent but provides suboptimal opportunities to harvest organs for transplantation. In such cases, every second counts because of the rapid deterioration of organs after cessation of blood circulation, and the consequent risk of their failure following transplantation.^[165] Accordingly, donor organs must be harvested within as little as 60 to 90 minutes following cessation of circulation to be eligible for transplantation.^[166] For this reason, the majority of donations resulting from cessation of circulation are planned and occur where a person who is receiving mechanical ventilation and/ or cardio-respiratory supportive treatments in an ICU is removed for reasons of donation.^[167] Nonetheless, approximately 30% of planned cessation of circulation donations do not proceed to transplantation as organ retrieval is not conducted within the required timeframe.^[168] Donations following cessation of circulation comprise approximately 30% of all donations in Australia,^[169] totalling 164 out of 548 donors in 2019 and 139 out of 463 donors in 2020 (to the nearest whole number).^[170]

The above-mentioned data signals that on average 169 out of 548 donors in 2019, and 144 out of 463 donors in 2020 donated following cessation of brain function or circulation. This data fails to account for the remaining 379 donors in 2019 and 319 in 2020. The relative importance of this unreported donation data and its impact on this article’s ability to furnish effective recommendations to improve donation rates is unclear. However, it does decrease the article’s ability to attain a sufficiently accurate and detailed snapshot of Australia’s contemporary donation and transplantation sector and its donation rates.

(b) Donors’ Medical, Behavioural and Travel History

Obtaining a thorough and accurate account of a donor’s ‘medical, behavioural and travel history’ is ‘critical to the assessment of the degree of risk to which the recipient of an organ... may be exposed’.^[171] This assessment considers: a donor’s history of disease (including congenital disease);^[172] surgeries impacting organ function; medical and non-medical drug intake;^[173] the presence of tumours and malignancies including metastatic cancer;^[174] and risk factors associated with the transmission of COVID-19 (including travel to high-risk areas of concern),^[175] HIV (particularly from male-to-male, and commercial sex),^[176] HBV and HCV.^[177]

Nowadays, COVID-19 screening is particularly critical when assessing donor eligibility given the ongoing pandemic.^[178] The clinical guidelines indicate that the ‘precise risk of donor-derived [COVID-19 transmission] is currently unknown’, although the consequences of transmission – should it occur – are potentially life threatening.^[179] As such, clinical studies to date report ‘very high rate[s] of mortality from COVID-19 among newly transplanted kidney recipients’ who received ‘immunosuppressive’ treatment(s).^[180] Accordingly, the potential risk factors associated with the incidental use of COVID-19 positive organs calls for routine COVID-19 screening of all deceased donors, ideally completed within 72 hours of donation.^[181] Screening should include a ‘combined nose and throat swab’ and ‘endotracheal aspirate’ (both PCR tests).^[182] Where ‘PCR-positive’, organs are ‘contraindicated’ and unfit for transplantation.^[183]

Nonetheless, the associated logistical and technical limitations of assessing a donor and their organ(s) for all potential risks means that ‘routine post-mortem examination has become an uncommon procedure in clinical medicine’,^[184] particularly when attempting to balance the ‘transmission of malignancy’ against the risks of a recipient dying while awaiting results from the rigorous and lengthy assessment process.^[185] For this reason, organ donation programs across all jurisdictions aim to ‘minimise unexpected infectious diseases while simultaneously maximising opportunities for transplantation’.^[186]

To maintain rapid, yet safe, turn-arounds for transplantation procedures, the nature of the donor organ risk screening undertaken is calculated on a case-by-case basis, and is dependent upon whether (i) there exists sufficient evidence to suggest that a disease or risk will present itself in a recipient following transplantation, (ii) the chances of morbidity or mortality are high, and (iii) if there exists a sufficiently accurate, rapid and affordable screening test to corroborate this evidence.^[187] Where these requisite elements are met, the benefits of screening must be weighed against the relative impact of screening to recipient safety and wellbeing.^[188]

Implicitly, there exists a correlation between the ‘donor organ risk screening’ undertaken and Australia’s donation and transplantation rates, as organ risk screening informs the decision to harvest (or not to harvest) an organ for transplantation into a compatible recipient. The clinical guidelines do not quantify this correlation. Attaining this data through quantitative analysis would enhance this article’s ability to provide a critical analysis of organ donation and transplantation practices in Australia, and to furnish effective recommendations to improve organ donation rates. However, given the narrow scope of this article, undertaking an independent study of donor risk screening is not possible; although, this may be explored further in subsequent research.

C NHMRC’s Ethical Guidelines for Organ Transplantation from Deceased Donors

Acknowledgement and respect for bioethics, as well as the human right to health, is critical to the ‘development and implementation of health policies, laws and practices, including those that relate to the allocation of health resources’.^[189] The National Health and Medical Research Council’s (NHMRC) Ethical Guidelines for Organ Transplantation from Deceased Donors (‘the ethical guidelines’)^[190] signals that this is particularly relevant for the allocation of scarce health resources such as human organs and tissue which, because of their scarcity, raise a number of ethical concerns.^[191] Notably, given the high demand and relative shortage of donor organs it is inevitable that ‘there will be many people who would benefit from an organ transplant but will not... receive one’.^[192] It is therefore essential that organ and tissue selection, removal and allocation laws, policies, and decision-making processes are guided by ethical principles and values.^[193] This should at all times remain transparent to all major stakeholders in the donation and transplantation process, including potential recipients, their family members and other relations, as well as participating transplant units or specialist clinicians.^[194]

Accordingly, the ethical guidelines serve to ‘support decision-making so that... health professionals have an ethical framework to guide clinical consideration and judgement’, ensuring that the decision-making process is ‘rigorous, consistent, transparent’ and in-line with community expectations.^[195] The guidelines inform ongoing revision of TSANZ’s Clinical Guidelines for Organ Transplantation from Deceased Donors. They are also consistent with the principles outlined in international documents, including the World Health Organisation’s (WHO) Guiding principles on human cell, tissue and organ transplantation^[196] (endorsed by the Australian Commonwealth),^[197] the International Covenant on Economic, Social and Cultural Rights,^[198] and the Declaration of Istanbul on Organ Trafficking and Transplant Tourism.^[199]

The following subsections identify the core ethical principles underpinning organ donation and transplantation laws and policy within Australia, as well as the significance of the right to health. These principles inform the article’s subsequent stipulation of recommendations, conducive to providing altruistic, ethical and compassionate advice.^[200]

1 Ethical Principles of Donation and Transplantation

(a) Altruistic Intention to Donate

Cadaveric organ donation in Australia is ‘an act of extraordinary generosity’ and is fundamentally dependent on the altruistic intention of individuals (and their families) to provide their consent to donate – reflecting an opt-in system of donation.^[201]

This has ramifications for clinical practice, and for this article’s recommendations.^[202] Namely, notions of altruism coincide with the ‘recognition that the continuance of [Australia’s organ procurement system] rests upon the willingness of [its people] to support it’ and calls for all eligible donors to consider organ donation in the name of the greater good.^[203] As a result, donor organs must not be obtained by exploitation or coercion, of which would constitute ‘a blatant violation of bodily integrity and autonomy’ or an ‘abusive act’.^[204] Nor should organ donation be motivated by payment to a donor or a donor’s family, which would constitute a violation of the sanctity of altruistic donation which must be characterised as a ‘gift given’, not bought.^[205]

(b) Anti-discrimination

The decision to offer a particular organ to a particular recipient (that is organ allocation) is informed by an evaluation of that recipient’s eligibility against a rigorous criterium – articulated in TSANZ’s clinical guidelines. The ethical guidelines strictly prohibit the use of unreasonably discriminatory criterion from this assessment process.^[206]

Accordingly, discrimination against a potential recipient based on race, cultural and religious belief, as well as gender, sexuality, disability, or age must play no role in assessing eligibility.^[207] Moreover, a potential recipient’s need for transplantation arising from past lifestyle choices, economic and social stature, previous refusal of an offer for an organ, or ‘refusal to participate in research’ likewise should not play a role in assessing eligibility.^[208] Nonetheless, the organ shortage means that a decision to offer an organ to one recipient over another based on these factors (that is ‘organ rationing’) may be permitted where such factors reduce the likelihood of a successful transplantation outcome in one of the recipients.^[209]

(c) Consent and Autonomy

The process of establishing informed consent prior to medical treatment, including for organ donation and transplantation, is further outlined by the ethical guidelines.^[210] These guidelines inform state and territory legislation, as well as the clinical guidelines.

According to the ethical guidelines, the processes required to establish consent for donation or transplantation must be evaluated on a case-by-case basis to remain sensitive to individualistic values, preferences and beliefs that may affect decision-making.^[211] However, in general, consent is established where (i) a person’s decision to consent is made without undue pressure from health care professionals, family members or friends, (ii) that person is provided sufficient information so that the consent can be characterised as ‘informed’, (iii) consent is conveyed in a cogent manner so that there is no mistaking that person’s intentions, and (iv) that person has capacity to consent to donate or undergo transplantation.^[212]

Where a person is assessed as incapable of providing consent as a result of some vitiating factor affecting capacity,^[213] the ethical guidelines provide scope for an elected representative to provide consent on that person’s behalf, although requires that representative to have been actively involved in ongoing discussions and decision-making processes.^[214]

(d) Anti-harm

Transplantation ‘should only be undertaken where it is believed that it provides a benefit to a recipient’.^[215] The necessary processes involved in evaluating benefit to a recipient are at once informed by the clinical and ethical guidelines. Evaluation should account for donor organ condition, as well as the ‘general health’ of the recipient and the likelihood of a successful transplantation outcome, weighed against the risk of not proceeding with transplantation.^[216]

The ethical guidelines indicate that ‘general health’ comprises both psychological and physical wellbeing.^[217] To ensure psychological and physical health, clinicians and health care professionals (including those belonging to multidisciplinary transplant units) have the capacity to refer recipients for medical intervention and treatment prior to transplantation (including dialysis prior to kidney transplantation), and for support following transplantation to ensure ongoing management of treatments,^[218] including the use of organ anti-rejection drugs such as immunosuppressants.^[219]

2 The Ethical Guidelines on the ‘Right to Health’

The ‘right of everyone to... the highest attainable standard of health’ is articulated in Article 12 of the 1976 International Covenant on Economic, Social and Cultural Rights (‘ICESCR’).^[220] The UN Committee of Economic, Social and Cultural Rights has declared that the right to health ‘must be understood as a right to the enjoyment of... facilities, goods, services and conditions necessary to realise’ the highest standard of health.^[221] This passage is broadly construed to include the right to quality and affordable health care services which are entrusted with ensuring the availability of health resources such as organs for transplantation, conducive to maintaining ‘the health and wellbeing of a person and their family’.^[222]

However, it is important to note that the UN Committee recognises that the right to health ‘cannot be ensured by a country, nor can countries provide protection against every possible cause of human [illness]’.^[223] Moreover, in absence of a Commonwealth provision for the right to health, maintaining health and wellbeing cannot be construed as a ‘right’, but rather an ‘aspiration of the common people’.^[224] Thus, the ‘right to health’ under Article 12 of the ICESCR is a mere ‘strong desire to achieve something high or great’, distinct from an enforceable right.^[225]

Notwithstanding this, enforcing the right to organs on grounds of the right to health is not desirable under Australia’s opt-in system of informed consent as it entails the mandatory harvesting of organs for transplantation – akin to an opt-out system of donation.^[226] Mandatory harvesting of organs is outside the Commonwealth’s power and would be contrary to the altruistic underpinnings of organ donation and transplantation in Australia.^[227] Ergo, this article does not engage with the right to health when furnishing its recommendations.^[228]

III Key Findings and Discussion: Organ and Tissue Donation in Australia

Part II of this article identified and examined the legislative instruments and policy underpinning Australia’s organ donation and transplantation system. It determined that current governance provides a rigorous framework which establishes the provisions for and in relation to the selection, removal and allocation of organs and tissue for transplantation. Australia’s regime supports key stakeholders in the organ donation and transplantation sector and provides them with a cogent and ethical framework to guide clinical indication, consideration, and judgment on a matter of significant health policy.

Despite current arrangements, the disparity between organ supply and demand continues as of 2021.^[229] From its analysis, this article has identified several constraining (limiting) factors within Australia’s donation and transplantation system that impede attempts to overcome the organ shortage, meet future demand for organs, and achieve nation-wide best practice. The following part of this article establishes and examines these limiting factors, informed by the works of key stakeholders within the area, to explicate their relative impact on donation and transplantation rates and outcomes. This process informs the article’s subsequent statement of recommendations to mitigate the impact of structural impediments within Australia’s system in the areas most likely to yield sustainable results over the long-term.

A Jurisdictional Variability: Organ and Tissue Legislation

The nature of the laws underpinning organ donation and transplantation practices within Australia point to a lack of harmonisation and to ‘fragmentation’ between jurisdictions.^[230] As a result, jurisdictional oversight occurs on a state and territory level,^[231] given the Commonwealth does not have an express power and has not enacted authoritative statute to regulate this area.^[232] Indeed, the only relevant Commonwealth statute, the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth), serves to establish the OTA and its accountable authority (that is the Board),^[233] neither of which determine state and territory law.^[234]

Consistent with conventional guiding principles of good governance, state and territory authority should implicitly ‘look to the Commonwealth to provide leadership..., ethical oversight’ and consistency to the interpretation of the law.^[235] However, as governance is state- and territory-based, each jurisdiction acts as ‘gatekeeper’ for the laws and policy regulating organ donation and transplantation practices, effectively excluding Commonwealth interference.^[236] Though not ‘outwardly reported’, this has culminated in significant gaps in the laws and policy used to regulate donation and transplantation, and has subsequently left state and territory governments with ‘little ... ability to keep pace with surgical needs’.^[237]

For instance, the 2006 Howard government’s National Clinical Taskforce on Organ and Tissue Donation (‘the Taskforce’) has indicated that Australia’s fragmented form of governance impedes efforts to increase organ donation and transplantation rates and has led to an absence of a single overarching or nationally-driven policy direction.^[238] This is reflected fundamentally in the inability of states and territories to remain consistent and current to ‘technology and changing practices within the sector’ – exemplified foremost by the disparate approaches used to assess organ donor and recipient eligibility (discussed in Part III) .^[239]

Additionally, inconsistency in the laws used between state and territory jurisdictions ‘fail[s] to empower all jurisdictions to adopt and enforce oversight’,^[240] with ‘some governments report[ing] capacity and responsibility gaps in their frameworks which disempower their role in oversighting jurisdictional tissue provision’.^[241] In this regard, PricewaterhouseCoopers reported that ‘state authorities’ (unnamed) were not adequately empowered to regulate surgeons’ importation of organs ‘due to a lack of reporting requirements and a [legislative] capacity to compel information’.^[242] As a result, that state was operating ‘without full information on the trade and distribution of tissue within its jurisdiction, and with ambiguity over the powers to intervene and regulate it’.^[243]

On the balance, key stakeholders and institutions within the sector indicate that jurisdictional fragmentation of the laws underpinning organ donation and transplantation practices impede efforts to increase organ donation and transplantation rates, achieve nation-wide best practice, and to ‘adapt to changing needs’ within the sector.^[244] However, the veracity of these findings is somewhat diminished due to a lack of quantitative data to support them.

Notwithstanding this, there is evidence to suggest that the implementation of a nationally driven approach to organ donation and transplantation would theoretically enhance Australia’s ability to overcome barriers posed by jurisdictional fragmentation, at least in the ‘short- to medium-term’.^[245] This view was reflected by government stakeholders in the OTA’s 2016 report into ‘Australia’s tissue sector’ which called for ‘sector level reform’ (including reforms to generate national oversight), followed by reforms to ‘[p]rofessional associations and end user stakeholders’ as a way to increase organ donation and transplantation rates.^[246] Indeed, should Australia’s organ donation and transplantation legal regime remain state- and territory-based (that is ‘fragmented’), organ donation may be constrained and ‘many possibilities for increasing organ donation and transplantation rates will go unexplored’.^[247]

B Jurisdictional Variability: Consent Registration Infrastructure

Cadaveric organ and tissue donation in Australia reflects an ‘opt-in’ system of donation.^[248] Organ and tissue may therefore be removed from a deceased person where a designated hospital officer, after making reasonable enquiries, concludes that the deceased had consented to the removal for reasons of transplantation.^[249] This article identified the AODR as the national register for Australians to record their consent to donate;^[250] although, recognised South Australia as an anomaly given its use of driver’s license consent registration arrangements. Those arrangements allow South Australians to capture their decision to donate upon registering for a driver’s license, at which point that consent data is transferred from a driver’s license database to the AODR.

Under these arrangements, a national survey on donor consent registrations conducted by Services Australia between 2019-2021 identified South Australia as reporting the highest proportion (%) of registrations with the AODR, with 51.93% of South Australia’s population having registered their consent to donate.^[251] For the same years, the Northern Territory, the Australian Capital Territory, and Victoria reported the lowest proportion of registrations with the AODR, at 4.23%, 8.19% and 8.49%, respectively.^[252]

As indicated by the OTA in its 2018 Review of the Australian organ donation, retrieval and transplantation system,^[253] South Australia’s registration rates have been greatly assisted by the continued use of the ‘drivers licensing legacy system’.^[254] A number of stakeholders consulted in that review additionally highlighted the bona fide effectiveness of the somewhat niche licensing system in registering organ donation intent, particularly in comparison to other jurisdictions which rely upon the AODR in isolation.^[255]

In the context of ‘donation rates’, higher donor registration rates increase the supply of organs from potential donors, whereas lower rates limit the supply of organs from potential donors. Thus, evidence in the literature (including the OTA’s 2018 review) which points to a correlation between ‘drivers licensing legacy system[s]’ and increased registrations should also point to increased rates of donation.^[256] By extension, evidence pointing to lower rates of registration under the AODR when used isolation should also point to decreased donation rates. The veracity of this conclusion is supported by data in the literature, including the OTA’s 2020 Australian Donation and Transplantation Activity Report which identified South Australia as ‘the leader in donation outcomes’, achieving a donation rate of 26 dpmp.^[257] By extension, the Northern Territory was identified as Australia’s weakest jurisdiction (16.3 dpmp).^[258]

On the balance, the correlation drawn between South Australia’s ‘licensing legacy system’ and increased registration rates indicates that national donation averages may increase through adoption of South Australia’s registration regime in the other jurisdictions.

C Jurisdictional Variability: Eligibility Criteria

The various criteria used to assess donor and recipient eligibility inform the decision to retrieve a particular donor organ for transplantation into a compatible recipient. Implicitly, there exists a correlation between these criteria and the donation and transplantation rates achieved between jurisdictions.^[259] As identified in this article, TSANZ is the body responsible for ensuring these criteria are ‘nationally uniform’; therefore, providing consistency ‘[to] the criteria by which donated organs are [selected] and allocated’.^[260] However, the eligibility criteria cannot be characterised as ‘uniform’, with the literature highlighting the use of varying donor eligibility criteria (some more stringent than others) between state and territory jurisdictions.^[261] Variability in the criteria used to assess donor eligibility has resulted in a disparity in the donation and transplantation rates achieved between jurisdictions.^[262]

A national survey on Australian donation and transplantation activity between 2018-2020 reported on average 170 (24.6%) out of 522 (75.4%) potential donors did not proceed to donation as they were deemed unsuitable when assessed against donor eligibility criteria.^[263] During this period, Queensland, Victoria, and South Australia reported the highest proportion of potential donors assessed as unsuitable for donation, with unsuitability rates of 27%, 28% and 29%, respectively.^[264] In contrast, only 16.33% of potential donors in Tasmania were deemed not medically suitable for donation.^[265]

Inconsistency in the unsuitability rates observed between jurisdictions is ‘indicative of the variability in the advancement of donation and transplantation techniques and the stringency of acceptance criteria applied in each state and territory’.^[266] Lower rates of unsuitability are a ‘direct [result] of the extended consideration of [sub-optimal organs] that were previously considered not suitable for donation’,^[267] which has ‘come about from improved techniques to optimise the use of organs’.^[268] For instance, the presence of HBV and HCV in donor organs has become less of a barrier to organ transplantation due to the increased availability of curative treatments, including prophylactic treatments for HBV and HCV antivirals.^[269] Conversely, higher rates of unsuitability are a result of the application of stringent and overly rigorous eligibility criteria that deem sub-optimal organs (including HBV- and HCV-positive organs) as inappropriate for transplantation purposes.

Accordingly, Tasmania’s low rate of unsuitability (16.33%) is attributable to its ‘larger risk appetite and less conservative approach to the use of the eligibility criteria’, whereas high unsuitability rates in Queensland, Victoria, and South Australia are attributable to the application of stringent eligibility criteria – evidence which is supported ‘anecdotally’.^[270]

Inconsistency in the criteria used between jurisdictions limits the supply of organs from potential donors on a national scale. There is potential to access a much wider pool of donors if this barrier is addressed. This has ramifications for the article’s recommendations to improve donation rates, suggesting that ‘techniques that optimise the use of expanded and nonstandard risk donors... and improve practices in the identification of potential donors’ have a quantifiable and positive impact on ‘Australia’s donation performance’.^[271]

In application, the contrast drawn between unsuitability rates in Tasmania and its use of optimised eligibility criteria versus those states utilising stringent criteria suggests that donation rates may be improved by harmonising jurisdictional eligibility criteria to reflect Tasmania’s regime.^[272] By extension, harmonising eligibility criteria also ensures that criteria is ‘nationally uniform’, in-line with TSANZ’s aspirations for consistency in ‘the criteria by which donated organs are [selected] and allocated’.^[273]

The literature is unclear as to what or who has driven a shift in the metrics of the criteria used to determine donor eligibility, nor the reasons behind it. Theoretically, this data could be obtained by completing a cross-country systematic interview of key stakeholders in the organ donation and transplantation sector, including medical practitioners (for instance designated hospital officers and transplant unit members). However, given the narrow scope of this article and the practical limitations imposed by COVID-19, undertaking an independent survey or case study of key stakeholders between state and territory jurisdictions is not possible; though, this may be explored further in subsequent research. Nonetheless, common sense would dictate that key stakeholders have acted in response to the growing need for donor organs or, at a fundamental level, to meet government-, hospital- and patient-centric goals.

D Consent Defaults: Australia’s Opt-in System, and Opt-out Systems

As detailed above, organ donation in Australia presupposes an individual’s express, free and informed consent^[274] – reflecting an opt-in system of donation.^[275] Provisions of consent are expressed in the law (stipulating that organ and tissue may be removed from a cadaver where a designated hospital officer concludes that the deceased had consented to the removal),^[276] and in the clinical and ethical guidelines (stipulating that donation is fundamentally dependent on the altruistic intention of individuals to provide their consent to donate).^[277]

Altruistic organ donation under an opt-in system ‘is naturally [viewed]... with...favour’ in Australia,^[278] and garners support from the general public and key stakeholders in the organ donation and transplantation sector.^[279] Yet, despite Australia’s stated support for donation under its opt-in system,^[280] the nation continues to suffer a persistent scarcity of organs for transplantation.^[281] This has culminated in concern that Australia’s existing opt-in system impedes efforts to overcome the organ shortage, meet future demand for organs, and achieve nation-wide best practice; and has been the motivating reason behind the evolution of hard-lined proposals for reform.^[282]

Of these proposals, the adoption of an opt-out system of donation is most prevalent in the literature and has prompted key stakeholders to ‘[investigate] whether an opt-out system of organ donation would be beneficial in increasing organ donation rates’.^[283] Under an opt-out system, ‘a deceased individual is classified as a potential donor in absence of [express] opposition to donation before death’.^[284] This system has operated with ‘a high degree of success [internationally]’, particularly in Spain – the ‘gold standard’ for organ donation, achieving donation rates of 49.61 dpmp.^[285] Discussions with ‘staff and persons’ living in Spain show that over time, ‘[an opt-out system’s] use has its greatest benefit by making donation the norm’ and has ‘engendered civic pride’.^[286] In relation to Spain, ‘Australia has a relatively low rate of organ donation’ of around 21.6 dpmp – placing Australia 16^th in the world.^[287]

The wide variation between donation rates in opt-in versus opt-out countries such as Spain ‘strongly suggests that this is one area of health policy where the right legislation can play an important role’ in improving donation and transplantation rates and outcomes.^[288] However, despite palpable quantitative evidence, the political climate in Australia has traditionally been opposed to an opt-out system of organ donation,^[289] with key stakeholders concluding that such a system ‘isn’t the key to increasing donation rates’.^[290]

The 2006 Howard government’s National Taskforce was among those stakeholders opposed to the implementation of an opt-out system in its report into Australia’s organ and tissue sector. The Taskforce, established to provide the Australian government with ‘evidence-based advice on ways to improve the rate of safe, effective and ethical organ... and tissue donation for transplantation in Australia’,^[291] released its final report in 2008 which included the identification of ‘six critical areas of action and 51 recommendations for improving’ Australia’s organ donation system.^[292] As a part of its report, the Taskforce expressed its disapproval for the adoption of an opt-out system within Australia, citing: ‘when international comparisons in donor rates according to consent laws [and actual practice] are considered, there is no clear correlation between opt-out systems and better performance in organ donation’.^[293] Moreover, ‘it [was] not expected that legislative change in isolation would bring about a substantial increase in donation rates’, as there exist other confounding variables that influence donation rates, including the eligibility criteria used to regulate organ and tissue selection, removal and allocation for transplantation.^[294] Accordingly, the Taskforce endorsed the continued use of Australia’s existing opt-in system which was cited to ‘balance individual and family rights’ to autonomy, making it a considerably fairer approach to organ procurement when compared to an opt-out system of donation.^[295]

Additionally, a number of government committees, including those of Tasmania, Queensland, Western Australia and NSW, were commissioned to commence independent reviews of organ and tissue donation governance, and to consider the adequacy of Australia’s existing opt-in system as compared against opt-out systems (particularly the ‘Spanish Model’).^[296] General consensus among the relevant government committees favoured the continued operation of Australia’s opt-in system,^[297] as there existed ‘no convincing evidence that the introduction of presumed consent (that is an opt-out system) in isolation would have a positive impact on organ and tissue donation’.^[298] Further, while opt-out legislation was ‘widely assumed... to yield significantly higher rates of organ donation’ in Spain,^[299] capitalised by that law’s ‘gold-standard’ appellation, ‘it [could not] be inferred from this that the introduction of presumed consent legislation per se [led] to an increase in organ donation rates’.^[300] Instead, it is far more likely that the Spanish experience and its success were dependent on the Spanish government’s decision to amalgamate its organ donation and transplantation infrastructure (comprising its donation legislation and programs)^[301] into a single, nationally drive approach – aptly named the National Transplant Organisation (Organización Nacional de Trasplantes).^[302]

Accordingly, the literature highlights the ‘superficial’ nature of opt-out systems, and of claims for a correlation between the enactment of opt-out legislation and increased donation rates.^[303] In doing so, the literature emphasises the importance of ‘a well organised [and harmonised] infrastructure’ to achieving increased donation rates.^[304] On this point, Queensland’s Review of Organ and Tissue Donation Procedures Select Committee indicated that ‘the introduction of any system of presumed consent without changes to the [infrastructure] would not increase organ and tissue donation rates in a country with a previously implemented opt-in system’.^[305] As a result, focusing on legislative reform to an opt-out system may be to ‘miss the target’ if greater donation gains could arise ‘through organisational and structural change’ to Australia’s existing system.^[306]

All committees additionally raised concerns for the ethical implications of adopting an opt-out system of donation, particularly in relation to the potential contravention of an ‘individual’s rights to autonomy’ which could pose the risk of ‘turning away’ the public from donation.^[307] As identified in this article, donation under an opt-in system is an act of altruism. It ‘is a precondition of [a donor’s] freedom so that the transplant can be characterised as being a gift and not interpreted as a coercive or abusive act’.^[308] Here, the violation of the sanctity of the dead is justified by the concept of the ‘ultimate gift of charity’ and the need for organs to be ‘given’ and not ‘taken’.^[309] Introducing an opt-out system has the potential to undermine the concept of donation as a gift and could incite a public perception that the state is exercising unwarranted and paternalistic intrusions over the dead,^[310] eroding ‘trust in health professionals and the government’.^[311] Thus, the only ethically just response to donation appears to be one that adheres to an informed consent system (that is an opt-in system).^[312]

More recently, the Australian government commissioned Ernst and Young (EY) to undertake an independent review of organ and tissue donation in Australia to provide ‘recommendations and evidence-based advice to inform the development of a future national strategy... in order to optimise deceased donation opportunities for maximum transplant outcomes’.^[313] The review, commencing in May 2018 and published December 2018, highlighted the need for improvements in governance transparency and accountability of key stakeholders in the sector.^[314] EY made no reference to the use of an opt-out system as a viable or sustainable solution to achieving increased rates of donation within Australia. This, alongside the prior mentioned reports and reviews, signals a noteworthy shift within the organ donation and transplantation sector, indicating that key stakeholders are orientating their legislative- and policy-centric goals to developing and capacitating Australia's existing opt-in system.

On the balance, although opt-out systems are objectively the benchmark in organ and tissue donation statistics, ‘[this] clinically focused... system is something Australians are not ready or prepared for’ – reflected in Australia’s current political climate and the reduced readiness of key stakeholders to comment on or to consider its endorsement.^[315] Moreover, the appeal of opt-out systems (including the Spanish model) appears to be wholly superficial,^[316] with key stakeholders concluding that there exists ‘no convincing evidence that the introduction of presumed consent in isolation would have a positive impact on organ and tissue donation’.^[317] Instead, increased donation rates in opt-out countries have been attributed to the implementation of a well organised and harmonised infrastructure.^[318] This has ramifications for the article’s subsequent recommendations to improve donation rates, suggesting that there exists far more potential to achieve greater donation gains ‘through organisational and structural change’, rather than through the enactment of opt-out legislation.^[319]

IV Rethinking Organ Donation: recommendations for reform

A review of the laws and policy underpinning organ donation and transplantation practices in Australia, informed by the ideas of leading academics and researchers that have produced work in this area, identified several constraining factors that impede attempts to overcome the organ shortage, meet future organ demand, and achieve nation-wide best practice. Accordingly, the following part provides evidence-based advice and recommendations, comprising wide-ranging legislative and infrastructural reform, to overcome these constraining factors in the areas most likely to yield measurable and sustainable increases in donation and transplantation rates in the long-term. All recommendations endorse a key principle adopted by the Howard Government’s National Taskforce in its 2008 report: ‘think nationally, act locally’.^[320]

A Recommendation #1: legislative harmonisation

A key finding of this article was that Australia lacked authoritative Commonwealth oversight. As a result, the provisions for and in relation to organ donation and transplantation are furnished on a state and territory level – a ‘fragmented’ form of governance. Inconsistency between state and territory laws reduces Australia’s ability to increase donation and transplantation rates, remain current to changing practices within the sector,^[321] and has precipitated gaps within the law that disempower government authorities to oversight jurisdictional tissue provision.

Consequently, this article recommends that there exists a shared responsibility for the amalgamation and implementation of nationally uniform Commonwealth organ donation and transplantation law between state and territory jurisdictions. This will create opportunities for state and territory governments and other key stakeholders to co-contribute to and deliver on organ and tissue services in a manner that best suits jurisdictional and national environments – consistent with the Taskforce’s desire to ‘think nationally, act locally’.^[322] Moreover, harmonisation of the law to generate Commonwealth oversight would allow for consistency between jurisdictions and would streamline the future introduction or revision of the provisions in relation to organ donation and transplantation. Theoretically, this would ensure all jurisdictions remain current to best practice procedure.

B Recommendation #2: licensing system registration trials

A second finding was that South Australia continues to report the highest proportion of donor registrations, and that this may be attributed to its use of a niche licensing legacy system (operating in conjunction with the AODR). By comparison, it was determined that the use of the AODR in isolation hampers registration rates in jurisdictions such as the Northern Territory, Victoria, and Queensland.

Accordingly, it is recommended that discussions between state and territory governments and stakeholders be opened to inform the revision and implementation of strategies to improve nation-wide donor registrations, having regard for the merits of South Australia’s licensing arrangements. As a part of this discussion, state and territory governments and stakeholders should be urged to undertake independent, regional studies regarding the effects of licensing arrangements on registration rates and to subsequently present their conclusions before the other relevant parties – consistent with the notion of ‘think nationally, act locally’.^[323] These studies should include licensing system trials that run for a minimum of six months. This time frame ensures that trials and their results are not constrained by logistical factors including time – as informed by the Australian Red Cross Lifeblood’s 1990 campaign ‘Go On! Say Yes’ which evaluated the ‘level of increase or decrease in donor consent rates’ over six months following the implementation of drivers’ license registration arrangements.^[324]

C Recommendation #3: eligibility criteria harmonisation

A third finding of this article was that donor eligibility criteria are inconsistent between state and territory jurisdictions. Variability in the criteria used to assess donor eligibility negatively impacts Australia’s mean donation rate and, additionally, prevents Australia from achieving the ‘nationally uniform’ criteria espoused for in TSANZ’s clinical guidelines.

Accordingly, Tasmania’s use of optimised eligibility criteria was observed to increase its risk appetite; therefore, lowering its donor unsuitability rates. This boosts the nation’s average donation rate. Conversely, jurisdictions using overly stringent and rigorous criteria reported increased unsuitability rates. This hampers the nation’s average donation rate.

Therefore, this article recommends that TSANZ undertake a review and revision of the national standards for determining donor eligibility, having regard for the efficacy and merit of Tasmania’s eligibility criteria. Subsequently, it is recommended that Tasmania’s eligibility criteria be trialled in other state and territory jurisdictions and, if proven effective, implemented nation-wide. As such, it is hypothesised that the introduction of Tasmania’s eligibility regime would coincide with decreasing unsuitability rates and, by extension, increasing donation rates.

D Recommendation #4: rebutting presumed consent (opt-out)

This article’s final key finding determined that Australia may overcome the organ shortage, meet future demand for organs, and achieve nation-wide best practice by orientating reform to capacitating Australia’s existing opt-in system, and not by moving to an opt-out system of donation. Indeed, focusing on reform away from an opt-in system and towards an opt-out system without corresponding infrastructural and legal reform ‘would not increase donation rates’ in Australia.^[325]

Hence, this article recommends against the introduction of an opt-out system of donation. Furthermore, it supports the continued capacitation of Australia’s existing opt-in system and has subsequently orientated its recommendations to reflect this.

V How to Proceed: strategic roadmap to reform

The OTA is best placed to lead the dissemination and implementation of this article’s recommendations across state and territory jurisdictions, given the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth) provides the OTA with responsibility for the formulation, supervision and dissemination of ‘policies..., protocols’ and information ‘relating to organ or tissue donation and transplantation matters’.^[326]

For the OTA to extend the ambit of its focus to embrace the enhanced governance of organ donation and transplantation, and to drive the implementation of this article’s recommendations, the OTA will ‘require adequate funding and support from the Australian Government’.^[327]

Theoretically, funding and support for the implementation of this article’s recommendations may be obtained where the Australian Government recognises Australia’s organ donation and transplantation sector as an area of law that ‘needs to be updated, improved or developed’.^[328] Where this occurs, the Attorney-General may issue a written request to the ALRC to undertake an inquiry with respects to the deficient area of law – referred to as a Terms of Reference (TOR). The TOR addresses the subject matter and scope of the inquiry, including the stakeholders and advisory committee consulted during the investigation.^[329] Following an initial inquiry and consultation, the ALRC will produce several ‘Consultation Documents’, comprising ‘Background Papers’ and ‘Consultation Papers’. Background Papers will provide a detailed account of the ALRC’s research, while Consultation Papers will set out draft proposals for reform and will call for public submissions, including academic research akin to this article.^[330] Through the submissions it receives, the ALRC can gauge public opinion with respects to the law under investigation which ultimately informs the ALRC in the formulation of its ‘final report’. This report may culminate in law reform following tabling in Parliament.^[331]

In giving effect to this process, the intention is to galvanise official and public discussion regarding organ procurement through publication of this research in a public forum, and in submitting a concise variation of this research to state and territory Health Ministers. The hope is that this will encourage the Australian Government to recognise the structural impediments and corresponding recommendations identified in this article, insofar as to issue a TOR to the ALRC for a formal inquiry into Australia’s organ donation and transplantation sector. Subsequent steps required to translate this article’s recommendations into legislative and policy reform may include academic submissions to the ALRC following the issuance of ‘Consultation Papers’.

On the balance, this article serves to encourage official powers within the Australian Government and organ procurement sector to reconsider Australia’s failing organ donation and transplantation system, and to subsequently manage its shortcomings.

According to Luc Delriviere, Senior Liver Transplant and Hepato-biliary Surgeon at Sir Charles Gairdner Hospital (WA), legal reform of this magnitude may take upwards of two to three years.^[332] As such, it was imperative to develop a clear strategy and endgame for reform when synthesising this article’s recommendations.

VI Concluding Remarks

Australia’s organ donation and transplantation sector is in need of significant reform if the supply is to ever meet the demand. The nation’s low rate of donation (21.6 dpmp) is a testament to the inadequacy of its current system. A lack of harmonisation in the laws and policy used to regulate the selection, removal and allocation of organs and tissue for transplantation are among the barriers identified in this article that limit the supply of organs from donors. This article’s legal and administrative critique indicates that a much wider pool of donor organs may be accessed if these barriers are addressed. Accordingly, this article has provided evidence-based advice and recommendations to overcome and grapple with these barriers.

In line with its aims, this article has additionally identified a viable reform process to translate its recommendations into legislative and policy reform. In giving effect to this process, the intention is to foster public discussion through publication of this article in a public forum, and in providing a concise variation of this research to state and territory Health Ministers.

However, readers of this article would be misguided if they are led to believe that reform is easily obtainable. This article is one step down the path to achieving a ‘gold-standard’ organ donation and transplantation system capable of overcoming the organ shortage, meeting future demand for organs, and achieving nation-wide best practice. To enact change and meet the demand, Australians nation-wide are called upon to recognise the inadequacy of our current system and, in doing so, advocate for change in hopes that a ‘relatively scarce resource’ becomes ever more accessible to those suffering life threatening disease(s).

***

---

* Jack Hassall is a LLB (Hons.) and Forensic Science graduate at the University of Canberra.

¹ Neera Bhatia and James Tibballs, ‘The Development of Property Rights Over Cadaveric Tissues and Organs: Legal Obstructions to the Procurement of Organs in an ‘Opt-Out’ System of Organ Donation in Australia and New Zealand’ (2017) 27 New Zealand Universities Law Review 946, 946-947; and National Health and Medical Research Council, Australian Government, Organ and Tissue Donation After Death, For Transplantation: Guidelines for Ethical Practice for Health Professionals (Report, March 2007) 4 (‘Organ and Tissue Donation After Death, For Transplantation’).

^[2] Matthew Thomas and Michael Klapdor, ‘The Future of Organ Donation in Australia: moving beyond the ‘gift of life’’ (Research Paper No 11, Parliamentary Library, Parliament of Australia, October 2008) (‘The Future of Organ Donation in Australia’).

^[3] National Clinical Taskforce on Organ and Tissue Donation, Final Report: Think Nationally, Act Locally (Final Report, Department of Health and Ageing, January 2008) 11 (‘Think Nationally, Act Locally’).

^[4] Cadaveric donation refers to donation occurring after an individual is pronounced medically deceased – a process governed by Australian state and territory legislation: Transplantation and Anatomy Act 1978 (ACT) ss 30 and 45; Human Tissue Act 1983 (NSW) ss 26 and 33; Transplantation and Anatomy Act 1979 (NT) ss 21 and 23; Transplantation and Anatomy Act 1979 (Qld) s 45; Death (Definition) Act 1983 (SA) s 2; Human Tissue Act 1985 (Tas) ss 25A and 27A; and Human Tissue Act 1982 (Vic) ss 26(7) and 41.

^[5] See, eg, Wendy Elizabeth Bonython and Bruce Baer Arnold, ‘Privacy, Personhood and Property in the Age of Genomics’ (2015) 4(3) Laws 377 (‘Privacy, Personhood and Property in the Age of Genomics’); C E Harris and S P Alcorn, ‘To solve a deadly shortage: economic incentives for human organ donation’ (2001) 16(3) Issues in Law & Medicine 213; Elizabeth King and Russell G Smith, ‘Human Tissue Transplantation Crime’ (Report No 87, Australian Institute of Criminology, 1998); and Human Rights Sub-Committee, Parliament of Australia, Compassion, Not Commerce: An Inquiry into Human Organ Trafficking and Organ Transplant Tourism (Parliamentary Report, November 2018) (‘Compassion, Not Commerce’).

^[6] See Transplantation and Anatomy Act 1978 (ACT); Human Tissue Act 1983 (NSW); Transplantation and Anatomy Act 1979 (NT); Transplantation and Anatomy Act 1979 (Qld); Transplantation and Anatomy Act 1983 (SA); Human Tissue Act 1985 (Tas); Human Tissue Act 1982 (Vic); and Human Tissue and Transplant Act 1982 (WA).

^[7] Think Nationally, Act Locally (n 4) 11. See also Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth) s 8.

^[8] Bhatia (n 2) 946-947.

^[9] Ibid.

^[10] Boronia Halstead and Paul Wilson, ‘Body Crime’: Human Organ Procurement and Alternatives to the International Black Markey (Trends and Issues in Crime and Criminal Justice Report, No 30, March 1991) 3.

^[11] Tom Faunce, ‘New Australian Federal Organ and Tissue Donation Legislation: Enhanced Transplant Services but Not “Opt-Out”’ (2009) 16 Journal of Law and Medicine 590, 590 and 591.

^[12] See, eg, Organ and Tissue Authority, 2019 Australian Donation and Transplantation Activity Report (Activity Report No 1, January 2020) <https://donatelife.gov.au/about-us/strategy-and-performance/our-data#accordion-0-0> (‘Organ and Tissue Authority 2019 Report’); Organ and Tissue Authority, 2020 Australian Donation and Transplantation Activity Report (Activity Report No 1, January 2021) <https://donatelife.gov.au/about-us/strategy-and-performance/our-data#accordion-0-0> (‘Organ and Tissue Donation 2020 Report’); and Philippe Steiner, ‘Gifts of Blood and Organs: The Market and “Fictious” Commodities’ (2003) 44 Revue Françoise de sociologie 146, 155-156.

^[13] Organ and Tissue Authority 2019 Report (n 13) 2; and Organ and Tissue Donation 2020 Report (n 13) 4.

^[14] Organ and Tissue Authority 2019 Report (n 13) 2; and Organ and Tissue Donation 2020 Report (n 13) 4.

^[15] Organ and Tissue Authority 2019 Report (n 13) 2; and Organ and Tissue Donation 2020 Report (n 13) 4.

^[16] See Organ and Tissue Authority 2019 Report (n 13) 2.

^[17] Ibid.

^[18] This data does not account for those individuals placed on dialysis and requiring a subsequent kidney transplant.

^[19] Faunce (n 12) 590-591 (emphasis added).

^[20] Think Nationally, Act Locally (n 4) 11. See generally Organ and Tissue Donation 2020 Report (n 13).

^[21] The Future of Organ Donation in Australia (n 3).

^[22] Think Nationally, Act Locally (n 4) 11.

^[23] See, eg, The Future of Organ Donation in Australia (n 3); Think Nationally, Act Locally (n 4) 157 (emphasis added); and P M McEwen, ‘Valid informed consent: the key to increasing supply of organs for transplantation?’ (2005) 7 Critical Care and Resuscitation 246, 246.

^[24] Bhatia (n 2) 947. See generally The Future of Organ Donation in Australia (n 3).

^[25] Alberto Abadie and Sebastian Gay, ‘The impact of presumed consent legislation on cadaveric organ donation: A cross-country study’ (2006) 25 Journal of Health Economics 599, 600. See also Robert M Veatch and Lainie F Ross, Transplantation Ethics (Georgetown University Press, 2^nd ed, 2015) 154-159; and Harriet Etheredge, ‘Assessing Global Organ Donation Policies: Opt-In vs Opt-Out’ (2021) 14 Risk Management and Healthcare Policy 1985, 1986. Cf David Shaw, ‘Presumed consent to organ donation and the family overrule’ (2017) 18(2) Journal of the Intensive Care Society 96, 96.

^[26] Amber Rithalia et al, ‘Impact of presumed consent for organ donation rates: a systemic review’ (2009) 338 British Medical Journal 284, 287; McEwen (n 24) 246; Abadie (n 26) 599; Adam Ashrad et al, ‘Comparison of organ donation and transplantation rates between opt-out and opt-in systems’ (2019) 95 Kidney International 1453, 1454; and A Zúñiga-Fajuri, ‘Increasing organ donation by presumed consent and allocation priority: Chile’ (2015) 93(3) Bulletin of the World Health Organization 199, 199. See generally Karthik K Tennankore et al, ‘Perspectives on Opt-Out Versus Opt-In Legislation for Deceased Organ Donation: An Opinion Piece’ (2021) 8 Canadian Journal of Kidney Health and Disease 1, 2.

^[27] As of the 5^th of November 2021. IRODaT, ‘Donation Activity Charts’, Worldwide Actual Deceased Organs Donors 2019 (PMP) (Web Page, 2021) <https://www.irodat.org/?p=database#data>. See also Brian Willis and Muireann Quigley, ‘Opt-out organ donation: on evidence and public policy’ (2014) 107(2) Journal of The Royal Society of Medicine 56, 57; and Rithalia (n 27) 287.

^[28] Faunce (n 12) 590-591.

^[29] Think Nationally, Act Locally (n 4) 157.

^[30] See, eg, Think Nationally, Act Locally (n 4); Legislative Council Select Committee, Parliament of Tasmania, Organ Donation (Parliamentary Paper No 15, 2008) (‘Select Committee of Tasmania’); Review of Organ and Tissue Donation Procedures Select Committee, Parliament of Queensland, Organ and Tissue Donation: Report of the Review of Organ and Tissue Donation Procedures Select Committee (Parliamentary Paper No 52, October 2008) (‘Select Committee of Queensland’); Standing Committee on Uniform Legislation and Intergovernmental Agreements, Parliament of Western Australia, Organ Donation and Transplantation (Parliamentary Paper No 25, 2000) (‘Standing Committee of Western Australia’); and New South Wales Ministry of Health, Parliament of New South Wales, Increasing Organ Donation in NSW (Discussion Paper No 1, August 2012) (‘Increasing Organ Donation in NSW’).

^[31] Think Nationally, Act Locally (n 4) 157 (emphasis added). See also Compassion, Not Commerce (n 6) 44; and Ashrad (n 27) 1453.

^[32] Petru Cotrau et al, ‘Consent Model, Opt-in/Opt-out System, and Organ Donation Rates in European Union Countries’ (2019) 42(1) Applied Medical Informatics 36, 37.

^[33] Abadie (n 26) 600.

^[34] Willis (n 28) 57.

^[35] Kidney Health Australia, Kidney Health Australia Submission: Legislative Council Inquiry into Organ Donation in Victoria (Report, May 2011) 3.

^[36] Think Nationally, Act Locally (n 4) 157; and Etheredge (n 26) 1985.

^[37] Think Nationally, Act Locally (n 4) 15, 147 and 157 (emphasis added). See also Compassion, Not Commerce (n 6) 44.

^[38] Think Nationally, Act Locally (n 4) 15.

^[39] Organ and Tissue Authority 2019 Report (n 13) 2; Organ and Tissue Donation 2020 Report (n 13) 2. See also The Future of Organ Donation in Australia (n 3); and IRODaT (n 28).

^[40] McEwen (n 24) 246.

^[41] Australian and New Zealand Intensive Care Society, The Statement on Death and Organ Donation (Report Edition 4.1, 2021) 27 (‘The Statement on Death and Organ Donation’).

^[42] Melanie Miller, ‘A proposed solution to the present organ donation crisis based on a hard look at the past’ (1987) 75(1) Circulation 20, 20 and 21.

^[43] See generally Australian and New Zealand Organ Donation Registry, ANZOD Annual Report 2020 (Annual Report, January 2021); Services Australia, Australian Organ Donor Register Statistics (Annual Report No 1, 31 January 2021); Organ and Tissue Authority 2019 Report (n 13); Organ and Tissue Authority 2020 Report (n 13); and The Future of Organ Donation in Australia (n 3).

^[44] See Human Tissue Act 1983 (NSW); Human Tissue Act 1982 (Vic); Human Tissue Act 1985 (Tas); Human Tissue and Transplant Act 1982 (WA); Transplantation and Anatomy Act 1978 (ACT); Transplantation and Anatomy Act 1979 (Qld); Transplantation and Anatomy Act 1979 (NT); and Transplantation and Anatomy Act 1983 (SA).

^[45] See Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth).

^[46] See, eg, Organ Donation (Deemed Consent) Act 2019 (UK); and legislative devices underpinning the Organización Nacional de Trasplantes (National Transplant Organisation) in Spain.

^[47] Terry Hutchinson and Nigel Duncan, ‘Defining and Describing What We Do: Doctrinal Legal Research’ [2012] DeakinLawRw 4; (2012) 17(1) Deakin Law Review 83, 83.

^[48] Australian Law Reform Commission, Human Tissue Transplants (Report No 7, 30 June 1977) (‘Human Tissue Transplants’).

^[49] Ibid 50-60; and Mt Isa Mines v. Pusey (1971) 45 ALJR 88, 92. Cf P Devlin, Samples of Lawmaking (Oxford University Press, 1962) 102, 103.

^[50] See generally Transplantation and Anatomy Act 1978 (ACT); Human Tissue Act 1983 (NSW); Transplantation and Anatomy Act 1979 (NT); Transplantation and Anatomy Act 1979 (Qld); Transplantation and Anatomy Act 1983 (SA); Human Tissue Act 1985 (Tas); Human Tissue Act 1982 (Vic); and Human Tissue and Transplant Act 1982 (WA) (emphasis added).

^[51] Additionally, the Commonwealth lacks express power to regulate other areas of donation such as ‘donor conception’ – the process of conceiving a baby using donated sperm, eggs or embryos through self-insemination or IVF. Donor conception is outside the scope of this article. A point of entry for literature regarding this is: Senate Standing Committee on Legal and Constitutional Affairs, Parliament of Australia, Inquiry into donor conception in Australia (Final Report, 10 February 2011).

^[52] Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth) s 8.

^[53] Ibid ss 8(4) and 13A. Consistent with s 12 of the Public Governance, Performance and Accountability Act 2013 (Cth).

^[54] Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth) s 9(1).

^[55] The Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth), in effect from the 1^st of January 2009, establishes the Australian Organ and Tissue Donation and Transplantation Authority and the Australian Organ and Tissue Donation and Transplantation Board. It does not regulate organ and tissue donation and transplantation in Australia.

^[56] Transplantation and Anatomy Act 1978 (ACT) s 2; Human Tissue Act 1983 (NSW) s 4(1); Transplantation and Anatomy Act 1979 (NT) ss 4 and 6; Transplantation and Anatomy Act 1979 (Qld) s 4(1); Transplantation and Anatomy Act 1983 (SA) s 5(1); Human Tissue Act 1985 (Tas) s 3(1); Human Tissue Act 1982 (Vic) s 3(1); and Human Tissue and Transplant Act 1982 (WA) s 3(1).

^[57] LexisNexis, Halsbury’s Laws of Australia (online at 31 July 2021) Tissue Transplantation, ‘8 Definition of ‘tissue’’ [4510] (‘Halsbury’s Definition of Tissue’).

^[58] Ibid.

^[59] For example, in Re Denman [2004] 2 Qd R 595 (Atkinson J) the harvesting of sperm from a deceased male was permitted for reasons of inseminating the deceased’s wife. Cf Baker v Queensland [2003] QSC 2.

^[60] Transplantation and Anatomy Act 1978 (ACT) s 6; Human Tissue Act 1983 (NSW) s 6; Transplantation and Anatomy Act (NT) s 6; Transplantation and Anatomy Act 1979 (Qld) s 8; Transplantation and Anatomy Act 1983 (SA) s 7; Human Tissue Act 1985 (Tas) s 5; Human Tissue Act 1982 (Vic) s 5; and Human Tissue and Transplant Act 1982 (WA) s 6.

^[61] The Statement on Death and Organ Donation (n 42) 10.

^[62] Ibid 23.

^[63] Ibid 10.

^[64] Ibid 11.

^[65] Human Tissue Transplants (n 49).

^[66] Halsbury’s Definition of Tissue (n 58).

^[67] Human Tissue Transplants (n 49) 114.

^[68] Ibid 119.

^[69] The Statement on Death and Organ Donation (n 42) 13.

^[70] Transplantation and Anatomy Act 1978 (ACT) ss 30 and 45; Human Tissue Act 1983 (NSW) ss 26 and 33; Transplantation and Anatomy Act 1979 (NT) ss 21 and 23; Transplantation and Anatomy Act 1979 (Qld) s 45(1); Death (Definition) Act 1983 (SA) s 2; Human Tissue Act 1985 (Tas) ss 25A and 27A; and Human Tissue Act 1982 (Vic) ss 26(7) and 41. See generally The Statement on Death and Organ Donation (n 42).

^[71] The Transplantation Society of Australia and New Zealand, Clinical Guidelines for Organ Transplantation from Deceased Donors (Report, May 2021) 6 (‘Clinical Guidelines for Organ Transplantation from Deceased Donors’).

^[72] Ansett Australia Ltd v Dale [2001] NSWCA 314; (2001) 22 NSWCCR 527 (Davies AJA).

^[73] Standing Committee of Western Australia (n 31) 47.

^[74] The Statement on Death and Organ Donation (n 42) 12.

^[75] Transplantation and Anatomy Act 1978 (ACT) s 30(1); Human Tissue Act 1983 (NSW) s 26(1); Transplantation and Anatomy Act 1979 (NT) s 21(1); Transplantation and Anatomy Act 1983 (SA) s 24(2); Human Tissue Act 1985 (Tas) s 25A(1); Human Tissue Act 1982 (Vic) s 26(7)(b); and Human Tissue and Transplant Act 1982 (WA) s 24(2).

^[76] See generally Organ and Tissue Donation 2020 Report (n 13).

^[77] Transplantation and Anatomy Act 1979 (Qld) ss 45(1) and (2).

^[78] Halsbury’s Definition of Tissue (n 58) [280]. See Transplantation and Anatomy Act 1978 (ACT) s 30; Human Tissue Act 1983 (NSW) s 26(2)(b); Transplantation and Anatomy Act 1979 (NT) s 21(2); Transplantation and Anatomy Act 1979 (Qld) s 45(2); Human Tissue and Transplant Act 1982 (WA) s 24(2). See also The Statement on Death and Organ Donation (n 42) 12.

^[79] Transplantation and Anatomy Act 1978 (ACT) s 30.

^[80] Human Tissue Act 1983 (NSW) s 26(2)(b).

^[81] Transplantation and Anatomy Act 1979 (NT) s 21(2).

^[82] Transplantation and Anatomy Act 1979 (Qld) s 45(2).

^[83] Human Tissue and Transplant Act 1982 (WA) s 24(2).

^[84] Doodeward v Spence [1908] HCA 45; (1908) 6 CLR 406 differentiated between a cadaver in its natural state and a cadaver that has undergone some processing such as embalming (and by extension contemporary preservation techniques such as plastination and cryonics), discussed for example in Bonython, ‘Privacy, Personhood and Property in the Age of Genomics’ (n 6); and Bruce Baer Arnold, ‘Thawing Out Personhood, Unconscionability and Succession in Cryonics’ (2020) 17(1) Canberra Law Review 91.

^[85] See, eg, Calma v Sesar [1992] NTSC 17; (1992) 2 NTLR 37 (‘Calma’); and AW v CW [2002] NSWSC 301; (2002) 191 ALR 392, 19 (Barret J).

^[86] Walworth v Holt (1841) 4 My & Cr 619, 681 (Lord Cottenham).

^[87] Calma (n 86) 9 (Martin J) (emphasis added) citing Robertson v Pinegrove Memorial Park Limited (1986) ACLD 498 (Waddel J).

^[88] Crimes Act 1900 (ACT) s 48; Criminal Code 1900 (NT) s 140(b); Crimes Act 1900 (NSW) s 81C; Criminal Code 1899 (Qld) s 236(b); Criminal Code 1924 (Tas) s 139(b); Crimes Act 1958 (Vic) s 34B; and Criminal Code 1913 (WA) s 214(2). This view was also taken in Devlin (n 50) 83-103; and Lord Justice Edmund Davies, ‘A Legal Look at Transplants’ (1969) 62 Proceedings of the Royal Society of Medicine 633.

^[89] See generally Transplantation and Anatomy Act 1978 (ACT); Human Tissue Act 1983 (NSW); Transplantation and Anatomy Act 1979 (NT); Transplantation and Anatomy Act 1979 (Qld); Transplantation and Anatomy Act 1983 (SA); Human Tissue Act 1985 (Tas); Human Tissue Act 1982 (Vic); and Human Tissue and Transplant Act 1982 (WA).

^[90] Section 22(5) of the Transplantation and Anatomy Act 1979 (Qld) states that a person may, during his or her lifetime, give written consent (or consent through the AODR) to the removal of tissue after his or her death. In contrast, the remaining jurisdictions require potential donors to register their intent to donate with the Australian Organ Donor Register (AODR).

^[91] Transplantation and Anatomy Act 1978 (ACT) s 27(1); Human Tissue Act 1983 (NSW) s 23(1); Transplantation and Anatomy Act 1979 (NT) s 18(1)(a); Transplantation and Anatomy Act 1983 (SA) s 21(2); Human Tissue Act 1985 (Tas) s 23(1); Human Tissue Act 1982 (Vic) s 26(1)(c); and Human Tissue and Transplant Act 1982 (WA) s 22(2)(a).

^[92] ‘Senior available next of kin’ is defined by state and territory legislation under the following sections: Transplantation and Anatomy Act 1978 (ACT) s 2 (dictionary); Human Tissue Act 1983 (NSW) s 4(1); Transplantation and Anatomy Act 1979 (NT) s 4; Transplantation and Anatomy Act 1979 (Qld) s 4(1); Transplantation and Anatomy Act 1983 (SA) s 5(1); Human Tissue Act 1985 (Tas) s 3(1); Human Tissue Act 1982 (Vic) s 3(1); and Human Tissue and Transplant Act 1982 (WA) s 3(1).

^[93] Transplantation and Anatomy Act 1978 (ACT) s 27(2); Human Tissue Act 1983 (NSW) s 23(3); Transplantation and Anatomy Act 1979 (NT) s 18(1)(b); Transplantation and Anatomy Act 1979 (Qld) ss 22(1) and 22(2); Transplantation and Anatomy Act 1983 (SA) s 21(3); Human Tissue Act 1985 (Tas) s 23(2); Human Tissue Act 1982 (Vic) s 26(1); and Human Tissue and Transplant Act 1982 (WA) s 22(2)(b).

^[94] ‘Next of kin’ used in place of ‘senior available next of kin’. Refer to footnote (n 93) for definitions of ‘senior next of kin’.

^[95] Transplantation and Anatomy Act 1978 (ACT) s 27(3); Transplantation and Anatomy Act 1979 (NT) s 18(1)(b)(ii); Transplantation and Anatomy Act 1983 (SA) s 21(3)(d); and Human Tissue Act 1982 (Vic) s 26(1)(e).

^[96] Bhatia (n 2) 946-947; and Select Committee of Tasmania (n 31) 9.

^[97] Select Committee of Tasmania (n 31); Bernadette Richards and Wendy A Rogers, ‘Organ donation after cardiac death: legal and ethical justifications for antemortem intervention’ (2007) 187(3) Medical Journal of Australia 168, 168; and ANZOD Registry, Section 3: Deceased Organ Donation Pathway (Annual Report, 2018) 3 (‘ANZOD Section 3: Deceased Organ Donation Pathway 2018’).

^[98] ANZOD Section 3: Deceased Organ Donation Pathway 2018 (n 98) 3.

^[99] The Organ and Tissue Authority, Review of the Australian organ donation, retrieval and transplantation system (Final Report, Department of Health, 12 December 2018) 43 (‘Review of the Australian organ donation, retrieval and transplantation system’).

^[100] Australian Government Services Australia, ‘How to register’, Australian Organ Donor Register (Web Page, August 2021) <https://www.servicesaustralia.gov.au/individuals/services/medicare/australian-organ-donor-register/how-register>.

^[101] Review of the Australian organ donation, retrieval and transplantation system (n 100) 43.

^[102] Ibid.

^[103] Philip Hamilton, ‘Australian Organ and Tissue Donation and Transplantation Authority Amendment (Governance and Other Measures) Bill 2021’ (Flagpost, Parliamentary Library, Parliament of Australia, 8 July 2021).

^[104] Consistent with the requirements of s 12 of the Public Governance, Performance and Accountability Act 2013 (Cth).

^[105] Hamilton (n 104).

^[106] Australian Organ and Tissue Donation and Transplantation Authority Amendment (Governance and Other Measures) Bill 2021 (Cth) sch 1 item 12 and 18.

^[107] Ibid item 24.

^[108] See generally Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth).

^[109] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 1. See also Mandeep R Mehra et al, ‘Listing Criteria for Heart Transplantation: International Society for Heart and Lung Transplantation Guidelines for the Care of Cardiac Transplant Candidates – 2006’ (2006) 25(9) The Journal of Heart and Lung Transplantation 1024, 1030.

^[110] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) vii.

^[111] Ibid. See also A G Ross Sheil and Bruce M Hall, ‘The History of the Transplantation Society of Australia and New Zealand’ in Brian D Tait (ed), More Than A Footnote: The Story of Organ Transplantation in Australia and New Zealand (Australian Scholarly Publishing, 2012) 493.

^[112] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) vii (emphasis added).

^[113] National Health and Medical Research Council, Australian Government, Ethical guidelines for organ transplantation from deceased donors (Report, April 2016) 1 (‘Ethical guidelines for organ transplantation from deceased donors’).

^[114] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 1. Despite calling for ‘suitably experienced’ transplant surgeons and physicians, TSANZ’s clinical guidelines do not define suitable experience.

^[115] Ibid.

^[116] Ibid 64.

^[117] This article does not engage with ‘organ-specific criteria’. They are beyond the scope of this article’s research. Points of entry for organ-specific criteria can be found at: Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 48-117.

^[118] Ethical guidelines for organ transplantation from deceased donors (n 114) 1.

^[119] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 1 and 2.

^[120] Blanche C et al, ‘Heart transplantation in patients seventy years of age and older: a comparative analysis of outcome’ (2001) 121 Journal of Thoracic Cardiovascular Surgery 532, 532-541; Mehra (n 110) 1030; Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 1; and Steven Ivulich and Gregory Snell, ‘Long-term management of elderly patients taking immune suppressive medications’ (2020) 49(3) Clinical 100, 100.

^[121] Mehra (n 110) 1030 citing Bull DA et al, ‘Long-term results of cardiac transplantation in patients older than sixty years’ (1996) 111 Journal of Thoracic Cardiovascular Surgery 423; and Borkon AM et al, ‘An Analysis of the effect of age on survival after heart transplant’ (1999) 18 Journal of Heart Lung Transplants 668, 668-674.

^[122] Jose M Valderas et al, ‘Defining Comorbidity: Implications for Understanding Health and Health Services’ (2009) 7(4) Analysis of Family Medicine 357, 357.

^[123] Ibid.

^[124] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 2.

^[125] Randall Sung et al, ‘Excess Risk of Renal Allograft Loss Associated with Cigarette Smoking’ (2001) 71(12) Transplantation 1752, 1752-1757; and P Botha et al, ‘Smoking after cardiac transplantation’ (2008) 8(4) American Journal of Transplantation 886, 886.

^[126] Mary Amanda Dew et al, ‘Meta-Analysis of Risk for Relapse to Substance Use After Transplantation of the Liver or Other Solid Organs’ (2010) 14(2) Liver Transplantation 159, 159-172.

^[127] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 3.

^[128] Ibid. TSANZ does not define ‘screening tests’ in this instance. However, it may be assumed that any relevant screening tests undertaken are chosen by members of the relevant multidisciplinary transplant unit on a case-by-case basis.

^[129] D Telles-Correia et al, ‘Adherence Correlates in Liver Transplant Candidates’ (2009) 5 Transplant Proceedings 1731, 1731 citing G L Lisson et al, ‘A brief psychological intervention to improve adherence following transplantation’ (2005) 10 Analysis of Transplantation 52, 52- 57.

^[130] Telles-Correia (n 130) 1731.

^[131] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 2; Telles-Correia (n 130) 1731 citing R M Bunzel and Laederach-Hofmann, ‘Solid organ transplantation: are there predictors for posttransplant noncompliance?: A literature overview’ (2000) 70 Transplantation 711, 711-716; B Bush, ‘Psychological, emotional, and neurological factors influencing compliance and liver transplantation outcomes’ (2004) 9 Current Opinion in Organ Transplantation 104, 104; D Telles-Correia et al, ‘Validation of multidimensional adherence questionnaire for liver transplanted patients (MAQ)’ (2008) 21 Acta Médica Portuguesa 31, 31; and D Telles-Correia et al, ‘Psychiatric approach of liver transplantation’ (2006) 19 Acta Médica Portuguesa 165, 165.

^[132] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 3.

^[133] Ibid.

^[134] Ibid 3 and 4; and Ethical guidelines for organ transplantation from deceased donors (n 114) 5.

^[135] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 3 and 4.

^[136] Ibid.

^[137] Ibid 4.

^[138] See generally Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479 (‘Rogers’).

^[139] Ethical guidelines for organ transplantation from deceased donors (n 114) iv.

^[140] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 2 (emphasis added).

^[141] Rogers (n 139) 490 (cf the standard applied in Bolam v Friern Hospital Management Committee (1957) 1 WLR 582).

^[142] Australian Law Reform Commission, Equality, Capacity and Disability in Commonwealth laws: Informed Consent to Medical Treatment (Discussion Paper No 81, 20 May 2014) (‘Equality, Capacity and Disability in Commonwealth laws’); Bernadette Richards, ‘Informed Choice, Not Informed Consent: Towards a meaningful consideration of pre-treatment advice’ (PhD Thesis, University of Adelaide, 2012) 96; Loane Skene and Richard Smallwood, ‘Informed consent: lessons from Australia’ (2002) 324 British Medical Journal 39, 39; and Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 2.

^[143] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 2; and Equality, Capacity and Disability in Commonwealth Laws (n 143) 228-234.

^[144] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 2 (emphasis added).

^[145] Ibid (emphasis added).

^[146] Entry points for literature discussing the use of HBV- and HCV- positive organs can be found at: Danae Bixler et al, ‘Hepatitis B and C virus infections transmitted through organ transplantation investigated by CDC, United Stated, 2014-2017’ (2019) 19(9) American Journal of Transplantation 2570; Meghan Sise et al, ‘Balancing the risk and rewards of utilizing organs from Hepatitis C viraemic donors’ (2019) 24(3) Current Opinion Organ Transplant 351; and Kelley Weinfurtner and K Reddy, ‘Hepatitis C viraemic organs in solid organ transplantation’ (2021) 74(3) Journal of Hepatology 716.

^[147] TSANZ indicates that HIV-positive organs may be used in ‘exceptional circumstances’, such as in the case of ‘life-preserving donations’. See generally Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 22, 51 and 52.

^[148] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 13.

^[149] Ibid 8.

^[150] Ibid 2.

^[151] Ethical guidelines for organ transplantation from deceased donors (n 114) 14.

^[152] Ibid iv.

^[153] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 8.

^[154] Ethical guidelines for organ transplantation from deceased donors (n 114) 2.

^[155] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 2.

^[156] Ethical guidelines for organ transplantation from deceased donors (n 114) 2.

^[157] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 8.

^[158] The Statement on Death and Organ Donation (n 42) 10.

^[159] See generally Human Tissue Transplants (n 49).

^[160] The Statement on Death and Organ Donation (n 42).

^[161] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 6 (emphasis added).

^[162] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 6.

^[163] Ibid.

^[164] Calculated using data extracted from Organ and Tissue Authority 2019 Report (n 13); and Organ and Tissue Donation 2020 Report (n 13).

^[165] See generally the discussion in Human Tissue Transplants (n 49) under Part II.

^[166] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 7.

^[167] The Organ and Tissue Authority, National Protocol for Donation after Cardiac Death (Report No 1, 2010) 10-13 (currently under review as of 3 August 2021); and Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 7.

^[168] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 7 citing ANZOD Section 3: Deceased Organ Donation Pathway 2018 (n 98).

^[169] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 7 citing ANZOD Registry, Section 2: Deceased Organ Donation (Annual Report, 2018).

^[170] Calculated using data extracted from Organ and Tissue Authority 2019 Report (n 13) 2; and Organ and Tissue Donation 2020 Report (n 13) 2.

^[171] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 8; and M Green et al, ‘Donor-derived transmission events in 2013: a report of the Organ Procurement Transplant Network Ad Hoc Disease Transmission Advisory Committee’ (2015) 99(2) Transplant 282, 282-287.

^[172] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 37. Diseases cited include Ornithine transcarbamylase (OTC) deficiency, Alpha-1-antitrypsin deficiency, Marfan syndrome, diabetes, hypertension, and other cardiovascular diseases.

^[173] Points of entry for literature discussing the impacts of donor drug use on transplantation outcomes include: Shih-jui Lin et al, ‘Effect of Donors’ Intravenous Drug Use, Cigarette Smoking, and Alcohol Dependence on Kidney Transplant Outcome’ (2005) 80(4) Transplantation 482; Guy MacGowan et al, ‘Effects of drug abuse, smoking and alcohol on donor hearts and lungs’ (2019) 32 Transplant International 1019; and David Baran et al, ‘Intoxicated Donors and Heart Transplant Outcomes’ (2021) 14 Circulatory Heart Failure 849.

^[174] Points of entry for literature discussing the use of malignant donor organs for transplantation, and the inherent risks, include: Shanzhou Huang et al, ‘Outcomes of Organ Transplantation from Donors with a Cancer History’ (2018) 24 Medical Science Monitor 997; I Penn, ‘Transmission of cancer from organ donors’ (1995) 15(3) Nefrologia 205; M A Nalesnik et al, ‘Donor-Transmitted Malignancies in Organ Transplantation: Assessment of Clinical Risk’ (2011) 11(6) American Journal of Transplantation 1140; Sheng Zhang et al, ‘Organ transplantation from donors (cadaveric or living) with a history of malignancy: Review of the literature’ (2014) 28(4) Transplantation Reviews 169; and Rajeev Desai et al, ‘Cancer Transmission From Organ Donors – Unavoidable But Low Risk’ (2012) 94(12) Transplantation Journal 1200.

^[175] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 16.

^[176] A point of entry for literature discussing the ethical implications of using HIV-positive donor organs, and the inherent risks, can be found at: Bram Wispelwey et al, ‘The transplantation of solid organs from HIV-positive donors to HIV-negative recipients: ethical implications’ (2015) 41 Journal of Medical Ethics 367.

^[177] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 9.

^[178] In 2020, Australia’s organ donation and transplantation rates dropped due to the emergence of COVID-19. Challenges including COVID-19 restrictions (such as border closures and flight reductions) negatively affected the donation and transplantation sector. See Organ and Tissue Donation 2020 Report (n 13) 1 and 2.

^[179] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 16.

^[180] Ibid citing Enver Akalin et al, ‘Covid-19 and Kidney Transplantation’ (2020) 25 The New England Journal of Medicine 2475, 2475.

^[181] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 16.

^[182] Ibid.

^[183] Ibid 17.

^[184] Ibid 10.

^[185] Ibid 2.

^[186] Ibid 10.

^[187] Ibid.

^[188] Ibid.

^[189] Ethical guidelines for organ transplantation from deceased donors (n 114) 4.

^[190] Ibid.

^[191] Ibid v (emphasis added).

^[192] Ibid.

^[193] Ibid.

^[194] Ibid 5.

^[195] Ibid.

^[196] World Health Organisation, Guiding Principles on Human Cell, Tissue and Organ Transplantation, World Health Assembly Res, 63^rd mtg, WHO Doc WHO/C/RES/Summary (November 2010) (‘Guiding Principles on Human Cell, Tissue and Organ Transplantation’).

^[197] Ethical guidelines for organ transplantation from deceased donors (n 114) 5.

^[198] Committee on Economic, Social and Cultural Rights, General Comment No. 14: Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights, ESC D, 22^nd sess, Agenda Item 3, UN Doc E/C. 12/2000/4 (11 August 2000) para 2 (‘Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights’); and International Covenant on Economic, Social and Cultural Rights, Australia, signed 18 December 1972, ATS 5 (entered into force 10 March 1976) art 12(2)(d) (‘ICESCR’).

^[199] Participants in the International Summit on Transplant Tourism and Organ Trafficking Convened by the Transplantation Society and International Society of Nephrology in Istanbul, Turkey, ‘The Declaration of Istanbul on Organ Trafficking and Transplant Tourism’ (2008) 3(5) Clinical Journal of American Society of Nephrology 1227.

^[200] The Statement on Death and Organ Donation (n 42) 27.

^[201] Ethical guidelines for organ transplantation from deceased donors (n 114) 6.

^[202] William J Fitzpatrick, ‘Human altruism, evolution and moral philosophy’ (2017) 4 Royal Society Open Science 1, 1.

^[203] Ethical guidelines for organ transplantation from deceased donors (n 114) 6.

^[204] Pradeep Kumar Prabhu, ‘Is Presumed Consent an Ethically acceptable way of obtaining organs for transplant?’ (2019) 20(2) Journal of Intensive Care Society 92, 94 quoting B Farsides, ‘Respecting wishes and avoiding conflict: understanding the ethical basis for organ donation and retrieval’ (2012) 108(1) British Journal of Anaesthesia 73, 74; and Pope Benedict XVI, ‘A unique testimony of charity’ (Speech, Vatican City, November 7, 2008).

^[205] Prabhu (n 205) 92; and Guiding Principles on Human Cell, Tissue and Organ Transplantation (n 197). Cf Richard Titmuss, The Gift Relationship, From Human Blood to Social Policy (Allen & Unwin, 1971); and Iain McLean and Jo Poulton, ‘Good Blood, Bad Blood, and the Market: The Gift Relationship Revisited’ (1986) 6(4) Journal of Public Policy 431.

^[206] Ethical guidelines for organ transplantation from deceased donors (n 114) 6.

^[207] Ibid.

^[208] Ibid.

^[209] Bioethics regarding organ rationing is outside the scope of this article. Points of entry for organ rationing can be found at these sources: James Neuberger, ‘Brining Rationality to Rationing? – The Challenges of Organ Allocation’ (2016) 100(4) Transplantation 708; James Neuberger, ‘Rationing life-saving resources – how should allocation policies be assessed in solid organ transplantation?’ (2011) 25(1) Transplant International 3; Allison Tong et al, ‘Rationing scarce organs for transplantation: healthcare provider perspectives on wait-listing and organ allocation’ (2013) 27(1) Clinical Transplantation 60; and A L Caplan, ‘Organ transplant rationing: a window to the future?’ (1987) 68(5) Health Program 40.

^[210] Ethical guidelines for organ transplantation from deceased donors (n 114) 6.

^[211] Ibid.

^[212] Ibid 6 and 7.

^[213] Discussions regarding a patient’s capacity to provide consent is outside the scope of this article. Points of entry for this can be found at: Equality, Capacity and Disability in Commonwealth Laws (n 143); Willi Horner-Johnson and Danielle Bailey, ‘Assessing Understanding and Obtaining Consent from Adults with Intellectual Disabilities for a Health Promotion Study’ (2013) 10(3) Journal of Policy and Practice in Intellectual Disabilities 260; and Lesley Goldsmith et al, ‘Informed consent to healthcare interventions in people with learning disabilities’ (2008) 64(6) Journal of Advanced Nursing 549.

^[214] Ethical guidelines for organ transplantation from deceased donors (n 114) 6 and 7.

^[215] Ibid 7.

^[216] Ibid.

^[217] Ibid.

^[218] Ibid.

^[219] Ivulich (n 121) discusses several conventional immunosuppressants used to prevent organ rejection, and the ‘unique challenges’ presented by their use in patients over 65. This is of relevance to the age exclusion criteria in the clinical guidelines discussed in Part II.

^[220] Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights (n 199) para 2; and ICESCR (n 199). See also John Tobin, The Right to Health in International Law (Oxford University Press, 2012).

^[221] ICESCR (n 199); and Attorney-General’s Department, ‘Right to Health’ Public sector guidance sheet (Web Page, 2021) < https://www.ag.gov.au/rights-and-protections/human-rights-and-anti-discrimination/human-rights-scrutiny/public-sector-guidance-sheets/right-health> (‘AG: Right to Health’).

^[222] Ethical guidelines for organ transplantation from deceased donors (n 114) 4; and Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights (n 199) para 2.

^[223] AG: Right to Health (n 222).

^[224] António Guterres, The Highest Aspiration: A Call to Action for Human Rights, UN Doc (24 February 2020) 1 <https://www.un.org/sg/sites/www.un.org.sg/files/atoms/files/The_Highest_Asperation_A_Call_To_Action_For_Human_Right_English.pdf>; and Merriam-Webster, (online at 1 May 2021) ‘aspiration’ (def 1(a)) <https://www.merriam-webster.com/dictionary/aspiration>.

^[225] Guterres (n 225) 1; and Merriam-Webster (n 225).

^[226] Etheredge (n 26) 1988.

^[227] W Glannon, ‘Do the sick have a right to cadaveric organs?’ (2003) 29 Journal of Medical Ethical 153, 153.

^[228] Points of entry regarding the right to cadaveric organs for transplantation can be found at: Glannon (n 228); Judit Sándor, ‘Right to Health and the Human Organ: Right as Consequence?’ (2014) 5(2) Pravni Zapisi 384; Aparna R Dalal, ‘Philosophy of organ donation: review of ethical facets’ (2015) 5(2) World Journal of Transplantation 44; Jordan Miller et al, ‘‘If I donate my organs it’s a gift, if you take them it’s theft’: a qualitative study of planned donor decisions under opt-out legislation’ (2019) 19 BMC Public Health 1; and Jalal M Cartwright-Shamoon, ‘Human Rights and Presumed Consent for Organ Donation in the UK’ (2008) 77(3) Ulster Medical Journal 206.

^[229] See generally Organ and Tissue Authority 2019 Report (n 13); Organ and Tissue Authority 2020 Report (n 13); and IRODaT (n 28).

^[230] Think Nationally, Act Locally (n 4) 11 and 16.

^[231] Ibid 32.

^[232] Ibid 11. See also Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth) s 8.

^[233] Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth) ss 8 and 13A.

^[234] Ibid.

^[235] The Organ and Tissue Authority, Final Report: Analysis of the Australian tissue sector (Final Report, November 2016) 39 (‘Analysis of the Australian tissue sector’).

^[236] Ibid.

^[237] Ibid 40.

^[238] The Future of Organ Donation in Australia (n 3); Think Nationally, Act Locally (n 4) 11 and 16; and Analysis of the Australian tissue sector (n 236) vi.

^[239] Analysis of the Australian tissue sector (n 236) 39.

^[240] Ibid 41.

^[241] Ibid.

^[242] Ibid.

^[243] Ibid.

^[244] Analysis of the Australian tissue sector (n 236) 42.

^[245] The Future of Organ Donation in Australia (n 3) (emphasis added).

^[246] Review of the Australian organ donation, retrieval and transplantation system (n 100) 71.

^[247] The Future of Organ Donation in Australia (n 3).

^[248] Bhatia (n 2) 946-947.

^[249] Transplantation and Anatomy Act 1978 (ACT) s 27(1); Human Tissue Act 1983 (NSW) s 23(1); Transplantation and Anatomy Act 1979 (NT) s 18(1)(a); Transplantation and Anatomy Act 1983 (SA) s 21(2); Human Tissue Act 1985 (Tas) s 23(1); Human Tissue Act 1982 (Vic) s 26(1)(c); and Human Tissue and Transplant Act 1982 (WA) s 22(2)(a).

^[250] Review of the Australian organ donation, retrieval and transplantation system (n 100) 102 citing Australian Health Ministers’ Conference, ‘Transplant donor’s wishes to prevail: joint communique’ (Media Release, 27 January 2005) 1.

^[251] Australian Government Services Australia, AODR Intent registrations 2021 (Annual Report, No 1, 2021) <https://www.servicesaustralia.gov.au/organisations/about-us/statistical-information-and-data/medicare-statistics/australian-organ-donor-register-statistics/australian-organ-donor-register> (‘AODR Intent registrations 2021’); Australian Government Services Australia, AODR Intent registrations 2020 (Annual Report, No 1, 2020) <https://www.servicesaustralia.gov.au/organisations/about-us/statistical-information-and-data/medicare-statistics/australian-organ-donor-register-statistics/australian-organ-donor-register> (‘AODR Intent registrations 2020’); and Australian Government Services Australia, AODR Intent registrations 2019 (Annual Report, No 1, 2019) <https://www.servicesaustralia.gov.au/organisations/about-us/statistical-information-and-data/medicare-statistics/australian-organ-donor-register-statistics/australian-organ-donor-register> (‘AODR Intent registrations 2019’).

^[252] AODR Intent registrations 2021 (n 252); AODR Intent registrations 2020 (n 252); and AODR Intent registrations 2019 (n 252).

^[253] Review of the Australian organ donation, retrieval and transplantation system (n 100).

^[254] Ibid 102.

^[255] Ibid (emphasis added).

^[256] Ibid.

^[257] Organ and Tissue Donation 2020 Report (n 13) 7.

^[258] Ibid.

^[259] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 1; Review of the Australian organ donation, retrieval and transplantation system (n 100) 99; and Mehra (n 110) 1030.

^[260] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) vii.

^[261] Review of the Australian organ donation, retrieval and transplantation system (n 100) 99.

^[262] Ibid.

^[263] ANZOD Registry, Section 3: Deceased Organ Donation Pathway (Annual Report, 2019) 7 (‘ANZOD Section 3: Deceased Organ Donation Pathway 2019’); ANZOD Registry, Section 3: Deceased Organ Donation Pathway (Annual Report, 2020) 7 (‘ANZOD Section 3: Deceased Organ Donation Pathway 2020’); and ANZOD Registry, Section 3: Deceased Organ Donation Pathway (Annual Report, 2021) 7 (‘ANZOD Section 3: Deceased Organ Donation Pathway 2021’).

^[264] ANZOD Section 3: Deceased Organ Donation Pathway 2019 (n 264) 7; ANZOD Section 3: Deceased Organ Donation Pathway 2020 (n 264) 7; and ANZOD Section 3: Deceased Organ Donation Pathway 2021 (n 264) 7.

^[265] ANZOD Section 3: Deceased Organ Donation Pathway 2019 (n 264) 7; ANZOD Section 3: Deceased Organ Donation Pathway 2020 (n 264) 7; and ANZOD Section 3: Deceased Organ Donation Pathway 2021 (n 264) 7.

^[266] Review of the Australian organ donation, retrieval and transplantation system (n 100) 100.

^[267] Ibid (emphasis added).

^[268] Ibid 99.

^[269] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) 13.

^[270] Review of the Australian organ donation, retrieval and transplantation system (n 100) 100.

^[271] Ibid 99.

^[272] Ibid.

^[273] Clinical Guidelines for Organ Transplantation from Deceased Donors (n 72) vii; and Analysis of the Australian tissue sector (n 236) iv.

^[274] Bhatia (n 2) 946-947; Select Committee of Tasmania (n 31) 9; Queensland Bioethics Centre, Submission No 006 to Review of Organ and Tissue Donation Procedures Select Committee, Parliament of Queensland, Organ and Tissue Donation: Report of the Review of Organ and Tissue Donation Procedures Select Committee (20 July 2008) 1; and Australian Medical Students Association, Policy Document Organ and Tissue Donation (Policy Document, 2019) 1.

^[275] Organ and Tissue Donation After Death, For Transplantation (n 2) 32 (emphasis added).

^[276] Transplantation and Anatomy Act 1978 (ACT) s 27(1); Human Tissue Act 1983 (NSW) s 23(1); Transplantation and Anatomy Act 1979 (NT) s 18(1)(a); Transplantation and Anatomy Act 1983 (SA) s 21(2); Human Tissue Act 1985 (Tas) s 23(1); Human Tissue Act 1982 (Vic) s 26(1)(c); and Human Tissue and Transplant Act 1982 (WA) s 22(2)(a). Cf Queensland statute which states under s 22(5) of the Transplantation and Anatomy Act 1979 (Qld) that a person may, during his or her lifetime, give written consent to the removal of tissue after his or her death.

^[277] Ethical guidelines for organ transplantation from deceased donors (n 114) 6.

^[278] Transplant Australia, Submission No 034 to Review of Organ and Tissue Donation Procedures Select Committee, Parliament of Queensland, Organ and Tissue Donation: Report of the Review of Organ and Tissue Donation Procedures Select Committee (14 August 2008) 2.

^[279] Faunce (n 12) 590 and 591.

^[280] Organ and Tissue Authority 2019 Report (n 13) 2; Organ and Tissue Donation 2020 Report (n 13) 2; and Steiner (n 13) 155-156.

^[281] Organ and Tissue Authority 2019 Report (n 13) 2; Organ and Tissue Donation 2020 Report (n 13) 2; and Steiner (n 13) 155-156.

^[282] McEwen (n 24) 246.

^[283] Select Committee of Tasmania (n 31) 14 (emphasis added).

^[284] Abadie (n 26) 600.

^[285] As of the 5^th of November 2021. See generally IRODaT (n 28); and Willis (n 28) 57 quoting Rithalia (n 27) 287.

^[286] Luc Delriviere et al, ‘Adopting an opt-out registration system for organ and tissue donation in Western Australia’ (Research Paper, Parliamentary Library, Parliament of Western Australia, February 2011) 15 citing Joseph L Verheijde et al, ‘Enforcement of presumed-consent policy and willingness to donate organs as identified in the European Union Survey: the role of legislation in reinforcing ideology in pluralistic societies’ (2009) 90(1) Health Policy 26, 26-30; and Queensland Bone Bank and Queensland Skin Bank, Submission No 024 to Review of Organ and Tissue Donation Procedures Select Committee, Parliament of Queensland, Organ and Tissue Donation: Report of the Review of Organ and Tissue Donation Procedures Select Committee (August 2008) 1.

^[287] As of the 5^th of November 2021. See generally IRODaT (n 28); and Willis (n 28) 57 quoting Rithalia (n 27) 287.

^[288] Faunce (n 12) 590 and 591.

^[289] Bhatia (n 2) 954.

^[290] Select Committee of Tasmania (n 31) 17 citing Matthew Jose, Submission No 12 to Legislative Council Select Committee, Parliament of Tasmania, Organ Donation (1 October 2007) 1.

^[291] Think Nationally, Act Locally (n 4) 27; and The Future of Organ Donation in Australia (n 3).

^[292] The Future of Organ Donation in Australia (n 3).

^[293] Think Nationally, Act Locally (n 4) 15.

^[294] Think Nationally, Act Locally (n 4) 157 (emphasis added).

^[295] Ibid 15.

^[296] See generally Select Committee of Tasmania (n 31); Select Committee of Queensland (n 31); Standing Committee of Western Australia (n 31); and Increasing Organ Donation in NSW (n 31).

^[297] Select Committee of Tasmania (n 31) 4; Select Committee of Queensland (n 31) 11; and Increasing Organ Donation in NSW (n 31) 27.

^[298] Select Committee of Queensland (n 31) 11, 17 and 43 (emphasis added). See also Etheredge (n 26) 1988.

^[299] Willis (n 28) 57.

^[300] Increasing Organ Donation in NSW (n 31) 29; and Willis (n 28) 57 quoting Rithalia (n 27) 287 (emphasis added).

^[301] Select Committee of Tasmania (n 31) 16.

^[302] Organización Nacional de Trasplantes, ‘Legislación Básica’, Información Especializada (Web page, 2021) <http://www.ont.es/infesp/Paginas/LegislacionBasica.aspx> (emphasis added); Willis (n 28) 57; and R Matesanz, ‘A decade of continuous improvement in cadaveric organ donation: the Spanish model’ (2001) 21(5) Nerfología 59, 59.

^[303] Chris J Rudge, ‘Organ Donation: opting in or opting out?’ (2018) 68 British Journal of General Practice 62, 62 (emphasis added). See also Increasing Organ Donation in NSW (n 31) 29; Select Committee of Tasmania (n 31) 16; and Willis (n 28) 57.

^[304] Willis (n 28) 57.

^[305] Select Committee of Queensland (n 31) 38.

^[306] Willis (n 28) 57.

^[307] Select Committee of Queensland (n 31) 39 and 41.

^[308] Prabhu (n 205) 92 citing Benedict (n 205).

^[309] Prabhu (n 205) 92; and Monks of Solesmes, The Human Body: Papal Teaching (St. Paul Editions, 1960) 55 citing Pius XII, ‘Allocution to a group of eye specialises’ (Speech, Vatican City, May 14 1956).

^[310] Select Committee of Queensland (n 31) 49; Standing Committee of Western Australia (n 31) 29; and Prabhu (n 205) 96.

^[311] Prabhu (n 205) 96. See also Etheredge (n 26) 1988 citing Haoyang Yan and J Frank Yates, ‘Improving acceptability of nudges: Learning from attitudes towards opt-in and opt-out policies’ (2019) 14(1) Judgement and Decision Making 26, 29.

^[312] Prabhu (n 205) 94 citing Robert M Veatch and J B Pitt, ‘The myth of presumed consent: ethical problems in organ procurement strategies’ (1995) 27(2) Transplantation Proceedings 888, 892.

^[313] Review of the Australian organ donation, retrieval and transplantation system (n 100) 8.

^[314] Review of the Australian organ donation, retrieval and transplantation system (n 100) 10-18.

^[315] See, eg, Donna Simmers, Submission No 004 to Review of Organ and Tissue Donation Procedures Select Committee, Parliament of Queensland, Review of Organ and Tissue Donation Procedures (20 July 2008) 1.

^[316] Rudge (n 304) 62.

^[317] Select Committee of Queensland (n 31) 11, 17 and 43 (emphasis added).

^[318] Willis (n 28) 57.

^[319] Ibid.

^[320] Think Nationally, Act Locally (n 4) 150.

^[321] Analysis of the Australian tissue sector (n 236) 39.

^[322] Think Nationally, Act Locally (n 4) 150.

^[323] Think Nationally, Act Locally (n 4) 150.

^[324] Ibid 120.

^[325] Select Committee of Queensland (n 31) 38.

^[326] Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Cth) s 11(1).

^[327] Review of the Australian organ donation, retrieval and transplantation system (n 100) 71.

^[328] See generally Australian Law Reform Commission Act 1996 (Cth); Australian Law Reform Commission, Law Reform Process (Government Web Page, August 2021) <https://www.alrc.gov.au/about/law-reform-process/> (‘Law Reform Process’); and Jacqueline Lipton et al, ‘Responsible Government, Representative Democracy and the Senate: Options for Reform’ [1997] UQLawJl 2; (1997) 19(2) The University of Queensland Law Journal 194, 194 and 195.

^[329] Law Reform Process (n 329).

^[330] Ibid.

^[331] Ibid.

^[332] Delriviere (n 287) 25.