Organ and tissue donation is a consideration which often arises at the end of life, both for people who are dying and their families. In some cases donation of organs and tissue may be relatively straightforward, and a person with capacity may specify their wishes in relation to donation. In other cases however, particularly where the person who is dying has impaired capacity, or where the potential donor has already died, the situation becomes more legally and ethically complex. Some people find that while it is generally easy to support the idea of organ and tissue donation, it becomes more difficult when confronted with a request to consent to the donation of a deceased family member’s organs.
This webpage explores the law relating to organ and tissue donation from deceased donors. Donation by living donors is not discussed here, however further information about living donation is available at from the National Health and Medical Research Council or the DonateLife Network, the lead Australian Government body for organ and tissue donation.
Key legislation and terminology
In Australia organ and tissue donation is governed by the Human Tissue Act in each Australian State and Territory. These Acts are very similar in each jurisdiction.
Organ and tissue donation is also governed by guidelines issued by the National Health and Medical Research Council (NHMRC) which outline ethical standards for donation, and their implications for clinical practice. Two guidelines of particular relevance to deceased donation are:
- Organ and tissue donation after death, for transplantation: guidelines for ethical practice for health professionals (‘Ethical practice guidelines’). These guidelines outline the processes for donation, and ethical principles for health professionals involved in donation after death.
- Ethical guidelines for organ transplantation from deceased donors (‘Deceased Donor Guidelines’). These guidelines inform ethical practice in assessing the suitability of donor organs for transplantation, and allocating organs and vascularised tissue composite allografts (parts of the body that comprise multiple tissues such as muscle, bone, nerve and skin, as a functional unit i.e. a hand or face).
‘Tissue’ is defined in the Human Tissue Acts to include an organ, part of a human body or a substance extracted from the human body, other than blood. ‘Tissue’ can therefore refer to both organs and other bodily tissue. Kidneys are the predominant organ donated and transplanted in Australia.
‘Blood’ is governed by other specific parts of the legislation, so will not be discussed in depth on this webpage. However, in Western Australia it is important to note that ‘blood’ has a broad meaning and includes any substance derived from blood and from any organ and tissue, including bone marrow and the placenta.
The Human Tissue Acts distinguish between ‘regenerative tissue’ and ‘non-regenerative tissue’:
- ‘Regenerative tissue’ is tissue which, after injury or removal, is replaced in the body by natural processes. Examples include bone marrow, blood and skin.
- ‘Non-regenerative tissue’ is all other forms of tissue (i.e. most organs, such as kidneys).
‘Death’ is defined in all jurisdictions as either:
- irreversible cessation of all brain function (‘brain death’); or
- irreversible cessation of circulation of blood (‘circulatory death’ or ‘cardiac death’).
‘Deceased donor’ is a person declared dead by established medical criteria, for whom organs and/or tissues are recovered for the purpose of transplantation into another person. Deceased donation occurs after brain death, or after circulatory death. At present, most deceased donors experience brain death, with a smaller group suffering circulatory death. Brain death remains the preferred donation pathway as the organs are generally of better quality, and more organs can be retrieved in comparison to circulatory death.
What are the principles of organ and tissue donation?
The Ethical Practice Guidelines outline principles for organ donation and transplantation. The principles emphasise:
- that donation of organs and tissues is an act of altruism and human solidarity;
- organs and tissues for transplantation should be obtained in ways that respect human dignity, respect the wishes of the deceased, and give precedence to the potential donor's and family’s needs over the interest of organ procurement; and
- that the choice not to donate should be respected and the family shown understanding for their decision.
When can deceased donation occur?
The Human Tissue Acts and Ethical Practice Guidelines provide guidance about when organ and tissue donation can occur. Under the Ethical Practice Guidelines, in order for donation to occur it is essential that:
- Death has occurred, due to either brain death or circulatory/cardiac death.
- Appropriate procedures are carried out for provision of information and seeking of consent.
- Suitability for organ and tissue donation is determined.
- The designated officer (or a nominated doctor in a hospital) gives authorisation.
The Human Tissue Acts also require that determination of death occur before tissue is removed, in accordance with the definitions of death discussed earlier on this webpage.
This law is strictly applied. See for example the Florida case of In Re TACP, which considered whether or not an infant was legally dead for the purpose of donating organs.
What is involved in the donation process?
Once death has been determined (or imminent death identified), there are specific steps to be followed for lawful organ donation to occur.
When a person dies in a hospital, the ‘designated officer’ has decision-making authority for the removal of organs and tissue. All hospitals have a designated officer who is responsible for authorising and coordinating organ donation. The designated officer must determine whether the deceased had either expressed a wish to donate tissue, or had consented to its removal. Removal of organs cannot proceed if there is evidence that the deceased had objected to organ donation.
The Acts require that reasonable steps must be taken to ascertain the intent or wishes of the deceased. For example, a person may have registered their consent or objection to donation on the Australian Organ Donor Register. In New South Wales, the evidence that the deceased consented must be in writing, or the deceased must have, during their last illness, orally expressed a wish to donate in the presence of two witnesses. In Victoria, the deceased’s consent must be in writing where possible. A person who has indicated their donation wishes on the Organ Donation Register will have complied with the writing requirement of New South Wales and Victoria.
Before donation can proceed, the deceased’s family (in particular the senior available next of kin) must be consulted and must consent to the donation. If the family consents, the designated officer can make a decision about the removal of organs and tissue. Consent is discussed further on this webpage below.
Additional requirements apply where brain death has occurred. In all jurisdictions, except for Western Australia, there must be certification by two doctors that all appropriate tests have been carried out and that irreversible cessation of brain function (‘brain death’) has occurred. In Western Australia, while there is no formal certification requirement, it is expected that two medical officers have examined the person and declared that irreversible cessation of all brain function has occurred.
It is important to note that not everyone will be suitable to be a deceased donor. In fact, DonateLife has identified that only 1% of people who die in hospital are medically suitable to be deceased donors. This is because particular circumstances must exist in order to donate. For example, generally the death must occur in an intensive care unit or in a hospital emergency department.
Further information about the process of donating organs and tissue is available from the DonateLife Network.
Who consents to organ and tissue donation when the donor dies?
The person’s consent must be verified in order for deceased donation to occur. Australia has an ‘opt-in’ informed consent model whereby persons with decision-making capacity have the option to record their consent to donation of organs and tissues on the Australian Organ Donation Register. However, the family of the deceased will be asked to provide consent before donation can proceed, even if a person has already recorded their consent to donation on the Register.
The Human Tissue Acts provide a priority list of family members who will be approached for consent to deceased donation. If the first person on the priority list is not available, then the designated officer must seek out the next person on the list to provide consent. The person with the highest priority is referred to as the ‘senior available next of kin’.
Where the deceased donor is an adult (i.e. a person aged over 18 years), the priority order is the same in each State and Territory (aside from slight variations in terminology):
- Spouse or de facto, domestic and same sex partners. In Western Australia, in cases of conflict, i.e. where the person has both a spouse and a de facto partner, the one with whom the deceased was living will be given priority
- Adult son or daughter.
- Brother or sister.
Where a deceased donor is a child, the priority order (in all States except Western Australia and Queensland) is as follows:
- Adult brother or sister.
- The child’s guardian.
In Queensland and Western Australia an older child's domestic partner or spouse who is over 18 years of age will be given priority over a parent, sibling or guardian.
‘Parent’ is defined differently in some States. For example, the New South Wales definition includes biological parent, step-parent or adoptive parent. In South Australia parent includes ‘the guardian of the child’. The ACT, Tasmania, Victoria and Western Australia Acts specifically exclude a guardian or anyone else in loco parentis from the definition of parent.
If there is some concern regarding the death, and the designated officer considers the death is reportable to the Coroner, then only the Coroner can consent to the removal of tissue.
What happens if there are differing views about whether or not donation should occur?
From time to time there will be differing views within families about whether donation should occur. In some cases, the senior available next of kin may be reluctant to consent to the donation, despite the deceased having expressed a wish to donate, or having signed the Australian Organ Donor Register.
The Ethical Practice Guidelines state that where there is a clear dispute or strong resistance to the removal of tissue among next of kin, removal of organs or tissue will not occur and the family’s objections to donation will prevail. This is the case even when the potential donor had expressed a wish to donate, or had registered their consent. The Ethical Practice Guidelines emphasise respect, dignity and support for remaining family members, and as such, the wishes of the family preside over those of the deceased.
Can organ and tissue donation occur where the deceased objected to donation?
No. Where a person clearly states during their life that they do not wish to donate, donation will not occur.
Who is eligible to receive deceased donors’ organs, and how are decisions about allocation of organs and transplantation made?
Decision-making about who will receive a deceased donor’s organs, and allocating organs for transplantation are complex processes governed by the Deceased Donor Guidelines and other clinical guidelines. The procedures for determining a person’s eligibility to receive a transplantation, assessing the suitability of organs for donation, and allocating organs to recipients (including potential recipients with impaired decision-making capacity) are detailed in the Deceased Donor Guidelines, available on the NHMRC’s website.
Current issues in organ and tissue donation
Australia continues to have a low organ donation rate, with the numbers of people on recipient waiting lists consistently exceeding donors. In January 2009 the Australian Organ and Tissue Donation and Transplantation Authority was established to encourage a national approach to organ donation and to facilitate improved organ donor rates. Since this time there has been a steady increase in donor rates. However, given the continued high demand for organs, mechanisms to encourage donation will undoubtedly remain a policy issue into the future, and other donation frameworks such as an ‘opt in’ and ‘opt out’ approach, may be explored. For further information about donation rates and initiatives to enhance donation, visit the DonateLife Network.
Donation after circulatory death
The ethical and legal implications of donation after circulatory or cardiac death (i.e. donation after diagnosis of death by cardiac criteria, usually following the removal of life support in the intensive care environment) is an emerging issue. The line between life and death is less clearly defined in these situations, and some argue the exact time of death is less certain than for brain stem death. After circulatory death, organs must be removed as soon as possible to maintain the viability and quality of the organ for transplantation. The main legal and ethical issues identified in the Ethical Practice Guidelines include that the donor may receive treatment or care before death which benefits the organ/tissue recipients but not the donor; that medical care of the donor may be affected by the need to remove organs immediately upon death; and uncertainty about whether the donor will die within the timeframe in which organs remain viable for transplantation. For further information about donation and circulatory death, see the Australian Organ and Tissue Authority National Protocol for Donation after Cardiac Death July 2010.
Posthumous removal of sperm
Retrieval of sperm from a deceased donor is a complex legal issue which has emerged in recent years. This area of law is governed by the Human Tissue Acts (in relation to removal of sperm), Assisted Reproductive Technology Acts (in New South Wales, Victoria, South Australia, and Western Australia, in relation to use of a deceased’s sperm), NHMRC Guidelines and the common law.
The NHMRC Guidelines state that assisted reproductive technology (ART) clinics must not use the sperm of a person who is deceased, dying, or in a postcoma unresponsive state, to achieve pregnancy, without the clearly expressed and witnessed consent of the donor to use of the sperm after his death. Counselling of the prospective parent about the consequences of the use must also occur.
Supreme Court decisions have confirmed that the Court has power to authorise posthumous retrieval of sperm and its storage (see for example Re section 22 of the Human Tissue and Transplant Act 1982 (WA); Ex parte C and most recently Re Patteson). However, the Courts have stated that use of sperm for reproduction is a separate legal issue for consideration, and requires a further application to the Court. The Assisted Reproductive Technology Acts in New South Wales, Western Australia, South Australia and Victoria prohibit the use of extracted semen for insemination. This is largely for policy reasons, in particular so that a person can control their genetic material. However, if the person consents to the posthumous use of his sperm before he dies, the use of the sperm could be permitted. In Victoria, there are other conditions that must be satisfied before retrieved sperm can be used.
In Re TACP 609 So 2d 588 (Fla 1992)
‘Baby Theresa’ suffered from anencephaly (she was missing part of the skull and brain but had a brain stem and brain stem activity). Infants with this condition usually die within hours of birth. Her condition was diagnosed in utero and her parents decided to proceed with the pregnancy and opted for a caesarean delivery to reduce the risk of harm to her organs. They planned to donate her organs in order to give life to other sick children. Baby Theresa was born and was breathing independently when her parents took steps to donate her organs. The hospital was not comfortable with this as she had a brain stem and did not fit either of the definitions of death. The issue was whether or not she could be declared legally dead for the purpose of donating organs. The Florida Supreme Court agreed with the hospital. The parents’ request was denied despite their argument that her death was both imminent and inevitable.
Re Patteson  QSC 104
Ms Patteson sought orders authorising the removal of the testes and spermatozoa from the body of her fiancè who had died the previous night, to be stored by an IVF clinic pending a future application to the court for their use. Evidence provided to the court indicated that Ms Patteson and her fiancè were anxious to conceive a child together.
The Supreme Court permitted the removal and storage of the tissue, on an interim basis, pending a further court application to use the tissue. It found that the balance of convenience was strongly in favour of these orders as they provided Ms Patteson with the opportunity to reflect on whether to proceed with the use of the material and ensured that any such future application would not be futile due to a loss of viability of the sperm.
C sought urgent orders for the removal and storage of the sperm and tissue of her husband, who had died the previous day. This would enable C to undergo a future in vitro fertilisation procedure to have a child, subject to the court approving this at a separate hearing. C gave evidence she and her husband had been trying to conceive for nearly two years. Her husband had consented to the plan of having a baby. However, the hospital where her husband’s body was located told C she needed a court order authorising removal of the sperm.
The Supreme Court approved the removal of C’s husband’s sperm, and confirmed that the Human Tissue and Transplantation Act (WA) permits a hospital’s designated officer to authorise the removal of sperm at the request of the senior available next of kin. The Court also ordered that the sperm and tissue, once removed, could not be used for any purpose without a further order of the Court.
Richards, Bernadette, ‘Organ and Tissue Donation’ in Ben White, Fiona McDonald and Lindy Willmott (eds), Health Law in Australia (2nd ed, Law Book Co), p743-770.
McGee, Andrew & Gardiner, Dale. (2017). Permanence can be defended Bioethics, 31(3), pp. 220-230.
McGee, Andrew & Gardiner, Dale. (2016, In press). Donation after the circulatory determination of death: Some responses to recent criticisms Journal of Medicine and Philosophy.
Gardiner, Dale & McGee, Andrew. (2016, In press). Death, permanence and current practice in donation after circulatory death QJM: An International Journal of Medicine.
Smith, Malcolm. (2014). Posthumous conception in South Australia : the case continues in Re H, AE (No 3)  SASC 196. Queensland Lawyer, 34(1), pp. 15-18.
McGee, Andrew & White, Ben. (2013). Is providing elective ventilation in the best interests of potential donors? Journal of Medical Ethics, 39(3), pp. 135-138.
Then, Shih-Ning & Appleby, Gabrielle. (2010). Tissue transplantation from children: Difficulties in navigating state and federal systems. University of New South Wales Law Journal, 33(2), pp. 305-336.