An overhaul of the rules governing the use of human tissue in Australia looks increasingly likely as the Australian Law Reform Commission (ALRC) embarks on a reform initiative. This reform is aimed at boosting the country’s historically low organ donation rates.
This marks the first review since the ALRC’s 1977 report, which laid the foundation for the human tissue acts. With significant advancements in medicine, technology, and community attitudes over the past half-century, the starting point now is to legally define human tissue. This definition could potentially encompass substances such as human milk, fetal and fecal tissue, and “newly engineered materials that include human cells or cell lines,” according to the ALRC’s discussion paper.
Defining Death and Its Implications
The “most difficult and sensitive” question, according to Dr. Maeghan Toews, co-leader of the inquiry, will be whether to establish a uniform legal definition of medical death. “The concept of death raises not only legal but also spiritual and philosophical issues that people have different views on,” she explains.
For the medical and research communities, particularly the organ and tissue donation and transplant sector, the outcome has significant implications for ethical oversight, consent, and medical interventions. It is hoped that reforms will help lift donation rates, as only about a third of Australians were registered organ or tissue donors in 2024, with a national consent rate of 53 percent, well below pre-Covid levels.
Technological Advances and Legal Barriers
Changing the definition of death could remove legal barriers that currently prevent Australian hospitals from using international technology known as normothermic regional perfusion (NRP). This technology preserves donated organs, particularly livers, in the body of a deceased patient, potentially increasing the number of available organs for transplant. “Up to 20 percent of the organs that we currently don’t use, but have considered for use, could be trialed,” says Angela Webster, a professor of epidemiology at the University of Sydney and a transplant physician at Westmead Hospital.
Addressing Disparities and Building Trust
As part of a broader focus on making organ and tissue transplants more equitable, the review is also consulting on ways to address the “disparity in access to kidney transplants for Aboriginal and Torres Strait Islander people.” The aim is to avoid “unintended negative consequences” for Indigenous people and research participants, given the “long history of taking tissue from First Nations communities without consent for research and educational purposes.”
Efforts are also underway to identify “specific rules” to help restore trust from First Nations communities in Australian medical research. Louise Baur, president of the Australian Academy of Health and Medical Sciences, notes that reform to ensure the ethical and efficient use of locally donated tissue would “strengthen Australia’s sovereign research capacity and reduce reliance on overseas jurisdictions.”
International Context and Research Funding
Australian health and medical researchers are still grappling with the impact of US government funding cuts to joint projects under the Trump administration. The directives to pull back on diversity, equity, and inclusion efforts and cuts to scientific funding and personnel in key government health agencies have had international consequences. There are calls within the sector for Australia to diversify research funding sources, ahead of this year’s expected release of an updated National Health and Medical Research Strategy.
Proposals for a National Framework
Among the 49 proposals in the ALRC’s discussion paper are the creation of a national legislative framework and an overarching national regulator. This would “harmonise and modernise” the “complex, fragmented and nationally inconsistent framework of oversight, guidance, and legislation” across Commonwealth, state, and territory jurisdictions.
“Some states and territories have different rules about what is and isn’t allowed before and after death, or in that dying phase, and that could impact how well those organs work,” says Webster. At Westmead Hospital, three transplant patients from different states are receiving organs from interstate donors, highlighting the current complexities.
Concerns and Opportunities
While the prospect of streamlined regulation is welcomed, there is concern that the new legal framework may “seek to encroach or seep into clinical practice guidelines.” The health and medical research sector faces “layers of complexity” due to disparate human tissue acts, according to Dianne Nicol, a distinguished professor of law and a fellow of the Australian Academy of Health and Medical Sciences.
Nicol highlights concerns about the use of personal information, leading to “self-regulation” out of fear of breaching state or Commonwealth laws. “Genetic technology has improved so much that any human tissue has a person’s DNA in it, making it possible to sequence and identify the person,” she explains. This raises questions of consent and ownership, particularly for the operation of Australian biobanks.
Looking Ahead
Expectations in the medical community are high for the changes this review will bring. Toews has already indicated that the final reforms will require a “fairly substantial” overhaul of the existing legislation. Nicol emphasizes the need to balance ethical considerations and respect for donors with the need for innovation.
Webster agrees, noting a tension between harmonizing practices across states and territories and aligning with international standards. “We’re worried that we might be putting ourselves in more cages,” she cautions.
The ALRC’s report is due to be handed to the federal attorney-general midyear after further consultations, marking a significant step in shaping the future of organ donation and tissue use in Australia.
