The Australian Law Reform Commission (ALRC) has published an Issues Paper entitled “Review of Human Tissue Laws” (Issues Paper) with submissions closing on 4 July 2025.
The Issues Paper sets out that there is a lack of available, viable human tissue not only in relation to life-saving interventions for those who need it, but also for research which develops and enhances public health initiatives.
The ALRC suggests that improving access to human tissue could involve enhancing the effectiveness of existing donation systems (such as those for transplantation, research, and education), removing unnecessary barriers to donation, and developing an effective system to determine who is eligible for tissue and organ donation post-mortem.
Currently, the use and retrieval of human tissue in Australia is governed by a blend of laws, regulations, policies and ethical guidelines. The Issues Paper invites individuals, organisations, and professional associations with an interest in the area of human tissue laws to make submissions to the ALRC to share their experiences interacting with the existing human tissue landscape.
The ALRC requests that submissions respond to any of the eight questions outlined in the Issues Paper. These questions broadly request opinions regarding:
- the collection and use of human tissue in Australia;
- which aims, objectives or principles should guide the proposed reform;
- whether respondents agree with the ALRC's proposed priority reform areas; and
- any additional areas of reform that have otherwise not been addressed in the Issues Paper.
The Issues Paper suggests that reforms should prioritise respect for the human body and personhood, equitable participation, and the maintenance of public trust. Key areas for reform include the definitions of "tissue" and "death," legal protections for adult and child donors (both living and deceased), protections for individuals with limited decision-making capacity, the use of tissue in research, post-mortem donation authorisation, privacy concerns for donors and recipients, the use of tissue in educational settings, and the advertisement and trade of human tissue.
In its Inquiry, the ALRC has noted it is unlikely to consider the safety of cells, tissues and organs (regulated by the Therapeutic Goods Administration), coronial inquests except as they intersect with Australian Human Tissue Acts (HTAs), human cloning, embryonic research, human gamete regulation (except as they intersect with HTAs), and First Nations ancestral remains (to the extent that they are dealt with under cultural heritage laws).
Submissions can be made to the ALRC via the link here, and are due on 4 July 2025.
The Health Law team at Russell Kennedy will be closely following this review with interest and will issue further alerts in due course.
How we can help
If you have questions, please contact Jaqueline Wilson, Jonathan Teh, or a member of our Health team.
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