The Australian Law Reform Commission (ALRC) is conducting an inquiry into the national legal framework governing the use of human tissue – a framework that significantly affects clinical practice, biomedical research, and therapeutic innovation.
Human tissue plays a vital role in modern medicine. It covers everything from organs and blood to skin, bone, and even cells. These tissues are used in a wide range of treatments including organ transplants, blood transfusions to support surgery and trauma care, skin grafts to treat burns, and bone and tendon donations to help with reconstructive surgery.
Beyond direct treatment, human tissue is also critical in medical research, education and innovation. Tissue samples are used in genetic testing and to develop new therapies. As medical technologies advance, with therapies such as stem cell treatments and Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies, the ways human tissue is used continue to expand.
The background
Human tissue in Australia is primarily regulated by the Human Tissue Acts (HTAs) in each state and territory.1 In New South Wales, for example, the Human Tissue Act 1983 (NSW) governs the donation and use of human tissue. 'Tissue' is defined broadly to include organs, body parts and substances extracted from or forming part of the human body.2
Since the 1970s, rules around human tissue have developed in a complex and sporadic way, with states and territories heading in slightly different directions in governance. A key example is the prohibition on trading in human tissue. All jurisdictions restrict the sale and supply of tissue, but the scope varies. In New South Wales, Australian Capital Territory, Queensland, South Australia and Northern Territory, the ban does not apply once tissue has been processed for therapeutic, medical or scientific purposes.3 Ministers also retain a discretion to authorise transactions in 'special circumstances'.4
Some states have gone further. In Victoria, Western Australia, South Australia and Queensland, laws also prohibit advertising for trade without ministerial approval.5 In Queensland, the trade of human tissue is generally banned, but tissue banks can charge to recover the costs of removing, storing or distributing donated tissue.6
For nearly 50 years, Australia’s laws on human tissue have remained largely unchanged despite social, technological and scientific advancements. Now, the ALRC has launched a national review, and called for submissions, asking whether our rules are keeping pace with modern science, ethics and community expectations.
Intersecting regulation: The case of CAR-T therapy
One example of how complex the current framework can be is CAR-T therapy. This innovative cancer treatment involves extracting a patient’s own or a donor’s genetically modified cells. Since it uses human tissue, CAR-T therapy is potentially captured by state prohibitions on trade under the HTAs. At the same time however, CAR-T products are also regulated as therapeutic goods under the Therapeutic Goods Act 1989 (Cth).7
This overlap highlights why reform is necessary: to give clarity on how laws should apply to cutting-edge therapies, and to help manufacturers understand how to responsibly commercialise and advertise products derived from human tissue in Australia.
Key areas for reform
Some of the key issues identified by the ALRC include:
- Refining the definition of 'human tissue' – determining what body parts and substances are to be included under that definition.
- Public trust in donation systems – improving transparency, addressing misconceptions, and introducing stronger safeguards to encourage donation.
- Transplant tourism – considering whether Australians should be prohibited from travelling overseas to purchase organs, aligning with bans on organ trafficking under the Criminal Code Act 1995 (Cth).
- Mandatory referral to DonateLife – requiring clinicians in critical care to notify DonateLife of all potential donors, helping standardise processes and improve donation rates.
- Equitable access – ensuring fairer allocation of donated tissue, particularly for Aboriginal and Torres Strait Islander communities.
- Reconsidering tissue classifications – reviewing the distinction between ‘regenerative’ and ‘non-regenerative’ tissue. Non-regenerative tissue is not permitted to be donated for purposes other than transplantation, which introduces a barrier to research that may impede scientific progress.
- Modernising the definition of death – aligning statutory definitions with clinical practice, e.g. 'permanent cessation' versus 'irreversible cessation of circulation of blood'.
- Consent frameworks – clarifying the weight of registered donor intent versus family objection, and revisiting the role of the 'senior available next of kin'.
- Protecting vulnerable donors – strengthening safeguards around donations by children and people with impaired decision-making capacity.
Implications
The ALRC’s inquiry could potentially reshape the regulatory environment for clinicians, researchers and therapeutic good manufacturers who deal with human tissue. Clearer and nationally consistent laws will assist healthcare practitioners navigate consent, referral and allocation frameworks with greater confidence, reducing administrative complexity and legal risk. For manufacturers and innovators, particularly those developing therapies derived from human tissue, reform could provide much needed certainty on how products may be commercialised, advertised and supplied across Australia. At the same time, new obligations are likely to emerge around transparency, and reporting and ethical safeguards, requiring those impacted to adapt policies and processes in line with standards. As such, there are likely to be additional regulatory and compliance risks and costs.
Conclusion
The ALRC’s inquiry has the potential to modernise and unify Australia’s human tissue laws. For clinicians, researchers, and healthcare product manufacturers, the reforms could reduce uncertainty, streamline compliance, and better support the use of emerging therapies.
For the wider public, the reform is an opportunity to strengthen trust in the donation system and reinforce Australia’s commitment to ethical and transparent use of human tissue in healthcare.
The ALRC has been asked to provide its final report to the Attorney-General by 16 August 2026.
1 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); Human Tissue and Transplant Act 1982 (WA).
2 Human Tissue Act 1983 (NSW) s 4.
3 Human Tissue Act 1983 (NSW) ss 32(1)-(2); Transplantation and Anatomy Act 1978 (ACT) ss 44(1)-(2); Transplantation and Anatomy Act 1979 (Qld) s 42AA(1)(b); Transplantation and Anatomy Act 1983 (SA) s 35(3); Transplantation and Anatomy Act 1979 (NT) s 22E(3)(c).
4 Human Tissue Act 1983 (NSW) s 32(4); Transplantation and Anatomy Act 1978 (ACT) s 44(4); Transplantation and Anatomy Act 1979 (Qld) s 40(2)); Transplantation and Anatomy Act 1983 (SA) s 35(6); Transplantation and Anatomy Act 1979 (NT) s 22F(1); Human Tissue and Transplant Act 1982 (WA) s 29E(1).
5 Human Tissue Act 1982 (Vic) s 40; Human Tissue and Transplant Act 1982 (WA) s 30; Transplantation and Anatomy Act 1979 (Qld) s 41; Transplantation and Anatomy Act 1983 (SA) s 35(7).
6 Transplantation and Anatomy Act 1979 (Qld) s 42A.
7 Therapeutic Goods Act 1989 (Cth) s 32A.
