Reform at a glance

Australia's human tissue laws have not undergone a major national review since the Australian Law Reform Commission's (ALRC) 1977 model law. In the intervening decades, State and Territory Acts have diverged, becoming inconsistent and, in some areas, out of date. This, in addition to a lack of coordinated amendment mechanisms and the absence of a national regulator - have created uncertainty for clinicians and researchers, barriers to research, administrative burden, and gaps in oversight of tissue banking and research biobanking. The ALRC's Discussion Paper, published in November 2025, presents reform proposals aimed at a modern, nationally consistent framework for how human tissue is obtained, stored and used, and invites stakeholder input.

The Discussion Paper forms part of the ALRC's ongoing review into human tissue laws, which we summarised when the Issues Paper was released May 2025. In total, the Discussion Paper includes 49 reform proposals and 47 consultation questions.

Key proposals

1. A nationally consistent framework and national regulator

A central proposal is a nationally consistent legal and regulatory framework, supported by a National Regulator to provide oversight and maintain consistency. The Discussion Paper proposes establishing a National Regulator - either by expanding the Organ and Tissue Authority, creating a new statutory body incorporating it, or establishing a new body alongside it - with functions including national policy-setting, binding codes and standards, accreditation and licensing across the tissue banking and research sectors, and monitoring, investigation and enforcement.

2. Clear objects clause

The Discussion Paper proposes an objects clause for new human tissue legislation, encompassing modernisation and adaptability; increasing access to the benefits of tissue donation; consistency with international human rights obligations; promoting equity; respect for dignity and autonomy; preventing exploitation; and promoting public trust. The National Regulator would be required to consider these objects when creating guidelines and codes of practice.

3. Equitable access

The existing Human Tissue Acts do not include provisions dealing with equitable access to human tissue donation, transplantation, and use. The Discussion Paper notes that First Nations peoples and some other groups face barriers to donating organs and do not have equal access to organs for transplantation, and proposes that promoting equity and reducing inequities in access to human tissue and the benefits of human tissue use should be included as an explicit object of new human tissue legislation.

4. Modernising the definition of ‘tissue’

The Discussion Paper proposes a broad definition of ‘human tissue’ with a flexible mechanism allowing the National Regulator to adjust scope and provide interpretive guidance, intended to address existing discrepancies across jurisdictions and better accommodate future scientific and medical developments. The ALRC specifically consults on whether materials such as human milk, foetal tissue, faecal tissue, posthumous gametes, and cell lines should be excluded entirely or for specific purposes.

5. Determination of death

The Discussion Paper proposes a uniform legal standard defining death as ‘permanent cessation of the person's critical brain functions’, with determinations required to accord with accepted medical practice and additional safeguards - including written confirmation by two suitably senior medical practitioners where respiration is artificially maintained. A ‘Dead Donor Rule’ safeguard is also proposed, requiring independence between the practitioner determining death and the practitioner involved in the removal or use of tissue.

Updating the standard for determining death would likely allow normothermic regional perfusion (NRP) to be practiced in Australia. NRP is a technique used in some countries where doctors recirculate a donor's blood in their body after their heart stops beating to help repair organs before they are removed for transplantation. Historically, NRP has not been practiced in Australia because of concerns that it would be inconsistent with the 'irreversible cessation of the circulation of blood' requirement for a person to be legally determined dead.

6. Consent - living donation

The Discussion Paper proposes a simplified consent standard for adult living donors, moving away from the current "regenerative/non-regenerative" tissue distinction and instead focusing safeguards on risk to the donor, requiring voluntary and informed consent (including as to nature, effects, material risks and intended uses) and a right to withdraw before removal.

7. Consent - deceased donation

The Discussion Paper proposes a uniform framework allowing individuals to consent to post-mortem donation, and - where they lack capacity or die without valid consent - permitting an authorised decision-maker to consent having regard to the person's beliefs, values and preferences. National protocols for donation by voluntary assisted dying patients are also proposed.

8. Research and biobanking

The Discussion Paper recommends that living adults be able to consent to tissue removal for research, with rights to information and the ability to withdraw consent for future use. It recommends the donor have the right to access information about how their tissue is being used and whether it is identifiable, de-identified or re-identifiable, and the right to withdraw consent for future use at any time. Proposed provisions regarding deceased donation for research purposes largely mirror those for deceased donations for medical purposes. It also proposes a nationally consistent pathway permitting tissue removal from children for research where HREC-approval is obtained and appropriate safeguards are met.

9. Trade prohibitions

The existing Human Tissue Acts prohibit trade in human tissue. However, the way the Human Tissue Acts address these concerns is inconsistent, the cost-recovery rules lack clarity about what costs can be recovered, and there is no oversight to ensure tissue banks are operating ethically.

The Discussion Paper proposes a uniform national prohibition on offering, giving, or receiving any ‘reward’ for human tissue, with defined exceptions for legitimate cost recovery and a mechanism allowing the proposed National Regulator to grant additional exemptions where the public interest justifies it and the risk of exploitation is low. One of the most contested issues in this space is whether paid plasma donation should be permitted. Countries that currently pay plasma donors include the United States, Austria, Germany, Hungary, and others. Proponents argue that a remuneration scheme can be made safe and would secure Australia's plasma supply, while opponents raise concerns about coercion of vulnerable donors and compromise of safety standards. The ALRC has sought stakeholder input on whether paid plasma donation should be permitted as an exception to the trade prohibition.

A significant related gap exists in relation to imported tissue more broadly: Australia's demand for tissue products is not being met domestically, and there are no provisions in the Human Tissue Acts regarding imported tissue - meaning there are no legal requirements for imported tissue to be sourced from consenting donors who have not been coerced or paid. There is also no offence capturing Australians who travel overseas to purchase an organ for transplantation - so-called ‘transplant tourism’ - although the Criminal Code Act 1995 (Cth) does criminalise the movement of persons across Australian borders for the purpose of facilitating unlawful organ removal. A 2018 parliamentary review recommended the creation of a new criminal offence of trafficking in human organs - including the solicitation of a commercial organ transplant - applying regardless of whether the conduct occurred within or outside Australia, with the Australian Government accepting this recommendation in principle in 2021. However, criminal provisions addressing organ trafficking in the transplant tourism context have not yet been implemented. The Discussion Paper asks whether the trade prohibition should have extra-territorial effect, and whether that is best achieved through the state and territory Human Tissue Acts or through amendment to the Criminal Code.

10. Privacy

The Discussion Paper proposes a uniform prohibition on the public disclosure of a donor or recipient's personal information, being information identifying or reasonably identifying them, without their consent. Clinicians would be permitted to disclose clinically relevant donor information to potential recipients, provided disclosure is limited to reduce re-identification risk. Consent to disclosure could be given by the donor or recipient, or by an authorised decision-maker if the person is deceased, a child or lacking capacity.

Modelled on Victorian HTA provisions, health practitioners, health authorities and DonateLife staff would be authorised to access and share relevant information for donor identification and screening, with provisions prevailing over conflicting laws.

What this means for your business

The proposed reforms would have wide-ranging implications across the healthcare, research, and tissue supply sectors. Key impacts to be aware of include:

• A more structured national regulatory environment - a proposed National Regulator with powers to set binding codes and standards, issue licences, investigate, and impose penalties means all entities involved in the retrieval, storage, processing, distribution, or use of human tissue should expect greater oversight and begin assessing their compliance readiness now.
• Consent documentation and patient information - healthcare providers will need to review existing consent forms and information materials to ensure they meet any new requirement that donors be fully informed of intended uses, including any commercial applications, before consent is given.
• Research and biobank governance - research institutions and biobanks should prepare for a legislated consent framework for research tissue use, including participant withdrawal rights, as well as potential new national oversight requirements for research tissue collections not currently subject to direct legal regulation.
• Tissue banking and imported tissue - tissue banks should expect clearer and more closely scrutinised cost-recovery rules, and clients relying on imported tissue should monitor proposals to introduce ethical sourcing obligations and extra-territorial trade prohibitions, which would close a significant current regulatory gap.
• Equity and cultural safety obligations - entities involved in donation, allocation, and transplantation services should anticipate an increased policy and governance emphasis on equitable access, with equity proposed as an express legislative objective and further provisions on this issue remaining open for stakeholder input.

Key dates and status

The ALRC is scheduled to deliver its final report to the Australian Government by 16 August 2026.

Our perspective

If implemented effectively, a nationally consistent framework and regulator could deliver long overdue clarity, strengthen public confidence and reduce barriers to research, innovation and ethical tissue supply. However, the breadth of reform also creates risk. Rising compliance expectations, new consent standards and ethical sourcing obligations may require significant operational uplift. Ultimately, the success of this reform will depend on striking the right balance between national consistency and regulatory flexibility, but its impact on healthcare, research and tissue banking could be significant.

Please contact us if you would like to discuss the implications of these reforms for your organisation.