Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023

Administered by Department of Health, Disability and Ageing

Legislation au F2024L00091 Regulations Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

 

Australian Organ and Tissue Donation and Transplantation Authority Act 2008

 

Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023

 

Purpose and operation

 

The purpose of amending the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020 (OTA Regulations) is to ensure consistency with the terms now defined in the Australian Organ and Tissue Donation and Transplantation Authority Amendment (Disclosure of Information) Act 2023 (Amending Act), which will be inserted into the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (Act).

 

The Amending Act allows the Australian Organ and Tissue Donation and Transplantation Authority (OTA) and DonateLife staff to obtain consent for the disclosure of information from an extended list of “authorised family members” of a deceased donor, or deceased recipient, for the purposes of including information about the respective deceased donor or recipient in their community awareness and educational activities, and for family members to commemorate their loved ones in remembrance services. The disclosure of information is restricted to the purposes of the activities and by the people defined in the legislation.

 

Where a living donor or recipient is under 16 years of age, or is 16 or 17 years of age and does not have legal capacity to consent, the Amending Act provides that information identifying the donor or recipient may be published, disseminated or disclosed with the consent of the parent or legal guardian of that donor or recipient. 

The purpose of the Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023 (Amending Regulations) is to amend the OTA Regulations to remove the provision authorising a parent or guardian to consent to the publication or dissemination of information likely to enable identification of donor under 18. The Amending Regulations ensure the OTA Regulations operate consistently with the Amending Act.

 

Authority

 

Section 60 of the Act provides that the Governor-General may make regulations prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

Reliance on subsection 33(3) of the Acts Interpretation Act 1901

 

Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

 

Commencement

 

The Amending Regulations commence at the same time as the Amending Act. The Amending Act commences on 21 February 2024, which is six months after the date of Royal Assent.

 

Consultation

 

Consultation on the Amending Act was undertaken and the resulting amendments to remove section 8 from the OTA Regulations are a consequential amendment.

 

Consultation on the Amending Act followed standard consultation requirements. The following bodies and organisations were consulted:

-            The Organ and Tissue Authority;

-            The Department of the Prime Minister and Cabinet;

-            The Attorney General’s Department;

-            All States and Territories (two rounds of consultation);

-            The National Aboriginal Community Controlled Health Organisation;

-            The Australian Indigenous Doctors’ Association; and

-            The Congress of Aboriginal and Torres Strait Islander Nurses and Midwives.

 

General

 

This instrument is a legislative instrument for the purposes of the Legislation Act 2003.

 

Details of this instrument are set out in Attachment A.

 

This instrument is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

 


ATTACHMENT A

 

Details of the Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023

 

 

Section 1 – Name

 

Section 1 provides that the name of this instrument is the Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023.

 

Section 2 – Commencement

 

Section 2 provides that the whole of this instrument commences at the same time as Schedule 1 to the Australian Organ and Tissue Donation and Transplantation Authority Amendment (Disclosure of Information) Act 2023 commences.

 

Section 3 – Authority

 

Section 3 provides that the instrument is made under the Australian Organ and Tissue Donation and Transplantation Authority Act 2008.

Section 4 – Schedules

 

Section 4 provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

Schedule 1—Amendments

 

Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020

1        Item 1 repeals section 8 of the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020, which provides that the parent or legal guardian of the donor is authorised to give consent to the publication or dissemination of information where a donor is less than 18 years old.


 


ATTACHMENT B

 

Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023

 

This Disallowable Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the legislative instrument

The Australian Organ and Tissue Donation and Transplantation Authority Amendment (Disclosure of Information) Act 2023 (the Amending Act) amends the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (the Act) to allow the Australian Organ and Tissue Donation and Transplantation Authority (OTA), DonateLife agencies, grant recipients and “authorised family members” to publish, disseminate or disclose information about deceased organ or tissue donors or recipients without breaching state or territory legislation. This will enable sharing of information for educational campaigns and commemorative purposes. The definition of ‘authorised family members’ includes a parent or legal guardian of the donor or recipient.

 

Where a living donor or recipient is under 16 years of age, or is 16 or 17 years of age and does not have legal capacity to consent, the Amending Act provides that information identifying the donor or recipient may be published, disseminated or disclosed with the consent of the parent or legal guardian of that donor or recipient. 

The Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023 (Amending Regulations) amends the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020 (OTA Regulations) to remove the provision that authorises a parent or guardian to consent to the publication or dissemination of information likely to enable identification of donor under 18 years of age. The Amending Regulations would ensure the OTA Regulations operate consistently with the Amending Act.

 

Human Rights Implications

The Regulations do not engage any of the applicable rights or freedoms because the Regulations repeal a matter required to give effect to the Act.

 

Conclusion

The Regulations are compatible with human rights as they do not raise any human rights issues.

 

The Hon. Ged Kearney MP

Assistant Minister for Health and Aged Care

 

Overview

The Australian Organ and Tissue Donation and Transplantation Authority Amendment (Disclosure of Information) Act 2023 (the Amending Act) was introduced to amend the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (the Act). The Act was enacted by the Parliament of Australia to address the need for consistency in the disclosure of information about deceased organ and tissue donors and recipients. The Amending Act ensures that the Australian Organ and Tissue Donation and Transplantation Authority (OTA) and related entities can share information for educational campaigns and commemorative purposes, while remaining compliant with state and territory legislation. The Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023 (Amending Regulations) were introduced to align the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020 with the Amending Act, particularly in relation to the consent requirements for the disclosure of information about donors and recipients under the age of 18. The purpose of the Amending Act is to allow the OTA, DonateLife agencies, grant recipients, and "authorised family members" to disclose information about deceased donors and recipients for community awareness and educational activities, and for family members to commemorate their loved ones in remembrance services. The Amending Regulations amend the OTA Regulations to remove the provision that authorised a parent or guardian to consent to the publication or dissemination of information that could identify a donor under 18 years of age. This change ensures that the OTA Regulations operate consistently with the Amending Act. The Amending Regulations were made under section 60 of the Act and are compatible with human rights as they do not raise any human rights issues.

Scope and Application

The Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023 amends the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020 to ensure consistency with the Australian Organ and Tissue Donation and Transplantation Authority Amendment (Disclosure of Information) Act 2023. These Regulations apply to the Australian Organ and Tissue Donation and Transplantation Authority, DonateLife agencies, and relevant family members, to allow them to disclose information about deceased donors or recipients for community awareness, educational activities, and remembrance services. This is done within the confines of the newly defined terms in the Amending Act. Notably, these Regulations exclude the authority of parents or legal guardians to consent to the publication or dissemination of information likely to enable identification of donors under 18 years of age, a provision that has been repealed. This amendment ensures the Regulations are aligned with the legislative changes introduced by the Amending Act. The Regulations apply across Australia, as they are made under the authority of the Australian Organ and Tissue Donation and Transplantation Authority Act 2008. The Regulations commenced on 21 February 2024, the same day as the Amending Act.

Key Provisions

The Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023 (Amending Regulations) primarily aim to align the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020 (OTA Regulations) with the Australian Organ and Tissue Donation and Transplantation Authority Amendment (Disclosure of Information) Act 2023 (Amending Act). The key change introduced by these Regulations is the repeal of section 8 of the OTA Regulations (section 4, Schedule 1), which previously authorised a parent or legal guardian to consent to the publication or dissemination of information that might identify a donor who was under 18 years of age at the time of donation. This repeal ensures that the OTA Regulations are consistent with the terms and purposes defined by the Amending Act. The Amending Regulations impose specific obligations on the Australian Organ and Tissue Donation and Transplantation Authority (OTA) and other relevant parties. These include ensuring that any disclosure of information about deceased donors or recipients is restricted to purposes related to community awareness and educational activities, or for family members to commemorate their loved ones in remembrance services (section 1, Schedule 1). Furthermore, the Regulations mandate that any information identifying a living donor or recipient under 16 years of age, or a 16 or 17-year-old donor or recipient who lacks legal capacity, can only be published, disseminated, or disclosed with the consent of the donor's or recipient's parent or legal guardian (section 1, Schedule 1). This aligns with the provisions of the Amending Act, which also outlines the permissible uses of such information. Failure to comply with the provisions of the Amending Regulations could result in civil or criminal consequences, although the specific penalties are not detailed within the explanatory statement. Generally, breaches of legislative instruments can result in penalties that vary depending on the nature and severity of the breach. For example, in cases of serious misconduct or failure to comply with statutory obligations, penalties may include fines and, in some cases, imprisonment. However, the exact penalties would need to be referred to the primary legislation or any associated enforcement guidelines. The Regulations themselves are designed to ensure that all information disclosure activities are conducted within the legal framework established by the Amending Act, thereby safeguarding the rights and privacy of donors, recipients, and their families.

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Area of Law
Health Law
Medical Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Consent
Human Rights Compatibility

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.