Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00169 Regulations In force Legislative Instrument

Legislation content

Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020

made under the

Australian Organ and Tissue Donation and Transplantation Authority Act 2008

Compilation No. 1

Compilation date: 21 February 2024

Includes amendments: F2024L00091

Registered: 21 February 2024

About this compilation

This compilation

This is a compilation of the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020 that shows the text of the law as amended and in force on 21 February 2024 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

Contents

1 Name

3 Authority

5 Definitions

6 Substances that are not tissue

7 Alternative name for Australian Organ and Tissue Donation and Transplantation Authority

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

1  Name

  This instrument is the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020.

3  Authority

  This instrument is made under the Australian Organ and Tissue Donation and Transplantation Authority Act 2008.

5  Definitions

  In this instrument:

Act means the Australian Organ and Tissue Donation and Transplantation Authority Act 2008.

6  Substances that are not tissue

  For the purposes of the definition of tissue in section 4 of the Act, the following substances are specified:

 (a) blood and blood products, including progenitor cells such as those in cord blood or bone marrow;

 (b) reproductive tissue, including sperm and eggs;

 (c) foetal tissue;

 (d) stem cell tissue.

7  Alternative name for Australian Organ and Tissue Donation and Transplantation Authority

  The name Organ and Tissue Authority is specified for the purposes of subsection 8(2) of the Act.

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

 

Endnote 2—Abbreviation key

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

Sub‑Ch = Sub‑Chapter(s)

cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020

26 Feb 2020 (F2020L00169)

27 Feb 2020 (s 2(1) item 1)

 

Australian Organ and Tissue Donation and Transplantation Authority Amendment Regulations 2023

22 Jan 2024 (F2024L00091)

21 Feb 2024 (s 2(1) item 1)

—

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2.....................

rep LA s 48D

s 4.....................

rep LA s 48C

s 8.....................

rep F2024L00091

Schedule 1................

rep LA s 48C

 

 

Overview

The Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020 were enacted under the Australian Organ and Tissue Donation and Transplantation Authority Act 2008. These regulations address the need for a comprehensive framework to oversee and regulate the donation, storage, and transplantation of human organs and tissues in Australia. The objective is to ensure a safe, ethical, and efficient organ and tissue donation and transplantation system that meets national and international standards. The Australian Parliament established these regulations to provide a robust regulatory environment that supports the activities of the Australian Organ and Tissue Donation and Transplantation Authority, ensuring the highest standards in the handling and transplantation of organs and tissues. These regulations specify substances that are not considered tissue for the purposes of the Act, including blood and blood products, reproductive tissue, foetal tissue, and stem cell tissue. They also set out the alternative name "Organ and Tissue Authority" for the Australian Organ and Tissue Donation and Transplantation Authority, as referred to in the Act. The regulations are designed to support the overarching goal of enhancing the organ and tissue donation and transplantation system in Australia, ensuring that it operates in a manner that is safe, ethical, and responsive to the needs of patients requiring transplants.

Scope and Application

The Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020, made under the Australian Organ and Tissue Donation and Transplantation Authority Act 2008, apply to the activities and operations of the Australian Organ and Tissue Donation and Transplantation Authority, referred to as the Organ and Tissue Authority. These regulations establish the framework within which the Authority conducts its functions related to organ and tissue donation and transplantation. The regulations encompass the definitions relevant to the Act, including specifying certain substances that are not considered tissue, such as blood and blood products, reproductive tissue, foetal tissue, and stem cell tissue. The regulations are applicable across Australia, with the Authority’s jurisdiction extending nationwide to ensure a cohesive approach to organ and tissue donation and transplantation. The Act itself and these regulations provide a structured approach to the donation, recovery, and transplantation processes, ensuring that they are conducted ethically and efficiently. While the regulations are comprehensive, they do not cover every possible scenario, and some exclusions or exemptions may be detailed in subordinate instruments or further legislation.

Key Provisions

The Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020, made under the Australian Organ and Tissue Donation and Transplantation Authority Act 2008, provide detailed provisions governing the donation and transplantation of organs and tissues in Australia. The regulations outline key definitions (Regulation 5) and specify substances that are not considered tissue for the purposes of the Act (Regulation 6). The Organ and Tissue Authority, an alternative name for the Australian Organ and Tissue Donation and Transplantation Authority, is also specified (Regulation 7). The regulations impose specific obligations on parties involved in the donation and transplantation process. For instance, they mandate that certain substances, such as blood and blood products, reproductive tissue, foetal tissue, and stem cell tissue, be excluded from the definition of tissue under the Act (Regulation 6). Additionally, the regulations establish the authority and scope of the Organ and Tissue Authority, ensuring that it has the necessary framework to oversee and regulate organ and tissue donation and transplantation activities (Regulation 5). Violations of the regulations can lead to various penalties and consequences. While the specific penalties are not detailed in the text provided, under the Australian Organ and Tissue Donation and Transplantation Authority Act 2008, breaches of related legislative provisions can result in civil or criminal penalties. For instance, the Act provides for fines and imprisonment for offences such as unauthorised activities related to the donation and transplantation of organs and tissues. The maximum penalties can vary depending on the nature and severity of the offence, but they are intended to enforce compliance and uphold the integrity of the donation and transplantation processes. In summary, the Australian Organ and Tissue Donation and Transplantation Authority Regulations 2020 provide a structured framework for the donation and transplantation of organs and tissues in Australia. They define key terms, specify substances excluded from the definition of tissue, and outline the authority of the Organ and Tissue Authority. Compliance with these regulations is essential to ensure the ethical and effective operation of the donation and transplantation processes.

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Regulatory Standards
Instrument
Regulation
Concepts
Definitions & Interpretation
Regulatory Standards
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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.