Research Involving Human Embryos Act 2002
No. 145, 2002
Compilation No. 9
Compilation date: 14 October 2024
Includes amendments: Act No. 39, 2024
About this compilation
This compilation
This is a compilation of the Research Involving Human Embryos Act 2002 that shows the text of the law as amended and in force on 14 October 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
Part 1—Preliminary
1 Short title
2 Commencement
3 Object of Act
4 Operation of Act
5 Act to bind the Crown
6 External Territories
7 Definitions
Part 2—Regulation of the use of excess ART embryos and other material
Division 1—Interpretation
8 Definitions
9 Meaning of excess ART embryo
Division 2—Offences
10 Offence—use of excess ART embryo
10A Offence—use of other embryos
10B Offence—certain activities involving use of human eggs
11 Offence—use of embryo that is not an excess ART embryo
11A Offence—use of material created under mitochondrial donation licence
12 Offence—breaching a general licence or mitochondrial donation licence condition
12A Person not liable for conduct purportedly authorised
Division 3—Embryo Research Licensing Committee of the NHMRC
13 Establishment of Committee
14 Functions of Committee
15 Powers of Committee
16 Membership of Committee
17 Terms of appointment
18 Annual report
19 Reports to Parliament
Division 4—General licences
20 Applying for a general licence
21 Determination of application by Committee
22 Notification of decision
23 Period of a general licence
24 Conditions of general licences
25 Variation of a general licence
26 Suspension or revocation of a general licence
27 Surrender of a general licence
28 Notification of variation, suspension or revocation of a general licence
Division 4A—Mitochondrial donation licences
Subdivision A—Kinds of…
Overview
The Research Involving Human Embryos Act 2002 was enacted to address ethical and regulatory concerns arising from scientific advancements in human reproduction, particularly involving human embryos created through assisted reproductive technology (ART). The Act was passed by the Parliament of Australia and received Royal Assent on 19 December 2002, with various sections coming into force at staggered dates up until 19 June 2003. The primary objective of the Act is to regulate activities involving human embryos to ensure ethical considerations are met and to maintain public confidence in scientific research and medical advancements. The Act applies to constitutional corporations, trade or commerce between Australia and other places, and matters within the legislative power of the Commonwealth. It also binds the Crown in its various capacities, extends to all external territories, and includes detailed definitions relevant to its scope, such as "constitutional corporation," "human embryo," and "excess ART embryo." The Act established the Embryo Research Licensing Committee of the National Health and Medical Research Council (NHMRC) to oversee licensing and regulatory functions, ensuring that research and clinical practices involving human embryos are conducted responsibly and ethically.
Scope and Application
The Research Involving Human Embryos Act 2002 governs certain activities involving human embryos created by assisted reproductive technology (ART) or other means, with a specific focus on ethical and scientific concerns related to human reproduction. This Act applies to constitutional corporations, activities conducted in the course of constitutional trade or commerce, matters within the legislative power of the Commonwealth, Commonwealth authorities, and purposes related to statistics collection and dissemination. It also extends to every external territory of Australia. The Act regulates the use of excess ART embryos and other material, establishing offences for unauthorised use, creation, and manipulation of human embryos. It sets up the Embryo Research Licensing Committee of the National Health and Medical Research Council (NHMRC) to oversee the issuance of general licences and mitochondrial donation licences. These licences permit various research and clinical activities involving human embryos under specific conditions and oversight. The Act also addresses the disclosure and protection of information, the review of certain decisions, and the appointment of inspectors for compliance monitoring. Additionally, it outlines the interaction with state laws, the review of the Act's operation, and the making of regulations necessary for its implementation.
Key Provisions
- The Research Involving Human Embryos Act 2002 (the Act) regulates activities involving the use of human embryos created by assisted reproductive technology (ART) or by other means, particularly focusing on excess ART embryos. Key provisions include the definition of "excess ART embryo," which refers to embryos created for ART treatment that are not needed by the woman for whom they were created and her spouse. The Act outlines offences for the use of excess ART embryos, other embryos, and human eggs, including penalties of imprisonment for up to 5 years. Additionally, it prohibits certain activities involving human eggs and the use of material created under mitochondrial donation licences, unless authorised by a general licence or a mitochondrial donation licence.
- Obligations under the Act include obtaining proper consent from responsible persons before using excess ART embryos or human eggs, creating or using other embryos, or creating or using material under a mitochondrial donation licence. The Act also mandates that activities must be in accordance with any restrictions on such consent and must be approved by a Human Research Ethics Committee. The Act further imposes specific conditions on general licences and mitochondrial donation licences, including reporting, monitoring, and record-keeping obligations. Licence holders are required to ensure compliance with these conditions and may face suspension, revocation, or variation of their licences for non-compliance.
- Offences under the Act include the intentional use of excess ART embryos or other embryos without authorisation, the creation or use of human eggs outside the body of a woman for research purposes without a general licence, and the use of material created under a mitochondrial donation licence without permission. Penalties for these offences include imprisonment for up to 5 years. Additionally, there are specific offences related to breaching the conditions of general licences or mitochondrial donation licences, with the same penalty of imprisonment for up to 5 years. The Act also provides for civil and criminal consequences for the disclosure of confidential commercial information and the unauthorised disclosure of information from the Mitochondrial Donation Donor Register, with penalties of imprisonment for up to 2 years.
- Area of Law
- Medical Law
- Regulatory Law
- Research Ethics
- Biotechnology Law
- Genetic Engineering Law
- Human Rights Law
- Instrument
- Act
- Concepts
- Definitions & Interpretation
- Commencement Provisions
- Repeal & Amendment
- Enforcement Powers
- Regulatory Standards
- Monitoring powers
- Review & Sunset Clauses
- Licensing & Registration
- Offence Provisions
- Transitional Provisions
- Reporting & Disclosure Obligations
- Extraterritorial Application
- Administrative Discretion
