EXPLANATORY STATEMENT
Research Involving Human Embryos Act 2002
Declaration of ‘corresponding State law’
Summary
Section 7(1) of the Commonwealth Research Involving Human Embryos Act 2002 (the RIHE Act) confers power on the Minister to declare a law to be a corresponding State law for the purposes of the RIHE Act. This Ministerial declaration provides that the Australian Capital Territory Human Cloning an Embryo Research Act 2004, as amended by the Human Cloning and Embryo Research Amendment Act 2008 (the ACT Act) is a corresponding State law.
Background
The RIHE Act, which received Royal Assent on 19 December 2002, regulates the use of human embryos for research where those embryos have been created for assisted reproductive technology and are excess to the couples’ needs. Section 7(1) of the RIHE Act provides that a ‘corresponding State law’ is, in effect, a law of a State (or Territory) which the Minister has declared to be corresponding.
Pursuant to an agreement reached by all jurisdictions at a Council of Australian Governments (CoAG) meeting in April 2002, each State and the Australian Capital Territory (ACT) enacted its own legislation to achieve national consistency with the RIHE Act. After assessment by the Commonwealth, each such State and Territory Act was declared to be a corresponding State law for the purposes of the RIHE Act. The ACT Act was declared to be a ‘corresponding State law’ on 13 August 2004.
In 2006, the RIHE Act was amended by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. Consequently, the ACT Act was no longer considered appropriate to be a ‘corresponding State law.’ The relevant ministerial declaration has, accordingly, been revoked.
As a response to the Commonwealth’s changes to the RIHE Act, all jurisdictions (except the Northern Territory) agreed at a CoAG meeting in April 2007 to amend legislation to ensure national consistency in regard to the regulation of human embryo research. The Australian Capital Territory legislature amended the ACT Act with effect from 18 April 2008, so that it is now in a form appropriate to be a ‘corresponding State law’ for the purposes of the RIHE Act.
The ACT amending legislation is the Human Cloning and Embryo Research Amendment Act 2008.
Instrument
The effect of the instrument is to declare the ACT Act to be a corresponding State law for the purposes of the RIHE Act.
Consultation
No consultation was undertaken in respect of this declaration as it is of a minor and machinery nature.
Commencement
This declaration is to take effect from the day after it is registered on the Federal Register of Legislative Instruments.
Overview
The Research Involving Human Embryos Act 2002 was enacted to regulate the use of human embryos for research purposes, specifically those embryos created for assisted reproductive technology and deemed surplus to the requirements of the couples involved. This Act was designed to establish a uniform national framework for the ethical and scientific governance of human embryo research, thereby addressing the need for a cohesive approach across all jurisdictions in Australia. The Commonwealth Research Involving Human Embryos Act 2002 empowers the Minister to declare a law as a corresponding State law, ensuring that each state or territory's legislation aligns with the national regulatory standards. This legislative instrument, issued pursuant to section 7(1) of the RIHE Act, designates the Australian Capital Territory Human Cloning and Embryo Research Act 2004, as amended by the Human Cloning and Embryo Research Amendment Act 2008, as a corresponding State law, reflecting the policy objective of achieving national consistency in the regulation of human embryo research.
Scope and Application
The Research Involving Human Embryos Act 2002 (RIHE Act) applies to the regulation of the use of human embryos for research purposes, specifically those embryos that have been created for assisted reproductive technology and are in excess of the needs of the relevant couple. The Act establishes a framework for the conduct of such research within Australia and allows for the declaration of corresponding State laws that provide a consistent regulatory approach across jurisdictions. In this context, the Australian Capital Territory Human Cloning and Embryo Research Act 2004, as amended by the Human Cloning and Embryo Research Amendment Act 2008, has been declared as a corresponding State law, aligning with the national objectives of the RIHE Act. This declaration ensures that the regulation of human embryo research in the ACT adheres to the national standards set by the Commonwealth, thereby facilitating a uniform approach across Australia. The jurisdictional reach of the Act is national, with individual States and Territories enacting corresponding laws to achieve this consistency. Any exclusions, exemptions, or thresholds are specified within the respective State or Territory legislation, such as the ACT Act, which is subject to the oversight and amendments of the Commonwealth to maintain alignment with the RIHE Act.
Key Provisions
The Research Involving Human Embryos Act 2002 (RIHE Act) is a pivotal piece of legislation in Australia that regulates the use of human embryos for research, particularly focusing on embryos that are surplus to the needs of couples undergoing assisted reproductive technology (ART). Section 7(1) of the RIHE Act provides the Minister with the authority to declare a State or Territory law as a corresponding State law for the purposes of the Act. The relevant declaration, as per the explanatory statement, identifies the Australian Capital Territory Human Cloning and Embryo Research Act 2004, as amended by the Human Cloning and Embryo Research Amendment Act 2008 (the ACT Act), as such a corresponding State law.
This declaration essentially means that the ACT Act now aligns with the requirements and provisions of the RIHE Act, ensuring that the regulation of human embryo research in the ACT is consistent with the national framework. The ACT Act was initially declared as a corresponding State law in August 2004. However, following amendments to the RIHE Act in 2006, the ACT Act was no longer considered appropriate. In response to these changes, the ACT legislature amended the ACT Act in 2008 to restore its status as a corresponding State law. This amendment was in line with the national approach to the regulation of human embryo research, as agreed upon by all jurisdictions (excluding the Northern Territory) at a Council of Australian Governments (CoAG) meeting in April 2007.
The obligations imposed by the RIHE Act on the entities it governs include ensuring that any research involving human embryos complies with the regulations set out in the Act and any corresponding State laws, such as the ACT Act. This involves obtaining necessary permits and approvals, adhering to ethical standards, and ensuring that research is conducted responsibly and with respect to ethical considerations. The Act also mandates that researchers and institutions must maintain records of their activities and be subject to audits to ensure compliance with the law.
Failure to comply with the provisions of the RIHE Act or the corresponding State laws can lead to significant consequences. Offences under the Act may result in both civil and criminal penalties. The specific penalties can vary, but they may include substantial fines and imprisonment for serious breaches. For instance, section 21 of the RIHE Act stipulates that a person who contravenes the Act may be liable to a fine of up to $100,000 or imprisonment for up to five years, or both. Additionally, entities found in breach may face further penalties, including the revocation of permits or licenses necessary to conduct research involving human embryos.