EXPLANATORY STATEMENT
Instruments of Revocation
Research Involving Human Embryos Act 2002
Section 33 (3) of the Acts Interpretation Act 1901 provides that ‘where an Act confers powers to make, grant or issue any instrument (including rules, regulations or by-laws) the power shall, unless the contrary intention appears, 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.’
Background
The Research Involving Human Embryos Act 2002 (RIHE) received Royal Assent on 19 December 2002. The RIHE Act regulated the use of human embryos for research where those embryos were created for assisted reproductive technology and were excess to the couples’ needs.
Section 7 of the RIHE Act defines ‘corresponding State law’ in such a way as to contemplate declarations by the Minister, by notice in the Gazette, of a law of a State (which is defined to include the Australian Capital Territory and the Northern Territory) to be such a ‘corresponding State law.’ This is for constitutional reasons arising out of the agreement by COAG on 5 April 2002, as a consequence of which all States and Territories entered into an Inter-Governmental Agreement. The Inter-Governmental Agreement included a provision that ‘each State and Territory (would) use its best endeavours to submit to its Parliament, within 12 months of 19 December 2002, a Bill or Bills that would have the effect of achieving national consistency with the Commonwealth Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002.’
All jurisdictions except the Northern Territory have, accordingly, enacted legislation containing regulatory provisions identical to those of the RIHE Act as originally enacted. Each such piece of legislation has been declared variously by your predecessors, the Honourable Kevin Andrews and Julie Bishop, to be a ‘corresponding State legislation’ for the purposes of section 7 of the RIHE Act.
The Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 was assented to on 12 December 2006. The relevant provisions commence on 12 June 2007. That Act amends aspects of the regulatory scheme and, as a result the corresponding State law in each jurisdiction will cease to reflect the Commonwealth legislation from that date.
Instrument
To take account of amendments made to the RIHE Act, the Instruments of Revocation revoke the declarations that State laws relating to research involving human embryos in Queensland, New South Wales, Victoria, Tasmania, South Australia, Western Australia and the Australian Capital Territory, are corresponding State laws for the purpose of section 7 of the RIHE Act.
Consultation
No consultation was undertaken in respect of these Revocations as they are of a minor and machinery nature.
Commencement
These Instruments of Revocation take effect on and from 12 June 2007, the date on which the amendments made by the Prohibition of Human Cloning for Reproduction and the Regulation of Human embryo Research Amendment Act 2006 take effect.
Overview
The Research Involving Human Embryos Act 2002 was enacted to address the need for regulation of the use of human embryos in research, particularly those embryos that were created for assisted reproductive technology purposes and were surplus to the requirements of the couples involved. This Act was designed to establish a consistent regulatory framework across Australia, thereby ensuring that research involving human embryos adheres to national standards. The Research Involving Human Embryos Act 2002 was passed by the Parliament of Australia and aims to provide a regulatory structure that balances scientific research with ethical considerations. To align with the amendments introduced by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006, the Instruments of Revocation were issued to revoke the previous declarations of corresponding State laws, ensuring that the regulatory framework remains consistent and up-to-date with current legislative standards.
Scope and Application
The Research Involving Human Embryos Act 2002 (RIHE) applies to the use of human embryos for research, specifically those embryos created for assisted reproductive technology and deemed surplus to the needs of the couples involved. This Act is intended to provide a regulatory framework for such research activities across Australia, with a focus on ensuring ethical standards and compliance with national guidelines. The RIHE Act's jurisdiction extends to the Commonwealth, all states, and territories except the Northern Territory, as these jurisdictions have enacted corresponding legislation achieving national consistency with the RIHE Act and the Prohibition of Human Cloning Act 2002. The Act, through its declarations of corresponding State laws, ensures a unified approach to the regulation of human embryo research across Australia. These Instruments of Revocation, effective from 12 June 2007, reflect the amendments introduced by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006, thereby updating the declarations of corresponding State laws to align with the revised Commonwealth legislation.
Key Provisions
The main operative sections of the Research Involving Human Embryos Act 2002 (RIHE Act) pertain to the regulation of research involving human embryos, specifically those created for assisted reproductive technology that are in excess of the needs of the couples involved. The Act, as originally enacted, allowed for the declaration of corresponding State laws to ensure national consistency in the regulation of such research (section 7). The 2006 amendments, which took effect on 12 June 2007, introduced changes to the regulatory scheme, necessitating the revocation of previous declarations regarding corresponding State laws. This revocation ensures that the regulatory provisions in the various jurisdictions no longer mirror the Commonwealth legislation as amended.
The RIHE Act imposes specific obligations on entities and individuals involved in research with human embryos. These include adherence to the regulations set out in the Act and any corresponding State laws that have been declared. Researchers must ensure that their activities comply with the legal requirements concerning the creation, use, and storage of human embryos for research purposes. Furthermore, the Act mandates that any research involving human embryos must be approved by an ethics committee and that proper consent must be obtained from the individuals involved.
The Act also outlines various offences and penalties for breaches of its provisions. While specific penalties are not detailed in the explanatory statement, the Act generally provides for significant penalties for non-compliance. Such penalties may include substantial fines and imprisonment for serious offences, reflecting the gravity with which the regulation of human embryo research is treated. Civil consequences may also arise for breaches of the Act, including the possibility of compensation claims for any harm caused by non-compliant research activities.
The revocation of the declarations regarding corresponding State laws means that the previously consistent regulatory frameworks across jurisdictions will no longer apply uniformly. This change requires entities and individuals to remain aware of and comply with the amended provisions of the RIHE Act and any new State laws that may be enacted to address the regulatory scheme post-amendment. Failure to comply with these requirements can result in enforcement actions by relevant authorities, leading to the aforementioned civil or criminal penalties.