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Territory have, accordingly, enacted legislation containing regulatory provisions identical to those of the RIHE Act as originally enacted.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 (RIHE Act) was enacted to address the need for regulation concerning the use of human embryos in research, particularly those created for assisted reproductive technology that were in excess of the needs of the couples involved. This Act established a framework for the ethical conduct of research involving human embryos, aligning with the Commonwealth Prohibition of Human Cloning Act 2002 and the Inter-Governmental Agreement. Section 7 of the RIHE Act allows for the declaration of corresponding State laws, which all jurisdictions except the Northern Territory have enacted to achieve national consistency. However, with the passage of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006, which amended the RIHE Act, the corresponding State laws required updating. Consequently, the Instruments of Revocation were issued to revoke the previous declarations of corresponding State laws, ensuring they reflect the amended federal legislation. These revocations, which are of a minor and administrative nature, commenced on 12 June 2007, the same date as the amendments.
Scope and Application
The Research Involving Human Embryos Act 2002 governs the use of human embryos for research purposes, specifically those embryos that are in excess to the needs of couples seeking assisted reproductive technology. The Act applies to individuals and entities engaged in research activities involving human embryos, ensuring that such activities are conducted within a regulated framework. Jurisdictionally, the Act is a Commonwealth law, but it incorporates corresponding State laws to achieve national consistency across Australia. The Act’s scope includes the declaration of State laws as corresponding State laws, facilitating a unified regulatory approach. The amendments introduced by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 led to the revocation of previous declarations of corresponding State laws, effective from 12 June 2007. These revocations were administrative and did not require consultation, reflecting the minor machinery nature of the changes.
Key Provisions
The Instruments of Revocation outlined in the explanatory statement for the Research Involving Human Embryos Act 2002 (RIHE) primarily serve to revoke previous declarations that certain state laws are corresponding state laws under section 7 of the RIHE Act (section 33(3) of the Acts Interpretation Act 1901). These instruments are necessary due to amendments introduced by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006, which came into effect on 12 June 2007. The revocations apply to the state laws of Queensland, New South Wales, Victoria, Tasmania, South Australia, Western Australia, and the Australian Capital Territory.
Under the RIHE Act, the Minister has the authority to declare a state law as a corresponding state law through a notice in the Gazette (section 7). This mechanism was intended to ensure that state laws align with the federal prohibition on human cloning and the regulation of human embryo research, as agreed upon by COAG on 5 April 2002. The amendments made by the 2006 Act have altered the regulatory scheme, necessitating the revocation of earlier declarations to reflect the updated federal legislation.
The obligations imposed by the RIHE Act on parties involved in research involving human embryos include compliance with the federal and corresponding state laws. Researchers, institutions, and other entities must adhere to the regulatory provisions outlined in the RIHE Act and the corresponding state laws to ensure ethical and legal conduct in their activities. This includes obtaining necessary licences and permits, adhering to guidelines for the use and storage of human embryos, and reporting any research activities as required by the legislation.
Failure to comply with the provisions of the RIHE Act or the corresponding state laws can result in civil and criminal consequences. Offences under the RIHE Act can lead to penalties, with maximum penalties specified in the legislation for various breaches. For example, unauthorised research involving human embryos can incur significant fines and imprisonment terms, reflecting the seriousness of non-compliance with the stringent regulatory framework. It is crucial for parties to understand and fulfil their obligations to avoid facing these potential penalties and consequences.