EXPLANATORY STATEMENT
Ministerial Declaration of Corresponding State Law
Research Involving Human Embryos Act 2002
Summary
Section 7 of the Commonwealth Research Involving Human Embryos Act 2002 (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 specified parts of the Victorian Infertility Treatment Act 1995 (ITA) are such 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 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. Accordingly in 2003, specified parts of the ITA were declared to be a ‘corresponding State law’.
Subsequently, in 2006, the RIHE Act was amended in certain respects by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. A consequence of the amendments is that the ITA, in the form previously declared to be a ‘corresponding State law’, is no longer 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 The relevant ministerial declaration has, accordingly, been revoked.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 Victorian legislature amended the ITA with effect from 12 June 2007, so that it is now in a form appropriate to be a ‘corresponding State law’ for the purposes of the RIHE Act.
The Victorian amending legislation is the Infertility Treatment Amendment Act 2006. This amended Part 2A and section 166 in the ITA. The relevant provisions now mirror the provisions of the RIHE Act.
Instrument
The effect of the instrument is to declare Part 2A and section 166 of the Victorian ITA 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 Ministerial Declaration of Corresponding State Law Research Involving Human Embryos Act 2002 was enacted in 2002 to address the need for national consistency in the regulation of human embryo research across Australia. This Act empowers the Minister to declare a law of a State or Territory as a corresponding State law for the purposes of the Act. The Research Involving Human Embryos Act 2002 received Royal Assent on 19 December 2002 and was enacted by the Parliament of Australia to regulate the use of human embryos for research purposes. The policy objective of the Act is to ensure that human embryos created for assisted reproductive technology and are surplus to the needs of the couples involved are used ethically and responsibly for research.
In 2003, the Victorian Infertility Treatment Act 1995 was declared a corresponding State law for the purposes of the Research Involving Human Embryos Act 2002. However, after amendments to the Act in 2006, the Victorian Act was no longer appropriate as a corresponding State law. As a result, all jurisdictions except the Northern Territory agreed to amend their legislation to ensure national consistency in the regulation of human embryo research. The Victorian legislature subsequently amended the Infertility Treatment Act 2006, and this Ministerial Declaration was made to declare the amended Part 2A and section 166 of the Victorian Act as a corresponding State law for the purposes of the Research Involving Human Embryos Act 2002.
Scope and Application
The Ministerial Declaration of Corresponding State Law Research Involving Human Embryos Act 2002 applies to specified parts of the Victorian Infertility Treatment Act 1995, which have been declared as a corresponding State law to the Commonwealth Research Involving Human Embryos Act 2002. This declaration is concerned with the regulation of research involving human embryos created for assisted reproductive technology that are surplus to the needs of the couples involved. The Act applies to entities and persons involved in the provision of infertility treatment services in Victoria, and to the conduct and transactions related to the creation and use of human embryos for research purposes. The jurisdictional reach of this declaration is limited to the State of Victoria, although it is part of a broader national regulatory framework designed to ensure consistency across all Australian jurisdictions. There are no stated exclusions or exemptions within this declaration, but it is understood that the Act would not apply to embryos created for research purposes outside of the assisted reproductive technology context. The application of the Act may be further extended or restricted through subordinate instruments, although this specific declaration is of a minor and machinery nature and does not introduce new provisions or alter the existing scope of the ITA as it pertains to human embryo research.
Key Provisions
The main operative sections of this Ministerial Declaration (F2007L03795) are sections 7 of the Commonwealth Research Involving Human Embryos Act 2002 (RIHE Act) and the specified parts of the Victorian Infertility Treatment Act 1995 (ITA). Section 7 of the RIHE Act provides the power for the Minister to declare a law to be a corresponding State law for the purposes of the RIHE Act, and this declaration specifies that the parts of the ITA are such a corresponding State law (section 7). The specified parts of the ITA that are now considered a corresponding State law include Part 2A, which concerns the use of embryos in research, and section 166, which deals with the licensing of activities related to human embryos (F2007L03795).
The obligations and requirements imposed by this Act on the parties or entities it governs primarily concern the regulation of research involving human embryos. The Victorian ITA, as amended, must now mirror the provisions of the RIHE Act to ensure national consistency in the regulation of human embryo research. This includes ensuring that any research involving human embryos complies with the licensing requirements and ethical standards set out in the amended ITA. The obligations also include the implementation of measures to monitor and enforce compliance with these regulations, ensuring that all activities involving human embryos are conducted in accordance with the law.
There are potential offences, penalties, or consequences for breaches of the provisions of the ITA as declared to be a corresponding State law. The RIHE Act itself does not specify particular penalties but leaves it to the relevant State or Territory law to impose sanctions for non-compliance. Under the amended ITA, unauthorised activities involving human embryos can lead to civil or criminal penalties, including fines and imprisonment, depending on the severity of the breach. The exact penalties would be determined according to the provisions of the ITA.
The declaration takes effect from the day after it is registered on the Federal Register of Legislative Instruments. This means that once the declaration is officially registered, the amended parts of the ITA will be recognised as a corresponding State law, and the obligations and requirements outlined therein will come into force. The declaration ensures that the Victorian legislation is aligned with the national regulatory framework for research involving human embryos, facilitating compliance and enforcement across jurisdictions.