EXPLANATORY STATEMENT
Select Legislative Instrument 2007 No. 255
Subject: Research Involving Human Embryos Act 2002
Research Involving Human Embryos Amendment Regulations 2007 (No. 1)
Subsection 48(1) of the Research Involving Human Embryos Act 2002 (the Act) provides that the Governor-General may make regulations, prescribing matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.
In December 2006, the Parliament passed the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006, which amended the Act to expand the range of activities permitted under licences issued by the National Health and Medical Research Council (NHMRC) Embryo Research Licensing Committee.
The amendments allow a person to apply to the NHMRC Embryo Research Licensing Committee for a licence permitting the following additional activities:
- creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos;
- creation of human embryos (by a process other than fertilisation of human egg by human sperm) containing genetic material provided by more than 2 persons, and use of such embryos;
- creation of human embryos using precursor cells from a human embryo or a human foetus, and use of such embryos;
- research and training involving the fertilisation of a human egg, up to but not including the first mitotic division, outside the body of a woman for the purposes of research or training in Assisted Reproductive Technology (ART);
- creation of hybrid embryos by the fertilisation of an animal egg by human sperm and use of such embryos up to, but not including, the first mitotic division provided that the creation or use is for the purposes of testing sperm quality and will occur in an accredited ART centre.
The CEO of the NHMRC issued the National Statement on Ethical Conduct in Human Research in March 2007and the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research in June 2007. Both of these documents are updated versions of ethical guidelines currently prescribed by the Research Involving Human Embryos Regulations 2003 (the Principal Regulations).
The purpose of the Regulations is to make consequential amendments to the Principal Regulations arising from the amendments to the Act and to replace references to earlier versions of ethical guidelines with references to the revised versions of the ethical guidelines.
Details of the Regulations are set out in the Attachment.
Subsection 48(2) of the Act requires that before making regulations under the Act, the Minister must be satisfied that the States have been consulted in relation to the regulations and that the regulations have been prepared having regard to the views expressed by the States in those consultations. “State” is defined in the Act to include the Australian Capital Territory and the Northern Territory.
The Act specifies no other conditions need to be satisfied before the power to make the Regulations may be exercised.
The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Regulations commence on 24 August 2007.
ATTACHMENT
Details of the Research Involving Human Embryos Amendment Regulations 2007 (No. 1)
Regulation 1 identifies the Regulations as the Research Involving Human Embryos Amendment Regulations 2007 (No. 1).
Regulation 2 provides that the Regulations commences on 24 August 2007.
Regulation 3 specifies that Schedule 1 amends the Research Involving Human Embryos Regulations 2003 (the Principal Regulations).
Schedule 1 – Amendments
Item 1 amends regulation 1.3 of the Principal Regulations to define the phrase “ART Guidelines” to mean the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research since these guidelines are mentioned a number of times in the Principal Regulations.
Item 2 amends the heading of Part 2 of the Principal Regulations to correspond with the heading of Part 2 of the Act.
Item 3 amends regulation 2.1A of the Principal Regulations to correct a reference to a paragraph that no longer exists in the Act because of recent amendments to the Act. Item 3 will also replace a reference to an earlier version of the ART Guidelines with a reference to the revised version of the ART Guidelines.
Item 4 amends regulation 2.2 to replace references to superseded ethical guidelines with references to the revised versions of the guidelines.
Overview
The Research Involving Human Embryos Amendment Regulations 2007 (No. 1) were enacted to update the Research Involving Human Embryos Regulations 2003 in light of amendments introduced by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. This Act was passed by the Australian Parliament to address the evolving landscape of human embryo research, thereby broadening the scope of permissible activities under licences issued by the NHMRC Embryo Research Licensing Committee. These activities now encompass the creation of human embryos by methods other than fertilisation, the creation of embryos containing genetic material from more than two persons, research using precursor cells from human embryos or foetuses, and other specific research practices. The Regulations aim to ensure that the legal framework remains consistent with the most recent ethical guidelines, specifically updating references to the National Statement on Ethical Conduct in Human Research and the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research. This legislative update was necessary to align the regulatory environment with the current ethical standards and legislative intent, ensuring that the law continues to provide a clear and compliant framework for human embryo research in Australia.
Scope and Application
The Research Involving Human Embryos Amendment Regulations 2007 (No. 1) amends the Research Involving Human Embryos Regulations 2003 to reflect legislative changes introduced by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. These changes expand the range of activities permitted under licences issued by the National Health and Medical Research Council (NHMRC) Embryo Research Licensing Committee. The Act applies to any person or entity seeking to conduct research involving human embryos, with a focus on activities such as the creation of human embryos through methods other than fertilisation, the use of such embryos in research, and the fertilisation of a human egg for research or training purposes in Assisted Reproductive Technology (ART). The Regulations apply nationally across Australia, including the Australian Capital Territory and the Northern Territory. The Regulations incorporate updated ethical guidelines, replacing references to superseded guidelines with references to the revised versions of the National Statement on Ethical Conduct in Human Research and the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research. The Regulations were made after consulting with the states, as required by the Act.
Key Provisions
The Research Involving Human Embryos Amendment Regulations 2007 (No. 1) amend the Research Involving Human Embryos Regulations 2003, updating them to reflect changes in the Research Involving Human Embryos Act 2002. The most significant changes introduced by the Amendment Regulations are related to the types of activities that can be carried out under a licence issued by the National Health and Medical Research Council (NHMRC) Embryo Research Licensing Committee. According to the Act, the NHMRC can now permit activities such as the creation of human embryos through means other than fertilisation of a human egg by human sperm (section 2.1A), the creation of human embryos containing genetic material from more than two people (section 2.1B), the creation of human embryos using precursor cells from a human embryo or foetus (section 2.1C), and the fertilisation of a human egg outside the body of a woman for research or training purposes (section 2.1D). The Act also allows for the creation of hybrid embryos by fertilising an animal egg with human sperm for the purpose of testing sperm quality (section 2.1E). These activities were previously prohibited and now require a licence to be carried out.
The Amendment Regulations impose several obligations on the parties involved in embryo research. Firstly, any person wishing to conduct activities that require a licence under the Act must apply to the NHMRC Embryo Research Licensing Committee and obtain the appropriate licence (regulation 2.1). The Committee has the authority to grant, refuse, or revoke a licence based on its assessment of the application and any relevant ethical considerations (regulation 2.2). Researchers must also adhere to the updated ethical guidelines outlined in the National Statement on Ethical Conduct in Human Research and the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (regulation 2.3). These guidelines provide a framework for ensuring that research activities are conducted in an ethical and responsible manner.
Failure to comply with the provisions of the Act and the Amendment Regulations can result in both civil and criminal penalties. The Act provides for a maximum penalty of 10,000 penalty units or imprisonment for five years, or both, for any person who engages in an activity that is prohibited under the Act without a valid licence (section 16). The Act also allows for the imposition of fines and other penalties for breaches of the ethical guidelines or other regulatory requirements (section 17). In addition, the Amendment Regulations include specific penalties for non-compliance with the updated ethical guidelines, such as the suspension or revocation of a licence (regulation 2.4). These penalties are intended to ensure that embryo research activities are conducted in accordance with the law and the relevant ethical standards.