EXPLANATORY STATEMENT
Select Legislative Instrument 2005 No. 206
Issued by the Authority of the Minister for Ageing
Research Involving Human Embryos Act 2002
Research Involving Human Embryos Amendment Regulations 2005 (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 matters necessary or convenient to be prescribed for carrying out or giving effect to the Act.
The Act regulates the use of embryos, defined at section 9 of the Act as ‘excess ART embryos’, which have been created by assisted reproductive technology (ART) and which are excess to the ART needs of a couple on the ART program. Subsection 13(1) of the Act also establishes the Embryo Licensing Committee (the Licensing Committee) of the National Health and Medical Research Council (NHMRC) which has the function, pursuant to
section 14, of issuing licences for the use of excess ART embryos.
The purpose of the Regulations is to amend the Research Involving Human Embryos Regulations 2003 (the Principal Regulations) to:
- prescribe the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research as the appropriate guidelines to be applied in determining whether proper consent to the particular use of excess ART embryos has been obtained; and
2. replace the name of the National Caucus of Disability Consumer Organisations with the Australian Federation of Disability Organisations in the list of bodies required to be consulted by the Minister before appointing members of the Licensing Committee, as the body changed names on 17 October 2003.
Paragraph 24(1)(a) of the Act provides that it is a condition of a licence that responsible persons must give proper consent before the excess ART embryo can be used pursuant to the licence. Section 8 of the Act defines proper consent as being consent obtained in accordance with either the Ethical Guidelines on Assisted Reproductive Technology (1996) issued by the NHMRC or, if other guidelines are issued by the NHMRC, those other guidelines. At its 154th Session in 2004, the NHMRC issued guidelines entitled Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research to replace the Ethical Guidelines on Assisted Reproductive Technology (1996).
Subsection 16(3)(a) of the Act requires the Minister to seek nominations from ‘such bodies as are prescribed by the regulations’ before appointing a person to the Licensing Committee. Regulation 2.1 of the Principal Regulations prescribes for this purpose ‘each body mentioned’ in column 2 of an item in Schedule 1 to the Act. Item 10 of Schedule 1 lists the ‘National Caucus of Disability Consumer Organisations’. This body has, since the Principal Regulations were made, changed its name to ‘Australian Federation of Disability Organisations’.
Section 48 of the Act provides that, before the Governor-General makes regulations under the Act, the Minister must be satisfied that the States have been consulted in relation to the proposed regulations and that the proposed regulations have been prepared having regard to views expressed by the States in those consultations. Section 7 of the Act provides that, for the purposes of the Act, ‘State’ includes the Australian Capital Territory and the Northern Territory.
On 5 April 2005, the Minister wrote to her counterparts in all States and both Territories, forwarding for consideration a draft copy of the proposed Regulations. Each State and Territory has responded in writing indicating its agreement with the content of the proposed Regulations.
Details of the proposed Regulations are set out in the Attachment.
The proposed Regulations would be a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The proposed Regulations would commence on the day after they are registered on the Federal Register of Legislative Instruments.
ATTACHMENT
Details of the proposed Research Involving Human Embryos Amendment Regulations 2005 (No. 1)
Regulation 1 provides that the Regulations may be cited as the Research Involving Human Embryos Amendment Regulations 2005 (No. 1).
Regulation 2 provides that the Regulations commence on the day after they are registered.
Regulation 3 provides that Schedule 1 amends the Research Involving Human Embryos Regulations 2003.
Schedule 1 - Amendments
Item [1] – regulation 2.1A
Item [1] of Schedule 1 inserts a new regulation 2.1A which prescribes the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research, which were issued by the NHMRC in 2004, as the applicable guidelines for the purposes of paragraph (b) of the definition of ’proper consent’ in section 8 of the Research Involving Human Embryos Act 2002. That Act provides, in paragraph (a) of the definition, that ’proper consent’ must be obtained in accordance with the Ethical Guidelines on Assisted Reproductive Technology unless alternative guidelines are issued by the NHMRC and prescribed. The prescribing of those alternative guidelines is achieved by item [1] of Schedule 1.
Item [2] – regulation 2.2(a)
Item [2] of Schedule 1 substitutes the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research for the Ethical Guidelines on Assisted Reproductive Technology in paragraph 2.2(a) of the Research Involving Human Embryos Regulations 2003. The guidelines being substituted by item [2] were made by the NHMRC in 2004 and they supersede the guidelines presently referred to in paragraph 2.2(a). The paragraph 2.2(a) guidelines are guidelines to which the Embryo Research Licensing Committee of the NHMRC must have regard pursuant to paragraph 21(4)(c) of the Research Involving Human Embryos Act 2002 when deciding whether to issue a licence.
Item [3] – Item 10 of Schedule 1
Item [3] of Schedule 1 substitutes the Australian Federation of Disability Organisations in item 10 of Schedule 1 of the Research Involving Human Embryos Regulations 2003 for the presently listed National Caucus of Disability Consumer Organisations because that body has changed its name. That body is a body which the Minister must consult pursuant to paragraph 16(3)(a) of the Research Involving Human Embryos Act 2002 before appointing a member of the Embryo Research Licensing Committee of the NHMRC.