Commonwealth Consolidated Acts

RESEARCH INVOLVING HUMAN EMBRYOS ACT 2002 - NOTES

No. 145, 2002

Compilation No. 9

Compilation date: 14 October 2024

Includes amendments: Act No. 39, 2024

About this compilation

This compilation

This is a compilation of the Research Involving Human Embryos Act 2002 that shows the text of the law as amended and in force on 14  October 2024 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

Part 1--Preliminary

1 Short title

2 Commencement

3 Object of Act

4 Operation of Act

5 Act to bind the Crown

6 External Territories

7 Definitions

Part 2--Regulation of the use of excess ART embryos and other material

Division 1--Interpretation

8 Definitions

9 Meaning of excess ART embryo

Division 2--Offences

10 Offence--use of excess ART embryo

10A Offence--use of other embryos

10B Offence--certain activities involving use of human eggs

11 Offence--use of embryo that is not an excess ART embryo

11A Offence--use of material created under mitochondrial donation licence

12 Offence--breaching a general licence or mitochondrial donation licence condition

12A Person not liable for conduct purportedly authorised

Division 3--Embryo Research Licensing Committee of the NHMRC

13 Establishment of Committee

14 Functions of Committee

15 Powers of Committee

16 Membership of Committee

17 Terms of appointment

18 Annual report

19 Reports to Parliament

Division 4--General licences

20 Applying for a general licence

21 Determination of application by Committee

22 Notification of decision

23 Period of a general licence

24 Conditions of general licences

25 Variation of a general licence

26 Suspension or revocation of a general licence

27 Surrender of a general licence

28 Notification of variation, suspension or revocation of a general licence

Division 4A--Mitochondrial donation licences

Subdivision A--Kinds of mitochondrial donation licences and what they authorise

28A Kinds of mitochondrial donation licences

28B Carrying out activities authorised by mitochondrial donation licences

28C What a pre-clinical research and training licence authorises

28D What a clinical trial research and training licence authorises

28E What a clinical trial licence authorises

28F What a clinical practice research and training licence authorises

28G What a clinical practice licence authorises

Subdivision B--Applying for a mitochondrial donation licence

28H Applying for a mitochondrial donation licence

Subdivision C--Determining applications for mitochondrial donation licences

28J Determination of application by Committee

28K Notification of decision

28L Matters to be specified in a mitochondrial donation licence

28M Period of a mitochondrial donation licence

Subdivision D--Conditions of mitochondrial donation licences

28N Conditions of mitochondrial donation licences generally

28P Additional condition of clinical trial licences and clinical practice licences--Committee approval before creation or placement of embryo

28Q Other conditions of clinical trial licences and clinical practice licences

Subdivision E--Ongoing requirements for holders of mitochondrial donation licences

28R Clinical trial licences and clinical practice licences--information about donors and children

28S Clinical trial licences and clinical practice licences--requirement for ongoing monitoring protocols and to notify adverse events

28T Record-keeping obligations for all holders of mitochondrial donation licences

Subdivision F--Variation, suspension, revocation and surrender

28U Variation of a mitochondrial donation licence

28V Suspension or revocation of a mitochondrial donation licence

28W Surrender of a mitochondrial donation licence

28X Notification of variation, suspension or revocation of a mitochondrial donation licence

Division 5--Protection and disclosure of information

29 NHMRC Licensing Committee to make certain information publicly available

29A Mitochondrial Donation Donor Register

30 Confidential commercial information may only be disclosed in certain circumstances

Division 6--Review provisions

31 Meaning of terms

32 Review of decisions

Part 3--Monitoring powers

33 Appointment of inspectors

34 Identity card

35 Powers available to inspectors for monitoring compliance

36 Monitoring powers

37 Power to secure

37A Monitoring warrants

37B Details of warrant to be given to occupier etc.

37C Announcement before entry

37D Occupier entitled to be present during search

38 Inspector must produce identity card on request

39 Consent

40 Compensation for damage

41 Extended operation of Part

Part 4--Commonwealth/State arrangements

42 Operation of State laws

43 Conferral of functions on Commonwealth officers and bodies

44 When duty imposed

45 Review of certain decisions

Part 5--Miscellaneous

Division 1--Arrangements relating to clinical trials of mitochondrial donation techniques

46 Arrangements relating to clinical trials of mitochondrial donation techniques

46A Terms and conditions relating to clinical trial arrangements

46B Minister or Secretary may delegate powers in relation to arrangements

46C Relationship of this Division with the Public Governance, Performance and Accountability Act 2013

46D Executive power of the Commonwealth

Division 2--Other miscellaneous matters

47 Interaction with the Gene Technology Act 2000

47A Immunity from civil actions relating to mitochondrial donation licences

47B Review of operation of Act every 7 years

48 Regulations

Endnotes

Endnote 1--About the endnotes

Endnote 2--Abbreviation key

Endnote 3--Legislation history

Endnote 4--Amendment history

Endnotes

Endnote 1--About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1--About the endnotes

Endnote 2--Abbreviation key

Endnote 3--Legislation history

Endnote 4--Amendment history

Abbreviation key--Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history--Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section  15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and "(md not incorp)" is added to the amendment history.

Endnote 2--Abbreviation key

 

ad = added or inserted	o = order(s)
am = amended	Ord = Ordinance
amdt = amendment	orig = original
c = clause(s)	par = paragraph(s)/subparagraph(s)
C[x] = Compilation No. x	/sub-subparagraph(s)
Ch = Chapter(s)	pres = present
def = definition(s)	prev = previous
Dict = Dictionary	(prev ... ) = previously
disallowed = disallowed by Parliament	Pt = Part(s)
Div = Division(s)	r = regulation(s)/rule(s)
ed = editorial change	reloc = relocated
exp = expires/expired or ceases/ceased to have	renum = renumbered
effect	rep = repealed
F = Federal Register of Legislation	rs = repealed and substituted
gaz = gazette	s = section(s)/subsection(s)
LA = Legislation Act 2003	Sch = Schedule(s)
LIA = Legislative Instruments Act 2003	Sdiv = Subdivision(s)
(md) = misdescribed amendment can be given	SLI = Select Legislative Instrument
effect	SR = Statutory Rules
(md not incorp) = misdescribed amendment	Sub-Ch = Sub-Chapter(s)
cannot be given effect	SubPt = Subpart(s)
mod = modified/modification	underlining = whole or part not
No. = Number(s)	commenced or to be commenced

Endnote 3--Legislation history

 

Act	Number and year	Assent	Commencement	Application, saving and transitional provisions
Research Involving Human Embryos Act 2002	145, 2002	19 Dec 2002	s 3-9 and 13-48: 16 Jan 2003 (s 2(1) items 2, 4) s 10-12: 19 June 2003 (s 2(1) item 3) Remainder: 19 Dec 2002 (s 2(1) item 1)
National Health and Medical Research Council Amendment Act 2006	50, 2006	9 June 2006	Sch 1 (items 116-121: 1 July 2006 (s 2(1) item 2)	--
Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006	172, 2006	12 Dec 2006	Sch 2 and 3: 12 June 2007 (s 2(1) item 2)	Sch 3
Same-Sex Relationships (Equal Treatment in Commonwealth Laws--General Law Reform) Act 2008	144, 2008	9 Dec 2008	Schedule 9 (item 2): 10 Dec 2008 (s 2(1) item 24)	--
Public Governance, Performance and Accountability (Consequential and Transitional Provisions) Act 2014	62, 2014	30 June 2014	Sch 11 (items 122, 123) and Sch 14: 1 July 2014 (s 2(1) items 6, 14)	Sch 14
as amended by
Public Governance and Resources Legislation Amendment Act (No. 1) 2015	36, 2015	13 Apr 2015	Sch 2 (items 7-9) and Sch 7: 14 Apr 2015 (s 2)	Sch 7
as amended by
Acts and Instruments (Framework Reform) (Consequential Provisions) Act 2015	126, 2015	10 Sept 2015	Sch 1 (item 486): 5 Mar 2016 (s 2(1) item 2)	--
Acts and Instruments (Framework Reform) (Consequential Provisions) Act 2015	126, 2015	10 Sept 2015	Sch 1 (item 495): 5 Mar 2016 (s 2(1) item 2)	--
Statute Update Act 2016	61, 2016	23 Sept 2016	Sch 2 (items 92-94): 21 Oct 2016 (s 2(1) item 1)	--
Mitochondrial Donation Law Reform (Maeve's Law) Act 2022	26, 2022	1 Apr 2022	Sch 1 (items 9-18, 33-105, 117, 118): 1 Oct 2022 (s 2(1) item 2)	Sch 1 (items 117, 118)
Financial Framework (Supplementary Powers) Amendment Act 2024	27, 2024	30 May 2024	Sch 1 (items 12-14): 31 May 2024 (s 2(1) item 2)	--
Administrative Review Tribunal (Consequential and Transitional Provisions No. 2) Act 2024	39, 2024	31 May 2024	Sch 15 (items 19, 35): 14 Oct 2024 (s 2(1) item 2)	--

Endnote 4--Amendment history

 

Provision affected	How affected
Part 1
s. 3.....................	am. No. 172, 2006
s 4.....................	am No 26, 2022
s 7.....................	am No 172, 2006; No 144, 2008; No 26, 2022
Part 2
Part 2 heading.............	rs No 172, 2006; No 26, 2022
Division 1
s 8.....................	am No 50, 2006; No 172, 2006 (md incorp); No 26, 2022
Division 2
s 10....................	am No 61, 2016; No 26, 2022
s 10A...................	ad No 172, 2006
	am No 61, 2016; No 26, 2022
s 10B...................	ad No 172, 2006
	am No 61, 2016; No 26, 2022
s 11....................	am No 172, 2006; No 61, 2016; No 26, 2022
s 11A...................	ad No 26, 2022
s 12....................	am No 61, 2016; No 26, 2022
s 12A...................	ad No 172, 2006
	am No 26, 2022
Division 3
s. 13....................	am. No. 50, 2006; No 62, 2014
s 14....................	am No 26, 2022
s. 16....................	am. No. 172, 2006
s. 18....................	am. No. 50, 2006; No 62, 2014
s 19....................	am No 26, 2022
Division 4
Division 4 heading..........	rs No 26, 2022
s 20....................	am No 172, 2006; No 26, 2022
s 21....................	am No 145, 2002; No 50, 2006; No 172, 2006; No 26, 2022
s 22....................	am No 26, 2022
s 23....................	am No 26, 2022
s 24....................	am No 145, 2002; No 172, 2006; No 26, 2022
s 25....................	am No 26, 2022
s 26....................	am No 26, 2022
s 27....................	am No 26, 2022
s 28....................	am No 26, 2022
Division 4A
Division 4A...............	ad No 26, 2022
Subdivision A
s 28A...................	ad No 26, 2022
s 28B...................	ad No 26, 2022
s 28C...................	ad No 26, 2022
s 28D...................	ad No 26, 2022
s 28E...................	ad No 26, 2022
s 28F...................	ad No 26, 2022
s 28G...................	ad No 26, 2022
Subdivision B
s 28H...................	ad No 26, 2022
Subdivision C
s 28J....................	ad No 26, 2022
s 28K...................	ad No 26, 2022
s 28L...................	ad No 26, 2022
s 28M...................	ad No 26, 2022
Subdivision D
s 28N...................	ad No 26, 2022
s 28P...................	ad No 26, 2022
s 28Q...................	ad No 26, 2022
Subdivision E
s 28R...................	ad No 26, 2022
s 28S...................	ad No 26, 2022
s 28T...................	ad No 26, 2022
Subdivision F
s 28U...................	ad No 26, 2022
s 28V...................	ad No 26, 2022
s 28W...................	ad No 26, 2022
s 28X...................	ad No 26, 2022
Division 5
Division 5 heading..........	rs No 26, 2022
s 29....................	am No 172, 2006; No 26, 2022
s 29A...................	ad No 26, 2022
s 30....................	am No 61, 2016
Division 6
s 31....................	am No 172, 2006; No 26, 2022; No 39, 2024
s 32....................	am No 172, 2006; No 26, 2022; No 39, 2024
Part 3
s 34....................	am No 61, 2016
s 35....................	am No 172, 2006; No 26, 2022
s 36....................	am. No. 172, 2006
s 37....................	am. No. 172, 2006
s 37A...................	ad. No. 172, 2006
s 37B...................	ad. No. 172, 2006
s 37C...................	ad. No. 172, 2006
s 37D...................	ad. No. 172, 2006
Part 4
s 45....................	am No 39, 2024
Part 5
Part 5 heading.............	rs No 26, 2022
Division 1
Division 1................	rs No 26, 2022
s 46....................	rs No 26, 2022
s 46A...................	ad No 26, 2022
s 46B...................	ad No 26, 2022
s 46C...................	ad No 26, 2022
	am No 27, 2024
	ed C8
s 46D...................	ad No 26, 2022
Division 2
Division 2................	rs No 26, 2022
s 47....................	am No 50, 2006
	rs No 26, 2022
s 47A...................	ad No 172, 2006
	rs No 26, 2022
s 47B...................	ad No 172, 2006
	rs No 26, 2022
s 47C...................	ad No 172, 2006
	rep No 26, 2022
Division 3 heading..........	rep No 26, 2022
s 48....................	am No 26, 2022