Western Australia
Human Reproductive Technology Act 1991
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Endnotes, Compilation table, and Table of provisions that have not come into operation
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Notes amongst text (italicised and within square brackets)
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·removed (because it was repealed or deleted from the law); or
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Reprinted under the Reprints Act 1984 as at 12 July 2002
Human Reproductive Technology Act 1991
CONTENTS
Part 1 — Preliminary
Division 1 — Introduction
1.Short title3
2.Commencement3
3.Interpretation and application3
4.The objects of this Act13
5.Administration of this Act14
Division 2 — Specific offences
6.Unlicensed practices17
7.Offences relating to reproductive technology18
Part 2 — The Council
8.Establishment of Council21
9.Nominations, and recommendations, for membership22
10.Committees23
11.Delegation by the Council24
12.Relationship of the Council to the Minister25
13.Powers, and relationship to the Council, of the Commissioner of Health26
14.Functions of the Council29
Part 3 — The Code of Practice
Division 1 — Compilation of the Code
15.The concept of the Code of Practice33
16.The implementation of the Code of Practice35
17.Matters which shall be dealt with by the Code, subject to exception by way of regulations37
18.Matters which may be dealt with in the Code37
19.Principles to be embodied in the Code39
20.Principles applicable to projects of research39
21.The Code and directions, generally41
Division 2 — Consents
22.Consents, generally43
23.When procedures may be carried out46
24.Storage47
Division 3 — Rights of control, etc.
25.Rights in relation to gametes49
26.Control, dealing and disposal in relation to an egg in the process of fertilisation or an embryo50
Part 4 — Licensing, etc.
Division 1 — Licensing
27.Licences, and the person responsible52
28.Exemptions relating to artificial insemination53
29.Applications, generally55
30.Interim authorisations and transitional directions57
Division 2 — Directions and conditions
31.Directions, generally59
32.Terms, conditions and directions specifically applicable60
33.Conditions applicable to all licences and exemptions61
34.Contravention of a condition or direction64
35.Notice and coming into operation of directions and conditions64
Division 3 — Suspension or cancellation, and disciplinary action
36.Suspension or cancellation of a licence or exemption, other than on disciplinary grounds65
37.Summary determinations66
38.Disciplinary action67
39.Matters that may be the subject of disciplinary action72
40.Penalties73
41.Effect on pending procedures75
Division 4 — Supreme Court powers
42.Appeals76
43.Restraint of continuing contravention78
Division 5 — Information
44.Records of procedures79
45.Registers of identity82
46.Access to information83
47.Annual returns, etc.84
48.Exchange of information85
49.Confidentiality85
50.False or misleading statements and records87
Division 6 — Supervision, etc.
51.Supervision88
52.Licensee liable for act of employee, etc.90
53.Offences by bodies corporate and partnerships91
Part 5 — Enforcement
Division 1 — Powers of authorised officers
54.Powers of authorised officers93
55.Entry, search and seizure, by warrant96
Division 2 — Proceedings
56.Complaints for an offence97
57.Averments, and other evidentiary matters97
Part 6 — Administration
Division 1 — Staff
58.Use of staff and facilities of departments, agencies and instrumentalities, and engagement of consultants, etc.101
59.Staff102
Division 2 — Subsidiary legislation
60.Regulations, and subsidiary legislation generally103
Division 3 — General
61.Review of Act104
Schedule — Provisions relating to the membership and proceedings of the Council and the annual report on reproductive technology105
1.The Chair of the Council105
2.Deputies, etc.105
3.Term of office106
4.Remuneration and leave of members107
5.Premature vacation of office108
6.Personal or pecuniary interests109
7.Meetings and proceedings111
8.Unanimous resolution may be passed without meeting112
9.Committees112
10.Protection of members, etc.113
11.Annual report on reproductive technology113
Notes
Compilation table115
Provisions that have not come into operation116
Defined Terms
Reprinted under the Reprints Act 1984 as at 12 July 2002
Western Australia
Human Reproductive Technology Act 1991
An Act to establish the Western Australian Reproductive Technology Council; to require the compilation of a Code relating to the practice of, the procedures used in, and the ethics governing, human reproductive technology; to make provision with respect to the use of that technology in relation to artificially assisted human conception and for the regulation of certain research; and for related purposes.
Preamble
Whereas:
A.In enacting this legislation Parliament is seeking to give help and encouragement to those eligible couples who are unable to conceive children naturally or whose children may be affected by a genetic disease.
B.Parliament considers that the primary purpose and only justification for the creation of a human egg in the process of fertilisation or embryo in vitro is to so assist these couples to have children, and this legislation should respect the life created by this process by giving an egg in the process of fertilisation or an embryo all reasonable opportunities for implanting.
C.Although Parliament recognises that research has enabled the development of current procedures and that certain non harmful research and diagnostic procedures upon an egg in the process of fertilisation or an embryo may be licit, it does not approve the creation of a human egg in the process of fertilisation or an embryo for a purpose other than the implantation in the body of a woman.
D.Parliament considers the freezing and storage of a human egg in the process of fertilisation or an embryo to be acceptable only:
(i)as a step in the process of implanting; and
(ii)only in extraordinary circumstances once the freezing and storage of eggs can be carried out successfully.
The Parliament of Western Australia enacts as follows:
Part 1 — Preliminary
Division 1 — Introduction
This Act may be cited as the Human Reproductive Technology Act 1991 1.
The provisions of this Act shall come into operation on such day as is, or days as are respectively, fixed by proclamation and in any event this Act, or so much of it as has not been proclaimed, shall come into operation 18 months after the date upon which it receives the Royal Assent 1.
3.Interpretation and application
(1)In this Act, unless the contrary intention appears —
“artificial fertilisation procedure” means any —
(a)artificial insemination procedure; or
(b)in vitro fertilisation procedure;
“artificial insemination procedure” means a procedure where human sperm are introduced, by a non‑coital method, into the reproductive system of a woman but which is not, and is not an integral part of, an in vitro fertilisation procedure;
“authorised officer” means —
(a)the Commissioner of Health; or
(b)a person authorised by the Commissioner, generally or in relation to particular functions, circumstances, or purposes, as may be specified in the relevant certificate issued under section 59(2); and
(c)in relation to the powers referred to in section 44(3)(c) or section 49(4)(b), includes a reference to the Director‑General, or an officer of the department established under section 4 of the Community Services Act 1972 whom the Director‑General has authorised in writing;
“biological parent” means a person who —
(a)is the source of an egg or sperm used in an artificial fertilisation procedure; and
(b)is the genetic parent of an embryo developed, or of a child born, as a consequence of that procedure;
“Chairperson” means the member appointed to that office under clause 1(1) of the Schedule, and includes a reference to a person acting in that office;
“chimaera” means a single living organism which has a mixed genetic origin as a consequence of combining cells derived from —
(a)different human embryos; or
(b)the human and other species;
“cloning” means the use of reproductive technology for the purpose of producing, from one original, a duplicate or descendant that is, or duplicates or descendants that are, genetically identical, live born and viable;
“Code of Practice” or “Code” means the Code of Practice compiled under section 14(1)(c), as from time to time amended and in force;
“Commissioner of Health” or “Commissioner” means the person who holds or is acting in the office of ‘Commissioner’ within the meaning of section 3(1) of the Health Act 1911;
“committee” means a committee of the Council;
“condition” in relation to a licence or exemption, includes —
(a)a limitation, restriction or prohibition; and
(b)any other provision of that licence or exemption affecting its operation or the authorisation conferred,
whether or not it purports to be expressed by way of a condition;
“Council” means the Western Australian Reproductive Technology Council established by section 8;
“counselling services” include —
(a)the screening or assessment of potential participants;
(b)the provision of information; and
(c)generally, assisting participants to address personal issues arising from infertility and its treatment;
“Deputy Chairperson” means the member for the time being appointed or selected to that office under clause 1(3) of the Schedule, and includes a reference to a person acting in that office;
“directions” means directions given under Division 2 of Part 4;
“director”, in relation to a body corporate, includes —
(a)a member of the board or committee of management of the body corporate;
(b)a person occupying or acting in a position to which paragraph (a) refers, by whatever name the position is called and whether or not validly appointed to occupy or duly authorised to act in the position; and
(c)any person in accordance with whose directions or instructions directors of the body corporate are accustomed to act;
“Director‑General” means the person who holds or is acting in the office of ‘Director‑General’ within the meaning of section 7 of the Community Services Act 1972;
“effective consent” is to be construed in accordance with section 22(8);
“embryo” means a live human embryo, in the stage of development which occurs from —
(a)the completion of the fertilisation of the egg; or
(b)the initiation of parthenogenesis,
to the time when, excluding any period of storage, 7 completed weeks of the development have occurred;
“embryo flushing” means a surgical procedure whereby an egg in the process of fertilisation, or an embryo, is flushed from the body of a woman before it has implanted in her uterus;
“Executive Officer” means the person appointed as the Executive Officer of the Council under section 8(2)(b), and includes a reference to a deputy to that person appointed under clause 2(2) of the Schedule when acting in the place of that person;
“exemption” means an exemption which is applied for in relation to the licensing requirement and is not refused, or is specifically issued, under section 28;
“fertilisation”, for the purposes of this Act, means the process that commences at the moment of inclusion of a sperm head within the plasma membrane of an egg, and is completed with the appearance of a two‑cell zygote;
“guidelines” means, except in section 14(3), the information set out in Part 2 of the Code;
“in vitro fertilisation procedure” means a procedure, not being a storage procedure, which —
(a)is consequent upon the removal of an egg from the body of a woman, and carried out for one or more of the following purposes —
(i)the fertilisation of that egg, within or outside her body;
(ii)the keeping or use of that egg with intent to derive from it an egg in the process of fertilisation or an embryo; or
(iii)the keeping or use of that egg in the process of fertilisation or embryo so derived;
(b)is directed at the introduction into the body of a woman of —
(i)an egg, whether produced by that woman or by another woman; or
(ii)an egg in the process of fertilisation or an embryo, whether produced by that woman or by another woman and whether or not fertilisation began outside the body into which it is introduced;
or
(c)is a procedure in relation to artificially assisted human conception which is prescribed for the purposes of this definition;
“Institutional Ethics Committee” means a body which is recognized by the Council, as having —
(a)in relation to ethical matters, the role of overseeing all the aspects of a reproductive technology practice, or of research, carried on by a licensee; and
(b)functions, and a composition, complying with requirements set out in the Statements on Human Experimentation, and supplementary notes, of the National Health and Medical Research Council from time to time;
“licence” means a licence granted under Part 4;
“licensee” means a person holding a licence under this Act and also includes a reference to —
(a)a person who is authorised under section 30 to carry on the practice of a licensee;
(b)the person responsible, in relation to any licence or exemption;
(c)a person authorised or permitted, in accordance with section 51, to carry on, supervise or manage a reproductive technology practice or specified activities;
(d)a registered medical practitioner to whom an exemption under section 28 applies; and
(e)in relation to the duties of keeping, and maintaining the confidentiality of, any record to which this Act relates, a person who as a licensee has, or at any earlier time had, such a duty under this Act in respect of that record;
“licensing authority” means —
(a)in relation to an application or matter that under section 42 is to be determined on appeal — the Commissioner of Health acting in accordance with an Order made by the Supreme Court;
(b)in relation to disciplinary matters to which section 38 applies — the Commissioner of Health acting on and in accordance with the advice of the Council; and
(c)in relation to the exercise of any other power in respect to which the Commissioner has a discretion, and whether or not acting with the advice of the Council, the Commissioner of Health;
“medical practitioner” has the meaning given in the Medical Act 1894;
“member” means member of the Council, and includes a reference to a deputy or other person acting in the place of a member;
“nominated member” means a member of the Council, other than the Executive Officer;
“parthenogenesis” in relation to an embryo means development initiated in the absence of, and otherwise than by, fertilisation;
“participant”, in relation to any artificial fertilisation procedure, means —
(a)a person who —
(i)undergoes that procedure; or
(ii)is the donor, or being a woman is the recipient, of gametes, of an egg in the process of fertilisation, or of an embryo used in that procedure;
or
(b)a person from whom, by reason of this Act, a consent to the carrying out of that procedure is required;
“person responsible” in relation to a licence or exemption means the individual under whose supervision the storage or practice authorised is, or is to be, carried on;
“person to whom the licence applies” is to be construed in accordance with subsection (5);
“premises” includes any land, any vehicle, vessel or aircraft, and any part of premises;
“procedure” means any treatment, course of treatment or cycle of treatment involving reproductive technology, but may also include any part of such treatment or any other service or process which is defined in and described by the Code as constituting for the purposes of this Act a procedure of a specified kind;
“proprietary company” means a proprietary company within the meaning of the Corporations Act 2001 of the Commonwealth;
“Public Health Official” means a person designated as such for the purposes of this Act under section 7 of the Health Legislation Administration Act 1984;
“record” means —
(a)any book, account, document, financial records (within the meaning of the Corporations Act 2001 of the Commonwealth), paper, return, register or other source of information compiled, recorded or stored in written or encoded form or on microfilm, or by electronic or other means or process;
(b)the contents, in a printout or other intelligible format, of records that are kept, by computer or otherwise, in a format that is not readily intelligible; and
(c)any other sources of information prescribed for the purposes of this definition;
“related body corporate”, in relation to a specified body corporate, means a body corporate that is, within the meaning of the Corporations Act 2001 of the Commonwealth, related to the specified body corporate;
“reproductive technology” means that branch of medical science which is concerned with —
(a)artificial fertilisation procedures;
(b)the keeping or use of gametes intended for use in an artificial fertilisation procedure, eggs in the process of fertilisation or embryos; or
(c)other procedures or matters incidental thereto;
“research” means systematic investigations carried out for the primary purpose of adding to general knowledge but includes the carrying out of an experiment, and “project of research” shall be construed accordingly;
“Rules” means the rules contained in Part 1 of the Code;
“storage procedure” shall be construed in accordance with subsection (4);
“subsidiary legislation” includes the Rules and any direction having legislative effect;
“this Act” includes a reference to —
(a)the regulations;
(b)the Rules and the guidelines; and
(c)such directions as are published in the Gazette;
“treatment” includes medical, surgical and obstetric services.
(2)This Act so far as it relates to the keeping or use of, or any offence relating to, an egg in the process of fertilisation or an embryo applies —
(a)only to such keeping or use as takes place outside the body of a woman; and
(b)only if the egg or the embryo has been or is —
(i)developed in consequence of an in vitro fertilisation procedure; or
(ii)collected or taken from a woman, before it has implanted in her uterus, by embryo flushing or by a procedure prescribed for the purposes of this subparagraph.
(3)In this Act, a reference —
(a)to gametes generally, or to eggs or to sperm respectively, means, except where otherwise explicitly stated, human gametes, eggs or sperm which are live;
(b)to an egg, except where the context otherwise indicates, does not include a reference to an egg in the process of fertilisation;
(c)to a “reproductive technology practice” or “practice” includes all activities authorised under a licence issued or exemption granted under this Act, including storage, unless the context otherwise requires; and
(d)to the keeping of sperm, does not include keeping for purposes other than for use in an artificial fertilisation procedure.
(4)In relation to gametes, an egg in the process of fertilisation or any embryo, a reference in this Act —
(a)to keeping, includes storing, whether by cryo‑preservation or in any other way, in such a state as temporarily arrests or suspends metabolic function; and
(b)to any gametes which are, or egg, egg in the process of fertilisation or embryo which is, “stored”, means kept in such a state,
and “store” and “storage” shall be construed accordingly.
(5)References in this Act to a “person to whom the licence applies” are to —
(a)the licensee;
(b)the person responsible;
(c)any person designated in a notice given to the licensing authority by the licensee or the person responsible, as a person to whom the licence applies; and
(d)any person acting under the direction of the licensee, the person responsible or of the person so designated.
(6)In this Act a reference to what is “proper” or “suitable” shall be construed having regard to any relevant provision of the Code.
(7)A requirement in this Act to provide or produce a record includes, where the record is not written or not written in the English language, a requirement that any person having the power to do so provide or produce a statement written in the English language supported by details of any encoding involved, setting forth such of the particulars in the record as are not written or are not written in the English language in such a manner as to allow for verification.
(8)Where directions are published in the Gazette those directions are to be taken to be subsidiary legislation to which the Interpretation Act 1984 applies, but not to be regulations within the meaning or for the purposes of section 42 of that Act.
(9)For the purposes of this Act, a person occupies a position of authority in a body if that person —
(a)where the body is a body corporate, is a director;
(b)exercises or exerts, or is in a position to exercise or exert, control or substantial influence over the body in the conduct of its affairs; or
(c)manages, or is deemed to manage, the business of the practice to be carried on under a licence,
or, where a body corporate is a proprietary company, if that person is a shareholder in that proprietary company.
(10)This Act binds the Crown.
[Section 3 amended by No. 57 of 1997 s. 75; No. 10 of 2001 s. 108.]
The objects of this Act are —
(a)to regulate, and to provide guidance in, the use of reproductive technology by —
(i)the establishment of the Council, with the functions referred to in section 14;
(ii)the compilation and implementation of a Code of Practice;
(iii)the imposition of licensing requirements; and
(iv)the enforcement of this Act;
(b)to ensure adherence to standards in the practice of reproductive technology that are proper and suitable;
(c)to allow beneficial developments in reproductive technology, but to discourage, and if required to prohibit, developments or procedures that are not both proper and suitable;
(d)to ensure —
(i)that artificial fertilisation procedures may only be carried out for the benefit of persons who, in accordance with this Act, are eligible to be so treated;
(ii)that the participants are adequately assessed medically as to the need for any procedure, and counselled and informed as to its implications;
(iii)that the welfare of participants is properly promoted; and
(iv)that the prospective welfare of any child to be born consequent upon a procedure to which this Act relates is properly taken into consideration;
(e)to require that equity, welfare and general standards prevailing in the community are taken into account in the practice of reproductive technology; and
(f)to provide a forum whereby —
(i)debate by the community on reproductive technology issues may be conducted;
(ii)proper standards to evaluate and monitor reproductive technology can be determined, established and maintained; and
(iii)policy decisions may be made about reproductive technology,
on an informed basis.
(1)Subject to the Minister, the administration of this Act is vested in the Commissioner of Health who —
(a)shall be responsible for the implementation of the licensing system set out in Part 4; and
(b)may give directions to licensees.
(2)The Western Australian Reproductive Technology Council established under section 8 shall —
(a)compile the Code of Practice;
(b)advise the Minister, generally; and
(c)advise the Commissioner of Health on licensing and disciplinary matters,
but shall give effect to instructions given by the Minister under section 12(3) and, if the Commissioner of Health is empowered under section 13 to discharge functions of the Council, shall assist the Commissioner in so doing.
(3)The Code of Practice shall be compiled and implemented in accordance with Part 3.
(4)Regulations made under this Act shall have effect notwithstanding any inconsistency with the Code of Practice, but the Minister shall not recommend the making of regulations in relation to any matter in respect of which a Rule is, or could be, made under the Code unless, in the opinion of the Minister —
(a)the making of the regulation is necessary to ensure the coming into operation of a provision which is required to have effect sooner than the procedure set out in section 16 would permit; or
(b)the regulation is required for the purposes of section 13(2).
(5)Directions given by the Commissioner of Health shall have effect, except to the extent of any inconsistency with the regulations or the Code, in accordance with section 31.
(6)A report on the use of human reproductive technology in the State during the preceding financial year shall be furnished annually by the Council to the Commissioner who shall thereafter submit the annual report required by clause 11 of the Schedule to the Minister who shall, within 14 sitting days after the submission of that report, cause copies of it to be laid before each House of Parliament.
(7)For parliamentary purposes, and for the conduct of the public business of the Minister, the Minister is entitled —
(a)to be furnished by the Commissioner and the Council with —
(i)any report concerning the activities or proceedings of the Commissioner, the Council or the committees of the Council; and
(ii)all information in their respective possession,
as the Minister may from time to time require; and
(b)to have, and to retain copies of, any record required to be kept, or kept, under this Act, or under any Order or resolution of either House of Parliament in relation to this Act,
but the Minister shall ensure that the confidentiality of any record or other information to which this Act applies is not thereby prejudiced.
(8)For the purposes of subsection (7), the Minister may —
(a)request the Commissioner or the Council to furnish, or to give the Minister access to, information, and to supply records; and
(b)make use of the services of any staff of the Commissioner or of the Council, or of any other person engaged in the administration or enforcement of this Act, for the purposes of obtaining access to information or copies of records,
and the Executive Officer is authorised to ensure compliance with any requirement of the Minister made under this section.
(9)In this section —
“record” includes any data that is compiled, recorded, encoded or stored, and any film, tape, disc or other device or medium on which it can or may be found;
“information” means —
(a)any record relating to the functions of the Commissioner or the Council;
(b)any other document or information which relates to the Commissioner or the Council or to reproductive technology which is in the custody or control of the Commissioner or of the Council and is specified, or of a description specified, by the Minister;
“parliamentary purposes” means the purpose of —
(a)answering a question asked in a House of Parliament; or
(b)complying with a written law, or an order or resolution of a House of Parliament, that requires information to be furnished to a House of Parliament.
Division 2 — Specific offences
(1)No person shall cause or permit —
(a)any procedure to be carried out related to the storage of —
(i)an egg intended for use in an in vitro fertilisation procedure;
(ii)an egg in the process of fertilisation; or
(iii)an embryo;
(b)sperm, having been obtained from different men, to be kept; or
(c)an artificial fertilisation procedure, other than an artificial insemination to which section 28(3) applies, to be carried out,
except pursuant to a licence or exemption by which it is authorised under this Act.
(2)A body corporate that commits an offence against subsection (1) is liable to a fine not exceeding $50 000.
(3)A person other than a body corporate who commits an offence against subsection (1) is liable to a fine not exceeding $25 000 or to imprisonment for 5 years, or both.
(4)If an offence referred to in subsection (1) is shown to have been committed after the service upon the alleged offender of a notice in the prescribed form signed by the Commissioner of Health drawing attention to a continuing state of affairs alleged in that notice to contravene subsection (1), the offender is liable to a penalty of $10 000, in addition to the penalty specified in subsection (2) or (3), in respect of each day on which that offence is continued after the service of that notice.
(5)It shall not be a defence to proceedings for an offence against this section to allege that the defendant believed that what was done was —
(a)authorised by a licence or exemption under this Act; or
(b)done at the request of, or with the consent of, a participant.
7.Offences relating to reproductive technology
(1)A person, whether or not a licensee, who causes or permits —
(a)research to be conducted upon or with an egg in the process of fertilisation, or any embryo, not being research in respect of which the Council has already granted relevant approval or all requisite specific prior approvals have been sought and obtained under section 20;
(b)a diagnostic procedure to be carried out upon or with an egg in the process of fertilisation, or any embryo, not being a procedure which is —
(i)authorised by the Code; or
(ii)specifically approved by the Council;
(c)an embryo, being produced by an in vitro fertilisation procedure or collected by embryo flushing, to be —
(i)maintained; or
(ii)kept outside the body of a woman,
after 14 completed days, excluding any period of storage, from the time the gametes were mixed have occurred;
(d)any procedure to be carried out directed at —
(i)human cloning;
(ii)the obtaining of an embryo by means of embryo flushing; or
(iii)the production of a chimaera;
(e)a nucleus of a cell of an egg in the process of fertilisation or any embryo to be replaced;
(f)the genetic structure of any cell to be altered while the cell forms part of an egg in the process of fertilisation or any embryo;
(g)an embryo or egg in the process of fertilisation to be placed in the body of any animal;
(h)any live egg in the process of fertilisation or live embryo, not being a human egg or embryo, to be placed in the body of any woman; or
(j)gametes, an egg in the process of fertilisation or an embryo to be supplied for valuable consideration,
commits an offence.
(2)In subsection (1)(j) the reference to “valuable consideration” —
(a)shall be taken to include a reference to any inducement, discount or priority offered; and
(b)shall not be taken to include the reasonable disbursement of any expense incurred by the supplier in relation to that supply.
(3)A body corporate that commits an offence against subsection (1) is liable to a fine not exceeding $50 000.
(4)A person other than a body corporate who commits an offence against subsection (1) is liable to a fine not exceeding $25 000 or to imprisonment for 5 years, or both.
(5)A person who —
(a)being a licensee, keeps or uses any gametes, or any egg in the process of fertilisation or embryo in contravention of this Act; or
(b)being a person to whom a licence applies or applied, fails to comply with a direction given for the purpose of section 30(4)(a),
commits an offence.
Penalty: $10 000 or 2 years imprisonment.
Part 2 — The Council
(1)As soon as is practicable after the coming into operation of this Part, there shall be established a body of persons, to be known as the Western Australian Reproductive Technology Council, which shall have the functions conferred under this Act.
(2)The Council shall consist of —
(a)10 nominated members, to be appointed by the Governor on the recommendation of the Minister, of whom —
(i)7 shall be individuals respectively selected from panels comprising the names of not less than 2 individuals submitted in accordance with section 9(1) by each of —
(A)the Royal Australian College of Obstetricians and Gynaecologists;
(B)the Australian Medical Association;
(C)the Law Society of Western Australia;
(D)3 other bodies, being bodies having interests relevant to this Act; and
(E)the Minister charged with the administration of the Community Services Act 1972;
and
(ii)3 shall be individuals selected by the Minister having regard to section 9(2);
and
(b)an ex officio member appointed by the Minister, subject to subsection (3), as the Executive Officer of the Council.
(3)The person appointed as the Executive Officer —
(a)shall be an individual who is an officer of, or who carries out duties in, the department of the Public Service of the State principally assisting the Minister in the administration of the Health Act 1911; and
(b)shall not be eligible to be appointed or selected to hold or act in the office of Chairperson or Deputy Chairperson.
(4)Appointment as a member under subsection (2) does not render the provisions of Part 3 of the Public Sector Management Act 1994 or of any other Act applying to persons as officers of the Public Service of the State applicable to the person so appointed, or affect or prejudice the application of those provisions if they applied immediately before the appointment.
(5)The Minister shall cause each appointment under subsection (2) to be notified in the Gazette.
(6)The Schedule has effect with respect to the membership and proceedings of the Council.
[Section 8 amended by No. 32 of 1994 s. 19; No. 1 of 1996 s. 4.]
9.Nominations, and recommendations, for membership
(1)A panel of nominees to be submitted under section 8(2) shall —
(a)be so compiled, if practicable having regard also to the requirement that the Council should comprise individuals who have special knowledge and experience in the areas that the Council is required to deal with under this Act but should still be reasonably representative of the general community, as to include both a man and a woman; and
(b)be submitted to the Minister within such time, after the receipt of a notice from the Minister that the submission of the nominations is required, as is specified in that notice,
but if any requisite panel of names is not submitted within the specified time the Minister may nominate instead an individual to represent the relevant interest and a nomination so made shall be deemed to have been submitted under paragraph (b).
(2)In recommending persons for membership of the Council the Minister shall endeavour to ensure that —
(a)the Council has available to it from its own membership —
(i)adequate representation of the interests of women, of parents, of the children born of reproductive technology, and of participants in reproductive technology;
(ii)expertise in reproductive technology;
(iii)relevant experience in public health matters; and
(iv)relevant ethical guidance,
and also that any other appropriate discipline, experience or background is adequately reflected in so far as is practicable;
(b)the Council is constituted of equal numbers of men and women;
(c)no one person is the sole representative of disparate interests; and
(d)no more than one member of the Council at any time —
(i)is a licensee; or
(ii)is a person who has a pecuniary or other beneficial interest, other than an interest of a prescribed kind, in the practice of a licensee.
(1)The Council may from time to time appoint committees of such members, or such members and other persons, as it thinks fit and may discharge, continue, reconstitute or alter any committee so appointed.
(2)The Minister or the Commissioner of Health may request the Council to furnish the advice of an appropriate committee on any matter related to the provisions or operation of this Act and, unless the Council otherwise requires, the committee may consider the matter and give to the Minister or the Commissioner directly a written report as to that advice.
(3)The Council may instruct a committee with respect to its constitution, membership, terms of reference and proceedings, and incidental and related matters.
(4)Instructions given by the Council under subsection (3) which relate to —
(a)the constitution or terms of reference of a committee; or
(b)the conditions of appointment to a committee of persons other than members, and the grounds on which such a person may be removed from office,
shall not be given otherwise than as approved by the Minister, either generally or for a particular case.
(1)The Council may by resolution, either generally or as otherwise provided in the resolution, delegate to —
(a)a member;
(b)a committee;
(c)the Commissioner of Health;
(d)a public authority who or which —
(i)under any written law carries out any duty or administration or exercises any power in the State in relation to a function appropriate to the requirements of the Council; and
(ii)is approved by the Minister to act in that capacity on behalf of the Council,
or, subject to subsection (2)(a), a member or officer of that public authority; or
(e)subject to the approval of the Minister, some other person engaged in the administration or enforcement of this Act,
any function vested in the Council, other than the function of advising the Commissioner on disciplinary matters.
(2)Where a delegation under subsection (1) is given otherwise than to a member or a committee, the powers delegated shall not be exercisable until —
(a)where the delegation is to a member or officer of a public authority, the Council has satisfied the Commissioner that the delegate has sufficient knowledge and experience to give effect to the objects of this Act; and
(b)a notice, giving sufficient particulars to describe the function delegated and to identify the person who is to be the delegate, has been published in the Gazette.
(3)A resolution delegating a function of the Council may, if the Minister approves, authorise the delegate to further delegate to any other person any function, or any power or duty, referred to in the resolution, and the provisions of section 59 of the Interpretation Act 1984 shall apply to and in relation to any such further delegation as they apply to a delegation.
(4)Where a person is authorised under subsection (1) or subsection (3) to perform a function of the Council as a delegate, the performance of that function by the delegate is deemed to be performance of the function by the Council.
12.Relationship of the Council to the Minister
(1)The Council shall, as soon as is practicable after being requested to do so, furnish to the Minister such advice relating to reproductive technology matters or this Act as the Minister may seek.
(2)The Council shall —
(a)consider any proposal made by the Minister in relation to the affairs of the Council;
(b)if so required by the Commissioner of Health, consult the Minister before continuing with a proposed course of action that in the opinion of the Commissioner amounts to a major initiative; and
(c)if so requested, report to the Minister on any proposal, whether made by the Minister, the Commissioner or the Council, or on any existing or prior proceedings or function.
(3)The Minister, having regard to the objects of this Act, may give instructions in writing to the Council in relation to any function of the Council, either generally or with respect to a particular matter (but not in relation to dealings with, or the licensing of, any particular person), and the Council shall —
(a)subject to subsection (4), give effect to any such instruction; and
(b)include in the annual report to be furnished under section 5(6) the text of any such instruction.
(4)Where, in the opinion of the Council, an instruction given by the Minister fails to give due regard to one or more of the objects of this Act the Council shall so advise the Minister, giving such particularity as the Minister may require, and thereupon if the terms of the instruction given are not agreed, or agreed as amended by the Minister, after consultation between the Minister and the Council, the Council may cause a report on the disagreement to be laid before each House of Parliament.
13.Powers, and relationship to the Council, of the Commissioner of Health
(1)The Commissioner of Health may at any time require the Council to advise on reproductive technology matters, on the evaluation or monitoring of licensee compliance with the regulations, any directions, and the Code of Practice, on public education, on the compilation of the reports to be furnished under this Act, or on the administration or enforcement of this Act, and the Council shall, as soon as is practicable, furnish that advice.
(2)Where —
(a)a decision relevant to a function of the Council is, in the opinion of the Commissioner having regard to the objects of this Act, required to be taken in the interests of public health;
(b)that decision has not been, and in the opinion of the Commissioner is not likely promptly to be, taken by the Council and the Commissioner has so informed the Minister;
(c)the Commissioner has, by instrument in writing signed personally by the Minister, been required to consider and if appropriate to take that decision;
(d)the Commissioner has thereafter made known to the Council the decision which the Commissioner has taken and any requirements made of the Council as to the discharge of the function in question; and
(e)the function is not thereafter, in the opinion of the Minister, properly discharged by the Council,
the Commissioner may, if so instructed by the Minister, thereafter discharge that function as though a delegate of the Council specifically authorised to do so, and any reference in this Act to a function of the Council may for the purposes of this subsection be construed as including a reference to the Commissioner so acting as delegate.
(3)Any question arising between the Council, or any committee or member, and the Commissioner as to the operation of this section, or as to a conflict between instructions given by the Minister and requirements made known by the Commissioner respectively, shall be addressed to, and having regard to the objects of this Act may be determined by, the Minister.
(4)Subject to subsection (5), the Commissioner of Health may, by an instrument in writing signed personally, delegate to a person who is an officer of, or who carries out duties in, the department of the Public Service of the State principally assisting the Minister in the administration of the Health Act 1911, either generally or as otherwise provided by that instrument, any function in the administration of this Act vested in or required to be discharged by the Commissioner.
(5)Subsection (4) does not apply to or in relation to —
(a)the power to take a decision required under subsection (2)(c);
(b)the power to license;
(c)any disciplinary function referred to in section 37 or 38; or
(d)any other function in relation to which the Minister otherwise directs.
(6)Where —
(a)a requirement under this section is made known by the Commissioner to the Council; or
(b)the Commissioner has been required to exercise any power under subsection (2)(c),
the Commissioner shall include in the annual report to be submitted to the Minister the text of that requirement, particulars as to the function to which the requirement related and as to the manner in which the power under subsection (2)(c) and any function thereby effected was discharged or purported to have been discharged, and any reason given to the Council for the requirement or for the discharge of the function, and shall include in relation to such matters such information as the Council may request that is contained in the report required to be furnished by the Council.
(7)Subject to sections 31 and 32, the Commissioner may impose conditions and give directions in relation to any licence or exemption.
(8)In the discharge of any function, or in imposing any condition, and in giving any direction under this Act the Commissioner shall, where practicable and requested, afford to an applicant or licensee reasons for any determination which may be made in relation to that person and a reasonable opportunity to show cause why the determination should not be given effect.
(1)Subject to section 13(2), the functions of the Council are —
(a)to advise the Minister —
(i)on reproductive technology and any matter that is connected with, or incidental to, reproductive technology; and
(ii)generally, as to the administration and enforcement of this Act;
(b)to advise the Commissioner of Health —
(i)on matters relating to licensing under this Act, including but not limited to the suitability of any applicant for a licence or of any licensee to carry out particular procedures or approved research and as to the conditions that should be imposed on any licence; and
(ii)generally as to the administration and enforcement of this Act and particularly on disciplinary matters, having regard to any findings made by, or report received from, a committee of inquiry appointed under section 38;
(c)after consultation with bodies representing persons having relevant expertise or sections of the public having appropriate interests, to compile and to cause to be published, to review, and to amend, a Code of Practice which —
(i)sets out Rules, guidelines and relevant information;
(ii)establishes the ethical standards required of licensees, and gives effect to the principles specified in, and the requirements of, this Act; and
(iii)provides for such other matters as may be instructed by the Minister, or as the Council may determine,
regulating the proper conduct of any reproductive technology practice, and of any procedure, required to be licensed and the proper discharge of the functions of the person responsible and other persons to whom a licence applies, having due regard to this Act;
(d)subject to paragraph (e), to encourage and facilitate, research —
(i)into the cause, prevention and treatment of all types of human infertility, adequate attention being given both to female and to male infertility; and
(ii)as to the social and public health implications of reproductive technology;
(e)to ensure that no project of research is carried out by or on behalf of a licensee upon or with —
(i)any egg collected in the course of an in vitro fertilisation procedure;
(ii)gametes intended for subsequent use in an artificial fertilisation procedure;
(iii)any egg in the process of fertilisation;
(iv)any embryo; or
(v)any participant,
otherwise than in accordance with this Act and pursuant to a general or specific prior approval given by the Council;
(f)to consider applications for, and where proper grant, approval to carry out research to which paragraph (e) applies;
(g)to promote informed public debate, and to consult with bodies representing the public or sections of the public, on the ethical, social, economic and public health issues that arise from reproductive technology;
(h)to communicate and collaborate with other bodies having similar functions, in Australia and elsewhere,
and, generally, to give effect or to cause effect to be given to the objects of this Act.
(2)The Council shall not grant approval to any research being conducted, or any diagnostic procedure to be carried out, upon or with an egg in the process of fertilisation, or any embryo, unless the Council is satisfied —
(a)that the proposed research or procedure is intended to be therapeutic for that egg or embryo; and
(b)that existing scientific and medical knowledge indicates that no detrimental effect on the well‑being of any egg in the process of fertilisation or any embryo is likely thereby to occur.
(3)Where a person contravenes —
(a)any provision of, or requirement under, this Act, not being a direction; or
(b)any direction given by the Commissioner, being a direction which is consistent with the Code or is not inconsistent with —
(i)ethical guidelines laid down by the National Health and Medical Research Council, as for the time being prescribed;
(ii)criteria established by the Reproductive Technology Accreditation Committee for the Fertility Society of Australia, as for the time being prescribed; or
(iii)a provision of, or any principal set out in, or requirement under, this Act, as from time to time amended,
the Council shall endeavour to ensure, if necessary by disciplinary action under section 38, that effect is given to that provision, requirement or direction.
Part 3 — The Code of Practice
Division 1 — Compilation of the Code
15.The concept of the Code of Practice
(1)The Code of Practice shall be divided into Parts, as follows —
(a)Part 1 — which shall set out the Rules which, subject to section 16, are to have effect as subsidiary legislation and may also set out or refer to conditions that may be imposed on a licence —
(i)generally, by regulations or by directions published under section 35(1); or
(ii)specifically, by reference to the appropriate Rule in, or in a subsequent direction relating to or endorsement on, that particular licence;
(b)Part 2 — containing guidelines, either specifically published by the Council or referred to in accordance with section 60, which —
(i)set out the ethics and relevant professional information as to the practices that should govern, and the procedures to be used in and the services to be provided in relation to, the conduct of reproductive technology; and
(ii)set out specific terms which are there defined or identified as intended to describe the medical detail or circumstances applicable to a condition or direction that may be imposed in respect of a practice, procedure or licence of a particular kind;
and
(c)Part 3 — containing notices and other ancillary information that the Council authorises for circulation.
(2)In so far as is practicable, a Rule shall be expressed in terms likely to be understandable by persons not medically qualified but may, where it is necessary to explain or enlarge upon those terms, contain or refer to medical or other detail either explicitly, by a reference complying with section 60(3), or by reference to —
(a)appropriate terms specifically defined in the guidelines contained in Part 2 of the Code; or
(b)a description, text or requirement included or referred to in those guidelines.
(3)The Rules may provide that where a person is convicted of a specified offence under this Act the licence of that person, or any exemption held by that person, shall, with immediate mandatory effect and notwithstanding any appeal that may be lodged, be thereby deemed to be —
(a)cancelled; or
(b)otherwise affected in a manner specified in the Rules;
and effect shall be given to any such Rule but without prejudice to the conduct of any disciplinary action that may be brought under section 38 in relation to the facts disclosed at the proceedings for that offence.
(4)In any proceedings under this Act —
(a)the Code, and any particular provision of the Code, shall be an admissible document; and
(b)where it is alleged that a person has contravened this Act —
(i)a failure to comply with the Rules may be relied on as establishing liability;
(ii)a failure to have regard to the guidelines under the Code may be relied on as tending to establish liability; and
(iii)proof of compliance with the guidelines may be relied on as tending to negative liability,
but, notwithstanding that the failure on the part of a person to comply with the Code may not be the subject of any such proceedings, the licensing authority in considering any application may, at discretion, take into account any alleged tendency on the part of the applicant not to have regard to the guidelines.
16.The implementation of the Code of Practice
(1)A provision of Part 1 of the Code of Practice, whether in the original text or as from time to time amended, shall not have legislative effect, and shall not be taken into account in considering any application or in any disciplinary proceedings under this Act, unless —
(a)the provision has been promulgated as a proposed Rule, or being a condition is referred to in a proposed Rule;
(b)that proposed Rule has been published in the Gazette; and
(c)that proposed Rule has, in accordance with subsection (2), been laid before each House of Parliament, within 6 sitting days of such House next following that publication and thereafter has come into operation,
unless the regulations specifically otherwise provide.
(2)A proposed Rule required by subsection (1) to be laid before each House of Parliament —
(a)shall be accompanied by a copy, certified by the Executive Officer as correct, of the relevant excerpt from any condition, text or requirement (within the meaning of section 60(4)) approved or adopted, or referred to in or by the guidelines, for the purposes of that Rule;
(b)may not be amended, or have its provisions substituted, by resolution of the House;
(c)shall be so laid, for 14 sitting days of that House, whether in the same session or during the same Parliament or otherwise; and
(d)shall come into operation on a date to be published after the expiry of that period of 14 sitting days in each House, by notice in the Gazette, unless subsection (3) otherwise provides.
(3)(a)Where notice of motion to disallow any proposed Rule is given in either House the proposed Rule shall not be given effect unless and until —
(i)the motion has been defeated or the notice or the motion withdrawn; or
(ii)if the motion or notice of it has lapsed by prorogation or dissolution, notice of a motion to disallow the Rule has not been given within 14 sitting days of the commencement of sitting of Parliament next after such prorogation or dissolution; or
(iii)such further motion has been dealt with in accordance with subparagraphs (i) or (ii);
(b)Where a resolution disallowing any proposed Rule has been passed by either House that Rule shall be deemed revoked and shall not be given effect.
(4)Where a resolution disallowing a proposed Rule has been passed under subsection (3), notice of that resolution shall be published in the Gazette within 21 days thereafter.
(5)The Executive Officer shall —
(a)ensure that a compiled text of the Code is available from the Council, together with any relevant excerpt from a text or requirement which is referred to in the Code but which was not published originally by the Council; and
(b)endeavour to ensure that —
(i)on any Rule coming into operation; and
(ii)on any change to the guidelines being introduced,
notice is brought to the attention of licensees likely to be thereby affected,
as soon as is practicable.
17.Matters which shall be dealt with by the Code, subject to exception by way of regulations
As a matter of principle but without limiting the generality of section 14(1)(c), in the compilation of the Code of Practice the Council shall prohibit —
(a)the mixing in the same artificial fertilisation procedure of multiple sources of eggs or sperm, of eggs in the process of fertilisation, or of embryos in such a manner as may create confusion as to the biological parentage of any child born as a result of the procedure; or
(b)the development of any egg in the process of fertilisation or any embryo other than with a view to its future implantation into a particular woman.
18.Matters which may be dealt with in the Code
(1)The Code may make provision, and may impose conditions or prohibitions, in relation to the following matters —
(a)ovarian stimulation undertaken by a licensee;
(b)artificial fertilisation procedures likely to lead to multiple pregnancies;
(c)the treatment of any gametes intended for use in an artificial fertilisation procedure, including their genetic modification;
(d)the circumstances in which, the periods and purposes for which, and the methods by which, an embryo may be kept and maintained outside a human body, or any gametes, egg in the process of fertilisation or embryo may be stored;
(e)any treatment or other services to which this Act applies that may be provided by licensees;
(f)the donation, use, supply, export from the State, posthumous use, or other dealing in or disposal of, gametes, eggs in the process of fertilisation or embryos by licensees;
(g)the privacy of patients, and the conduct of authorised officers, during the carrying out of any inspection or investigation; and
(h)the giving or withdrawal of recognition to Institutional Ethics Committees by the Council for the purposes of this Act.
(2)Subject to the requirements of this Part, the regulations or the Code may —
(a)establish criteria as to the consent required of participants in prescribed circumstances, as to the qualifications of counsellors and the adequacy of the services provided for counselling, and as to the particular circumstances when counselling should be offered, ensuring that any question as to a consent required or given is decided on a basis of adequate and relevant information, as regards —
(i)procedures of different kinds;
(ii)the outcome of procedures, with particular reference to the control, possession and disposal of any gametes, egg in the process of fertilisation or embryo; and
(iii)the type and quality of the treatment or other services, or of any assistance, provided or to be provided, or not likely to be provided,
and as to the nature and extent of the information to be supplied; and
(b)provide for —
(i)the obtaining and recording of an effective consent on the part of particular participants; and
(ii)the effect of any consent given.
19.Principles to be embodied in the Code
(1)The Council in compiling the Code of Practice shall have regard to the principles set out in section 17 and sections 22, 23, 24, 25 and 26.
(2)Until the principles referred to in subsection (1) are embodied in the Code —
(a)where any of those principles is specifically referred to in directions given for the purposes of this Act, a failure to give effect to it on the part of a licensee may for the purposes of sections 14(3), 29(5)(a) and 39(2)(a) be taken to be a contravention of a requirement under this Act; and
(b)otherwise, in so far as any of those principles is relevant to the conduct of a practice or any procedure —
(i)effect shall be given to the principle by all persons to whom this Act applies; and
(ii)on any application or in disciplinary proceedings, the manner of observance of any such principle is a matter which the licensing authority may take into account.
20.Principles applicable to projects of research
(1)A licence shall not be capable of authorising any research contravening the condition referred to in subsection (3).
(2)No licensee shall carry out, or authorise or facilitate or become involved in the carrying out of, any project of research —
(a)upon or with —
(i)gametes obtained in the course of an in vitro fertilisation procedure or intended for use in an artificial fertilisation procedure; or
(ii)an egg in the process of fertilisation, or any embryo whether or not live;
or
(b)involving any person who is a participant in an artificial fertilisation procedure,
unless general or specific approval relevant to that project has already been granted by the Council, or unless specific prior approval from the Council for that particular project of research is sought for in such manner as may be required by the Code or directions, and if the Council so requires is also sought from a specific Institutional Ethics Committee recognized by the Council, and is obtained.
(3)Every licence is subject at all times to the condition that any project of research shall be carried out in accordance with the terms of, and any conditions applicable to, the approval given and not otherwise.
(4)The Council, subject to subsection (5), may under the Code grant general approval to the carrying on by any licensee of a project of research of a kind or in relation to matters specified in the Code, but may impose conditions as to the manner in which the research is to be carried on.
(5)The Rules or directions may make provision as to —
(a)the requirements with which a licensee proposing to carry out any research must comply in seeking approval to the proposal, for the manner of submitting that proposal to an Institutional Ethics Committee or to the Council, and for the furnishing by the licensee of a report on that proposal from such a Committee to the Council or the Commissioner;
(b)any requirement for —
(i)counselling;
(ii)the obtaining from any person of an effective consent,
for the purposes of the research;
(c)generally, the ethics and standards that should apply to the carrying out of projects of research by or involving licensees.
(6)In considering whether to grant approval to a project of research, the Council shall have regard to any decision or report which may have been made by an Institutional Ethics Committee and may adopt a decision or report so made as sufficient grounds for the grant of approval by the Council.
21.The Code and directions, generally
Without limiting the generality of section 14(1)(c), the Code, or directions, may make provision as to —
(a)the criteria by which the appropriateness of a proposed artificial fertilisation procedure is to be assessed;
(b)the means of determining and evaluating the considerations which should or may be taken into account before an artificial fertilisation procedure is commenced, including the diagnostic procedures involved;
(c)the method by which, and the extent to which, donors or prospective donors of gametes, eggs in the process of fertilisation or embryos are to be assessed or selected;
(d)the practice and procedures to be carried out in relation to the collection, keeping, use and disposal of gametes, eggs in the process of fertilisation or embryos, or for securing that such eggs or embryos are in a suitable condition for implantation;
(e)the responsibilities of persons carrying out any procedures to which this Act applies;
(f)the establishment of a basis for determining questions as to the control of, and the power to deal with or dispose of, gametes, eggs in the process of fertilisation or embryos;
(g)the means of disposal, or prohibitions or restrictions in respect of the disposal, of gametes, eggs in the process of fertilisation or embryos;
(h)limitations to be placed on the use of gametes, eggs in the process of fertilisation or embryos which may be donated by any one individual donor;
(j)the circumstances in which any egg in the process of fertilisation or embryo derived from the use of reproductive technology shall be allowed to succumb;
(k)what, for the purposes of this Act, may constitute an authorised diagnostic procedure in relation to any egg in the process of fertilisation or an embryo or an approved project of research, or may be carried out or performed in any particular kind of research, and what shall not;
(m)the assessment of applications seeking approval to carry out any project of research;
(n)the requirement that prior approval of an Institutional Ethics Committee specified in, or ascertainable by reference to, those Rules, be a condition applicable to any particular practice, kind of practice or procedure or kind of procedure;
(o)the making, retention and confidentiality of records; and
(p)such other matters relating to the practice of reproductive technology as may be specified in, or are required by or to be carried out or determined in accordance with, the regulations.
Division 2 — Consents
(1)Where by or under this Act consent is required to be given in relation to the use or keeping of any gametes, egg in the process of fertilisation or embryo —
(a)the gametes of a person shall not be used, or for such a use be received by a licensee or participant, unless —
(i)there is an effective consent, by that person, to the gametes being so used; and
(ii)the gametes are used in accordance with that consent;
(b)the gametes of a person shall not be kept in storage unless —
(i)there is an effective consent, by that person, to the storage; and
(ii)the gametes are stored in accordance with that consent;
(c)the gametes of a person shall not be used in an in vitro fertilisation procedure unless there is an effective consent, by that person, to any egg in the process of fertilisation or embryo thereby derived being used for a consequential purpose authorised by this Act;
(d)where the development of an egg in the process of fertilisation or an embryo was brought about by an in vitro fertilisation procedure it shall not be kept in storage unless —
(i)there is an effective consent, by each person from whose gametes the egg or embryo was derived, to the storage; and
(ii)the egg or embryo is stored in accordance with that consent;
(e)where the development of an egg in the process of fertilisation or an embryo was brought about by an in vitro fertilisation procedure, it shall not be used for any purpose, or for such a purpose be received by a licensee or participant, unless —
(i)there is an effective consent, by each person from whose gametes the egg or embryo was derived, to the use for that purpose;
(ii)the purpose is authorised by this Act; and
(iii)that egg or embryo is used in accordance with that consent,
and the Code may make further provision in relation to such, or related, matters.
(2)Where a consent is given in general terms to the use or storage of gametes separately, whether eggs or sperm, that consent shall be taken to relate to the use or storage of any of those eggs or sperm, and also to any egg in the process of fertilisation or embryo derived from the use of the gametes, for any purpose, save that —
(a)any such consent may be given subject to specific conditions in its terms; and
(b)notwithstanding subsection (4) or that an egg in the process of fertilisation, or an embryo, may have developed which is derived from the use of gametes the subject of any particular consent, in so far as it relates to any egg or sperm that has not been used that consent may be varied or withdrawn,
but where an egg in the process of fertilisation, or an embryo, has been developed from any gametes the consent thereafter to be required is not a consent to the use of those gametes but a specific consent relating to that particular egg in the process of fertilisation or embryo only.
(3)The terms of any effective consent may from time to time be varied or the consent withdrawn, unless subsection (4) applies, by notice given by the person who gave the consent to the person keeping the gametes, egg in the process of fertilisation or embryo to which the consent is relevant.
(4)The terms of any effective consent to the use of any gametes, egg in the process of fertilisation or embryo can not be varied, and such a consent can not be withdrawn, once the gametes have, or that egg or embryo has, been used.
(5)A consent to the use of an egg in the process of fertilisation or an embryo must specify one or more of the following purposes —
(a)use in providing treatment to the person giving consent, or that person and another named person together; or
(b)use in providing treatment to persons, other than the person giving consent, who are —
(i)named in the consent; or
(ii)to be selected in accordance with circumstances specified in the consent,
and may specify conditions subject to which the egg or embryo shall or shall not be so used.
(6)A consent to the keeping of any gametes, egg in the process of fertilisation or embryo must —
(a)specify the maximum period of storage, if that is to be less than such limit as may be prescribed or may be determined in accordance with section 24(1)(b); and
(b)give instructions as to what is, subject to this Act, to be done with the gametes, the egg or the embryo if the person who gave the consent is unable by reason of incapacity or otherwise to vary the terms of the consent or to withdraw it,
and may specify conditions subject to which the gametes, or the egg or embryo, shall or shall not remain in storage.
(7)Before a licensee gives effect to a consent given for the purposes of this Act the licensee shall ensure that each participant has been provided with a suitable opportunity to receive —
(a)proper counselling about the implications of the proposed procedures; and
(b)such other relevant and suitable information as is proper or as may be specifically required by the Code or directions,
including an explanation of the effect of subsection (3) and subsection (4).
(8)For the purposes of this Act a consent to the use or keeping of any gametes, egg in the process of fertilisation or embryo shall not be taken to be effective unless —
(a)it is given in writing;
(b)any condition to which it is subject is met;
(c)it has not been withdrawn; and
(d)those gametes are, or that egg or embryo is, kept and used in accordance with the consent.
(9)Where a consent required by or under this Act is not given, or is not effective, or is not complied with that matter may be a cause for disciplinary action or proceedings for an offence but does not necessarily affect the rights of any person.
23.When procedures may be carried out
An in vitro fertilisation procedure may be carried out where —
(a)it would be likely to benefit —
(i)persons who, as a couple, are infertile; or
(ii)a couple whose child would otherwise be likely to be affected by a genetic abnormality or disease;
(b)each of the participants required to do so has given an effective consent;
(c)the persons seeking to be treated as members of a couple are —
(i)married to each other; or
(ii)are co‑habiting in a heterosexual relationship as husband and wife and have done so for periods aggregating at least 5 years, during the immediately preceding 6 years;
(d)the reason for infertility is not age or some other cause prescribed for the purpose of this paragraph; and
(e)consideration has been given to the welfare and interests of —
(i)the participants; and
(ii)any child likely to be born as a result of the procedure,
and in the opinion of the licensee that consideration does not show any cause why the procedure should not be carried out,
but not otherwise.
(1)In relation to the storage of any eggs, sperm, egg in the process of fertilisation or embryo —
(a)the primary purpose stated in any consent to the storage of an egg in the process of fertilisation or any embryo must relate to the probable future implantation of that egg or embryo; and
(b)the Code may make provision as to what, in particular circumstances, constitutes an excessive time for the storage of —
(i)eggs or sperm;
(ii)an egg in the process of fertilisation; or
(iii)an embryo,
but no egg in the process of fertilisation or embryo shall be stored for a period in excess of the permitted storage period except with the approval of the Council under subsection (1a).
(1a)The Council may approve in writing a longer storage period for an egg in the process of fertilisation or an embryo if it considers that there are special reasons for doing so in a particular case.
(1b)An approval under subsection (1a) may be subject to conditions and is to specify the date on which the longer storage period ends.
(1c)An approval under subsection (1a) can only be given before the end of the permitted storage period, or if a longer storage period has previously been approved under subsection (1a), before the end of that period.
(1d)The Council is to inform the Minister of each approval given under subsection (1a), but in such a manner that the identity of the biological parents cannot be ascertained from the approval.
(2)Where the persons on behalf of whom the storage of any gametes, egg in the process of fertilisation or embryo was undertaken have died, or the licensee otherwise does not have and can not obtain any instructions or consent required for the purposes of this Act in relation to the storage the control and the power of disposal are deemed to vest in the Commissioner of Health who shall, subject to section 22(6) and any instructions or conditions to which effect may then be given, direct that any such egg or embryo be made available for the purpose of providing treatment for a specific recipient, unless a court of competent jurisdiction otherwise requires.
(3)Where a licensee is directed by the Commissioner to allow any gametes, egg in the process of fertilisation or embryo to succumb the licensee shall be required thereupon to comply and shall not be liable to any person for so doing.
(4)In this section —
“permitted storage period” means —
(a)in the case of the storage of an egg in the process of fertilisation or embryo starting before 8 October 1993, the period ending 7 October 1996; and
(b)in any other case, 3 years.
[Section 24 amended by No. 1 of 1996 s. 5 and 6.]
Division 3 — Rights of control, etc.
25.Rights in relation to gametes
In relation to any rights in, or power to deal with or dispose of, gametes —
(a)in respect of both eggs and sperm, all rights remain vested in the respective gamete providers, unless and until otherwise dealt with, as though personal property subject to section 7(1)(j);
(b)where gametes are donated with effective consent to a licensee, all rights in those gametes vest in the licensee subject to the limitation that, in accordance with that consent, the gametes may be used —
(i)for the purpose of initiating an in vitro fertilisation procedure intended to develop an egg in the process of fertilisation or an embryo for implantation into a recipient named in, or to be selected in accordance with circumstances specified, in that consent;
(ii)for artificial insemination purposes;
(iii)in, or in connection with, an approved project of research; or
(iv)for the purposes of diagnostic procedures,
and not otherwise, but if the gametes are not so used they shall, subject to section 26(1)(c) and (d), be allowed to succumb; and
(c)in respect to gametes donated subject to a consent which is conditional and which are not used, if a condition to which the consent was made subject is not observed, the rights, subject to section 22(6) and any instructions to which effect can then be given, revert to the donor and in default vest in the Commissioner of Health.
26.Control, dealing and disposal in relation to an egg in the process of fertilisation or an embryo
(1)In relation to rights to the control of, or power to deal with or dispose of, any egg in the process of fertilisation or embryo that is outside the body of a woman —
(a)each person on whose behalf it is developed or is being or is to be, kept for implantation has, subject to section 7(1)(j), the right to decide how an egg in the process of fertilisation or embryo is to be dealt with or disposed of, so that —
(i)such a person shall have, while storage continues, the right to review the decision to store from time to time and may withdraw consent or vary the terms of any consent; and
(ii)any question as to the nature or extent of the respective rights or powers may, subject to subsection (2), be referred to a court of competent jurisdiction;
(b)in the event of the death of one member of a couple in whom the rights are vested, those rights vest solely in the survivor;
(c)where from any gametes an egg in the process of fertilisation or embryo is developed, whether or not with effective consent, the individual rights of a gamete provider or person to whom the gametes were provided and of a licensee cease at the moment fertilisation begins and the rights thereafter vest jointly in the couple on whose behalf that egg or embryo was developed;
(d)where an egg in the process of fertilisation or an embryo has been developed on behalf of a couple and is no longer required for that purpose, if all the participants in a proposed procedure give an effective consent it may be donated for the purpose of providing treatment for a specific recipient; and
(e)on the commencement of an implantation procedure the rights in an egg in the process of fertilisation or in an embryo vest in the woman receiving it, whether or not —
(i)that recipient was eligible to undergo the procedure; or
(ii)any consent required was given or, if given, was effective.
(2)Where rights in relation to an egg in the process of fertilisation or an embryo are vested in a couple and the couple disagree about its use or continued storage, the Commissioner of Health shall, on application by a member of that couple, direct the licensee storing the egg or embryo to ensure that the storage is maintained subject to —
(a)payment of the proper charges of the licensee for the storage;
(b)any limitation as to the time of storage prescribed or determined in accordance with section 24(1)(b); and
(c)any order made by a court of competent jurisdiction which otherwise requires.
Part 4 — Licensing, etc.
Division 1 — Licensing
27.Licences, and the person responsible
(1)On application under section 29 the Commissioner of Health, having referred the matter to and had regard to any advice received from the Council, may grant —
(a)a storage licence;
(b)a practice licence;
(c)both a storage licence and a practice licence; or
(d)an exemption under section 28,
to a person, or to a body of persons (whether or not incorporated) who practise together.
(2)In accordance with its terms a storage licence may authorise the licensee to carry out any procedure related to —
(a)the storage of —
(i)any egg intended for use in an in vitro fertilisation procedure;
(ii)any egg in the process of fertilisation; or
(iii)any embryo;
(b)the keeping of sperm, having been obtained from different men; and
(c)any project of research related to such storage and approved under section 20.
(3)In accordance with its terms a practice licence may authorise the licensee to carry out any artificial fertilisation procedure, not being a storage procedure, and any project of research approved under section 20.
(4)A licence —
(a)shall be granted in a form approved by the Commissioner specifying —
(i)the kind or kinds of licence granted;
(ii)any particular condition imposed specifically on that licence or the respective licences, or in substitution for a condition which would otherwise apply;
(iii)the conditions set out in the Code which apply to a licence of that kind, and any particular modifications to the text of those conditions which are to apply to that licence;
(iv)such other terms or matters as may be set out in the Rules or directions and are to apply;
(v)the person responsible; and
(vi)the premises to which the licence relates;
(b)continues in force, unless the operation of that licence is suspended or the licence is cancelled, for a period of 5 years or such shorter period as may be specified in that licence; and
(c)may be varied, in accordance with this Act, as to its terms and conditions during that period,
but is not capable of being transferred by or on behalf of the licensee.
28.Exemptions relating to artificial insemination
(1)Subject to subsection (2), an exemption shall be deemed to have been issued, and a licence under this Act is not required, in respect of an artificial insemination procedure where —
(a)the procedure is carried out by a medical practitioner who has —
(i)applied for exemption from the licensing requirement in the prescribed manner, notifying the Commissioner of the kind of procedures that will be carried out by that practitioner; and
(ii)lodged with the Commissioner a written undertaking in the prescribed form to observe and comply with the Code of Practice and any directions;
and
(b)in relation to that medical practitioner, and to a procedure of that kind, that application is not refused or the exemption is not subsequently revoked,
but where the Commissioner notifies the medical practitioner in writing that conditions are to be imposed in relation to any practice or procedure and issues to that practitioner a certificate of exemption in the prescribed form applicable to that practice or procedure, the exemption conferred by this subsection in relation to that practice or a procedure of that kind shall be taken to be subject to the conditions that are set out in that certificate.
(2)A person who holds an exemption deemed to have been or specifically issued under subsection (1) is —
(a)subject to the like disciplinary procedures in relation to that exemption as would have been applicable had the exemption been a licence under this Act; and
(b)shall be deemed in respect of the practice or procedure thereby authorised to be the person responsible under that licence.
(3)A licence or an exemption under this Act is not required in respect of artificial insemination where the artificial insemination is carried out by prescribed persons in prescribed circumstances.
(1)An application for a licence or exemption shall be —
(a)made in the first instance to the Commissioner of Health, in writing, and, if a form or manner of making an application of that kind is prescribed, as prescribed;
(b)accompanied by the prescribed fee, if any; and
(c)supported by such further or other information as the Commissioner may in a particular case require.
(2)The Commissioner, or a person authorised by the Commissioner, may cause an investigation or inquiry to be made into the background and antecedents of an applicant, or of any person who occupies a position of authority in a body which is an applicant, or who would become a person to whom the licence applies, or who may be directly materially interested in the reproductive technology practice to be carried on under the proposed licence or exemption.
(3)Where the licensing authority is of the opinion that the information provided in relation to the application is insufficient to enable it to determine the application, it need not consider the application until the applicant has provided it with such further information as it may require.
(4)The licensing authority shall not grant a licence or issue an exemption to a person, or to a body corporate of which a person who occupies a position of authority in that body is a person, or to a body of persons where a member of that body is a person, who —
(a)is an undischarged bankrupt, has applied to take the benefit of any law for the relief of bankrupt or insolvent debtors, has compounded with creditors (whether separate creditors of that person or the creditors of a partnership which includes that person), or made an assignment or arrangement for the benefit of creditors;
(b)being a body corporate, is under receivership or official management or is in liquidation; or
(c)is disqualified from holding a licence, or holds a licence which is suspended, pursuant to an Order made in disciplinary proceedings under this Act.
(5)A licence shall not be granted to an applicant, and a licence shall not be renewed in favour of an existing holder, unless the licensing authority is satisfied —
(a)that every person who would become a person to whom the licence applies is, for the purposes of this Act, a fit and proper person;
(b)that adequate and appropriate premises, equipment, staff, supervision, support services and facilities are available, and are likely to remain available, for the purposes to which the licence relates; and
(c)that the licence is needed to fulfil a genuine social need.
(6)In relation to any application for the grant or renewal of a licence the applicant —
(a)may be required to satisfy the licensing authority —
(i)if the applicant is a body of persons or a body corporate, that any person who occupies a position of authority in that body is for the purpose of this Act a fit and proper person to occupy that position;
(ii)that any person who has a material interest in the reproductive technology practice to be carried on under the licence is a fit and proper person to have that interest;
(iii)if the application is made on behalf of a body of persons associated together, as to the nature of their common interest;
and
(b)shall be required to satisfy the licensing authority as to —
(i)the character, qualifications and experience of the individual who is to be the person responsible;
(ii)the manner in which any person who would under the proposed licence be a person to whom the Act applies has in the past observed the requirements of this Act;
(iii)matters relating to the counselling of participants and the obtaining of an informed and effective consent; and
(iv)the compilation, safe keeping, retention, storage and confidentiality of records.
(7)An application —
(a)may be refused, even if the applicant meets all the requirements of this Act; or
(b)may be granted, if there is evidence of substantial compliance with this Act, even if the application does not comply entirely with the requirements of this Act,
and shall be dealt with on its merits, after such inquiry as the licensing authority thinks fit, in a manner that the licensing authority considers to be in the public interest.
(8)Where the licensing authority waives or modifies any requirement for formal compliance with any procedure relating to an application, conditions may be imposed in relation to that waiver or modification.
30.Interim authorisations and transitional directions
(1)Where a person who claims to be entitled to carry on the activities carried on, or formerly carried on, by a particular licensee but who would not otherwise be authorised under this Act —
(a)applies to the Commissioner of Health for approval so to carry on; and
(b)the Commissioner is satisfied that —
(i)by reason of death, insolvency or other sufficient cause the licensee is unable or unwilling to carry on those activities, and the person has a claim or an entitlement to an interest in the licensed activities; and
(ii)there is nothing that would have precluded the grant of a licence of the same kind to that person,
the Commissioner may cause the name of that person to be endorsed on the licence, if that person then proposes to apply for a licence to carry on thereafter those activities or any of them.
(2)The endorsement of the name of a person on a licence under subsection (1) authorises that person to carry on the activities to which the licence relates until —
(a)an application for a licence made by that person in respect of those activities has been determined;
(b)by notice in writing given by the Commissioner to that person, the authorisation conferred by the endorsement is cancelled; or
(c)the expiry of a period of 12 months,
whichever first occurs.
(3)Where a licensee dies, or being a body corporate ceases to carry on licensed activities, and an individual who is a person to whom the licence applied does any act which that individual would have been authorised to do if the licensee had continued to carry on those activities that act shall be treated as authorised by the licence, until directions terminating the authorisation take effect.
(4)Where a licence has been varied or has ceased to have effect, or is to be varied or cease to have effect, directions may be given for the purpose of securing the continued discharge of the functions of the person responsible under that licence and, in particular, may —
(a)require any gametes, egg in the process of fertilisation, embryo or other thing kept or record held under that licence, or information available to a person to whom that licence applied, to be transferred to the licensing authority or any other person; or
(b)provide for the discharge of the duties in question by any other person, and authorise the carrying on of the practice licensed and the exercise of powers by or under the supervision of any other person, if that other person consents.
(5)For the purposes of the giving under this section of any direction to “a person to whom the licence applies”, a licence which is varied or ceases to have effect shall be deemed to continue to be applicable to the person to whom the direction is given.
Division 2 — Directions and conditions
(1)The Commissioner of Health may from time to time give directions, or directions varying or revoking such directions, in relation to any matter for which —
(a)directions are expressly authorised to be given under this Act; or
(b)a provision of the Code has been, or could be, made,
giving due regard to the principles set out in the Act.
(2)Where in relation to any matter a relevant regulation or Rule applies or any direction is inconsistent with any other provision of the Code which has been specifically applied, the regulation, Rule or other provision of the Code prevails.
(3)Directions may be given to any person to whom a licence applies, and a person to whom any requirement contained in directions is applicable shall comply with the requirement.
(4)Anything done by a person pursuant to directions is to be treated for the purposes of this Act as done pursuant to a licence.
32.Terms, conditions and directions specifically applicable
(1)Without derogating from the generality of the discretion conferred on the licensing authority, the licensing authority may impose terms, conditions or directions which it considers desirable in order to —
(a)ensure that the safety, health or welfare of persons is not at risk;
(b)regulate the kind of practice and procedure, or any project of research, authorised and the manner in which it shall be carried out;
(c)limit the authority conferred under a licence or exemption;
(d)require action therein specified to be undertaken by the holder —
(i)within a time or at times therein specified; or
(ii)on occasions or in circumstances therein specified,
in relation to the premises to which the licence or exemption relates, the conduct of the reproductive technology practice carried on, or otherwise in the public interest;
(e)prevent improper arrangements or practices; or
(f)ensure compliance with the requirements of, or with terms fixed, conditions imposed or directions given, under this Act.
(2)A term or condition applicable to a licence or exemption, other than a term or condition imposed specifically by Part 3, this Part or the regulations, may be varied or cancelled, or may be imposed subsequent to the grant of the licence or the issue of the exemption, at discretion by the licensing authority if evidenced —
(a)by a notice in writing setting out particulars of the term or condition concerned (which may be a reference to the Rules or directions) and served on the licensee; or
(b)by being endorsed on the licence or exemption or being included, or so referred to, in a revised version,
as the Commissioner of Health may require, but no such term or condition shall have effect in so far as it may be inconsistent with the Rules for the time being.
(3)The licensing authority at any time may, on the application of the licensee or the person responsible, vary the terms of, or revoke, a licence or any condition other than a condition imposed by section 33.
33.Conditions applicable to all licences and exemptions
(1)Every licence and every exemption shall at all times be subject to the general condition that the ethics and practices that should govern, and the procedures to be used in, the conduct of reproductive technology in so far as they —
(a)are for the time being set out in —
(i)the Code; or
(ii)where no relevant Rule has been brought into operation, directions;
and
(b)are applicable to —
(i)every licence or exemption;
(ii)a licence or exemption of that kind; or
(iii)that licence or exemption, specifically,
are to be observed by the licensee in relation to the reproductive technology practice carried on by the licensee.
(2)Every licence granted or exemption issued under this Act is subject to the conditions —
(a)that the practice authorised thereby shall be carried on —
(i)under the supervision of the person responsible;
(ii)only on the premises to which the licence or exemption relates; and
(iii)in accordance with this Act and the terms, conditions and directions applicable,
but in no other manner;
(b)that any authorised officer, on production if so required of the certificate issued under section 59 or other identification as such, shall be permitted to enter the premises to which the licence or exemption relates and inspect them, including any equipment or records, to observe any procedure and to take account of any gametes, eggs in the process of fertilisation or embryos, there;
(c)that every participant to be treated has been given a suitable opportunity to receive proper counselling about the implications of the treatment and has been provided with such relevant information as is proper;
(d)that the requirements of this Act as to the obtaining and recording of effective consents be complied with;
(e)that no artificial fertilisation procedure shall be carried out in a body, other than the body of a living woman who specifically consents to the procedure;
(f)that proper records in relation to the practice, procedures and participants be maintained, in such manner and form and including such information about such matters as this Act or the terms or conditions of the licence or exemption may require or the Commissioner may by directions specify;
(g)that, where any gametes, egg in the process of fertilisation or embryo is supplied to a person to whom another licence applies, that person shall be provided with such information additional to that otherwise required as the Commissioner may by directions specify;
(h)that the licensing authority shall be provided, in such form and at such times as directions may specify, with such copies of or extracts from records to which this Act relates, or other information for the purposes of this Act, as the Commissioner may by directions specify; and
(j)that no information shall be removed from any records maintained under the licence or exemption before the expiry of such period as may be prescribed for records of that kind, except with the written approval of the Commissioner.
(3)Every storage licence is subject to the conditions —
(a)that gametes of a person or an egg in the process of fertilisation or an embryo shall be stored only if received or acquired from —
(i)a person to whom a licence applies; or
(ii)a person who satisfies the licensee that they can give an effective consent to that storage;
(b)that an egg in the process of fertilisation or an embryo the development of which was brought about by an in vitro fertilisation procedure, otherwise than under the authorisation conferred by a practice licence held by the same licensee, shall be stored only if received or acquired from —
(i)another person to whom a licence applies; or
(ii)a person who satisfies the licensee that they can give an effective consent to that storage;
(c)that gametes, eggs in the process of fertilisation or embryos which are or have been stored shall not be supplied to a person unless that person is a person to whom a licence or an exemption applies, or the supply has been otherwise authorised under this Act; and
(d)that no gametes, egg in the process of fertilisation or embryo shall be stored for longer than this Act authorises.
34.Contravention of a condition or direction
A contravention of a condition or a direction applicable to a licence or exemption, whether —
(a)applicable generally under this Act;
(b)applicable to licences or exemptions of a particular kind or in particular circumstances; or
(c)specifically imposed on or given in relation to that licence or exemption or a particular matter,
shall not be taken to be an offence, unless the regulations specifically otherwise provide, but any such contravention may constitute grounds for disciplinary action and may be taken into account in considering any application.
35.Notice and coming into operation of directions and conditions
(1)A notice relating to a term or condition for the purposes of section 32(2) or a notice giving directions generally —
(a)shall be signed by the Commissioner of Health;
(b)may be published, and if not published shall be brought to the attention of the persons to whom it is applicable in such a way as, in the opinion of the licensing authority, is likely to be effective;
(c)when published in the Gazette, is to be (whether or not subject to specified exceptions) of general application, or to apply generally to licences or exemptions of the kind specified in that notice, and is not required to refer to the particular licence or exemption to which it relates; and
(d)shall be served on each licensee.
(2)Where directions are to be applicable only to a particular person, or in particular circumstances, the directions shall in so far as is practicable be given by serving notice in writing of these directions on the person in relation to whom they are to have effect, but may be given by a notice under subsection (1).
(3)A condition which is imposed or varied after the grant of the licence or the issue of the exemption to which it relates, or a direction given, takes effect on the date specified —
(a)in the notice served on the licensee setting out the particulars;
(b)in the endorsement made on, or revised version of, the licence or exemption; or
(c)in the Gazette notice,
as the case may be.
Division 3 — Suspension or cancellation, and disciplinary action
36.Suspension or cancellation of a licence or exemption, other than on disciplinary grounds
(1)The Commissioner of Health, on application made by the licensee, may suspend the operation of any licence or exemption.
(2)The Commissioner of Health may suspend the operation of any licence or exemption, or cancel any licence or revoke an exemption, by notice given to the licensee or delivered to any premises to which the licence or exemption relates —
(a)with immediate effect, by reason of any requirement of public health, where in the opinion of the Commissioner of Health imminent risk of serious harm to a person may occur; or
(b)with effect from a date not earlier than 3 months after service of that notice, where in the opinion of the Commissioner of Health the licensee has failed to carry on a reproductive technology practice, or to carry out the procedures authorised by the licence or exemption, in the manner required by the public interest,
but a licensee thereby affected may appeal under section 42.
(3)Where a suspension, cancellation or revocation has been imposed with immediate effect pursuant to section 36(2)(a) and the licensee has commenced an appeal under section 42 then, unless a Judge otherwise orders, which order may be upon terms including terms as to undertakings by the Commissioner of Health as to damages, such suspension, cancellation or revocation shall lapse or be rescinded at the expiration of 21 days from the commencement of such appeal.
(1)If it appears to the Commissioner of Health that a licensee or a person to whom section 40(2) applies may, by reason of a matter of a kind referred to in section 39, be liable to a penalty and that a penalty appropriate to the case is provided by section 40(1)(a) to (f), the Commissioner may, on making a summary determination to that effect, issue a written warning or impose a penalty of that kind summarily, but in all cases the Commissioner may report the matter to the Council under section 38(1) and if —
(a)such a penalty appears to the Commissioner not to be appropriate; or
(b)effect is not given under subsection (3) to the summary penalty imposed,
the Commissioner shall report any matter for disciplinary action to the Council.
(2)Notice of a summary determination made under subsection (1) and of any warning or penalty proposed to be so imposed shall be given in writing by the Commissioner —
(a)to the person to be warned or liable to the penalty; or
(b)if that is not practicable, by publication in the Gazette,
setting out short particulars of the reason and giving that person a reasonable opportunity, within a period specified in that notice, to show cause to the Commissioner why effect should not be given to that determination.
(3)If within the period specified in the notice given under subsection (2), the person to be warned or liable for the penalty summarily imposed —
(a)consents to the summary determination; or
(b)endeavours to show cause why effect should not be given to the summary determination, but otherwise submits to the discretion of the Commissioner and does not request that any matter alleged be referred to a committee of inquiry under section 38,
effect may, by notice in writing to that person, be given to the summary determination and thereupon the warning or penalty proposed, or such lesser penalty as the Commissioner may think appropriate and specify instead in that notice, shall, as from the date specified in that notice, be thereby imposed.
(1)Where the licensee or other person liable to a warning or penalty does not consent to a summary determination or submit to the discretion of the Commissioner of Health under section 37, and the Commissioner reports the matter alleged to the Council, or if it appears to the Commissioner that a penalty provided by section 40(1)(a) to (f) may not be appropriate and the Commissioner reports the matter for disciplinary action to the Council, the Council may, and if the Commissioner so requires shall, appoint a committee of inquiry to —
(a)consider submissions or hear evidence and make findings on the balance of probabilities, as to the matter; and
(b)submit recommendations to the Council, by way of a written report,
in relation to any disciplinary action, and on the Council making known its advice to the Commissioner the Commissioner shall make a final determination in accordance with that advice.
(2)A committee of inquiry appointed under subsection (1) in relation to any matter for which a person may be liable for disciplinary action —
(a)may be conducted on the basis of written submissions, unless that person otherwise requires;
(b)if conducted as a hearing —
(i)shall afford that person reasonable opportunity to call or give evidence, cross examine witnesses and make submissions;
(ii)may be assisted by a legal practitioner appointed by the Council;
(iii)shall permit that person to be represented, by a legal practitioner or otherwise; and
(iv)if that person does not appear, may be conducted in the absence of that person;
(c)may inspect any document, exhibit or other thing produced before the committee, and retain it for such reasonable period as the committee thinks fit, and make copies of any document or any of its contents;
(d)may inspect any place or facilities relevant to the proceedings;
(e)may by summons in the prescribed form signed by the Executive Officer call upon any person to appear before it to —
(i)give evidence in such manner as may be directed;
(ii)produce such papers, documents, exhibits or other things; and
(iii)furnish such information,
as the committee determines to be necessary or proper for its purpose;
(f)may require any person to swear or affirm that the person will truly answer all questions relating to a matter being inquired into by the committee that are put to the person either by or before the committee (and for that purpose the person presiding, the Executive Officer or an officer employed in the Public Service of the State and assisting the committee may administer any oath or affirmation); and
(g)require any person appearing before the committee, and any person whose conduct is or becomes a matter of inquiry at a hearing whether or not that person was initially summoned to appear, to answer any relevant question put to that person by a member of the committee or by any other person appearing before the committee.
(3)A person is not excused from complying with a requirement under subsection (2) to swear or affirm, or to answer any question, on the ground that the answer to a question put to the person might incriminate the person or render the person liable to a penalty, but an answer given by a person pursuant to a requirement under subsection (2) is not admissible in evidence against the person in any civil proceedings or in any proceedings for an offence other than —
(a)under this Act;
(b)perjury; or
(c)an offence arising out of the false or misleading nature of that answer.
(4)A person who discloses to a committee of inquiry under this section information that would otherwise be confidential shall not be taken to have committed thereby any breach of a principle of professional ethics and shall not be liable in respect of any breach of a contractual obligation as to confidentiality.
(5)In the course of any proceedings a committee of inquiry may —
(a)receive in evidence any transcript of evidence in proceedings before a court or other person acting judicially and draw any conclusion of fact from that evidence;
(b)receive and admit any evidence given by affidavit or statutory declaration, or otherwise in a manner the person presiding determines to be appropriate, having regard to the principles of natural justice;
(c)adopt, in the discretion of the person presiding, any finding, decision, or judgment of a court or other person acting judicially that is relevant to the proceedings before the committee; and
(d)adjourn the hearing from time to time or from place to place, upon such conditions as the person presiding thinks fit.
(6)A person who —
(a)having been served with a summons to attend before a committee of inquiry, fails without reasonable excuse (proof of which lies upon that person) to attend in obedience to the summons;
(b)having been served with a summons to produce before the committee any document, exhibit or other thing, fails without reasonable excuse (proof of which lies upon that person) to comply with the summons;
(c)fails to provide access to any place or facility required by a committee of inquiry, being a person who could have granted or obtained that access;
(d)misbehaves before a committee of inquiry, wilfully insults the committee of inquiry or any member, or interrupts the proceedings of a committee of inquiry; or
(e)fails without reasonable excuse (proof of which lies upon that person) to swear or affirm, or to answer any question, when required to do so by a committee of inquiry,
commits an offence.
Penalty: $5 000.
(7)On imposing any penalty in relation to disciplinary proceedings the Commissioner shall make known the reasons for making the determination and if, within 7 days thereafter, the person liable to the penalty requests the Executive Officer to furnish further and better particulars of those reasons the Executive Officer shall endeavour to ensure that the request is complied with and shall cause the reasons for the determination to be set out in writing in sufficient detail to enable the question of an appeal to be considered.
(8)Where a question of law arises in relation to any disciplinary proceedings before a committee of inquiry, the committee may require that the person raising that question prepare and file in the Supreme Court, in the manner required by the rules of court in relation to questions of law for the opinion of that Court, a case for the opinion of the Court upon the question.
(9)Regulations made under this Act may make provision in relation to the proceedings, and to the immunity or liability of persons appearing, before a committee of inquiry, and as to the power of the person presiding to order that proceedings be heard in camera.
39.Matters that may be the subject of disciplinary action
(1)A penalty under section 40 may be imposed by the Commissioner of Health —
(a)at discretion without further inquiry, but on the basis of and in accordance with the advice of the Council, where the Council has considered the report of a committee of inquiry appointed under section 38; and
(b)in accordance with any Order of the Supreme Court, where an appeal has been heard under section 42.
(2)It may be a cause for disciplinary action if —
(a)any reproductive technology practice, or any procedure authorised under a licence or exemption, is not properly conducted or carried out in accordance with the licence or that exemption;
(b)a person to whom the licence applies has contravened a requirement of this Act, a term or condition of that licence or any direction;
(c)a licensee has contravened a term or condition applicable to an exemption;
(d)a person to whom the licence applies has been convicted of —
(i)an offence under this Act;
(ii)an offence under the Health Act 1911 in relation to the conduct of the reproductive technology practice or premises to which the licence or exemption relates; or
(iii)an offence in the State or elsewhere that, in the opinion of the Commissioner, implies that the person is unfit to be a licensee;
(e)a licensee at a material time employed or engaged, in relation to the practice carried on under the licence or exemption, a person who in the course of that practice committed any offence of a kind to which paragraph (d) refers and of which that person was convicted;
(f)the person to whom the licence applies, or any person holding a position of authority in a body that holds a licence or who has a material interest in a reproductive technology practice, is or becomes not a fit and proper person to hold that position or to be so interested;
(g)activities conducted under the licence or on the premises to which this licence relates are jeopardizing public health, and the continuation of the licence or exemption would not be in the public interest;
(h)the premises to which the licence relates, or other circumstances material to the conduct of the practice authorised, are no longer suitable for the research or procedures authorised under the licence or exemption;
(j)information given for the purposes of this Act by or on behalf of the licensee was in any material respect false or misleading;
(k)information which this Act requires to be kept confidential is not so kept;
(m)the safety, health or welfare of persons who resort to a reproductive technology practice as participants or prospective participants is endangered by an act or neglect of the licensee; or
(n)an Order made under section 40 in respect of a determination previously made under section 37 or 38 has been contravened.
(1)The Commissioner of Health may, in relation to any disciplinary action in respect of which a determination has been made under this Act, by Order of which notice in writing shall be given to the person liable to the penalty, impose any one or more of the following penalties —
(a)a reprimand;
(b)the imposition of a condition to which a licence or exemption is to be subject, limiting the authority conferred by the licence or exemption;
(c)the variation or cancellation of a term or condition to which a licence or exemption is subject;
(d)a requirement that a person to whom the licence applies or who is interested in the licence or exemption enter into a written undertaking or a bond, or give a prescribed security, for future conduct;
(e)a requirement as to the conduct of the reproductive technology practice under the licence or exemption, contravention of which may result in its mandatory suspension;
(f)a requirement that specified action be taken by the person responsible within a specified period, contravention of which may result in mandatory suspension of the licence or exemption;
(g)the suspension of the operation of a licence or exemption —
(i)until further order; or
(ii)for a specified period;
(h)the suspension of the operation of the licence or exemption for so long as a person to whom subsection (2) applies is —
(i)the holder of a position of authority in a body that holds a licence; or
(ii)directly or indirectly materially interested in a reproductive technology practice carried on under a licence or exemption,
subject to subsection (3);
(j)the cancellation of a licence, or the revocation of an exemption;
(k)the disqualification, for such period as the licensing authority thinks fit, of a licensee from holding a licence or exemption; or
(m)an Order that the person to whom the licence applies pay to the Crown a monetary penalty not exceeding the prescribed amount,
and may make such other ancillary Order, including an Order for the payment of costs not exceeding the prescribed amount, as the licensing authority thinks fit.
(2)Where the licensing authority finds that a proper cause for disciplinary action exists in relation to a licence or an exemption held by a proprietary company, any penalty that by subsection (1)(d), (e) or (j) might have been imposed in relation to the licence or exemption, whether or not a penalty is imposed on the licensee, may be imposed on or in relation to any person who occupies a position of authority in that company or any related body corporate, subject to subsection (3).
(3)The licensing authority shall not impose a penalty under subsection (1)(j) or subsection (2) where it is proved that the person concerned —
(a)did not know of, and could not reasonably have been aware of or have prevented, the matter upon which the ground of complaint was made out; or
(b)had taken reasonable steps to prevent the occurrence of a matter of the kind to which the complaint related.
41.Effect on pending procedures
(1)The suspension of the operation of a licence or exemption, the cancellation of a licence, the revocation of an exemption or a change in the terms and conditions imposed in relation to a licence or exemption does not, unless the Commissioner of Health otherwise directs, relieve the licensee or former licensee of any obligation in relation to the completion of any artificial fertilisation procedure then being undergone by a participant.
(2)Where a licence or exemption under which a procedure was commenced, or was purportedly commenced, ceases to have effect the Commissioner, if that would be in the best interests of a participant, may give directions to the person responsible requiring that the procedure, or specified matters relating to the procedure, be carried out and completed by —
(a)a person specified in the direction; or
(b)some other person authorised to do so under this Act,
and may require that to be done at the expense of the licensee, and may take such steps as are necessary to ensure that the expense is met.
(3)Where any egg in the process of fertilisation or any embryo is, or gametes are, kept by a licensee and the licence or exemption under which the keeping took place ceases to have effect the Commissioner of Health may require that such egg, embryo or gametes be stored in accordance with this Act thereafter in a manner and by a person approved by the Commissioner.
Division 4 — Supreme Court powers
(1)Where the licensing authority —
(a)refuses an application for —
(i)the grant, variation or renewal of a licence;
(ii)an exemption under section 28; or
(iii)an authorisation under section 30;
(b)decides to impose or vary any condition in respect of a licence or exemption; or
(c)suspends the operation of a licence or exemption, cancels a licence or revokes an exemption conferred under section 28 —
(i)under section 36(2); or
(ii)as a consequence of a contravention of an Order made under section 43,
notice shall be given in writing by the Commissioner of Health to the applicant or the licensee of that decision, setting out short particulars of the reason, and giving that person a reasonable opportunity, within a period specified in that notice, to make representations or show cause to the Commissioner as to why the decision should be varied or should not have effect or continuing effect.
(2)An applicant or licensee to whom a notice under subsection (1) relates may request the Executive Officer to furnish further and better particulars of the reasons for the decision and the Executive Officer shall endeavour to ensure that the request is complied with and shall cause the reasons for the decision to be set out in writing in sufficient detail to enable the question of an appeal to be considered.
(3)An appeal lies to a Judge of the Supreme Court —
(a)on the part of the applicant or licensee, against a decision of the kind to which subsection (1) refers to which effect is given; and
(b)on the part of any person liable to a penalty thereunder or to be adversely affected thereby, against any decision made by the Commissioner of Health —
(i)by way of a summary determination in respect of a disciplinary matter; or
(ii)consequent upon a committee of inquiry appointed under section 38, in disciplinary action taken under this Act,
and the Judge may confirm, quash or vary any such decision, or may refer the matter back to the Commissioner of Health, and make any consequential or ancillary Orders.
(4)Unless a Judge otherwise directs, no appeal against a decision under subsection (3) shall be commenced after 30 days from the day on which —
(a)effect was given to the decision, if of a kind to which subsection (1) refers; or
(b)in any other case, the person affected received notice of the decision, or if further and better particulars of the reason for the decision are requested, received those particulars.
(5)The decision of a Judge under this section shall be given effect to by the Council and the Commissioner of Health.
(6)An appeal under this section shall be brought and the proceedings conducted in such manner as may be prescribed by rules of court or, if no such rule is applicable, as a Judge may direct.
(7)Rules of court may make provision regulating the practice and procedure of the Supreme Court in relation to appeals and other matters under this Act.
43.Restraint of continuing contravention
(1)Where the Supreme Court is satisfied on application made by the Commissioner of Health that a licensee is by any act committing, or permitting the commission of, a continuing contravention of any term, condition or direction applicable to a licence or exemption the Court may —
(a)by Order restrain the continuance of that act; and
(b)make a further Order that —
(i)the operation of the licence or exemption may be suspended for a specified period; or
(ii)the licence may be cancelled or the exemption revoked with immediate effect,
by the Commissioner of Health if the Commissioner of Health is satisfied that the restraint Order has been contravened.
(2)The continued existence of anything in a state, or the intermittent repetition of any act, contrary to a term or condition of a licence or exemption or to any direction may be deemed for the purposes of subsection (1) to constitute a continuing contravention.
(3)Proceedings under this section shall not prejudice any disciplinary action under this Act that may be taken in relation to the same or a similar contravention.
Division 5 — Information
(1)A licensee shall make, maintain, keep and retain a proper record —
(a)showing in relation to gametes, eggs in the process of fertilisation and embryos kept or used by that licensee —
(i)if gametes, the identity and consent of the donor from whom, and the date when, received;
(ii)if an egg in the process of fertilisation or an embryo, its biological parentage and date of fertilisation;
(iii)the place, period and method of collection and of keeping; and
(iv)the identity of any person to whom gametes, an egg in the process of fertilisation or an embryo was supplied, of every person for whom the gametes were, or an egg in the process of fertilisation or an embryo was, used in an artificial fertilisation procedure, and, if known, the ultimate recipient;
(b)in relation to all artificial fertilisation procedures carried out by or on behalf of the licensee showing —
(i)the identity of, and full particulars as to the consent given by, each participant;
(ii)the reasons why each participant was assessed as being an eligible person in respect of that procedure;
(iii)the nature of the procedure;
(iv)the identity of the individual who carried out that procedure; and
(v)where known —
(A)the outcome of the procedure;
(B)whether any children were born that appear to the person responsible to have been born as a result of the procedure; and
(C)sufficient particulars to identify each such child;
(c)of all research relating to reproductive technology conducted, authorised or facilitated by or on behalf of that licensee; and
(d)any other information, procedure or matter of which a record is required under this Act or any other written law,
in such a manner as to comply with the terms of, and any condition imposed on, the licence or any approval or direction relating to that licence and any requirement under this Act, unless the Commissioner of Health, in writing, otherwise directs.
(2)Subsection (1) does not apply to the holder of an exemption conferred under section 28, except in so far as the Commissioner of Health —
(a)by a condition imposed on that exemption, requires; or
(b)in writing, otherwise directs.
(3)A person required by subsection (1) to make a record of a matter shall —
(a)make up the record as soon as is practicable after the occurrence to which it relates;
(b)keep and retain a proper record, in such a manner as to keep secure the confidential nature of the information contained in that record, in a place in the State approved by the Commissioner of Health for the purpose, for the prescribed number of years after the date on which it was compiled; and
(c)make the record available for inspection by an authorised officer,
and no information shall be removed from any such record before the expiry of such period as may be specified in the Rules or by directions for information of that kind.
(4)A licensee shall, if so required by the Commissioner of Health, furnish in a form acceptable to the Commissioner any record to which subsection (1) applies and reports containing such further or other information as the Commissioner may reasonably require —
(a)in respect of any research;
(b)concerning —
(i)any artificial fertilisation procedure using; or
(ii)the keeping, or any facility or procedure relating to the keeping, of,
any gametes, egg in the process of fertilisation or an embryo; or
(c)relating to any other matter, specified by the Commissioner as being relevant to the administration of this Act, whether in relation to that licence or exemption or otherwise,
in respect of such period, or in relation to such circumstances, at and within such times, and verified in such manner and by such a person, as the Commissioner may direct.
(5)Where a person ceases to be a licensee, any record required to have been kept under this section by that person shall be retained, in a manner and at a place approved by the Commissioner of Health for that purpose, by or on behalf of that person or may be lodged with the Commissioner.
(6)A person who, being a person to whom the relevant licence applies or applied, fails —
(a)to make, maintain, keep or retain a record or report, as required by this section;
(b)to keep secure the confidential information contained in such a record; or
(c)to make such a record available for inspection by an authorised officer,
commits an offence.
Penalty: $5 000.
(1)The Commissioner of Health shall cause to be kept, in a place and manner approved by the Minister, registers —
(a)containing current information supplied by, or otherwise obtained from, licensees in respect of —
(i)the identity of participants;
(ii)the outcome of procedures, showing the genetic origin of the gametes, egg in the process of fertilisation or embryo used;
(iii)the identity of children born as a result of an artificial fertilisation procedure, including the identity of each biological parent; and
(iv)such relevant demographic and clinical information,
as may have been required to be supplied under this Act;
(b)showing the prescribed current information relating to —
(i)licences, licensees other than persons to whom subparagraph (ii) applies, and persons approved as managers; and
(ii)persons to whom an exemption under section 28 applies, the conditions subject to which, and the procedures in relation to which, the exemption applies and whether the exemption is affected by a suspension;
(c)information which has been so supplied or obtained under paragraph (a) or entered pursuant to paragraph (b), but is no longer current;
(d)setting out a record, complying with the prescribed requirements, of disciplinary proceedings under this Act; and
(e)in relation to such other matters as may be prescribed.
(2)A register kept for the purposes of subsection (1) shall be compiled in a manner which enables such information as a person is entitled to under this Act, or any other written law, to be made readily available but keeps secure the confidential nature of the remainder of the register.
(1)Nothing in this Act shall be construed as preventing a person who is or was a participant in relation to any procedure from obtaining access to information being kept by a licensee about that person in respect of that procedure under this Act, and a licensee shall facilitate any such access requested.
(2)A person, on payment of the prescribed fee, shall be entitled to be furnished with information in a register kept under section 45(1)(a), (b) or (c) if the information supplied related to that person in their capacity as a participant in an artificial fertilisation procedure.
(3)A person may, on payment of the prescribed fee, be furnished with information in a register kept under section 45 if —
(a)it does not identify, but relates to —
(i)a biological parent of that person; or
(ii)a child of which that person is a biological parent;
(b)it is sought by a person so authorised by the Commissioner of Health;
(c)it discloses only the social or public health connotations of reproductive technology; or
(d)a written law so provides,
but not otherwise, unless subsection (2) applies.
(4)Nothing in this Act prohibits access to information in the register being given to —
(a)an authorised officer, for the purposes of the administration of this Act or a prescribed written law; or
(b)a licensee or a person authorised by that licensee, in relation to information previously supplied by that licensee but not otherwise, in order to carry out an artificial fertilisation procedure or to conduct research.
(1)A licensee, or a person who during the period to which the requirement relates was a licensee, shall furnish to the Commissioner of Health, in the prescribed manner, an annual return and explanatory documents, which may be required to include participant identifying information, showing such information as may be required by —
(a)the Rules;
(b)the regulations; or
(c)the Commissioner of Health, by direction in writing.
(2)A person who fails to comply with a requirement made under subsection (1) commits an offence.
Penalty: $5 000.
The Commissioner of Health may disclose, or authorise the disclosure of, information gained in the course of the administration of this Act to —
(a)authorities vested with the administration of laws relating to reproductive technology or surrogacy in other States and Territories of the Commonwealth; or
(b)any other bodies that may require the information for the purpose of discharging duties of a public nature,
respecting the affairs of any person or the administration of this Act, but not in such a manner as to disclose the identity of any person who is, or was, a donor of gametes or an embryo, a participant, or a child conceived through artificial fertilisation, unless authorised by that person or by any other written law.
(1)A person shall not divulge, or communicate to any other person, any information disclosed or obtained by reason of this Act respecting the identity of —
(a)a donor of gametes, an egg in the process of fertilisation or an embryo;
(b)a participant in any procedure involving reproductive technology; or
(c)a child born as a result of any artificial fertilisation procedure,
unless subsection (2) applies.
(2)Information to which subsection (1) applies may be divulged or communicated —
(a)for a purpose necessary to the carrying out of any procedure, or the conduct of any research, to which this Act applies;
(b)for the purposes of and in the course of the administration of this Act, or pursuant to a request of the Minister made for the purposes of section 5;
(c)as may be authorised or required by the Code or the regulations;
(d)with the consent of each donor, participant or child in question or other person whose identity may be disclosed in so far as it does not identify any person who was a participant in the relevant procedure and who has not given such consent; or
(e)under an authorisation conferred by another written law.
(3)A person shall not produce in any court or to any other person, or permit any other person to have access to, a record that is, in the course of the administration of this Act or for purposes authorised by this Act, in the custody of that person and discloses, or may disclose, the identity of —
(a)a donor of gametes, an egg in the process of fertilisation or an embryo;
(b)a participant in any procedure involving reproductive technology; or
(c)a child born as a result of any artificial fertilisation procedure,
unless subsection (4) applies.
(4)Subsection (3) shall not apply where the production or access —
(a)has been approved by the Commissioner of Health, or a person to whom the function of approving it is delegated, and is required for the purposes of any proceedings —
(i)of the Council;
(ii)of the licensing authority; or
(iii)in respect of an offence under this Act;
(b)is required by an authorised officer for the purpose of carrying into effect the provisions of this Act; or
(c)is authorised under any other written law,
but in any such case so far as is practicable the information which is necessary in respect of any particular matter shall be provided in a manner that will not identify the individual to whom it refers.
(5)A person who contravenes subsection (1) or subsection (3) commits an offence.
Penalty: $5 000, or imprisonment for 12 months.
50.False or misleading statements and records
(1)A person who in, or in relation to, any —
(a)application, disciplinary proceedings or matter to be determined by the licensing authority; or
(b)return or other record required, made, maintained, kept or produced under or for the purposes of this Act,
makes a statement that —
(c)is false or misleading in a material particular; or
(d)has omitted from it a matter or thing the omission of which renders the information misleading in a material respect,
commits an offence.
Penalty: $5 000.
(2)It is a defence to a prosecution of a person for an offence under subsection (1) if that person proves that when the statement was made the person —
(a)believed on reasonable grounds that the false matter was true;
(b)believed on reasonable grounds that the misleading matter was not misleading;
(c)in the case of an omission, believed on reasonable grounds —
(i)that no material had been omitted, being material matter the omission of which would make the statement false or misleading; or
(ii)that the omitted matter was not material.
(3)A person who, by an act intended to falsify or destroy the record, alters or destroys any record required, made, maintained, kept or produced under this Act commits an offence.
Penalty: $5 000.
Division 6 — Supervision, etc.
(1)A licence or exemption can not —
(a)authorise any practice to be carried on except under the supervision of one individual as the person responsible; or
(b)apply in relation to premises other than such as are specified in the licence.
(2)It shall be the duty of the person responsible to secure —
(a)that the other persons to whom the licence applies are of such character, and are so qualified by training and experience, as to be suitable persons to participate in the practice authorised by the licence;
(b)that proper equipment is used;
(c)that proper arrangements are made for the keeping of gametes, eggs in the process of fertilisation and embryos and for the disposal of gametes or any such eggs or embryos that succumb;
(d)that suitable procedures are used in the course of treatment; and
(e)that any terms, conditions or directions applicable to the licence are observed and complied with.
(3)Where a person is permitted by a licensee to conduct, supervise or manage any reproductive technology practice, or any storage, for which a licence is required under this Act, that person may, for the purposes of any disciplinary proceedings or proceedings for an offence under this Act, be deemed to have been the person responsible in relation to that practice.
(4)It may be made a condition of a licence or exemption that a reproductive technology practice, or specified activities of the practice, shall not be carried on in the absence of a specified person.
(5)Except where the Commissioner has given prior approval to the temporary absence of the person responsible, if for any reason the person responsible in relation to any licence or exemption is not to carry out that function, the licensee shall forthwith give notice to that effect to the Commissioner of Health.
(6)Where the person specified in the licence or exemption as the person responsible ceases, or is to cease, to carry out that function and the licensee proposes to appoint or employ some other individual to carry out that function the licensee shall give notice to that effect to the Commissioner of Health who may, within 7 days after receiving the notice of the proposed appointment or employment of any individual as the person responsible in relation to any licence or exemption, notify the licensee that the individual proposed does not have the approval of the licensing authority, and on receiving such a notice from the Commissioner the licensee shall terminate any such appointment or employment with effect from a date not later than 21 days after the date of the notice.
(7)Where —
(a)a requirement is made of a licensee under this Act; or
(b)an element of a contravention of this Act is an act or omission on the part of a licensee,
the person responsible in relation to the licence or exemption in question is, subject to section 53(1)(b), liable accordingly.
(8)Where a person appointed or employed as, or deemed to be, the person responsible in relation to any practice resigns or for any other reason ceases so to act, the licensee remains, and —
(a)in the case of a licensee which is a company, the directors;
(b)in the case of a licensee which is a body corporate other than a company, the committee of management; and
(c)in any other case, such persons as occupy a position of authority in the affairs of the licensee,
jointly and severally remain, liable for the conduct of the practice.
52.Licensee liable for act of employee, etc.
(1)Where an employee or agent of the licensee, or a person acting, or purporting to act, on behalf of the licensee, commits in relation to the conduct of a reproductive technology practice a contravention of this Act for which the licensee would have been responsible or liable had it been committed by the licensee, the licensee may be deemed also to be liable to disciplinary action or, in the case of an offence, the same penalty.
(2)A licensee may be proceeded against under subsection (1) notwithstanding that the employee or agent has not been made the subject of disciplinary proceedings or convicted under this Act.
(3)It is a defence in disciplinary proceedings or to a complaint for an offence against subsection (1) to show that the licensee —
(a)did not know of and could not reasonably have been aware of or have prevented; or
(b)had taken reasonable steps to prevent,
the contravention committed by the employee or agent.
53.Offences by bodies corporate and partnerships
(1)Where a body corporate is convicted of an offence under this Act, which in this subsection is referred to as the principal offence, then —
(a)where a person is or at a material time was —
(i)an officer of, or a person occupying a position of authority in, that body corporate; or
(ii)a person purporting to act in any such capacity,
and that person was in any way, by act or omission, directly or indirectly, knowingly concerned in or party to the commission of the principal offence, that person as well as the body corporate shall be deemed to have committed the principal offence; and
(b)unless it is proved that —
(i)such direction had been given; and
(ii)such supervision had been exercised or caused to be exercised,
as were reasonably necessary to ensure that the principal offence was not committed, a person who is or is deemed to be the person responsible in relation to any practice in respect of which that offence was committed shall be deemed to have committed the offence as well,
and each shall be liable to the penalty that is prescribed for the principal offence.
(2)For the purposes of this section, in relation to a body corporate, a person shall be taken to be an officer of the body corporate if the person would be an officer within the meaning of the definition of that term contained in section 9 of the Corporations Act 2001 of the Commonwealth.
(3)Where the affairs of a body corporate are managed by its members, subsection (1) applies in relation to the acts and defaults of a member in connection with functions of management as if the member were a director of the body corporate.
(4)Where proceedings for an offence under this Act are taken against a body corporate a person who by virtue of this section would be liable to a penalty as well as the body corporate may, on the request of the Commissioner of Health, be convicted on the proceedings on which the body corporate is convicted if the court is satisfied that the person had reasonable notice that the Commissioner of Health intended to make that request.
(5)Where this Act provides that a licensee commits an offence in specified circumstances the reference to the licensee shall be construed as a reference to each person who holds the licence or exemption.
[Section 53 amended by No. 10 of 2001 s. 109.]
Part 5 — Enforcement
Division 1 — Powers of authorised officers
54.Powers of authorised officers
(1)An authorised officer, at any time, may —
(a)enter and inspect any premises on which that person has reasonable cause to believe —
(i)any egg in the process of fertilisation or any embryo is kept;
(ii)any gametes intended for use in an artificial fertilisation procedure, not being sperm derived from only one man, are kept;
(iii)any artificial fertilisation procedure is being, has been or is likely to be carried out;
(iv)any research is being, has been or is likely to be conducted, upon or with gametes or participants or any egg in the process of fertilisation or embryo; or
(v)an offence under this Act has been, is being or is likely to be, committed,
and inspect any equipment, examine any records, and take possession or an account of any gametes, egg in the process of fertilisation or embryo, there;
(b)require any licensee, or any person who is apparently in a position to do so, to —
(i)provide any record or other information, or any assistance, reasonably required by the authorised officer relating to any matter with respect to activities to which this Act may apply carried on at any such premises; and
(ii)answer any question put to that person by the authorised officer on such a matter;
and
(c)require any person having possession of records relevant to a reproductive technology practice conducted under a licence or pursuant to an exemption, or to transactions involving the possession or use of gametes, an egg in the process of fertilisation or an embryo, to produce those records for inspection.
(2)An authorised officer may —
(a)examine any record found or produced under this section;
(b)in the case of any record kept otherwise than in a readily intelligible format, require a person having the power to do so to produce the record in a legible form;
(c)make copies of, or take extracts from, any such record; and
(d)take possession of and retain any such record for such reasonable period as may be necessary for the purposes of this Act,
but shall endeavour to ensure that, so far as is practicable, the confidentiality of the record or any other record to which this Act applies is not thereby prejudiced.
(3)An authorised officer entering and inspecting premises to which subsection (1) relates may —
(a)take possession of anything which that officer has reasonable grounds to believe may be required —
(i)for the purpose of the functions of the licensing authority relating to the grant, variation, suspension and revocation of licences; or
(ii)for the purpose of being used in evidence in any disciplinary proceedings or proceedings for an offence under this Act,
and retain it for so long as it may be required for that purpose; and
(b)for that purpose, take such steps as appear to be necessary for preserving any such thing or preventing interference with it, including requiring any person having the power to do so to give such assistance as may reasonably be required.
(4)A person is not excused from complying with a requirement under this section to answer any question or producing any thing on the ground that the answer to a question put to the person or the production of that thing might incriminate the person or render the person liable to a penalty, but an answer given by a person pursuant to a requirement under this section is not admissible in evidence against the person in any civil proceedings or in any proceedings for an offence other than —
(a)under this Act;
(b)perjury; or
(c)an offence arising out of the false or misleading nature of that answer.
(5)A person who discloses to an authorised person under this section information that would otherwise be confidential shall not be taken to have committed thereby any breach of a principle of professional ethics.
(6)Notwithstanding anything in this section to the contrary, the powers conferred hereunder shall only be exercised at reasonable times and at reasonable intervals unless the authorised officer has good grounds or a reasonable belief for doing otherwise and has prior to exercising the powers other than at reasonable times and intervals recorded his grounds or beliefs in writing and signed that record and had his signature witnessed in writing, noting the date and time of signature. The authorised officer shall place his record of grounds upon a register kept by the Commissioner of Health for that purpose as soon as practicable.
(7)A person who —
(a)hinders an authorised officer in the exercise of powers conferred by this section;
(b)fails, without reasonable excuse, to comply with a requirement of an authorised officer under this section;
(c)fails, without reasonable excuse, to answer, to the best of the knowledge, information and belief of that person, a question put to that person by an authorised officer; or
(d)impersonates an authorised officer,
commits an offence.
Penalty: $5 000.
55.Entry, search and seizure, by warrant
(1)Where a justice is satisfied, upon complaint, that there is reason to suspect that an offence is, or is likely to be, committed under this Act at any premises, the justice may, by warrant in the prescribed form stating the proposed purpose, empower any authorised officer or member of the Police Force to enter, with such other persons as may be necessary to assist, upon those premises using such force as may be necessary and any such warrant continues to have effect until the purpose for which it was granted is satisfied.
(2)A warrant under subsection (1) authorises the holder and such other persons as are necessary to assist —
(a)to arrest any person suspected of being concerned in an offence under this Act and found on the premises to which the warrant relates;
(b)to seize all records or other things which there are reasonable grounds for believing may be required as evidence for the purposes of disciplinary proceedings or as an offence under this Act; and
(c)to search —
(i)the premises; and
(ii)all persons found at or in the immediate vicinity of the premises and suspected of being concerned in an offence under this Act.
Division 2 — Proceedings
(1)All proceedings for an offence under this Act shall be —
(a)instituted by a complaint laid in the name of the Commissioner of Health; and
(b)dealt with by a court constituted by a magistrate.
(2)A prosecution for an offence under this Act may be commenced until 5 years have elapsed since the date on which the matter of complaint arose, but not thereafter.
57.Averments, and other evidentiary matters
(1)In disciplinary proceedings under this Act or proceedings for an offence under this Act, an allegation in the complaint —
(a)that a substance referred to in the complaint was or contained gametes, an egg in the process of fertilisation or an embryo as may be there specified;
(b)that a person named in the complaint is (or is not), or was (or was not) on a specified date —
(i)licensed;
(ii)licensed in respect of any specified procedure or practice;
(iii)approved as the person responsible in relation to a specified practice;
(iv)an employee or agent of a specified licensee; or
(v)the holder of a specified exemption;
(c)that any premises named in the complaint are (or are not), or were (or were not) on a specified date, premises to which a specified licence or specified exemption relates;
(d)that a licence or exemption referred to in the complaint is, or was on a specified date, subject to specified conditions or not so subject, or was of a specified class, or suspended;
(e)that a person named in the complaint is, or was on a specified date, an authorised officer or otherwise authorised by the licensing authority;
(f)that a person named in the complaint has, or had on a specified date, a specified function by virtue of a delegation under this Act; or
(g)that a delegation under this Act is, or was on a specified date, subject to specified conditions,
shall be accepted as proved in the absence of proof to the contrary.
(2)In subsection (1) —
“specified” means specified in the complaint; and
“complaint
(3)In proceedings under this Act against a person named in a licence or certificate of exemption as the holder of that licence or exemption, the person shall be taken to be the holder of that licence or exemption in the absence of proof to the contrary.
(4)In any legal proceedings, a document apparently certified by the Commissioner of Health to be a licence, notice or other document issued under this Act, or to be a copy of a licence, notice or other document issued under this Act, or to be a document or a copy of a document furnished to the licensing authority, shall be —
(a)accepted as such in the absence of proof to the contrary; and
(b)for all purposes, without producing the original, sufficient evidence as to what matter was contained in the document.
(5)In all proceedings in which the giving of any notice by the licensing authority, or of any other document required or authorised under this Act, has to be proved, the defendant is deemed to have received notice to produce that document, and, until the contrary is shown, the giving of the notice or the due service of the document may be sufficiently proved by the production of what purports to be a copy, bearing what purports to be a certificate signed by the person giving that notice or authorised to issue the original document, or the Commissioner of Health, as the case may be, that the copy is a true copy of the original and that the original notice was given or document served on the date specified in the certificate.
(6)The validity of any notice or other document or of its service is not affected by any error, misdescription, or irregularity which is not calculated to mislead, or which in fact does not mislead.
(7)In all courts and before all persons authorised to receive evidence —
(a)a signature purporting to be that of the Minister, or of the Commissioner of Health or any other authorised officer, shall be taken to be the signature of the person whose signature it purports to be in the absence of proof to the contrary;
(b)a certificate purporting to be signed by the Commissioner of Health —
(i)that a notice or other document of the description mentioned in the certificate has or has not been given to or served on a person under this Act; or
(ii)as to the date of and the contents of any notice so given or any document so served,
is evidence of those matters as specified in the certificate.
(8)Where proceedings are taken in the name of the Commissioner of Health by an authorised officer no proof shall be required of the appointment of that officer or of the authority of that officer to take those proceedings, and the averment in the complaint that the officer is so authorised shall be deemed to be proof of the fact, in the absence of proof to the contrary.
(9)A certificate, purporting to be signed by the Commissioner of Health, certifying that on a day specified in the certificate a person named in the certificate was a delegate of the Commissioner of Health under section 13(4) to whom such functions of the Commissioner of Health as are specified in the certificate had been delegated on terms, if any, so specified shall be admissible in evidence in any proceedings and, in the absence of proof to the contrary, shall be proof of the matters stated in the certificate.
(10)In any proceedings against a person for failing or neglecting duly to furnish the licensing authority with any information required by the licensing authority a certificate, purporting to be signed by the Commissioner of Health, certifying —
(a)that the defendant was so required to furnish the licensing authority with the information of the nature specified in the certificate; and
(b)that the licensing authority has not been furnished with the information so required,
shall be admissible in evidence in those proceedings and, in the absence of proof to the contrary, shall be proof of the matters so stated therein.
Part 6 — Administration
Division 1 — Staff
58.Use of staff and facilities of departments, agencies and instrumentalities, and engagement of consultants, etc.
(1)The Council may, by arrangement made between it and the Minister concerned, and on such terms and conditions as may be mutually arranged by it with that Minister and with the relevant employing authority within the meaning of the Public Sector Management Act 1994, make use, either full‑time or part‑time, of —
(a)the services of any officer or employee employed in the Public Service of the State or in a State agency or instrumentality or otherwise in the service of the Crown in right of the State; or
(b)any facilities of a department of the Public Service of the State or of a State agency or instrumentality.
(2)The Council may, with the prior approval of the Minister, engage under contracts for services such consultants and professional or technical or other assistance as it considers necessary to enable the Council to exercise and perform its functions.
(3)Subsections (1) and (2) shall not be taken to prejudice the operation of the Health Legislation Administration Act 1984 in so far as that Act may apply to this Act.
(4)Where the services of a person are for the time being utilized by the Council under this Act, it does not prejudice the existing or accruing rights of that person under the Public Sector Management Act 1994 2 or any other written law, and service rendered on behalf of the Council pursuant to this Act shall be regarded as not constituting a break in the service in which the person would otherwise have been employed.
[Section 58 amended by No. 32 of 1994 s. 19.]
(1)Subject to this section —
(a)officers required to —
(i)ensure that licensees, and their procedures and practices, conform to the requirements of this Act; and
(ii)examine records relating to reproductive technology;
and
(b)such other officers as may be required,
shall be appointed under, and shall hold office subject to and in accordance with, Part 3 of the Public Sector Management Act 1994, to assist the Commissioner of Health in the administration of this Act.
(2)The Commissioner of Health shall issue to —
(a)a person appointed pursuant to subsection (1)(a);
(b)a Public Health Official required to exercise power as an authorised officer; or
(c)a person to whom a function is delegated pursuant to section 13(4),
a certificate of identity in the prescribed form, and that certificate shall specify the particular functions or circumstances in relation to which, and the purposes for which, the person may exercise powers conferred by this Act or may be expressed to operate as a general authorisation for the purposes of this Act.
(3)A person shall not be eligible for appointment under this section unless, in relation to the functions which they are to carry out, that person has such qualifications or training as may be required by this Act in relation to an appointment of that kind.
(4)A person shall not be appointed or permitted to assist the Commissioner of Health in the administration of this Act in so far as that may involve access to information identifying participants in any artificial fertilisation procedure unless that person is specifically authorised by the Commissioner to carry out that function.
[Section 59 amended by No. 32 of 1994 s. 19.]
Division 2 — Subsidiary legislation
60.Regulations, and subsidiary legislation generally
(1)The Governor, on the recommendation of the Minister, may make regulations prescribing all matters that are required or permitted by this Act to be dealt with by the Code or to be prescribed, or are necessary or convenient to be prescribed, for giving effect to the purposes of this Act.
(2)Regulations made under this section may prescribe offences, and a penalty for any contravention of those regulations which shall —
(a)in the case of a contravention relating to any offence that is also prohibited by the Code of Practice, not exceed $5 000; and
(b)in any other case, not exceed $2 500.
(3)For the purpose of any Rule the Council by a resolution may, and in and for the purposes of any direction the Commissioner may, approve or adopt, with or without modification but subject to subsection (4), a text or any requirement imposed, issued or approved elsewhere.
(4)Where subsidiary legislation under this Act includes or refers to any text or requirement (including any criteria, standard, specification, formula or other means of conveying detailed information) which is approved or adopted, with or without modification, under subsection (3) that legislation has effect —
(a)as if the text or the requirement identified by reference to the person or body from which it originated (being the text or requirement at the date of its approval or adoption or as may otherwise be specified, unless it is specified that the text or requirement applicable shall be that as from time to time amended) were set out in full; and
(b)where the text or requirement is to apply as from time to time amended, as if any modification determined by the Council or the Commissioner at the time the text or requirement was approved or adopted (unless the modification itself is later amended under this Act) prevailed over any subsequent amendment to that text or requirement made by the originating person or body that is inconsistent with the modification.
Division 3 — General
(1)The Minister shall carry out a review of the operation and effectiveness of this Act as soon as is practicable after the expiry of 5 years from its commencement and in the course of that review the Minister shall consider and have regard to —
(a)the effectiveness of the operations of the Council and the committees of the Council;
(b)the need for the continuation of the functions conferred, on the Council and on the Commissioner of Health respectively by this Act; and
(c)such matters, other than those referred to in paragraphs (a) and (b), as appear to the Minister to be relevant to the operation and effectiveness of this Act.
(2)The Minister shall prepare a report based on the review made under subsection (1) and shall, as soon as is practicable after that preparation, cause that report to be laid before each House of Parliament.
[62, 63.Omitted under the Reprints Act 1984 s. 7(4)(e).]
[Sections 5 and 8]
Provisions relating to the membership and proceedings of the Council and the annual report on reproductive technology
(1)The Governor shall, on the recommendation of the Minister, appoint a member as Chairperson to preside over the proceedings of the Council.
(2)A person may be appointed under subclause (1) on terms that require the fulltime employment of that person in the performance of the duties of the office.
(3)The Council shall from time to time appoint (for a term fixed by the Council) one of its members to preside as Deputy Chairperson in the absence or incapacity of the Chairperson, but if neither the Chairperson or the Deputy Chairperson is present the members of the Council who are present at a meeting, whether or not a person who is the deputy of the Chairperson or of the Deputy Chairperson is present, shall select a Deputy Chairperson to preside over those proceedings and the person so selected has, whilst so acting, the functions and entitlements of the Chairperson.
(4)Where a member who is appointed or selected as a Deputy Chairperson is performing the functions of the Chairperson, the deputy of that member may act in the place of the member.
(1)On the nomination of the body or person by which or whom the member is nominated, the Minister may appoint a deputy to any member, other than the Executive Officer, who shall, subject to clause 1(3), act in the place of the member on the Council when the person who is the member can not so act.
(2)The Minister may appoint a deputy to the Executive Officer to act in the place of the Executive Officer when that person is unable to carry out any function required by this Act.
(3)While a person is acting in the place of a member on the Council or a committee, under clause 1(4) or this clause, that person is deemed to be a member, and has all the functions and entitlements of that member.
(4)The Minister may make such arrangements as the Minister considers appropriate for the receipt of nominations for the purposes of an appointment under subclause (1), and any such appointment may be made —
(a)for a period; or
(b)in relation to particular circumstances,
specified in the instrument of appointment.
(5)Where —
(a)a member and the deputy of that member can not, or do not, act in that capacity; or
(b)a member can not or does not so act and no deputy has been nominated,
the Minister may appoint a person who in the opinion of the Minister is representative of the same interests as that member to act in place of that member, and while so acting the appointee shall be deemed to be the deputy of the member.
(6)The appointment of a person under this clause to act in the place of a member may be terminated at any time by the Minister.
(7)No act or omission of a person acting under this clause in place of a member shall be questioned on the ground that the occasion for so acting had not arisen or had ceased.
(1)Except as otherwise provided by this Act —
(a)a nominated member holds office for such term, not exceeding 3 years, as is specified in the instrument of appointment; and
(b)may be reappointed.
(2)On the occasion of the first appointments to the Council, the term of office of one‑half of the nominated members shall not exceed 18 months.
(3)The Executive Officer shall hold office as a member —
(a)subject to subclause (4), for such term as may be specified in the instrument of appointment —
(i)by reference to the office or employment which that person holds at the time of appointment; or
(ii) otherwise;
or
(b)if no term is so specified, until such time as is determined by the Minister.
(4)Where a person appointed as the Executive Officer ceases to comply with the requirements of section 8(3)(a), that person thereby ceases to hold that office.
(5)Where the office of a nominated member becomes vacant otherwise than under clause 5, a nominated member continues in office until a successor comes into office, notwithstanding that the term for which that member was appointed has expired.
(6)Where an office of nominated member becomes vacant otherwise than by effluxion of time a person appointed to the vacancy shall hold office only for the balance of the term of the person whose vacancy is filled.
(7)When the office of a member becomes vacant, the Minister shall ensure that a person is appointed to that vacant office in accordance with this Act.
4.Remuneration and leave of members
(1)A member, and any person appointed to a committee or requested to attend a meeting of the Council or a committee, is entitled to be paid from the funds of the Council —
(a)unless the person is an officer of the Public Service, such remuneration; and
(b)such allowances,
as may be determined by the Minister after consultation with the Minister for Public Sector Management 3.
(2)The Council may grant leave of absence to a member on such terms and conditions as, subject to any direction given by the Minister, the Council determines.
5.Premature vacation of office
(1)The office of a nominated member becomes vacant if —
(a)the member —
(i)resigns that office by written notice addressed to the Minister; or
(ii)dies;
(b)the member becomes bankrupt, applies to take the benefits of any law for the relief of bankrupt or insolvent debtors, compounds with creditors (whether separate creditors of that person or the creditors of a partnership which includes that person), or makes an assignment or arrangement for the benefit of creditors;
(c)the member is absent without leave of the Council from 3 consecutive meetings of the Council of which the member was given notice; or
(d)the member is removed from office by the Governor on the recommendation of the Minister —
(i)for neglect of duty, misbehaviour, or incompetence;
(ii)by reason of impairment, within the meaning of Part IVA of the Equal Opportunity Act 1984, affecting the performance of the duties of the member;
(iii)by reason of the member having acquired, since the date of appointment, a personal or pecuniary interest incompatible with the required perception of the status of a member; or
(iv)on the grounds that the member has not retained the confidence of the body or person by which or whom the member was nominated.
(2)In subclause (1)(d)(i), “misbehaviour” shall be construed as including having a direct personal or pecuniary interest (other than an interest to which clause 6(6) applies) in a matter to which this Act relates and which is not disclosed to the Council or a relevant committee.
6.Personal or pecuniary interests
(1)If a matter arising before the Council or a committee (other than a question of general principle) affects the personal or pecuniary interests of a person directly, that person is ineligible to vote on that matter unless —
(a)subclause (6) applies;
(b)a direction given by the Minister under subclause (3) applies; or
(c)the Council or that committee, as the case may be, otherwise determines under subclause (3),
and, if ineligible, shall abstain from voting.
(2)A member, and any person appointed to a committee or requested to attend a meeting of the Council or a committee, who has a direct personal or pecuniary interest, not being an interest to which subclause (6) applies, in a matter being considered or about to be considered by the Council or a committee shall before, or as soon as practicable after, the matter arises for consideration —
(a)disclose fully, as soon as possible after the relevant facts have come to the knowledge of that person, the nature of the interest at a meeting of the Council or that committee, as the case requires; and
(b)subsequently, where the person is present at any meeting of the Council or a committee where the relevant matter is to be considered, declare shortly the nature of the interest and where and when it was disclosed fully under this subclause.
(3)A disclosure under subclause (2) shall be recorded in the minutes of the meeting of the Council or the committee concerned, as the case requires, and the person having the interest shall not, unless the Minister otherwise directs or the Council or that committee, as the case may be, otherwise determines —
(a)be present during any deliberation; or
(b)take part in any decision,
of the Council or that committee with respect to the matter to which the disclosure relates.
(4)For the purpose of the making of a determination by the Council or the committee concerned, as the case requires, under subclause (3) in relation to a person who has made a disclosure under subclause (2), the person who has the interest in the matter to which the disclosure relates shall not —
(a)be present during any deliberation of the Council or that committee for the purpose of making that determination; or
(b)take part in the making of that determination by the Council or that committee.
(5)A person who contravenes subclause (1), (2), (3) or (4) commits an offence.
Penalty: $5 000.
(6)The Minister may, on being satisfied on the application of any person that the nature and extent of any interest of that person has been fully disclosed to the Minister, direct in writing that the interest is an interest to which this clause, other than this subclause and subclauses (7) and (8), shall not apply.
(7)Where the Minister gives a direction under subclause (6), the person having that interest shall lodge a copy of the direction with the Executive Officer, who shall report the direction, but not the nature or extent of any interest disclosed, to the next meeting of the Council.
(8)Any question as to whether or not an interest is of the nature and extent disclosed under subclause (6) may be determined by the Minister.
(9)The requirements of this clause do not apply in a case where the interest of the person consists only of being —
(a)a member or creditor of a corporation that is interested in a contract or proposed contract related to the matter arising; or
(b)a member of a body by which that person was nominated for the purposes of this Act,
if the interest of that person may properly be regarded as not being both a material personal and also a pecuniary interest of the person.
(10)For the purposes of this clause, a general notice given to the Council or the committee by a person to the effect that the person is an officer of or associated with a specified corporation, firm or body and is to be regarded as having a pecuniary interest in any contract that may, after the date of the notice, be made with that corporation, firm or body shall be deemed to be a sufficient disclosure of that interest if —
(a)the notice states the nature and extent of the interest of the person in the corporation or firm or body; and
(b)the extent of the interest of that person in the corporation, firm or body is not greater than is stated in the notice.
(1)The first meeting of the Council shall be convened by the Minister and thereafter meetings shall be held at the times and places determined by the Council but the Chairperson or any 4 members may, on reasonable notice being given as far as is practicable to all members, call a meeting at any time.
(2)At a meeting of the Council, 6 members eligible to vote constitute a quorum.
(3)Subject to subsection (2), the Council may act notwithstanding vacancies in its membership.
(4)The Chairperson, or in the absence of the Chairperson a person appointed or selected as Deputy Chairperson under clause 1(3), shall preside at a meeting of the Council and shall have a deliberative vote, but in the case of an equality of votes shall not, unless subclause (6) applies, have a casting vote.
(5)Subject to subclause (6), questions arising at a meeting of the Council shall be decided, in open voting, by a majority of the votes of the members present and eligible to vote.
(6)If the votes cast on a question are equally divided the question shall remain unresolved until a subsequent meeting of the Council, but if the votes cast on the question at that subsequent meeting are again equally divided the question shall be decided on the casting vote of the person presiding.
(7)For the purposes of determining the existence of a majority or quorum in accordance with section 54 of the Interpretation Act 1984 a member, or person appointed to a committee, who is precluded under clause 6 from taking part in any deliberation or decision at a meeting with respect to a matter shall be deemed to be absent from the meeting while that matter is being deliberated or decided.
(8)The Council may request a person whom the Council considers may assist it with professional or technical advice on any matter to attend a meeting of the Council or a committee and contribute to the discussion of that matter, but any such person shall not take part in any decision with respect to that matter, or be counted for the purpose of determining the existence of a quorum.
(9)The Council shall cause accurate minutes to be kept of the proceedings at its meetings, and make them available for inspection by, or by a person on behalf of, the Minister.
(10)Subject to this Act, the proceedings of the Council shall be conducted as it thinks fit but, if regulations made or directions given by the Minister relate to any such matter, in accordance with those regulations or directions.
8.Unanimous resolution may be passed without meeting
(1)A resolution of the Council, in writing and signed or assented to by each member by letter, telegram, telex, electronic mail or facsimile transmission, shall be as valid and effectual as if it had been passed at a meeting of the Council.
(2)The Executive Officer shall report the passing of a resolution under subsection (1) to the next meeting of the Council.
(1)A committee shall, as soon as is practicable after receiving notification of any matter referred to it by the Council, consider the matter and give to the Council a written report as to the advice or findings of the committee in relation to the matter within such period as the Council directs.
(2)Subject to this Act, each committee may determine its own procedures.
10.Protection of members, etc.
(1)A person who —
(a)is a member;
(b)is appointed to a committee;
(c)is requested to attend a meeting of the Council or a committee;
(d)is authorised by a delegation or further delegation under section 11 to perform a function on behalf of the Council; or
(e)is otherwise a person engaged in the administration or enforcement of this Act,
is not personally liable for any act done or omitted to be done in good faith by the Council, a committee or that person when so acting or attending.
(2)No proceedings, civil or criminal, shall be taken or lie against any person for any act, matter or thing done or omitted to be done, or required to be done or omitted to be done —
(a)by a person purportedly for the purposes of the administration of this Act; or
(b)in reliance on or pursuant to any Order, direction, or requirement apparently given, issued or made in accordance with the provisions of this Act,
unless it was negligent, malicious or lacked reasonable and probable cause.
11.Annual report on reproductive technology
(1)The report to be furnished by the Council to the Commissioner of Health on the use of reproductive technology in the State and the operations of the Council in the preceding year ending 30 June shall be so furnished by such date as, in the opinion of the Commissioner, will enable the Commissioner to submit an annual report to the Minister not later than 30 September in each year.
(2)The report to be furnished by the Council to the Commissioner, and the annual report to be submitted to the Minister, under subclause (1) —
(a)shall set out —
(i)any significant developments in the use of, or in the procedures or techniques used in, reproductive technology during the year, whether in the State or elsewhere;
(ii)details of research specifically approved by, or being conducted with the prior approval of, the Council during that year;
(iii)in statistical terms, the activities of persons licensed under this Act and carried on during that year; and
(iv)any discernible social trends that became apparent during that year and are, or may be, attributable to the use of reproductive technology;
(b)shall contain particulars of —
(i)any contravention of this Act, or of any terms, condition or direction relating to a licence or exemption; and
(ii)any other matter within the responsibilities of the Council or the Commissioner,
that is, in the opinion of the Council or of the Commissioner, of significance to the public interest; and
(c)shall, if that is practicable, be combined with any annual report that may be required to be submitted in relation to this Act under the Financial Administration and Audit Act 1985.
[Schedule amended by No. 78 of 1995 s. 147.]
Notes
1This reprint is a compilation as at 12 July 2002
|
Short title |
Number and year |
Assent |
Commencement |
|
Human Reproductive Technology Act 1991 |
22 of 1991 |
8 Oct 1991 |
Div. 1 of Pt. 1, Pt. 2, Pt. 6 and Schedule: 6 Mar 1992 (see s. 2 and Gazette 6 Mar 1992 p. 1107); |
|
Acts Amendment (Public Sector Management) Act 1994 s. 19 |
32 of 1994 |
29 Jun 1994 |
1 Oct 1994 (see s. 2 and Gazette 30 Sep 1994 p. 4948) |
|
Sentencing (Consequential Provisions) Act 1995 s. 147 |
78 of 1995 |
16 Jan 1996 |
4 Nov 1996 (see s. 2 and Gazette 25 Oct 1996 p. 5632) |
|
Human Reproductive Technology Amendment Act 1996 |
1 of 1996 |
4 Apr 1996 |
s. 5: 8 Apr 1993 (see s. 2(2)); |
|
Statutes (Repeals and Minor Amendments) Act 1997 s. 75 |
57 of 1997 |
15 Dec 1997 |
15 Dec 1997 (see s. 2(1)) |
|
Corporations (Consequential Amendments) Act 2001 Pt. 32 |
10 of 2001 |
28 Jun 2001 |
15 Jul 2001 (see s. 2 and Gazette 29 Jun 2001 p. 3257 and Cwlth Gazette 13 Jul 2001 No. S285) |
1aOn the date as at which this reprint was prepared, provisions referred to in the following table had not come into operation and were therefore not included in compiling the reprint. For the text of the provisions see the endnote referred to in the table.
Provisions that have not come into operation
|
Short title |
Number and year |
Assent |
Commencement |
|
Acts Amendment (Lesbian and Gay Law Reform) Act 2002 Pt. 11 4 |
3 of 2002 |
17 Apr 2002 |
To be proclaimed (see s. 2) |
2Under the Public Sector Management Act 1994 s. 112(1), a reference to the Public Service Act 1978 is to be read as a reference to the Public Sector Management Act 1994. The reference was changed under the Reprints Act 1984 s. 7(3)(g).
3 Under the Public Sector Management Act 1994 s. 112(2), a reference in a written law to the Public Service Commissioner is, unless the contrary intention appears or it is otherwise provided under the Acts Amendment (Public Sector Management) Act 1994, to be construed as if it had been amended to be a reference to the Minister for Public Sector Management (as defined in the Interpretation Act 1984). This reference was amended under the Reprints Act 1984 s. 7(5)(a).
4On the date as at which this reprint was prepared, the Acts Amendment (Lesbian and Gay Law Reform) Act 2002 Pt. 11 had not come into operation. It reads:
“
Part 11 — Human Reproductive Technology Act 1991
71.Human Reproductive Technology Act 1991 amended
The amendments in this Part are to the Human Reproductive Technology Act 1991.
The preamble is amended as follows:
(a)in paragraph A by deleting “couples who are unable to conceive children naturally or whose children may be affected by a genetic disease.” and inserting instead —
“ persons who wish to be parents. ”;
(b)in paragraph B by deleting “so assist these couples” and inserting instead —
“
assist persons who are unable to conceive children naturally due to medical reasons or whose children are otherwise likely to be affected by a genetic abnormality or disease,
”.
Section 21 is amended by inserting after paragraph (h) the following paragraph —
“
(i)the means of identifying, for the purposes of sections 24 and 26, the person or persons on behalf of whom any gametes, egg in the process of fertilisation or embryo are stored, kept for implantation or developed which, in accordance with consents given, may be —
(i)a woman or man; or
(ii)a couple who are married, or in a de facto relationship with each other whether they are different sexes or both female;
”.
(1)Section 23(a) is amended as follows:
(a)by deleting subparagraph (i) and “or” after it and inserting instead —
“
(i)persons who, as a couple, are unable to conceive a child due to medical reasons;
(ia)a woman who is unable to conceive a child due to medical reasons; or
”;
(b)in subparagraph (ii) by inserting after “couple” —
“ or a woman ”.
(2)Section 23(c)(ii) is deleted and the following subparagraph is inserted instead —
“
(ii)in a de facto relationship with each other and are of the opposite sex to each other;
”.
Section 24(2) is amended by inserting before “persons” —
“ person or ”.
Section 26(1) is amended as follows:
(a)in paragraph (c) by deleting “developed;” and inserting instead —
“
developed, or vest in the woman on whose behalf that egg or embryo was developed;
”.
(b)in paragraph (d) by inserting after “couple” —
“ or a woman ”.
”.
Defined Terms
[This is a list of terms defined and the provisions where they are defined. The list is not part of the law.]
Defined TermProvision(s)
artificial insemination procedure3(1)
authorised officer3(1)
biological parent3(1)
Chairperson3(1)
chimaera3(1)
cloning3(1)
Code3(1)
Code of Practice3(1)
Commissioner3(1)
Commissioner of Health3(1)
committee3(1)
complaint57(2)
condition3(1)
Council3(1)
counselling services3(1)
Deputy Chairperson3(1)
directions3(1)
director3(1)
Director‑General3(1)
effective consent3(1)
embryo3(1)
embryo flushing3(1)
Executive Officer3(1)
exemption3(1)
fertilisation3(1)
guidelines3(1)
in vitro fertilisation procedure3(1)
information5(9)
Institutional Ethics Committee3(1)
licence3(1)
licensee3(1)
licensing authority3(1)
medical practitioner3(1)
member3(1)
misbehaviourSch. cl. 5(2)
nominated member3(1)
parliamentary purposes5(9)
parthenogenesis3(1)
participant3(1)
permitted storage period24(4)
person responsible3(1)
person to whom the licence applies3(1)
practice3(3)(c)
premises3(1)
procedure3(1)
project of research3(1)
proprietary company3(1)
Public Health Official3(1)
record3(1), 5(9)
related body corporate3(1)
reproductive technology3(1)
reproductive technology practice3(3)(c)
research3(1)
Rules3(1)
specified57(2)
storage procedure3(1)
storage3(4)(b)
store3(4)(b)
stored3(4)(b)
subsidiary legislation3(1)
this Act3(1)
treatment3(1)
valuable consideration7(2)
By Authority: JOHN A. STRIJK, Government Printer