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This Act may be cited as the Human Reproductive Technology Act 1991.
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.
In this Act, unless the contrary intention appears —
artificial fertilisation procedure means any —
artificial insemination procedure; or
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 —
the CEO; or
a person authorised by the CEO, generally or in relation to particular functions, circumstances, or purposes, as may be specified in the relevant certificate issued under section 59(2);
in relation to the powers referred to in section 44(3)(c) or 49(4)(b), includes a reference to the CEO as defined in section 3 of the Children and Community Services Act 2004 or an officer as defined in that section authorised in writing by that CEO;
in relation to the powers referred to in section 54, a person on whom the powers are conferred by the CEO under section 53ZQ(4);
biological parent means a person who —
is the source of a human egg or human sperm used in an artificial fertilisation procedure; and
is the genetic parent of a human embryo developed, or of a child born, as a consequence of that procedure;
CEO has the meaning given by section 3 of the Health Legislation Administration Act 1984;
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;
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;
committee means a committee of the Council;
Commonwealth Human Embryo Act means the Research Involving Human Embryos Act 2002 of the Commonwealth;
condition in relation to a licence or exemption, includes —
a limitation, restriction or prohibition; and
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 —
the screening or assessment of potential participants; and
the provision of information; and
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 member of the board or committee of management of the body corporate; and
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
any person in accordance with whose directions or instructions directors of the body corporate are accustomed to act;
effective consent is to be construed in accordance with section 22(8);
excess ART embryo has the meaning given to that term in section 53T;
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 that is applied for and is not refused, or is specifically issued, under section 28; or
an exemption under section 28A;
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 when an embryo is formed;
guidelines means, except in section 14(3), the information set out in Part 2 of the Code;
human egg means a live human egg;
human embryo has the meaning given to that term in section 3A;
human gamete means a human egg or a human sperm;
human sperm means live human sperm or spermatids;
in vitro fertilisation procedure means a procedure, not being a storage procedure, which —
is consequent upon the removal of a human egg from the body of a woman, and carried out for one or more of the following purposes —
the fertilisation of that egg, within or outside her body; or
the keeping or use of that egg with intent to derive from it a human egg undergoing fertilisation or a human embryo; or
the keeping or use of that human egg undergoing fertilisation or human embryo so derived;
or
is directed at the introduction into the body of a woman of —
a human egg;
a human egg undergoing fertilisation or a human embryo, whether or not fertilisation began outside the body into which it is introduced;
or
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 recognised by the Council, as having —
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
functions, and a composition, complying with requirements of the NHMRC relating to ethical oversight of research involving humans;
licence means a licence granted under Part 4;
licence supervisor, 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;
licensee means a person holding a licence under Part 4 and also includes a reference to —
a person who holds an exemption under section 28A; and
a person who is authorised under section 30 to carry on the practice of a licensee; and
the licence supervisor, in relation to any licence or exemption; and
a person authorised or permitted, in accordance with section 51, to carry on, supervise or manage a reproductive technology practice or specified activities; and
a registered medical practitioner to whom an exemption under section 28 applies; and
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;
medical practitioner means a person registered under the Health Practitioner Regulation National Law (Western Australia) in the medical profession;
member means member of the Council, and includes a reference to a deputy or other person acting in the place of a member;
NHMRC means the National Health and Medical Research Council established by the National Health and Medical Research Council Act 1992 of the Commonwealth;
NHMRC licence means a licence granted under —
section 53ZB; or
section 21 of the Commonwealth Human Embryo Act;
nominated member means a member of the Council, other than the Executive Officer;
participant, in relation to any artificial fertilisation procedure, means —
a person who —
undergoes that procedure; or
is the donor, or being a woman is the recipient, of human gametes, of a human egg undergoing fertilisation or of a human embryo used in that procedure;
or
a person from whom, by reason of this Act, a consent to the carrying out of that procedure is required;
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 by the CEO under section 60A(1);
record means —
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; and
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
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 —
artificial fertilisation procedures; or
the keeping or use of human gametes intended for use in an artificial fertilisation procedure, human eggs undergoing fertilisation or human embryos; or
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;
summary conviction penalty, in relation to a crime, has the same meaning as that term has in section 5 of The Criminal Code;
this Act includes a reference to —
the regulations; and
the Rules and the guidelines; and
such directions as are published in the Gazette;
treatment includes medical, surgical and obstetric services;
woman means any female human.
This Act, other than Part 4A or 4B so far as it relates to the keeping or use of, or any offence relating to, a human egg undergoing fertilisation or a human embryo applies —
only to such keeping or use as takes place outside the body of a woman; and
only if the egg or the embryo has been or is developed in consequence of an in vitro fertilisation procedure.
In this Act, a reference —
[(a) deleted]
to a human egg, except where the context otherwise indicates, does not include a reference to a human egg undergoing fertilisation; and
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
to the keeping of human sperm, does not include keeping for purposes other than for use in an artificial fertilisation procedure.
In relation to human gametes, a human egg undergoing fertilisation or a human embryo a reference in this Act —
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
to any human gametes which are or a human egg or embryo which is, stored, means kept in such a state,
and store and storage shall be construed accordingly.
References in this Act to a “person to whom the licence applies” are to —
the licensee; and
the licence supervisor; and
any person designated in a notice given to the CEO by the licensee or the licence supervisor, as a person to whom the licence applies; and
any person acting under the direction of the licensee, the licence supervisor or of the person so designated.
In this Act a reference to what is “proper” or “suitable” shall be construed having regard to any relevant provision of the Code.
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.
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.
For the purposes of this Act, a person occupies a position of authority in a body if that person —
where the body is a body corporate, is a director; or
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
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.
Nothing in this Act, or in a licence, authorisation or approval under this Act, authorises or permits the use of a human embryo for technical or commercial purposes in the testing, creation or manufacture of cosmetic products such as lipstick, mascara, face moisturising creams and other like beauty products.
This Act binds the Crown.
[Section 3 amended: No. 57 of 1997 s. 75; No. 10 of 2001 s. 108; No. 17 of 2004 s. 5; No. 18 of 2004 s. 4; No. 34 of 2004 Sch. 2 cl. 14; No. 55 of 2004 s. 522 and 540; No. 28 of 2006 s. 266 and 270(1); No. 22 of 2008 Sch. 3 cl. 28; No. 35 of 2010 s. 95; No. 19 of 2016 s. 157.]
In this Act —
human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.
For the purposes of the definition of human embryo in subsection (1), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.
[Section 3A inserted: No. 17 of 2004 s. 6.]
Generally, the objects of this Act are —
to regulate, and to provide guidance in, the use of reproductive technology by —
the establishment of the Council, with the functions referred to in section 14; and
the compilation and implementation of a Code of Practice; and
the imposition of licensing requirements; and
the enforcement of this Act;
and
to ensure adherence to standards in the practice of reproductive technology that are proper and suitable; and
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; and
to ensure —
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; and
that the participants are adequately assessed medically as to the need for any procedure, and counselled and informed as to its implications; and
that the welfare of participants is properly promoted; and
that the prospective welfare of any child to be born consequent upon a procedure to which this Act relates is properly taken into consideration;
and
to require that equity, welfare and general standards prevailing in the community are taken into account in the practice of reproductive technology; and
to provide a forum whereby —
debate by the community on reproductive technology issues may be conducted; and
proper standards to evaluate and monitor reproductive technology can be determined, established and maintained; and
policy decisions may be made about reproductive technology,
on an informed basis.
The particular objects of Part 4A are set out in section 53A.
The particular objects of Part 4B are set out in section 53S.
[Section 4 amended: No. 17 of 2004 s. 7; No. 18 of 2004 s. 5.]
Subject to the Minister, the administration of this Act is vested in the CEO who —
shall be responsible for the implementation of the licensing system set out in Part 4; and
may give directions to licensees.
The Western Australian Reproductive Technology Council established under section 8 shall —
compile the Code of Practice; and
advise the Minister, generally; and
advise the CEO on licensing and disciplinary matters,
but shall give effect to instructions given by the Minister under section 12(3) and, if the CEO is empowered under section 13 to discharge functions of the Council, shall assist the CEO in so doing.
The Code of Practice shall be compiled and implemented in accordance with Part 3.
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 —
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
the regulation is required for the purposes of section 13(2).
Directions given by the CEO shall have effect, except to the extent of any inconsistency with the regulations or the Code, in accordance with section 31.
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 CEO 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.
For parliamentary purposes, and for the conduct of the public business of the Minister, the Minister is entitled —
to be furnished by the CEO and the Council with —
any report concerning the activities or proceedings of the CEO, the Council or the committees of the Council; and
all information in their respective possession,
as the Minister may from time to time require; and
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.
For the purposes of subsection (7), the Minister may —
request the CEO or the Council to furnish, or to give the Minister access to, information, and to supply records; and
make use of the services of any staff of the CEO 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.
In this section —
information means —
any record relating to the functions of the CEO or the Council;
any other document or information which relates to the CEO or the Council or to reproductive technology which is in the custody or control of the CEO or of the Council and is specified, or of a description specified, by the Minister;
parliamentary purposes means the purpose of —
answering a question asked in a House of Parliament; or
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;
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.
[Section 5 amended: No. 28 of 2006 s. 270.]
This Division does not apply in relation to an excess ART embryo except in relation to a use of such an embryo that is an exempt use as defined in section 53W(2).
[Section 5A inserted: No. 17 of 2004 s. 8.]
No person shall cause or permit —
any procedure to be carried out related to the storage of —
a human egg intended for use in an in vitro fertilisation procedure; or
a human egg undergoing fertilisation; or
a human embryo;
or
human sperm, having been obtained from different men, to be kept; or
an artificial fertilisation procedure, other than an artificial insemination to which section 28(3) applies, to be carried out; or
any other use, outside the body of a woman, of a human embryo, if the use is not for a purpose relating to the reproductive technology treatment of the woman,
except pursuant to a licence or exemption by which it is authorised under this Act.
A person who contravenes subsection (1) commits a crime and is liable to imprisonment for 5 years.
Summary conviction penalty: Imprisonment for one year.
[(3) deleted]
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 CEO 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.
It shall not be a defence to proceedings for an offence against this section to allege that the accused believed that what was done was —
authorised by a licence or exemption under this Act; or
done at the request of, or with the consent of, a participant.
[Section 6 amended: No. 17 of 2004 s. 9; No. 84 of 2004 s. 82; No. 28 of 2006 s. 270(1).]
A person, whether or not a licensee, must not cause or permit —
research to be conducted upon or with a human egg undergoing 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; or
a diagnostic procedure to be carried out upon or with a human egg undergoing fertilisation, or any embryo, not being a procedure which is —
authorised by the Code; or
specifically approved by the Council.
A person who contravenes subsection (1) commits a crime and is liable to imprisonment for 5 years.
Summary conviction penalty: Imprisonment for one year.
[(3), (4) deleted]
A person who —
being a licensee, keeps or uses human gametes, a human egg undergoing fertilisation or a human embryo in contravention of this Act; or
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: 2 years imprisonment.
[Section 7 amended: No. 17 of 2004 s. 10.]
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.
The Council shall consist of —
10 nominated members, to be appointed by the Governor on the recommendation of the Minister, of whom —
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 —
the Royal Australian College of Obstetricians and Gynaecologists; and
the Australian Medical Association; and
the Law Society of Western Australia; and
3 other bodies, being bodies having interests relevant to this Act; and
the Minister charged with the administration of the Children and Community Services Act 2004;
and
3 shall be individuals selected by the Minister having regard to section 9(2);
and
an ex officio member appointed by the Minister, subject to subsection (3), as the Executive Officer of the Council.
The person appointed as the Executive Officer —
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 this Act; and
shall not be eligible to be appointed or selected to hold or act in the office of Chairperson or Deputy Chairperson.
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.
The Minister shall cause each appointment under subsection (2) to be notified in the Gazette.
The Schedule has effect with respect to the membership and proceedings of the Council.
[Section 8 amended: No. 32 of 1994 s. 19; No. 1 of 1996 s. 4; No. 34 of 2004 Sch. 2 cl. 14; No. 19 of 2016 s. 158.]
A panel of nominees to be submitted under section 8(2) shall —
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
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).
In recommending persons for membership of the Council the Minister shall endeavour to ensure that —
the Council has available to it from its own membership —
adequate representation of the interests of women, of parents, of the children born of reproductive technology, and of participants in reproductive technology; and
expertise in reproductive technology; and
relevant experience in public health matters; and
relevant ethical guidance,
and also that any other appropriate discipline, experience or background is adequately reflected in so far as is practicable; and
the Council is constituted of equal numbers of men and women; and
no one person is the sole representative of disparate interests; and
no more than one member of the Council at any time —
is a licensee; or
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.
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.
The Minister or the CEO 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 CEO directly a written report as to that advice.
The Council may instruct a committee with respect to its constitution, membership, terms of reference and proceedings, and incidental and related matters.
Instructions given by the Council under subsection (3) which relate to —
the constitution or terms of reference of a committee; or
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.
[Section 10 amended: No. 28 of 2006 s. 270.]