Human Reproductive Technology Regulations 1993 01-h0-00 Xml

Crest Western Australia

Human Reproductive Technology Act 1991

Human Reproductive Technology Regulations 1993

Western Australia

Human Reproductive Technology Regulations 1993

Contents

1. Citation1

1A.Interpretation1

2. Exemptions relating to artificial insemination1

3. Applications for licences2

4. Registers of identity, etc.3

4A.Form of warrant5

5. Authorised officers5

Schedule 1 — Forms

Notes

Compilation table12

Other notes12

Defined terms

Human Reproductive Technology Act 1991

Human Reproductive Technology Regulations 1993

1. Citation

These regulations may be cited as the Human Reproductive Technology Regulations 1993.

[Regulation 1 amended: Gazette 18 Sep 2018 p. 3513.]

1A.Interpretation

In these regulations —

Department means the department of the Public Service principally assisting in the administration of the Act.

[Regulation 1A inserted: Gazette 15 Dec 2006 p. 5628.]

2. Exemptions relating to artificial insemination

(1)An application by a medical practitioner for exemption under section 28(1) of the Act in respect of artificial insemination procedures shall be —

(a)lodged with the Department;

(b)in writing, substantially in accordance with Schedule 1 Form 1, and containing the undertaking prescribed in that Form;

(c)accompanied by —

(i)a fee of $50; and

(ii)evidence of the medical qualification of the applicant;

(d)signed by the applicant.

(2)A certificate of exemption in respect to which conditions are to be imposed shall be issued under section 28(1) of the Act in the form of Schedule 1 Form 2..

(3)Where an artificial insemination procedure is carried out by a person, other than by a medical practitioner, no licence or exemption under the Act is required if the person carrying out the procedure —

(a)is acting under the direction of a licensee; and

(b)where donor sperm is used, has given in writing an undertaking to the licensee directing the procedure to furnish to that licensee such detail as may be possible, and is required by that licensee, of the outcome of the procedure.

[Regulation 2 amended: Gazette 15 Dec 2006 p. 5628; 18 Sep 2018 p. 3513.]

3. Applications for licences

(1)An application for a licence, or for the renewal of a licence, shall be lodged with the Department.

(2)An application for a practice licence shall be accompanied by a fee of $1 629.

(3)An application for a storage licence shall be accompanied by a fee —

(a)if —

(i)sperm is not to be collected at the premises to which the licence relates; or

(ii)the sperm which is to be collected there is not intended for use in donor insemination,

of $204; and

(b)if sperm intended for use in donor insemination is to be collected at the premises to which the licence relates, of $1 018; and

(c)if eggs or embryos are to be stored, of $1 018.

[Regulation 3 amended: Gazette 15 Dec 2006 p. 5628; 15 Jul 2014 p. 2465; 30 Jun 2017 p. 3571; 25 May 2018 p. 1637; SL 2020/97 r. 10.]

4. Registers of identity, etc.

(1)For the purpose of a register required to be kept under section 45(1)(b)(i) of the Act, the prescribed information to be shown in respect of a licence is —

(a)the full name and address of the licensee;

(b)the kind of licence;

(c)the date of grant, the date of expiry;

(d)any date from which the operation of the licence was, is, or is to be suspended, and the period of suspension ordered;

(e)each condition, term or matter currently and specifically applicable, whether as required by section 27(4)(a)(ii), (iii) and (iv) or by any condition, term or matter subsequently imposed, or as varied, and the period for which it is to apply;

(f)the full name and address of the person responsible, and of any person approved as a manager or as temporarily responsible, specifying the period applicable;

(g)the address of the premises to which the licence relates, containing such detail as is sufficient to identify those premises; and

(h)the date, and the outcome, of any monitoring or review.

(2)For the purpose of a register required to be kept under section 45(1)(b)(ii) of the Act, the prescribed information to be shown in respect to persons to whom an exemption under section 28 of the Act applies is —

(a)the full name and address of the holder of the exemption;

(b)the kind of procedures to which the exemption relates;

(c)the date the exemption takes effect;

(d)the date of issue of any certificate of exemption;

(e)any date from which the operation of any exemption deemed to have been or specifically issued was, is, or is to be suspended, and the period of suspension ordered;

(f)each condition currently and specifically applicable, and the period for which it is to apply;

(g)the full name and address of the person responsible; and

(h)if the exemption, or any condition, relates to specific premises the address of those premises containing such detail as is sufficient to identify those premises.

(3)For the purpose of the register required to be kept under section 45(1)(d) of the Act, the prescribed requirements to be shown in relation to any disciplinary proceedings are —

(a)the name of the licensee or other person to whom the proceedings relate;

(b)the kind of licence, and the premises, to which the proceedings relate;

(c)the nature of the matters alleged as requiring disciplinary action;

(d)each kind of disciplinary action taken, and the date on which it was taken;

(e)whether any, and what, summary determination was made, consent given or cause shown;

(f)whether any, and what, warning or penalty was imposed by the CEO summarily;

(g)the nature of any allegation made to the State Administrative Tribunal by the CEO;

(h)the outcome of any allegation to the State Administrative Tribunal, including any penalty imposed by the Tribunal; and

[(j), (k)deleted]

(l)the nature, and outcome, of any review by the State Administrative Tribunal.

(4)The CEO shall cause to be kept, in a place and manner approved by the Minister, registers containing information relating to —

(a)the export from the State of gametes, eggs in the process of fertilisation or embryos; and

(b)the subsequent use, or other dealing in or disposal, of the exported material,

as may be required to be supplied by any provision of the Code, by a direction given under section 31(1)(b), or by a condition imposed under any such provision or direction.

[Regulation 4 amended: Gazette 12 May 1995 p. 1775; 30 Dec 2004 p. 6939; 15 Dec 2006 p. 5628-9.]

4A.Form of warrant

A warrant for the purposes of section 55(1) of the Act must be in the form of Schedule 1 Form 3.

[Regulation 4A inserted: Gazette 18 Sep 2018 p. 3513.]

5. Authorised officers

The certificate of identity to be issued to an authorised officer or other person to whom section 59(2) of the Act applies shall show —

(a)the full name, and a photograph of the face, of that person;

(b)whether that person —

(i)is generally authorised for the purposes of the Act;

(ii)is authorised only for specific named functions or in particular circumstances; and

(iii)is, or is not, to be given right of access to participant identifying information;

(c)the signature of the holder; and

(d)the signature of the CEO , and the date of issue,

on a background clearly stating the name of the Act, and identifying an officer of the Department of whom inquiries may be made.

[Regulation 5 amended: Gazette 15 Dec 2006 p. 5629.]

Schedule 1 — Forms

[r. 2(1) and (2) and 4A]

[Heading inserted: Gazette 18 Sep 2018 p. 3513.]

FORM 1

HUMAN REPRODUCTIVE TECHNOLOGY ACT 1991

HUMAN REPRODUCTIVE TECHNOLOGY REGULATIONS 1993

APPLICATION FOR EXEMPTION IN RESPECT OF ARTIFICIAL INSEMINATION PROCEDURES

I ..............................................................................................................................

(Full name of applicant)

of ............................................................................................................................

(Address, fax. and telephone number of applicant)

being a licensed medical practitioner, hereby apply for an exemption from the licensing requirements of the Human Reproductive Technology Act 1991 in respect of the carrying out of artificial insemination procedures of the following kind —

................................................................................................................. (Specify)

I understand that the conditions specified in s. 33 of the Act will apply to this exemption.

I undertake —

(a)to observe and comply with —

(i)the Code of Practice; and

(ii)any direction from the Chief Executive Officer of the Department of Health,

in so far as it relates to any relevant artificial insemination procedure;

(b)to furnish such detail as is possible and may be required to —

(i)the storage licensee from whom sperm was obtained; or

(ii)if the sperm was not obtained from a storage licensee, the Chief Executive Officer of the Department of Health,

of the outcome of each procedure I perform, or authorise, involving donor insemination;

and

(c)to comply with any requirement made under the Act as to the obtaining of effective consent from participants.

Signed .........................................Date ............./............./.............

For further information contact:

Coordinator/Reproductive Technology
Department of Health
189 Royal Street
EAST PERTH 6004

Phone (08) 9222 4260
Fax (08) 9222 4236

[Form 1 amended: Gazette 15 Dec 2006 p. 5629; 18 Sep 2018 p. 3513.]

FORM 2

HUMAN REPRODUCTIVE TECHNOLOGY ACT 1991

HUMAN REPRODUCTIVE TECHNOLOGY REGULATIONS 1993

EXEMPTION IN RESPECT OF ARTIFICIAL INSEMINATION PROCEDURES

This certificate of exemption is issued in accordance with section 28(1) of the

Act to ......................................................................................................................

(Full name of holder)

of ............................................................................................................................

(Address of holder)

.................................................................................................................................

who, as the person responsible for the supervision of all practices related to the procedures, has been granted an EXEMPTION from the requirement of the Act to be licensed to carry out ARTIFICIAL INSEMINATION PROCEDURES of the kind listed below —

................................................................................................................................

subject, in addition to the conditions specified in s. 33 of the Act, to the following specific conditions —

................................................................................................................................

........................................................................
Signed (Chief Executive Officer, Department of Health)

For information contact:

Coordinator/Reproductive Technology
Department of Health
189 Royal Street
EAST PERTH 6004

Phone (08) 9222 4260
Fax (08) 9222 4236

[Form 2 amended: Gazette 15 Dec 2006 p. 5629; 18 Sep 2018 p. 3513.]

FORM 3

Human Reproductive Technology Act 1991 s. 55		Warrant authorising entry to premises
To
Application	The applicant has applied under the Human Reproductive Technology Act 1991 s. 55(1) to me, a Justice of the Peace, for a warrant authorising entry to premises.
Applicant’s details	Full name of authorised officer/member of the Police Force
	Office/Rank held		Number assigned for official purposes to applicant
Suspected offence(s)
Purpose of warrant
Warrant	This warrant authorises you to enter the premises described below, with such other persons as may be necessary to assist, and to exercise the powers in the Human Reproductive Technology Act 1991 section 55(2). This warrant authorises the use of such force as may be necessary.
Premises to be entered
Effect of warrant	This warrant continues to have effect until the purpose for which it is granted is satisfied.
Issuing details	Name of Justice of the Peace
	Date		Time
JP’s signature	Issued by me on the above date and at the above time. Justice of the Peace

[Form 3 inserted: Gazette 18 Sep 2018 p. 3514.]

Notes

This is a compilation of the Human Reproductive Technology Regulations 1993 and includes amendments made by other written laws. For provisions that have come into operation, and for information about any reprints, see the compilation table.

Compilation table

Citation	Published	Commencement
Human Reproductive Technology (Licences and Registers) Regulations 1993 1	19 Mar 1993 p. 1642‑6	19 Mar 1993
Human Reproductive Technology (Licences and Registers) Amendment Regulations 1995	12 May 1995 p. 1775	12 May 1995
Human Reproductive Technology (Licences and Registers) Amendment Regulations 2004	30 Dec 2004 p. 6939	1 Jan 2005 (see r. 2 and Gazette 31 Dec 2004 p. 7130)
Reprint 1: The Human Reproductive Technology (Licences and Registers) Regulations 1993 as at 11 Mar 2005 (includes amendments listed above)
Human Reproductive Technology (Licences and Registers) Amendment Regulations 2006	15 Dec 2006 p. 5628-9	15 Dec 2006
Human Reproductive Technology (Licences and Registers) Amendment Regulations 2014	15 Jul 2014 p. 2464-5	r. 1 and 2: 15 Jul 2014 (see r. 2(a)); Regulations other than r. 1 and 2: 16 Jul 2014 (see r. 2(b))
Health Regulations Amendment (Fees and Charges) Regulations 2017 Pt. 8	30 Jun 2017 p. 3568‑74	1 Jul 2017 (see r. 2(b))
Health Regulations Amendment (Fees and Charges) Regulations 2018 Pt. 8	25 May 2018 p. 1632‑9	1 Jul 2018 (see r. 2(b))
Human Reproductive Technology (Licences and Registers) Amendment Regulations 2018	18 Sep 2018 p. 3512‑14	r. 1 and 2: 18 Sep 2018 (see r. 2(a)); Regulations other than r. 1 and 2: 19 Sep 2018 (see r. 2(b))
Health Regulations Amendment (Fees and Charges) Regulations 2020 Pt. 5	SL 2020/97 26 Jun 2020	1 Jul 2020 (see r. 2(b))

Other notes

1Now known as the Human Reproductive Technology (Licences and Registers) Regulations 1993; citation changed (see note under r. 1).

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)

Department1A