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Version No. 005

Assisted Reproductive Treatment Regulations 2009

S.R. No. 177/2009

Version incorporating amendments as at30 October 2014

TABLE OF PROVISIONSRegulation Page

1 Objective 12 Authorising provision 13 Commencement 14 Definition 15 Form of consent to treatment procedure 16 Counselling prior to treatment procedure 17 Form of donor's consent 28 Counselling prior to donation 29 Counselling prior to surrogacy arrangement 310 Prescribed costs actually incurred that may be reimbursed to the

surrogate mother 411 Counselling prior to posthumous use of gametes or embryos 412 Disposal of embryos 513 Register kept by registered ART provider 513A Register of pre-1988 donor treatment procedures to be kept by

registered ART Provider 514 Register kept by doctor carrying out artificial insemination 515 Central Register kept by the Registrar 516 Fee for applications for information 617 Requirements for entries in the Voluntary Register 618 Information and documents to be provided for ART registration 6

__________________

SCHEDULES 7

SCHEDULE 1—Consent to Carrying out a Treatment Procedure 7

SCHEDULE 2—Consent to Donation of Gametes or embryos 9

1

SCHEDULE 3—Information to be Recorded in Register Kept by Registered ART Provider 10

1 Information relating to donors of gametes and embryos kept or stored by a registered ART provider 10

2 Information relating to disposal by the registered ART provider of any gametes or embryos formed outside the body of a woman 11

3 Information relating to each woman on whom a donor treatment procedure is carried out by a registered ART provider and the partner, if any, of each woman 12

4 Information relating to each donor treatment procedure carried out on a woman by the registered ART provider 13

5 Information relating to the use of donor gametes or donor embryos in a treatment procedure carried out by a registered ART provider 14

6 Information relating to sex selection in a treatment procedure carried out by a registered ART provider 15

7 Information relating to gametes or embryos transferred to or from the registered ART provider or doctor 16

8 Information relating to collection and storage of gametes or embryos by registered ART provider 17

9 Information relating to consent and withdrawal of consent to the storage and removal from storage of gametes or embryos 19

10 Information relating to transfer into or out of Victoria of donor gametes or donor embryos that have been or are stored or kept by a registered ART provider 20

11 Information relating to consent or withdrawal of consent for a treatment procedure carried out by a registered ART provider 22

12 Information relating to donor's consent and withdrawal of consent 22

13 Information relating to outcome of a donor treatment procedure 2214 Information relating to each child born as a result of a donor

treatment procedure carried out by the registered ART provider 23

SCHEDULE 3A—Information to be Recorded in Register of Pre-1988 Donor Treatment Procedures Kept by Registered Art Provider 25

1 Information relating to donors of gametes used in pre-1988 donor treatment procedures 25

2 Information relating to each woman on whom a pre-1988 donor treatment procedure was carried out by a registered ART provider and the partner, if any, of each woman 26

3 Information relating to outcome of pre-1988 donor treatment procedures 27

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4 Information relating to each pre-1988 donor treatment procedure carried out on a woman by the registered ART provider 28

5 Information relating to the use of donor gametes in a pre-1988 donor treatment procedure carried out by a registered ART provider 29

6 Information relating to each child born as a result of a pre-1988 donor treatment procedure carried out by the registered ART provider 30

SCHEDULE 4—Information to be Recorded in Register Kept by a Doctor Carrying Out Artificial Insemination using donor sperm 32

1 Information in relation to each artificial insemination carried out by a doctor using donor sperm 32

2 Information in relation to the donor 323 Information in relation to a woman who is artificially

inseminated using donor sperm and of her partner, if any 344 Information about a child born as a result of an artificial

insemination carried out by a doctor using donor sperm 345 Information in relation to consent or withdrawal of consent to

artificial insemination 356 Information relating to donor's consent or withdrawal of

consent 35

SCHEDULE 5—Information to be Kept in Central Register 37

═══════════════

ENDNOTES 41

1. General Information 41

2. Table of Amendments 42

3. Explanatory Details 43

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Version No. 005


S.R. No. 177/2009

Version incorporating amendments as at30 October 2014

1 Objective

The objective of these Regulations is to prescribe various matters necessary to give effect to the Assisted Reproductive Treatment Act 2008.

2 Authorising provision

These Regulations are made under section 124 of the Assisted Reproductive Treatment Act 2008.

3 Commencement

These Regulations come into operation on 1 January 2010.

4 Definition

In these Regulations—

the Act means the Assisted Reproductive Treatment Act 2008.

5 Form of consent to treatment procedure

For the purposes of section 10(1)(a) of the Act, the prescribed form is the form set out in Schedule 1.

6 Counselling prior to treatment procedure

For the purposes of section 13 of the Act, the following matters are prescribed—

(a) the options or choices available to the particular woman and her partner, if any;

1

(b) the possible outcomes of a treatment procedure;

(c) any issue or concern raised by the woman or her partner, if any, in relation to the treatment procedure;

(d) advising children about their donor origins and rights to information;

(e) the Central Register and the information required to be kept in the Central Register;

(f) issues relating to the use of donated gametes or embryos in the treatment procedure;

(g) issues relating to genetic siblings who share a common genetic parent but are raised in different families.

7 Form of donor's consent

For the purposes of section 17(1)(a) of the Act, the prescribed form is the form set out in Schedule 2.

8 Counselling prior to donation


(a) the requirements of the Act in relation to disclosing the identity of the donor to the Registrar and disclosing information to donor-conceived children if they seek that information;

(b) any issue or concern raised by the donor in relation to the donation, for example—

(i) the possible impact of donation on the donor's partner, if any;

(ii) the possible impact of donation on the donor's children, if any.

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r. 7

9 Counselling prior to surrogacy arrangement

For the purposes of section 43(a) of the Act, the following matters are prescribed—

(a) the implications of surrogacy for the relationship between—

(i) if there are 2 commissioning parents, the commissioning parents; and

(ii) if the surrogate mother has a partner, the surrogate mother and her partner; and

(iii) the commissioning parent and the surrogate mother; and

(iv) all parties to the surrogacy; and

(v) if donor gametes or embryos are to be used, the donor and the donor's partner, if any, and all parties to the surrogacy;

(b) the implications of surrogacy for any existing children of the surrogate mother or the commissioning parent;

(c) the possibility of medical complications for the surrogate mother or the child;

(d) the possibility of any party deciding not to proceed with the surrogacy;

(e) the attitudes of all parties towards the conduct of the pregnancy;

(f) the attitudes of all parties to investigation of a genetic abnormality, the possibility of termination of pregnancy or other complications;

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r. 9

(g) the need for the parties to agree on a process for resolving disputes—

(i) relating to the pregnancy; or

(ii) arising during the pregnancy;

(h) if there are 2 commissioning parents, the commissioning parents' intentions for care of the child if one of them dies;

(i) possible grief reactions on the part of the surrogate mother and her partner, if any;

(j) ways of telling the child about surrogacy;

(k) attitudes toward an ongoing relationship between the surrogate mother, her family and the child.

10 Prescribed costs actually incurred that may be reimbursed to the surrogate mother

For the purposes of section 44(2) of the Act, the following costs are prescribed—

(a) any reasonable medical expenses associated with the pregnancy or birth that are not recoverable under Medicare, health insurance or another scheme;

(b) any legal advice obtained for the purposes of section 43(c) of the Act;

(c) travel costs related to the pregnancy or birth.

11 Counselling prior to posthumous use of gametes or embryos


(a) the grieving process;

(b) the possible impact on the child to be born as a result of the treatment procedure.

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r. 10

12 Disposal of embryos

For the purposes of section 34(2)(b) of the Act, an embryo must be disposed of by allowing the embryo to stand in its container, at room temperature, in a secure area for a period of not less than 24 hours.

13 Register kept by registered ART provider

For the purposes of section 49(1) of the Act, the prescribed information is the information listed in Schedule 3.

13A Register of pre-1988 donor treatment procedures to be kept by registered ART Provider

For the purposes of section 49A of the Act, the prescribed information is the information listed in Schedule 3A.

14 Register kept by doctor carrying out artificial insemination

For the purposes of section 50(2) of the Act, the prescribed information is the information listed in Schedule 4.

15 Central Register kept by the Registrar

(1) For the purposes of section 53(b) of the Act, the prescribed information is the information set out in Schedule 5.

(2) A registered ART provider or doctor who has carried out artificial insemination other than on behalf of a registered ART provider using donor gametes must provide to the Registrar—

(a) the information set out in Schedule 5; and

(b) for the purposes of performing administrative functions relating to the Central Register, the address and telephone number of—

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Reg. 13A inserted by S.R. No. 192/2014 reg. 5.

(i) the donor; and

(ii) the woman on whom the treatment procedure was carried out and her partner, if any.

16 Fee for applications for information

For the purposes of sections 56(3)(b) and 60A(2)(b) of the Act, the prescribed fee for an application is 518 fee units.

17 Requirements for entries in the Voluntary Register

For the purposes of section 71(4) of the Act, the Voluntary Register must be kept in an electronic form that is readily convertible into legible print in the English language.

18 Information and documents to be provided for ART registration

For the purposes of section 74(2)(c) of the Act, an application must include the name of the designated officer appointed, employed or engaged by the ART provider.

__________________

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Reg. 16 amended by S.R. No. 192/2014 reg. 6.

r. 16

SCHEDULES

SCHEDULE 1Regulation 5

CONSENT TO CARRYING OUT A TREATMENT PROCEDURE

PART A

Consent of woman who will undergo treatment procedure

I, (name of woman who will undergo treatment procedure) of (address) consent to the following treatment procedure being carried out on me—

artificial insemination;

assisted reproductive treatment.

Signed:

Name: (print name)

Date:

*PART B

Consent of partner of woman who will undergo treatment procedure

I, (name of partner of woman who will undergo treatment procedure) of (address) consent to the following treatment procedure being carried out on (name of woman who will undergo treatment procedure)—

artificial insemination;

assisted reproductive treatment.

Signed:

Name: (print name)

Date:

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PART C

Statement by counsellor

I, (name of counsellor who provided counselling under section 13 of the Assisted Reproductive Treatment Act 2008) of (address) *have/*have not sighted a criminal records check in relation to (name of woman who will undergo treatment procedure) *and (name of partner of woman who will undergo treatment procedure).

Signed:

Name: (print name)

Date:

*Delete if inapplicable.

__________________

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CONSENT TO DONATION OF GAMETES OR EMBRYOSName(s) of donor(s):

Donation:

*sperm/*oocytes; or

embryos created from donors' sperm and oocytes

*I/*We, (name(s) of donor(s)) of (address(es) of donor(s)) consent to the *gametes donated by me/*embryos donated by us being used in the following treatment procedures—

(specify treatment procedures for which donor's gametes or donors' embryos may be used)

Treatment procedures using *my gametes/*our embryos may be carried out on a maximum of (insert number not exceeding 10) women.

This consent lapses—

10 years from the date on which it is given;

OR

at the end of the following period: (insert period not exceeding 10 years).

Signed: (signature of each donor)

Name(s): (print name(s))

Date:

*Delete if inapplicable.

__________________

Sch. 2 S.R. No. 177/2009


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INFORMATION TO BE RECORDED IN REGISTER KEPT BY REGISTERED ART PROVIDER

1 Information relating to donors of gametes and embryos kept or stored by a registered ART provider

The following information is required in relation to each donor of gametes, and each person who produced the gametes from which a donated embryo was formed—

(a) the unique donor identifier;

(b) the full name of the donor;

(c) the date of birth of the donor;

(d) the donor's place of birth (suburb or town and country);

(e) the sex of the donor;

(f) any other name by which the donor is or has been known;

(g) the date on which the registered ART provider sighted the donor's passport, driver licence or other identification bearing the donor's photograph and signature;

(h) the donor's residential address and contact telephone number;

(i) the date and place where the donor produced the gamete;

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(j) if the gametes or embryo were not produced at the premises of the registered ART provider, the date on which the gamete or embryo was received by the registered ART provider;

(k) the ethnic background of the donor's parents and grandparents;

(l) the donor's height;

(m) the donor's build;

(n) the donor's blood group;

(o) any genetic abnormality of the donor and, if available, any results of tests undertaken in relation to that abnormality;

(p) the number of women who have children conceived using the donor's gametes or an embryo formed from the donor's gametes, including the donor and any current or former partner of the donor;

(q) the total number of children born as a result of treatment procedures carried out by the registered ART provider using the donor's gametes or embryo formed from his or her gametes;

(r) whether the donor has donated gametes to any other registered ART provider or a doctor.

2 Information relating to disposal by the registered ART provider of any gametes or embryos formed outside the body of a woman

(1) The following information is required in relation to gametes disposed of by the registered ART provider—

(a) the date and place where the gametes were produced;

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(b) the unique donor identifier or unique patient identifier of person who produced the gametes;

(c) the date of disposal of the gametes.

(2) The following information is required in relation to each embryo formed outside the body of the woman disposed of by the registered ART provider—

(a) the date on which the embryo was formed;

(b) the embryo reference number;

(c) the unique donor identifier or unique patient identifier of persons who produced the gametes used to form the embryo;

(d) the date of disposal of the embryo.

3 Information relating to each woman on whom a donor treatment procedure is carried out by a registered ART provider and the partner, if any, of each woman

(1) The following information is required in relation to each woman on whom a donor treatment procedure is carried out by the registered ART provider—

(a) the name of the doctor performing the procedure;

(b) the full name of the woman;

(c) the date of birth of the woman;

(d) the place of birth of the woman (suburb or town and country);

(e) any genetic abnormality of the woman and, if available, any results of tests undertaken in relation to that abnormality;

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(f) if the woman has given birth to a child as a result of a previous treatment procedure—

(i) the name of the registered ART provider or doctor who carried out the treatment procedure; and

(ii) if the child was conceived using donor gametes, the unique donor identifier.

(2) If the woman has a partner, the following information is required in relation to her partner—

(a) the full name of the partner;

(b) the date of birth of the partner;

(c) the place of birth of the partner (suburb or town and country);

(d) the partner's gender;

(e) if the partner's gametes will be used in the treatment procedure, any genetic abnormality of the partner and, if available, any results of tests undertaken in relation to that abnormality.

4 Information relating to each donor treatment procedure carried out on a woman by the registered ART provider

(1) The following information is required in relation to each donor treatment procedure carried out on a woman by the registered ART provider—

(a) the unique patient identifiers of the woman on whom the treatment procedure is carried out and, if applicable, her partner;

(b) the date of the woman's consent to undergo the treatment procedure and, if applicable, the date of her partner's consent to the treatment procedure;

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(c) the date and place where the treatment procedure was carried out;

(d) the kind of treatment procedure carried out;

(e) the name of the doctor who carried out the treatment procedure;

(f) the date on which the treatment cycle commenced;

(g) in relation to the donor of gametes or embryos used in the treatment procedure—

(i) whether the donor was known to the woman; and

(ii) the date of the donor's consent to use the gametes or embryos in a treatment procedure; and

(iii) the unique donor identifiers for each person who produced the gametes or embryo used; and

(iv) if a donor embryo is used in the treatment procedure, the embryo reference number;

(h) the outcome of the treatment procedure.

5 Information relating to the use of donor gametes or donor embryos in a treatment procedure carried out by a registered ART provider

(1) The following information is required in relation to each treatment procedure using donor gametes or donor embryos carried out by the registered ART provider—

(a) whether the gametes or embryo used in the treatment procedure were thawed or fresh;

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(b) if the gametes or embryo used in the treatment procedure were transferred to the registered ART provider, the date the gametes or embryo were received by the registered ART provider and from whom the gametes or embryo were transferred;

(c) the outcome of the treatment procedure.

(2) The following information is required in relation to the formation or attempted formation of an embryo outside the body of a woman by a registered ART provider for the purposes of a donor treatment procedure—

(a) the embryo reference number;

(b) the name of the doctor performing the treatment procedure;

(c) the registered ART provider record number, unique donor identifier or unique patient identifier of the man who produced the sperm or the woman who produced the oocyte;

(d) the date on which the gametes were produced;

(e) the time and date at which the sperm and oocyte were placed together;

(f) the time and date at which fertilisation was confirmed.

6 Information relating to sex selection in a treatment procedure carried out by a registered ART provider

The following information is required in relation to each treatment procedure carried out by a registered ART provider using sex selected embryos—

(a) the number of sex selected embryos used;

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(b) if sex selected embryos were used to avoid the risk of transmission of a genetic abnormality or a genetic disease, the particular abnormality or disease;

(c) if the Patient Review Panel approved the use of sex selected embryos, evidence of that approval;

(d) the embryo reference number;

(e) the name of the doctor performing the treatment procedure;

(f) the registered ART provider record number, unique donor identifier or unique patient identifier of the man who produced the sperm or the woman who produced the oocyte;

(g) the date on which the gametes were produced;

(h) the time and date at which the sperm and oocyte were placed together;

(i) the time and date at which fertilisation was confirmed.

7 Information relating to gametes or embryos transferred to or from the registered ART provider or doctor

The following information is required in relation to each transfer of gametes or embryos to or from the registered ART provider or doctor—

(a) the date of transfer;

(b) the name of the registered ART provider or doctor from whom, or to whom, the gametes or embryo were transferred;

(c) the name of the person who authorised the transfer;

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(d) either—

(i) the unique donor identifier or the unique patient identifier of the person who produced the gametes; or

(ii) in the case of an embryo, the unique donor identifier or unique patient identifier of each person who produced the gametes from which the embryo was formed;

(e) the date and place where the gametes were produced;

(f) if an embryo is transferred, the embryo reference number;

(g) the reason for the transfer.

8 Information relating to collection and storage of gametes or embryos by registered ART provider

(1) The following information is required in relation to gametes or embryos collected by the registered ART provider—

(a) either—



(b) the date and place where gametes were provided.

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(2) The following information is required in relation to gametes or embryos stored by the registered ART provider—

(a) either—



(b) in the case of an embryo, the embryo reference number;

(c) the date and place where the gametes or embryo were produced or collected;

(d) if the gametes or embryo were transferred from another registered ART provider or a doctor, the name of that provider or doctor;

(e) the date first placed in storage or, if the gametes or embryo were transferred from another registered ART provider or a doctor, the date first placed in storage by that provider;

(f) the place of storage;

(g) in the case of stored gametes, whether the Patient Review Panel has approved a longer or further storage period in accordance with section 31A of the Act, and if so, the longer or further period approved;

(h) in the case of stored embryos, if—

(i) the persons who produced the gametes from which the embryo was created have consented to a longer storage

Sch. 3

Sch. 3 cl. 8(2)(g) substituted by S.R. No. 52/2013 reg. 4(1)(a).

Sch. 3 cl. 8(2)(h) amended by S.R. No. 52/2013 reg. 4(1)(b)(i).

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period in accordance with section 33(2)(b)(ii) of the Act; or

Sch. 3Sch. 3 cl. 8(2)(h)(ii) amended by S.R. No. 52/2013 reg. 4(1)(b).

(ii) the Patient Review Panel has approved a longer or further storage period in accordance with section 33A of the Act—

the longer or further storage period consented to or approved, as the case requires;

(i) the date the gametes or embryo were removed from storage.

9 Information relating to consent and withdrawal of consent to the storage and removal from storage of gametes or embryos

(1) The following information is required in relation to each consent or withdrawal of consent to the storage or removal from storage of gametes or embryos given to the ART provider—

(a) the unique donor identifier or unique patient identifier of the person providing or withdrawing consent;

(b) the date of the consent or withdrawal of consent.

(2) If the consent relates to storage, the following information is also required—

(a) the date the consent lapses or any other storage period specified in the consent;

(b) whether a longer or further storage period has been approved by the Patient Review Panel under section 31A or 33A of the Act, and if so, the period approved;

Sch. 3 cl. 9(2)(b) substituted by S.R. No. 52/2013 reg. 4(2).

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(c) in the case of an embryo, whether the persons who produced the gametes from which the embryo was created have consented to a longer storage period in accordance with section 33(2)(b)(ii) of the Act, and if so, the period specified.

10 Information relating to transfer into or out of Victoria of donor gametes or donor embryos that have been or are stored or kept by a registered ART provider

(1) The following information is required in relation to the taking out of Victoria of donor gametes or donor embryos that have been, or are, stored or kept by the registered ART provider—

(a) either—



(b) in the case of an embryo, the embryoreference number;

(c) the reason for taking the gametes or embryo out of Victoria;

(d) the date that the Authority approved taking the gametes or embryo out of Victoria;

(e) the date that the gametes or embryo was taken out of Victoria;

(f) the place to which the gametes or embryo were sent;

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(g) the name of the person at the registered ART provider who authorised the transfer;

(h) the date that the gametes or embryo were first placed in storage by the registered ART provider.

(2) The following information is required in relation to the bringing into Victoria of donor gametes or donor embryos that have been, or are, stored or kept by the registered ART provider—

(a) either—



(b) in the case of an embryo, the embryo reference number;

(c) the reason for bringing the gametes or embryo into Victoria;

(d) the place from which the gametes or embryo were received;

(e) the date the gametes or embryo were received by the registered ART provider;

(f) the name of the person at the registered ART provider who authorised the receipt of the gametes or embryo;

(g) the date the gametes or embryo were first placed in storage at the registered ART provider, unless the gametes or embryo were used in a treatment procedure immediately

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after being received by the registered ART provider.

11 Information relating to consent or withdrawal of consent for a treatment procedure carried out by a registered ART provider

The following information is required in relation to each consent to the carrying out of a treatment procedure provided under section 10(1) of the Act—

(a) the date the consent was signed;

(b) the unique patient identifier of the person providing the consent, or the person's name;

(c) the date on which the person received counselling in accordance with section 13 of the Act and the name of the counsellor who provided the counselling;

(d) if the consent is withdrawn, the date on which consent was withdrawn.

12 Information relating to donor's consent and withdrawal of consent

The following information is required in relation to each consent provided by a donor under section 16 of the Act—

(a) the date the donor signed the consent;

(b) the date the consent lapses under section 21 of the Act;

(c) if the consent is withdrawn, the date on which consent was withdrawn.

13 Information relating to outcome of a donor treatment procedure

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The following information is required in relation to the outcome of each donor treatment procedure carried out by the registered ART provider—

(a) the unique patient identifiers of the woman who underwent the treatment procedure and her partner (if any);

(b) the unique donor identifiers;

(c) the date on which the treatment procedure was carried out;

(d) the outcome of the treatment procedure.

14 Information relating to each child born as a result of a donor treatment procedure carried out by the registered ART provider

The following information is required in relation to each child born (including each child born in a multiple birth) as a result of a donor treatment procedure carried out by the registered ART provider—

(a) the unique patient identifiers of the woman who underwent the procedure and her partner, if any;

(b) the unique donor identifier;

(c) the date on which procedure was carried out;

(d) the child's name and sex;

(e) the child's date of birth;

(f) the place of birth (full address);

(g) the child's birth weight;

(h) the child's gestational age;

(i) any physical or other abnormality discerned at or about the time of birth;

(j) if the child was not liveborn, the reason;

(k) if the birth was a multiple birth—

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(i) the place of each child in the order of birth; and

(ii) the total number of children of the birth, whether liveborn or not.

__________________

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SCHEDULE 3ARegulation 13A

INFORMATION TO BE RECORDED IN REGISTER OF PRE-1988 DONOR TREATMENT PROCEDURES KEPT BY

REGISTERED ART PROVIDER

1 Information relating to donors of gametes used in pre-1988 donor treatment procedures

The following information is required in relation to each pre-1988 donor of gametes—




(d) the donor's place of birth (suburb or town and country);

(e) the sex of the donor;

(f) any other name by which the donor is or has been known;

(g) the donor's residential address and contact telephone number;

(h) the date and place where the donor produced the gamete;

(i) if the gametes were not produced at the premises of the registered ART provider, the date on which the gamete was received by the registered ART provider;

(j) the ethnic background of the donor's parents and grandparents;

(k) the donor's height;

(l) the donor's build;

Sch. 3A inserted by S.R. No. 192/2014 reg. 7.

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(m) the donor's blood group;

(n) any genetic abnormality of the donor and, if available, any results of tests undertaken in relation to that abnormality;

(o) the donor's hair colour;

(p) the donor's eye colour;

(q) the donor's marital status;

(r) the donor's occupation;

(s) the donor's education;

(t) the donor's interests;

(u) the number of women who have children conceived using the donor's gametes including the donor and any current or former partner of the donor;

(v) the total number of children born as a result of treatment procedures carried out by the registered ART provider using the donor's gametes;

(w) whether the donor has donated gametes to any other registered ART provider or a doctor.

2 Information relating to each woman on whom a pre-1988 donor treatment procedure was carried out by a registered ART provider and the partner, if any, of each woman

(1) The following information is required in relation to each woman on whom a pre-1988 donor treatment procedure was carried out by the registered ART provider—

(a) the name of the doctor performing the procedure;

(b) the full name of the woman;

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(c) the date of birth of the woman;

(d) the place of birth of the woman (suburb or town and country);

(e) any genetic abnormality of the woman and, if available, any results of tests undertaken in relation to that abnormality;

(f) if the woman gave birth to a child as a result of a previous treatment procedure—

(i) the name of the registered ART provider or doctor who carried out the treatment procedure; and

(ii) if the child was conceived using donor gametes, the unique donor identifier.

(2) If the woman had a partner, the following information is required in relation to her partner—

(a) the full name of the partner;

(b) the date of birth of the partner;

(c) the place of birth of the partner (suburb or town and country);

(d) the partner's gender;

(e) if the partner's gametes were used in the treatment procedure, any genetic abnormality of the partner and, if available, any results of tests undertaken in relation to that abnormality.

3 Information relating to outcome of pre-1988 donor treatment procedures

The following information is required in relation to the outcome of each pre-1988 donor treatment procedure that was carried out by the registered ART provider—

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(a) the unique patient identifiers of the woman who underwent the treatment procedure and her partner (if any);


(c) the date on which the treatment procedure was carried out;

(d) the outcome of the treatment procedure;

(e) if there was a miscarriage of a pregnancy resulting from the treatment procedure—

(i) the date on which the miscarriage occurred (if known); and

(ii) the reason for the miscarriage (if known).

4 Information relating to each pre-1988 donor treatment procedure carried out on a woman by the registered ART provider

The following information is required in relation to each pre-1988 donor treatment procedure carried out on a woman by the registered ART provider—

(a) the unique patient identifiers of the woman on whom the treatment procedure is carried out and, if applicable, her partner;

(b) the date of the woman's consent to undergo the treatment procedure and, if applicable, the date of her partner's consent to the treatment procedure;

(c) the date and place where the treatment procedure was carried out;

(d) the kind of treatment procedure carried out;

(e) the name of the doctor who carried out the treatment procedure;

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(f) the date on which the treatment cycle commenced;

(g) in relation to the donor of gametes used in the treatment procedure—

(i) whether the donor was known to the woman; and

(ii) the date of the donor's consent to use the gametes in a treatment procedure; and

(iii) the unique donor identifiers for each person who produced the gametes used; and

(h) the outcome of the treatment procedure.

5 Information relating to the use of donor gametes in a pre-1988 donor treatment procedure carried out by a registered ART provider

(1) The following information is required in relation to each pre-1988 treatment procedure using donor gametes carried out by the registered ART provider—

(a) whether the gametes used in the treatment procedure were thawed or fresh;

(b) if the gametes used in the treatment procedure were transferred to the registered ART provider, the date the gametes were received by the registered ART provider and from whom the gametes were transferred;

(c) the outcome of the treatment procedure.

(2) The following information is required in relation to the formation or attempted formation of an embryo outside the body of a woman by a registered ART provider for the purposes of a donor treatment procedure—

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(a) the embryo reference number;

(b) the name of the doctor performing the treatment procedure;

(c) the registered ART provider record number, unique donor identifier or unique patient identifier of the man who produced the sperm or the woman who produced the oocyte;

(d) the date on which the gametes were produced;

(e) the time and date at which the sperm and oocyte were placed together;

(f) the time and date at which fertilisation was confirmed;

(g) the outcome of the treatment procedure.

6 Information relating to each child born as a result of a pre-1988 donor treatment procedure carried out by the registered ART provider

The following information is required in relation to each child born (including each child born in a multiple birth) as a result of a pre-1988 donor treatment procedure carried out by the registered ART provider—

(a) the unique patient identifiers of the woman who underwent the procedure and her partner, if any;


(c) the date on which the procedure was carried out;




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(i) the place of each child in the order of birth; and


__________________

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INFORMATION TO BE RECORDED IN REGISTER KEPT BY A DOCTOR CARRYING OUT ARTIFICIAL INSEMINATION

USING DONOR SPERM

1 Information in relation to each artificial insemination carried out by a doctor using donor sperm

The following information is required in relation to each artificial insemination carried out by the doctor using donor sperm—

(a) the unique patient identifier of the woman who is inseminated;

(b) the date and place at which the insemination took place;

(c) the date the sperm was received by the doctor;

(d) the unique donor identifier;

(e) whether the donor is known to the woman or her partner (if any);

(f) if any drugs were used to induce ovulation, the drugs used;

(g) date on which the doctor sighted the donor's passport, driver licence or other identification bearing the donor's photograph and signature.

2 Information in relation to the donor

The following information is required in relation to the donor of sperm used for the artificial insemination—



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(d) the place of birth of the donor (suburb or town and country);

(e) any other names by which the donor is or has been known;

(f) the residential address and contact telephone number of the donor;

(g) the date on and place at which the donor produced the sperm;

(h) the date the sperm of the donor was received by the doctor;

(i) ethnic background of the donor's parents and grandparents;

(j) the donor's height;

(k) the donor's build;

(l) the donor's blood group;

(m) any genetic abnormality of the donor and, if available, any results of tests undertaken in relation to that abnormality;

(n) the number of women who have children conceived using the donor's sperm or an embryo formed from the donor's sperm, including any current or former partner of the donor;

(o) the total number of children born as a result of artificial inseminations carried out by the doctor using the donor's sperm;

(p) whether the donor has donated sperm to any registered ART provider or another doctor;

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(q) the date on which the donor received counselling in accordance with section 18 of the Act, and the name of the counsellor who provided the counselling.

3 Information in relation to a woman who is artificially inseminated using donor sperm and of her partner, if any

The following information is required in relation to each woman who is artificially inseminated by the doctor using donor sperm and her partner, if any—

(a) the full name of the woman and her partner;

(b) the date of birth of the woman and her partner;

(c) the place of birth of the woman and her partner;

(d) if the woman has a partner, her partner's gender.

4 Information about a child born as a result of an artificial insemination carried out by a doctor using donor sperm

The following information is required in relation to each child born (including each child born in a multiple birth) as a result of an artificial insemination carried out by the doctor using donor sperm—

(a) the unique patient identifier of the woman who was artificially inseminated;


(c) the date on which the artificial insemination was carried out;



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(i) the place of each child in the order of birth;


5 Information in relation to consent or withdrawal of consent to artificial insemination

The following information is required in relation to each consent to artificial insemination provided under section 10 of the Act—

(a) the date on which the consent was provided;

(b) the date on which counselling was provided under section 13 of the Act to the person giving consent;

(c) the name of the counsellor who provided counselling under section 13 of the Act;

(d) if the consent is withdrawn, the date on which the consent was withdrawn.

6 Information relating to donor's consent or withdrawal of consent

The following information is required in relation to each consent provided by a donor under section 16 of the Act—

(a) the date on which the consent was provided;

(b) the date the consent lapses under section 21 of the Act;

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(c) if the consent is withdrawn, the date on which the consent was withdrawn.

__________________

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Sch. 5 amended by S.R. No. 74/2010 reg. 3.Sch. 5

SCHEDULE 5Regulation 15(1)

INFORMATION TO BE KEPT IN CENTRAL REGISTER

(1) The following information is required in relation to a child born as a result of a donor treatment procedure—

(a) the date of birth;

(b) the sex;

(c) the name and address of the place of birth.

(2) The following information is required in relation to the woman on whom the donor treatment procedure was carried out—

(a) birth name;

(b) unique patient identifier;

(c) date of birth;

(d) place of birth (suburb or town).

(3) The following information is required in relation to the partner (if any) of the woman on whom the donor treatment procedure was carried out—

(a) birth name;

(b) unique patient identifier, if applicable;

(c) date of birth;

(d) place of birth (suburb or town).

(4) The following information is required in relation to the donor treatment procedure—

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(a) if the treatment procedure was carried out by a registered ART provider—

(i) the name of the registered ART provider;

(ii) the address of the registered ART provider;

(b) if the treatment procedure was carried out by a doctor other than on behalf of a registered ART provider—

(i) the name of the doctor; and

(ii) the address of the doctor; and

(iii) the registration number or code given to the doctor by the Medical Board of Australia under the Health Practitioner Regulation National Law;

(c) the outcome of the treatment procedure, whether a birth, a pregnancy or unknown.

(5) The following information (if it has been collected by the registered ART provider or doctor) is required in relation to the donor of the gametes or each donor of the embryo used in the donor treatment procedure—

(a) any other name by which the donor has been known;

(b) the sex of the donor;

(c) the unique donor identifier;

(d) in the case of a donor embryo, the embryo reference number;

(e) the donor's date of birth;

(f) the donor's place of birth (suburb or town and country);

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(g) whether the donor has donated gametes, other than to the registered ART provider or doctor who carried out the treatment procedure;

(h) the date of the donor's consent to use the gametes or embryos in a treatment procedure;

(i) the number of women who have children conceived using the donor's gametes or an embryo formed from the donor's gametes, including the donor and any current or former partner of the donor;

(j) the number of children born as a result of treatment procedures carried out by the registered ART provider or the doctor using the donor's gametes or embryo;

(k) any genetic abnormality of the donor (if known);

(l) the donor's hair colour;

(m) the donor's eye colour;

(n) the donor's build;

(o) the donor's height;

(p) the donor's blood group;

(q) the donor's marital status;

(r) the donor's occupation;

(s) the donor's education;

(t) the donor's interests;

(u) if known—

(i) the donor's father's country of birth;

(ii) the donor's mother's country of birth;

(iii) the donor's paternal grandfather's country of birth;

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(iv) the donor's paternal grandmother's country of birth;

(v) the donor's maternal grandfather's country of birth;

(vi) the donor's maternal grandmother's country of birth.

═══════════════

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ENDNOTES

1. General InformationThe Assisted Reproductive Treatment Regulations 2009, S.R. No. 177/2009 were made on 15 December 2009 by the Governor in Council under section 124 of the Assisted Reproductive Treatment Act 2008, No. 76/2008 and came into operation on 1 January 2010: regulation 3.

The Assisted Reproductive Treatment Regulations 2009 will sunset 10 years after the day of making on 15 December 2019 (see section 5 of the Subordinate Legislation Act 1994).

Endnotes S.R. No. 177/2009


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2. Table of AmendmentsThis Version incorporates amendments made to the Assisted Reproductive Treatment Regulations 2009 by statutory rules, subordinate instruments and Acts.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Assisted Reproductive Treatment Amendment Regulations 2010, S.R. No. 74/2010Date of Making: 10.8.10Date of Commencement: 10.8.10

Assisted Reproductive Treatment Amendment Regulations 2013, S.R. No. 52/2013Date of Making: 7.5.13Date of Commencement: 7.5.13

Assisted Reproductive Treatment Amendment Regulations 2014, S.R. No. 192/2014Date of Making: 29.10.14Date of Commencement: 30.10.14: reg. 3

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––



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3. Explanatory DetailsFee Units

These Regulations provide for fees by reference to fee units within the meaning of the Monetary Units Act 2004.

The amount of the fee is to be calculated, in accordance with section 7 of that Act, by multiplying the number of fee units applicable by the value of a fee unit.

The value of a fee unit for the financial year commencing 1 July 2014 is $13.24. The amount of the calculated fee may be rounded to the nearest 10 cents.

The value of a fee unit for future financial years is to be fixed by the Treasurer under section 5 of the Monetary Units Act 2004. The value of a fee unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.



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