was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and

is excess to the needs of:

the woman for whom it was created; and

her spouse (if any) at the time the embryo was created.

each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or

each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.

the excess ART embryo is created other than by using a mitochondrial donation technique and the use of the embryo by the person is authorised by a general licence; or

the excess ART embryo is created using a mitochondrial donation technique and the use of the embryo by the person is permitted under section 28B (carrying out activities authorised by mitochondrial donation licences); or

the use by the person is an exempt use within the meaning of subsection (2).

the use consists only of:

storage of the excess ART embryo; or

removal of the excess ART embryo from storage; or

transport of the excess ART embryo; or

the use consists only of observation of the excess ART embryo; or

the use consists only of allowing the excess ART embryo to succumb; or

the use is carried out by an accredited ART centre, and:

the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and

the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or

the use is carried out by an accredited ART centre, and:

the use is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; and

the excess ART embryo was not created using a mitochondrial donation technique as permitted under section 28B (carrying out activities authorised by mitochondrial donation licences); or

the use is of a kind prescribed by the regulations for the purposes of this paragraph.

the conduct by the person is purportedly authorised by a provision of a general licence or mitochondrial donation licence; and

the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and

the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.

for a general licence—an offence against section 10, 10A, 10B or 12; or

for a mitochondrial donation licence—an offence against:

section 10; or

section 10A, in so far as it applies because of subparagraph (b)(i) or (ii) of that section; or

section 10B in so far as it applies to a pre-clinical research and training licence, a clinical trial research and training licence or a clinical practice research and training licence; or

section 11, 11A or 12.

mitochondrial donation licence includes a purported mitochondrial donation licence.

sections 5D and 5E;

section 35;

section 41;

section 80;

subsections 82(1C) and (2).

(a) National Health and Medical Research Council Act 1992;section 42A of the

(b) Public Governance, Performance and Accountability Act 2013 (which deals with the duty to disclose interests) and any rules made for the purposes of that section.section 29 of the

a member of AHEC;

a person with expertise in research ethics;

a person with expertise in a relevant area of research;

a person with expertise in assisted reproductive technology;

a person with expertise in a relevant area of law;

(f) a person with expertise in consumer health issues relating to disability and disease;

a person with expertise in consumer issues relating to assisted reproductive technology;

a person with expertise in the regulation of assisted reproductive technology;

a person with expertise in embryology.

(a) seek nominations from the States and from such bodies as are prescribed by the regulations for the purpose;

(b) consult, and have regard to the views expressed by, the States on the proposed appointment; and

be satisfied upon receipt of a written declaration by the member proposed to be appointed that the member proposed does not have a direct or indirect pecuniary interest in a body that undertakes uses of excess ART embryos or human eggs, or creation or uses of other embryos, being an interest of a kind that could conflict with the proper performance of the member’s functions.

as the Chairperson under subsection (4); or

as the member mentioned in paragraph (1)(h);

unless a majority of the States agree with that appointment.

30 June of each year; and

31 December of each year; and

any other time required by either House of Parliament;

that must include information about:

the operation of this Act; and

the general licences and mitochondrial donation licences issued under this Act.

approvals under subsection 28P(3) (including applications for such approvals and the outcomes of those applications);

births of children as a result of pregnancies achieved using a mitochondrial donation technique under a clinical trial licence or a clinical practice licence;

adverse events notified to the NHMRC Licensing Committee under paragraph 28S(3)(a).

use of excess ART embryos;

creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos;

creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos;

creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos;

research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in assisted reproductive technology;

creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if:

the creation or use is for the purposes of testing sperm quality; and

the creation or use will occur in an accredited ART centre.

any activity that involves the use of a mitochondrial donation technique; or

the use of any material created, developed or produced under a mitochondrial donation licence.

must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and

must be accompanied by the fee (if any) prescribed by the regulations.

that appropriate protocols are in place:

to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see paragraph 24(1)(a)); and

to enable compliance with any restrictions on such consent;

that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the National Statement.

(a) restricting the number of excess ART embryos, other embryos or human eggs, to that likely to be necessary to achieve the goals of the activity or project proposed in the application;

the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means;

(c) any relevant guidelines, or relevant parts of guidelines, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this paragraph;

the HREC assessment of the application mentioned in paragraph (3)(c);

such additional matters (if any) as are prescribed by the regulations.

the applicant;

the HREC that assessed and approved the activity or project proposed in the application as mentioned in paragraph 21(3)(c);

the relevant State body in relation to the State in which the use is to occur.

comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and

remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.

each responsible person in relation to the excess ART embryo, human egg or other embryo must have given proper consent to that creation or use; and

the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject.

the persons authorised by the licence to use excess ART embryos or human eggs, or create or use other embryos;

the number of excess ART embryos or human eggs authorised to be used under the licence, or the number of other embryos authorised to be created or used under the licence;

reporting;

monitoring;

information to be given by the licence holder to persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos.

the licence holder; and

such other persons authorised by the licence to use excess ART embryos or human eggs, or to create or use other embryos as are specified in the licence.

(a) a general licence may provide that the guidelines referred to in the definition of proper consent in subsection (9) apply in a modified form in relation to the use, under the licence, of excess ART embryos that are unsuitable for implantation; and

if a general licence so provides, the guidelines as modified by the licence have effect in relation to the giving of consent for such creation or use.

in relation to an excess ART embryo:

each person who provided the egg or sperm from which the embryo was created; and

the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and

any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and

any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or

in relation to an embryo other than an excess ART embryo—each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation or use of the embryo; or

in relation to a human egg—the woman who was the biological donor of the egg.

the licence holder; and

the HREC and the relevant State body to which the NHMRC Licensing Committee notified its decision on the application for the licence under section 22.

the licence is in force; and

the licence holder is a constitutional corporation.

the licence is in force; and

carrying out the activity is authorised by a law of that State.

developing the permitted technique specified in the licence for potential future use in a clinical setting as a way to minimise the risk of women’s offspring inheriting mitochondria that would predispose them to mitochondrial disease, but without the immediate aim of:

conducting a clinical trial; or

using the technique in a clinical practice setting;

better understanding the technique, including its safety and efficacy in minimising the risk of women’s offspring inheriting mitochondria that would predispose them to mitochondrial disease;

building expertise in the technique and how to use it.

creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos;

creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence:

by fertilisation of a human egg by a human sperm outside the body of a woman; or

other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

creation of human embryos by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, using the permitted technique specified in the licence, and use of such embryos;

research and training involving the fertilisation of a human egg by a human sperm up to, including and after the first mitotic division, outside the body of a woman for the purposes of research or training in the use of the permitted technique specified in the licence;

use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence.

result in the development of a human embryo for a period of more than 14 days, excluding any period when development is suspended; or

involve placing a human embryo into the body of a woman for the purposes of achieving pregnancy in that woman.

developing protocols for using the technique safely and effectively, in a clinical trial setting, for the purpose of minimising the risk of women’s offspring inheriting mitochondria that would predispose them to mitochondrial disease;

ensuring that each embryologist nominated under subsection 28H(5) has technical competence in the use of the technique in accordance with those protocols;

ensuring that the holder’s facilities, equipment, processes and protocols for using the technique are suitable for using the technique in a clinical trial setting.

creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos;

creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence:

by fertilisation of a human egg by a human sperm outside the body of a woman; or

other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

creation of human embryos by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, using the permitted technique specified in the licence, and use of such embryos;

research and training involving the fertilisation of a human egg by a human sperm up to, including and after the first mitotic division, outside the body of a woman for the purposes of research or training in the use of the permitted technique specified in the licence;

use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence.

result in the development of a human embryo for a period of more than 14 days, excluding any period when development is suspended; or

involve placing a human embryo into the body of a woman for the purposes of achieving pregnancy in that woman.

creating a human embryo for a trial participant, using the permitted technique specified in the licence, with the intention of minimising the risk of the embryo inheriting mitochondria that would predispose any resulting child to mitochondrial disease;

placing the embryo in the body of the trial participant for the purposes of achieving her pregnancy.

creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos;

creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence:

by fertilisation of a human egg by a human sperm outside the body of a woman; or

other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

(c) alteration of the genome of a human cell (Prohibition of Human Cloning for Reproduction Act 2002) using the permitted technique specified in the licence, in such a way that the alteration is heritable by descendants of the human whose cell was altered;within the meaning of section 15 of the

placement in the body of a woman of any of the following kinds of human embryo created using the permitted technique specified in the licence:

a human embryo created by a process other than the fertilisation of a human egg by human sperm;

a human embryo that contains genetic material provided by more than 2 persons;

(iii) a human embryo that contains a human cell (Prohibition of Human Cloning for Reproduction Act 2002) whose genome has been altered in such a way that the alteration is heritable by descendants of the human whose cell was altered;within the meaning of section 15 of the

use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence.

developing protocols for using the technique safely and effectively, in a clinical practice setting, for the purpose of minimising the risk of women’s offspring inheriting mitochondria that would predispose them to mitochondrial disease;

ensuring that each embryologist nominated under subsection 28H(5) has technical competence in the use of the technique in accordance with those protocols;

ensuring that the holder’s facilities, equipment, processes and protocols for using the technique are suitable for using the technique in a clinical practice setting.

creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos;

creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence:

by fertilisation of a human egg by a human sperm outside the body of a woman; or

other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

creation of human embryos by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, using the permitted technique specified in the licence, and use of such embryos;

research and training involving the fertilisation of a human egg by a human sperm up to, including and after the first mitotic division, outside the body of a woman for the purposes of research or training in the use of the permitted technique specified in the licence;

use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence.

result in the development of a human embryo for a period of more than 14 days, excluding any period when development is suspended; or

involve placing a human embryo into the body of a woman for the purposes of achieving pregnancy in that woman.

creating a human embryo for a patient, using the permitted technique specified in the licence, with the intention of minimising the risk of the embryo inheriting mitochondria that would predispose any resulting child to mitochondrial disease;

placing the embryo in the body of the patient for the purposes of achieving her pregnancy.

creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos;

creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence:

by fertilisation of a human egg by a human sperm outside the body of a woman; or

other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

(c) alteration of the genome of a human cell (Prohibition of Human Cloning for Reproduction Act 2002) using the permitted technique specified in the licence, in such a way that the alteration is heritable by descendants of the human whose cell was altered;within the meaning of section 15 of the

placement in the body of a woman of any of the following kinds of human embryo created using the permitted technique specified in the licence:

a human embryo created by a process other than the fertilisation of a human egg by human sperm;

a human embryo that contains genetic material provided by more than 2 persons;

(iii) a human embryo that contains a human cell (Prohibition of Human Cloning for Reproduction Act 2002) whose genome has been altered in such a way that the alteration is heritable by descendants of the human whose cell was altered;within the meaning of section 15 of the

use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence.

a pre-clinical research and training licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28C(2); or

a clinical trial research and training licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28D(2); or

a clinical trial licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28E(2); or

a clinical practice research and training licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28F(2); or

a clinical practice licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28G(2).

a pre-clinical research and training licence;

a clinical trial research and training licence;

a clinical trial licence.

more than one kind of mitochondrial donation licence; or

more than one permitted technique for a mitochondrial donation licence.

be in the form approved by the NHMRC Licensing Committee; and

specify the following:

the kind of mitochondrial donation licence;

the permitted technique to which the licence will relate; and

be made in accordance with:

the requirements specified in the regulations for the purposes of this subparagraph (if any); and

such other requirements (if any) as are specified in writing by the NHMRC Licensing Committee and are not inconsistent with requirements specified under subparagraph (i); and

be accompanied by the fee (if any) prescribed by the regulations.

an application to contain, or be accompanied by, such information as is required by the form; and

any such information to be verified by statutory declaration.

Subdivision C—Determining applications for mitochondrial donation licences

that appropriate protocols are in place to enable proper consent to be obtained before any of the following activities are carried out under the licence (see paragraph 28N(1A)(a)):

an excess ART embryo, a human egg or a human sperm is used;

a human zygote or a human embryo (other than an excess ART embryo) is created or used;

any material not covered by subparagraph (i) or (ii) of this paragraph is created, developed, produced or used;

that appropriate protocols are in place to enable compliance with any restrictions on such consent;

that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the National Statement.

(a) restricting the number of excess ART embryos, other embryos, or human eggs or zygotes, to that likely to be necessary to achieve the goals of the activity or project proposed in the application;

(b) any relevant guidelines, or relevant parts of guidelines, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this paragraph;

the HREC assessment of the application mentioned in paragraph (2)(b);

whether the applicant has complied with the conditions of any other mitochondrial donation licence.

the applicant has in place protocols for using the technique safely and effectively in a clinical trial or in clinical practice (as the case requires) for the purpose of minimising the risk of women’s offspring inheriting mitochondria that would predispose them to mitochondrial disease; and

each embryologist nominated under subsection 28H(5) has:

consented in writing to being so nominated; and

demonstrated technical competence in the use of the technique in accordance with the protocols referred to in paragraph (a) of this subsection; and

understands the embryologist’s obligations under this Act; and

the applicant’s facilities, equipment and processes for using the technique under the licence are suitable for that purpose; and

the staff, other than embryologists, who will carry out activities directly connected with the clinical trial or clinical practice (as the case requires) are appropriately qualified, trained and competent to do so; and

the applicant is likely to be able to comply with its obligations under section 28R (information about donors and children); and

the applicant has protocols in place to ensure that each donor in relation to a use of the technique is aware that any children born as a result of a pregnancy achieved by using the technique will be able to obtain information about the donor in accordance with subsections 29A(4) and (6) (disclosure of information on the Mitochondrial Donation Donor Register); and

the applicant has protocols in place to ensure that trial participants or patients (as the case requires) have been fully informed about:

the risks involved in using mitochondrial donation techniques; and

alternatives to using mitochondrial donation techniques.

matters that the NHMRC Licensing Committee may, must or must not have regard to when deciding whether to issue a mitochondrial donation licence; and

matters that the NHMRC Licensing Committee must be satisfied of before issuing a mitochondrial donation licence; and

procedural and other requirements that the NHMRC Licensing Committee must follow in deciding whether to issue a mitochondrial donation licence; and

requirements for demonstrating the technical competence of an embryologist in the use of a particular mitochondrial donation technique for the purposes of subparagraph (5)(b)(ii).

the applicant;

the HREC that assessed and approved the activity or project proposed in the application as mentioned in paragraph 28J(2)(b);

the relevant State body in relation to the State in which the use is to occur.

comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and

remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.

an excess ART embryo, a human egg or a human sperm is used;

a zygote or a human embryo (other than an excess ART embryo) is created or used;

any material not covered by paragraph (a) or (b) of this subsection is created, developed, produced or used.

each responsible person in relation to the material referred to in paragraph (1)(a), (b) or (c) must have given proper consent to the carrying out of the activity;

the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject.

embryologists and other persons authorised by the licence to carry out activities that are authorised by the licence;

the number of human eggs authorised to be used under the licence, or the number of embryos or zygotes authorised to be created or used under the licence;

reporting;

monitoring;

information to be given by the licence holder to the following:

embryologists and other persons authorised by the licence to carry out activities that are authorised by the licence;

other persons;

disposing of material produced by using the relevant mitochondrial donation technique as authorised by the licence.

each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates; and

each other person who carries out activities that are authorised by the licence.

the licence holder; and

each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates; and

each other person who carries out activities that are authorised by the licence.

(a) that is obtained in accordance with guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this paragraph; and

in relation to which such other requirements (if any) as are prescribed by the regulations for the purposes of this paragraph are satisfied.

responsible person, in relation to material mentioned in an item of the following table, means a person mentioned in column 2 of the item.

provide in relation to the withdrawal of consent; and

without limiting paragraph (a) of this subsection, provide that consent cannot be withdrawn in specified circumstances.

creating a human embryo for the woman using the mitochondrial donation technique to which the licence relates;

placing a human embryo created for the woman using the mitochondrial donation technique to which the licence relates in the body of the woman for the purposes of achieving her pregnancy.

that there is a particular risk of the woman’s offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease; and

that there is a significant risk that the mitochondrial disease that would develop in those offspring would result in a serious illness or other serious medical condition; and

that other available techniques that could potentially be used to minimise the risks referred to in paragraphs (a) and (b) would be inappropriate or unlikely to succeed; and

that the woman and her spouse (if any) have attended counselling and been fully informed of:

the risks involved in using mitochondrial donation techniques; and

alternatives to using mitochondrial donation techniques; and

that the woman has given written consent to the making of the application; and

of such other matters as are specified in the regulations for the purposes of this paragraph.

the clinical basis of the risk of the woman’s offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease;

the inheritance pattern in the woman’s family;

the likely clinical manifestations of disease for the woman’s offspring.

may require an application to contain, or be accompanied by, such information as is required by the form and require the information to be verified by statutory declaration; but

must not require an application to contain, or be accompanied by, any of the following information:

the name of a trial participant or patient;

any other information that could be used to discover the identity of a trial participant or patient, other than information that is directly necessary for the purpose of determining an application.

5 years after the approval is granted;

the time a child is born alive as a result of a pregnancy achieved in the woman by the placement of a human embryo under the approval as described in paragraph (1)(b).

the licence holder; and

each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates.

that the technique specified in the licence only be used under the licence by an embryologist specified in the licence;

that the embryologist’s use of the technique is in accordance with the protocols mentioned in paragraph 28J(5)(a);

that the embryologist remains technically competent to use the technique;

that a human embryo created for a woman using the technique is not selected for implantation in that woman on the basis of the sex of the embryo.

the licence holder; and

for a condition set out in paragraph (1)(b) or (d)—each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates.

Subdivision E—Ongoing requirements for holders of mitochondrial donation licences

the donor’s full name;

the donor’s residential address at the time the donor gave the proper consent required by paragraph 28N(1A)(a) to the use of the donor’s egg;

the donor’s date and place of birth;

any other information the donor gives the licence holder, for the purposes of inclusion on the Mitochondrial Donation Donor Register under section 29A, at the time referred to in paragraph (b) of this subsection;

any other information about the donor prescribed by the regulations for the purposes of this paragraph.

has nuclear DNA from a woman and a man; and

contains mitochondria from a human egg of a different woman;

the woman mentioned in paragraph (b) is the donor in relation to that use of the technique.

the child’s full name;

the child’s sex;

the child’s date of birth;

any other information about the child prescribed by the regulations for the purposes of this paragraph.

as soon as practicable after the birth of the child, notify the Secretary and the NHMRC Licensing Committee of that fact, in the form (if any) approved by the Secretary; and

give the Secretary, in the form (if any) approved by the Secretary:

the information collected as required by subsection (1) for the donor in relation to the particular use of the technique that achieved the pregnancy, as soon as practicable after the birth of the child; and

the information collected as required by subsection (3) for the child, as soon as practicable after the person collects the information.

a trial participant or patient; or

a child of a trial participant or patient.

the holder of a clinical trial licence or a clinical practice licence;

an embryologist specified in such a licence;

a person authorised by such a licence to carry out an activity authorised by the licence.

monitoring the pregnancy of trial participants who achieve pregnancy using a mitochondrial donation technique under the licence and any childbirths resulting from such pregnancies; and

monitoring the ongoing health and development of children born as a result of such pregnancies; and

seeking the ongoing engagement of trial participants referred to in paragraph (a), and children referred to in paragraph (b), in relation to such monitoring; and

notifying in accordance with subsection (3) adverse events, for those participants or children, that the person becomes aware of as a result of monitoring referred to in paragraph (a) or (b) of this subsection.

monitoring the pregnancy of patients who achieve pregnancy using a mitochondrial donation technique under the licence and any childbirths resulting from such pregnancies; and

notifying in accordance with subsection (3) adverse events, for those patients, that the person becomes aware of as a result of monitoring referred to in paragraph (a) of this subsection.

the NHMRC Licensing Committee; and

the Secretary; and

such other persons as are prescribed by the regulations for the purposes of this paragraph;

within the period, in a form and manner, and in accordance with any other requirements, specified in the regulations.

a trial participant or patient; or

a child of a trial participant or patient.

is or was the holder of a mitochondrial donation licence; and

for a mitochondrial donation licence other than a clinical practice research and training licence or a clinical practice licence—is a constitutional corporation.

the licence holder; and

the HREC and the relevant State body to which the NHMRC Licensing Committee notified its decision on the application for the licence under section 28K.

the name of the person to whom the licence was issued;

for a general licence—a short statement about the nature of the uses of excess ART embryos or human eggs, and creations or uses of other embryos, that are authorised by the licence;

for a mitochondrial donation licence—a short statement about the nature of the uses of excess ART embryos or human eggs, and creations or uses of other embryos or zygotes, that are authorised by the licence;

for a general licence—the number of excess ART embryos or human eggs authorised to be used under the licence, and the number of other embryos authorised to be created or used under the licence;

for a mitochondrial donation licence—the number of excess ART embryos or human eggs authorised to be used under the licence, and the number of other embryos or zygotes authorised to be created or used under the licence;

in any case:

any conditions to which the licence is subject; and

the date on which the licence was issued; and

the period throughout which the licence is to remain in force.

was born as a result of the use of a mitochondrial donation technique under a mitochondrial donation licence; and

is 18 or over;

may apply, in the form approved by the Secretary, for the Secretary to disclose to the person information in the register about the donor in relation to the use of the technique.

the person discloses information; and

the person knows the information is on the register; and

the person has the information only because of performing duties or functions under this section or paragraph 28R(5)(b); and

the disclosure is not:

in accordance with subsection (6) of this section; or

by order of a court.

information that must be included in the register in addition to the information mentioned in subsection (1);

correcting or updating information on the register;

the keeping and maintenance of the register;

the verification of information included in an application to the Secretary under subsection (4) or (5) for the disclosure of information on the register, including by statutory declaration.

the person discloses confidential commercial information that the person has only because of performing duties or functions under this Act or under a corresponding State law; and

the person knows that the information is confidential commercial information; and

the disclosure is not:

to the Commonwealth, a Commonwealth authority or a State agency in the course of carrying out duties or functions under this Act or under a corresponding State law; or

by order of a court; or

with the consent of each person to whom the information has a commercial or other value.

the person discloses confidential commercial information that the person has only because of a disclosure permitted under subsection (1) or this subsection; and

the person knows that the information is confidential commercial information; and

the disclosure is not:

to the Commonwealth, a Commonwealth authority or a State agency in the course of carrying out duties or functions under this Act or under a corresponding State law; or

by order of a court; or

with the consent of each person to whom the information has a commercial or other value.

the Crown in right of a State;

a Minister of a State;

a State Government department;

an instrumentality of a State, including a body corporate established for a public purpose by or under a law of a State;

a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:

the Crown in right of a State;

a person or body covered by paragraph (b) or (d);

a person or body covered by either of the above subparagraphs.

a decision under section 21 or 28J not to issue a licence;

a decision in respect of the period throughout which the licence is to be in force under section 23 or 28M;

a decision to specify a licence condition under subsection 24(4) or 28N(4);

a decision to modify guidelines under subsection 24(8) in respect of a licence;

a decision to vary or refuse to vary a licence under section 25 or 28U;

a decision to suspend or revoke a licence under section 26 or subsection 28V(1) or (2);

a decision under subsection 28P(3) not to grant an approval to carry out an activity referred to in paragraph 28P(1)(a) or (b) in relation to a trial participant or patient.

in relation to the carrying out of activities by a constitutional corporation in connection with conducting a clinical trial under a clinical trial licence referred to in section 28E, and associated activities; and

for money to be payable by the Commonwealth to the constitutional corporation for that purpose.

vary in accordance with the terms or conditions of the arrangement; or

vary with the consent of the non-Commonwealth party or parties to the arrangement.

the Commonwealth; or

(b) a person (a protected person) covered by an item of the following table;

in respect of loss, damage or injury of any kind suffered by another person as a result of anything done, or omitted to be done, by a protected person in relation to a matter mentioned in the relevant item:

(a) the period of 7 years starting on the commencement of Schedule 1 to the Mitochondrial Donation Law Reform (Maeve’s Law) Act 2022; and

each subsequent 7-year period.

(a) undertaken by the persons who undertake the review for the relevant 7-year period required by Prohibition of Human Cloning for Reproduction Act 2002; andsection 25 of the

undertaken concurrently with the review mentioned in paragraph (a).

the Commonwealth and the States; and

a broad range of persons with expertise in or experience of relevant disciplines;

and the views of the Commonwealth, the States and the persons mentioned in paragraph (b) must be set out in the report to the extent that it is reasonably practicable to do so.

required or permitted by this Act to be prescribed; or

necessary or convenient to be prescribed for carrying out or giving effect to this Act.

the States have been consulted in relation to the proposed regulations; and

the proposed regulations have been prepared having regard to views expressed by the States in those consultations.

Division 4 (general licences) of Part 2;

Division 4A (mitochondrial donation licences) of Part 2;

a definition in section 7 or 8 of an expression that is used in either or both of those Divisions.

Endnotes

Endnote 1—About the endnotes

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

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key— E ndnote 2

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

Legislation history and amendment history— E ndnotes 3 and 4

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

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

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

Editorial changes

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

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

Misdescribed amendments

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

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

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history