Mitochondrial Donation Law Reform (Maeve's Law) Act 2022 (26 of 2022)

Schedule 1   Mitochondrial donation

Part 1   Main amendments

Research Involving Human Embryos Act 2002

17   After Division 4 of Part 2

Insert:

Division 4A - Mitochondrial donation licences

Subdivision A - Kinds of mitochondrial donation licences and what they authorise

28A Kinds of mitochondrial donation licences

There are 5 kinds of mitochondrial donation licences, which are as follows:

(a) pre-clinical research and training licences referred to in section 28C;

(b) clinical trial research and training licences referred to in section 28D;

(c) clinical trial licences referred to in section 28E;

(d) clinical practice research and training licences referred to in section 28F;

(e) clinical practice licences referred to in section 28G.

28B Carrying out activities authorised by mitochondrial donation licences

(1) A person may carry out an activity as authorised by a pre-clinical research and training licence, a clinical trial research and training licence or a clinical trial licence (see section 28C, 28D or 28E) if:

(a) the licence is in force; and

(b) the licence holder is a constitutional corporation.

(2) Subsection (1) applies despite a law of a State.

(3) A person may carry out an activity as authorised by a clinical practice research and training licence or a clinical practice licence (see section 28F or 28G) in a particular State if:

(a) the licence is in force; and

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

28C What a pre-clinical research and training licence authorises

(1) A pre-clinical research and training licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence in undertaking research and training for the purpose of doing all of the following:

(a) 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:

(i) conducting a clinical trial; or

(ii) using the technique in a clinical practice setting;

(b) 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;

(c) building expertise in the technique and how to use it.

(2) The activities are as follows:

(a) 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;

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

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

(ii) other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

(c) 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;

(d) 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;

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

(3) A pre-clinical research and training licence does not authorise any use of a human embryo that would:

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

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

28D What a clinical trial research and training licence authorises

(1) A clinical trial research and training licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, in undertaking research and training for the purpose of doing all of the following in preparation for using the permitted technique specified in the licence in a particular clinical trial:

(a) 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;

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

(c) 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.

(2) The activities are as follows:

(a) 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;

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

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

(ii) other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

(c) 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;

(d) 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;

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

(3) A clinical trial research and training licence does not authorise any use of a human embryo that would:

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

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

28E What a clinical trial licence authorises

(1) A clinical trial licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, for the purpose of doing both of the following in conducting a clinical trial to determine whether the permitted technique specified in the licence is sufficiently safe and effective to use in a clinical practice setting:

(a) 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;

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

(2) The activities are as follows:

(a) 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;

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

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

(ii) 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 (within the meaning of section 15 of the 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;

(d) 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:

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

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

(iii) a human embryo that contains a human cell (within the meaning of section 15 of the 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;

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

(3) A clinical trial licence does not authorise any use of a human embryo that would result in the development of the embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.

28F What a clinical practice research and training licence authorises

(1) A clinical practice research and training licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, in undertaking research and training for the purpose of doing all of the following in preparation for using the permitted technique specified in the licence in a clinical practice setting:

(a) 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;

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

(c) 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.

(2) The activities are as follows:

(a) 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;

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

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

(ii) other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

(c) 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;

(d) 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;

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

(3) A clinical practice research and training licence does not authorise any use of a human embryo that would:

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

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

28G What a clinical practice licence authorises

(1) A clinical practice licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, for the purpose of doing both of the following in a clinical practice setting:

(a) 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;

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

(2) The activities are as follows:

(a) 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;

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

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

(ii) 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 (within the meaning of section 15 of the 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;

(d) 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:

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

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

(iii) a human embryo that contains a human cell (within the meaning of section 15 of the 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;

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

(2) A clinical practice licence does not authorise any use of a human embryo that would result in the development of the embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.

Subdivision B - Applying for a mitochondrial donation licence

28H Applying for a mitochondrial donation licence

(1) A person may, subject to subsections (2) to (7), apply to the NHMRC Licensing Committee for:

(a) 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

(b) 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

(c) 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

(d) 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

(e) 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).

(2) A person cannot apply for any of the following licences unless the person is a constitutional corporation:

(a) a pre-clinical research and training licence;

(b) a clinical trial research and training licence;

(c) a clinical trial licence.

(3) A person cannot apply for a clinical trial licence relating to a particular mitochondrial donation technique unless the person has held a clinical trial research and training licence relating to that technique.

(4) A person cannot apply for a clinical practice licence relating to a particular mitochondrial donation technique unless the person has held a clinical practice research and training licence relating to that technique.

(5) An application for a mitochondrial donation licence relating to a particular mitochondrial donation technique must nominate one or more embryologists who will be authorised to use the technique under the licence.

(6) A single application cannot relate to:

(a) more than one kind of mitochondrial donation licence; or

(b) more than one permitted technique for a mitochondrial donation licence.

(7) An application for a mitochondrial donation licence must:

(a) be in the form approved by the NHMRC Licensing Committee; and

(b) specify the following:

(i) the kind of mitochondrial donation licence;

(ii) the permitted technique to which the licence will relate; and

(c) be made in accordance with:

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

(ii) 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

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

(8) A form approved for the purposes of paragraph (7)(a) may require:

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

(b) any such information to be verified by statutory declaration.

Subdivision C - Determining applications for mitochondrial donation licences

28J Determination of application by Committee

(1) If a person applies under subsection 28H(1) for a mitochondrial donation licence relating to a mitochondrial donation technique that is a permitted technique for the licence, the NHMRC Licensing Committee must decide, in accordance with this section, whether or not to issue the licence.

(2) The NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following:

(a) 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)):

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

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

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

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

(b) 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.

(3) In deciding whether to issue the licence, the NHMRC Licensing Committee must have regard to the following:

(a) restricting the number ofexcess 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;

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

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

(4) Without limiting section 15, the NHMRC Licensing Committee may also request, and have regard to, advice from any person having appropriate expertise.

(5) The NHMRC Licensing Committee must not issue a clinical trial licence, or a clinical practice licence, relating to a particular mitochondrial donation technique unless it is satisfied that:

(a) 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

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

(i) consented in writing to being so nominated; and

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

(iii) understands the embryologist's obligations under this Act; and

(c) the applicant's facilities, equipment and processes for using the technique under the licence are suitable for that purpose; and

(d) 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

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

(f) 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

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

(i) the risks involved in using mitochondrial donation techniques; and

(ii) alternatives to using mitochondrial donation techniques.

(6) The regulations may specify:

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

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

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

(d) 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).

28K Notification of decision

(1) The NHMRC Licensing Committee must notify its decision on an application for a licence under section 28H to the following:

(a) the applicant;

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

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

(2) If the NHMRC Licensing Committee decides to issue the licence, it must, in addition to issuing the licence to the applicant, give a copy of the licence to the bodies mentioned in paragraphs (1)(b) and (c).

28L Matters to be specified in a mitochondrial donation licence

If the NHMRC Licensing Committee decides to issue a mitochondrial donation licence, the licence must specify the following matters:

(a) the mitochondrial donation technique to which the licence relates;

(b) the activity or activities referred to in subsection 28C(2), 28D(2), 28E(2), 28F(2) or 28G(2) (as the case requires) that are authorised by the licence;

(c) the name of each embryologist nominated under subsection 28H(5).

28M Period of a mitochondrial donation licence

(1) A mitochondrial donation licence:

(a) 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

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

(2) A mitochondrial donation licence is not in force throughout any period of suspension.

Subdivision D - Conditions of mitochondrial donation licences

28N Conditions of mitochondrial donation licences generally

(1) A mitochondrial donation licence is subject to the condition that the requirements of subsection (1A) are met before any of the following activities are carried out as authorised by the licence:

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

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

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

(1A) The requirements are as follows:

(a) 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;

(b) 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.

(2) A mitochondrial donation licence is subject to the condition that a report to the NHMRC Licensing Committee for the purposes of paragraph (1A)(b) must not include the name, or any other information that could be used to discover the identity, of a responsible person.

(3) A mitochondrial donation licence is subject to the condition that the carrying out of an activity referred to in paragraph (1)(a), (b) or (c) must be in accordance with any restrictions to which the proper consent under paragraph (1A)(a) is subject.

(4) A mitochondrial donation licence is subject to such other conditions as are specified in the licence.

(5) The conditions specified in the licence may include, but are not limited to, conditions relating to the following:

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

(b) 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;

(c) reporting;

(d) monitoring;

(e) information to be given by the licence holder to the following:

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

(ii) other persons;

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

(6) The licence conditions set out in subsections (1), (2) and (3) apply to:

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

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

(7) Licence conditions specified in the licence apply to:

(a) the licence holder; and

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

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

(8) In this Division:

proper consent in relation to the carrying out of an activity referred to in paragraph (1)(a), (b) or (c) means consent:

(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

(b) 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.

Responsible persons for material

(9) Without limiting paragraph (b) of the definition of proper consent in subsection (8), regulations made for the purposes of that paragraph may:

(a) provide in relation to the withdrawal of consent; and

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

28P Additional condition of clinical trial licences and clinical practice licences - Committee approval before creation or placement of embryo

(1) A clinical trial licence or clinical practice licence is subject to the condition that an approval granted under subsection (3) is in force at the time either of the following activities are carried out in relation to a woman who is a trial participant or patient (as the case requires) for the licence:

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

(b) 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.

(2) The licence holder for a clinical trial licence or a clinical practice licence may apply to the NHMRC Licensing Committee, in the form approved by the Committee and in accordance with such other requirements (if any) as are specified in writing by the Committee, for approval to carry out an activity referred to in paragraph (1)(a) or (b) in relation to a woman who is a trial participant or patient (as the case requires) for the licence.

(3) If the NHMRC Licensing Committee receives an application under subsection (2), the Committee must decide whether or not to grant the approval.

(4) The NHMRC Licensing Committee must not grant the approval unless it is satisfied:

(a) 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

(b) 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

(c) 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

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

(i) the risks involved in using mitochondrial donation techniques; and

(ii) alternatives to using mitochondrial donation techniques; and

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

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

(5) In deciding whether to grant the approval, the NHMRC Licensing Committee must have regard to the following:

(a) the clinical basis of the risk of the woman's offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease;

(b) the inheritance pattern in the woman's family;

(c) the likely clinical manifestations of disease for the woman's offspring.

(5A) Without limiting section 15, the NHMRC Licensing Committee may also request, and have regard to, advice from any person having appropriate expertise.

(6) The NHMRC Licensing Committee must notify its decision on an application under subsection (2) to the licence holder.

(7) A form approved by the NHMRC Licensing Committee for the purposes of subsection (2):

(a) 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

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

(i) the name of a trial participant or patient;

(ii) 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.

(8) An approval granted by the NHMRC Licensing Committee in relation to a woman for the purposes of subsection (1) comes into force when it is granted and ceases to be in force at the earlier of the following times:

(a) 5 years after the approval is granted;

(b) 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).

(9) The licence condition set out in subsection (1) applies to:

(a) the licence holder; and

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

28Q Other conditions of clinical trial licences and clinical practice licences

(1) A clinical trial licence or a clinical practice licence is subject to the following conditions:

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

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

(c) that the embryologist remains technically competent to use the technique;

(d) 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.

(2) The licence conditions set out in this section apply to:

(a) the licence holder; and

(b) 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

28R Clinical trial licences and clinical practice licences - information about donors and children

(1) The holder of a clinical trial licence or a clinical practice licence must collect the following information for the donor in relation to each use of a mitochondrial donation technique under the licence:

(a) the donor's full name;

(b) 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;

(c) the donor's date and place of birth;

(d) 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;

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

(2) If a particular use of a mitochondrial donation technique results in the creation of a zygote that:

(a) has nuclear DNA from a woman and a man; and

(b) 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.

(3) A person who is or was the holder of a clinical trial licence or a clinical practice licence must use the person's best endeavours to collect the following information for each child born alive as a result of a pregnancy achieved using a mitochondrial donation technique under the licence:

(a) the child's full name;

(b) the child's sex;

(c) the child's date of birth;

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

(4) A person who is or was the holder of a clinical trial licence or a clinical practice licence must keep records of information the person collects as required by subsection (1) or (3) for the period prescribed by the regulations for the purposes of this subsection.

(5) If a person who is or was the holder of a clinical trial licence or a clinical practice licence becomes aware that a child has been born alive as a result of a pregnancy achieved using a mitochondrial donation technique under the licence, the person must:

(a) 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

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

(i) 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

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

(6) A person who is or was the holder of a clinical trial licence or a clinical practice licence must not include in a notification for the purposes of paragraph (5)(a) the name, or any other information that could be used to discover the identity, of:

(a) a trial participant or patient; or

(b) a child of a trial participant or patient.

(6A) A person who is or was the holder of a clinical trial licence or a clinical practice licence must take reasonable steps to ensure that information the person collects as required by subsection (1) or (3) is not disclosed to another person except for the purpose of complying with this Act.

(6B) A person who is or was any of the following must not disclose information collected as required by subsection (1) or (3) to another person except for the purpose of complying with this Act:

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

(b) an embryologist specified in such a licence;

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

(6C) Subsections (6A) and (6B) apply despite a law of a State. However, those subsections do not prevent a person from disclosing information to a Registrar of births, deaths and marriages (however described) of a State in accordance with a law of that State relating to the notification or registration of births.

Note: A defendant bears an evidential burden in relation to the matter in this subsection (see subsection 13.3(3) of the Criminal Code).

(7) Despite subsections (1), (3), (4), (5), (6), (6A) and (6B), in the case of a clinical trial licence a person is not subject to a requirement under any of those subsections unless the person who is or was the holder of the licence is a constitutional corporation.

(8) A person commits an offence if the person intentionally engages in conduct knowing that, or reckless as to whether, the conduct breaches a requirement under subsection (1), (3), (4), (5), (6), (6A) or (6B) to which the person is subject.

Penalty for a contravention of this subsection: Imprisonment for 2 years.

28S Clinical trial licences and clinical practice licences - requirement for ongoing monitoring protocols and to notify adverse events

(1) A person who is or was the holder of a clinical trial licence must have in place, and comply with, protocols for:

(a) 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

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

(c) 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

(d) 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.

(2) A person who is or was the holder of a clinical practice licence must have in place, and comply with, protocols for:

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

(b) 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.

(3) If a person who is or was the holder of a clinical trial licence or a clinical practice licence becomes aware of an adverse event for a trial participant referred to in paragraph (1)(a), a child referred to in paragraph (1)(b) or a patient referred to in paragraph (2)(a), the person must notify the adverse event to:

(a) the NHMRC Licensing Committee; and

(b) the Secretary; and

(c) 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.

(4) Without limiting subsection (3), the regulations may require a notification to be in the form approved by the CEO of the NHMRC and to contain any information required by the form.

(5) A person who is or was the holder of a clinical trial licence or a clinical practice licence must not include in a notification for the purposes of subsection (3) the name, or any other information that could be used to discover the identity, of:

(a) a trial participant or patient; or

(b) a child of a trial participant or patient.

(6) Despite subsections (1), (3) and (5), in the case of a clinical trial licence a person is not subject to a requirement under any of those subsections unless the person is a constitutional corporation.

(7) A person commits an offence if the person intentionally engages in conduct knowing that, or reckless as to whether, the conduct breaches a requirement under subsection (1), (2), (3) or (5) to which the person is subject.

Penalty: Imprisonment for 2 years.

(8) In this section:

adverse event , for a trial participant or patient, or a child of a trial participant, has the meaning given by the regulations.

28T Record-keeping obligations for all holders of mitochondrial donation licences

(1) The regulations may prescribe record-keeping obligations that apply in relation to the use of mitochondrial donation techniques under mitochondrial donation licences.

(2) Regulations for the purposes of subsection (1) may impose such obligations only on a person who:

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

(b) for a mitochondrial donation licence other than a clinical practice research and training licence or a clinical practice licence - is a constitutional corporation.

(3) Regulations for the purposes of subsection (1) may prescribe penalties, not exceeding 50 penalty units, for offences against such regulations.

Subdivision F - Variation, suspension, revocation and surrender

28U Variation of a mitochondrial donation licence

(1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, vary a mitochondrial donation licence if the Committee believes on reasonable grounds that it is necessary or desirable to do so.

(2) The NHMRC Licensing Committee may vary a mitochondrial donation licence under subsection (1) on its own initiative or on application by the licence holder.

(3) Without limiting subsection (1), the NHMRC Licensing Committee may vary the licence by specifying additional conditions or varying existing conditions.

(4) The NHMRC Licensing Committee must not vary a mitochondrial donation licence in such a way that, had a person applied under section 28H for the licence as varied, the Committee would not have been permitted by this Division to issue the licence.

28V Suspension or revocation of a mitochondrial donation licence

(1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, suspend or revoke a mitochondrial donation licence if the Committee believes on reasonable grounds that a condition of the licence has been breached.

(2) If the holder of a mitochondrial donation licence is convicted of an offence under this Act or the regulations, or the Prohibition of Human Cloning for Reproduction Act 2002, the NHMRC Licensing Committee must, by notice in writing given to the licence holder, revoke each mitochondrial donation licence held by the licence holder.

(3) If the holder of a pre-clinical research and training licence, a clinical trial research and training licence or a clinical trial licence stops being a constitutional corporation at a particular time, the NHMRC Licensing Committee is taken to have revoked the licence at that time.

28W Surrender of a mitochondrial donation licence

The holder of a mitochondrial donation licence may surrender the licence by written notice given to the NHMRC Licensing Committee.

28X Notification of variation, suspension or revocation of a mitochondrial donation licence

(1) If the NHMRC Licensing Committee varies, suspends or revokes a mitochondrial donation licence, the Committee must notify:

(a) the licence holder; and

(b) 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.

(2) The NHMRC Licensing Committee must also notify the bodies mentioned in paragraph (1)(b) if a mitochondrial donation licence is surrendered.