Title Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021
Database Explanatory Memoranda
Date 10-05-2022 09:33 AM
Source House of Reps
System Id legislation/ems/r6697_ems_3548f5a3-edd4-4d62-8047-e5df95ac7834


Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021

2019-2020-2021

 

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

 

 

MITOCHONDRIAL DONATION LAW REFORM (MAEVE’S LAW) BILL 2021

 

 

 

 

 

 

 

 

 

 

 

SUPPLEMENTARY EXPLANATORY MEMORANDUM

 

 

 

Amendments to be moved on behalf of the Government

 

 

 

 

 

 

 

(Circulated by authority of the Minister for Health and Aged Care, the Hon Greg Hunt MP)


 

 

 


 

Contents

GENERAL OUTLINE.. 1

Financial impact statement 2

Statement of compatibility with human rights. 3

Abbreviations used in this supplementary explanatory memorandum.. 8

NOTES ON AMENDMENTS. 9

 

 

 

 

 

 

 

 

 

 


AMENDMENTS TO THE MITOCHONDRIAL DONATION LAW REFORM (MAEVE’S LAW) BILL 2021

 

GENERAL OUTLINE

The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 (the Bill) amends various laws to allow for mitochondrial donation to be introduced into Australia for research and human reproductive purposes, with regulatory oversight by the Embryo Research Licensing Committee (the ERLC) of the National Health and Medical Research Council (the NHMRC). The Bill limits the circumstances in which mitochondrial donation can be used. It can be used only to minimise the risk of a woman’s offspring inheriting mitochondria that would predispose the offspring to mitochondrial disease. In permitting and regulating the use of mitochondrial donation, the Bill balances a range of scientific and ethical concerns.

The Government amendments propose to amend the Bill so that it clearly achieves the underlying policy aims and appropriately addresses the ethical and other issues.

In summary, the amendments:

·         clarify the operation of the Bill, by making it express that:

-        prescribed mitochondrial donation techniques are restricted to ones that source mitochondria from human eggs, and

-        the ERLC is able to seek advice of external experts when exercising its powers and performing its functions, and that such experts will be protected from a range of civil actions when providing that advice

·         require proper consent to be obtained in a broader range of circumstances, namely, before any of the following are done under a mitochondrial donation licence:

-        an excess ART embryo is used (the Bill already requires proper consent before a human egg or a human sperm is used under a mitochondrial donation licence)

-        a human zygote, or any other embryo, is created or used, or

-        any other material is created, developed, produced or used

·         enhance donor privacy by limiting the information that can be accessed by persons born from the use of mitochondrial donation about their mitochondrial donor to the information that can be accessed from the Mitochondrial Donation Donor Register under the amendments made by the Bill

·         ensure that as much information as possible about the use of mitochondrial donation can be reported to the Parliament without compromising the privacy of persons involved in the mitochondrial donation process, by preventing ERLC reports to the Parliament from including information that identifies, or could be used to identify, the following persons, in order to further protect their privacy:

-        mitochondrial donors

-        trial participants, and patients, who make use of mitochondrial donation, and

-        persons born from the use of mitochondrial donation, and

·         ensure that embryos cannot be selected for implantation in a woman following the use of a mitochondrial donation technique on the basis of the sex of the embryo.

In relation to this final measure, selection and implantation of male embryos has been suggested to address a potential risk for mitochondrial disease to re-emerge in future generations, even after the use of a mitochondrial donation technique. Some hold the view that selection and implantation of male embryos only should be mandatory, in order to address this risk. Others, however, question whether this risk is sufficiently significant as to warrant being addressed by embryo sex selection, particularly given the range of ethical questions that embryo sex selection raises.

The Bill as introduced would have permitted prospective parents to make their own choices about embryo sex selection in order to manage this risk, after having been counselled about all risks associated with mitochondrial donation, and about alternatives to using mitochondrial donation techniques. The Bill would have imposed a condition on clinical trial and clinical practice licences, requiring only male embryos to be selected for implantation, if:

·         the trial participant or patient, and her spouse (if any), after attending mandatory pre‑treatment counselling, so request, and

·         it is safe and practicable to do so.

The Government amendments omit this condition, and insert a new licence condition in its place. Under this licence condition, a human embryo created for a woman using a licensed mitochondrial donation technique is not to be selected for implantation in that woman on the basis of the sex of the embryo.

This amendment follows the review of the Bill by the Community Affairs Legislation Committee, which delivered its report in August 2021. The Committee set out some concluding comments at paragraph 3.76 of its report. One was that, should the Bill be passed, additional clarification, amendment or further consideration may be appropriate in relation to embryo sex selection. In particular, the Committee referred to whether the provisions of the Bill that would enable a woman the option of selecting the sex of embryos is necessary and appropriate. The Committee received feedback that:

·         the proposed approach would create a risk to the viability of the embryo and is unnecessary

·         given the differences of opinion internationally and among experts, it is unreasonable to expect families contemplating mitochondrial donation to make this decision, and

·         this would equate to ‘selective erasure of female embryos, hence future girls and women’.

Under the amendment, it would still be possible to select embryos for implantation in order to reduce the risk of transmission of a genetic condition, disease or abnormality. However, the selection could not be on the basis of the sex of the embryo.

Financial impact statement

The Government amendments are not expected to have any financial impact.


 

Statement of compatibility with human rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021

 

These amendments are compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Government amendments

Mitochondrial donation allows women whose mitochondria would otherwise predispose their potential children to mitochondrial disease, to have a biological child who would not inherit that predisposition.

Among other things, the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 (the Bill) does the following.

Legalising mitochondrial donation

First, the Bill legalises mitochondrial donation for particular research, training and reproductive purposes. In doing so, it defines the term ‘mitochondrial donation technique’, and permits regulations to be made that prescribe particular techniques that can be used under a mitochondrial donation licence.

Government amendment

Amendments 1 and 10 will amend the definition of ‘mitochondrial donation technique’ to expressly restrict the mitochondrial donation techniques that can be prescribed to ones that source mitochondria from human eggs.

These amendments will expressly clarify a restriction that is already implicitly present in the Bill.

The need for proper consent under mitochondrial donation licences

Second, mitochondrial donation involves manipulations of human eggs or human zygotes, and a central feature of the Bill is the need for ‘proper consent’ to be obtained for the use of human eggs and human sperm in such techniques.

Government amendment

Amendments 2, 3, 4, 5, 6, 7 and 9 will ensure that proper consent is also required for the use of a broader range of biological material under mitochondrial donation licences, such as human zygotes and human embryos.

Regulation of mitochondrial donation

Third, the Bill empowers the Embryo Research Licensing Committee (the ERLC) of the National Health and Medical Research Council to provide regulatory oversight of mitochondrial donation. One of the ERLC’s functions is to make decisions about applications for mitochondrial donation licences. The Bill expressly permits the ERLC to seek advice from external experts when doing so. Persons providing that advice are provided with immunity from a range of civil actions when providing that advice. Another of the ERLC’s functions is to approve trial participants and patients for the use of mitochondrial donation.

Government amendment

Amendment 8 will insert a new subsection that expressly permits the ERLC to request, and have regard to, advice from any person having appropriate expertise when making such decisions.

This amendment will expressly clarify a power that is already implicitly present in the Bill.

Amendment 16 will ensure that persons providing such advice will be provided with an immunity from civil actions relating to advice provided in response to such a request. This immunity will be equivalent to the immunity currently provided under the Bill to persons providing advice in response to requests for advice from the ERLC which relate to decisions about applications for mitochondrial donation licences.

Mitochondrial Donation Donor Register

Fourth, the Bill establishes a Mitochondrial Donation Donor Register (the Register). The Bill requires holders of 2 types of mitochondrial donation licence – clinical trial licences and clinical practice licences – to obtain personal information for inclusion on the Register. A person born as a result of using mitochondrial donation will, after they turn 18, be able to access identifiable information from the Register about their mitochondrial donor.

Government amendment

Amendments 11, 12, 13 and 14 will further restrict how this information can be handled, and ensure that the information collected can be used only for the purposes of complying with the Act, or with a State or Territory law that relates to the notification or registration of births.

A failure to comply with these restrictions could subject a person to a penalty of imprisonment for up to 2 years.

The amendments will further protect the privacy of persons whose information appears on the Register.

Reports to Parliament

Fifth, the Bill requires the ERLC to report on mitochondrial donation licences in its reports to Parliament.

Government amendment

Amendment 15 will prevent those reports from including certain specified information if the ERLC considers that it identifies, or could reasonably be used to identify, the following persons:

·         mitochondrial donors

·         trial participants, and patients, who make use of mitochondrial donation, and

·         persons born from the use of mitochondrial donation.

The amendment will further protect the privacy of such persons.

Human rights implications

The Bill’s explanatory memorandum includes a detailed statement of compatibility with human rights. This statement concludes that the Bill is compatible with human rights because:

·         it promotes the right to health and the best interests of the child

·         it does not affect the right to life, and

·         to the extent that it may limit the right to privacy and the right to freedom of opinion and expression, those limitations are for a legitimate purpose and are reasonable, necessary and proportionate.

In Report 5 of 2021, the Parliamentary Joint Committee on Human Rights had no comment in relation to the Bill, on the basis that:

·         it did not engage, or it only marginally engages, human rights

·         it did not promote human rights, and/or

·         it permissibly limited human rights.

Amendments 1 to 10 and 16

Amendments 1, 8 and 10 simply clarify the existing operation of the Bill, and do not further engage with human rights. Amendments 2, 3, 4, 5, 6, 7, 9 and 16 extend the circumstances in which licence holders are required to obtain proper consent, and deal with other consequential changes, and do not engage any of the human rights referred to in the Human Rights (Parliamentary Scrutiny) Act 2011.

Amendments 11, 12, 13 and 14

Amendments 11, 12, 13 and 14 engage:

·         the right to privacy (Article 16 of the Convention of the Rights of the Child (the CROC), and Article 17 of the International Covenant on Civil and Political Rights (the ICCPR)), and

·         the right to freedom of opinion and expression – Article 19 of the ICCPR.

Right to privacy

Article 17 of the ICCPR prohibits arbitrary or unlawful interference with an individual’s privacy, family, home or correspondence. The right to privacy includes respect for informational privacy, and any provisions of an Act which permit the disclosure of personal information will engage the right to privacy. To be permissible as a matter of international human rights law, interferences with privacy must be according to law and not arbitrary. In order not to be arbitrary, they must be reasonable and necessary in the particular circumstances, as well as proportionate to the objectives they seek to achieve.

The purpose of the Register is to enable individuals born as a result of the use of mitochondrial donation techniques to seek identifiable information about their donor, after turning 18. Donors would have been aware of this before consenting to donating eggs for use in the mitochondrial donation technique. This is considered to be a legitimate objective.

Amendments 11, 12, 13 and 14 will ensure that privacy is sufficiently maintained, by ensuring that any information collected for inclusion on, and access from, the Register can only be disclosed for the purpose of complying with the Research Involving Human Embryos Act 2002 as amended by the Bill, or for the purposes of notifying or registering births in accordance with the law of the relevant State or Territory. As these amendments tighten the circumstances in which personal information may be disclosed, they are reasonable, necessary and proportionate.

Right to freedom of opinion and expression

Amendments 11, 12, 13 and 14 contain limitations on the communication or publication of information. As such, they engage the right to freedom of expression under Article 19(2) of the ICCPR.

The purpose of the amendments is to protect the privacy of donors and children born as a result of pregnancies achieved using a mitochondrial donation technique. This is a legitimate objective under Article 19(3) of the ICCPR, which provides that freedom of expression may be restricted where necessary ‘[f]or respect of the rights … of others’.

The amendments are therefore reasonable, necessary and proportionate to achieving a legitimate objective. In particular, the amendments contain provisions which provide for legitimate disclosures of information – such as disclosures for the purpose of complying with the Research Involving Human Embryos Act 2002 as amended by the Bill, or for the purpose of updating births, deaths and marriages registries in accordance with State or Territory law.

For these reasons, these amendments are sufficiently precise so as to remain consistent with the right to freedom of opinion and expression under international human rights law.

Amendment 15

Amendment 15 also engages the right to privacy and the right to freedom of opinion and expression.

Right to privacy

Amendment 15 will limit the information that can be included in reports by the ERLC to the Parliament.

It is consistent with the right to privacy, as the sensitive information (including information regarding trial participants or patients, children born as a result of pregnancies achieved using a mitochondrial donation technique, or any adverse events) can only be included in a report to the Parliament where the identities of relevant persons are protected.

Right to freedom of opinion and expression

Amendment 15 contain limitations on the communication or publication of information. As such, it engages the right to freedom of expression under Article 19(2) of the ICCPR.

However, amendment 15 does not contain an outright prohibition on the inclusion of the relevant information in a report by the ERLC to the Parliament, but rather, requires that any publication of such information protect the identities of relevant persons.

Because of this, amendment 15 is sufficiently precise so as to remain consistent with the right to freedom of expression under international human rights law.

Amendment 17

Amendment 17 does not engage any human rights.

Consequential amendments to be made to the statement of compatibility with human rights

To address the Government amendments, the statement of compatibility with human rights contained in the Bill’s explanatory memorandum is amended as follows:

·         On page 11, at the end of the first full paragraph, add:

‘In addition, subsections 28R(6A) to (6C) further restrict disclosure of this information.’

·         On page 12, after the first paragraph, insert the following additional paragraph:

‘Further, under new subsection 19(4) of the Research Involving Human Reproduction Act 2002, the ERLC will be restricted as to the kind of information it can publish in its reports to Parliament under section 19.’

·         On page 12, at the end of the second paragraph, add:

‘The legitimate and rational purpose of the interference with freedom of opinion and expression under new subsection 19(4) is similarly to ensure that these rights to privacy are upheld. The Bill does not create an offence for not complying with this provision.’

Conclusion

The Government amendments are compatible with human rights. The amendments either do not engage with human rights, or else limit the right to privacy and the right to freedom of opinion and expression, but only for a legitimate purpose and in a manner that is reasonable, necessary and proportionate.

 

[Circulated with authority by the Minister for Health and Aged Care, Hon Greg Hunt MP]

Abbreviations used in this supplementary explanatory memorandum

This supplementary explanatory memorandum uses the following abbreviated references:

Abbreviation

Full reference

ART

Assisted Reproductive Technology

Bill

Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021

ERLC

Embryo Research Licensing Committee of the NHMRC

NHMRC

National Health and Medical Research Council

Register

Mitochondrial Donation Donor Register

RIHE Act

Research Involving Human Embryos Act 2002

RIHE Regulations

Research Involving Human Embryos Regulations 2017

Secretary

Secretary of the Department of Health


 

NOTES ON AMENDMENTS

Amendment 1. Schedule 1, item 10 (source of mitochondria)

1.             Item 10 of the Bill amends the RIHE Act to insert several definitions, including a definition of the term ‘mitochondrial donation technique’. This definition is central to the amendments made by the Bill. As a result of this definition, it will be possible to make regulations that prescribe particular mitochondrial donation techniques, which could be used subject to a mitochondrial donation licence. This definition limits the scope of the power to make regulations prescribing mitochondrial donation techniques, as all prescribed techniques need to be ones that satisfy all of the criteria specified in this definition. Item 20 of Schedule 1 to the Bill amends the RIHE Regulations to prescribe 5 mitochondrial donation techniques.

2.             Amendment 1 amends this definition. The amendment makes it express that mitochondrial donation techniques will be limited to ones that, among other things, result in the creation of a zygote that contains mitochondria from a human egg of a different woman. The underlying intention is to ensure that the Bill prevents the RIHE Regulations from being amended to prescribe mitochondrial donation techniques that rely on mitochondria sourced other than from an egg cell (for example, from stem cells).

3.             Amendment 1 is intended to clarify, rather than alter, the effect of the amendments made by the Bill; other amendments made by the Bill already ensure that mitochondrial donation techniques are limited to ones that source mitochondria from human eggs. However, feedback received on the Bill has highlighted the importance of this limitation, and that the Bill should leave no doubt that the definition of ‘mitochondrial donation technique’ is limited in this manner. Amendment 1 responds to this feedback, and puts this issue beyond doubt.

4.             Amendment 1 is related to amendment 10, which is discussed below.

Amendment 2. Schedule 1, item 17 (proper consent)

Amendment 3. Schedule 1, item 17 (proper consent)

Amendment 4. Schedule 1, item 17 (proper consent)

Amendment 5. Schedule 1, item 17 (proper consent)

Amendment 6. Schedule 1, item 17 (proper consent)

Amendment 7. Schedule 1, item 17 (proper consent)

5.             Under the RIHE Act as currently in force, a licence holder needs ‘proper consent’ before an excess ART embryo or human egg is used, or any other embryo is created or used under the licence. The term ‘proper consent’ is correspondingly defined in relation to the use of an excess ART embryo or a human egg, or the creation or use of any other embryo.

6.             The Bill amends the RIHE Act so that a mitochondrial donation licence holder will need ‘proper consent’ before a human egg or a human sperm is used in carrying out a mitochondrial donation technique. The Bill inserts a new definition of ‘proper consent’, which applies in relation to mitochondrial donation licences, and which is correspondingly defined in relation to the use of a human egg or a human sperm.

7.             Mitochondrial donation licences can also authorise the use of excess ART embryos, other embryos or zygotes, created under a mitochondrial donation licence, as well other material created, developed or produced under such a licence. However, the Bill does not expressly require proper consent to such activities.

8.             Amendments 2, 3, 4, 5, 6 and 7, together with amendment 9, amend the Bill to ensure that ‘proper consent’ is needed for this broader range of activities under a mitochondrial donation licence. In particular, ‘proper consent’ will be needed before any of the following activities are carried out as authorised by a mitochondrial donation licence:

·         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, or

·         any other material is created, developed, produced or used.

9.             Amendment 7 will amend the definition of ‘responsible person’, to deal with who is required to give the consent. The definition is based on the existing definition of ‘responsible person’ under the RIHE Act, but adapted to deal with mitochondrial donation.

10.         As a result, ‘proper consent’ under mitochondrial donation licences will be needed in a corresponding range of circumstances to when it is currently needed under general licences.

Amendment 8. Schedule 1, item 17 (expert advice)

11.         Under the amendments made by the Bill, the ERLC has a central decision‑making role. Two principal decision points are:

·         Under new section 28J of the RIHE Act, the ERLC decides whether to grant a mitochondrial donation licence.

·         Under new section 28P, the ERLC decides whether to approve a particular trial participant or patient for mitochondrial donation.

12.         When making a decision under section 28J, new subsection 28J(4) ensures that the ERLC is able to request, and have regard to, advice from any person having appropriate expertise. This is without limiting existing section 15 of the RIHE Act, which provides that the ERLC has power to do all things necessary or convenient to be done for or in connection with the performance of its functions.

13.         When making decisions under section 28P, it is possible that the ERLC will have a similar need to seek external expertise. However, section 28P does not include a provision similar to subsection 28J(4).

14.         Amendment 8 will amend section 28P to provide expressly that the ERLC is able, when making decisions under that provision, to request, and have regard to, advice from any person having appropriate expertise.

15.         This amendment is intended to clarify, rather than alter, the operation of the amendments made by the Bill. Even without this amendment, the ERLC would be able to rely on existing section 15 of the RIHE Act when making decisions under new section 28P. However, feedback received on the Bill has highlighted the need for the ERLC to be able to rely on appropriate expertise when performing functions and exercising powers under the RIHE Act as amended. This amendment responds to this feedback, and is intended to put the ERLC’s powers in this regard beyond doubt.

Amendment 9. Schedule 1, item 17 (proper consent)

16.         Amendment 9 is minor amendment that is consequential to the amendments made by amendment 3.

Amendment 10. Schedule 1, item 17 (source of mitochondria)

17.         Subsection 28R(1) of the RIHE Act, inserted by the Bill, requires some licence holders to collect identifiable information about donors, for eventual inclusion on the Mitochondrial Donation Donor Register (the Register). Subsection 28R(2) defines the term ‘donor’. Amendment 10 reflects the change made by amendment 1, and refers to mitochondrial donation techniques that rely on mitochondria sourced from donated human eggs.

Amendment 11. Schedule 1, item 17 (disclosure of information)

18.         The Bill inserts new section 29A into the RIHE Act. Subsection 29A(1) requires the Secretary to keep the Register.

19.         A person born as a result of the use of a mitochondrial donation technique, and who is 18 or over, will be able to access identifiable information about their mitochondrial donor from the Register. A woman who has donated an egg for use in a mitochondrial donation technique will be able to access her own information from the Register. The donor will be able to infer, by the presence of their information on the Register, that a child has been born as a result of their donated egg.

20.         Holders of clinical trial licences and clinical practice licences are required to collect information for inclusion on the Register, under new subsections 28R(1) and (3) of the RIHE Act. When a licence holder becomes aware that a child has been born as a result of the use of a mitochondrial donation technique, the licence holder is required to give the Secretary the information required to be included in the Register, under new subsection 28R(5).

21.         These provisions address ethical concerns with mitochondrial donation, by ensuring that mitochondrial donation is not anonymous, and that persons born as a result of the use of mitochondrial donation techniques are able to access identifiable information about their mitochondrial donor. However, given the newness of mitochondrial donation, the Bill proceeds cautiously, by:

·         only permitting persons born as a result of mitochondrial donation to access information from the Register after they have turned 18

·         not providing for broader access to the Register, for example, to parents or guardians of persons born from use of mitochondrial donation techniques, and

·         not permitting mitochondrial donors to access identifiable information about persons born as a result of their donation.

22.         However, mitochondrial donation techniques make use of donated human eggs. It has become apparent that, under the Bill as introduced, and under current regulation of ART in Australia:

·         in States that have a donor register for use in ART – information about mitochondrial donors could potentially also appear on the State donor registers

·         in all States – information about mitochondrial donors could potentially be accessible directly from an ART clinic, and

·         in both cases – a broader range of information about mitochondrial donors could potentially be accessible from the State donor register or ART clinic, by a broader range of persons, and from an earlier age, than is contemplated under the Bill.

23.         This would undermine the cautious approach to making information about mitochondrial donors available that the Bill seeks to implement.

24.         Amendment 11 seeks to ensure that the Bill implements the intended policy. It inserts 3 new subsections into section 28R of the RIHE Act.

25.         New subsection 28R(6A) will require a holder, or former holder, of a clinical trial licence or a clinical practice licence to take reasonable steps to ensure that the information collected as required by new subsections 28R(1) and (3) is not disclosed to another person, except for the purpose of complying with the RIHE Act. The new subsection does not prescribe the specific steps that must be taken, as these will depend on the licence holder’s or former licence holder’s individual circumstances.

26.         New subsection 28R(6B) will require certain persons not to disclose information collected as required by subsections 28R(1) and (3), except for the purpose of complying with the RIHE Act. This subsection applies to any person who is or was:

·         a holder of a clinical trial licence or a clinical practice licence

·         an embryologist specified in such a licence (see subsection 28H(5) of the RIHE Act, to be inserted by item 17 of Schedule 1 to the Bill), or

·         a person authorised by such a licence to carry out an activity authorised by the licence (see paragraph 28N(5)(a) of the RIHE Act, to be inserted to be inserted by item 17 of Schedule 1 to the Bill).

27.         Mitochondrial donation licences can be subject to conditions. Conditions that can be specified in licences include ones relating to:

·         reporting (new paragraph 28N(5)(c))

·         monitoring (new paragraph 28N(5)(d)), and

·         information to be given by the licence holder to a range of persons (new paragraph 28N(5)(e)).

28.         It is intended that any disclosure of information that was required by conditions specified in a licence, such as conditions of this nature, would be for the purposes of complying with the RIHE Act, and hence not contrary to new subsection 28R(6B).

29.         New subsection 28R(6C) will ensure that subsections 28R(6A) and (6B):

·         prevail over any inconsistent State or Territory laws, but

·         do not prevent compliance with State or Territory laws that deal with notification or registration of births.

30.         The intended effect of amendment 11 is that information about mitochondrial donors will be accessible only through the Register, and only in accordance with the RIHE Act as amended by the Bill. The amendments are intended to prevent information about mitochondrial donors being provided under State or Territory laws for the purpose of being included on, and accessed from, a jurisdictional donor register, or being provided to a person born as a result of mitochondrial donation directly by the accredited ART centre that performed the technique.

31.         While the amendment does permit some disclosure of information collected under subsections 28R(1) and (3) of the RIHE Act, the permission is narrow, and necessary for the proper operation of the RIHE Act and State and Territory laws referred to in subsection 28R(6C). As a result, the provisions are reasonable, necessary and proportionate.

Amendment 12. Schedule 1, item 17 (disclosure of information)

32.         In the case of a clinical trial licence, the licence holder must be a constitutional corporation (new subsections 28H(2) and 28V(3) of the RIHE Act). In the case of a clinical trial licence, subsection 28R(7) of the RIHE Act limits the application of subsections 28R(1), (3), (4), (5) and (6) to when the licence holder, or former licence holder, is a constitutional corporation. Amendment 12 will apply this limitation also to new subsections 28R(6A) and (6B) (which are inserted by amendment 11).

Amendment 13. Schedule 1, item 17 (disclosure of information)

33.         Amendment 13 further amends subsection 28R(7) of the RIHE Act, and is consequential upon the amendment made by amendment 12.

Amendment 14. Schedule 1, item 17 (disclosure of information)

34.         Subsection 28R(8) of the RIHE Act provides that non‑compliance with subsections 28R(1), (3), (4), (5) and (6) can be an offence, punishable by imprisonment for up to 2 years. Amendment 14 amends subsection 28R(8) to subject non‑compliance with subsections 28R(6A) and (6B) (inserted by amendment 11) to the same penalty.

Amendment 15. Schedule 1, after item 55 (reports to Parliament)

35.         Under existing section 19 of the RIHE Act, the ERLC:

·         is able, at any time, to cause a report about matters relating to its functions to be tabled in either House of the Parliament, and

·         is required to cause 6‑monthly reports to be tabled in either House of Parliament, which include information about the operation of, and licences issued under, the RIHE Act.

36.         Item 55 of Schedule 1 to the Bill amends section 19 of the RIHE Act, to ensure that the mandatory reports also include information about the operation of mitochondrial donation licences.

37.         Amendment 15 further amends section 19 of the RIHE Act by inserting a new subsection 19(4). It restricts the extent to which the ERLC’s reports under section 19 are able to report on:

·         approvals under subsection 28P(3) of the RIHE Act

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

·         adverse events notified to the ERLC under paragraph 28S(3)(a).

38.         More specifically, it provides that a report under section 19 must not include information about these matters, unless the ERLC considers that the information:

·         does not identify any person, and

·         is not reasonably capable of being used to identify any person (that is, the information is not reasonably capable of being re‑identified).

39.         New subsection 19(4) refers to whether the ERLC ‘considers’ that the information about the matters referred to in new paragraphs 19(4)(a), (b) or (c) does not identify, and is not reasonably capable of being used to identify, any person. It is intended that the operation of this subsection would hinge on the ERLC’s view of this matter; this is not intended to be an objective test.

40.         Accordingly, new subsection 19(4) will involve the ERLC making a decision as to this matter. This decision could affect the interests of persons, namely, trial participants or patients, and children born as a result of mitochondrial donation. Ordinarily, when an administrative decision affects the interests of persons, then in accordance with the Administrative Review Council’s guide What decisions should be subject to merits review, 1999, it would be appropriate to subject the decision to review on its merits. However, in the present case, it is thought that this decision is one that would be unsuitable for merits review.

41.         It would not be practicable to provide a right of administrative review before the ERLC makes a decision, because the amendments to the RIHE Act have deliberately been designed to ensure that the ERLC will in almost all instances not have any identifiable information about trial participants or patients, or children born as a result of mitochondrial donation, and would therefore be unable to contact potentially affected persons in order to give them an opportunity to seek merits review. Consistently with paragraphs 4.49 to 4.51 of the Administrative Review Council’s guide, after the ERLC’s report is tabled in the Parliament, the ERLC’s decision would be unsuitable for merits review, because there would be no appropriate remedy after tabling. Because of this, merits review has not been provided.

42.         This is also because the ERLC’s reports under subsection 19(3) of the RIHE Act are due at regular, fixed intervals, and the reporting timetable would not leave any real opportunity for a merits review process.

43.         This amendment is aimed at balancing, on the one hand, the need for proper transparency about mitochondrial donation, and on the other hand, the privacy of mitochondrial donors, trial participants and patients who make use of mitochondrial donation, and persons born as a result of mitochondrial donation. It seeks to ensure that as much information as possible about the use of mitochondrial donation can be reported to the Parliament without compromising the privacy of persons involved in the process.

Amendment 16. Schedule 1, item 103 (expert advice)

44.         Amendment 16 is consequential upon the amendment made by amendment 8.

45.         Item 103 of Schedule 1 to the Bill amends the RIHE Act to insert new section 47A, which will confer immunity from certain civil actions onto certain persons specified in that section (‘protected persons’) in respect of certain matters (‘protected matters’).

46.         A person who the ERLC requests to provide advice under subsection 28J(4) of the RIHE Act (to be inserted by item 17 of Schedule 1 to the Bill) is specified as a ‘protected person’ in respect of the provision of the requested advice, under section 47A of the RIHE Act as proposed to be inserted by the Bill. As such, they will benefit from this immunity from civil actions relating to mitochondrial donation licences.

47.         Amendment 16 will provide that a person who the ERLC requests to provide advice under new subsection 28P(5A) (which would be inserted by amendment 8) is also a ‘protected person’ in respect of the provision of the requested advice. As a result, all persons who the ERLC requests to provide advice, whether under subsection 28J(4) or 28P(5A) of the RIHE Act, would be treated in the same manner under the Bill.

48.         The policy rationale for section 47A of the RIHE Act is set out in detail in the explanatory memorandum to the Bill, paragraphs 292 to 299.

Amendment 17. Schedule 1, item 17 (sex selection)

49.         Amendment 17 omits paragraph 28Q(1)(d) of the RIHE Act, which the Bill as introduced would have inserted, and substitutes a new paragraph (d) in its place.

50.         New paragraph 28Q(1)(d) of the RIHE Act will ensure that a human embryo created for a trial participant or a patient using a mitochondrial donation technique is not selected for implantation in that woman on the basis of the sex of the embryo. The intention underlying this amendment is that it would override any other State or Territory laws, and any ethical guidelines, that might otherwise have permitted embryos to be selected for implantation on the basis of their sex.

51.         However, the amendment is not intended to prevent embryos from being selected for implantation in order to reduce the risk of transmission of a serious genetic condition, disease or abnormality, so long as the selection is not on the basis of the sex of the embryo.

52.         As this would be a licence condition, a contravention would expose a holder of clinical trial or a clinical practice licence to a criminal penalty of imprisonment for up to 5 years, under section 12 of the RIHE Act as it is to be amended by the Bill.