Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 [2021] AUSStaCSBSD 80 (21 April 2021)

• Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021
• Significant matters in delegated legislation39
• Significant matters in delegated legislation
• Incorporation of external material into the law 41
• Privacy
• Significant matters in delegated legislation 43

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

Purpose	This bill seeks to amend various legislation to allow for mitochondrial donation to be introduced into Australia for research and human reproductive purposes
Portfolio	Health
Introduced	House of Representatives on 24 March 2021

Significant matters in delegated legislation^[39]

1.78 Proposed paragraph 28H(7)(d) provides that an application for a mitochondrial donation licence must be accompanied by the fee, if any, prescribed by the regulations.

1.79 The committee has scrutiny concerns regarding the inclusion of a fee-making power within delegated legislation where the face of the bill contains no cap on the maximum fee amount or any information or guidance as to how a fee will be calculated.

1.80 In this instance, the committee's scrutiny concerns are heightened as the explanatory memorandum also contains no information as to how the fee will be calculated or how it will be ensured that a fee charged to a person will be both necessary and appropriate.

1.81 In these circumstances, the committee considers that, at a minimum, a provision stating that the fee must not be such as to amount to taxation should be included on the face of the bill. In this regard, the committee notes the advice set out at paragraph 24 of the Office of Parliamentary Counsel Drafting Direction No. 3.1.^[40]

1.82 In light of the above, the committee requests the minister's detailed advice as to:

• how the amount of any fee charged will be calculated and how it will be ensured that a fee charged to a person will be necessary and appropriate; and

• whether the bill can be amended to provide at least high-level guidance regarding how fees will be calculated, including, at a minimum, a provision stating that the fee must not be such as to amount to taxation.

Significant matters in delegated legislation
Incorporation of external material into the law ^[41]

1.83 Proposed subsection 28N(8) provides that in Division 4A of Part 2, 'proper consent', in relation to the use of a human egg or a human sperm, means consent:

• obtained in accordance with guidelines issued by the CEO of the National Health and Medical Research Council under the National Health and Medical Research Council Act 1992 and prescribed by the regulations; and

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

1.84 In addition, proposed subsection 28N(9) states that the regulations may provide in relation to the withdrawal of consent, including that consent cannot be withdrawn in certain circumstances.

1.85 Similarly, proposed subsection 24(9) provides that in Division 4 of Part 2 'proper consent' in relation to the use of an excess ART embryo or a human egg, means consent 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.

1.86 The meaning of proper consent is relevant to items in the bill which seek to set up a framework for issuing general licences and mitochondrial donation licences and for attaching conditions to those licences.

1.87 The committee's view is that significant matters, such as provisions defining the scope of key terms as well as requirements relating to the withdrawal of consent, should be included in primary legislation unless a sound justification for the use of delegated legislation is provided. In this instance, the explanatory memorandum contains no justification regarding why it is necessary to rely on delegated legislation to determine the scope of the definition of 'proper consent' nor why significant matters such as when, or whether, consent may be withdrawn should be left to delegated legislation.

1.88 The explanatory memorandum provides a general justification for the use of delegated legislation in the explanation provided in relation to item 105. However, while noting this explanation, the explanatory memorandum does not directly address why it is appropriate to leave the matters in subsections 28N(8) and (9) and subsection 24(9) to delegated legislation.

1.89 The committee's scrutiny concerns in this instance are heightened by the incorporation of external material into the law under proposed paragraph 28N(1)(a) and proposed subsection 24(9).

1.90 Item 105 inserts subsection 48(3) into the Research Involving Human Embryos Act 2002, which provides for external material to be incorporated as in force from time to time. Item 107 amends the Research Involving Human Embryos Regulations 2017 to apply the ART guidelines,^[42] as in force from time to time, while item 20 inserts proposed regulation 7J to prescribe the ART guidelines for the purposes of proposed subsection 28N(8).

1.91 The committee notes that the current definition of 'proper consent' is defined with reference to guidelines issued by the CEO of the National Health and Medical Research Council as existing from the commencement of the Research Involving Human Embryos Regulations 2017.

1.92 At a general level, the committee will have scrutiny concerns where provisions in a bill allow the incorporation of legislative provisions by reference to other documents because such an approach:

• raises the prospect of changes being made to the law in the absence of parliamentary scrutiny, (for example, where an external document is incorporated as in force 'from time to time' as it is here this would mean that any future changes to that document would operate to change the law without any involvement from Parliament);

• can create uncertainty in the law; and

• means that those obliged to obey the law may have inadequate access to its terms (in particular, the committee will be concerned where relevant information, including standards, accounting principles or industry databases, is not publicly available or is available only if a fee is paid).

1.93 As a matter of general principle, any member of the public should be able to freely and readily access the terms of the law. Therefore, the committee's consistent scrutiny view is that where material is incorporated by reference into the law it should be freely and readily available to all those who may be interested in the law. In this regard, the committee notes that the ART Guidelines are available on the NHMRC website, along with other external material incorporated into the regulatory scheme such as the National Statement on Ethical Conduct in Human Research 2007.

1.94 In light of the above, the committee requests the minister's detailed advice as to:

• why it is considered necessary and appropriate to leave provisions defining the scope of the term ‘proper consent’ (proposed paragraph 28N(8)(b) and proposed subsection 24(9)) and requirements relating to the withdrawal of consent (proposed subsection 28N(9) to delegated legislation; and

• whether the bill can be amended to include at least high-level guidance regarding these matters on the face of the primary legislation.

1.95 The committee also requests the minister's advice as to:

• why it is considered necessary and appropriate to apply the ART Guidelines as in force or existing from time to time (noting that this means that future changes to the guidelines and therefore the definition of ‘proper consent’ will be incorporated into the law without any parliamentary scrutiny); and

• whether the bill could be amended to provide for the meaning of 'proper consent' on the face of the instrument or the bill, rather than relying on the incorporation of the ART Guidelines.

Privacy
Significant matters in delegated legislation ^[43]

1.96 Proposed paragraph 28R(1)(e) provides that the regulations may prescribe information that the holder of a clinical trial licence or a clinical practice licence must collect for a donor. Similarly, proposed paragraph 28R(3)(d) provides that the regulations may prescribe information that the holder of a clinical trial licence or a clinical practice licence must collect for a child born alive as a result of mitochondrial donation.

1.97 The committee notes that a legislative instrument, made by the executive, is not subject to the full range of parliamentary scrutiny inherent in bringing proposed changes in the form of an amending bill. The committee's view is that significant matters, such as requirements relating to the collection of personal information, should be included in primary legislation unless a sound justification for the use of delegated legislation is provided. In this instance, the explanatory memorandum states:

In relation to [the information collecting powers], this regulation-making power mirrors similar provision that is made in State assisted reproductive technology laws that provide for donor registers. Were this power not to be included, Commonwealth laws would be out of step with similar State laws in this respect. This regulation-making power ensures that there is flexibility as to the sort of information collected for storage on the Mitochondrial Donation Donor Register for eventual provision to children born of the procedures.^[44]

1.98 While noting this explanation, the committee has generally not accepted a desire for administrative flexibility or consistency with existing provisions to be sufficient justifications for leaving significant matters to delegated legislation.

1.99 The explanatory memorandum also provides a general justification for the use of delegated legislation in the explanation provided in relation to item 105. However, while noting this explanation, the explanatory memorandum does not directly address why it is appropriate to leave the information-collection powers identified above to delegated legislation. The committee's scrutiny concerns in this instance are heightened by the potential impact on the privacy of donors and children born as a result of mitochondrial donation.

1.100 In light of the above, the committee requests the minister's detailed advice as to:

• why it is considered necessary and appropriate to leave the scope of sensitive information-collection powers to delegated legislation; and

• whether the bill can be amended to include further guidance regarding these matters on the face of the primary legislation.

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[39] Schedule 1, item 17, proposed paragraph 28H(7)(d). The committee draws senators’ attention to this provision pursuant to Senate Standing Order 24(1)(a)(iv).

[40] Office of Parliamentary Counsel, Drafting Direction No. 3.1 Constitutional law issues, September 2020, para 24.

[41] Schedule 1, item 17, proposed subsections 28N(8) and (9). The committee draws senators’ attention to these provisions pursuant to Senate Standing Order 24(1)(a)(iv) and (v).

[42] Ethical guidelines on the use of assisted reproductive technology in clinical practice and research, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992.

[43] Schedule 1, item 17, proposed paragraphs 28R(1)(e), 28R(3)(d), 28S(3)(c) and subsections 28S(4) and 28S(8). The committee draws senators’ attention to these provisions pursuant to Senate Standing Order 24(1)(a)(i) and (iv).

[44] Explanatory memorandum, p. 35.