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Australian Senate Standing Committee for the Scrutiny of Bills - Scrutiny Digests |
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Purpose
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This bill seeks to amend various legislation to allow for mitochondrial
donation to be introduced into Australia for research and
human reproductive
purposes
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Portfolio
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Health
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Introduced
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House of Representatives on 24 March 2021
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Bill status
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Before the House of Representatives
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2.61 In Scrutiny Digest 6 of 2021 the committee requested the minister's 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.[32]
Minister's response[33]
2.62 The minister advised:
Calculation of the fee and ensuring it is necessary and appropriate
The ability to make regulations prescribing fees for licences under existing provisions of the RIHE Act (namely, s20(2)(b)) is a long-standing feature of the Act. Since the commencement of the RIHE Act, a fee has never been prescribed for licence applications. The RIHE Act currently makes no provision for how any fee that might be prescribed is to be calculated, nor did the explanatory memorandum that accompanied the corresponding Bill indicate how this would be done. The existing provisions of the RIHE Act have generally operated successfully for many years, and have served as the basis for many of the amendments proposed by the Bill to legalise and regulate mitochondrial donation. Accordingly, the Bill has not proposed to deal expressly with how the amount of any fee charged will be calculated.
Section 28H(7)(d) of the RIHE Act would only allow ‘fees’ to be prescribed. The ordinary meaning of a ‘fee’ is a sum of money paid for services. That is to say, the reference to ‘fee’ in this provision implicitly restricts the level of any amount that might be prescribed, to a sum paid for services.
There is no plan to prescribe a fee for licence applications under this provision in the foreseeable future. However, decisions as to whether a fee should be prescribed, and if so, the amount of the fee, would be made in accordance with applicable policies such as the Australian Government Charging Framework (RMG 302) and the Australian Government Cost Recovery Guidelines (RMG 304) (the CRGs). The CRGs apply to all non‑corporate Commonwealth entities, such as the Department of Health. Consistently with the CRGs, cost recovery fees can apply to regulatory activities such as licences. Under the CRGs, the amount of cost recovery fees is aligned with expenses incurred in providing the activity (such as processing applications for licences). That is to say, fees would be set at a cost-recovery level.
There is also a body of case law that would be applied in setting the level of any fee that might be prescribed, in order to ensure that it could properly be characterised as a fee for services. This body of case law would limit the amount of any fee that could be charged under this provision, and would ensure that any fee charged did not amount to a tax.
Taken together, there is an implicit limit on the level of a fee that could be prescribed for the purposes of existing s20(2)(b) of the RIHE Act, or for the purposes of proposed s28H(7)(d). This implicit limit stems from a mixture of government policy and law, and would serve to ensure that any fees that might be prescribed would be necessary and appropriate.
Amendment to the Bill regarding how fee will be calculated and stating that it must not amount to taxation
In light of the above comments, I consider that it is not necessary for the Bill to be amended to provide further guidance regarding how fees will be calculated.
The Committee has drawn my attention to paragraph 24 of the drafting direction, which refers to provisions that state that a fee must not be such as to amount to taxation. This drafting direction states that:
• there is no legal need for a provision of this kind, but
• a statement such as this can avoid confusion and emphasise that the provision is dealing with fees and not taxes, and warn administrators that there is some limit to the level and type of fee which may be imposed.
My understanding is that, because of the lack of legal necessity for provisions of this kind, they are not routinely included in Commonwealth legislation. I further understand that ordinary constitutional law principles would preclude the prescription of a fee that amounts to taxation under a provision such as proposed s 28H(7)(d) of the RIHE Act, even without the inclusion of such a provision.
Because of this, I do not consider it necessary for the Bill to be amended to deal with how fees will be calculated, nor do I consider it necessary for the Bill to be amended to state that prescribed fees must not be such as to amount to taxation.
However, in view of the Committee’s comments, I propose updating the explanatory memorandum to reflect my response.
Committee comment
2.63 The committee thanks the minister for this response. The committee notes the minister's advice that the ability to make regulations that prescribe fees is a longstanding feature of the Research Involving Human Embryos Act 2002 (the RIHE Act) and that the RIHE Act does not currently provide guidance as to how those fees will be calculated. The minister also advised that the currently existing powers to prescribe fees for licence applications have never been exercised and that there is currently no plan to prescribe a fee under proposed paragraph 28H(7)(d) of the RIHE Act.
2.64 The committee further notes the minister's advice that, should a fee be prescribed, it will be made in accordance with applicable policies such as the Australian Government Charging Framework (RMG 302) and the Australian Government Cost Recovery Guidelines (RMG 304). Relatedly, the minister advised that, because the ordinary meaning of 'fee' is a sum of money paid for services, proposed paragraph 28H(7)(d) is implicitly restricted to only providing a power to prescribe fees to this level.
2.65 While noting this advice, the committee reiterates its 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. The committee has generally not accepted consistency with existing legislation, non-legislative policy guidance or a lack of current intention to prescribe a fee to be a sufficient justification for not including guidance on the calculation of fees on the face of the primary legislation.
2.66 In this context, the committee notes that it is quite common for bills allowing for the charging of fees within delegated legislation to include a provision noting that the fee must be not be such as to amount to taxation.[34] While there is no legal need to include such a provision, the committee considers that it is nonetheless important to include to avoid confusion and to emphasise the point that the amount calculated under the regulations will be a fee and not a tax. In addition, as set out in the OPC Drafting Direction, such a provision is useful as it may warn administrators that there is some limit on the level and type of fee which may be imposed.
2.67 From a scrutiny perspective, the committee considers that the bill should be amended to provide, at a minimum, that a fee prescribed under proposed paragraph 28H(7)(d) must not be such as to amount to taxation.
2.68 The committee draws this matter to the attention of senators and leaves to the Senate as a whole the appropriateness of allowing delegated legislation to prescribe the amount of a mitochondrial donation licence application fee in circumstances where there is no guidance on the face of the bill regarding how the amount of any fee will be calculated.
2.69 The committee thanks the minister for his proposal to update the explanatory memorandum reflecting the advice provided to the committee and requests that an addendum containing the key information provided by the minister be tabled in the Parliament as soon as practicable.
2.70 The committee also draws this matter to the attention of the Senate Standing Committee for the Scrutiny of Delegated Legislation.
2.71 In Scrutiny Digest 6 of 2021 the committee requested the minister's 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.
2.72 The committee also requested 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.[36]
Minister's response
2.73 The minister advised:
Why it is necessary and appropriate to rely on delegated legislation
Prescribing guidelines by regulation
Relying on guidelines issued by the CEO of the NHMRC to deal with the meaning of ‘proper consent’ is a long-standing feature of regulations made under the RIHE Act. The existing provisions of the RIHE Act have operated successfully for many years, and have served as the basis for many of the amendments proposed by the Bill to legalise and regulate mitochondrial donation. Accordingly, for provisions relating to mitochondrial donation, the Bill has similarly proposed to deal with the meaning of ‘proper consent’ through guidelines issued by the CEO of the NHMRC. As I understand it, the Committee has not raised concerns with this aspect of the Bill.
Under the National Health and Medical Research Council Act 1992 (the NHMRC Act), the CEO of the NHMRC issues a range of guidelines. As the Committee notes, s24(9) of the RIHE Act would (as s8 currently does) define ‘proper consent’ for general licences in terms of guidelines that are prescribed by regulation. Paragraph (a) of the definition of ‘proper consent’ in s 28N(8) would provide similarly for mitochondrial donation licences. In each case, the regulation would make it clear which, out of the range of guidelines that may be issued by the CEO of the NHMRC, is relevant. Without this power, there might be doubt about this, and so this aspect of the regulation‑making power simply operates to put this issue beyond doubt.
Delegated legislation provisions that deal with withdrawals of consent
With regard to withdrawal of consent, this has traditionally been dealt with fully by guidelines issued by the CEO of the NHMRC, and it is likely that such guidelines would continue to deal with this matter. That is to say, there is no current proposal to make regulations that deal with the matter referred to in paragraph (b) of the definition of ‘proper consent’ in proposed s28N(9) of the RIHE Act in the foreseeable future.
However, in view of the importance of ‘proper consent’, and withdrawals of consent, under the legislative scheme, this regulation‑making power would ensure that the government would be able to legislate quickly to ensure that this issue is addressed fully, in the event that it was not dealt with adequately in guidelines issued by the CEO of the NHMRC.
Further, the Bill would amend the RIHE Act to enable new mitochondrial donation techniques to be prescribed, by amendments to regulations made under the RIHE Act, in the future (although none are currently proposed). For such new techniques, it is conceivable that there would be a need for new rules around when consent is withdrawn, which could hinge on technical details of the mitochondrial donation technique. Accordingly, this regulation‑making power is thought to be a necessary incident of the power to prescribe, through regulations made under the RIHE Act, additional mitochondrial donation techniques.
Whether the Bill can be amended to include high-level guidance
In view of the above comments, I am of the view that it would not be appropriate for the Bill to be amended to include high‑level guidance as to these matters. These regulation‑making powers are primarily included to ensure that appropriate guidelines are referenced, and to ensure that the legislative scheme can respond appropriately to unforeseen technological advances, and to new mitochondrial donation techniques that might be developed and prescribed in regulations made under the RIHE Act in the future. It is necessary for there to be a reasonable degree of flexibility in order to ensure that this can properly be done.
Why it is necessary and appropriate to apply the ART Guidelines as in force or existing from time to time
I fully understand the basis of the Committee’s concerns with regard to reliance on documents as existing from time to time, and generally speaking, I share the same concerns. However, for the purposes of the RIHE Act, it is necessary and appropriate for the ART Guidelines to be incorporated as existing from time to time, due to:
• the new and developing nature of mitochondrial donation, particularly as applied for human reproductive purposes, and
• the importance and centrality of the notion of ‘proper consent’ to the regulatory scheme, and the need to ensure that it reflects the most up-to-date guidelines and current best practice.
The Bill’s explanatory memorandum already outlines general reasons for the appropriateness of the RIHE Act being able to rely on documents as in force or existing from time to time (paragraph 295, final bullet point, and paragraphs 306 to 314). Further to that, I note that, under the NHMRC Act, it is possible for the CEO of the NHMRC Act to issue guidelines, and to vary and revoke them, from time to time. In addition, the CEO of the NHMRC can issue interim guidelines, in urgent circumstances. Such guidelines can then be confirmed, varied or revoked, following a public consultation process, and can automatically be revoked after a period of time. Urgent interim guidelines can be issued, and varied or revoked, in relatively short timeframes.
If there was a matter relating to ‘proper consent’ that the CEO of the NHMRC thought important enough to deal with in variations to the ART Guidelines, or in urgent interim ART Guidelines, it would be important that this be reflected in the ART Guidelines as applied under the RIHE Act. Further, if interim guidelines were to be varied or revoked, it would be important that the varied guidelines be applied under the RIHE Act, or that the revoked guidelines not be applied.
However, given the normal timeframes for amending Acts of Parliament or regulations, if the ART Guidelines were not applied as existing from time to time, there would be a significant risk that appropriate legislative amendments could not be implemented in time to reflect such changes to the ART Guidelines. As a result, guidelines would potentially be applied that were not up-to-date, or that did not reflect best practice. The proposed drafting would avoid this unwelcome outcome.
Whether the Bill could be amended to provide for the meaning of 'proper consent', rather than relying on delegated legislation
In view of the above comments, I am not of the opinion that the Bill could be amended to fully and comprehensively deal with the meaning of ‘proper consent’. Rather, I consider that the currently proposed use of delegated legislation provides for an appropriate way of dealing with this important ethical issue.
However, in view of the Committee’s comments, I propose updating the explanatory memorandum to reflect my response.
Committee comment
2.74 The committee thanks the minister for this response. The committee notes the minister's advice that defining 'proper consent' by reference to guidelines issued by the CEO of the National Health and Medical Research Council (NHMRC) is a long-standing feature of the regulations made under the RIHE Act. The minister advised that the intention of leaving the definition of 'proper consent' to delegated legislation is that the regulations will clarify which specific guidelines are relevant. Moreover, the minister advised that dealing with requirements relating to the definition of 'proper consent' in regulations would allow this issue to be legislated quickly, in the event that it is not dealt with adequately in guidelines issued by the CEO of the NHMRC.
2.75 Similarly, the committee notes the minister's advice that the requirements relating to the withdrawal of consent have previously been dealt with fully by reference to guidelines issued by the CEO of the NHMRC. As such, the minister advised that there is currently no proposal to make regulations that deal with the matter in proposed paragraph 28N(9)(b) of the RIHE Act (that is, specified circumstances where consent cannot be withdrawn). As with the definition of proper consent, the minister advised that this regulation‑making power would ensure that the government would be able to legislate quickly to ensure that this issue is addressed fully, in the event that it was not dealt with adequately in guidelines issued by the CEO of the NHMRC.
2.76 The committee notes that in the current ART Guidelines the definition of 'valid consent', which is used interchangeably with 'proper consent', includes a number of matters that could be included on the face of the primary legislation. For example, for consent to be valid the person giving consent must be considered to have the capacity to provide consent.[37] The committee notes that this requirement is unlikely to change and, as such, it remains unclear to the committee why at least high-level guidance regarding the definition of 'proper consent' cannot be provided on the face of the primary legislation.
2.77 The committee's scrutiny concerns in this instance are heightened by the fact that the definition of proper consent is contained in policy guidance and is therefore not subject to scrutiny by the Parliament. As a result, there is no opportunity for Parliament to scrutinise or have oversight of the definition of 'proper consent', which is a significant definition in relation to when mitochondrial donation will be appropriate.
2.78 The committee also reiterates its consistent scrutiny view that significant matters, such as when consent may be withdrawn, should be included in primary legislation unless a sound justification for the use of delegated legislation is provided. The committee has generally not accepted a desire for administrative flexibility to be a sufficient justification for leaving significant matters to delegated legislation. The committee therefore does not consider that the minister's response has provided an adequate justification as to why the requirements relating to the withdrawal of consent should be left to delegated legislation.
2.79 In relation to the ART Guidelines,[38] the committee notes the minister's advice that it is necessary and appropriate to incorporate these guidelines as existing from time to time, because of the developing nature of mitochondrial donation and because of the need to provide an up-to-date definition of 'proper consent'. The minister advise that if the ART Guidelines were not applied as existing from time to time, there would be a significant risk that appropriate legislative amendments could not be implemented in time to reflect changes that may be needed to the ART Guidelines. As a result, if the ART Guidelines were not applied as existing from time to time, guidelines could potentially be applied that were not up-to-date, or that did not reflect best practice.
2.80 The committee draws this matter to the attention of senators and leaves to the Senate as a whole the appropriateness of allowing the scope of 'proper consent', as well as requirements relating to the withdrawal of consent, to be left to delegated legislation and non-legislative policy guidance.
2.81 The committee thanks the minister for his proposal to update the explanatory memorandum reflecting the advice provided to the committee and requests that an addendum containing the key information provided by the minister be tabled in the Parliament as soon as practicable.
2.82 The committee also draws this matter to the attention of the Senate Standing Committee for the Scrutiny of Delegated Legislation.
2.83 In Scrutiny Digest 6 of 2021 the committee requested the minister's 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.[40]
Minister's response
2.84 The minister advised:
Why it is necessary and appropriate to leave this matter to delegated legislation
Comments on proposed s28R(1)(e) of the RIHE Act
In relation to proposed s28R(1)(e) of the RIHE Act, questions about whether and what information about a mitochondrial donor should be made available to a person born of mitochondrial donation is a controversial ethical area.
• Some consider that mitochondrial donors should be entirely anonymous, that is, that no information about mitochondrial donors should be made available to persons born of mitochondrial donation. This is sometimes said to be on the basis that mitochondrial donation is akin to organ donation, and sometimes on the basis of a view that donated mitochondrial DNA makes a relatively small contribution to the identity of persons born as a result of mitochondrial donation.
• Others view mitochondrial donors as akin to ordinary gamete donors. For that reason, they consider that the same information about mitochondrial donors should be made available as is made available about ordinary gamete donors.
The Bill seeks to balance these competing views by adopting a ‘middle ground’, by ensuring that mitochondrial donation is not anonymous, but by limiting the kinds of information that can be obtained about a mitochondrial donor to an appropriate amount. However, the balance sought to be struck by proposed s28R(1)(e) is novel. It is possible that the way in which these competing ethical contentions should best be balanced might require fine tuning over time, in view of matters such as developments in mitochondrial donation technologies, developments in community attitudes to mitochondrial donation, and any new mitochondrial donation techniques that might be prescribed in the future in regulations made under the RIHE Act. This reflects the notion that mitochondrial donation is a relatively new technology, and its use in human reproduction even newer.
It is also important to bear in mind 2 additional factors.
The first is the serious manner in which the Bill would treat the privacy of mitochondrial donors:
• The Register would not be publicly available (s29A(3)).
• There would be criminal penalties for disclosing the information of the Register other than in accordance with the amended provisions of the RIHE Act (proposed s29A(7)).
• Amendments to the Freedom of Information Act 1982 would ensure that information on the Register could not be obtained under that Act.
That is to say, while the Bill would provide this regulation making power which would enable collection of additional personal information about mitochondrial donors, the Bill would also contain a range of provisions that would ensure that this information is treated very carefully, and not disclosed other than to its intended recipient.
The second is that mitochondrial donors would be voluntarily participating in this scheme, and would be fully aware of these arrangements (s28J(5)(f) of the RIHE Act). No question of compulsory collection of personal information would arise.
Comments on proposed s 28R(3)(d) of the RIHE Act
However, an important countervailing privacy concern is that information included on the Register about a mitochondrial donor should be released to a person born using that mitochondrial donor’s donated human eggs, and to no other person.
The principal reason for requiring this personal information about persons born of mitochondrial donation to be collected under s 28R(3) is to ensure that, if a person were to make an application under s 29A(4), they could be reliably matched with an entry in the Register. That is to say, the information collected under s28R(3) would be important in protecting the privacy of mitochondrial donors, and ensuring that information about them is not disclosed inappropriately.
It is currently anticipated that the information specified in ss28R(3)(a), (b) and (c) would be enough to enable this matching to be undertaken with confidence. Because of that, there is no plan to prescribe further information for the purposes of s28R(3)(d) in the foreseeable future. However, the possibility cannot be ruled out that, in the future, it might become necessary to collect additional personal information about persons born as a result of mitochondrial donation, in order to ensure that persons making an application under s29A(4) can be matched reliably with an entry in the Register. This regulation making power would ensure that swift regulatory action could be taken if necessary so as to properly protect the privacy of mitochondrial donors.
Whether the Bill can be amended to include further guidance regarding these matters
Having regard to the above comments, I do not consider it possible at this stage for the Bill to include further guidance regarding what matters might be prescribed under these provisions. There is no current plan for additional matters to be prescribed, and anything that might be prescribed in the future would be in response to circumstances that are currently unforeseeable.
However, in view of the Committee’s comments, I propose updating the explanatory memorandum to reflect my response.
Committee comment
2.85 The committee thanks the minister for this response. The committee notes the minister's advice that there are competing views as to the extent to which it is appropriate to make information available in relation to mitochondrial donors. The minister advised that the bill attempts to balance these competing views by limiting the kinds of information that can be obtained under the scheme while also ensuring that mitochondrial donation is not anonymous. The minister further advised that this approach to privacy may be subject to change over time as developments occur in relation to mitochondrial donation techniques and in community attitudes to mitochondrial donation.
2.86 In addition, the minister advised that the bill contains a number of provisions that would protect privacy and that as mitochondrial donors would be voluntarily participating in this scheme no question of compulsory collection of personal information would arise. The minister advised that information collected under proposed subsection 28R(3) would be important in protecting the privacy of mitochondrial donors, and ensuring that information about them is not disclosed inappropriately because it would ensure that, if a person were to make an application under proposed subsection 29A(4), they could be reliably matched with an entry in the Register. While there are currently no plans to prescribe further information for the purposes of proposed paragraph 28R(3)(d), in the future it may be necessary to prescribe this additional information to ensure that persons making an application under subsection 29A(4) can continue to be matched reliably with an entry in the Register.
2.87 The committee thanks the minister for his proposal to update the explanatory memorandum reflecting the advice provided to the committee and requests that an addendum containing the key information provided by the minister be tabled in the Parliament as soon as practicable.
2.88 In light of the information provided, the committee makes no further comment on this matter.
[31] 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).
[32] Senate Scrutiny of Bills Committee, Scrutiny Digest 6 of 2021, pp. 25–26.
[33] The minister responded to the committee's comments in a letter dated 10 May 2021. A copy of the letter is available on the committee's website: see correspondence relating to Scrutiny Digest 8 of 2021 available at: www.aph.gov.au/senate_scrutiny_digest.
[34] See, for example, subsection 399(3) of the Export Control Act 2020 and subsection 32(4) of the Hazardous Waste (Regulation of Exports and Imports) Act 1989.
[35] 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).
[36] Senate Scrutiny of Bills Committee, Scrutiny Digest 6 of 2021, pp. 26–28.
[37] 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, p. 10.
[38] 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.
[39] 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).
[40] Senate Scrutiny of Bills Committee, Scrutiny Digest 6 of 2021, pp. 28–29.
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