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

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2019-2020-2021

 

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

ADDENDUM TO THE EXPLANATORY MEMORANDUM

 

 

 

 

This addendum:

●      responds to concerns raised by the Senate Standing Committee for the Scrutiny of Bills in Scrutiny Digest No. 6 of 2021 , dated 21 April 2021, and

●      replaces figure 1 on page 67 of the explanatory memorandum with a figure that illustrates the mitochondrial donation process more clearly.

 

 

 

 

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

 

 

 



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

 

 

 

NOTES ON CLAUSES

Research Involving Human Embryos Act 2002

After paragraph  86, add:

86A.   New paragraph 28H(7)(d) of the RIHE Act requires an application for a mitochondrial donation licence to be accompanied by the fee (if any) prescribed by the regulations. This paragraph mirrors existing paragraph 20(2)(b) of the RIHE Act, which requires an application for a general licence to be accompanied by the fee (if any) prescribed by the regulations. It is intended that new paragraph 28H(7)(d) operate in the same manner as existing paragraph 20(2)(b). To date, no fee has yet been prescribed for the purposes of paragraph 20(2)(b) of the RIHE Act. Similarly, the Bill does not amend the RIHE Regulations to prescribe a fee for the purposes of new paragraph 28H(7)(d).

86B.    It is intended that a ‘fee’ in this context, if prescribed, would be in the nature of a fee for service, and would be an amount that recovers the costs of the ERLC in undertaking its statutory functions relating to licence applications. Decisions as to whether fees would be prescribed for the purposes of these provisions, and the amount of any such fee that might be prescribed, would be reached in accordance with ordinary governmental guidelines for charging, and determining the amount of, a fee. As such, the amount of the fee would not be such that it amounts to taxation. Additionally, regulations prescribing fees would be disallowable legislative instruments, and hence the Parliament would have oversight of any fee that might be prescribed.

 

 

Omit paragraph 112, substitute:

112.    With regards to paragraph (a) of the definition of ‘proper consent’ in new subsection 28N(8) of the RIHE Act, the Bill amends the RIHE Regulations to insert new section 7J, which prescribes the ‘ART Guidelines’ for the purposes of this definition (see item 20).

112A. The need for this regulation-making power is two-fold.

112B.  First, the ART Guidelines currently deal with ‘proper consent’ in the context of assisted reproductive technology generally. It is possible that the CEO of the NHMRC might, in the future, find it necessary to issue guidelines dealing with ‘proper consent’ specifically in the context of mitochondrial donation. Given that possibility, it is important for there to be the flexibility to prescribe the appropriate guidelines for the purposes of the definition of ‘proper consent’ in new subsection 28N(8) of the RIHE Act.

112C.  Second, the Bill amends the RIHE Act to enable new mitochondrial donation techniques to be prescribed, by amendments to regulations made under the RIHE Act, in the future. For such new techniques, it is conceivable that there would be a need for different guidelines relating to ‘proper consent’ for different mitochondrial donation techniques. Accordingly, it is important for there to be the flexibility to prescribe appropriate guidelines for different mitochondrial donation techniques.

112D. With regards to paragraph (b) of the definition of ‘proper consent’ in new subsection 28N(8) of the RIHE Act, new subsection 28N(9) will provide that, without limiting this paragraph, regulations made for the purposes of that paragraph may:

●      provide in relation to withdrawal of consent, and

●      without limiting the above, provide that consent cannot be withdrawn in specified circumstances.

112E.  The need for this regulation-making power is also two-fold.

112F.  First, withdrawal of consent has traditionally been dealt with fully by guidelines issued by the CEO of the NHMRC, and it is likely that such guidelines will fully deal with this matter for the purposes of mitochondrial donation. Because of that, the Bill does not amend the RIHE Regulations to prescribe any matters for the purposes of new paragraphs 28N(9)(a) and (b) of the RIHE Act. However, under the legislative scheme, ‘proper consent’ and withdrawals of consent are fundamental concepts. Accordingly, new subsection 28N(9) ensures that it will be possible to legislate quickly to ensure that withdrawal of consent is addressed fully with regards to mitochondrial donation, in the event that there is some aspect of withdrawal that is not dealt with in guidelines issued by the CEO of the NHMRC.

112G. Second, the Bill amends the RIHE Act to enable new mitochondrial donation techniques to be prescribed, by amendments to regulations made under the RIHE Act, in the future. 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 additionally is a necessary incident of the power to prescribe, through regulations made under the RIHE Act, additional mitochondrial donation techniques.

112H. This approach of relying on delegated legislation is consistent with the report of the Senate Inquiry, in which the Community Affairs References Committee indicated that a regulatory and oversight regime for mitochondrial donation would most appropriately be done through regulations, which could be amended and adapted to keep up to date with changing scientific knowledge, with the review and approval of the Parliament (paragraphs 5.97, 5.98 and 5.102).

 

 

 

After paragraph 137, add:

137A. New paragraph 28R(1)(e) permits regulations to be made prescribing other information about mitochondrial donors, that would be included in the Mitochondrial Donation Donor Register, and eventually be made available to persons born of mitochondrial donation upon request. 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 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 human 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 (which, in some States, is significantly more information than is to be made available about mitochondrial donors).

137B.  The amendments made by the Bill seek to balance these competing views 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. The regulation-making power under new paragraph 28R(1)(e) of the RIHE Act ensures that the information made available about mitochondrial donors can be modified over time in a range of circumstances that reflect the notion that mitochondrial donation is a relatively new technology, and its use in human reproduction even newer, including:

●      if it turns out that the way in which these competing ethical contentions should best be balanced requires fine-tuning

●      if changes are necessitated by developments in prescribed mitochondrial donation techniques, or

●      as community attitudes to mitochondrial donation develop.

137C.  The Bill seeks to allay possible concerns relating to prescribing personal information that is collected via regulation, by:

●      providing that the Mitochondrial Donation Donor Register is not publicly available (new subsection 29A(3) of the RIHE Act)

●      providing for criminal penalties for disclosing the information included in the Mitochondrial Donation Donor Register other than in accordance with the amended provisions of the RIHE Act (new subsection 29A(7) of the RIHE Act)

●      amending the Freedom of Information Act 1982 to ensure that information included in the Mitochondrial Donation Donor Register cannot be obtained under that Act (items 21, 22 and 23 of the Bill), and

●      ensuring that mitochondrial donation (together with the associated collection of this information) is entirely voluntary, and that donors are fully aware that their information might be made available in the future in accordance with these arrangements (new paragraph 28J(5)(f) of the RIHE Act).

137D. As a result, the Bill makes a range of amendments to ensure that this information is treated very carefully, and not disclosed other than to its intended recipient.

137E.  New paragraph 28R(3)(d) of the RIHE Act permits regulations to be made prescribing other information about children born of mitochondrial donation, that would be included in the Mitochondrial Donation Donor Register.

137F.  The principal reason for requiring personal information to be collected under new subsection 28R(3) of the RIHE Act is to ensure that, if a person were to make an application under new subsection 29A(4) of the RIHE Act for information about their mitochondrial donor, they could be reliably matched with an entry in the Mitochondrial Donation Donor Register. That is to say, the information collected under new subsection 28R(3) is important in protecting the privacy of mitochondrial donors, by ensuring that information included in the Mitochondrial Donation Donor Register about a mitochondrial donor can be released only to a person born using that mitochondrial donor’s donated human eggs.

137G. It is currently anticipated that the information that will be specified in new paragraphs 28R(3)(a), (b) and (c) of the RIHE Act will be enough to enable this matching to be undertaken with confidence. Because of that, the Bill does not amend the RIHE Regulations to prescribe further information for the purposes of paragraph 28R(3)(d) of the RIHE Act. However, the possibility cannot be ruled out that, in the future, it might become necessary to collect additional personal information about children born as a result of mitochondrial donation, in order to ensure that persons making an application under new subsection 29A(4) of the RIHE Act can be matched reliably with an entry in the Mitochondrial Donation Donor Register. This regulation-making power ensures that swift regulatory action could be taken if necessary in order to properly protect the privacy of mitochondrial donors.

137H. This approach of relying on delegated legislation is consistent with the report of the Senate Inquiry, in which the Community Affairs References Committee indicated that a regulatory and oversight regime for mitochondrial donation would most appropriately be done through regulations, which could be amended and adapted to keep up to date with changing scientific knowledge, with the review and approval of the Parliament (paragraphs 5.97, 5.98 and 5.102).

 

 

 

In paragraph  138, omit ‘the second bullet point’, substitute ‘new subsection 28R(4) of the RIHE Act (the second bullet point of paragraph 136 above)’.

 

 

After paragraph  254, add:

254A. The definition of ‘proper consent’ refers to guidelines issued by the CEO and prescribed by regulations made for the purposes of the definition. The reasons for this regulation-making power are similar to those outlined at paragraph 112B, above.

254B.  Section 7 of the RIHE Regulations currently prescribes the ART Guidelines for the purposes of the definition of ‘proper consent’ in existing section 8 of the RIHE Act. Item 112 amends section 7 of the RIHE Regulations so that it instead prescribes the ART Guidelines for the purposes of the definition of ‘proper consent’ in new subsection 24(9) of the RIHE Act.

 

Research Involving Human Embryos Regulations 2017

Omit paragraph 316, substitute:

316.    Items 107, 108 and 109 effectively amend the defined terms indicated so that references are to those documents as existing from time to time. See further at item 105, discussed above.

316A. In relation to item 107, unlike the current definition of ‘ART Guidelines’, the RIHE Regulations will refer to the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research as existing from time to time, rather than as existing at a particular time. It is necessary and appropriate for the ART Guidelines to be incorporated as existing from time to time, and not only as at a particular time, due to a combination of the following factors:

●      the central nature of ‘proper consent’ under the mitochondrial donation provisions, where ‘proper consent’ is defined as being consent obtained in accordance with guidelines issued by the CEO of the NHMRC, and relevantly, the ART Guidelines

●      the new and developing nature of mitochondrial donation, particularly as applied for human reproductive purposes

●      the ability of the CEO of the NHMRC to vary and revoke guidelines from time to time, and issue new guidelines (including urgent interim ones), and

●      the need to refer to the current version of the ART Guidelines issued by the CEO of the NHMRC, to ensure that the RIHE Act always incorporates the most up-to-date version of these guidelines.

316B.  In relation to item 108, the definition of ‘National Statement’ is being repealed on the basis that term is instead defined in the RIHE Act - see item 40. The term ‘National Statement’ is intended to have the same meaning in the RIHE Regulations, noting paragraph 13(1)(b) of the Legislation Act.



 

REGULATION IMPACT STATEMENT

Omit figure 1, substitute: