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2016 THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA HOUSE OF REPRESENTATIVES AUSTRALIAN ORGAN AND TISSUE DONATION AND TRANSPLANTATION AUTHORITY AMENDMENT (NEW GOVERNANCE ARRANGEMENTS) BILL 2016 EXPLANATORY MEMORANDUM (Circulated by authority of the Assistant Minister for Health and Aged Care the Hon Ken Wyatt AM MP)AUSTRALIAN ORGAN AND TISSUE DONATION AND TRANSPLANTATION AUTHORITY AMENDMENT (NEW GOVERNANCE ARRANGEMENTS) ACT 2016 INTRODUCTION AND OUTLINE 1 FINANCIAL IMPACT 2 STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS 3 COMMENCEMENT 5 SCHEDULE 1 - AMENDMENTS 5 NOTES In this Explanatory Memorandum, a reference to a Part or a section in bold italics (eg Part 3.2 or section 186) is a reference to a Part or a section as it will appear in the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 as amended by this Bill. A reference to an item in bold type (item 120) is a reference to an item in Schedule 1 to this Bill. A reference to "states" includes a reference to the Australian Capital Territory and the Northern Territory. i
AUSTRALIAN ORGAN AND TISSUE DONATION AND TRANSPLANTATION AUTHORITY AMENDMENT (NEW GOVERNANCE ARRANGEMENTS) BILL 2016 INTRODUCTION AND OUTLINE The Australian Organ and Tissue Donation and Transplantation Authority Amendment (New Governance Arrangements) Bill 2016 amends the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (the AOTDTA Act) to establish the Australian Organ and Tissue Donation and Transplantation Authority (AOTDTA) Board, and abolish the existing AOTDTA Advisory Council. In early 2015, the Department of Health engaged Ernst and Young to undertake a Review of the implementation of the national reform agenda on organ and tissue donation and transplantation (the EY Review). The EY Review was prompted by several concurrent pressures in the organ and tissue donation sector, including declining organ donation rates in 2014, following a period of steady growth. The EY Review made 24 recommendations, including recommended changes to the governance arrangements for the AOTDTA to improve strategic oversight of the DonateLife Network, as well as performance monitoring, succession planning and mentoring of the Chief Executive Officer (CEO). This Bill does not change the functions of the AOTDTA, but transfers the functions and responsibilities currently vested in the CEO to the Board, once established. The Board will assume the role of accountable authority under the Public Governance, Performance and Accountability Act 2013 (PGPA Act), and will be directly accountable to the Commonwealth Minister. The Bill provides that the Board will be responsible for a range of functions including: to ensure the proper, efficient and effective performance of the Authority's functions; to determine objectives, strategies and policies to be followed by the Authority; such other functions as are determined in an instrument and given by the Minister. The CEO's role, once the Bill is enacted, will be to manage the day-to-day administration of the AOTDTA. The Board may delegate some of its functions to the CEO to ensure the AOTDTA runs efficiently and effectively. The Board will comprise of: the Chair; the Deputy Chair; the CEO; and 5 other members. 1
The Chair is to have substantial experience in, or substantial knowledge of, public administration, business or management. Appointed Board members, including the Deputy Chair, are required to have substantial experience, or substantial knowledge of, at least one of the following fields: public hospital administration; community leadership or representation in relation to organ or tissue donation and transplantation; consumer health issues; promotion of health issues; any other appropriate field of expertise; or the person has substantial clinical expertise in organ or tissue donation; or the person has substantial clinical expertise in organ or tissue transplantation; or the person is a consumer of health services. The Bill also sets out appointment conditions for Board members and makes minor changes to the appointment conditions for the CEO of the AOTDTA. Financial Impact Statement The EY Review estimated the cost of establishing and maintaining a Board to govern the AOTDTA to be approximately $200,000. Any additional financial impact will be met within existing funding arrangements. 2
Statement of Compatibility with Human Rights Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 AUSTRALIAN ORGAN AND TISSUE DONATION AND TRANSPLANTATION AUTHORITY AMENDMENT (NEW GOVERNANCE ARRANGEMENTS) ACT 2016 This Bill is 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 Bill The Australian Organ and Tissue Donation and Transplantation Authority Act 2008 (AOTDTA Act) is the establishing legislation for the Australian Organ and Tissue Donation and Transplantation Authority (AOTDTA). The AOTDTA is a Statutory Authority under the Health portfolio and is responsible for establishing a nationally coordinated approach to organ and tissue donation for transplantation in partnership with the states and territories, clinicians, consumers and the community. This Bill will amend the AOTDTA Act to reflect recommendations, relating to the governance arrangements for the AOTDTA, from the Ernst and Young Review of the Implementation of the national reform agenda on organ and tissue donation and transplantation. This Bill, once enacted by proclamation, will amend the AOTDTA Act to abolish the AOTDTA Advisory Council, and establish the Australian Organ and Tissue Donation and Transplantation Board (the Board) to govern the AOTDTA. These amendments will improve accountability and transparency for the AOTDTA, strategic oversight of the DonateLife Network, as well as performance monitoring, succession planning and mentoring of the Chief Executive Officer (CEO). Human rights implications This Bill does not impede on the human rights of any individual. Conclusion This Bill is compatible with human rights as it does not raise any human rights issues. The Hon Ken Wyatt AM MP, the Assistant Minister for Health and Aged Care 3
AUSTRALIAN ORGAN AND TISSUE DONATION AND TRANSPLANTATION AUTHORITY AMENDMENT (NEW GOVERNANCE ARRANGEMENTS) ACT 2016 Clause 1 - Short Title This clause is a formal provision which provides that the Bill, once enacted, may be referred to as the Australian Organ and Tissue Donation and Transplantation Authority Amendment (New Governance Arrangements) Act 2016. Clause 2 - Commencement This clause provides that Sections 1 to 3 of the Bill will commence on the day this Act receives Royal Assent. Schedules 1 and 2 of the Bill will be enacted on a day to be fixed by proclamation, or 1 July 2017. Clause 3 - Schedule(s) This clause provides that each Act that is specified in a Schedule to this Bill is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item has effect according to its terms. Schedules 1 and 2 will commence from 1 July 2017. Schedule 1 amends the AOTDTA Act. Schedule 2 provides for transitional arrangements. SCHEDULE 1 -- AMENDMENT OF THE AUSTRALIAN ORGAN AND TISSUE DONATION AND TRANSPLANTATION AUTHORITY ACT 2008 Schedule 1 amends the AOTDTA Act to provide for consequential and other amendments in view of the inclusion of provisions relating to the establishment of the Australian Organ and Tissue Donation and Transplantation Authority Board. Item 1 - Section 3 This item repeals the Simplified Outline, and substitutes a new Simplified Outline. Item 2 - Section 4 This item repeals definitions relating to the Advisory Council and its membership. Item 3 - Section 4 This item establishes definitions relating to the Board and its membership. Item 4 - Section 4 (definition of vacancy) This item repeals the definition. Item 5 - Section 5 This item repeals the section relating to the vacancy in the office of an Advisory Council member, as this is no longer required once the Advisory Council is abolished. 4
Item 6 - Paragraph 8 (3)(a) This item repeals paragraph 8 (3)(a). Once the Bill is enacted, the Authority will consist of: (a) the Board; (aa) the CEO; and (b) the staff of the AOTDTA. Item 7 - At the end of Section 8 This item provides for the Purposes of the PGPA Act 2013: the AOTDTA is a listed entity; the Board assumes the role of accountable authority for the AOTDTA; officials of the AOTDTA include: o appointed Board members; o the CEO; o the staff of the AOTDTA; o consultants engaged by the AOTDTA under section 26; o persons whose services are made available to the Authority under Section 27 - persons assisting the CEO; and o expert advisory committee members. the purposes of the Authority comprise the functions of: o the Authority, as outlined in Section 11; o the Board, as outlined in new section 13B; o the CEO, as outlined in new section 14B; and o the expert advisory committee, as outlined in section 45. Item 8 - Section 9 This item repeals the section. This section is no longer required as the addition of Item 7, nullifies the need for Section 9. Item 9 - Part 3 (heading) This item repeals the heading - Chief Executive Officer of the Authority. Under the new governance arrangements, the functions previously vested in the CEO will be transferred to the Board. This Part will now be referred to as "the Authority". Item 10 - Division 1 of Part 3 (heading) This item repeals the heading - CEO. Item 11 - Section 10 This item repeals the section 10 - CEO. Item 12 - Section 11 (heading) This item repeals the heading "Functions of the CEO" and substitutes this with the new heading for Section 11 - Function of the Authority. Item 13 - Subsection 11(1) This item omits each reference to "CEO" and substitutes "Authority". 5
Item 14 - Subsection 11(2) This item omits reference to "CEO" and substitutes "Authority". Item 14 provides that this subsection will now refer to the Authority. Specifically, the sentence fragment "CEO may perform the CEO's" is to be omitted, and substituted with "Authority may perform the Authority's". Item 15 - Section 12 (heading) This item repeals the heading "CEO must have regard to certain objectives etc.", and substitutes "Authority must have regard to certain objectives etc." Item 16 - Section 12 Section 12 refers to certain objectives that the CEO must have regard to in performing his or her functions. Section 12 will now refer to the certain objectives that the Authority must have regard to in performing the Authority's functions. This item omits each reference to "CEO" and substitutes "Authority". Item 17 - Paragraph 12(h) Paragraph 12(h) refers to such other matters as the CEO considers relevant. This item omits reference to the CEO in this paragraph, and substitutes reference to the Authority. Item 18 - After section 13 This item repeals Section 13, and substitutes provisions enabling the Minister, by legislative instrument, to give written directions to the Authority about the performance of the Authority's functions. Item 19 This item inserts: Part 2A - Australian Organ and Tissue Donation and Transplantation Board. Part 2A - Australian Organ and Tissue Donation and Transplantation Board 13A - Establishment of the Board This clause establishes the Board. 13B -Functions of the Board This clause establishes the functions of the Board as the following: ensuring the proper, efficient and effective performance of the Authority's functions; to determine objectives, strategies and policies to be followed by the Authority; and such other functions as are given to the Board, by this Act or any other law; and such other functions (if any) as are determined in an instrument made under subsection (2) and given by the Minister to the Chair; and to do anything incidental or conducive to the performance of any of the above functions. Subsection (2) provides that the Minister may determine other functions under paragraph (1)(d) by legislative instrument. 6
Subsection (3) provides that the Board has power to do all things necessary or convenient to be done for or in connection with the performance of its functions. 13C Delegation by the Board This clause provides that the Board may delegate any of its functions or powers under section 13CA to the CEO in writing. If functions or powers have been delegated to the CEO, the CEO must comply with any directions given by the Board. 13D Minister may give directions to the Board 13D(1) provides that the Minister may give written directions to the Authority about the performance of its functions, by means of a legislative instrument. A note in clause 13A draws to the reader's attention that section 42 and Part 4 of Chapter 3 of the Legislation Act 2003 do not apply for the purposes of paragraphs 44(2)(b) and 54(2)(b) of that Act. 13D(2) provides that directions given under sub-section 13A(1) must be of a general nature. 13D(3) provides that the Authority must comply with a direction given by the Minister under sub-section 13A(1). Clause 13E - Membership This clause sets out the membership of the Board as comprising: the Chair; the Deputy Chair; the CEO; and five other members. The membership of the Board, with its balance of expertise is intended to facilitate the Board in its governing capacity, while representing the various interests of the organ and tissue sector. The establishment of the Board does not preclude the AOTDTA from retaining its other expert advisory committees, allowing the Authority to receive advice from a range of appropriate expert sources to assist it in the performance of its functions. Clause 13F - Appointment of appointed Board members This clause sets out that Board members are to be formally appointed by the Commonwealth Minister, on a part-time basis, by written instrument. This clause relates to "appointed board members" which, as per the definition in Section 4, mean a Board member other than the CEO. The Commonwealth Minister will appoint all Board members. The Chair will be nominated by the Commonwealth. Before appointing the Deputy Chair and Board members, the Commonwealth Minister must request that: the jurisdictions provide a written notice nominating one or more persons for the role of Deputy Chair; and COAG Health Council provide a written notice nominating persons for appointment as Board members. 7
This clause also provides that the Chair is to have substantial experience in, or substantial knowledge of, public administration, business or management. This clause also provides that Board members, including the Deputy Chair, are required to have substantial experience, or substantial knowledge of, at least one of the following fields: public hospital administration; community leadership or representation in relation to organ or tissue donation and transplantation; consumer health issues; promotion of health issues; any other appropriate field of expertise; or the person has substantial clinical expertise in organ or tissue donation; or the person has substantial clinical expertise in organ or tissue transplantation; or the person is a consumer of health services. In appointing the appointed Board members (other than the Chair), the Minister must ensure, where possible, an appropriate mix of persons from the above fields of expertise. 13G Nominations for appointment of certain appointed Board members Deputy chair This provision requires the Minister to request nominations for persons for the position of Deputy Chair from each State and Territory Health Minister. State and Territory Health Ministers must only nominate persons for the position of Deputy Chair that satisfy one or more of the criteria for Board members as described in 13(E). The Commonwealth Minister is required to consider any nominations provided by State and Territory Health Ministers before appointing a person as Deputy Chair. Appointed Board members This provision requires the Minister to request the COAG Health Council to give a written notice nominating one or more persons for appointment as appointed Board members. The COAG Health Council must ensure that persons nominated satisfy one or more of the criteria for Board members as described in 13F(4). The Commonwealth Minister is required to consider any nominations provided by the COAG Health Council before appointing one or more person as appointed Board members. Clause 13H - Term of appointment This clause provides that the term of appointment for all board members will be set out in the written instrument of appointment and must not exceed 4 years. 8
Clause 13J - Acting appointment Acting as the Chair This clause provides for the Commonwealth Minister to, by written instrument, appoint an acting Chair or an acting member to the Board if there is a vacancy, or during a period when the Chair is absent from duty or from Australia, or is unable to perform the duties of the position for any reason. In appointing a member to act as Chair, the Minister should, in the first instance, consider appointing the Deputy Chair. Acting as an appointed Board member (other than the chair) This clause provides for the Commonwealth Minister to, by written instrument, appoint a person to act as an appointed Board member during a vacancy in the office or an appointed Board member or during any period when an appointed Board member is absent from the duty or from Australia, or is unable to perform the duties of the position for any reason. 13G(3) also provides that the Commonwealth Minister may only appoint a person to act as a Board member if the Minister is satisfied that the person is qualified under Clause 13F(4). This requires the Minister to maintain the balance of membership on the Board while any acting arrangements are in place. A note in clause 36 draws the reader's attention to section 33AB and 33A of the Acts Interpretation Act 1901, which provide further information about acting appointments, including validity of things done during an acting appointment. Clause13K - Remuneration This clause establishes that Board members are to be paid the remuneration that is determined by the Remuneration Tribunal or if no determination is in operation, the member is to be paid the remuneration that is prescribed by the regulations. This clause also sets out that a Board member is entitled to be paid the allowances that are prescribed by the regulations. This clause also sets out that this Section has effect subject to the Remuneration Tribunal Act 1973. Clause 13L - Leave of absence This clause provides that the Commonwealth Minister may grant leave of absence to the Chair of the Board, and that leave may be subject to terms and conditions determined by the Minister. This clause also provides that the Chair of the Board may grant leave of absence to another Board member. Any leave granted may be subject to terms and conditions that the Chair determines. This clause also provides that the Chair must notify the Commonwealth Minister if the Chair grants another Board member leave for a period exceeding 3 months. 9
Clause 13M - Other terms and conditions This clause provides that a Board member holds office on any terms and conditions, not covered by this Act, that are determined by the Commonwealth Minister. Clause 13N - Resignation This clause provides that a Board member, including the Chair, may resign by giving the Commonwealth Minister a written resignation. Clause 13P - Termination of appointment This clause provides that the Minister may terminate the appointment of a member of the Board for misbehaviour or physical or mental incapacity. This clause also provides that the Commonwealth Minister must terminate a Board member's appointment if the Board member does any of the things listed in paragraphs 13P(2)(a) to (c) inclusive. This includes: being absent from duty (except on leave of absence) for 3 consecutive Board meetings; becoming bankrupt; compounding with his or her creditors; assigning his or her remuneration for the benefit of his or her creditors; or failing to comply with Section 29 of the PGPA Act. Division 3 - Meetings of the Board Clause 13Q - Convening meetings This clause provides that the Board must convene at least 4 meetings each financial year, and hold such meetings as are necessary for the efficient performance of its functions. Clause 13R - Presiding at meetings This clause provides that the Chair must preside at all meetings at which he or she is present. This clause also provides that the Deputy Chair is to preside should the Chair not be present at a Board meeting, or if the Deputy Chair is not present- the other Board members present must appoint one of themselves to preside, through whatever mechanism they deem appropriate. Clause 13S - Quorum This clause provides that a quorum is constituted by a majority of Board members, being at least five members. This clause also provides that a Board member may be absent for the purposes of section 29 of the PGPA Act. Should a Board member leave a meeting and a quorum is no longer present, the remaining Board members at the meeting constitute a quorum. Clause 13T - Voting at meetings This clause provides that a question arising at a Board meeting is to be determined by a majority of votes. This clause also provides that the person presiding at meeting of the Board has a deliberative vote and, if votes are equal, a casting vote. 10
Clause 13U - Conduct of meetings This clause provides that the Board may regulate proceedings at its meetings as it considers appropriate. Clause 13V - Minutes This clause provides that the Board must keep minutes of its meetings. Clause 13W - Decisions without meetings This clause sets out the method by which Board members are taken to have made a decision without meeting. This clause also provides that the Board must keep a record of decisions made in accordance with this section. Item 20 - Division 2 of Part 3 (heading) This item repeals the heading - Appointment of the CEO. Item 21 - Before section 14 This item inserts the new Part 4 - Chief Executive Officer and staff etc. Clause 14A - CEO This clause provides that there is to be a CEO of the Authority. Clause14B - Functions of the CEO This clause sets out that the functions of the CEO include that: the CEO is responsible for the day-to-day administration of the Authority; the CEO is a member of the Board; the CEO has power to do all things necessary or convenient to be done for or in connection with the performance of his or her duties. the CEO is to act in accordance with objectives, strategies and policies determined by the Board; the Board may give written directions to the CEO about his or her duties; the CEO must comply with directions given by the Board. The CEO, who will be responsible for the day-to-day management and operation of the Organ and Tissue Authority, will also be a member of the Board. This arrangement has been instituted to improve operational efficacy of the AOTDTA, and will ensure that the strategic and policy objectives of the AOTDTA are efficiently integrated in day to day operations and activities. The CEO is not subject to Clause 13F, in that the Commonwealth Minister may appoint a CEO in consultation with the Chair of the Board, any person he or she deems suitable to the role of CEO. This clause also provides that a direction given to the CEO under sub-section 14B(4) is not a legislative instrument. This sub-section is included to assist readers, as the instrument is not a legislative instrument within the meaning of sub-section 8(1) of the Legislation Act 2003. 11
Item 22 - After subsection 14(1) This item inserts new subsection 14(1A). This clause provides that the Commonwealth Minister must consult the Chair of the Board, before appointing the CEO. Item 23 This item provides that the term served by the CEO will be 4 years. Item 24 - Division 4 of Part 3 This item repeals Division 4 - Delegation. Item 25 - Section 26 This item repeals the contents of Section 26 - Consultants, and substitutes that the Board may, on behalf of the Commonwealth, engage consultants to assist in the performance of the Authority's functions. The Board may delegate this power to the CEO if it so chooses. Item 26 - Section 27 (heading) This item repeals the heading - Persons assisting the CEO, and substitutes the new heading - Persons assisting the Authority. Item 27 - Section 27 This item provides that this subsection will now refer to the Authority. Specifically, this item omits each reference to CEO, and substitutes "Authority" Item 28 - Section 27 This item omits "CEO's" and substitutes "Authority's", in line with Item 29. Item 29 - Division 7 of Part 3 This item repeals Division 7 - Minister may give directions to the CEO. Item 30 - Part 4 This item repeals Part 4 - Australian Organ and Tissue Donation and Transplantation Advisory Council. Item 31 - Sections 44 to 47, and 49 to 50 Section 44 refers to the establishment of expert advisory committees. Section 45 refers to the function of expert advisory committees. Section 46 refers to the appointment of expert advisory committee members. Section 47 refers to the procedures of expert advisory committees. Section 49 refers to leaves of absence of expert advisory committee members. Section 50 refers to resignation of expert advisory committee members. This item omits reference to the CEO wherever occurring. Reference to the CEO is to be substituted with the Authority. The effect of this item provides that expert advisory committees may now be established by the Board, and all matters for consideration in regard to expert advisory committees are matters for the Board to consider. 12
Item 32 - Section 51 (heading) This item repeals the heading - Disclosure of interests to the CEO, and substitutes with the new heading - Disclosure of interests to the Board. Item 33 - Sections 51 and 53 This item omits all references to the "CEO", and substitutes all occurrences with "Board". Section 51 refers to the disclosure of interests which must be given by expert advisory committee members to the Board by written notice. Section 53 refers to other terms and conditions that expert advisory committee members may be subject to. These terms and conditions are to be determined by the Board. Item 34 - Part 5A This item repeals Part 5A. Part 5A refers to the application of the finance law. The relevant contents of Part 5A have been incorporated in subsection 8(4). Item 35 - Sections 54 to 56 Sections 54 to 56 refer to grants made by the CEO on behalf of the Commonwealth to: a state; a territory; or person other than a state or territory. This item provides that all reference to the "CEO" are to be substituted with references to the "Board. The effect of this item is that grants may now be made by the Board, on behalf of the Commonwealth, to a state, territory or individual, in accordance with the terms and conditions retained in these sections. 13
SCHEDULE 2 -- APPLICATIONS ETC. PROVISIONS 1 Definitions This provision defines the terms "commencement day" as the day on which this item commences, and "OTA Act" as the Australian Organ and Tissue Donation and Transplantation Authority Act 2008. 2 Application--subsection 14(1A) of the OTA Act The provision is in relation to Subsection 14(1A) of the OTA Act - CEO, as inserted by Schedule 1 to this Act. This applies in relation to an appointment made on or after the commencement of this item. 3 Application--amendment made by item 25 The provision is in relation to the amendment made by item 25 of Schedule 1 to this Act. It applies in relation to an appointment made on or after the commencement of this item. An existing appointment upon the commencement of this item is not bound by this provision. 4 Continued engagement of consultants This provision is in relation to consultants engaged under Section 26 upon commencement. (1) This item applies to a person if: (a) before the commencement day, the person was engaged by the CEO as a consultant under section 26 of the OTA Act; and (b) the engagement was in effect immediately before that day. (2) The person is taken, on and after the commencement day, to be engaged by the Board as a consultant under section 26 of the OTA Act, as substituted by Schedule 1 to this Act, on the same terms and conditions that applied to the person's engagement immediately before that day. (3) This item does not prevent those terms and conditions being varied on or after the commencement day. 5 Continued existence of expert advisory committees This provision is in relation to expert advisory committees established under section 44 upon commencement. (1) This item applies to an expert advisory committee if: (a) the committee was established by the CEO under section 44 of the OTA Act before the commencement day; and (b) the committee was in existence immediately before that day. (2) The expert advisory committee is continued in existence (and may be dealt with), on and after the commencement day, as if it were an expert advisory committee established by the Board under section 44 of the OTA Act, as amended by Schedule 1 to this Act. 6 Continuation of appointment of expert advisory committee members This provision is in relation to members of expert advisory committees established under section 44 upon commencement. 14
(1) This item applies to an appointment if: (a) the appointment was made by the CEO under section 46 of the OTA Act before the commencement day; and (b) the appointment is in force immediately before that day. (2) The appointment continues in force (and may be dealt with), on and after the commencement day, as if it were an appointment made by the Board under section 46 of the OTA Act, as amended by Schedule 1 to this Act. 7 Duties of accountable authority This provision notes that, for the purposes of sections 39, 42 and 46 of the Public Governance, Performance and Accountability Act 2013, the Board is the accountable authority of the Authority in relation to the reporting period (within the meaning of that Act) for the Authority that ends immediately before the commencement day. This may include, but is not limited to, reports such as annual reports, corporate plan and financial reports. 8 Transitional rules (1) This provision enables the Commonwealth Minister to make rules prescribing matters of a transitional nature relating to amendments or repeals made by this Act. Transitional issues that may be addressed through this provision could include, but is not limited to, provisions in relation to any policies, protocols and standards, and codes of practice declared by the CEO under 11(b) of the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 prior to these amendments, or the persons assisting the CEO under section 27 the Australian Organ and Tissue Donation and Transplantation Authority Act 2008 prior to these amendments. (2) This provision does not allow the Minister to make rules to: (a) create an offence or civil penalty; (b) provide powers of: (i) arrest or detention; or (ii) entry, search or seizure; (c) impose a tax; (d) set an amount to be appropriated from the Consolidated Revenue Fund under an appropriation in this Act; (e) directly amend the text of this Act. (3) This provision notes that this Act (other than subitem (2)) does not limit the rules that may be made for the purposes of subitem (1). 15