National Health and Medical Research Council Amendment Act 2006 (Cth)

National Health and Medical Research Council Amendment Act 2006 No. 50, 2006 An Act to amend the National Health and Medical Research Council Act 1992, and for related purposes Contents 1 Short title 2 Commencement 3 Schedule(s) Schedule 1—Amendments Part 1—Amendment of the National Health and Medical Research Council Act 1992 Part 2—Amendment of other Acts Australian Institute of Health and Welfare Act 1987 Food Standards Australia New Zealand Act 1991 Freedom of Information Act 1982 National Health Act 1953 Privacy Act 1988 Research Involving Human Embryos Act 2002 Therapeutic Goods Act 1989 Part 3—Amendment conditional on the Financial Framework Legislation Amendment Act (No. 1) 2006 National Health and Medical Research Council Act 1992 Part 4—Transitional provisions Division 1—Preliminary Division 2—Assets, liabilities and legal proceedings Division 3—Reference to, and things done by or in relation to, old NHMRC Division 4—Committees and Commissioner Division 5—Reporting obligations Division 6—Miscellaneous National Health and Medical Research Council Amendment Act 2006 No. 50, 2006 An Act to amend the National Health and Medical Research Council Act 1992, and for related purposes [Assented to 9 June 2006] The Parliament of Australia enacts: 1 Short title This Act may be cited as the National Health and Medical Research Council Amendment Act 2006. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provision(s) Commencement Date/Details 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day on which this Act receives the Royal Assent. 9 June 2006 2. Schedule 1, Parts 1 and 2 The later of: 1 July 2006 (a) the day after this Act receives the Royal Assent; and (b) 1 July 2006. 3. Schedule 1, Part 3 The latest of: 1 July 2006 (a) the day after this Act receives the Royal Assent; and (paragraph (b) applies) (b) 1 July 2006; and (c) immediately after the commencement of item 34 of Schedule 1 to the Financial Framework Legislation Amendment Act (No. 1) 2006. However, the provision(s) do not commence at all if the event mentioned in paragraph (c) does not occur. 4. Schedule 1, Part 4 The later of: 1 July 2006 (a) the day after this Act receives the Royal Assent; and (paragraph (b) applies) (b) 1 July 2006. Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent. (2) Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Schedule 1—Amendments Part 1—Amendment of the National Health and Medical Research Council Act 1992 1 Subsection 3(2) Omit "Council", substitute "NHMRC". 2 Section 4 (definition of appointed member) Repeal the definition. 3 Section 4 Insert: CEO means the Chief Executive Officer of the NHMRC referred to in section 6. 4 Section 4 (definition of Chief Executive Officer) Repeal the definition. 5 Section 4 (paragraph (b) of the definition of chief officer) Omit "authority; and", substitute "authority.". 6 Section 4 (paragraph (c) of the definition of chief officer) Repeal the paragraph. 7 Section 4 (definition of committee) Omit ", the Executive Committee". 8 Section 4 (definition of Commissioner) Omit "appointed under section 69", substitute "referred to in section 55". Note: The definitions of committee and Commissioner must be substituted in the appropriate alphabetical positions in section 4: see section 14A of the Acts Interpretation Act 1901. 9 Section 4 (definition of Commonwealth member) Repeal the definition. 10 Section 4 (definition of Council) Repeal the definition, substitute: Council means the Council of the NHMRC referred to in section 20. 11 Section 4 Insert: Embryo Research Licensing Committee of the NHMRC means the Embryo Research Licensing Committee of the NHMRC established by section 13 of the Research Involving Human Embryos Act 2002. 12 Section 4 (definition of Executive Committee) Repeal the definition. 13 Section 4 Insert: financial year means each period of 12 months commencing on 1 July. 14 Section 4 (definition of Health Minister) Repeal the definition. 15 Section 4 Insert: human research guidelines means guidelines for the conduct of medical research involving humans. 16 Section 4 Insert: information provider has the meaning given by subsection 80(1). 17 Section 4 Insert: interim human research guidelines means human research guidelines issued by the CEO under paragraph 7(1)(a) in the circumstances referred to in subsection 14(1) or (5). 18 Section 4 Insert: interim guidelines means guidelines issued by the CEO under paragraph 7(1)(a) in the circumstances referred to in subsection 14(1), (3) or (5). 19 Section 4 (definition of interim regulatory recommendation) Omit "section 14", substitute "subsection 14(1) or (3)". 20 Section 4 Insert: member: (a) of the Council—includes the Chair of the Council; and (b) of a committee—includes the Chair of that committee. 21 Section 4 Insert: NHMRC means the National Health and Medical Research Council. 22 Section 4 Insert: NHMRC officer has the meaning given by subsection 80(1). 23 Section 4 (definition of NHMRC Order) Repeal the definition. 24 Section 4 (definition of previous Fund) Repeal the definition. 25 Section 4 (definition of proclaimed day) Repeal the definition. 26 Section 4 (definition of regulatory recommendation) Omit "Council", substitute "CEO". 27 Section 4 (definition of reviewable action) Repeal the definition, substitute: reviewable action means: (a) action taken by the CEO or any delegate of the CEO in the performance of the CEO's function under paragraph 7(1)(c) in relation to an application for funding made on or after 24 June 1993; or (b) action taken by the Research Committee in the performance of its function under paragraph 35(2)(a) in relation to an application for funding made on or after 24 June 1993; and includes any unreasonable delay by the CEO or Committee in relation to his, her or its consideration of such an application or any failure or refusal of the CEO or Committee to consider such an application. 28 Section 4 Insert: staff of the NHMRC means the staff referred to in section 45. 29 Section 4 (definition of State or Territory health instrumentality) Repeal the definition. 30 Section 4 (definition of State or Territory member) Repeal the definition. 31 Part 2 Repeal the Part, substitute: Part 2—The National Health and Medical Research Council 5B Establishment of the NHMRC (1) The National Health and Medical Research Council is established by this section. (2) The NHMRC comprises the following: (a) the CEO; (b) the Council and committees; (c) the staff of the NHMRC. 5C Function of the NHMRC The function of the NHMRC (other than the CEO) is to assist the CEO in the performance of his or her functions. 5D Reference of matters to the CEO, Council and Principal Committees by the Minister (1) The Minister may refer to the CEO, the Council or a Principal Committee (other than the Embryo Research Licensing Committee of the NHMRC) any matter within the scope of the CEO, Council or Committee's functions. (2) The CEO, the Council or a Principal Committee must deal with a matter referred to him, her or it by the Minister under subsection (1). Instruments are not legislative instruments (3) An instrument under subsection (1) is not a legislative instrument. 5E Minister may give directions to the CEO, Council and Principal Committees (1) The Minister may, by writing, direct the CEO, the Council or a Principal Committee (other than the Embryo Research Licensing Committee of the NHMRC) as to the performance of the CEO, Council or Committee's functions or the exercise of the CEO, Council or Committee's powers. (2) Directions given by the Minister under subsection (1) must be of a general nature only, and, in particular, the Minister is not entitled to direct the CEO, the Council or a Principal Committee: (a) to recommend the allocation of research funds to a particular person, organisation, State or Territory; or (b) as to the manner of the CEO, Council or Principal Committee's treatment of particular scientific, technical or ethical issues. (3) The CEO, the Council or a Principal Committee must comply with any direction given by the Minister under subsection (1). (4) If the Minister gives a direction under subsection (1), the Minister must cause a statement setting out particulars of, and of the reasons for, the direction to be laid before each House of the Parliament within 15 sitting days of that House after giving the direction. Directions are not legislative instruments (5) A direction under subsection (1) is not a legislative instrument. 32 Part 3 (heading) Repeal the heading, substitute: Part 3—The Chief Executive Officer 33 Divisions 1 and 2 of Part 3 Repeal the Divisions, substitute: Division 1—Establishment and functions 6 The Chief Executive Officer There is to be a Chief Executive Officer of the NHMRC. Note: For the appointment, terms and conditions of the CEO, see Part 5. 7 Functions of the CEO (1) The functions of the CEO are: (a) in the name of the NHMRC, to inquire into, issue guidelines on, and advise the community on, matters relating to: (i) the improvement of health; and (ii) the prevention, diagnosis and treatment of disease; and (iii) the provision of health care; and (iv) public health research and medical research; and (v) ethical issues relating to health; and (b) to advise, and make recommendations to, the Commonwealth, the States and the Territories on the matters referred to in paragraph (a); and (c) to make recommendations to the Minister on expenditure: (i) on public health research and training; and (ii) on medical research and training; including recommendations on the application of the Account; and (d) any other functions conferred on the CEO in writing by the Minister; and (e) any other functions conferred on the CEO by this Act, the regulations or any other law; and (f) any functions incidental to any of the foregoing. Note: The Minister may delegate additional functions to the CEO: see section 82. Instruments are not legislative instruments (2) An instrument under paragraph (1)(d) is not a legislative instrument. 8 Timetables and procedures to assist CEO make recommendations on application of Account (1) Each financial year, the CEO must publish a timetable and procedures to assist him or her to make recommendations to the Minister on the application of the Account under paragraph 7(1)(c). Timetables and procedures are not legislative instruments (2) The timetable and the procedures are not legislative instruments. Division 2—Regulatory recommendations and guidelines Subdivision A—Regulatory recommendations made, and guidelines issued, by CEO 9 CEO to only make regulatory recommendations and issue guidelines as developed by Council (1) The CEO may only: (a) make a regulatory recommendation; or (b) issue guidelines under paragraph 7(1)(a); precisely as developed by the Council (or in the case of human research guidelines, as developed by the Australian Health Ethics Committee) and provided to the CEO by the Council for the purpose under this Division. Note: Subsection (1) does not apply if the recommendation or guidelines are urgent: see subsection 14(1). (2) However, the CEO is not obliged to make a particular recommendation or to issue particular guidelines (including human research guidelines) merely because the Council has provided the recommendation or guidelines to him or her in accordance with this Division. Regulatory recommendations and guidelines are not legislative instruments (3) Regulatory recommendations and guidelines are not legislative instruments. 10 Human research guidelines CEO to issue guidelines (1) Without limiting any of the matters on which the CEO may issue guidelines under subparagraph 7(1)(a)(v), the CEO must, under that subparagraph, issue human research guidelines. Australian Health Ethics Committee to develop guidelines (2) The Council may only provide human research guidelines to the CEO under subsection 9(1) precisely as developed by the Australian Health Ethics Committee and provided to the Council for the purpose under this Division. (3) However, the Council is not obliged to provide particular guidelines referred to in subsection (2) to the CEO merely because the Australian Health Ethics Committee has provided the guidelines to it in accordance with this Division. Guidelines must be tabled in Parliament (4) Human research guidelines issued by the CEO are to be laid before each House of the Parliament within 15 sitting days of that House of the issuing of the guidelines. 12 Consultation about regulatory recommendations (1) Before the Council provides a regulatory recommendation to the CEO for the purposes of subsection 9(1), the Council must consult persons or bodies in accordance with the steps set out in this section. Note: This section does not apply if the recommendation is urgent or of minor significance: see subsection 14(3) and section 14B. (2) As soon as practicable after deciding that, subject to consultation processes, it intends to provide a regulatory recommendation to the CEO, the Council must publish a notice, in the manner and form specified in the regulations: (a) stating its intention to provide the regulatory recommendation to the CEO; and (b) inviting persons or bodies to make submissions relating to the proposed recommendation in accordance with the procedures, and within the period, specified in the notice. (3) As soon as practicable after the end of the period specified under paragraph (2)(b), the Council must, having regard to any submissions received pursuant to the invitation referred to in that paragraph: (a) prepare a draft of the regulatory recommendation the Council proposes to provide to the CEO and publish a notice, in the manner and form specified in the regulations: (i) containing a summary of the draft recommendation; and (ii) stating where copies of the draft recommendation can be obtained; and (iii) inviting persons or bodies to make submissions relating to the draft recommendation in accordance with the procedures, and within the period, specified in the notice; or (b) publish, in the manner and form specified in the regulations, a notice stating that it no longer proposes to provide the recommendation to the CEO. (4) The Council must have regard to any submissions received pursuant to the invitation referred to in subparagraph (3)(a)(iii) before providing the recommendation to the CEO. 13 Consultation about guidelines Before: (a) the Council provides guidelines (other than human research guidelines) to the CEO for the purposes of subsection 9(1); or (b) the Australian Health Ethics Committee provides human research guidelines to the Council for the purposes of subsection 10(2); the Council or Committee must: (c) prepare a draft of the guidelines; and (d) publish a notice, in the manner and form specified in the regulations: (i) containing a summary of the draft guidelines; and (ii) stating where copies of the draft guidelines can be obtained; and (iii) inviting persons or bodies to make submissions relating to the draft guidelines in accordance with the procedures, and within the period, specified in the notice; and (e) have regard to any submissions received as a result of the invitation referred to in subparagraph (d)(iii). Note: This section does not apply if the guidelines are urgent or of minor significance: see subsections 14(3) and (5) and section 14B. 14 Interim regulatory recommendations and guidelines CEO may make interim regulatory recommendations and issue interim guidelines without Council in urgent circumstances (1) If a matter: (a) would ordinarily be the subject of a regulatory recommendation made, or guidelines issued, as provided to the CEO under subsection 9(1); and (b) must, in the opinion of the CEO, for any reason, be dealt with urgently; the CEO may, despite subsection 9(1), make a regulatory recommendation, or issue guidelines, without receiving them from the Council. (2) Within 30 days after the CEO makes an interim regulatory recommendation or issues interim guidelines in accordance with subsection (1), the CEO must publish a notice, in the manner and form specified in the regulations: (a) setting out his or her reasons for making the recommendation or issuing the guidelines; and (b) setting out: (i) a summary of the recommendation; or (ii) the guidelines; and (c) inviting persons or bodies to make submissions to: (i) in the case of human research guidelines—the Australian Health Ethics Committee; or (ii) otherwise—the Council; relating to the recommendation or guidelines in accordance with the procedures, and within the period, specified in the notice. Council may provide recommendations and guidelines to CEO without consultation in urgent circumstances (3) If a matter: (a) would ordinarily be the subject of a regulatory recommendation, or guidelines (other than human research guidelines), provided to the CEO under subsection 9(1); and (b) must, in the opinion of the Council, for any reason, be dealt with urgently; the Council may provide a regulatory recommendation or guidelines to the CEO without first undertaking one or more of the steps set out in section 12 or 13. (4) Within 30 days after the CEO makes an interim regulatory recommendation, or issues interim guidelines, provided to him or her in accordance with subsection (3), the Council must publish a notice, in the manner and form specified in the regulations: (a) setting out its reasons for providing the recommendation or guidelines to the CEO; and (b) setting out: (i) a summary of the recommendation; or (ii) the guidelines; and (c) inviting persons or bodies to make submissions to the Council relating to the recommendation or guidelines in accordance with the procedures, and within the period, specified in the notice. Australian Health Ethics Committee may provide human research guidelines to Council without consultation in urgent circumstances (5) If a matter: (a) would ordinarily be the subject of human research guidelines provided to the Council under subsection 10(2); and (b) must, in the opinion of the Australian Health Ethics Committee, for any reason, be dealt with urgently; the Committee may provide guidelines to the Council without first undertaking one or more of the steps set out in section 13. (6) Within 30 days after the CEO issues interim guidelines provided to the Council in accordance with subsection (5), the Australian Health Ethics Committee must publish a notice, in the manner and form specified in the regulations: (a) setting out its reasons for providing the guidelines to the Council; and (b) setting out the guidelines; and (c) inviting persons or bodies to make submissions to the Committee relating to the guidelines in accordance with the procedures, and within the period, specified in the notice. Council must advise CEO to confirm, vary or revoke interim regulatory recommendations or guidelines (7) If the CEO makes an interim regulatory recommendation or issues interim guidelines: (a) in the case of human research guidelines—the Australian Health Ethics Committee must: (i) as soon as practicable after, but not later than 30 days after, the end of the period specified in the relevant notice under subsection (2) or (6); and (ii) having regard to any submissions received; advise the Council to advise the CEO to confirm, vary or revoke the guidelines; or (b) otherwise—the Council must: (i) as soon as practicable after, but not later than 30 days after, the end of the period specified in the relevant notice under subsection (2) or (4); and (ii) having regard to any submissions received; advise the CEO to confirm, vary or revoke the recommendation or guidelines. (8) The Council may only advise the CEO to confirm, vary or revoke interim human research guidelines in accordance with the Committee's advice under paragraph (7)(a). However, the Council is not obliged to provide particular advice to the CEO merely because it has been advised to do so by the Committee in accordance with this section. Interim regulatory recommendations and guidelines automatically revoked after 45 days (9) If the CEO fails, within 45 days after the end of the period specified in the relevant notice under subsection (2), (4) or (6), to confirm, vary or revoke an interim regulatory recommendation or interim guidelines in accordance with the Council's advice (if any) under paragraph (7)(b) or subsection (8), the CEO is to be treated as having revoked the recommendation or guidelines. 14AA Consultation requirements do not apply to revoking guidelines (1) The Council may, without undertaking consultation, advise the CEO to revoke guidelines (other than human research guidelines). (2) The Australian Health Ethics Committee may, without undertaking consultation, advise the Council to advise the CEO to revoke human research guidelines. Note: The requirements of this Division still apply to variations of guidelines: see subsection 33(3) of the Acts Interpretation Act 1901. Subdivision B—Guidelines approved by CEO 14A Approval by CEO of guidelines for third parties (1) The CEO may, on the advice of the Council, approve guidelines prepared by a person or body from outside the NHMRC. (2) The Council may only advise the CEO to approve the guidelines if the Council is satisfied that the person or body, before submitting the guidelines to the CEO for his or her approval: (a) prepared a draft of the guidelines that the person or body proposed to submit to the CEO; and (b) published a notice, in a manner and form acceptable to the Council: (i) containing a summary of the draft guidelines; and (ii) stating where copies of the draft guidelines could be obtained; and (iii) inviting persons or bodies to make submissions relating to the draft in accordance with the procedures, and within the period, specified in the notice; and (c) had regard to any submissions received pursuant to the invitation referred to in subparagraph (b)(iii). Note: Subsection (2) does not apply if the guidelines are of minor significance: see section 14B. Subdivision C—Other provisions about consultation 14B Consultation may be dispensed with in certain circumstances (1) If: (a) the Council is satisfied that: (i) a proposed regulatory recommendation referred to in section 12; or (ii) proposed guidelines referred to in paragraph 13(a) or section 14A; raise issues that are of minor significance only; or (b) the Australian Health Ethics Committee is satisfied that proposed human research guidelines referred to in paragraph 13(b) raise issues that are of minor significance only; the Council or Committee may dispense with the requirement for all or any of the steps set out in section 12 or 13 or subsection 14A(2), as the case requires. (2) If the Council or Committee proposes to dispense with the requirement for all or any of the steps set out in section 12 or 13 or subsection 14A(2), the Council or Committee must publish a notice, in the manner and form, and within the period, specified in the regulations, stating its reasons for so proposing. 15 CEO must develop procedures (1) The CEO must develop and publish procedures to assist persons or bodies to make submissions under this Division. Procedures are not legislative instruments (2) The procedures are not legislative instruments. 34 Subsection 16(1) Omit "Council" (first occurring), substitute "CEO". 35 Paragraph 16(1)(a) Omit "Council's", substitute "CEO's". 36 Paragraph 16(1)(b) Omit "Council proposes to perform its", substitute "CEO proposes to perform his or her". 37 Subsection 16(3) Omit "Council", substitute "CEO". 38 Subsection 16(3) After "Minister", insert "and the Council". 39 Subsection 16(4) Omit "the proclaimed day", substitute "24 June 1993". 40 Subsection 17(1) Repeal the subsection, substitute: (1) Not later than 6 months before the end of a strategic plan, the CEO must prepare and give to the Minister a written review evaluating the CEO's success in implementing the strategic plan. 41 Subsection 18(1) Omit "the proclaimed day", substitute "24 June 1993". 42 Paragraph 18(5)(b) Omit "Council" (wherever occurring), substitute "CEO". 43 Subsection 18(6) Omit "Council" (wherever occurring), substitute "CEO". 44 Subsection 19(1A) Omit "Council", substitute "CEO". 45 Subsection 19(1) Omit "Council" (first and second occurring), substitute "CEO". 46 Subsection 19(1) Omit "its", substitute "his or her". 47 Subsection 19(1) Omit "Council" (third occurring), substitute "CEO". 48 Subsection 19(2) Omit "Council" (wherever occurring), substitute "CEO". 49 Subsection 19(3) Omit "Council", substitute "CEO". 50 Subsection 19(3) After "Minister", insert "and the Council". 51 Paragraph 19(4)(a) Omit "Council", substitute "CEO". 52 Part 4 Repeal the Part, substitute: Part 4—The Council and committees of the NHMRC Division 1—The Council of the NHMRC 20 Establishment of the Council of the NHMRC (1) The Council of the NHMRC is established by this section. (2) The Council of the NHMRC consists of the following: (a) the Chair; (b) the chief medical officer for the Commonwealth; (c) the chief medical officer for each State and Territory; (d) a person with expertise in the health needs of Aboriginal persons and Torres Strait Islanders; (e) a person with expertise in consumer issues; (f) a person with expertise in business; (g) at least 6, but no more than 11, persons with expertise in one or more of the following: (i) health care training; (ii) professional medical standards; (iii) the medical profession and post‑graduate medical training; (iv) the nursing profession; (v) public health research and medical research issues; (vi) public health; (vii) ethics relating to research involving humans; (viii) other appropriate expertise. Note: For the appointment, terms and conditions of the Chair and other members of the Council, see Part 5. 21 Functions of the Council (1) The functions of the Council are: (a) to provide advice to the CEO in relation to the performance of his or her functions; and (b) any other functions conferred on the Council in writing by the Minister after consulting the CEO; and (c) any other functions conferred on the Council by this Act, the regulations or any other law. Note: The CEO may delegate additional functions to the Council: see section 82. Instruments are not legislative instruments (2) An instrument under paragraph (1)(b) is not a legislative instrument. 22 Meetings of the Council The Chair of the Council must convene at least one Council meeting in each financial year. Note: The CEO may determine other matters relating to Council meetings: see section 40. 53 Part 5 (heading) Repeal the heading, substitute: Division 2—Principal Committees 54 At the end of subsection 35(1) Add: Note: For the constitution, functions and members of the Embryo Research Licensing Committee of the NHMRC, see Division 3 of Part 2 of the Research Involving Human Embryos Act 2002. 55 At the end of paragraph 35(2)(d) Add "in writing after consulting the CEO". 56 At the end of subsection 35(2) Add: ; and (e) any other functions conferred on the Committee by this Act, the regulations or any other law. Note: The CEO or the Council may delegate additional functions to the Research Committee: see section 82. 57 Subsections 35(3) and (4) Repeal the subsections, substitute: (3) The functions of the Australian Health Ethics Committee are: (a) to advise the Council on ethical issues relating to health; and (b) to develop and give the Council human research guidelines under subsection 10(2); and (c) any other functions conferred on the Committee in writing by the Minister after consulting the CEO; and (d) any other functions conferred on the Committee by this Act, the regulations or any other law. Note: The CEO or the Council may delegate additional functions to the Australian Health Ethics Committee: see section 82. 58 Paragraph 35(6)(b) Repeal the paragraph, substitute: (b) must have as its Chair a person who is: (i) a member of the Council; and (ii) not a member of the Research Committee. 59 At the end of subsection 35(6) Add: Note 1: For the appointment, terms and conditions of the Chair and other members of the Australian Health Ethics Committee, see Part 5. Note 2: In certain circumstances, the Chair may be a person who is not a member of the Council: see subsection (10). 60 Subsection 35(7) After "determine", insert ", in writing and after consulting the CEO,". 61 At the end of subsection 35(7) Add: Note: The CEO or the Council may delegate additional functions to a Principal Committee: see section 82. 62 Subsections 35(9) and (10) Repeal the subsections, substitute: (9) A Principal Committee other than the Australian Health Ethics Committee comprises: (a) a Chair, who must be a member of the Council; and (b) the members appointed by the Minister (whether Council members or not). Note 1: For the appointment, terms and conditions of the Chairs and other members of the Principal Committees, see Part 5. Note 2: In certain circumstances, the Chair of a Principal Committee may be a person who is not a member of the Council: see subsection (10). (10) Despite subparagraph (6)(b)(i) and paragraph (9)(a), the Chair of a Principal Committee may be a person who is not a member of the Council if: (a) the Minister does not consider that any member of the Council has the appropriate expertise to be Chair of the Principal Committee; and (b) another member of the Principal Committee is a member of the Council. 63 Subsection 35(11) Omit ", functions and constitution", substitute "and functions". 64 Subsections 35(12) and (13) Repeal the subsections, substitute: Instruments are not legislative instruments (12) An instrum