National Health and Medical Research

Council Act 1992

No. 225 of 1992

TABLE OF PROVISIONS

PART 1—PRELIMINARY

National Health and Medical Research

Council Act 1992

No. 225 of 1992

An Act to establish a National Health and Medical Research Council, and for related purposes

[Assented to 24 December 1992]

The Parliament of Australia enacts:

PART 1—PRELIMINARY

Short title

1. This Act may be cited as the National Health and Medical Research Council Act 1992.

Commencement

2.(1) Subject to subsection (2), the provisions of this Act commence on a day or days to be fixed by Proclamation.

(2) If a provision of this Act does not commence under subsection (1) within the period of 6 months commencing on the day on which this Act receives the Royal Assent, it commences on the first day after the end of that period.

Object of the Act etc.

3.(1) The object of this Act is to make provision for a national body to pursue activities designed:

(d)     to foster consideration of ethical issues relating to health.

(2) It is the intention of the Parliament that, to the extent that it is practicable to do so, the Council should adopt a policy of public consultation in relation to individual and public health matters being considered by it from time to time.

Interpretation

4. In this Act, unless the contrary intention appears:

“appointed member” means:

“ATSIC member” means the member of the Council appointed under paragraph 20(f);

“chief officer” means:

“committee” means a Principal Committee, the Executive Committee or a working committee;

“Commissioner” means the Commissioner of Complaints appointed under section 69 and includes a person appointed under section 76 to act as the Commissioner of Complaints in relation to a particular complaint;

“Commonwealth authority” means a body, whether incorporated or not, established by, or by or under a law of, the Commonwealth;

“Commonwealth Department” means a Department of State of the Commonwealth;

“Commonwealth member” means the member of the Council appointed under paragraph 20(e);

“Council” means the National Health and Medical Research Council;

“court” includes a tribunal, authority or person having power to require a person to produce documents or answer questions;

“Executive Committee” means the committee established under section 37;

“Fund” means the Medical Research Endowment Fund established by section 49;

“interest” means any direct or indirect, pecuniary or non-pecuniary interest;

“interim regulatory recommendation” means a regulatory recommendation made in the circumstances referred to in section 14;

“medical research” includes the laboratory-based or clinical study, or group or community-based study of the causes, treatment and prevention of human diseases and also includes dental research;

“NHMRC Order” means the Order in Council dated 23 August 1991 and cited as the National Health and Medical Research Council Order;

“previous Fund” means the Fund known as the Medical Research Endowment Fund and established under the Medical Research Endowment Act 1937 as a Trust Account for the purposes of section 62A of the Audit Act 1901;

“Principal Committee” means a committee established, or taken to be established, by the Minister under section 35;

“Privacy Commissioner” means the Privacy Commissioner within the meaning of the Privacy Act 1988;

“proclaimed day” means the day fixed by Proclamation for the commencement of section 6;

“public health research” includes the study of the health of a community or population for purposes directed at improving or protecting the health of that community or population;

“regulatory recommendation” means a recommendation of the Council that is intended to be given legal effect in a State by legislation of that State.

“reviewable action” means:

to an application for funding made on or after the proclaimed day;

and includes any unreasonable delay by the Council or Committee in relation to its consideration of such an application or any failure or refusal of the Council or Committee to consider such an application;

“State or Territory authority” means a body, whether incorporated or not, established by a State or Territory, or by or under a law of a State or Territory;

“State or Territory Department” means a Department of State of a State or Territory;

“State or Territory health instrumentality” means the Department of State of a State or Territory, or the State or Territory authority, that has principal responsibility for matters relating to health in the State or Territory;

“State or Territory member” means a member of the Council appointed under paragraph 20(d);

“Territory” means the Australian Capital Territory or the Northern Territory;

“working committee” means a committee established under section 39.

Act to bind Crown

5. This Act binds the Crown in right of the Commonwealth, of each of the States, of the Northern Territory and of the Australian Capital Territory, but nothing in this Act renders the Crown liable to be prosecuted for an offence.

PART 2—ESTABLISHMENT AND FUNCTIONS OF THE COUNCIL

Establishment

6.(1) There is established by this section a council to be known as the National Health and Medical Research Council.

(2) The Council:

(a)     is a body corporate with perpetual succession; and

(b)     has a seal; and

(c)     may sue and be sued under its corporate name.

(3) All courts, judges and persons acting judicially must take judicial notice of the imprint of the seal of the Council appearing on a document and must presume that the document was duly sealed.

Functions of the Council

7.(1) The functions of the Council are:

(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

(i) on public health research and training; and

(ii) on medical research and training;

including recommendations on the application of the Fund; and

(d) any functions incidental to any of the foregoing.

(2) Subject to the direction of the Minister, the Council has the general administration of this Act.

Ethics guidelines

8.(1) Without limiting any of the matters on which the Council may issue guidelines under subparagraph 7(1)(a)(v), the Council must issue guidelines under that subparagraph for the conduct of medical research involving humans.

(2)     The guidelines for the conduct of medical research involving humans must be issued precisely as developed by the Principal Committee known as the Australian Health Ethics Committee and provided to the Council for the purpose.

(3)     Sections 12, 13 and 14 and the procedures developed and published by the Council under section 15 apply to the activities of the Australian Health Ethics Committee in developing guidelines for the conduct of medical research involving humans as if the references in sections 12, 13 and 14 to the Council were references to that Committee and as if the procedures under section 15 had been developed to assist the Committee.

Reference of matters to the Council by the Minister

9.(1) The Minister may refer to the Council any matter within the scope of its functions.

(2) The Council must deal with a matter referred to it by the Minister.

Minister may give directions to the Council

10.(1) Subject to subsection (2), the Minister may give written directions to the Council as to the performance of its functions or the exercise of its 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 Council:

(3)     The Council must comply with any direction given by the Minister under subsection (1).

(4)     If the Minister gives a direction to the Council, 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.

PART 3—POWERS AND DUTIES OF THE COUNCIL

Division 1—Powers

Powers of the Council

11.(1) The Council has power to do all things necessary or convenient to be done in relation to the performance of its functions.

(2) Without limiting subsection (1), the Council may:

(d)     do anything incidental to any of its powers.

Division 2—Public consultation

Consultation by the Council

12.(1) Subject to sections 13 and 14, before the Council:

(a)     makes a regulatory recommendation; or

(b)     issues guidelines; or

(c)     engages in any other prescribed activity;

the Council must consult persons or bodies in accordance with the steps set out in this section.

(2) As soon as practicable after deciding that, subject to consultation processes, it intends to make a regulatory recommendation, issue guidelines or engage in a prescribed activity, the Council must publish a notice, in the manner and form specified in the regulations:

(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:

(i) containing the draft or outline; and

Consultation may be dispensed with or modified in certain circumstances

13.(1) If the Council is satisfied that a proposed regulatory recommendation, proposed guidelines or a proposed prescribed activity raises issues that are of minor significance only, the Council may omit all or any of the steps set out in section 12.

(2) If the Council proposes to omit all or any of the steps set out in section 12, the Council must publish a notice, in the manner and form, and within the period, specified in the regulations, of its reasons for so proposing.

(a) would ordinarily be the subject of a regulatory recommendation

made, or guidelines issued, after public consultation in accordance with section 12; and

the Council may make an interim regulatory recommendation or issue interim guidelines without first undertaking one or more of the steps set out in that section.

(2) If the Council makes an interim regulatory recommendation, or issues interim guidelines, without inviting submissions in accordance with paragraph 12(3)(a), the Council must, within 30 days after making the interim recommendation or issuing the interim guidelines, publish a notice, in the manner and form specified in the regulations:

(b)     setting out the interim recommendation or guidelines; and

(3) As soon as practicable after, but not later than 30 days after, the end of the period specified in the notice, the Council must, having regard to any submissions received:

(a)     confirm or vary the interim recommendation or guidelines; or

(b)     revoke the interim recommendation or guidelines.

(4) Where the Council fails, within 30 days after the end of the period referred to in paragraph (2)(c), to take any action under subsection (3) in relation to an interim regulatory recommendation or interim guidelines, the Council is to be treated as having revoked the interim recommendation or guidelines.

Council must develop procedures

15. The Council must develop and publish procedures to assist persons or bodies to make submissions under this Division.

Division 3—Strategic plans

Strategic plans

16.(1) The Council must develop, and prepare in writing, for each successive period referred to in subsections (4) and (5), a strategic plan setting out:

(2)     Without limiting the generality of subsection (1), each strategic plan must contain a national strategy for medical research and public health research.

(3)     Before preparing a strategic plan, the Council must consult with the Minister on the matters proposed for inclusion in the plan.

(4)     The first strategic plan is to relate to the period commencing on the proclaimed day and ending on 30 June 1994.

(5)     Each subsequent strategic plan is to relate to the period of 3 years commencing at the end of the period to which the immediately preceding strategic plan relates.

(6)     Each strategic plan must be laid before each House of the Parliament within 15 sitting days of that House after its receipt by the Minister.

Review of each plan

17.(1) Not later than 6 months before the end of a strategic plan, the Council must prepare and give to the Minister a written review evaluating the Council’s success in implementing its strategic plan.

(2) Each review must be laid before each House of the Parliament within 15 sitting days of that House after its receipt by the Minister.

Delivery and commencement of strategic plans

18.(1) The first strategic plan must be given to the Minister not later than one month after the proclaimed day.

(2)     The first strategic plan comes into force on the day on which it is given to the Minister.

(3)     Each subsequent strategic plan must be given to the Minister before the end of the period to which the immediately preceding plan relates.

(4)     Each subsequent strategic plan must take into account the review of the immediately preceding strategic plan prepared and given to the Minister in accordance with section 17.

(5)     Each subsequent strategic plan comes into force immediately after the end of the immediately preceding plan.

Variation of strategic plans

19.(1) The Council may, from time to time during the period in respect of which a strategic plan is in force, consider whether a variation of the plan is necessary.

(2) If the Council considers that the plan should be varied, the Council may prepare a written variation of the plan and give it to the Minister.

(3)     Before preparing a variation of a strategic plan, the Council must consult with the Minister on the matters proposed for inclusion in the variation.

(4)     If a variation of a strategic plan is given to the Minister:

(a)     the Council must forthwith vary the plan accordingly; and

PART 4—CONSTITUTION AND MEETINGS OF THE COUNCIL

Division 1—Constitution of the Council

Constitution of the Council

20. The Council consists of the following members:

(a)     the Chairperson;

(b)     the Secretary to the Council;

(e)     an officer of the Department nominated by the Minister;

(f)      a person:

(g) a person with expertise in health care training;

(k) an eminent scientist:

(ii) who has no current connection with the Council;

(m) a person with a background in, and knowledge of, business;

(p) a person with knowledge of environmental issues;

Appointment of members

21.(1) Subject to this section, the Minister must appoint the members of the Council other than the members referred to in paragraphs 20(b) and (c).

(2) The Minister must not appoint a person as Chairperson unless:

(3) The Minister must:

(g)     before appointing the member referred to in paragraph 20(m),

seek nominations from such peak business organisations as are prescribed for the purpose; and

(4)     The Chairperson may be appointed as a full-time or part-time member.

(5)     An appointed member, other than the Chairperson, must be appointed on a part-time basis only.

(6)     An appointed member holds office for the period, not exceeding 3 years, that is specified in the instrument of appointment, but is eligible for reappointment.

Secretary to the Council

22.(1) The Secretary to the Council is the person who, from time to time, holds or performs the duties of an office in the Senior Executive Service that is designated for the purpose by the Secretary to the Department.

(2) The Secretary to the Council is the executive officer of the Council having responsibility for its day-to-day activities.

Acting appointments

23.(1) If:

(a)     the office of Chairperson is vacant; or

the Minister may appoint a member, other than the Secretary to the Council, to act as Chairperson.

(2) If:

(b)     an appointed member, other than the Chairperson, is absent

from duty or from Australia or is, for any other reason, unable to perform the functions of the office of appointed member;

the Minister may, subject to subsection (3), appoint a person to act as the appointed member.

(3)     The Minister may appoint a person to act as a member referred to in paragraph 20(f), (g), (h), (i), (j), (k), (l), (m), (n), (o), (p) or (q) only if the person has the background, knowledge or expertise specified in the applicable paragraph.

(4)     Anything done by or in relation to a person purporting to act under this section is not invalid on the ground that:

(a)     the occasion for the person’s appointment had not arisen; or

(c)     the person’s appointment had ceased to have effect; or

(d)     the occasion for the person to act has not arisen or had ceased.

(b)     such allowances as are prescribed.

(2) If the Chairperson is also:

the Chairperson is not, unless the Minister otherwise directs in writing, entitled to remuneration under this Act.

(3) This section has effect subject to the Remuneration Tribunal Act 1973.

Remuneration and allowances of other Council members

25.(1) Subject to subsection (2), a Council member, other than the Chairperson, is to be paid:

(b)     such allowances as are prescribed.

(2) If a Council member is also:

the member is not entitled to remuneration under this Act.

(3) This section has effect subject to the Remuneration Tribunal Act 1973.

Leave of absence

26.(1) Subject to section 87E of the Public Service Act 1922, a full-time Chairperson has such recreation leave entitlements as are determined by the Remuneration Tribunal.

(2) The Minister may:

(3) The Chairperson may grant an appointed member, other than the Chairperson, leave of absence on such terms and conditions as the Chairperson determines.

Resignation

27. An appointed member may resign his or her office by delivering to the Minister a written notice signed by the member.

Termination of appointment

28.(1) The Minister may terminate the appointment of an appointed member for misbehaviour or for physical or mental incapacity.

(2) The Minister must terminate an appointed member’s appointment if the member:

(b)     is absent, except on leave of absence granted under section 26:

(3) The Minister must terminate the appointment of a person appointed:

if the person or body who nominated that person asks the Minister to terminate that person’s appointment.

(4) If the Minister terminates a member’s appointment, the Minister must give the member a written notice:

(b)     setting out the reasons for the termination.

(5) The Minister may terminate the appointment of a person appointed under paragraph 20(e) at any time.

Disclosure of interests

29.(1) Within a month of being appointed or commencing to hold office:

(a)     the Chairperson must give to the Minister; and

(b)     a member must give to the Chairperson;

a written statement of any interest the Chairperson or the member has that may relate to any activity of the Council.

(2)     A member who has an interest in a matter being considered or about to be considered by the Council at a Council meeting or otherwise must, as soon as possible after the relevant facts have come to his or her knowledge, disclose the nature of the interest at a Council meeting or, if the matter is to be decided before a Council meeting takes place, to the Minister or Chairperson.

(3)     A member who has disclosed an interest in a matter under subsection (2) must not, unless the Minister or the Chairperson otherwise determines:

(a)     be present when the Council considers the matter; or

(4)     A member’s disclosure at a Council meeting must be recorded in the minutes of the meeting.

(5)     A member’s disclosure, given otherwise than at a Council meeting, must be recorded in the minutes of the first Council meeting after the disclosure.

Division 2—Procedure of the Council

Meetings of the Council

30.(1) The Chairperson must convene at least one Council meeting in each calendar year and may convene such other Council meetings as he or she considers necessary for the Council to perform its functions efficiently.

(2)     If the Chairperson receives a written request signed by at least 10 members of the Council, the Chairperson must convene a meeting of the Council.

(3)     Members of the Council must be given reasonable notice of a meeting.

(4)     The Chairperson must preside at all meetings at which he or she is present.

(5)     If the Chairperson is absent from a meeting, a member who has been nominated by the Chairperson must preside at that meeting.

Quorum

31.(1) Subject to subsections (2) and (3), a quorum at a Council meeting is constituted by a majority of the members.

(2)     If, at a meeting, the Council proposes to make a regulatory recommendation or an interim regulatory recommendation, the quorum at the meeting must include a majority of the State and Territory members.

(3)     If the Commonwealth member, a State or Territory member, or the ATSIC member, is unable to attend a Council meeting, attendance at the meeting by another nominee of the Minister, of the Minister having administrative responsibility for the State or Territory health instrumentality concerned or of the Aboriginal and Torres Strait Islander Commission, as the case requires, is to be treated as attendance by the member.

Conduct of meetings

32.(1) The Council may regulate its proceedings as it considers appropriate.

(2) The Council must keep a record of the proceedings of Council meetings.

Council may determine a matter without meeting

33.(1) The Council may determine a method by which, in circumstances determined by the Council, its members may vote on a matter without a meeting.

(2) If, in circumstances so determined, members who would, if they were present at a Council meeting, constitute a quorum, vote without meeting on a matter in accordance with the method so determined, the matter is determined according to the same voting procedures as if:

(a)     it had been dealt with at a Council meeting; and

Voting

34.(1) A question that arises at a Council meeting is determined by a majority of the members present and voting.

(2) The member presiding at a Council meeting has a deliberative vote, and, if there is an equality of votes, also has a casting vote.

PART 5—COMMITTEES

Principal Committees

35.(1) The Minister must establish Principal Committees called the Medical Research Committee and the Australian Health Ethics Committee.

(2) The functions of the Medical Research Committee are:

(b)     to monitor the use of assistance provided from the Fund; and

(3) The functions of the Australian Health Ethics Committee are:

(a)     to advise the Council on ethical issues relating to health; and

(4)     Where guidelines are issued by the Council under subsection (3), such guidelines are to be laid before each House of the Parliament within 15 sitting days of that House of the issuing of the guidelines.

(5)     The Minister may establish such other Principal Committees as the Minister thinks are necessary to assist the Council to carry out any of its functions, and the Minister may abolish any such Committee.

(6)     The Australian Health Ethics Committee:

(7)     The Minister must determine the name and functions of a Principal Committee established under subsection (5).

(8)     The Australian Health Ethics Committee is constituted as provided in section 36.

(9)     A Principal Committee other than the Australian Health Ethics Committee must be constituted by:

(a)     a Chairperson; and

(10) The Minister must not determine:

unless the Minister has sought and received the advice of the Council in relation to those matters.

(11)     Before the end of a period of 30 days from the day on which the Minister establishes, or is taken to have established, the Medical Research Committee, the Australian Health Ethics Committee or another Principal Committee, the Minister must cause a notice of the establishment, functions and constitution of the Committee to be published in the Gazette.

(12)     Members of a Principal Committee must be appointed by the Minister on a part-time basis.

(13)     A member of a Principal Committee holds office for a period not exceeding 3 years that is specified in the instrument of appointment, but is eligible for reappointment.

Constitution of and appointment to the Australian Health Ethics Committee

36.(1) The Australian Health Ethics Committee consists of the following members:

(a)     the Chairperson;

(b)     a person with knowledge of the ethics of medical research;

(c)     a person who has expertise in law;

(d)     a person who has expertise in philosophy;

(e)     a person who has expertise in religion;

(f)      a person who has experience in medical research;

(g) a person who has experience in public health research;

(h) a person who has experience in social science research;

(i) a person who has experience in clinical medical practice;

(j) a person who has experience in nursing or allied health practices;

(k) a person with knowledge of the regulation of the medical profession;

(l) a person with understanding of health consumer issues;

(2)    There must be included among the members of the Committee individuals who collectively have membership of all the other Principal Committees.

(3)    Subject to subsections (4), (5) and (6), the Minister must appoint the members of the Australian Health Ethics Committee.

(4)    The Minister must not appoint a person as Chairperson unless:

(5) The Minister must not appoint the member referred to in paragraph 36(1)(b) unless:

(6) The Minister must:

Executive Committee

37.(1) The Council may establish an Executive Committee and may abolish the Executive Committee.

(2) The Executive Committee consists of the following members:

(a)     a Chairperson who is the Chairperson of the Council;

(c)     the Secretary to the Council;

(3)     The members referred to in paragraph (2)(d) are to be appointed by the Council as part-time members for a period, not exceeding 3 years, specified in the instrument of appointment.

(4)     Each member so appointed holds office for a period, not exceeding 3 years, that is specified in the instrument of appointment, but is eligible for reappointment.

(5) The functions of the Executive Committee are:

(a)     to act on behalf of the Council as its executive organ; and

Matters concerning a Principal Committee or the Executive Committee to be determined by the Council

38. The Council may determine:

(i) the convening of meetings; and

(ii) the number of members to constitute a quorum; and

(v) the voting rights of members; and

Working committees

39.(1) A Principal Committee may establish such working committees as it thinks necessary to help it to carry out its functions, and may abolish such committees.

(2)     A working committee is constituted by such persons (whether the persons are members of the Council or of the Principal Committee or other persons) as are appointed by the Principal Committee for the purpose.

(3)     Members of the working committee must be appointed on a part-time basis.

(4)     A member of the working committee holds office for the period, not exceeding 3 years, that is specified in the instrument of appointment, but is eligible for reappointment.

(5)     If a Principal Committee establishes a working committee under subsection (1), the Principal Committee must determine:

(a)     the functions of the working committee; and

(i) the convening of meetings; and

(ii) the number of members to constitute a quorum; and

(v) the rights of members; and

Arrangements to assist committees

40.(1) The Chairperson of a committee may enter into an arrangement for a person or persons to help the committee carry out its functions.

(2) An arrangement under subsection (1) may provide for the assistance to be provided on such terms and conditions, other than terms and conditions relating to remuneration and allowances, as the Chairperson thinks appropriate.

Remuneration and allowances of committee members and others

41.(1) If the Chairperson of the Council is also a member of a committee, he or she is to be paid, in respect of his or her duties as such a member, such allowances as are prescribed.

(2) Subject to subsection (4), a member of a committee (other than the Chairperson of the Council) is to be paid, in respect of his or her duties as a committee member:

(b)     such allowances as are prescribed.

(3)     A person who, under an arrangement made under section 40 or 48, assists the committee to carry out its functions, is entitled to be paid such allowances as are prescribed.

(4)     If a member of a committee:

(b)     also holds or performs the duties of an office or position

established by or under a law of the Commonwealth, a State or a Territory on a full-time basis;

the member is not entitled to remuneration under this Act in respect of the performance of his or her duties as a member.

(5) This section has effect subject to the Remuneration Tribunal Act 1973.

Leave of absence for committee members

42.(1) The Chairperson of the Council may grant a member of a Principal Committee leave of absence from his or her duties on that committee on such terms and conditions as the Chairperson of the Council determines.

(2)    The Chairperson of the Council may grant an appointed member of the Executive Committee leave of absence from his or her duties on the Committee on such terms and conditions as the Chairperson of the Council determines.

(3)    The Chairperson of a Principal Committee may grant a member of a working committee established by the Principal Committee leave of absence from his or her duties on the working committee on such terms and conditions as the Chairperson of the Principal Committee determines.

Resignation of committee members

43.(1) A member of a Principal Committee may resign his or her office by delivering to the Minister a written notice signed by the member.

(2)     An appointed member of the Executive Committee may resign his or her office by delivering to the Chairperson of the Council a written notice signed by the member.

(3)     A member of a working committee may resign his or her office by delivering to the Chairperson of the Principal Committee that established the working committee, a written notice signed by the member.

Termination of appointment of committee members

44.(1) The appropriate authority may terminate the appointment of a person who is:

(a)     the member of a Principal Committee; or

(b)     the appointed member of the Executive Committee; or

(c)     a member of a working committee;

for misbehaviour or for physical or mental incapacity.

(2) The appropriate authority must terminate the appointment of a person referred to in paragraph (l)(a), (b) or (c) if the person:

(3) If a person’s appointment is terminated, the appropriate authority must give the person a written notice:

(b)     setting out the reasons for the termination.

(4) For the purposes of this section:

“appropriate authority” means the following:

(a)     in the case of a member of a Principal Committee—the Minister;

PART 6—STAFF, CONSULTANTS AND WORK ARRANGEMENTS

Staff of the Council

45.(1) The staff of the Council must be comprised of persons appointed or employed under the Public Service Act 1922.

(2) The Council may make arrangements with the Secretary to the Department for the services of officers or employees of the Department appointed or employed under the Public Service Act 1922 to be made available to the Council.

Engagement of consultants

46.(1) The Council may arrange with the Secretary to the Department for persons having suitable qualifications or experience to be engaged as consultants to the Council.

(2) In determining the terms and conditions of a person’s engagement as a consultant, the Secretary to the Department must have regard to the views of the Council.

Council may arrange provision of facilities

47. The Council may make arrangements with the Secretary to the Department for the provision of facilities to the Council that are necessary for the Council to perform its functions or to exercise its powers under this Act.

(a)     the Secretary of a Commonwealth Department; or

(b)     the chief officer of a Commonwealth authority; or

(c)     the chief officer of a State or Territory Department or authority; for:

(2) The Council may make arrangements with the chief officer of a State or Territory Department or authority relating to any matter within the scope of the Council’s functions, including arrangements for the Council to undertake activities on behalf of a State or Territory Department or authority.

PART 7—MEDICAL RESEARCH ENDOWMENT FUND

Establishment of Medical Research Endowment Fund

49.(1) There is established by this subsection a fund, to be known as the Medical Research Endowment Fund.

(2)     Income received from the investment of money standing to the credit of the Fund forms part of the Fund.

(3)     The Fund is a Trust Account for the purposes of section 62A of the Audit Act 1901.

Payments into Fund

50. There is to be paid into the Fund:

Purposes of the Fund

51.(1) The purposes of the Fund are:

(a) to provide assistance:

(ii) to universities for the purpose of medical research; and

(iv) in the training of persons in medical research; and

(2)     Assistance under subsection (1) is to be provided in such cases and subject to such conditions as the Minister, acting on the advice of the Council, determines.

(3)     Without limiting the generality of the conditions to which a grant of assistance can be made under subparagraphs (l)(a)(i), (ii) or (iii), such assistance must not be provided unless the recipient agrees to comply with guidelines in force under subparagraph 7(l)(a)(v) that relate to the conduct of medical research involving humans.

Application of gifts or bequests

52.(1) Despite anything in this Act (other than subsection (2) of this section) or in the Audit Act 1901 (other than section 62B of that Act), any money that is:

is not to be dealt with except in accordance with the obligations of the Minister for Finance as trustee of the trust or as the person who has accepted the money subject to the condition, as the case may be.

(2) Separate accounts are to be kept of each sum of money standing to the credit of the Fund that represents an amount to which subsection (1) has a separate application.

Money repaid to Commonwealth

53. Money repaid to the Commonwealth in accordance with a condition determined under subsection 51(2) is to be paid into the Fund.

Transitional provision—Medical Research Endowment Fund

54.(1) The Medical Research Endowment Act 1937 is repealed.

(2)     The money and investments of the previous Fund become, on the proclaimed day, by force of this subsection, money and investments of the Fund.

(3)     If, immediately before the proclaimed day:

section 52 applies, on and after that day, in relation to so much of the Fund as represents that money or the income derived from the investment of that money as if:

(4)     Despite the repeal of the Medical Research Endowment Act 1937, section 9 of that Act continues in force on and after the proclaimed day in relation to a year ending before the proclaimed day as if that repeal had not been made.

(5)     If the proclaimed day is not a 1 January, section 83 has effect, in respect of the year in which the proclaimed day is included, as if references in that section to a recommendation under paragraph 7(1)(c) included not only a recommendation for the application of the Fund but also for the application of the previous Fund.

PART 8—COMMISSIONER OF COMPLAINTS

Division 1—Establishment and functions of Commissioner of Complaints

Commissioner of Complaints

55. For the purposes of this Act there is to be a Commissioner of Complaints.

Functions of Commissioner

56.(1) The functions of the Commissioner are:

(2) The Commissioner is not to enquire into the merits of a recommendation or a decision made by:

(a)     the Council; or

(b)     a delegate of the Council; or

(c)     the Medical Research Committee; in the course of a reviewable action.

Who may complain

57. A person whose interests are affected by a reviewable action may apply to the Commissioner to investigate a complaint concerning the action made on one or more of the grounds set out in section 58.

Grounds for complaint

58. The grounds for complaint concerning a reviewable action are the following:

(a)     that the action involved a breach of the rules of natural justice;

(b)     that the action was induced or affected by fraud;

How to make a complaint

59. A complaint must:

(a)     be in writing; and

(b)     be signed by the complainant; and

(c)     describe the action complained about; and

(d)     specify the nature of and grounds for the complaint; and

(e)     be lodged with the Commissioner.

Commissioner to investigate complaints

60. Subject to section 61, the Commissioner must investigate a complaint concerning reviewable action.

Discretion not to investigate

61.(1) The Commissioner may:

if:

(d)     the Commissioner has reasonable grounds for believing that:

(2)     If the Commissioner decides not to investigate a complaint or to discontinue an investigation, the Commissioner must give the complainant written notice of the decision.

(3)     The notice must include reasons for the decision.

(4)     If:

the Commissioner may decide:

(c)     not to investigate the complaint; or

(5) If the Commissioner decides, under subsection (4):

(a)     not to investigate a complaint; or

(b)     to discontinue an investigation already commenced; the Commissioner must:

(c)     transfer the complaint to the Privacy Commissioner; and

(6) A complaint transferred under subsection (5) is taken to be a complaint made to the Privacy Commissioner under Part V of the Privacy Act 1988.

Division 2—Procedure and powers of Commissioner

Council to be informed of investigation

62. Before the Commissioner begins to investigate a complaint concerning reviewable action, the Commissioner must inform the Council of the impending investigation.

Procedure of Commissioner

63. The Commissioner is to conduct an investigation:

(a)     in private; and

(b)     in such manner as the Commissioner thinks fit.

Co-operation with Commissioner

64.(1) A person to whom this section applies must, in relation to the investigation of a complaint, co-operate with the Commissioner and provide the Commissioner with any assistance the Commissioner requests.

(2) In particular, a person to whom this section applies must:

(b)     answer any questions that the Commissioner asks;

that the Commissioner has reasonable grounds for believing are relevant to the investigation.

(3) This section applies to the following:

(a)     the Council;

(b)     a member of the Council;

(c)     a member of the staff of the Council referred to in section 45;

(d)     a member of a committee;

(e)     a consultant engaged under section 46;

Immunity from penalty

65. If a person:

(a)     provides information, documents or other records; or

(b)     answers a question;

in response to a request from the Commissioner, the person is not subject to any liability or penalty under the law of the Commonwealth, a State or a Territory because the person:

(c)     provides the information, documents or other records; or

(d)     answers the question.

Reports by Commissioner

66. If the Commissioner:

the Commissioner:

(c)     must report to the Council about the complaint; and

Recommendations

67.(1) The Commissioner may, in relation to reviewable action concerning which a complaint has been made, recommend to the Council that:

(e)     some other thing should be done in relation to the action.

(2)     A copy of the Commissioner’s recommendation made to the Council in respect of a particular complaint must be given to the complainant.

(3)     The Council must, having regard to the recommendation:

(a)     take whatever action it considers appropriate; and

Annual report of Commissioner

68. The Commissioner must, as soon as practicable after the end of each calendar year, give the Council a written report of the Commissioner’s activities during that year.

Division 3—Appointment, terms and conditions of Commissioner

Appointment of Commissioner

69.(1) The Commissioner is to be appointed by the Minister after consultation with the Council.

(2) The Minister is not to appoint a person as the Commissioner unless the person has a background and expertise in one or more of the following fields:

(a)     scientific research;

(b)     medical research;

(c)     public health research.

Terms and conditions of appointment of Commissioner

70.(1) The Commissioner is to be appointed on a part-time basis.

(2) The Commissioner holds office on terms and conditions that the Minister determines in writing.

Period of Commissioner’s appointment

71.(1) The Commissioner holds office for the period determined by the Minister and specified in the Commissioner’s instrument of appointment.

(2)     The period determined by the Minister under subsection (1) must not exceed 3 years.

(3)     The Commissioner is eligible for reappointment.

Commissioner may enter into arrangements with Department

72. The Commissioner may make arrangements with the Secretary to the Department for:

Acting appointment

73.(1) The Minister may appoint a person to act as the Commissioner:

(2) Anything done by a person purporting to act under an appointment under this section is not invalid merely because:

(a)     the occasion for the appointment had not arisen; or

(c)     the appointment had ceased to have effect; or

(d)     the occasion for the person to act had not arisen or had ceased.

Remuneration and allowances

74.(1) The Commissioner is to be paid:

(b)     such allowances as are prescribed.

(2) This section has effect subject to the Remuneration Tribunal Act 1973.

Leave of absence

75. The Minister may grant leave of absence to the Commissioner on the terms and conditions that the Minister determines.

Disclosure of interests of Commissioner in relation to investigation

76.(1) If:

the Commissioner:

(2) If, in relation to the investigation of a complaint:

(a) the Commissioner discloses an interest under subsection (1); and

the Minister may appoint a person to perform the functions and exercise the powers of the Commissioner in relation to the complaint.

(3) A person appointed by the Minister under subsection (2) is to be appointed:

(a)     on such terms and conditions; and

(b)     for such period;

as the Minister determines.

(4) Any recommendation made by a person appointed under subsection (2) in relation to a complaint has the same effect as if it had been made by the Commissioner.

Termination of appointment of Commissioner

77.(1) The Minister may terminate the appointment of the Commissioner for misbehaviour or for mental or physical incapacity.

(2) The Minister must terminate the Commissioner’s appointment if the Commissioner:

(3) If the Minister terminates the Commissioner’s appointment, the Minister must give the Commissioner a written notice:

(b)     setting out the reasons for the termination.

Commissioner to protect personal information

78.(1) The Commissioner must not, except in the performance or exercise of his or her functions or powers under this Act:

(a)     make a record of; or

(b)     disclose to any person;

any information about another person that the Commissioner has had access to in the performance or exercise of his or her functions or powers under this Act.

(2) Except for the purposes of this Act, a court must not require the Commissioner to:

(b)     disclose any matter or thing of which he or she had notice;

if the Commissioner has such possession or notice because of the performance or exercise of his or her functions or powers under this Act.

Protection from civil actions

79. No civil proceedings may be brought against the Commissioner or a person assisting the Commissioner under an arrangement made under section 72 in relation to loss, damage, or injury of any kind suffered by a person in the course of the proper performance or exercise of the functions or powers of the Commissioner or of the person assisting the Commissioner under this Act.

PART 9—MISCELLANEOUS

Confidential commercial information

80.(1) In this section:

“Chairperson” means the Chairperson of the Council;

‘information provider” means a person who provides confidential commercial information to a person referred to in subsection (2).

(2) A person who is:

(a)     a member of the Council; or

(b)     the Commissioner; or

(d)     a member of a committee; or

(e)     a consultant engaged under section 46; or

must not disclose any information in respect of any matter under consideration by the Council, a Principal Committee, a working committee or the Commissioner that:

(3) Subsection (2) does not apply to anything done in the performance of duties, or in the exercise of powers or functions, under this Act.

(4)     Subsection (2) does not preclude the disclosure of confidential commercial information to a court in any proceeding, but the court must do all things necessary to prevent disclosure of that information to any other person, except for the purposes of the proceedings.

(5)     Despite subsection (2), the Chairperson may deal with confidential commercial information acquired by a member, consultant or person assisting a committee referred to in that subsection because of being such a member, consultant or person assisting a committee, in the following ways:

(6) Despite subsection (2), the Commissioner may deal with confidential commercial information acquired by the Commissioner or a person assisting the Commissioner because of being the Commissioner or a person assisting the Commissioner, in the following ways:

(7) The Chairperson or the Commissioner must not disclose any confidential information under paragraph (5)(c) or (6)(c) unless he or she:

(c) has considered any comments made by the information provider.

Penalty: Imprisonment for 2 years

(8) If the Chairperson or the Commissioner discloses confidential commercial information to a person or body under this section:

(a)     that person or body; and

(b)     any person under the control of that person or body;

is subject to the same obligations as a person referred to in subsection (2) who had acquired the information in the circumstances set out in that subsection.

(9) Despite subsection (2), the Chairperson may permit the information to be disclosed to:

(a)     the Secretary to a Commonwealth Department; or

(b)     the chief officer of a Commonwealth authority; or

(d)     a person assisting a committee;

for the purposes of giving effect to arrangements entered into under section 40 or 48.

(10)     Despite subsection (2), the Commissioner may permit the information to be disclosed to a person assisting the Commissioner for the purposes of giving effect to an arrangement entered into under section 72.

(11)     A person:

(a)     to whom this section applies; and

must not at any time, directly or indirectly, disclose the information to any person, except for the purposes of the arrangement.

Penalty: Imprisonment for 2 years

(12) Subsection (11) applies to a person who is or was:

(b)     a chief officer of a Commonwealth or State authority; or

(13)     The powers conferred by subsections (9) and (10) are in addition to, and not in derogation of, the powers conferred by subsections (5) and (6).

(14)     Nothing in subsection (5), (6), (9) or (10) is to be taken to limit the generality of subsection (4) or the operation of subsection (3).

Protection from civil actions

81.(1) No civil proceedings may be brought against a member in relation to loss, damage or injury of any kind suffered by a person in the course of the proper performance or exercise of the member’s functions or powers under this Act.

(2) In subsection (1):

“member” means the following:

(a)     a member of the Council;

(b)     a member of a Principal Committee;

(c)     a member of a working committee;

(d)     a person assisting a committee;

(e)     the Secretary to the Council;

(f)      a member of the staff of the Council referred to in section 45.

Delegation

82.(1) The Minister may delegate the power of the Minister under section 23 to the Secretary to the Department.

(2) The Council may, by resolution, delegate all or any of its powers to all or any of the following:

(a)     a Principal Committee;

(b)     the Executive Committee;

(c)     the Secretary to the Council.

(3)     A Principal Committee may delegate all or any of its powers, including a power delegated to it by the Council, to a working committee established under section 39.

(4)     A delegate must exercise a power delegated by the Minister, the Council or a Principal Committee in accordance with any directions of the Minister, the Council or the Principal Committee, as the case requires.

(5)     A delegation by the Council or by a Principal Committee continues in force despite a change in membership of the Council or Principal Committee, as the case requires.

Annual reports

83.(1) The Council must, as soon as practicable after the end of each calendar year, give to the Minister a written report of its operations during that year.

(2) Without limiting subsection (1), the report must include the following:

(a)     details of the membership of the Council;

(3) The Minister must cause a copy of the report to be laid before each House of the Parliament within 15 sitting days of that House after the Minister receives the report.

Exemption from taxation

84.(1) Subject to subsection (2), the Council is not subject to taxation under any law of the Commonwealth or of a State or Territory.

(2) The regulations may provide that subsection (1) does not apply in relation to taxation under a specified law.

Regulations

85. The Governor-General may make regulations prescribing matters:

PART 10—TRANSITIONAL

Existing Council membership

86.(1) The persons who, immediately before the proclaimed day, had been members of the National Health and Medical Research Council established by the NHMRC Order by virtue of an appointment are to be taken, with effect from that day, to have been appointed by the Minister to the Council established under this Act and to be entitled to continue to hold office as members of the Council until 31 December 1993.

(2)     The persons who, immediately before the proclaimed day, had been members of the National Health and Medical Research Council established by the NHMRC Order by virtue of being chairpersons of Principal Committees established under that Order are to be taken, with effect from that day, because of the operation of section 88 or 89, as the case requires, to be members of the Council established under this Act and to continue to hold office as members of the Council until 31 December 1993 unless the Principal Committee concerned is abolished before that day.

(3)     The person who, immediately before the proclaimed day, had been a member of the National Health and Medical Research Council established by the NHMRC Order, by virtue of being the Secretary to the Council as so established, is to be taken, with effect from that day, to continue to be the Secretary to the Council established by this Act as if the Secretary to the Department had designated the office held by that person in the Department for the purposes of section 22.

Existing Council activities

87. Any application made, or act, matter or thing that was, immediately before the proclaimed day, being done to, by or in respect of, the National Health and Medical Research Council established by the NHMRC Order is to be treated on and after that day, as if it were an application made, or an act, matter or thing that had been done to, by or in respect of, the National Health and Medical Research Council established by this Act.

Existing Medical Research Committee

88.(1) Despite the repeal of the NHMRC Order on the proclaimed day, the Medical Research Committee established by subclause 6(1) of the Order and in existence immediately before that day continues in existence on and after that day as if:

(2)     The persons who, immediately before the proclaimed day, had been members of the Medical Research Committee as established by the NHMRC Order are to be taken, with effect from that day, to have been duly appointed to the Committee as continued in existence under subsection (1) and to be entitled to continue to hold office as members of that Committee until 31 December 1993.

(3)     Any act, matter or thing that was, immediately before the proclaimed day, being done to, by or in respect of the Medical Research Committee as established by the NHMRC Order may, on or after that

day, be continued as an act, matter or thing being done to, by or in respect of that Committee as continued in existence under subsection (1).

Other existing Principal Committees

89.(1) Despite the repeal of the NHMRC Order on the proclaimed day, the various Principal Committees, other than the Medical Research Committee established by subclause 6(1) of the Order and in existence immediately before that day, continue in existence, under their respective names, on and after that day, as if:

(2)     The persons who, immediately before the proclaimed day, had been members of a particular Principal Committee established by the NHMRC Order, other than the Medical Research Committee, are to be taken, with effect from that day, to have been appointed by the Minister to the respective committee as continued in force under subsection (1) and to be entitled to continue to hold office as members of that committee until 31 December 1993 unless the committee as continued in force is abolished before that day.

(3)     Any act, matter or thing that was, immediately before the proclaimed day, being done to, by or in respect of a Principal Committee established by the NHMRC Order other than the Medical Research Committee may, on and after that day, be continued as an act, matter or thing being done to, by or in respect of, that committee as continued in existence under subsection (1).

Existing ethics guidelines

90. The guidelines entitled the “NHMRC Statement on Human Experimentation and Supplementary Notes” in force immediately before the proclaimed day are taken, with effect from that day and with the exception of the Supplementary Note 4, to be in force as if they had been made under subparagraph 7(1)(a)(v) and in compliance with section 8 until they are revised by the Council under this Act.

References in other laws to NHMRC Statement etc.

91. In any Commonwealth law, or in any document issued under such a law:

guidelines in force, or taken to be in force, from time to time, under subparagraph 7(1)(a)(v) of this Act, that relate to the conduct of medical research involving humans; and

[Minister’s second reading speech made in—

House of Representatives on 25 June 1992

Senate on 17 September 1992]