Bills Digest No. 58  1998-99 Health Legislation Amendment Bill (No.3) 1998


Numerical Index | Alphabetical Index

WARNING:
This Digest was prepared for debate. It reflects the legislation as introduced and does not canvass subsequent amendments. This Digest does not have any official legal status. Other sources should be consulted to determine the subsequent official status of the Bill.

CONTENTS

Passage History
Purpose
Background
Main Provisions
Concluding Comments
Endnotes
Contact Officer and Copyright Details

Passage History

Health Legislation Amendment Bill (No.3) 1998

Date Introduced:26 November 1998

House: House of Representatives

Portfolio: Health and Aged Care

Commencement: Royal Assent

Purpose

The purpose of the Health Legislation Amendment Bill (No.3) 1998 (the Bill) is to address administrative and procedural issues which may have impeded the National Health and Medical Research Council in the execution of its duties in a timely and efficient manner.

Background

1. National Health and Medical Research Council

The National Health and Medical Research Council Act 1992 (the Principal Act) established the National Health and Medical Research Council (Council) as a statutory body 56 years after its initial formation in 1936.

The Council comprises nominees of Commonwealth, State and Territory health authorities and the Aboriginal and Torres Strait Islander Commission, and people with a background in and knowledge of the medical and nursing professions, academia, trade unions, business, welfare, the environment and consumer issues.

The Council's strategies are pursued through three main programs, namely the Research Program, Advisory Program and Ethics Program. The Council has four Principal Committees that are responsible for planning and priority setting within each program.

2. Council Activities

The object of the Principal Act is to allow the national body to pursue activities designed:

  • to raise the standard of individual and public health throughout Australia
  • to foster the development of consistent health standards between the various States and Territories
  • to foster medical research and training and public health research and training throughout Australia, and
  • to foster consideration of ethical issues relating to health.

To the extent that it is practicable to do so, the Council must adopt a policy of public consultation in relation to individual and public health matters being considered by it from time to time.

3. Public Consultation Provisions

Section 12 of the Principal Act currently provides for a two step consultation process that must generally be followed prior to the Council making a regulatory recommendation, issuing guidelines or engaging in any other prescribed activity.(1)

The Council did not make any regulatory or interim regulatory recommendations in respect of the year ended 31 December 1997.(2)

The Council issued nine guidelines in 1997 covering such issues as guidelines for the control of meningococcal and a strategy for the detection and management of Hepatitis C in Australia.(3)

Council has issued 3 guidelines to 1 December 1998 covering acute pain management and toxicity assessment for carcinogenic soil contaminants. It did not make any regulatory or interim regulatory recommendations in the same period.

4. Adverse Comment

The Council has been the subject of some adverse comment suggesting that it has not discharged its functions in a timely and efficient manner. It appears that this may, in part, be due to administrative and procedural impediments.(4) The Bill proposes amendments to remedy some of the perceived difficulties in this area arising from the operation of the Principal Act. Particular attention is focused on streamlining the public consultation process for the issue of guidelines.

The Council submitted a proposal to the Minister seeking endorsement for changes to the Act(5) and the amendments sought have been incorporated into the Bill.

Main Provisions

Schedule 1 - Amendment of the National Health and Medical Research Council Act 1992

1. Amendments to the Public Consultation Process

Items 3 and 6 repeal sections 12 and 13 and insert new sections 12, 13, 14A and 14B, which distinguish, for the purposes of public consultation procedure, the issue of guidelines from other Council activities.

In summary, it is proposed that:

  • consultation for the making of a regulatory recommendation will remain a two step process (new section 12)
  • public consultation for the issue of guidelines will change to a one step process (new section 13)
  • the Council will continue to be able to issue guidelines prepared by external parties, but it is proposed that it may dispense with its prescribed consultation procedures in relation to those guidelines if it is clear that the party which prepared the guidelines followed a rigorous consultation process themselves, and (new section 14A)
  • the Council will continue to be able to dispense with or modify consultation procedures in certain circumstances. (new section 14B)

1.1 Public consultation required before making regulatory recommendations or engaging in other prescribed activities (other than issuing guidelines)

New section 12 states that before Council makes a regulatory recommendation or engages in any other prescribed activity it must consult persons or bodies in accordance with the steps set out in the section.

The section provides for a two step process requiring:

  • the publishing of a notice which states the Council's intention to make a recommendation or engage in an activity, and
  • the publishing of a notice which contains a summary of the consequent draft recommendation or outline of proposed activity and a statement detailing where copies of the draft or outline can be obtained.

Both notices must also contain a statement inviting submissions relating to the proposed recommendation or activity, the subject of the notice.

If the Council no longer proposes to make the recommendation or engage in the prescribed activity, then it must issue a notice to that effect.

1.2 Public consultation required before issuing guidelines

New section 13 states that before the Council issues guidelines it must:

  • after preparing a draft of the guidelines that the Council proposes to issue, publish a notice, which contains a summary of the draft guidelines and a statement detailing where copies of the draft can be obtained.

The notice must also contain a statement inviting submissions relating to the draft guidelines.

1.3. Approval of guidelines prepared by external parties

New section 14A streamlines the procedures for issuing guidelines prepared by another person or body.

The Council has issued a document setting out the standards that Council endorses in respect of implementation and development of clinical practice guidelines.(6)

Many organisations are implementing the standards endorsed by Council. It is therefore duplicating effort and causing unnecessary time delays to put externally generated guidelines through additional consultation processes as currently required by the legislation.

Accordingly, new section 14A states that if the Council is satisfied that the person or body who prepared the guidelines followed the same procedures that the Council itself would be obliged to follow (as set out in point 1.2 above) then the Council may approve the guidelines.

1.4 Consultation by Council may be dispensed with or modified in certain circumstances

Pursuant to new section 14B if Council is satisfied that proposed regulatory recommendations, guidelines or other activities raise issues that are of minor significance only the Council may omit all or any of the steps referred to in new sections 12, 13 or 14A.

Under new subsection 14B(2) Council must publish a notice setting out its reasons for its decision.

2. Principal Committees

2.1 Ministerial Obligations and powers

Under section 35(1) of the Principal Act the Minister must establish two Principal Committees, the Medical Research Committee and the Australian Health Ethics Committee.

Pursuant to section 35(5) the Minister may establish or abolish such other Principal Committees, as the Minister thinks necessary to assist Council to carry out any of its functions.

2.2 Restructuring of Committees

It is proposed to abolish the previously constituted Public Health Research and Development Committee and to include in the functions of the present Medical Research Committee matters relating to public health research.

To recognise the change in function it is also proposed to change all references to the 'Medical Research Committee' to 'Research Committee'.

Items 1 and 7 amend sections 4 and 35 of the Principal Act to omit all references to 'Medical Research Committee' and substitute 'Research Committee'.

Items 17 and 18 amend paragraphs 56(2)(c) and 67(1)(a) to reflect the name change.

Item 8 amends paragraph 35(2)(c) to include a reference to public health research in the functions of the renamed Research Committee.

3. Provisions relating to meetings of Principal Committees and the Executive Committee and appointment and duties of Deputy Chairpersons of those Committees

These amendments appear to be purely procedural refinements to the existing administrative structure to facilitate greater efficiency in the discharge of Council duties.

3.1 Appointment of Deputy Chairpersons

Item 9 inserts new section 37A, which allows for the appointment of a Deputy Chairperson to Principal and Executive Committees. This should help alleviate the heavy workloads and commitments of respective Chairpersons.

Item 10 amends subparagraph 38(b)(iii) to insert a reference to the Deputy Chairperson. This will mean that the Council is only obliged to appoint a member to preside at meetings if both the Chairperson and Deputy Chairperson are unavailable.

3.2 Council may establish working committees

Items 11, 12 and 13 amend section 39 to confer on Council powers analogous to those of Principal Committees to establish working committees. Consequential amendments are made to subsections 42(2), 43(3) and 44(4).

3.3 Council may delegate its powers to the Chairperson

Items 19 and 20 insert new paragraphs 82(2)(aa) and 82(2)(ba) to allow Council to delegate its powers to the Chairperson of the Council. This would permit streamlining of procedures. Currently Council can only delegate powers to a Principal Committee or Executive Committee.

Concluding Comments

1. Triennium Appointments

One of the identified sources of administrative difficulty relates to provisions concerning the appointment of members.

Section 26(1) states that an appointed member will hold office for a period not exceeding 3 years.

A member is eligible for re-appointment but there has been no practice of rotating membership to enable the transfer of corporate knowledge in an expedient manner. Thus every triennium substantive and valuable information is lost to the Council.

Apparently a submission has been made to the Minister seeking his endorsement for the proposal to rotate one half of the Council each half term.(7) It is not clear whether this will be achieved initially by terminating half the current membership appointments early or extending appointments for a further half term.

Section 21(6) does permit this process but it does not impose an obligation on the Minister or the Council to follow the procedure in the future.

2. Current Committee Structure Mirrors Proposed Amendments

The 1997 Annual Report of Council indicates that amendments to the Principal Committees proposed by the Bill have already been implemented. It states(8) that the Council has four Principal Committees, namely the Research Committee (for Public Health and Medical), the Strategic Research Development Committee, the Health Advisory Committee and the Australian Health Ethics Committee.

Endnotes

  1. Section 12 is subject to sections 13 and 14 which empower the Council to dispense with or modify the public consultation process if a proposed activity raises issues that are of minor significance only or if the Council is of the opinion that matters require urgent attention and should be the subject of interim regulatory recommendations or guidelines.

  2. National Health and Medical Research Council, 1997 Annual Report, p 87.

  3. Ibid.

  4. Sweet M, "Despair as NHMRC Slips into Disarray", The Sydney Morning Herald, 18 October 1998 and the Explanatory Memorandum to the Bill, p 2.

  5. National Health and Medical Research Council, Extracts from the 126th Session Reports, discussing amendments to the National Health and Medical Research Council Act 1992.

  6. National Health and Medical Research Council, Guidelines for the Development and Implementation of Clinical Practice Guidelines, 1998.

  7. National Health and Medical Research Council, Extracts from the 125th and 126th Session Reports, discussing amendments to the National Health and Medical Research Council Act 1992.

  8. National Health and Medical Research Council, 1997 Annual Report, pp 4-5.

 

Contact Officer and Copyright Details

Lesley Lang
2 December 1998
Bills Digest Service
Information and Research Services

This paper has been prepared for general distribution to Senators and Members of the Australian Parliament. While great care is taken to ensure that the paper is accurate and balanced, the paper is written using information publicly available at the time of production. The views expressed are those of the author and should not be attributed to the Information and Research Services (IRS). Advice on legislation or legal policy issues contained in this paper is provided for use in parliamentary debate and for related parliamentary purposes. This paper is not professional legal opinion. Readers are reminded that the paper is not an official parliamentary or Australian government document.

IRS staff are available to discuss the paper's contents with Senators and Members
and their staff but not with members of the public.

ISSN 1328-8091
© Commonwealth of Australia 1998

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Published by the Department of the Parliamentary Library, 1998.

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