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CONTENTS
Passage History
Purpose
Background
Main Provisions
Concluding Comments
Endnotes
Contact Officer and Copyright Details
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
-
- 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.
- National Health and Medical Research Council, 1997 Annual
Report, p 87.
- Ibid.
- Sweet M, "Despair as NHMRC Slips into Disarray",
The Sydney Morning Herald, 18 October 1998 and the
Explanatory Memorandum to the Bill, p 2.
- National Health and Medical Research Council, Extracts from the
126th Session Reports, discussing amendments to the
National Health and Medical Research Council Act 1992.
- National Health and Medical Research Council, Guidelines
for the Development and Implementation of Clinical Practice
Guidelines, 1998.
- 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.
- National Health and Medical Research Council, 1997 Annual
Report, pp 4-5.
Lesley Lang
2 December 1998
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ISSN 1328-8091
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