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This is a Bill, not an Act. For current law, see the Acts databases.
1998-1999-2000-2001
The
Parliament of the
Commonwealth of
Australia
HOUSE OF
REPRESENTATIVES
Presented and read a first
time
Health
Legislation Amendment Bill (No. 3)
2001
No. ,
2001
(Health and Aged
Care)
A Bill for an Act to amend
legislation relating to health, and for related purposes
Contents
Therapeutic Goods Act
1989 3
Therapeutic Goods Amendment (Medical Devices) Act
2001 8
Health Insurance Act
1973 9
Health Insurance Amendment (Professional Services Review) Act
1999 17
Health Insurance Commission (Reform and Separation of Functions) Act
1997 19
Health Insurance Act
1973 20
National Health Act
1953 21
Health Insurance Act
1973 22
A Bill for an Act to amend legislation relating to
health, and for related purposes
The Parliament of Australia enacts:
This Act may be cited as the Health Legislation Amendment Act
(No. 3) 2001.
(1) Subject to this section, this Act commences on the 28th day after the
day on which it receives the Royal Assent.
(2) If Schedule 1 to the Therapeutic Goods Amendment (Medical
Devices) Act 2001 commences before this section, items 3 and 21 of
Schedule 1 to this Act do not commence.
(3) If Schedule 1 to the Therapeutic Goods Amendment (Medical
Devices) Act 2001 does not commence before this section:
(a) item 4 of Schedule 1 to this Act does not commence;
and
(b) item 21 of Schedule 1 to this Act commences immediately
after the commencement of Schedule 1 to the Therapeutic Goods Amendment
(Medical Devices) Act 2001.
(4) Schedule 4 commences at the later of:
(a) the time when Parts 4 to 10 of the Administrative Review
Tribunal Act 2001 commence; and
(b) immediately after the commencement of Schedule 2 to this
Act.
(5) Schedule 6 commences, or is taken to have commenced, immediately
after the commencement of item 15 of Schedule 1 to the Health
Legislation Amendment (Medical Practitioners’ Qualifications and Other
Measures) Act 2001.
Subject to section 2, 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this Act is amended or repealed as set out in the applicable items in the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.
1 Subsection 3(1) (definition of approved
conformity assessment body)
Repeal the definition.
2 Subsection 3(1) (definition of conformity
assessment body)
Repeal the definition.
3 Subsection 3(1) (definition of conformity
assessment certificate)
Repeal the definition.
4 Subsection 3(1) (definition of conformity
assessment certificate)
Repeal the definition, substitute:
conformity assessment certificate means a certificate issued
under section 41EE.
5 Subsection 3(1)
Insert:
EC/EFTA attestation of conformity means an attestation of
conformity (within the meaning of the EC Mutual Recognition Agreement or the
EFTA Mutual Recognition Agreement) issued by an EC/EFTA conformity assessment
body that is approved by the Secretary in writing.
6 Subsection 3(1)
Insert:
EC/EFTA conformity assessment body means a Conformity
Assessment Body designated in one of the following Sectoral Annexes to the EC
Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement:
(a) Sectoral Annex (Medical Devices);
(b) Sectoral Annex (Medicinal Products GMP Inspection and Batch
Certification).
7 Subsection 3(1)
Insert:
international instrument means:
(a) any treaty, convention, protocol, agreement or other instrument that
is binding in international law; and
(b) a part of such a treaty, convention, protocol, agreement or other
instrument.
8 Subsection 3(1)
Insert:
non-EC/EFTA attestation of conformity, for a non-EC/EFTA MRA,
means an attestation of conformity issued, after the non-EC/EFTA MRA has come
into force, by a conformity assessment body that is designated in the
non-EC/EFTA MRA and approved by the Secretary in writing for the non-EC/EFTA
MRA.
9 Subsection 3(1)
Insert:
non-EC/EFTA MRA means an international instrument that
Australia is bound by, or is a party to, if:
(a) a purpose of the instrument is the recognition of attestations of
conformity; and
(b) the instrument satisfies the requirements (if any) set out in
regulations made for the purposes of this paragraph;
but does not include:
(c) the EC Mutual Recognition Agreement; or
(d) the EFTA Mutual Recognition Agreement.
10 After section 3A
Insert:
(1) The Minister may declare, in writing, that a country specified in the
declaration is covered by the non-EC/EFTA MRA specified in the
declaration.
(2) A declaration under subsection (1) must be published in the
Gazette.
11 At the end of
section 24D
Add:
(6) Despite subsection (5), if:
(a) the Secretary has given the applicant all evaluation reports relating
to the application; and
(b) the Secretary has given those reports, or proposes to give those
reports, to a committee established under the regulations to advise the
Secretary on applications to register therapeutic goods to which
subsection (1) applies; and
(c) the applicant withdraws the application after being given the reports,
and before the end of the period mentioned in subsection (1);
the evaluation is taken for the purposes of subsections (2), (3) and
(4) to be completed immediately before the time of withdrawal.
12 Subparagraph 25(2)(a)(i)
Repeal the subparagraph, substitute:
(i) if the goods are not therapeutic devices and a step in the manufacture
of the goods has been carried out in a country that is a member of the European
Community or a member of EFTA—an EC/EFTA attestation of conformity in
relation to the goods; or
(ia) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a country declared by the
Minister under section 3B to be covered by a non-EC/EFTA MRA—a
non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to
the goods; or
13 Paragraph 25B(1)(b)
Omit “a conformity assessment certificate”, substitute
“an EC/EFTA attestation of conformity”.
Note: The heading to section 25B is altered by omitting
“conformity assessment certificate” and substituting
“EC/EFTA attestation of conformity”.
14 Subparagraph 26(2)(a)(i)
Repeal the subparagraph, substitute:
(i) if the goods are not therapeutic devices and a step in the manufacture
of the goods has been carried out in a country that is a member of the European
Community or a member of EFTA—an EC/EFTA attestation of conformity in
relation to the goods; or
(ia) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a country declared by the
Minister under section 3B to be covered by a non-EC/EFTA MRA—a
non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to
the goods; or
15 Paragraph 26AA(1)(b)
Omit “a conformity assessment certificate”, substitute
“an EC/EFTA attestation of conformity”.
Note: The heading to section 26AA is altered by
omitting “conformity assessment certificate” and substituting
“EC/EFTA attestation of conformity”.
16 Subparagraph
26A(4)(a)(i)
Repeal the subparagraph, substitute:
(i) if a step in the manufacture of the medicine has been carried out in a
country that is a member of the European Community or a member of EFTA—an
EC/EFTA attestation of conformity in relation to the medicine; or
(ia) if a step in the manufacture of the medicine has been carried out in
a country declared by the Minister under section 3B to be covered by a
non-EC/EFTA MRA—a non-EC/EFTA attestation of conformity, for the
non-EC/EFTA MRA, in relation to the medicine; or
17 After paragraph 37(1)(d)
Insert:
(da) if the applicant proposes to carry out steps in the manufacture of
blood or blood components under the licence—contain information relating
to those steps set out in regulations made for the purposes of this paragraph;
and
18 After paragraph 40(4)(a)
Insert:
(aa) if:
(i) the holder of the licence carries out, or proposes to carry out, steps
in the manufacture of blood or blood components under the licence; and
(ii) regulations made for the purposes of this paragraph set out
particular information relating to those steps;
comply with a request by the Secretary to provide such information, in
accordance with those regulations; and
19 Application
(1) The amendment made by item 11 applies in relation to applications
made on or after the commencement of that item.
(2) The amendment made by item 17 applies in relation to applications
for licences made on or after the commencement of that item.
(3) Paragraph 40(4)(a) of the Therapeutic Goods Act 1989 as amended
by this Schedule applies in relation to a request made under that paragraph on
or after the commencement of this item, even if the licence to which the request
relates was granted before that commencement.
20 Transitional
(1) An approval of a body as an approved conformity assessment body that
was in force under the Therapeutic Goods Act 1989 immediately before the
commencement time has effect after the commencement time as if it were an
approval of the body by the Secretary in writing for the purposes of the
definition of EC/EFTA attestation of conformity in subsection 3(1)
of the Therapeutic Goods Act 1989 as in force after the commencement
time.
(2) In subitem (1):
commencement time means the time at which this item
commences.
Therapeutic Goods
Amendment (Medical Devices) Act
2001
21 Item 7 of
Schedule 1
Repeal the item, substitute:
7 Subsection 3(1)
Insert:
conformity assessment certificate means a certificate issued
under section 41EE.
1 Subsection 19D(11) (at the end of the
definition of disqualified practitioner)
Add:
; or (c) who is fully disqualified under an agreement that is in effect
under section 92; or
(d) who is fully disqualified under section 105; or
(e) in relation to whom a final determination under section 106TA
containing a direction under paragraph 106U(1)(h) that the practitioner be fully
disqualified is in effect; or
(f) who is fully disqualified for the purposes of this section under
section 106ZPM.
2 Subparagraph
23B(7)(a)(ii)
Omit “section 106T”, substitute
“section 106TA”.
3 Subparagraph
23B(7)(b)(ii)
Omit “section 106T”, substitute
“section 106TA”.
4 Subsection 23D(2)
Repeal the subsection, substitute:
(2) A determination takes effect at the end of the 28 day period beginning
on the day on which the notification of the determination was served on the
person.
(3) If an application for review of the determination is made under
section 23DAA within the period allowed for the application,
subsection (2) operates subject to any order by the Administrative Appeals
Tribunal or by a court in relation to the application.
5 At the end of
Part II
Add:
Application may be made to the Administrative Appeals Tribunal for review
of a determination (within the meaning of section 23D).
Note: Under section 27A of the Administrative
Appeals Tribunal Act 1975, the decision-maker must notify persons whose
interests are affected by the making of the decision of their right to have the
decision reviewed. In notifying any such persons, the decision-maker must have
regard to the Code of Practice determined under section 27B of that
Act.
6 Section 23DA (paragraph (e) of the
definition of relevant person)
Omit “section 106T”, substitute
“section 106TA”.
7 Paragraph 23DC(6)(d)
Omit “section 106T”, substitute
“section 106TA”.
8 Paragraph 23DF(7)(c)
Omit “section 106T”, substitute
“section 106TA”.
9 Section 81 (paragraph (a) of the
definition of legal services)
Before “an adjudicative referral”, insert “an instrument
making”.
10 At the end of
section 89
Add:
(3) To avoid doubt, the Director may consider the conduct mentioned in
subsection (6) in deciding whether to set up (and make an adjudicative
referral to) a Committee to consider whether the person under review has engaged
in inappropriate practice in connection with rendering or initiating the
referred services.
(4) The Director may, in making that decision, consider that conduct only
to the extent that it is in connection with rendering or initiating those
services.
(5) The Director may, in making that decision, consider that conduct
whether or not it was mentioned:
(a) in the reasons given by the Commission under paragraph 86(4)(b);
or
(b) during any prior counselling of the person under review.
(6) The conduct for the purposes of subsection (3) is as
follows:
(a) the conduct of the person under review;
(b) the conduct of a practitioner employed by the person under
review;
(c) the conduct of a practitioner employed by a body corporate of which
the person under review is an officer.
11 After subsection 93(1)
Insert:
(1A) To avoid doubt, the instrument making the adjudicative referral need
not specify conduct by the person under review.
12 Subsection 93(3)
Before “an adjudicative referral”, insert “an instrument
making”.
13 Subsection 93(4)
Before “adjudicative referrals”, insert “instruments
making”.
14 Paragraph 93(6)(b)
Before “adjudicative referral”, insert “instrument making
the”.
15 Subsection 93(7)
Before “adjudicative referral”, insert “instrument making
the”.
16 Subsection 93(8)
Before “adjudicative referral”, insert “instrument making
the”.
17 At the end of
section 102
Add:
(4) The notice may require the person under review to appear at the
hearing and give evidence to the Committee.
18 Sections 104 and
105
Repeal the sections, substitute:
(1) This section has effect if:
(a) the notice under section 102 requires the person under review to
appear at the hearing and give evidence to the Committee; and
(b) the person under review:
(i) fails to appear at the hearing; or
(ii) appears at the hearing but refuses or fails to give evidence or to
answer a question that the person is asked by a Committee member in the course
of the hearing.
(2) If the person under review is a practitioner, the Committee may
notify the Director of the person’s failure to appear at the hearing or
refusal or failure to give the evidence or to answer the question.
(3) The Committee may in any case:
(a) proceed with the hearing, despite section 103, even though the
person under review fails to appear or appears but refuses or fails to give
evidence or to answer a question; or
(b) propose to hold another hearing in accordance with
section 102.
(4) If the person under review subsequently:
(a) appears at a hearing; and
(b) gives evidence as required; and
(c) answers every question that the person is asked by a Committee member
in the course of the hearing;
then:
(d) paragraph (3)(a) ceases to apply; and
(e) the Committee must inform the Director that the person has appeared
and given evidence and answered questions (as required).
(5) Subsection (2) and paragraph (3)(a) do not apply
if:
(a) before the hearing takes place, the person notifies the Committee that
he or she has a medical condition preventing him or her from appearing or from
giving evidence or answering questions; and
(b) the person has complied with any reasonable requirements of the
Committee that he or she undergo medical examination to establish the existence
and extent of the medical condition; and
(c) the results of the medical condition indicate that the person has a
medical condition preventing him or her from appearing or from giving evidence
or answering questions.
(6) Subsection (2) and paragraphs (3)(b) and (4)(c) do not apply
in relation to a question if:
(a) the person under review refuses to answer the question on the ground
that the answer to the question might tend to incriminate him or her;
and
(b) the Committee believes that the answer might tend to do so.
(1) As soon as practicable after receiving a notice under subsection
104(2), the Director must:
(a) fully disqualify the person under review; and
(b) give the Commission written notice of the disqualification.
(2) As soon as practicable after being informed under paragraph 104(4)(e),
the Director must:
(a) revoke the disqualification; and
(b) give the Commission written notice of the revocation.
(3) If the person under review is disqualified under subsection (1),
the person may request the Committee, in writing, to hold another hearing in
accordance with section 102. The Committee must comply with the request as
soon as practicable.
(4) A request under subsection (3) must be made no later than 21 days
after the day on which a copy of a draft report is given to the person under
subsection 106KD(3).
19 Paragraph 106G(2)(a)
Before “the adjudicative referral”, insert “the
instrument making”.
20 Subsection 106H(1)
Before “adjudicative referral”, insert “instrument making
the”.
21 After subsection 106H(1)
Insert:
(1A) To avoid doubt, the Committee may consider the conduct
mentioned in subsection (1D) in finding whether the person under review has
engaged in inappropriate practice in connection with rendering or initiating
some or all of the specified services.
(1B) The Committee may, in making that finding, consider that conduct only
to the extent that it is in connection with rendering or initiating those
services.
(1C) The Committee may, in making that finding, consider that conduct
whether or not it was mentioned:
(a) in the reasons given by the Commission under paragraph 86(4)(b);
or
(b) in the reasons given by the Director under paragraph 93(6)(a);
or
(c) during any prior counselling of the person under review.
(1D) The conduct for the purposes of subsection (1A) is as
follows:
(a) the conduct of the person under review;
(b) the conduct of a practitioner employed by the person under
review;
(c) the conduct of a practitioner employed by a body corporate of which
the person under review is an officer.
22 Subsection 106H(2)
Omit “Despite subsection (1)”, substitute “Despite
subsections (1) and (1B)”.
23 After section 106S
Insert:
(1) The Director may give the Determining Authority any information that
the Director considers is relevant to the Authority making its draft
determination or final determination in accordance with
section 106U.
(2) The information must be given no later than the day on which the
Committee’s final report is given to the Determining Authority under
subsection 106L(4).
(3) If the Director gives the Determining Authority information under
subsection (1) at a particular time, the Director must also give the
information to the person under review at that time.
(4) The Determining Authority must consider the information in making its
draft determination or final determination in accordance with
section 106U.
24 Section 106ZPM
After “rendered”, insert “or initiated”.
25 At the end of
section 106ZPM
Add:
(2) If the Director considers that subsection (1) prevents medicare
benefits from being payable in respect of services rendered by the person under
review, the Director must give a notice to that effect to the person.
(3) The Director must give a copy of a notice under subsection (2) to
the Commission.
(4) If:
(a) subsection (1) prevents medicare benefits from being payable in
respect of services rendered by the person under review at a time; and
(b) the Director gave a notice under subsection (2) to the person
before that time;
the person is taken to be fully disqualified at that time for the purposes
of section 19D.
26 Paragraph 124FAA(2)(a)
Omit “section 106T”, substitute
“section 106TA”.
27 Subsection 124FAA(6)
Omit “section 106T”, substitute
“section 106TA”.
28 Section 129AD
Omit “section 106T”, substitute
“section 106TA”.
29 Application
(1) The amendment made by item 1 applies in relation to a person who,
on or after the day on which that item commences, becomes:
(a) fully disqualified under an agreement that is in effect under
section 92 of the Health Insurance Act 1973; or
(b) fully disqualified under section 105 of that Act; or
(c) fully disqualified in accordance with a direction under paragraph
106U(1)(h) of that Act contained in a final determination under
section 106TA of that Act; or
(d) fully disqualified for the purposes of section 19D of that Act
under section 106ZPM of that Act.
(2) The amendments made by items 4 and 5 apply in relation to
determinations made after the commencement of item 63 of Schedule 1 to
the Health Insurance Amendment (Professional Services Review) Act
1999.
(3) If such a determination was made before the commencement of this item,
subsection 23D(3) of the Health Insurance Act 1973 (as amended by this
Schedule) operates as if the reference in that subsection to the period allowed
for the application were a reference to the period of 28 days beginning on the
day of that commencement.
(4) The amendments made by items 17 and 18 apply in relation to
hearings held by Committees that are set up under section 93 of the
Health Insurance Act 1973 on or after the commencement of those
items.
(5) The amendments made by items 24 and 25 apply:
(a) in relation to a refusal or failure to comply with a requirement in a
notice under subsection 89B(2) of the Health Insurance Act 1973—if
the notice was given in relation to an investigative referral made on or after
the commencement of that item; or
(b) in relation to a refusal or failure to comply with a requirement in a
notice under subsection 105A(2) of that Act—if the notice was given by a
Committee set up under section 93 of that Act on or after the commencement
of that item.
30 Transitional
(1) In determining the meaning that Part VAA of the Health
Insurance Act 1973 had before the commencement of this item, the amendments
of that Part made by items 9, 11, 12, 13, 14, 15, 16, 19 and 20 are to be
disregarded.
(2) For the purposes of section 106SA of the Health Insurance Act
1973 (as inserted by item 23) , the Director may, on or after
the commencement of that item, give information to the Determining Authority
under that section even if the Committee’s final report to which the
information relates was prepared before the commencement of that item.
Health Insurance Amendment
(Professional Services Review) Act 1999
31 Item 65 of
Schedule 1
Omit “67(3)”, substitute “67(3), (3A)”.
32 At the end of subitem 67(3) of
Schedule 1
Add “but not on or after the commencement of Schedule 2
to the Health Legislation Amendment Act (No. 3)
2001”.
33 After subitem 67(3) of
Schedule 1
Insert:
(3A) Despite item 65, on or after the commencement of
Schedule 2 to the Health Legislation Amendment Act (No. 3)
2001:
(a) a Committee may exercise the power conferred on it by
section 105A of the Health Insurance Act 1973 (as amended by this
Schedule) in respect of an old matter; and
(b) the amendments made by this Schedule to the Health Insurance Act
1973 apply in relation to the exercise of the power by the
Committee.
34 Item 68 of
Schedule 1
Insert:
commencement of this Schedule means the commencement of this
Schedule (other than items 8 and 27).
Health Insurance
Commission (Reform and Separation of Functions) Act
1997
1 Item 81 of
Schedule 1
Omit “5”, substitute “7”.
1 Subsection 23D(3)
Omit “Administrative Appeals Tribunal”, substitute
“Administrative Review Tribunal”.
2 Section 23DAA
Omit “Administrative Appeals Tribunal”, substitute
“Administrative Review Tribunal”.
3 Section 23DAA (note)
Repeal the note, substitute:
Note: Section 56 of the Administrative Review
Tribunal Act 2001 requires the decision-maker to notify persons whose
interests are affected by the decision of the making of the decision and their
right to have the decision reviewed. In so notifying, the decision-maker must
have regard to guidelines issued under subsection (4) of that
section.
1 Subsection 67(7)
Repeal the subsection.
2 Subparagraph (s)(i) of
Schedule 1
Omit “6”, substitute “3”.
1 Subsection 19AB(4A)
Omit “subsection (4A)”, substitute
“subsection (4B)”.