Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Act 2025

No. 38, 2025

An Act to amend the law relating to health, and for related purposes

Contents

1 Short title 1

2 Commencement 2

3 Schedules 3

Schedule 1—Medicare integrity amendments 4

Part 1—Amendments relating to timeframe for bulk-billed claims 4

Division 1—Amendments commencing the day after Royal Assent 4

Dental Benefits Act 2008 4

Division 2—Contingent amendments if amendments relating to assignment of medicare benefits have not yet commenced 4

Health Insurance Act 1973 4

Division 3—Amendments commencing when Division 1 and amendments relating to assignment of medicare benefits have both commenced 5

Health Insurance Act 1973 5

Part 2—Amendments relating to criminal offences 6

Human Services (Medicare) Act 1973 6

Part 3—Amendments relating to approvals of pharmacists 9

Division 1—Requests for Minister to approve pharmacists 9

National Health Act 1953 9

Division 2—Other amendments 11

National Health Act 1953 11

Schedule 2—Therapeutic goods amendments 12

Part 1—Vaping measures 12

Therapeutic Goods Act 1989 12

Part 2—Persons assisting 16

Therapeutic Goods Act 1989 16

Part 3—Forfeiture 19

Therapeutic Goods Act 1989 19

Part 4—Enforceable directions 20

Therapeutic Goods Act 1989 20

Part 5—Delegation 21

Therapeutic Goods Act 1989 21

Part 6—Therapeutic goods shortages 22

Therapeutic Goods Act 1989 22

Part 7—Biologicals and breaching conditions of exemptions, approvals or authorities 24

Therapeutic Goods Act 1989 24

Part 8—Review of decisions 29

Therapeutic Goods Act 1989 29

Part 9—Other amendments 30

Therapeutic Goods Act 1989 30

Schedule 3—Public health tobacco amendments 32

Part 1—Advertisements of e-cigarette products that are vaping goods 32

Public Health (Tobacco and Other Products) Act 2023 32

Part 2—Sponsorship 34

Public Health (Tobacco and Other Products) Act 2023 34

Part 3—Phasing-in and phasing-out of tobacco product requirements 35

Public Health (Tobacco and Other Products) Act 2023 35

Part 4—Appointment of authorised officers 40

Public Health (Tobacco and Other Products) Act 2023 40

Schedule 4—Additional amendments to improve medicare integrity 41

Part 1—Amendments relating to administrative inquiries and recovery of overpayments 41

Division 1—Administrative inquiries 41

Health Insurance Act 1973 41

Division 2—Recovery of overpayments 44

Health Insurance Act 1973 44

Part 2—Use and derivative use immunity 47

Health Insurance Act 1973 47

Part 3—Transitional rules for amendments made by this Schedule 50

Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Act 2025

No. 38, 2025

An Act to amend the law relating to health, and for related purposes

[Assented to 4 September 2025]

The Parliament of Australia enacts:
1 Short title

This Act is the Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Act 2025.
2 Commencement 1

Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information Commencement information Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day this Act receives the Royal Assent. 4 September 2025
2. Schedule 1, Part 1, Division 1 The day after this Act receives the Royal Assent. 5 September 2025
3. Schedule 1, Part 1, Division 2 At the same time as the provisions covered by table item 2. However, the provisions do not commence at all if Schedule 1 to the Health Insurance Legislation Amendment (Assignment of Medicare Benefits) Act 2024 commences before that time. 5 September 2025
4. Schedule 1, Part 1, Division 3 The later of: (a) the commencement of the provisions covered by table item 2; and (b) immediately after the commencement of Schedule 1 to the Health Insurance Legislation Amendment (Assignment of Medicare Benefits) Act 2024.
5. Schedule 1, Parts 2 and 3 The day after this Act receives the Royal Assent. 5 September 2025
6. Schedules 2 to 4 The day after this Act receives the Royal Assent. 5 September 2025

Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act.

 2

Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act.
3 Schedules

Legislation 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.
Medicare integrity amendments

Dental Benefits Act 2008

 1 Subsection 15(2)

Omit “2 years”, substitute “1 year”.

 2 Application provision

The amendment of subsection 15(2) of the Dental Benefits Act 2008 made by this Division applies in relation to a claim for a dental benefit in respect of a dental service that is rendered on or after the commencement of this Division.

Health Insurance Act 1973

 3 Paragraph 20B(2)(b)

Omit all the words after “within”, substitute:

the following period after the rendering of the professional service, or such further period as is allowed in accordance with subsection (3A):

 i

if the claim is for a medicare benefit the right to the payment of which has been assigned under subsection 20A(2A)—2 years;

 ii

otherwise—1 year.

 4 Subsection 20B(3A)

Omit “lodging the claim than the period of 2 years referred to in paragraph (1)(b) or (2)(b)”, substitute “making the claim”.

 5 Subsection 20B(3B)

Omit “lodging”, substitute “making”.

 6 Application provision

The amendment of paragraph 20B(2)(b) of the Health Insurance Act 1973 made by this Division applies in relation to a claim for a medicare benefit in respect of a professional service that is rendered on or after the commencement of this Division.

Health Insurance Act 1973

 7 Paragraph 20B(1)(c)

Repeal the paragraph, substitute:

 c

within the following period after the rendering of the service, or such further period as is allowed in accordance with subsection (3A):

 i

(i) if the claim is for a medicare benefit the right to the payment of which would be taken to have been assigned under subsection 20A(2)—2 years;

 ii

otherwise—1 year.

 8 Application provision

Paragraph 20B(1)(c) of the Health Insurance Act 1973, as inserted by this Division, applies in relation to a claim for a medicare benefit in respect of a professional service that is rendered on or after the commencement of this Division.

Human Services (Medicare) Act 1973

 9 Section 3A

Repeal the section, substitute:

 3A Definition of relevant offence 1

(1) For the purposes of this Act, a relevant offence is any of the following:

 a

(a) an offence against the Health Insurance Act 1973;

 b

(b) an offence against the National Health Act 1953;

 c

(c) an offence against the Health and Other Services (Compensation) Act 1995;

 d

(d) an offence against the Medical Indemnity Act 2002;

 e

(e) an offence against the Dental Benefits Act 2008;

 f

(f) an offence against the Midwife Professional Indemnity (Commonwealth Contribution) Scheme Act 2010;

 g

(g) an offence against Criminal Code, that relates to:Division 134, 135, 136, 137, 141, 142, 144, 145, 372 or 400 of the

i

a claim for payment in respect of a professional service, dental service or supply or purported supply of pharmaceutical benefits; or

 ii

an indemnity scheme payment; or

 iii

(iii) a Commonwealth contribution (within the meaning of the Midwife Professional Indemnity (Commonwealth Contribution) Scheme Act 2010);

 h

(h) an offence against Crimes Act 1914, or section 11.1, 11.2, 11.2A, 11.3, 11.4 or 11.5 of the Criminal Code, that relates to an offence mentioned in another paragraph of this subsection.section 6 of the

2

In this section:

dental service has the same meaning as in the Dental Benefits Act 2008.

indemnity scheme payment has the same meaning as in the Medical Indemnity Act 2002.

professional service has the same meaning as in the Health Insurance Act 1973.

 10 Subsection 8U(1)

Omit “within the previous 60 days”.

 11 Paragraph 8ZG(3)(d)

Repeal the paragraph, substitute:

 d

the disposal, by either of the following means, of any other reproduction of the data in the control of a Departmental employee:

 i

returning the reproduction to a person who is the occupier of the premises at that time;

 ii

destroying the reproduction.

 12 Paragraph 8ZGA(3)(d)

Repeal the paragraph, substitute:

 d

the disposal, by either of the following means, of any other reproduction of the data in the control of a Departmental employee:

 i

returning the reproduction to a person who is the occupier of the premises at that time;

 ii

destroying the reproduction.

 13 Application provisions 1

(1) The definition of relevant offence under section 3A of the Human Services (Medicare) Act 1973, as inserted by this Part, applies in relation to conduct that:

 a

constitutes or may constitute an offence; and

 b

occurs before, on or after the commencement of this Part.

 2

(2) Paragraphs 8ZG(3)(d) and 8ZGA(3)(d) of the Human Services (Medicare) Act 1973, as inserted by this Part, apply in relation to a reproduction of data if:

 a

the reproduction is created as a result of entry to premises under a warrant issued under that Act; and

 b

the warrant is issued on or after the commencement of this Part.

National Health Act 1953

 14 Subsection 90A(5)

Repeal the subsection.

 15 Subsection 90B(4)

Repeal the subsection.

 16 Subsection 90B(5)

Omit “If the Minister decides to consider a request under subsection (1), the Minister must, within three months after making that decision”, substitute “The Minister must, within 4 months after the day a request is received under subsection (1)”.

 17 Subsection 90B(6)

Repeal the subsection, substitute:

 6

The Secretary must, by notice in writing, advise the pharmacist of the decision made, or taken to have been made, by the Minister under subsection (5).

 18 Before subsection 90C(1)

Insert:

Proceedings before the Administrative Review Tribunal or a federal court

 19 Subsection 90C(2)

Omit “subsection 90B(4) or (if applicable)”.

 20 At the end of section 90C

Add:

Previous requests in relation to premises

 3

(3) If a pharmacist makes a request (the previous request) under subsection 90B(1) in relation to a decision of the Secretary under section 90 rejecting the pharmacist’s application to supply pharmaceutical benefits at particular premises, the pharmacist must not make a further request under subsection 90B(1), in relation to the premises, unless at least 12 months have passed since the day the previous request was made.

 21 Subsection 90D(1)

Omit “to consider a request made by a pharmacist under subsection 90B(1) or whether to exercise the power under subsection 90A(2) in relation to such a request”, substitute “to exercise the power under subsection 90A(2) in relation to a request made by a pharmacist under subsection 90B(1)”.

 22 Paragraph 105AE(1)(c)

Repeal the paragraph, substitute:

 c

the Minister decides, or is taken to have decided, not to exercise the Minister’s power under subsection 90A(2) in respect of the Secretary’s decision.

 23 Application provision 1

(1) The amendments of the National Health Act 1953 made by this Part apply in relation to requests made by a pharmacist under section 90B(1) of that Act on or after the commencement of this item (subject to subitem (2)).

 2

(2) Subsection 90C(3) of the National Health Act 1953 applies where the previous request referred to in that subsection is made on or after the commencement of this item.

National Health Act 1953

 24 Paragraph 6(1)(ab)

Omit “sections 90A and 90B”, substitute “section 90A and subsection 90B(5)”.

 25 Subsection 99N(5)

Omit “2”, substitute “3”.

 26 Application provision

The amendment of National Health Act 1953 made by this Part applies in relation to an appointment that is:section 99N of the

Note: For reappointment, see Acts Interpretation Act 1901.section 33AA of the

a

made on or after the commencement of this item; or

 b

in force immediately before the commencement of this item.

 Therapeutic goods amendments

Therapeutic Goods Act 1989

 1 Chapter 2A (heading)

After “therapeutic goods”, insert “or vaping goods”.

 2 Section 9J

After “therapeutic goods” (wherever occurring), insert “or vaping goods”.

 3 Section 9K (heading)

After “therapeutic goods”, insert “or vaping goods”.

 4 Subsection 9K(1) (heading)

After “therapeutic goods”, insert “or vaping goods”.

 5 Subsection 9K(1)

After “therapeutic goods” (wherever occurring), insert “or vaping goods”.

 6 Subsection 9K(3) (heading)

After “therapeutic goods”, insert “or vaping goods”.

 7 Subsection 9K(3)

After “therapeutic goods” (wherever occurring), insert “or vaping goods”.

 8 Paragraphs 9L(1)(a) and (2)(a)

After “therapeutic goods” (wherever occurring), insert “or vaping goods”.

 9 Subparagraph 41QB(6)(b)(ii)

After “determination by the Secretary”, insert “under the regulations”.

 10 Subparagraph 41QB(6)(b)(ii)

Omit “because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods”.

 11 Subparagraph 41QB(9)(b)(ii)

After “determination by the Secretary”, insert “under the regulations”.

 12 Subparagraph 41QB(9)(b)(ii)

Omit “because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods”.

 13 Subparagraph 41QC(13)(b)(ii)

After “determination by the Secretary”, insert “under the regulations”.

 14 Subparagraph 41QC(13)(b)(ii)

Omit “because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods”.

 15 Subparagraph 41QD(7)(b)(ii)

After “determination by the Secretary”, insert “under the regulations”.

 16 Subparagraph 41QD(7)(b)(ii)

Omit “because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods”.

 17 At the end of subsection 41RB(2)

Add “and be accompanied by the fee (if any) prescribed by the regulations”.

 18 After paragraph 41RC(1)(a)

Insert:

 aa

the application is accompanied by the fee (if any) prescribed by the regulations for the purposes of subsection 41RB(2); and

 19 Section 42AD (heading)

After “advertisements”, insert “or generic information”.

 20 At the end of subsection 42AD(1)

Add:

Note: Part 5-1A deals with advertisements about vaping goods.

 21 Subsection 42AD(2)

Repeal the subsection, substitute:

Note: Part 5-1A deals with generic information in relation to vaping goods.

generic information, in relation to vaping goods, has the same meaning as in Part 5-1A.

 2

This Part does not apply in relation to generic information in relation to vaping goods.

 3

In this section:

 22 Subsection 42DZK(2)

Omit “If, in”, substitute “In”.

 23 Subsection 42DZK(2)

Omit “the Secretary is satisfied that there has been a contravention of this Act or the regulations,”.

 24 Subsection 42DZK(2)

After “do one or more of the following”, insert “if the Secretary is satisfied that it is in the interests of public health or safety to give the person the direction”.

 25 Subsections 52G(1) and (2)

After “therapeutic goods”, insert “or vaping goods”.

 26 After paragraph 52G(3)(o)

Insert:

 oa

an instrument under section 41R;

 ob

a consent under section 41RC;

 27 Application provisions 1

The amendments made by items 10 and 12 apply in relation to the supply of vaping goods on or after the commencement of this item.

 2

The amendments made by items 14 and 16 apply in relation to the possession of a quantity of a kind of vaping goods on or after the commencement of this item.

 3

(3) The amendments of sections 41RB and 41RC of the Therapeutic Goods Act 1989 made by this Part apply in relation to an application made on or after the commencement of this item.

 4

(4) The amendments of Therapeutic Goods Act 1989 made by this Part apply in relation to the dissemination of generic information on or after the commencement of this item.section 42DZK of the

Therapeutic Goods Act 1989

 28 Section 45A

Insert:

person assisting, in relation to an authorised person: see subsection 48AAA(2).

 29 After section 48

Insert:

 48AAA Persons assisting authorised persons

Authorised persons may be assisted by other persons

Powers, functions and duties of a person assisting

 1

An authorised person may be assisted by other persons in exercising powers or performing functions or duties under this Part, if that assistance is necessary and reasonable.

 2

(2) A person providing such assistance is a person assisting an authorised person.

 3

A person assisting an authorised person:

 a

may enter premises; and

 b

may exercise the powers and perform the functions or duties that an authorised person may exercise or perform under this Part; and

 c

must do so only in accordance with a direction given to the person assisting by the authorised person.

 4

A power exercised by a person assisting an authorised person as mentioned in subsection (3) is taken for all purposes to have been exercised by the authorised person.

 5

A function or duty performed by a person assisting an authorised person as mentioned in subsection (3) is taken for all purposes to have been performed by the authorised person.

 6

If a direction is given under paragraph (3)(c) in writing, the direction is not a legislative instrument.

 30 Subsection 48AA(1)

Omit “an authorised person who is”, substitute “all authorised persons, and all persons assisting the authorised persons, who are”.

 31 Subsection 48AA(1)

Omit “ceases its execution and leaves”, substitute “cease its execution and leave”.

 32 Subsection 48AA(2)

Omit “The authorised person”, substitute “One or more of the authorised persons, and the persons assisting the authorised persons,”.

 33 Paragraph 48AA(2)(b)

Omit “the authorised person is”, substitute “the authorised persons, and the persons assisting the authorised persons, are”.

 34 Subsection 48AA(3)

After “An authorised person”, insert “, or a person assisting the authorised person,”.

 35 Paragraph 48AA(3)(b)

After “the authorised person” (wherever occurring), insert “or person assisting the authorised person”.

 36 Subsection 48AA(4)

After “the authorised person”, insert “or person assisting the authorised person”.

 37 Subsection 48FA(1)

Omit all the words after “represents the occupier,”, substitute:

must provide:

with all reasonable facilities and assistance for the effective exercise of the powers of both the authorised person and the person assisting the authorised person.

 a

an authorised person executing the warrant; and

 b

any person assisting the authorised person;

 38 Application provisions 1

(1) Section 48AAA of the Therapeutic Goods Act 1989, as inserted by this Part, applies in relation to an entry to premises:

 a

if the entry is under a warrant—under a warrant that is issued or signed on or after the commencement of this Part; and

 b

otherwise—on or after the commencement of this Part.

 2

(2) The amendments of sections 48AA and 48FA of the Therapeutic Goods Act 1989 made by this Part apply in relation to a warrant that is issued or signed on or after the commencement of this Part.

Therapeutic Goods Act 1989

 39 Section 52AAA (heading)

Omit “under search warrant”.

 40 Paragraph 52AAA(1)(a)

Omit “a warrant issued under section 50”, substitute “Part 6-2”.

 41 Paragraph 52AAA(3)(b)

Repeal the paragraph, substitute:

 b

the provision of Part 6-2 under which the thing was seized and the grounds on which the thing was seized;

 42 Subsection 54(5) (note)

Omit “under a warrant”.

 43 Subsection 57(1A)

Omit “under search warrant”.

 44 Application provision

The amendments of Therapeutic Goods Act 1989 made by this Part apply in relation to a thing seized on or after the day on which this item commences.section 52AAA of the

Therapeutic Goods Act 1989

 45 Section 42YS

Omit:

substitute:

 b

it is necessary to exercise powers under this Part to protect the health and safety of humans;

 b

it is in the interests of public health or safety to give the person directions under this Part;

 46 Paragraph 42YT(1)(b)

Repeal the paragraph, substitute:

 b

it is in the interests of public health or safety to give the person directions under this section.

 47 Subsection 42YT(1) (note)

Repeal the note.

 48 Paragraphs 42YT(2)(a) and (b)

Omit “in compliance with this Act or the instrument”.

 49 After subsection 42YT(2)

Insert:

 2A

A notice given under subsection (2) must set out the Secretary’s reasons for giving the notice.

 50 Application provision

The amendments of Therapeutic Goods Act 1989 made by this Part apply in relation to directions given under that section on or after the day on which this item commences.section 42YT of the

Therapeutic Goods Act 1989

 51 Subsection 57(1A)

After “(enforcement),”, insert “section 45AB (Secretary may require information or documents), section 45AF (Secretary may inspect and copy documents), section 45AG (Secretary may retain documents),”.

Therapeutic Goods Act 1989

 52 Paragraph 19A(1)(a)

Repeal the paragraph, substitute:

 a

registered goods that could act as a substitute for the goods:

 i

are unavailable or are in short supply; or

 ii

may, in the reasonably foreseeable future, become unavailable or be in short supply; and

 53 Paragraph 19A(1A)(a)

Repeal the paragraph, substitute:

 a

registered goods that could act as a substitute for the goods:

 i

are unavailable or are in short supply; or

 ii

may, in the reasonably foreseeable future, become unavailable or be in short supply; and

 54 Paragraph 32CO(1)(c)

Repeal the paragraph, substitute:

 c

therapeutic goods included in the Register that could act as a substitute for the biological:

 i

are unavailable or are in short supply; or

 ii

may, in the reasonably foreseeable future, become unavailable or be in short supply; and

 55 Paragraph 32CO(1A)(c)

Repeal the paragraph, substitute:

 c

therapeutic goods included in the Register that could act as a substitute for the biological:

 i

are unavailable or are in short supply; or

 ii

may, in the reasonably foreseeable future, become unavailable or be in short supply; and

 56 Section 41H

Omit:

substitute:

 d

medical devices exempted if substitutes are unavailable or in short supply.

 d

medical devices exempted if substitutes are unavailable or in short supply or may, in the reasonably foreseeable future, become unavailable or be in short supply.

 57 Section 41HD (heading)

Omit “or in short supply”, substitute “etc.”.

 58 Paragraph 41HD(1)(c)

Repeal the paragraph, substitute:

 c

the kinds of medical devices included in the Register that could act as a substitute for the medical device:

 i

are unavailable or are in short supply; or

 ii

may, in the reasonably foreseeable future, become unavailable or be in short supply; and

 59 Paragraph 41HD(1A)(c)

Repeal the paragraph, substitute:

Therapeutic Goods Act 1989

 c

the kinds of medical devices included in the Register that could act as a substitute for the medical device:

 i

are unavailable or are in short supply; or

 ii

may, in the reasonably foreseeable future, become unavailable or be in short supply; and

 60 At the end of subsection 32CA(3)

Add:

Note: There are criminal offences and a civil penalty related to the breach of a condition of an exemption: see sections 32CP and 32CQ.

 61 Subsection 32CA(4)

Repeal the subsection.

 62 Section 32CC (note 1)

Omit “32CH and 32CI”, substitute “32CP and 32CQ”.

 63 Sections 32CH and 32CI

Repeal the sections.

 64 At the end of subsections 32CK(6) and (8)

Add:

Note: There are criminal offences and a civil penalty related to the breach of a condition of an approval: see sections 32CP and 32CQ.

 65 Subsection 32CK(9)

Repeal the subsection.

 66 Subsection 32CL(1)

Omit “(1) The”, substitute “The”.

 67 At end of subsection 32CL(1)

Add:

Note: There are criminal offences and a civil penalty related to the breach of a condition applicable under regulations made for the purposes of this section: see sections 32CP and 32CQ.

 68 Subsection 32CL(2)

Repeal the subsection.

 69 At the end of subsections 32CM(2) and (3)

Add:

Note: There are criminal offences and a civil penalty related to the breach of a condition of an authority: see sections 32CP and 32CQ.

 70 Paragraph 32CN(1)(c)

Omit “any”, substitute “either”.

 71 Subparagraphs 32CN(1)(c)(ii) and (e)(ii)

Repeal the subparagraphs.

 72 Paragraph 32CN(4)(c)

Omit “any”, substitute “either”.

 73 Subparagraph 32CN(4)(c)(ii)

Repeal the subparagraph.

 74 Paragraph 32CN(4A)(c)

Omit “any”, substitute “either”.

 75 Subparagraph 32CN(4A)(c)(ii)

Repeal the subparagraph.

 76 At the end of subsection 32CO(7)

Add:

Note: There are criminal offences and a civil penalty related to the breach of a condition of an approval under subsection (1), (1A) or (2): see sections 32CP and 32CQ.

 77 Subsection 32CO(8)

Repeal the subsection.

 78 At the end of Division 3 of Part 3-2A

Add:

Subdivision F—Offences and civil penalties relating to breaching conditions of exemptions, approvals or authorities

 32CP Offences for breaching a condition of an exemption, approval or authority 1

A person commits an offence if:

 a

the person does an act or omits to do an act; and

 b

the act or omission breaches:

 i

a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or

 ii

a condition of an exemption under section 32CB; or

 iii

a condition of an approval under section 32CK; or

 iv

a condition applicable under regulations made for the purposes of section 32CL; or

 v

a condition of an authority under section 32CM; or

 vi

a condition of an approval under subsection 32CO(1), (1A) or (2); and

 c

the act or omission:

 i

except for a breach of a condition referred to in subparagraph (b)(ii)—has resulted in, will result in, or is likely to result in harm or injury to any person; or

 ii

for a breach of a condition referred to in subparagraph (b)(ii)—has caused, will cause, or is likely to cause a serious risk to public health.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (2) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

Penalty: 100 penalty units.

 2

A person commits an offence if:

 a

the person does an act or omits to do an act; and

 b

the act or omission breaches:

 i

a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or

 ii

a condition of an exemption under section 32CB; or

 iii

a condition of an approval under section 32CK; or

 iv

a condition applicable under regulations made for the purposes of section 32CL; or

 v

a condition of an authority under section 32CM; or

 vi

a condition of an approval under subsection 32CO(1), (1A) or (2).

 3

A person commits an offence of strict liability if:

 a

the person does an act or omits to do an act; and

 b

the act or omission breaches:

 i

a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or

 ii

a condition of an exemption under section 32CB; or

 iii

a condition of an approval under section 32CK; or

 iv

a condition applicable under regulations made for the purposes of section 32CL; or

 v

a condition of an authority under section 32CM; or

 vi

a condition of an approval under subsection 32CO(1), (1A) or (2).

 32CQ Civil penalty for breaching a condition of an exemption, approval or authority

A person contravenes this section if:

Maximum civil penalty:

 a

the person does an act or omits to do an act; and

 b

the act or omission breaches:

 i

a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or

 ii

a condition of an exemption under section 32CB; or

 iii

a condition of an approval under section 32CK; or

 iv

a condition applicable under regulations made for the purposes of section 32CL; or

 v

a condition of an authority under section 32CM; or

 vi

a condition of an approval under subsection 32CO(1), (1A) or (2).

 a

for an individual—5,000 penalty units; and

 b

for a body corporate—50,000 penalty units.

 79 Section 53A (after table item 13FA)

Insert:

 80 Section 54BA (table item 18)

Omit “Subsection 32CH(1)”, substitute “Subsection 32CP(1)”.

 81 Application and transitional provisions 1

(1) The amendments of the Therapeutic Goods Act 1989 made by this Part apply in relation to acts or omissions that occur on or after the commencement of this Part.

 2

(2) Regulations made for the purposes of subsection 32CL(1) of the Therapeutic Goods Act 1989 that are in force immediately before the commencement of this item are taken, on and after that commencement, to have been made for the purposes of section 32CL of that Act.

Therapeutic Goods Act 1989

 82 Subsection 7(2)

Repeal the subsection.

 83 Subsection 60(1) (paragraph (a) of the definition of initial decision)

Repeal the paragraph.

 84 Transitional—applications for declaration that goods are or are not therapeutic goods 1

If:

 a

(a) an application had been made under subsection 7(2) of the Therapeutic Goods Act 1989 before the commencement of this item (the commencement time); and

 b

no decision on the application had been made on the application before the commencement time;

the Secretary must make a decision on the application, and notify the applicant of the decision, in writing, as soon as practicable after the commencement time.

Therapeutic Goods Act 1989

 2

(2) Despite the repeal of paragraph (a) of the definition of initial decision in subsection 60(1) of the Therapeutic Goods Act 1989 by this Part, section 60 of that Act continues to apply, as if that repeal had not happened, in relation to:

 a

an initial decision referred to in that paragraph that was made before the commencement time; and

 b

a decision made under subitem (1) of this item after the commencement time.

 85 Subsection 3(3)

Repeal the subsection.

 86 At the end of section 14

Add:

 16

The Secretary is not required to consider giving an applicant a consent unless the applicant has paid the fee that is prescribed by the regulations for the processing of the applicant’s application for a consent.

 87 At the end of section 14A

Add:

 6

The Secretary is not required to consider giving an applicant a consent unless the applicant has paid the fee that is prescribed by the regulations for the processing of the applicant’s application for a consent.

 88 Subsection 19(8)

After “paragraph (1)(a)”, insert “, or an authority under subsection (5),”.

 89 Paragraph 30(1)(b)

Omit “become”, substitute “are”.

 90 At the end of section 32BF

Add:

 10

The Secretary is not required to consider giving an applicant a consent mentioned in subsection (6) unless the applicant has paid the fee (if any) that is prescribed by the regulations for the processing of the applicant’s application for such a consent.

 91 After section 41MAA

Insert:

 41MAB Giving of consent by Secretary

The Secretary is not required to consider giving a consent mentioned in section 41MA or 41MAA to a person unless the person has paid the fee that is prescribed by the regulations for the person’s application for such a consent.

 92 At the end of section 61

Add:

 16

To avoid doubt, this section does not limit any other lawful release, disclosure or use of information held by the Department (including information that has been, or may be, released, disclosed or used under this section).

 93 Subsection 63(4)

Repeal the subsection, substitute:

 4

(4) Despite subsection 14(2) of the Legislation Act 2003, the regulations may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.

 94 Application and saving provisions 1

(1) The amendments of sections 14, 14A and 32BF of the Therapeutic Goods Act 1989, and the insertion of section 41MAB of that Act, made by this Part apply in relation to an application made on or after the commencement of this item.

 2

(2) The amendment of Therapeutic Goods Act 1989 made by this Part does not affect the validity of regulations in force under that Act immediately before the commencement of this item.section 63 of the

Public health tobacco amendments

Public Health (Tobacco and Other Products) Act 2023

 1 Section 18

Omit “A person who contravenes these prohibitions may commit an offence or be liable for a civil penalty.”, substitute “A person who contravenes these prohibitions may commit an offence or be liable for a civil penalty. The Therapeutic Goods Act also contains advertising offences and civil penalties in relation to therapeutic goods and vaping goods.”.

 2 Section 47

Repeal the section.

 3 Sections 53 to 55

Repeal the sections, substitute:

 53 Exception—exempt advertisements under the Therapeutic Goods Act 1

An advertisement for an e-cigarette product does not constitute an e-cigarette advertisement if:

 a

the e-cigarette product is a vaping good within the meaning of the Therapeutic Goods Act; and

 b

Part 5-1A of that Act (about regulation of advertising etc. for vaping goods) does not apply to the advertisement because of section 42DZA of that Act.

 2

An advertisement for an e-cigarette product does not constitute an e-cigarette advertisement to the extent that:

 a

the e-cigarette product is a vaping good within the meaning of the Therapeutic Goods Act; and

 b

an authorisation under section 42DZC of that Act is in force in relation to the advertising of that vaping good; and

 c

the advertisement complies with any conditions specified in the authorisation.

 4 Sections 57 to 59

Repeal the sections.

 5 Application provision

The amendments made by this Part apply in relation to the publishing of material on or after the day on which this item commences.

Public Health (Tobacco and Other Products) Act 2023

 6 Subsection 39(1)

Omit “individual”, substitute “person”.

 7 Subsection 66(1)

Omit “individual”, substitute “person”.

 8 Application provision

The amendments made by this Part apply in relation to a contribution (whether financial or otherwise) made on or after the day on which this item commences.

Public Health (Tobacco and Other Products) Act 2023

 9 Section 8

Insert:

conduct rule means subsection (1) of each of the following provisions:

 a

sections 94 to 100;

 b

sections 102 to 105;

 c

sections 108 to 114;

 d

sections 116 to 119.

 10 At the end of section 78

Add:

 4

Subsection (3) has effect subject to subsection 120A(2).

 11 At the end of section 82

Add:

 5

Subsection (4) has effect subject to subsection 120B(2).

 12 At the end of section 86

Add:

 7

Subsection (6) has effect subject to subsections 120C(2) and 120D(2).

 13 Subsection 120(1)

Repeal the subsection, substitute:

 1

This section applies in relation to each conduct rule.

 14 After Division 1 of Part 3.6

Insert:

 120A Phasing-in and phasing-out of health warnings 1

If:

 a

(a) provisions (the existing provisions) of regulations prescribing images or a combination of images (if any) are in force for the purposes of subsection 78(1); and

 b

(b) later regulations are made that contain provisions (the new provisions) amending the existing provisions;

then the later regulations may contain provisions (the phasing-in provisions) that provide that a prescribed conduct rule, to the extent that it relates to subsection 78(1), does not apply to prescribed conduct engaged in:

Note: Subsection 78(3) applies to the new provisions of the later regulations.

Note: For example, the later regulations may contain application provisions relating to the phasing out of the current health warnings on the retail packaging of tobacco products.

 c

by persons in relation to a tobacco product if the retail packaging of that product displays the images or combination of images (if any) that will be prescribed for the purposes of subsection 78(1) on the day on which the new provisions commence; and

 d

during one or more prescribed periods.

 2

Subsection 78(3) does not apply to the phasing-in provisions of the later regulations.

 3

This section does not limit the application, saving or transitional provisions that may be made by the later regulations in relation to the new provisions.

 120B Phasing-in and phasing-out of health promotion inserts 1

If:

 a

(a) provisions (the existing provisions) of regulations prescribing health promotion inserts are in force for the purposes of paragraph 82(1)(a); and

 b

(b) later regulations are made that contain provisions (the new provisions) amending the existing provisions;

then the later regulations may contain provisions (the phasing-in provisions) that provide that a prescribed conduct rule, to the extent that it relates to paragraph 82(1)(a) and health promotion inserts, does not apply to prescribed conduct engaged in:

Note: Subsection 82(4) applies to the new provisions of the later regulations.

Note: For example, the later regulations may contain application provisions relating to the phasing out of the current health promotion inserts on the retail packaging of tobacco products.

 c

by persons in relation to a tobacco product if the retail packaging, referred to in subsection 82(1), of that product includes the health promotion inserts that will be prescribed for the purposes of paragraph 82(1)(a) on the day on which the new provisions commence; and

 d

during one or more prescribed periods.

 2

Subsection 82(4) does not apply to the phasing-in provisions of the later regulations.

 3

This section does not limit the application, saving or transitional provisions that may be made by the later regulations in relation to the new provisions.

 120C Phasing-in and phasing-out of appearance requirements 1

If:

 a

(a) provisions (the existing provisions) of regulations prescribing an image or text are in force for the purposes of subsection 86(3); and

 b

(b) later regulations are made that contain provisions (the new provisions) amending the existing provisions;

then the later regulations may contain provisions (the phasing-in provisions) that provide that a prescribed conduct rule, to the extent that it relates to subsection 86(3) and images or text, does not apply to prescribed conduct engaged in:

Note: Subsection 86(6) applies to the new provisions of the later regulations.

Note: For example, the later regulations may contain application provisions relating to the phasing out of the current appearance requirements of a tobacco product.

 c

by persons in relation to a tobacco product if the appearance of that product complies with the requirements, relating to images or text, that will be prescribed for the purposes of subsection 86(3) on the day on which the new provisions commence; and

 d

during one or more prescribed periods.

 2

Subsection 86(6) does not apply to the phasing-in provisions of the later regulations.

 3

This section does not limit the application, saving or transitional provisions that may be made by the later regulations in relation to the new provisions.

 120D Phasing-in and phasing-out of physical features requirements 1

If:

 a

(a) provisions (the existing provisions) of regulations prescribing an image or text are in force for the purposes of subsection 86(4); and

 b

(b) later regulations are made that contain provisions (the new provisions) amending the existing provisions;

then the later regulations may contain provisions (the phasing-in provisions) that provide that a prescribed conduct rule, to the extent that it relates to subsection 86(4) and images or text, does not apply to prescribed conduct engaged in:

Note: Subsection 86(6) applies to the new provisions of the later regulations.

Note: For example, the later regulations may contain application provisions relating to the phasing out of the current physical features requirements of a tobacco product.

Public Health (Tobacco and Other Products) Act 2023

 c

by persons in relation to a tobacco product if the physical features of that product comply with the requirements, relating to images or text, that will be prescribed for the purposes of subsection 86(4) on the day on which the new provisions commence; and

 d

during one or more prescribed periods.

 2

Subsection 86(6) does not apply to the phasing-in provisions of the later regulations.

 3

This section does not limit the application, saving or transitional provisions that may be made by the later regulations in relation to the new provisions.

 15 Paragraph 150(1)(a)

Omit “in the Department”.

 Additional amendments to improve medicare integrity

Health Insurance Act 1973

 1 After section 129AAC

Insert:

 129AACA Notice to give information etc. relevant to Act administration

Chief Executive Medicare may require person to give information etc.

Content of notice

Period to comply with notice

Section not limited

that relates to powers to require information, a document or a thing to be given.

Meaning of relevant material

 1

If the Chief Executive Medicare reasonably suspects that a person has relevant material, the Chief Executive Medicare may, by notice in writing, require the person to give the relevant material:

 a

if the relevant material contains clinical details relating to an individual—to a specified APS employee in the Department who is a medical practitioner; or

 b

otherwise—to a specified APS employee in the Department.

 2

The notice must:

 a

specify all of the following:

 i

the relevant material;

 ii

the grounds on which the Chief Executive Medicare suspects that the person has the relevant material;

 iii

how the relevant material is to be given;

 iv

each person to whom the relevant material is to be given;

 v

the contact details of an APS employee in the Department who may be contacted in relation to the notice;

 vi

the period within which the person is required to give the relevant material; and

 b

contain a statement about the effect of section 129AACB (consequences of failure to give information etc. relevant to Act administration).

 3

The period specified for the purposes of subparagraph (2)(a)(vi) must be a period ending at least 21 days after the day on which the notice is given.

 4

The Chief Executive Medicare may, in writing, extend the period within which the person is required to give the relevant material. The Chief Executive Medicare may do so before or after the end of the period.

 5

This section is not limited by:

 a

any other provision of this Act; or

 b

(b) any provision of the Human Services (Medicare) Act 1973 or any other Act;

 6

(6) In this section, relevant material means information, a document or a thing that is relevant to the administration of this Act and includes information, a document or a thing that relates to:

 a

compliance with a requirement under this Act or an instrument made under this Act; or

 b

an amount paid under this Act; or

 c

a person’s entitlement to a benefit or payment under this Act.

 129AACB Consequences of failure to give information etc. relevant to Act administration 1

A person contravenes this subsection if:

 a

the person is given a notice under subsection 129AACA(1) requiring the person to give information, a document or a thing; and

 b

the person fails to comply with the requirement within:

 i

if the Chief Executive Medicare has, under subsection 129AACA(4), extended the period specified in the notice—the extended period; or

 ii

otherwise—the period specified in the notice.

Strict liability offence

Penalty: 30 penalty units.

Civil penalty

Civil penalty:

Note: A person who wishes to rely on this subsection in proceedings for a civil penalty order bears an evidential burden in relation to the matter in this subsection (see section 130H).

 2

A person commits an offence of strict liability if the person contravenes subsection (1).

 3

A person is liable for a civil penalty if the person contravenes subsection (1).

 a

for an individual—30 penalty units; and

 b

for a body corporate—150 penalty units.

 4

Subsection (3) does not apply if:

 a

the contravention is brought about by:

 i

another person over whom the defendant has no control; or

 ii

a non‑human act or event over which the defendant has no control; and

 b

the defendant could not reasonably be expected to guard against the contravention.

 2 Section 129AAD (heading)

Repeal the heading, substitute:

 129AAD Notice to produce documents relating to professional services

Health Insurance Act 1973

 3 Subsection 129AAI(1)

After “or (8)”, insert “, 129AAK(1)”.

 4 Subsection 129AAJ(3)

Omit “28”, substitute “45”.

 5 Subsection 129AAJ(4)

After “must”, insert “, unless the application has been withdrawn by the applicant”.

 6 After section 129AAJ

Insert:

 129AAK Recovery of amounts—overpayments in general

Amounts recoverable under this subsection

From whom the amount may be recovered

Note: For the purposes of paragraph (c), an example of an amount not in fact payable in respect of a professional service is a medical benefit that, in accordance with section 19AA, is not payable because the service was rendered by a medical practitioner who did not meet the requirements under that section.

Recovery does not preclude other enforcement actions

 1

An amount is recoverable under this subsection, as a debt due to the Commonwealth, if:

 a

the amount was paid purportedly under this Act in respect of a professional service to a person who was not entitled to be paid the amount under this Act in respect of that professional service; or

 b

the amount was paid purportedly by way of benefit or payment under this Act to a person who was not entitled to be paid the amount under this Act by way of that benefit or payment; or

 c

the amount was paid purportedly by way of benefit or payment under this Act, and the benefit or the right to the payment was assigned other than in accordance with section 20A.

 2

The amount may be recovered from:

 a

if subsection (3) applies to the amount—the person mentioned in paragraph (3)(b), or the estate of that person; or

 b

otherwise—the person to whom the amount was paid, or the estate of that person.

 3

This subsection applies to the amount if:

 a

the amount was paid, purportedly by way of benefit or payment under this Act, in respect of a professional service; and

 b

a person:

 i

rendered or purportedly rendered the service; or

 ii

is identified, in a claim for benefit or payment under this Act, as having rendered the service; and

 c

the amount was not in fact payable in respect of the service because:

 i

at the time the service was rendered or purportedly rendered, the person, the service, or the rendering or purported rendering of the service, did not meet a requirement under this Act or an instrument made under this Act; or

 ii

the person, the service, or the rendering or purported rendering of the service, breached a contract between the person and the Commonwealth; or

 iii

the service was rendered or purportedly rendered by a person who was, at the time, partly or fully disqualified under this Act or an instrument or agreement made under this Act.

 4

The recovery, by the Commonwealth, of an amount recoverable under subsection (1) does not preclude any other action being taken under this Act or any other Act in relation to any non-compliance with a requirement under this Act, or an instrument made under this Act, that resulted in the amount being recoverable under subsection (1).

 7 Section 129AC (heading)

Repeal the heading, substitute:

 129AC Recovery of amounts—false or misleading information, failure to produce document etc. 8 Subsection 129AED(3)

After “section”, insert “129AAK or”.

 9 After paragraph 129AEF(1)(a)

Insert:

 aaaa

an amount under subsection 129AAK(1) where any rights of review by the CEO under section 129AAJ have been exhausted or have expired;

 10 Subsection 129AEG(1)

After “(a),”, insert “(aaaa),”.

Health Insurance Act 1973

 11 At the end of subsection 106ZPQ(1)

Add:

Note: Under subsections 89B(2) and 105A(2), a person may be required to produce documents relevant to the Director’s review of the provision of services by a person, and documents relevant to the referral made to the Committee.

 12 Before subsection 106ZPQ(2)

Insert:

Use and derivative use immunity

 13 Subsection 106ZPQ(2)

Omit all the words after “evidence against”, substitute:

the person in any criminal or civil proceedings (including proceedings for the purposes of the National Law) other than the following:

Note: For the purposes of subparagraph (c)(ii), an example of an amount required by or under this Part to be repaid to the Commonwealth is an amount that is to be repaid to the Commonwealth in accordance with a final determination under section 106TA.

 a

proceedings for an offence against subsection 106ZPN(1) (failing to produce documents or give information) or section 106ZPP (false or misleading documents);

 b

proceedings before a Committee or the Determining Authority;

 c

proceedings to recover an amount that is:

 i

recoverable under this Part as a debt due to the Commonwealth; or

 ii

otherwise required by or under this Part to be repaid to the Commonwealth;

 d

any other proceedings in relation to compliance with a requirement under this Part.

 14 At the end of section 106ZPQ

Add:

Admissibility of information passed on under certain provisions

Admissibility of certain derivative materials

 3

Subsection (2) does not prevent information, a document or other thing being admitted in evidence in proceedings against the person if:

 a

the information, document or other thing is obtained by:

 i

an appropriate person or body for the person (within the meaning of subsection 106XA(4)); or

 ii

the appropriate body, or one of the appropriate bodies, referred to in subsection 106XB(3) in relation to the person; and

 b

the information, document or other thing is obtained under subsection 106XA(2) or (3) or subsection 106XB(2); and

 c

the proceedings are for the purposes of the National Law.

 4

Subsection (2) does not prevent information, a document or other thing being admitted in evidence in proceedings against the person if the information, document or other thing:

 a

is not a document produced under subsection 89B(2) or 105A(2); but

 b

is, as a result of the production of a document under subsection 89B(2) or 105A(2), created or obtained by:

 i

an appropriate person or body for the person (within the meaning of subsection 106XA(4)); or

 ii

the appropriate body, or one of the appropriate bodies, referred to in subsection 106XB(3) in relation to the person.

 15 Application provision

The amendments made by this Part to section 106ZPQ of the Health Insurance Act 1973 apply in relation to the admission of the following in any criminal or civil proceedings instituted on or after the commencement of this Part:

 a

a document produced before, on or after that commencement under subsection 89B(2) or 105A(2) of that Act;

 b

information, a document or other thing created or obtained before, on or after that commencement as a result of the production of a document before, on or after that commencement under subsection 89B(2) or 105A(2) of that Act.

 16 Transitional rules 1

The Minister may, by legislative instrument, make rules prescribing matters of a transitional nature (including prescribing any saving or application provisions) relating to the amendments or repeals made by this Schedule.

 2

To avoid doubt, the rules may not do the following:

 a

create an offence or civil penalty;

 b

provide powers of:

 i

arrest or detention; or

 ii

entry, search or seizure;

 c

impose a tax;

 d

(d) set an amount to be appropriated from the Consolidated Revenue Fund under an appropriation in this Act or the Health Insurance Act 1973;

 e

(e) directly amend the text of this Act or the Health Insurance Act 1973.

 3

This Schedule (other than subitem (2)) does not limit the rules that may be made for the purposes of subitem (1).

[Minister’s second reading speech made in—

Senate on 23 July 2025

House of Representatives on 25 August 2025]

(36/25)